An audit of indications and complications associated with elective hysterectomy at a public service hospital in South Africa spasms stomach pain carbamazepine 100mg. Non-Malignant Sequelae of Unconfined Morcellation at Laparoscopic Hysterectomy or Myomectomy muscle relaxant herbs buy generic carbamazepine 200 mg online. Immunohistochemical Profile of Uterine Leiomyoma With Bizarre Nuclei; Comparison With Conventional Leiomyoma spasms everywhere order 400mg carbamazepine fast delivery, Smooth Muscle Tumors of Uncertain Malignant Potential and Leiomyosarcoma spasms when urinating order 100 mg carbamazepine amex. Effectiveness of right-left inversion of a transverse-section magnetic resonance image during laparoscopic pelvic surgery muscle relaxant tablets order carbamazepine 100 mg visa. Morcellation and myomas: Balancing decisions around minimally invasive treatments for fibroids muscle relaxant rotator cuff order carbamazepine 100 mg overnight delivery. Unplanned pregnancy after ultrasoundguided percutaneous microwave ablation of uterine fibroids: A follow-up study muscle relaxant end of life generic 400mg carbamazepine otc. Efficacy of Tranexamic Acid on Myomectomy-Associated Blood Loss in Patients With Multiple Myomas: A Randomized Controlled Clinical Trial muscle relaxant vitamin buy carbamazepine 100 mg line. Successful use of laparoscopic myomectomy to remove a giant uterine myoma: a case report. Risk, risk reduction and management of occult malignancy diagnosed after uterine morcellation: a commentary. Surgical Treatment of Uterine Fibroids Within a Containment System and Without Power Morcellation. Differences in clinical characteristics for the determination of adenomyosis coexisting with leiomyomas. Patterns of Chromosomal Abnormalities that Can Improve Diagnosis of Uterine Smooth Muscle Tumors. The Role of Hysteroscopic and Robot-assisted Laparoscopic Myomectomy in the Setting of Infertility. Assessment of carboprost tromethamine for reducing hemorrhage in laparoscopic intramural myomectomy. Case-Mix Variables and Predictors for Outcomes of Laparoscopic Hysterectomy: A Systematic Review. Reproductive Outcome of Infertile Patients with Fibroids Based on the Patient and Fibroid Characteristics; Optimal and Personalized Management. Use of vasopressin vs epinephrine to reduce haemorrhage during myomectomy: a randomized controlled trial. Accidental ultrasound finding of a big asymptomatic intestinal leiomyoma in an anticoagulated patient with macrohematuria. Comparison of bidirectional barbed suture Stratafix and conventional suture with intracorporeal knots in laparoscopic myomectomy by office transvaginal hydrolaparoscopic follow-up: a preliminary report. Cold loops applied to bipolar resectoscope: A safe "one-step" myomectomy for treatment of submucosal myomas with intramural development. Giant cervical myoma associated with urinary incontinence and hydroureteronephrosis. The association between ultrasound features of adenomyosis and severity of menstrual pain. Unexpected Leiomyosarcoma 4 Years after Laparoscopic Removal of the Uterus Using Morcellation. Combined robotically-assisted laparoscopic left hepatectomy and total hysterectomy of enlarged uterus. Electromagnetic image guidance in gynecology: prospective study of a new laparoscopic imaging and targeting technique for the treatment of symptomatic uterine fibroids. Robotic hysterectomy using the Vessel Sealer for myomatous uteri: technique and clinical outcome. Small bowel obstruction from barbed suture following laparoscopic myomectomy-A case report. Power Morcellator Features Affecting Tissue Spill in Gynecologic Laparoscopy: An In-Vitro Study. Medical Device Safety and Surgical Dissemination of Unrecognized Uterine Malignancy: Morcellation in Minimally Invasive Gynecologic Surgery. Myomectomy by Robotically Assisted Laparoscopic Surgery: Results at Foch Hospital, Paris. Preventive Uterine Artery Occlusion: Benefits of the Laparoscopic Posterior Approach. Do submucous myoma characteristics affect fertility and menstrual outcomes in patients underwent hysteroscopic myomectomy? Impact of Obesity on Surgical Treatment for Endometrial Cancer: A Multicenter Study Comparing Laparoscopy vs Open Surgery, with Propensity-Matched Analysis. Safely Increase the Minimally Invasive Hysterectomy Rate: A Novel Three-Tiered Preoperative Categorization System Can Predict the Difficulty for Benign Disease. Techniques to reduce blood loss during open myomectomy: a qualitative review of literature. Conservative therapy with a gonadotropin-releasing hormone agonist for a uterine arteriovenous malformation in a patient with congenital heart disease. Literature review of outcomes and prevalence and case report of leiomyosarcomas and non-typical uterine smooth muscle leiomyoma tumors treated with uterine artery embolization. Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy: Long-Term Follow-up From a Randomized Trial. Flexible Carbon Dioxide Laser Fiber Versus Ultrasonic Scalpel in Robot-Assisted Laparoscopic Myomectomy. Comparison of Surgical Outcomes according to Suturing Methods in Single Port Access Laparoscopic Myomectomy. Single-port access versus conventional multi-port access total laparoscopic hysterectomy for very large uterus. Role of 3D Ultrasound and Doppler in Differentiating Clinically Suspected Cases of Leiomyoma and Adenomyosis of Uterus. Pregnancy Outcomes and Risk Factors for Uterine Rupture After Laparoscopic Myomectomy: A Single-Center Experience and Literature Review. The management of uterine fibroids in women with otherwise unexplained infertility. Intrauterine synechiae after myomectomy; laparotomy versus laparoscopy: Nonrandomized interventional trial. Uterine smooth muscle tumor analysis by comparative genomic hybridization: a useful diagnostic tool in challenging lesions. Vaginal Morcellation Inside Protective Pouch: A Safe Strategy for Uterine Extration in Cases of Bulky Endometrial Cancers: Operative and Oncological Safety of the Method. Minilaparoscopic versus standard laparoscopic hysterectomy for uteri >/= 16 weeks of gestation: surgical outcomes, postoperative quality of life, and cosmesis. Laparoscopic hysterectomy in large uteri: Experience from a tertiary care hospital in Bangladesh. Controlled removal of a large uterus within a bowel bag and morcellation in the bowel bag from the vagina. Is Cold Loop Hysteroscopic Myomectomy a Safe and Effective Technique for the Treatment of Submucous Myomas With Intramural Development? Efficacy of laparoscopic adenomyomectomy using double-flap method for diffuse uterine adenomyosis. Analysis of clinical, biological and obstetric factors influencing the decision to perform cesarean myomectomy. Transvaginal sonographic features of diffuse adenomyosis in 18-30-year-old nulligravid women without endometriosis: association with symptoms. A systematic literature review on the effect of tumor morcellation and surgical techniques. Fertility and Pregnancy Outcome after Myoma Enucleation by Minilaparotomy under Microsurgical Conditions in Pronounced Uterus Myomatosus. Learning Curve Analysis and Surgical Outcomes of Single-port Laparoscopic Myomectomy. Presentation and treatment of uterine leiomyoma in adolescence: a systematic review. Effects of morcellation of uterine smooth muscle tumor of uncertain malignant potential and endometrial stromal sarcoma: case series and recommendations for clinical practice. Robotically assisted gynecologic surgery: 2year experience in the French foch hospital. A critical assessment of morcellation and its impact on gynecologic surgery and the limitations of the existing literature. Clinical and histopathologic predictors of reoperation due to recurrence of leiomyoma after laparotomic myomectomy. The incidence of complications by hysterectomy for benign disease in correlation to an assumed preoperative score. Is vaginal hysterectomy is equally safe for the enlarged and normally sized nonprolapse uterus? Evaluation of the selective use of abdominopelvic drains at laparoscopic myomectomy: in enhanced recovery, do drains delay discharge home? Why is age a major determinant of reproductive outcomes after myomectomy in subfertile women? Accessibility and surgical outcomes of transumbilical single-port laparoscopy using straight instruments for hysterectomy in difficult conditions. Autoamputation of a pedunculated, subserosal uterine leiomyoma presenting as a giant peritoneal loose body. Uncertainties about laparoscopic myomectomy during pregnancy: A lack of evidence or an inherited misconception? Laparoscopic Myomectomy Using "Cold" Surgical Instruments for Uterine Corpus Leiomyoma: A Preliminary Report. Routes of hysterectomy in women with benign uterine disease in the Vancouver Coastal Health and Providence Health Care regions: a retrospective cohort analysis. Successful pregnancy following myomectomy for giant uterine fibroid in an infertile woman. Minilaparoscopic versus robotic radical hysterectomy plus systematic pelvic lymphadenectomy in early cervical cancer patients. Impact of morcellation on survival outcomes of patients with unexpected uterine leiomyosarcoma: a systematic review and meta-analysis. Preoperative diagnosis of usual leiomyoma, atypical leiomyoma, and leiomyosarcoma. The utility of caesarean myomectomy as a safe procedure: a retrospective analysis of 21 cases with review of literature. Selective genetic analysis of myoma pseudocapsule and potential biological impact on uterine fibroid medical therapy. Laparoscopic tumorectomy for a primary ovarian leiomyoma during pregnancy: A case report. Long unidirectional barbed suturing technique with extracorporeal traction in laparoscopic myomectomy. Histopathological audit of 373 nononcological hysterectomies in a teaching hospital. Recurrence of uterine tissue residues after laparoscopic hysterectomy or myomectomy. Laparoscopic versus abdominal myomectomy: practice patterns and health care use in British Columbia. Laparoscopic treatment of uterine fibroids: a comparison of peri-operative outcomes in laparoscopic hysterectomy and myomectomy. The Use of Single Versus Double Dose of Intravaginal Prostaglandin E2 "Misoprostol" prior to Abdominal Myomectomy: A Randomized Controlled Clinical Trial. Huge pyogenic cervical cyst with endometriosis, developing 13 years after myomectomy at the lower uterine segment: a case report. Preoperative treatment with letrozole in patients undergoing laparoscopic myomectomy of large uterine myomas: a prospective non-randomized study. Abdominal ultrasoundguided transvaginal myometrial core needle biopsy for the definitive diagnosis of suspected adenomyosis in 1032 patients: a retrospective study. Gynecologic robotic laparoendoscopic single-site surgery: prospective analysis of feasibility, safety, and technique. Impact of robotic technology on hysterectomy route and associated implications for resident education. Immunohistochemical localization of nerve fibers in the pseudocapsule of fibroids. Clinical efficiency investigation of laparoscopic uterine artery occlusion combined with myomectomy for uterine fibroids. Molecular analyses of 6 different types of uterine smooth muscle tumors: Emphasis in atypical leiomyoma. Use of dietary phytochemicals to target inflammation, fibrosis, proliferation, and angiogenesis in uterine tissues: promising options for prevention and treatment of uterine fibroids? Reproductive outcome following abdominal myomectomy for a very large fibroid uterus. Diffuse uterine leiomyomatosis in patient with successful pregnancy following new surgical management. Uterine sarcoma dissemination during myomectomy: if not "acceptable collateral damage," is it possible to mitigate the risk? Limits and complications of laparoscopic myomectomy: which are the best predictors? A combined ultrasound and histologic approach for analysis of uterine fibroid pseudocapsule thickness. A prospective matched case-control study of laparoendoscopic single-site vs conventional laparoscopic myomectomy. Immunohistochemical detection of promyelocytic leukemia zinc finger and histone 1. Fertility outcomes after uterine artery occlusion in the management of women with symptomatic uterine fibroids. Ultrasoundguided transvaginal radiofrequency myolysis for symptomatic uterine myomas. Modified novel technique for improving the success rate of applying seprafilm by using laparoscopy. Experience with a gonadotrophin-releasing hormone agonist prior to myomectomy-comparison of twice- vs thrice-monthly doses and a control group. Laparoendoscopic single-site myomectomy versus conventional laparoscopic myomectomy: a comparison of surgical outcomes. Clostridium hathewayi bacteraemia and surgical site infection after uterine myomectomy. Interval between hysterectomy and start of radiation treatment is predictive of recurrence in patients with endometrial carcinoma. Vaginal versus abdominal hysterectomy for the enlarged non-prolapsed uterus: a retrospective cohort study. Gynaecological laparoscopic surgery: eight years experience in the Yaounde GynaecoObstetric and Paediatric Hospital, Cameroon. Differences in the clinical phenotype of adenomyosis and leiomyomas: a retrospective, questionnaire-based study. Demonstration of laparoscopic resection of uterine sacculation (niche) with uterine reconstruction. Evaluation of the outcomes of laparoscopic hysterectomy for normal and enlarged uterus (>280 g). Fertility, pregnancy outcomes and deliveries following myomectomy: experience of a French Caribbean University Hospital. Ultrasoundguided high-intensity focused ultrasound vs laparoscopic myomectomy for symptomatic uterine myomas. A clinically feasible treatment protocol for magnetic resonance-guided highintensity focused ultrasound ablation in the liver. Safety and efficacy of sonographically guided highintensity focused ultrasound for symptomatic uterine fibroids: preliminary study of a modified protocol. Enhancing ablation effects of a microbubble-enhancing contrast agent ("SonoVue") in the treatment of uterine fibroids with high-intensity focused ultrasound: a randomized controlled trial. Effect of biological characteristics of different types of uterine fibroids, as assessed with T2weighted magnetic resonance imaging, on ultrasound-guided high-intensity focused ultrasound ablation. Intraprocedure contrast enhanced ultrasound: the value in assessing the effect of ultrasound-guided high intensity focused ultrasound ablation for uterine fibroids. Thermal fixation of swine liver tissue after magnetic resonance-guided high-intensity focused ultrasound ablation. Uterine artery embolization in single symptomatic leiomyoma: do anatomical imaging criteria predict clinical presentation and long-term outcome? Magnetic resonance image guided transurethral ultrasound prostate ablation: a preclinical safety and feasibility study with 28-day followup. Histopathology of breast cancer after magnetic resonance-guided high intensity focused ultrasound and radiofrequency ablation. Women seeking second opinion for symptomatic uterine leiomyoma: role of comprehensive fibroid center. Feasibility, Safety, and Efficacy of Accurate Uterine Fibroid Ablation Using Magnetic Resonance Imaging-Guided High-Intensity Focused Ultrasound With Shot Sonication. Magnetic resonance guided focused ultrasound for fibroid treatment-results of the second radiological gynecological expert meeting. Screening Magnetic Resonance Imaging-Based Prediction Model for Assessing Immediate Therapeutic Response to Magnetic Resonance Imaging-Guided High-Intensity Focused Ultrasound Ablation of Uterine Fibroids. Uterine-sparing minimally invasive interventions in women with uterine fibroids: a systematic review and indirect treatment comparison meta-analysis. Non-invasive magnetic resonance-guided high intensity focused ultrasound ablation of a vascular malformation in the lower extremity: a case report. Bone metastasis treatment using magnetic resonance-guided high intensity focused ultrasound.
For claim limitations that generally link the use of the judicial exception to a particular technological environment or field of use muscle relaxant 10mg buy 400mg carbamazepine otc, examiners should explain in an eligibility rejection why they do not meaningfully limit the claim spasms in neck purchase 200 mg carbamazepine with visa. For example spasms of the stomach discount 100mg carbamazepine amex, an examiner could explain that employing generic computer functions to execute an abstract idea spasms video carbamazepine 400mg on line, even when limiting the use of the idea to one particular environment muscle relaxant reversal discount carbamazepine 100 mg without a prescription, does not add significantly more muscle relaxant in spanish generic 200mg carbamazepine overnight delivery, similar to how limiting the abstract idea in Flook to petrochemical and oil-refining industries was insufficient spasms between ribs buy carbamazepine 100mg otc. Similarly spasms 1982 generic carbamazepine 400mg visa, a claim that qualifies as eligible after Step 2A (Pathway B) or Step 2B (Pathway C) of the full analysis would also be eligible if the streamlined analysis (Pathway A) were applied to that claim. It may not be apparent that an examiner employed the streamlined analysis because the result is a conclusion that the claim is eligible, and there will be no rejection of the claim on eligibility grounds. In practice, the record may reflect the conclusion of eligibility simply by the absence of an eligibility rejection or may include clarifying remarks, when appropriate. Also, a claim that recites a nature-based product, but clearly does not attempt to tie up the nature-based product, does not require a markedly different characteristics analysis to identify a "product of nature" exception. As an example, a claim directed to an artificial hip prosthesis coated with a naturally occurring mineral is not an attempt to tie up the mineral. Similarly, claimed products that merely include ancillary nature-based components, such as a claim that is directed to a cellphone with an electrical contact made of gold or a plastic chair with wood trim, would not require analysis of the nature-based component to determine whether the claims are directed to a "product of nature" exception because such claims do not attempt to improperly tie up the nature-based product. For instance, claims directed to clear improvements to computer-related technology do not need the full eligibility analysis. Claims directed to improvements to other technologies or technological processes, beyond computer improvements, may also avoid the full eligibility analysis. In these cases, when the claims were viewed as a whole, their eligibility was self-evident based on the clear improvement, so no further 2106. Such claims do not need to proceed through the full analysis herein as their eligibility will be self-evident. On the other hand, a claim that does not qualify as eligible after Step 2B of the full analysis would not be suitable for the streamlined analysis, because the claim lacks self evident eligibility. For instance, a claim directed to a complex manufactured industrial product or process that recites meaningful limitations along with a judicial exception may sufficiently limit its practical application so that a full eligibility analysis is not needed. As an example, a robotic arm assembly having a control system that operates using certain mathematical relationships is clearly not an attempt to tie up use of the mathematical relationships and would not require a full analysis to determine 2100-87 Rev. Although the Federal Circuit held these claims eligible at Step 2A as not being directed to abstract ideas, it would be reasonable for an examiner to have found these claims eligible at Pathway A based on the clear improvement, or at Pathway B (Step 2A) as not being directed to an abstract idea. If the claims are a "close call" such that it is unclear whether the claims improve technology or computer functionality, a full eligibility analysis should be performed to determine eligibility. Only when the claims clearly improve technology or computer functionality, or otherwise have self-evident eligibility, should the streamlined analysis be used. Although the Federal Circuit held these claims eligible at Step 2B (Pathway C) because they presented a "technology-based solution" of filtering content on the Internet that overcame the disadvantages of prior art filtering systems and that amounted to significantly more than the recited abstract idea, it also would be reasonable for an examiner to have found these claims eligible at Pathway A or B if the examiner had considered the technology-based solution to be an improvement to computer functionality. Accordingly, while it would be acceptable for applicants to cite training materials or examples in support of an argument for finding eligibility in an appropriate factual situation, applicants should not be required to model their claims or responses after the training materials or examples to attain eligibility. When evaluating a claimed invention for compliance with the substantive law on eligibility, examiners should review the record as a whole. The evaluation of whether the claimed invention qualifies as patent-eligible subject matter should be made on a claim-by-claim basis, because claims do not automatically rise or fall with similar claims in an application. For example, even if an independent claim is determined to be ineligible, the dependent claims may be eligible because they add limitations that integrate the judicial exception into a practical application or amount to significantly more than the judicial exception recited in the independent claim. And conversely, even if an independent claim is determined to be eligible, a dependent claim may be ineligible because it adds a judicial exception without also adding limitations that integrate the judicial exception or provide significantly more. Thus, each claim in an application should be considered separately based on the particular elements recited therein. The rejection should set forth a prima facie case of ineligibility under the substantive law. The concept of the prima facie case is a procedural tool of patent examination, which allocates the burdens going forward between the examiner and applicant. In particular, the initial burden is on the examiner to explain why a claim or claims are ineligible for patenting clearly and specifically, so that applicant 2106. Examination guidance, training, and explanatory examples discuss the substantive law and establish the policies and procedures to be followed by examiners in evaluating patent applications for compliance with the Rev. For example, the rejection should identify the judicial exception by referring to what is recited. If it is determined that the claim does not recite eligible subject matter, a rejection under 35 U. When making the rejection, the Office action must provide an explanation as to why each claim is unpatentable, which must be sufficiently clear and specific to provide applicant sufficient notice of the reasons for ineligibility and enable the applicant to effectively respond. A subject matter eligibility rejection under Step 2 should provide an explanation for each part of the Step 2 analysis: For Step 2A Prong One, the rejection should identify the judicial exception by referring to what is recited. For example, if the claim is directed to an abstract idea, the rejection should identify the abstract idea as it is recited. Similarly, if the claim is directed to a law of nature or a natural phenomenon, the rejection should identify the law of nature or natural phenomenon as it is recited. Examiners should give weight to all of the claimed additional elements in Prong Two, even if those elements represent well-understood, routine, conventional activity. Under the principles of compact prosecution, regardless of whether a rejection under 35 U. Thus, examiners should state all non-cumulative reasons and bases for rejecting claims in the first Office action. While not required, this explanation or justification may include citing to an appropriate court decision that supports the identification of the subject matter recited in the claim language as an abstract idea within one of the groupings. Examiners should be familiar with any cited decision relied upon in making or maintaining a rejection to ensure that the rejection is reasonably tied to the facts of the case and to avoid relying upon language taken out of context. Sample explanation: the claim recites the step of comparing collected information to a predefined threshold, which is an act of evaluating information that can be practically performed in the human mind. A subject matter eligibility rejection should point to the specific claim limitation(s) that recites. The rejection must explain why those claim limitations set forth or describe a judicial exception. Where the claim describes, but does not expressly set forth, the judicial exception, the rejection must also explain what subject matter those limitations describe, and why the described subject matter is a judicial exception. When the examiner has determined the claim recites an abstract idea, the rejection should identify the abstract idea as it is recited. Sample explanation: the claim recites the correlation of X, and X is a law of nature because it describes a consequence of natural processes in the human body. When the examiner has determined the claim recites a product of nature, the rejection should identify the exception as it is recited. Sample explanation: the claim recites X, which as explained in the specification was isolated from naturally occurring Y. X is a nature-based product, so it is compared to its closest naturally occurring counterpart (X in its natural state) to determine if it has markedly different characteristics. Because there is no indication in the record that isolation of X has resulted in a marked difference in structure, function, or other properties as compared to its counterpart, X is a product of nature exception. When making a rejection, it is important for the examiner to explain the rationale underlying the conclusion so that applicant can effectively respond. On the other hand, when appropriate, the examiner should explain why the additional elements integrate an exception into a practical application or provide an inventive concept by adding a meaningful limitation to the claimed exception. For claim limitations that recite a generic computer component performing generic computer functions at a high level of generality, such as using the Internet to gather data, examiners can explain why these generic computing functions do not meaningfully limit the claim. The explanation should address the additional elements both individually and as a combination when determining whether the claim as whole recites eligible subject matter. It is important to remember that a new combination of steps in a process may be patent eligible even though all the steps of the combination were individually well known and in common use before the combination was made. Thus, it is particularly critical to address the combination of additional elements, because while individually-viewed elements may not appear to 2100-91 Rev. For claim limitations that add insignificant extra-solution activity to the judicial exception. For example, adding a final step of storing data to a process that only recites computing the area of a two dimensional space (a mathematical relationship) does not add a meaningful limitation to the process of computing the area. As another example, employing well-known computer functions to execute an abstract idea, even when limiting the use of the idea to one particular environment, does not integrate the exception into a practical application or add significantly more, similar to how limiting the computer implemented abstract idea in Flook to petrochemical and oil-refining industries was insufficient. In the event a rejection is made, it is a best practice for the examiner to consult the specification to determine if there are elements that could be added to the claim to make it eligible. If so, the examiner should identify those elements in the Office action and suggest them as a way to overcome the rejection. Thus, the court does not require "evidence" that a claimed concept is a judicial exception, and generally decides the legal conclusion of eligibility without resolving any factual issues. In some cases, however, the courts have characterized the issue of whether additional elements are well-understood, routine, conventional activity as an underlying factual issue upon which the legal conclusion of eligibility may be based. When performing the analysis at Step 2A Prong One, it is sufficient for the examiner to provide a reasoned rationale that identifies the judicial exception recited in the claim and explains why it is considered a judicial exception. At Step 2A Prong Two or Step 2B, there is no requirement for evidence to support a finding that the exception is not integrated into a practical application or that the additional elements do not amount to significantly more than the exception unless the examiner asserts that additional limitations are well-understood, routine, conventional activities in Step 2B. Examiners should not assert that an additional element (or combination of elements) is well-understood, routine, or conventional unless the examiner finds, and expressly supports the rejection in writing with one or more of the following: (A) A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s). A specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U. A finding that an element is well-understood, routine, or conventional cannot be based only on the fact that the specification is silent with respect to describing such element. Examiners should be careful to ensure the claim limitations before the examiner are the same as those found to be well-understood, routine, conventional by the courts. The additional elements under examination should be recited in the same manner, meaning they should be recited at the same high level of generality as in those court decisions. It is not enough that the additional elements are similar to the elements at issue in those cases. Examiners should keep in mind that the courts have held computer-implemented processes to be significantly more than an abstract idea (and thus eligible), where generic computer components are able in combination to perform functions that are not merely generic. An appropriate publication could include a book, manual, review article, or other source that describes the state of the art and discusses what is well-known and in common use in the relevant industry. It does not include all items that might otherwise qualify as a "printed publication" as used in 35 U. Whether something is disclosed in a document that is considered a "printed publication" under 35 U. A document may be a printed publication but still fail to establish that something it describes is well-understood, routine, conventional activity. This option should be used only when examiners are certain, based upon their personal knowledge, that the additional element(s) represents well-understood, routine, conventional activity engaged in by those in the relevant art, in that the additional elements are widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U. For example, the examiner could take official notice that a generic computer component performing generic computer functions at a high level of generality, such as using the Internet to gather data, is well-understood, routine, conventional. If the judicial exception to which the claim is directed is a "tentative abstract idea," i. This form paragraph must be followed by a detailed explanation of the grounds of rejection using one or more of form paragraphs 7. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because [1] Examiner Note: 2106. In bracket 1, explain why the claimed invention is not patent eligible subject matter by identifying what the claim(s) is/are directed to and explain why it does not fall within at least one of the four categories of patent eligible subject matter recited in 35 U. For a claim that is directed to a judicial exception and is nonstatutory, use form paragraph 7. This judicial exception is not integrated into a practical application because [3]. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because [4]. This form paragraph is for use with all product (machine, manufacture, and composition of matter) and process claims, and for all claims directed to a law of nature, natural phenomenon (including a product of nature), or abstract idea. In bracket 1, identify whether the claim(s) are directed to a law of nature, a natural phenomenon (including a product of nature), or an abstract idea. In bracket 2, identify the exception by referring to how it is recited in the claim and explain why it is considered an exception. For example, "the Arrhenius equation, which is a law of nature and a mathematical concept which describes the relationship between temperature and reaction rate" or "the series of steps instructing how to hedge risk, which is a fundamental economic practice and thus grouped as a certain method of organizing human interactions. In bracket 3, explain why the combination of additional elements fails to integrate the judicial exception into a practical application. For example, if the claim is directed to an abstract idea with additional generic computer elements, explain that the generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer; or, if the claim is directed to a method of using a naturally occurring correlation, explain that data gathering steps required to use the correlation do not add a meaningful limitation to the method as they are insignificant extra-solution activity. In bracket 4, identify the additional elements and explain why, when considered separately and in combination, they do not add significantly more (also known as an "inventive concept") to the exception. Nonetheless, the claim limitation(s) is/are being treated as reciting an abstract idea because [1]. This form paragraph should be used to demonstrate that this approval has been obtained. In bracket 1, provide the justification for why the claim limitation(s) is/are being treated as an abstract idea. For example, provide an explanation of why the claim limitation is among the "basic tools of scientific and technological work. Applicant may argue that a claim is eligible because the claim as a whole integrates the judicial exception into a practical application or amounts to significantly more than the judicial exception when the additional elements are considered both individually and in combination. When an additional element is considered individually by the examiner, the additional element may be enough to integrate the judicial exception into a practical application or to qualify as "significantly more" if it meaningfully limits the judicial exception. In addition, even if an element does not integrate a judicial exception into a practical application or amount to significantly more on its own. For example, generic computer components that individually perform merely generic computer functions. It is especially necessary for the examiner to fully reevaluate their position when such additional elements are not discussed in the specification as being known generic functions/components/activities or are not treated by the courts as well-understood, routine, conventional activities. If the rejection is to be maintained, the examiner should consider whether evidence should be provided to further support the rejection and clarify the record for appeal. If an examiner still determines that the claim is directed to a judicial exception, the examiner should then reconsider in Step 2B whether the additional elements in combination (as well as individually) amount to an inventive concept. Such reconsideration is appropriate because, although preemption is not a standalone test for eligibility, it remains the underlying concern that drives the two-part framework from Alice Corp. For example, if a claim is found eligible because it improves upon existing technology, the examiner could reference the portion of the specification that describes the claimed improvement and note the claim elements that produce that improvement. The clarifying remarks may be made at any point during prosecution as well as with a notice of allowance. Clarifying remarks may be useful in explaining the rationale for a rejection as well. As an example, a rejection for failure to recite patent eligible subject matter in a claim to a computer readable medium could include an explanation that the broadest reasonable interpretation of the claim covers a carrier wave, which does not fall within one of the four categories of invention, and a suggestion to overcome the rejection by submitting a narrowing amendment to cover the statutory embodiments. These Guidelines have been promulgated to assist Office personnel in their review of applications for compliance with the utility requirement. The Guidelines do not constitute substantive rulemaking and hence do not have the force and effect of law. Rejections will be based upon the substantive law, and it is these rejections which are 2100-97 Rev. An invention has a well-established utility if (i) a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention. This requirement excludes "throw-away," "insubstantial," or "nonspecific" utilities, such as the use of a complex invention as landfill, as a way of satisfying the utility requirement of 35 U. An applicant need only provide one credible assertion of specific and substantial utility for each claimed invention to satisfy the utility requirement. The examiner should review any subsequently submitted evidence of utility using the criteria outlined above. The examiner should also ensure that there is an adequate nexus between the evidence and the properties of the now claimed subject matter as disclosed in the application as filed. If documentary evidence is not available, the examiner should specifically explain the scientific basis for his or her factual conclusions. The prima facie showing must contain the following elements: (i) An explanation that clearly sets forth the reasoning used in concluding that the asserted utility for the claimed invention is not both specific and substantial nor well-established; (ii) Support for factual findings relied upon in reaching this conclusion; and (iii) An evaluation of all relevant evidence of record, including utilities taught in the closest prior art. The prima facie showing must contain the following elements: (i) An explanation that clearly sets forth the reasoning used in concluding that the asserted specific and substantial utility is not credible; (ii) Support for factual findings relied upon in reaching this conclusion; and (iii) An evaluation of all relevant evidence of record, including utilities taught in the closest prior art. Office personnel are reminded that they must treat as true a statement of fact made by an applicant in relation to an asserted utility, unless countervailing evidence can be provided that shows that one of ordinary skill in the art would have a legitimate basis to doubt the credibility of such a statement. Similarly, Office personnel must accept an opinion from a qualified expert that is based upon relevant facts whose accuracy is not being questioned; it is improper to disregard the opinion solely because of a disagreement over the significance or meaning of the facts offered. Once a prima facie showing of no specific and substantial credible utility has been properly established, the applicant bears the burden of rebutting it. If the applicant responds to the prima facie rejection, the Office personnel should review the original disclosure, any evidence relied upon in establishing the prima facie showing, any claim amendments, and any new reasoning or evidence provided by the applicant in support of an asserted specific and substantial credible utility. Only where the totality of the record continues to show that the asserted utility is not specific, substantial, and 2100-99 Rev. If the applicant satisfactorily rebuts a prima facie rejection based on lack of utility under 35 U. The Office must examine each application to ensure compliance with the "useful invention" or utility requirement of 35 U. In discharging this obligation, however, Office personnel must keep in mind several general principles that control application of the utility requirement. An invention that is not a machine, an article of manufacture, a composition or a process cannot be patented.
The intersectoral approach requires analysis of all the social elements that can affect the control of cancer spasms after stent removal generic 400mg carbamazepine fast delivery. Those concerned with cancer control must work with authorities in agriculture muscle relaxant half life order carbamazepine 400 mg, commerce spasms under left breastbone cheap 100mg carbamazepine mastercard, communications muscle relaxant hair loss proven carbamazepine 200mg, education muscle relaxant 563 pliva carbamazepine 200mg free shipping, industry muscle relaxant valerian carbamazepine 200mg fast delivery, and law in order to achieve success spasms medication generic 100 mg carbamazepine mastercard. The spirit and philosophy of full participation must be part of the planning process muscle relaxant adverse effects generic 200 mg carbamazepine with mastercard. It is critical that the ministry of health understand, accept and adopt a stakeholder-driven the broad aims of the cancer control policy, which are: prevention of cancer; early detection, coupled with effective and efficient treatment of potentially curable disease; relief of pain and palliative care to improve the quality of life of patients; the principles on which the policy is to be based; an explicit statement of goals, objectives and priorities within the policy; the programmes, both new and revised, that will be required to carry out the policy; the resources currently available and those that will be required to carry out the policy in full; the roles and responsibilities of those involved in carrying out the various activities at the different levels of the health system; any legislative measures that will be required, such as those to control tobacco use, allocate funds for recommended activities, or ensure the availability of oral morphine; indicators for monitoring and evaluating the national cancer control programme. Good management is therefore essential to maintain momentum and introduce any necessary modifications. Such an approach encourages all participants in the programme, including staff volunteers, community groups, and patients to practice positive, initiative-taking behaviour and adopt a systematic approach to managing the various processes in order to prevent problems. Schematically, the programme can be seen as a system, with inputs, processes, outputs, and outcomes (Figure 11. The term resources is used here in a broad sense, implying people, staff, finance, facilities, techniques, methods, and so on. The processes are the means by which programme services are delivered, or how the programme organizes resources to carry out its mission. The outputs are the units of services provided or the direct products of programme activities. The outcomes are the impacts on the people receiving the services or participating in the programme. Leadership and team building the various activities of a national cancer control programme share common objectives. Competent management is needed to integrate these activities into a coherent programme. Key to competent management is the leadership of the programme, who should be facilitative, participatory and empowering in how vision and goals are established and carried out. Ideally, the individual selected as the programme coordinator should have technical competence and political influence, charisma, good management and communication skills, and relevant knowledge and experience in public health. It is also desirable for this individual to have expertise in public relations, fundraising, lobbying, consensus building, information systems and evaluation techniques. It may not be possible to find all these characteristics in one person, and a leadership team may therefore be a preferable solution. The coordinator needs to keep a balance among the prevention, treatment and palliative care components. This person also needs to be persevering, flexible and creative, in order to overcome the numerous barriers the programme will face. The board of the national cancer control programme should amply represent all key sectors of the community. It should consist of the people responsible for various programme activities, whether governmental or nongovernmental, including oncology specialists and the general public. This multidisciplinary group should work as a team, led by the programme coordinator. The board should have a constitution that sets out its mandate, specifies its accountability, defines its membership, and specifies the frequency of its meetings. The coordinator of the national cancer control programme should facilitate or reinforce the building of a network of local coordinators, backed by their own teams, who will take a leadership role in their areas or regions. Ideally, these local leaders should coordinate with the central organization, but keep their autonomy to administer their own resources and adjust national cancer control plans to their local situation. The functions of the board of the national cancer control programme are given in Box 11. Effective teams are results-oriented and are committed to project objectives, milestones, goals and strategies. In the work environment the most important standards relate to the group performance. Characteristics of good team building include the following: team is clear about goals and established targets; each team member is willing to contribute; team leader has good interpersonal skills and is committed to team approach; high level of interdependence exists among team members; team develops a relaxed climate for communication; team members develop mutual trust; team and individuals are prepared to take risks; roles of team members are defined; team norms are defined; team members know how to examine team and individual errors without personal animosity; team has capacity to create new ideas; team members know that they can each influence the team agenda. A high proportion of health professionals, who work mainly at the clinical level, may resist public health approaches. In addition, health managers and their team generally work in unfavourable conditions, have low salaries and have to perform competing tasks for other programmes. When resources are limited, there is a need to provide actively for psychosocial and cultural incentives, such as public and private acknowledgement of their efforts, enhancement of the contribution each team member plays in the achievement of the common goal, and continuous training. The written plan for the national cancer control programme Steps in development of the national cancer control programme were dis134 cussed in the previous chapter. Oversight of this process and the preparation of a written plan are the responsibility of the programme board, working by itself or through coordination of the work of various committees. The following outline has served as a valuable model for national cancer control programme plans: assessment of the cancer situation; clear definition of goals and objectives identification of the priority needs of the country; outlining the strategies for cancer control; assessment of resources available and how they are organized in the health system; setting of achievable targets, and indicating by whom, when and where they are to be carried out. Acceptance of the plan may be facilitated by drafting a discussion paper on cancer control, and circulating it for comment by the government and by nongovernmental organizations. Review and approval of a plan can be a lengthy process, but a draft plan that the board can use for lobbying may assist in speeding up the process. Copies of national cancer control programme plans and related materials for a number of developed and developing countries are available in the literature and on the Internet. Implementing a National Cancer Control Programme Written guidelines For each priority area, evidence-based guidelines should be elaborated. These guidelines should be accepted by consensus, and must address clinical and management aspects, in order to standardize the procedures and contribute to quality assurance of the different activities. Programmes that already exist When the national cancer control plan and the priorities for initial cancer control activities have been agreed, the resources to implement the plan must be mobilized, either by bidding for new resources or by using existing resources. It may often be possible to mobilize existing resources that can be incorporated into the national cancer control programme or with which the programme can collaborate in order to maximize their usefulness. Close coordination 135 Implementing a National Cancer Control Programme with hepatitis B virus vaccination programmes and schistosomiasis control projects should be planned in areas where these diseases present significant problems. The national cancer control programme should be integrated into, and collaborate with, existing healthcare systems, both public and private, at the different levels of care, including hospitals, and primary health care clinics. The programme cannot, however, be run exclusively within any one of these levels, since activities will be concerned with different levels, or sometimes a combination of levels. Diagnosis and treatment require a multidisciplinary approach, and coordination among the different disciplines should be enhanced to improve quality of care. Primary healthcare centres have a major role to play in public health education and early detection; medical, paramedical, and community care workers should be the resource persons for these activities, and an effective link in the referral chain. Active participation of primary health care workers is an important component of an effective cancer control programme. Partnership Partners who are engaged in the fight against cancer may come from governmental, nongovernmental, and private sectors, as well as professional organizations. Partners from each sector must play a role in the development of a national cancer control programme, though the relative extent of that role will vary from country to country. In some countries, funding for treatment comes from the central government, while funding for disease prevention and screening is provided by local government sources. It is very important that all players are aware of the complexity of the national situation and of the role each can or should play to achieve the goals of a national cancer control programme. A comprehensive and systematic approach to the cancer problem, as presented in a national cancer control programme, gives all partners the opportunity of contributing their best to a unified endeavour. The nongovernmental sector is an important source of technical knowhow, expertise, and resources, and provides outreach to the professional and public communities. The need for community participation in cancer control and patient care is evident. This need is particularly acute in developing countries, given the resource constraints and operational limitations of their governmental health care systems. In many countries, major portions of their healthcare budgets are dedicated to the control of communicable diseases, leaving little for allocation to noncommunicable diseases. Nongovernmental and voluntary organizations should, therefore, play a significant role in reducing disparities in the level of cancer prevention, early detection and patient care that governmental health systems are able to provide. Implementing a National Cancer Control Programme A budget for cancer control In drawing up the budget of the national cancer control programme, it is useful to start by identifying all the budgets currently used for every aspect of cancer control. Bodies already active in related activities may be defensive about their budgets, but should understand that there may be opportunities for the reallocation or sharing of resources in the future, when the national programme has developed a sense of common purpose. Even if precise budgetary information is not available, it is useful to estimate current expenditure on each of the four major strategy components: primary prevention, early diagnosis and screening, treatment (surgery, radiotherapy and chemotherapy), and palliative care. Based upon agreement within the national cancer control programme board on priorities, and with the relevant agencies, resources should be reallocated from unproductive areas to areas with greater potential for success. The very process of developing a national cancer control programme will facilitate the mobilization of funds and may increase the accessibility of funds within the country. In addition, international donors are likely to be attracted by a well-conceived programme that promises to increase the efficiency and effectiveness of cancer control. Fund-raising from these and other sources is a major part of the responsibilities of the programme coordinator and board. Information systems Information systems should be developed in order to monitor the programme processes and indicate ad hoc changes to improve them. For example, effective patient care requires timely diagnosis, treatment and adequate follow-up. A good information system should be able to identify delays or bottlenecks in the system, and impediments to follow-up and adherence so that such problems can be readily solved. Ideal, comprehensive, information systems can be very costly and difficult to maintain. In limited resource settings, information systems should be tailored to the basic needs of the selected priorities, and carefully developed to ensure the monitoring and evaluation of key process components and outcome measures in the priority areas. Information systems should be linked to population-based cancer registries in the areas where they exist so outcome measures such as incidence, stage distribution and survival can be provided by the surveillance system. Legislation In some countries, legislation may be needed to provide the necessary authority for those who are to run the national cancer control programme. In others, legislation may have to be introduced or amended to allow the costs of some activities (for example, screening tests) to be covered by the government or by health insurance schemes. Which are key processes for a national cancer control programme to fulfil its goals? Processes should be managed to meet the requirements and needs of cus138 tomers, providers and other stakeholders. Clear roles and responsibilities must be established for managing the process and the interrelations with functions of other processes or programmes must be identified as well. The processes must align with the national cancer control programme objectives and should include continual improvement of performance. Decisions and actions should be based on the analysis of data and information to improve results, and not rely merely on opinions as usually occurs. The following paragraphs describe some key processes that are useful to consider when implementing or reorienting a national cancer control programme. These processes are based on principles of quality management as well as on practical experiences at the country level. Implementing a National Cancer Control Programme Launching the programme A successful launch can facilitate public acceptance of a national cancer control programme, increase the understanding of the principles underlying the programme, and rally support for its strategies. Once the programme plan has been developed, consideration can be given to the approaches to be used for launching the programme. If only minimal resistance is anticipated and if there is confidence that the planned strategies can be successfully implemented nationally, the programme board can move directly to a launch with a national conference. If any resistance is anticipated, careful analysis of the situation is needed to identify the barriers and the possible mechanisms for overcoming them. In some cases it is preferable to focus the programme initially in a demonstration area. Demonstration areas Experience gained by various countries show that it is often advisable to start small and consider that success breeds success. Efforts can concentrate on a demonstration area, which has a good likelihood of successfully implementing one or two priority initiatives that can serve as entry points. Thus political and financial support can be enhanced and the expansion of the programme both geographically and thematic can be considered in a second stage, once concrete achievements can be demonstrated. Step-by-step implementation A step-by-step process is recommended when starting or reorienting a cancer control programme, especially in a developing country setting. Implementation of a cancer control programme may proceed in a series of stages, each stage having clear measurable objectives and representing the basis for the development of the next stage, thereby permitting visible and controlled progress. Every stage should involve decision-makers and operational staff from the different levels of care that need to participate actively. Optimizing existing resources from the start Quite often, priority setting is neglected or does not follow the proper methodology. Thus, it is essential that at the first stage the programme considers reallocation of existing resources according to the new strategies, and foresees the development and incorporation of new technologies that are cost-effective, sustainable and of benefit to the majority of the targeted population. Organizing activities of the priority areas with a systemic approach Activities carried out according to the selected priorities should be tailored to the populations at risk. The activities should be adequately organized so as to make the best use of the available resources. Furthermore, it is important to take a systemic approach to ensure that the various interrelated components of the intervention strategy that share common objectives, are coordinated, directed to achieving the objectives, and integrated with other related pro140 grammes or initiatives. An example of such an organization approach for a cervical cancer screening programme was given in Figure 10. Different components at various levels of care are essential and complementary parts of the system. All these components need to be managed efficiently in order to guarantee quality and their permanent coordination. They also need to be continuously monitored to achieve reduction in incidence and mortality from invasive cancer. Furthermore, each component is a subsystem with its own particular management process. At the primary level of care, where the majority of the women at risk are screened, the activities are integrated with programmes of reproductive health, other preventive clinical services and community-outreach initiatives. At the secondary and tertiary levels the components are integrated with the hospital services that provide diagnosis, treatment, and eventually, palliative care to the cases that were not detected early by the system. Implementing a National Cancer Control Programme Education and training Ideally, health professionals, including nurses, doctors and health managers, should have some public health training during their undergraduate and post-graduate courses. Such training should give healthcare providers knowledge and skills in epidemiology, screening, and health services organization and management. Programmes to educate and train health care professionals, consumers, and other stakeholders should be tailored to the type of audience, the local situation and the momentum in the national cancer control programme development so as to ensure that they contribute to improving the programme. The teaching of behavioural modification skills should be encouraged, as many aspects of cancer prevention, treatment and palliative care require behavioural changes from the public, the patient and the health worker. One way of establishing a broad base of support and improving programme performance, is to hold a national problem-solving workshop with the participation of professionals from all related disciplines and from all levels of the health system, covering all the targeted administrative areas. The goal of the workshop could be to strengthen national capacity to manage cancer control programmes. The initiative includes follow-up meetings to reinforce the processes generated by the initial workshop. Continuous training of health care workers needs to be developed along the lines of quality management. That is, it should focus on active involvement, continual improvement and innovation and creativity. Such training is key to achieving the desired changes in behaviour in line with new policies, and thus to improve the performance of the programme. A common problem encountered in the implementation of a national cancer control programme is how to produce a change in the established practices of professional workers. The spiral of problem solving and team learning is an effective methodology to deal with this situation (Salas 2001). This methodology is a combination of problem-based learning methodology (Barrows and Tamblyn 1980) and the study of work for better decision-making (Sketchley et al. The approach is designed to give ownership of the process to the local manager and team by promoting their active participation in planning, implementation, monitoring and evaluation. The basic assumptions underlying this approach are that: health workers can learn from their workplace experiences; human and material resources already in use can be redirected through low cost intervention to produce a more efficient programme; formal lines of authority in the public health sector must be respected to minimize resistance and improve potential support; existing levels of authority are interested in improving the programme when they are involved, respected, motivated, trained and supported. The methodological principles governing this intervention concern both personal and collective components. The first personal principle is that programme leaders must begin by changing themselves before asking others around them to change. Individuals perceive obstacles as limiting their possible choices, so an important principle is to stop that restrictive attitude and think of obstacles as an opportunity for creativity. Another important personal principle is to learn not only from personal experience, but from everyone, thus people should always be open to new ideas. Further, each person deserves respect and appreciation, so rejection and criticism should be avoided. As a collective, the group always needs to keep the big picture in mind, continuously aware of what part is taking place at any given time. The objective should always be clarified first, and then the plan of action should be designed to achieve that objective. Another important principle is that the use of available resources should be optimized first, before consideration of adding any new resources. Similarly, the focus of the group should be teamwork, using the skills and talents of existing staff. When an outline of any plan is developed, part of the plan should always be left open to allow the local team to make adjustments and to innovate.
For inventions in an unpredictable art spasms in neck 200mg carbamazepine with amex, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus spasms leg quality 100mg carbamazepine. Instead spasms hands fingers purchase 100mg carbamazepine otc, the disclosure must adequately reflect the structural diversity of the claimed genus muscle relaxant radiolab order 400 mg carbamazepine overnight delivery, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus muscle relaxant succinylcholine 200mg carbamazepine mastercard," or by the establishment of "a reasonable structure-function correlation muscle relaxant medicines cheap carbamazepine 400 mg free shipping. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces spasms hindi meaning best carbamazepine 400 mg. For example muscle relaxants sleep discount carbamazepine 400 mg fast delivery, in the molecular biology arts, if an applicant disclosed an amino acid sequence, it would be unnecessary to provide an explicit disclosure of nucleic acid sequences that encoded the amino acid sequence. Since the genetic code is widely known, a disclosure of an amino acid sequence would provide sufficient information such that one would accept that an applicant was in possession of the full genus of nucleic acids encoding a given amino acid sequence, but not necessarily any particular species. If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U. However, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. When an explicit limitation in a claim "is not present in the written description whose benefit is sought it must be shown that a person of ordinary skill would have understood, at the time the patent application was filed, that the description requires that limitation. If the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U. In rejecting a claim, the examiner must set forth express findings of fact regarding the above analysis which support the lack of written description conclusion. These findings should: (A) Identify the claim limitation at issue; and (B) Establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed. A general allegation of "unpredictability in the art" is not a sufficient reason to support a rejection for lack of adequate written description. Upon Reply by Applicant, Again Determine the Patentability of the Claimed Invention, Including Whether the Written Description Requirement Is Satisfied by Reperforming the Analysis Described Above in View of the Whole Record the above only describes how to determine whether the written description requirement of 35 U. Regardless of the outcome of that determination, Office personnel must complete the patentability determination under all the relevant statutory provisions of title 35 of the U. Once Office personnel have concluded analysis of the claimed invention under all the statutory provisions, including 35 U. The Office action should clearly communicate the findings, conclusions, and reasons which support them. When possible, the Office action should offer helpful suggestions on how to overcome rejections. If the whole record now demonstrates that the written description requirement is satisfied, do not repeat the rejection in the next Office action. If the record still does not demonstrate that the written description is adequate to support the claim(s), repeat the rejection under 35 U. If the examiner concludes that the claimed subject matter is not supported [described] in an application as filed, this would result in a rejection of the claim on the ground of a lack of written description under 35 U. While the test or analysis of description requirement and new matter issues is the same, the examining procedure and statutory basis for addressing these issues differ. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter. Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed. If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to , or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. Furthermore, when a party to an interference seeks the benefit of an earlier-filed U. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify Rev. The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. A description as filed is presumed to be adequate, unless or until sufficient evidence or reasoning to the contrary has been presented by the examiner to rebut the presumption. The examiner, therefore, must have a reasonable basis to challenge the adequacy of the written description. If the specification fails to disclose sufficient corresponding structure, materials, or acts that perform the entire claimed function, then the claim limitation is indefinite because the applicant has in effect failed to particularly point out and distinctly claim the invention as required by 35 U. These findings should: (A) Identify the claim limitation(s) at issue; and (B) Establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed. Omission of a Limitation Upon reply by applicant, before repeating any rejection under 35 U. A claim that omits an element which applicant describes as an essential or critical feature of the invention originally disclosed does not comply with Rev. The shape limitation was considered to be unnecessary since the specification, as filed, did not describe the tapered shape as essential or critical to the operation or patentability of the claim. A claim which omits matter disclosed to be essential to the invention as described in the specification or in other statements of record may also be subject to rejection under 35 U. Addition of Generic Claim the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. While these and other cases find that recitation of an undisclosed species may violate the description requirement, a change involving subgeneric terminology may or may not be acceptable. Applicant was not entitled to the benefit of a parent filing date when the claim was directed to a subgenus (a specified range of molecular weight ratios) where the parent application contained a generic disclosure and a specific example that fell within the recited range because the court held that subgenus range was not described in the parent application. Each case must be decided on its own facts in terms of what is reasonably communicated to those skilled in the art. Appellants submit to us, as they did to the board, an imaginary specific example patterned on specific example 6 by which the above butyl compound is made so that we can see what a simple change would have resulted in a specific supporting disclosure being present in the present specification. If new matter is added to the claims, the examiner should reject the claims under 35 U. The examiner should still consider the subject matter added to the claim in making rejections based on prior art since the new matter rejection may be overcome by applicant. When the claims have not been amended, per se, but the specification has been amended to add new matter, a rejection of the claims under 35 U. Applicant should therefore specifically point out the support for any amendments made to the disclosure. If an applicant amends or attempts to amend the abstract, specification or drawings of an application, an issue of new matter will arise if the content of the amendment is not described in the application as filed. Stated another way, information contained in any one of the specification, claims or drawings of the application as filed may be added to any other part of the application without introducing new matter. If both the claims and specification contain new matter either directly or indirectly, and there has been both a rejection and objection by the examiner, the issue becomes appealable and should not be decided by petition. An amendment to correct an obvious error does not constitute new matter where one skilled in the art would not only recognize the existence of error in the specification, but also the appropriate correction. This prohibition applies regardless of the language of the foreign priority documents because a claim for priority is simply a claim for the benefit of an earlier filing date for subject matter that is common to two or more applications, and does not serve to incorporate the content of the priority document in the application in which the claim for priority is made. For applications filed on or after September 21, 2004, where all or a portion of the specification or drawing(s) is inadvertently omitted from the U. Accordingly, a rewording of a passage where the same meaning remains intact is permissible. The mere inclusion of dictionary or art recognized definitions known at the time of filing an application may not be considered new matter. If there are multiple definitions for a term and a definition is added to the application, it must be clear from the application as filed that applicant intended a particular definition, in order to avoid an issue of new matter and/or lack of written description. The application may later be amended to recite the function, theory or advantage without introducing prohibited new matter. The mere fact that a certain thing may result from a given set of circumstances is not sufficient. The invention that one skilled in the art must be enabled to make and use is that defined by the claim(s) of the particular application or patent. The purpose of the requirement that the specification describe the invention in such terms that one skilled in the art can make and use the claimed invention is to ensure that the invention is communicated to the interested public in a meaningful way. The information contained in the disclosure of an application must be sufficient to inform those skilled in the relevant art how to both make and use the claimed invention. Detailed procedures for making and using the invention may not be necessary if the description of the invention itself is sufficient to permit those skilled in the art to make and use the invention. The information incorporated is as much a part of the application as filed as if the text was repeated in the application, and should be treated as part of the text of the application as filed. Replacing the identified material incorporated by reference with the actual text is not new matter. Therefore, the fact that an additional limitation to a claim may lack descriptive support in the disclosure as originally filed does not necessarily mean that the limitation is also not enabled. In other words, even if a new limitation is not described in the original disclosure, the addition of a new limitation in and of itself may not create an enablement problem provided that one skilled in the art could make and use the claimed invention with the new limitation. Consequently, such limitations must be analyzed for both enablement and description using their separate and distinct criteria. Furthermore, when the limitation is not described in the specification portion of the application as filed but is in the claims, the limitation in and of itself may enable one skilled in the art to make and use the claimed invention. When claimed subject matter is only presented in the claims and not in the specification portion of the application, the specification should be objected to for lacking the requisite support for the claimed subject matter using form paragraph 7. This is an objection to the specification only and enablement issues should be treated separately. The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Minerals Separation Ltd. Accordingly, even though the statute does not use the term "undue experimentation," it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. Any part of the specification can support an enabling disclosure, even a background section that discusses, or even disparages, the subject matter disclosed therein. The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. In Wands, the court noted that there was no disagreement as to the facts, but merely a disagreement as to the interpretation of the data and the conclusion to be made from the facts. The court held that the specification was enabling with respect to the claims at issue and found that "there was considerable direction and guidance" in the specification; there was "a high level of skill in the art at the time the application was filed;" and "all of the methods needed to practice the invention were well known. After considering all the factors related to the enablement issue, the court concluded that "it would not require undue experimentation to obtain antibodies needed to practice the claimed invention. It is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others. A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. The determination that "undue experimentation" would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. Failure to disclose other methods by which the claimed invention may be made does not render a claim invalid under 35 U. Naturally, for unstable and transitory chemical intermediates, the "how to make" requirement does 2100-427 Rev. A key issue that can arise when determining whether the specification is enabling is whether the starting materials or apparatus necessary to make the invention are available. In the biotechnical area, this is often true when the product or process requires a particular strain of microorganism and when the microorganism is available only after extensive screening. The same can be said if certain chemicals are required to make a compound or practice a chemical process. When a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation. In contrast, when a compound or composition claim is not limited by a recited use, any enabled use that would reasonably correlate with the entire scope of that claim is sufficient to preclude a rejection for nonenablement based on how to use. If multiple uses for claimed compounds or compositions are disclosed in the application, then an enablement rejection must include an explanation, sufficiently supported by the evidence, why the specification fails to enable each disclosed use. In other words, if any use is enabled when multiple uses are disclosed, the application is enabling for the claimed invention. A prophetic example describes an embodiment of the invention based on predicted results rather than work actually conducted or results actually achieved. An applicant need not have actually reduced the invention to practice prior to filing. The court held that "The mere fact that something has not previously been done clearly is not, in itself, a sufficient basis for rejecting all applications purporting to disclose how to do it. The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. For example, it is not necessary to specify the dosage or method of use if it is known to one skilled in the art that such information could be obtained without undue experimentation. If one skilled in the art, based on knowledge of compounds having similar physiological or biological activity, would be able to discern an appropriate dosage or method of use without undue experimentation, this would be sufficient to satisfy 35 U. Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art. But because only an enabling disclosure is required, applicant need not describe all actual embodiments. In other words, lack of working examples or lack of evidence that the claimed invention works as described should never be the sole reason for rejecting the claimed invention on the grounds of lack of enablement. A single working example in the specification for a claimed invention is enough to preclude a rejection which states that nothing is enabled since at least that embodiment would be enabled. However, a rejection stating that enablement is limited to a particular scope may be appropriate. The presence of only one working example should never be the sole reason for rejecting claims as being broader than the enabling disclosure, even though it is a factor to be considered along with all the other factors. To make a valid rejection, one must evaluate all the facts and evidence and state why one would not expect to be able to extrapolate that one example across the entire scope of the claims. In other words, if the art is such that a particular model is recognized as correlating to a specific condition, then it should be accepted as correlating unless the examiner has evidence that the model does not correlate. Even with such evidence, the examiner must weigh the evidence for and against correlation and decide whether one skilled in the art would accept the model as reasonably correlating to the condition. Since the initial burden is on the examiner to give reasons for the lack of enablement, the examiner must also give reasons for a conclusion of lack of correlation for an in vitro or in vivo animal model example. However, a rigorous or an invariable exact correlation is not required, as stated in Cross v. An in vitro or in vivo animal model example in the specification, in effect, constitutes a "working example" if that example "correlates" with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute "working examples. Proof of enablement will be required for other members of the claimed genus only where adequate reasons are advanced by the examiner to establish that a person skilled in the art could not use the genus as a whole without undue experimentation. The "amount of guidance or direction" refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. The "predictability or lack thereof" in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability. This will especially be the case where the statement is, on its face, contrary to generally accepted scientific principles. Most often, additional factors, such as the teachings in pertinent references, will be available to substantiate any doubts that the asserted scope of objective enablement is in fact commensurate with the scope of protection sought and to support any demands based thereon for proof. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. This is because it is not reasonably predictable from the disclosure of one species, what other species will work. In order to make a rejection, the examiner has the initial burden to establish a reasonable basis to question the enablement provided for the claimed invention. A specification disclosure which contains a teaching of the manner and process of making and using an invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as being in compliance with the enablement requirement of 35 U. Assuming that sufficient reason for such doubt exists, a rejection for failure to teach how to make and/or use will be proper on that basis. As stated by the court, "it is incumbent upon the Patent Office, whenever a rejection on this basis is made, to explain why it doubts the truth or accuracy of any statement in a supporting disclosure and to back up assertions of its own with acceptable evidence or reasoning which is inconsistent with the contested statement. Otherwise, there would be no need for the applicant to go to the trouble and expense of supporting his presumptively accurate disclosure. This standard is applicable even when there is no evidence in the record of operability without undue experimentation beyond the disclosed embodiments. However, it is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.
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