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 .
DETAILED ACTION
Response to Amendment
1. Claims 1, 35 and 41 have been amended and claims 36, 37 and 39 canceled as requested in the amendment filed on April 10, 2026. Following the amendment, claims 1-3, 6-11, 14-20, 22, 23, 27, 31-35, 38 and 40-45 are pending in the instant application.
2. Claims 1-3, 6-11, 14-20, 22, 23, 27, 31-35, 38 and 40-45 are under examination in the instant office action.
3. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
4. New grounds of rejection necessitated by Applicant’s amendment are set forth below.
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 invention, 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 invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, 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 of carrying out his invention.
5. Claims 1-3, 6-11, 14-20, 22, 23, 27, 31-35, 38 and 40-45, as amended, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter rejection under the provisions of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), written description.
MPEP § 714.02 states that Applicant’s reply to the Office action must be fully responsive. Specifically, “Applicant should also specifically point out the support for any amendments made to the disclosure. See MPEP § 2163.06”. Further, MPEP § 2163.06 states that if new matter is added to the claims, the rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ) - written description requirement, is appropriate. The proscription against the introduction of new matter in a patent application serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981). Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement.
35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph sets forth the written description requirement as follows: The specification shall contain a written description of the invention, 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 of carrying out his invention. Compliance with the written description requirement is a question of fact. See Vas-Cath lnc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1116-17 (Fed. Cir. 1991).
The basic function of a patent specification is to disclose an invention. The written description serves a quid pro quo function “in which the public is given ‘meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.’” Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 922, 69 USPQ2d 1886, (Fed. Cir. 2004) (quoting Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970, 63 USPQ2d 1609. 63 USPQ2d 1618, (Fed. Cir. 2002)). In other words, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention,” Vas-Cath Inc., 935 F.2d at 1563-64, and demonstrate that by disclosure in the specification of the patent.
In the instant case, independent claims 1 and 35, as currently presented, specifically require possession of the methods comprising the steps of (1) selecting a patient with lipodystrophy in need of reducing chronic pain, anxiety, and/or depression; (2) administering to the patient a baseline Patient Health Questionnaire-9 (PHQ-9) or a Short Form-36 Health Questionnaire (SF-36) prior to administering, to the patient, an effective amount of a leptin receptor (LEPR) agonist; (3) scoring the baseline PHQ-9 or SF-36; (4) administering to the patient the effective amount of the LEPR leptin receptor agonist antibody; (5) administering a subsequent PHQ-9 or SF-36 after administering the LEPR agonist; and (6) scoring the subsequent PHQ-9 or SF-36. The specification as originally filed does not provide written description for the inventive concept as currently in claims. Thus, the written support for the new limitation is not readily apparent in the specification as filed. This affects all dependent claims.
Applicant submits at p. 10 of the Response that the amendment is supported by paragraphs [111], [1112], [126] and [127]. After careful analysis of the cited paragraphs, the Examiner concludes that the text of the specification does not explain the currently claimed methods in all the necessary details. Specifically, the cited paragraphs [111] and [112] describe a patient, one patient, suffering from lipodystrophy, type 1 diabetes, early onset severe steatohepatitis with fibrosis, additional autoimmune features, pancreatitis and pain “due to hypertriglyceridemia and massive hepatomegaly.” Paragraphs [126] and [127] describe administering PHQ-9 test to the patient treated with the LEPR agonist antibody. It is understood that the instant specification describes new, previously not fully appreciated, effects of administration of LEPR agonist antibody to patients with lipodystrophy, wherein the treatment itself has been fully described previously and awarded patent protection, see art rejection in section 7 of Paper mailed on December 11, 2025. However, the limitations of the presently amended claims are not described within the specification in full detail of the inventive concept.
Because the instant claims now recite limitations which were not clearly disclosed in the specification as filed, these limitations introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C. 112.
To obviate the instant rejection of record, Applicant is invited to provide sufficient written support for the limitations indicated above. See MPEP 714.02 and 2163.06.
Conclusion
6. No claim is allowed.
7. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
June 9, 2026
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