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 . 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5 June, 2025 has been entered.
Claims Status
Claims 1, 4, 5, and 12-16 are pending.
Claim 1 has been amended.
Withdrawn Objections
The objection to the drawings due to the use of color is hereby withdrawn due to a successful petition for color drawings.
Withdrawn Rejections
The rejection of claims 1-5, 7, and 12-16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to inconsistencies between the sequence listing and the claim for a polypeptide is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 112(a)
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 1, 4, 5, and 12-16 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.
Claim 1, and claims dependent on it, has been amended to exclude a genus of peptides. However, this genus of peptides is not mentioned in the disclosure in any way, making this amendment new matter.
response to applicant’s arguments
Applicants argue that the excluded genus consists entirely of sequences described by applicants, making it proper.
Applicant's arguments filed 5 June, 2025 have been fully considered but they are not persuasive.
Applicants argue that they can give a negative limitation for sequences they have described in their specification. While this is correct, that is not what applicants have done. They have spelled out a specific subgenus, which is not described in the disclosure as filed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
first rejection
Claim(s) 1-5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Resmark et al (J. Clin. Med. (Jan 2019) 8 (153)) in view of Cai et al (Curr. Top. Med. Chem. (2009) 9(6) p554-563, cited by applicants), Doering et al (J. Med. Chem (2017) 60(10) p4342-4357), and Chaki et al (Curr. Topics Med. Chem. (2007) 7 p1145-1151).
Resmark et al discuss treatment of anorexia nervosa (title). This disorder is characterized by a restriction of energy intake and weight loss (1st page, 1st paragraph). Many patients have comorbid psychological diseases, such as depression and anxiety (2nd page, 1st paragraph). Psychotherapy and nutritional therapy are the mainstay of treatment of this disease, while organoleptics (i.e. antipsychotic agents) are used on a case by case basis (table 1, 4th page).
The difference between this reference and the instant claims is that this reference does not discuss treating anorexia nervosa patients.
Cai et al discuss melanotropins for treatment of feeding disorders (title). Administration of an MC3R agonist stimulates food intake (6th page, 2nd paragraph), which would be useful in treating patients that do not eat enough. MC4R agonists have been used to treat obesity (p10, 7th paragraph), the opposite pharmaceutical effect as desired for patients that do not eat enough, suggesting that MC4R antagonists may be beneficial in such patients. This reference links the MC3R and MC4R to eating behavior, and suggest therapeutic intervention at these receptors.
Doering et al discuss tetrapeptides that are agonists to the MC3R and antagonists to the MC4R (title), which are integral in maintaining energy homeostasis and body weight regulation (p4342, 1st column, 1st paragraph). A lead compound Ac-His-Arg-(pI)DPhe-Tic-NH2 was used as the starting point (p4344, 2nd column, 2nd paragraph). A library of compounds was made, where the His was substituted with Arg, His, Pip, 3Bal, Tic, Phe, and Nal(2’)(both l and d isomers), and the Tic was substituted with Bip, 3Bal, Tic, Phe, and Nal(2’) (p4345, 2nd column, 1st paragraph). Note that these are the same sequences that applicants are using in their claimed method. Many of these sequences were MC3R agonists and MC4R antagonists (table 1, p4346, entire page), the same pharmaceutical effects that Cai et al suggest will be useful for treating eating disorders linked to starvation.
Chaki et al discuss the effect of MC4 antagonists (such as the peptides of Doering et al) on anxiety (title). These compounds have anxiolytic effects (abstract), so would be expected to help with anxiety.
Therefore, it would be obvious to use the peptides of Doering et al to treat the starvation of anorexia nervosa, as described by Resmark et al, as the pharmaceutical behavior of these peptides match what Cai et al state will increase feeding. As Doering et al mention that the targets of these peptides are integral to energy homeostasis and body weight regulation, the same problem that Resmark et al teaches is an issue in anorexia nervosa, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Resmark et al mentions that anorexia nervosa is characterized by starvation. Cai et al teaches that the pharmaceutical effect of the peptides of Doering et al will cause increased food intake, making it obvious to use these sequences for treating this disorder. Resmark et al teaches that the disorder is characterized by anxiety. Chaki et al teaches that the MC4 antagonism of the peptides of Doering et al will have a beneficial effect on anxiety. Thus, the combination of references renders obvious claims 1, 2, and 5.
Resmark et al teaches that the disorder is characterized by depression, rendering obvious claims 3 and 4.
These are the same sequences as claimed by applicants, so will have the same binding affinity, rendering obvious claim 7.
Resmark et al teach that psychotherapy and nutritional management are the approved therapy for anorexia nervosa, rendering obvious claim 16.
response to applicant’s arguments
Applicants argue that a person of skill in the art would not select a sequence selective for MC3R over MC4R for treatment of anxiety.
Applicant's arguments filed 5 June, 2025 have been fully considered but they are not persuasive.
The rejection is not written as treatment of anxiety, but rather for treating anorexia, where some patients may have anxiety.
second rejection
Claim(s) 1-5 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Resmark et al (J. Clin. Med. (Jan 2019) 8 (153)) in view of Cai et al (Curr. Top. Med. Chem. (2009) 9(6) p554-563, cited by applicants), Doering et al (J. Med. Chem (2017) 60(10) p4342-4357), Chaki et al (Curr. Topics Med. Chem. (2007) 7 p1145-1151), and Le Tourneau et al (J. Natl. Cancer Inst. (2009) 101 p708-720).
The teachings of Resmark et al, Cai et al, Doering et al, and Chaki et al were given above, and will not be repeated here. As noted above, these references render obvious claims 1-5, 7, and 16.
The difference between the combination of those references and the remaining claims is that the references do not discuss a dose schedule.
Le Tourneau et al discuss dose escalation methods for optimizing drug dosing (title). The main goal of the phase I clinical trial is to establish the dose and dose schedule of new drugs or drug combinations (abstract). The goal is to avoid subtherapeutic doses while preserving safety and maintaining rapid accrual (p708, 1st column, 2nd paragraph). For drugs that are not toxicity limited, the occurrence of drug-related biological effects is suggested as the endpoint (p708, 2nd column, 1st paragraph). A number of different protocols for performing this optimization are given (fig 2, p711, top of page). This reference discusses how to optimize the dose schedule for new drugs.
Therefore, it would be obvious to optimize the dose schedule for the peptides of Doering et al, as described by Le Tourneau et al, to assure rapid accrual and to maximize therapeutic effect while minimizing toxicity. As every drug used must have the dose and dose schedule optimized, an artisan in this field would have experience in doing so, and so would have a reasonable expectation of success.
response to applicant’s arguments
Applicants have presented the same arguments for both rejections under this statute, which were answered after the first rejection.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658