DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04 November 2025 has been entered.
Status of Application, Amendments and/or Claims
The amendment and Applicant’s arguments, 04 November 2025, has been entered in full. Claims 16-19, 23, 24, 26-29 are withdrawn from consideration as being drawn to a non-elected invention. Claims 10 and 25 are canceled. Claims 1, 2, 20-22, are amended. Claims 1-9, 11-15, 20-22 are under examination.
Withdrawn Objections And/Or Rejections
The rejection to claims 1-9, 11-15, 20-22 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first paragraph, written description, as set forth at pages 3-7 of the previous Office Action (04 August 2025), is withdrawn in view of the amendment (04 November 2025).
The rejections to claims 1-9, 11-15, 20-22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre- AIA ), second paragraph, as set forth at pages 8-11 of the previous Office Action (04 August 2025), is withdrawn in view of the amendment (04 November 2025).
The objection to claims 20, 21 and 22 as set forth at pages 11 of the previous Office Action (04 August 2025), is withdrawn in view of the amendment (04 November 2025).
MATTER OF RECORD
The elected species of antigen-binding peptides that specifically bind to at least one perilipin-1 epitope, wherein said antigen-binding peptides comprise heavy chain (CDR1-CDR3)/light chain (CDR1-CDR3), is free of prior art. The additional species antigen-binding peptides have been rejoined for prosecution.
The Examiner notes that an antigen-binding peptide comprising the heavy chain CDRs 1-3 and the light chain CDRs1-3, as recited in claims 1(i)-xlixlii, are free of the art.
Claims 1-9, 11, 12, 14, 15, 20-22 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(b), claims 16 and 24, directed to the process of making or using the allowable product, previously withdrawn from consideration as a result of a restriction requirement, is hereby rejoined and fully examined for patentability under 37 CFR 1.104. Claims 17-19, 23, 26-29 are directed to the inventions of bispecific antigen-binding proteins, isolated nucleic acids and a method of treating obesity do not require all the limitations of an allowable product claim, and have NOT been rejoined.
Because a claimed invention previously withdrawn from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement between Group I (claims 1-9, 11-15, 20-23) and Group II (claims 16 and 24) as set forth in the Office action mailed on 25 September 2024 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
NEW CLAIM REJECTIONS/OBJECTIONS
Claim Rejections-35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “capable” in claim 13 is a relative term which renders the claim indefinite. The term “capable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Amending claim 13 to recite, “The antigen-binding peptide according to claim 1, wherein said antigen-binding peptide binds to a perilipin-1 fragment presented on an adipocyte..”, would be remedial.
Claim Rejections-35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, enablement
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.
Claims 16 and 24 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 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.
The instant claims are not enabled for the following reasons:
1. The Examples fail to teach administering the claimed product to an obese subject. The Examples fail to teach the use of an art accepted model to discern in vivo treatments for obesity.
One cannot extrapolate the teachings of the specification to the claimed invention because the in vitro experimental data presented is clearly not drawn to subjects who are obese. There is no guidance on or exemplification of any correlation between any of the in vitro assays and treating obesity in a patient. The specification provides insufficient guidance with regard to these issues and provides no working examples which would provide guidance to one skilled in the art and no evidence has been provided which would allow one of skill in the art to predict the efficacy of the claimed methods with a reasonable expectation of success.
The art teaches the importance of using an art recognized animal model to study diseases and conditions.
See wherein Speakman et al. teach that obesity stems from a prolonged imbalance between the levels of energy intake and expenditure, with the resultant surplus being stored as body lipids. Speakman et al. state, “animal models have been a cornerstone of studies of environmental effects, such as epigenetics, responses to high-fat and low-calorie diets and the identification and development of pharmaceuticals for obesity treatment”. Speakman et al. teach various examples of the animal work that has been performed, and focuses on the variation in approaches that have been taken and their potential.
Speakman discusses the work of Powell et al. (see page 59, first column, 2nd full paragraph). It was observed that knockout mice could provide future prospective identification of putative pharmaceutical targets for drug development. The scientist reviewed the phenotypes of 21 different types of knockout mice where the gene knocked out was a potential therapeutic target for obesity. These were compared with the phenotypes of mice treated with therapeutics designed for the same targets. Of the 21 obesity gene targets considered, 16 showed a close correspondence between the knockout phenotype and drug effect in mice and/or rats. The knockout phenotypes mimicked not only the effects of therapeutics in rodents, but also the effects when relevant therapeutics targeting the same genes were delivered to humans. Speakman et al. concludes by stating that the use of animal models to study phenomena that underlie obesity (genetic, physiological, epigenetic and environmental) as well as investigations of potential treatments in animals has provided an enormous amount of information that has had both direct and indirect impacts on our understanding of the condition. The use of animal models will continue to be the cornerstone of our understanding of the underlying physiological and genetic basis of energy regulation, taste and smell perception and food choice behavior. Moreover, animal models will also continue to provide a vital test bed for putative pharmaceuticals and novel dietary intervention techniques that may impact on the epidemic (Speakman et al. Animal models of obesity. Obesity Reviews Vol 8, Suppl 1:55-61; 2007).
2. Secondly, even if the claims were enabled for treating obesity, they would not be enabled for preventing obesity.
“Prevent” means to completely stop a condition from occurring. “Prevention” is not a relative term, it is total. The specification would not be enabled for a method of preventing or stopping obesity. A very high degree of evidence is required, which is accepted in the art, that an absolute protection from the pathology exists over an extended period of time. It could not be predicted that an administered antigen-binding peptide that specifically bind to at least one of the recited perilipin-1 epitopes, wherein said antigen-binding peptide comprises the recited heavy chain (CDR1-CDR3)/light chain (CDR1-CDR3), would completely stop obesity from ever occurring.
Due to the inherent unpredictability and the large quantity of experimentation necessary to show that the onset of obesity has been completely prevented; the lack of direction/guidance presented in the specification regarding an enabling correlation between the presented in vitro data and administering the claimed product to a subject to treat obesity; the absence of working examples regarding same; the complex nature of the invention; and the state of the art which establishes the use of (proper) animal models that accurately mimics the conditions/disease to be treated; undue experimentation would be required of the skilled artisan to make and/or use the claimed invention.
Allowable subject Matter
Claims 1-9, 11, 12, 14, 15, 20-22 are allowed.
Conclusion
Claims 13, 16 and 24 are rejected.
Claims 1-9, 11, 12, 14, 15, 20-22 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M DEBERRY whose telephone number is (571)272-0882. The examiner can normally be reached M-F 9:00-6:30 pm (alt Fri).
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/R.M.D/Examiner, Art Unit 1647 12/20/2025
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647