DETAILED ACTION
The amendment submitted on March 11, 2026 has been entered. Claims 1, 3-4, 6-13, and 15-22 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Withdrawn Objections and Rejections
The objection to the specification is withdrawn in view of the information disclosure statements submitted on March 11, 2026 and March 12, 2026.
The rejection of claims 1-4, 6-9, 12-13, and 15-17 under 35 U.S.C. 102(a)(1) as being anticipated by US 2007/0213306 A1 by Hausknecht is withdrawn because the limitations of claims 5 and 14, which were not rejected on this basis, have been incorporated into independent claims 1 and 12, respectively.
Maintained Rejections Claim Rejections – 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the inven-tion, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the inven-tion.
Claims 1, 3-4, 6-13, and 15-22, as amended, are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is “reasonable” or is “undue.” Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. See Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP 2164.01. Upon considera-tion of each of these factors, the examiner concludes that one of skill in the art would be burdened with undue experimentation when attempting to make and use the invention as claimed.
The claims recite “preventing” hernia, but the search of the prior art reveals that there is no such known pharmaceutical therapy. The search of the prior art reveals that one cannot prevent hernias with medication alone because caused by physical weakness or tears. “How To Prevent and Treat Hernias” by The Surgical Clinic (retrieved from https://thesurgicalclinics.com/ on December 9, 2025) discloses that “not all hernias are preventable, but there are steps you can take to reduce your risk of developing a hernia.” The steps that one might take to reduce the risk of hernia include maintaining a healthy weight through a balanced diet and regular exercise can help reduce the risk of developing a hernia, exercise regularly, avoid lifting heavier than you can and using poor lifting techniques, prevent constipation, and manage other health problems, among other things. Note that this reference does not disclose that there is any known medica-tion that can be used for the prevention of hernias, so one of skill in the art would be skeptical that such a therapy is even possible. Turning to applicant’s specification (see the examples at pp. 28-30), applicant describes certain experiments that are evidently planned. Importantly, the examples in the specification are written in the present tense or the future tense, and therefore do not describe anything that has actually been reduced to practice. In the absence of such information, one of skill in the art would be burdened with undue experimentation when attempting the ascertain whether or not it is possible to prevent hernias with medication alone.
Finally, with respect to new claims 21-22, even though the preamble of the claims states that it is a “method for inhibiting proliferation of fibroblasts, fibrosis, muscle atrophy, or hernia development in lower abdominal muscle of a human subject assigned male at birth,” the claims nevertheless read on a method of preventing a hernia.
Response to Arguments
Applicant argues that “[t]he specification, including the overlooked working examples, provides sufficient disclosure to enable hernia prevention. The present claims find adequate support in the specification. A skilled artisan would have been able to practice the claimed invention without undue experimentation in view of the disclosure, including working examples. Peer-reviewed acceptance and publication with working examples presenting in the present specification provide evidence that a skilled artisan would not have been skeptical of the claimed methods and that they could make and use the technology without undue experimentation. Moreover, there is no basis for asserting that any claim for a method of treatment must be 100% effective.” See applicant’s Remarks, submitted March 11, 2026, at pp. 5-8. The examiner agrees that there is no requirement of law that applicant must demonstrate 100% efficacy. The enable-ment standard set forth in MPEP 2163 is that applicant must provide “sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” Even though § 112(a) does not use the term “undue experimen-tation,” it is Office policy to require that a claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. See MPEP 2164.01. The examiner appreciates the scientific merit of applicant’s laboratory experiments, but the best evidence before the examiner is that there is no known pharmaceutical method of preventing a hernia. Applicant’s arguments have been fully considered, but are not persuasive. The rejection is accordingly maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
April 1, 2026