DETAILED ACTION
This Action is in response to the communication filed on 03/26/2026.
Claims 1-5, 13-20 are pending.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/08/2026 was filed after the mailing date of the final Office action on 12/29/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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.
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.
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.
Claims 1-5, 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tam et al. (Cell Metabolism, 2012; of record – cited in 02/08/2026 IDS; hereinafter “Tam”).
Tam teaches treating Diet Induced Obesity (DIO) mice by administering JD5037 to the mice, which results in partial inhibiting circulating leptin in the mice wherein the circulating leptin levels appear to be reduced in the range of 50-70% compared to controls (e.g., see Figure 5F and description thereof). Tam states:
“To further test whether reversal of the hyperleptinemia is sufficient to restore leptin sensitivity, DIO mice were infused with leptin at different rates for 7 days and simultaneously treated with daily oral doses of 3 mg/kg JD5037 or vehicle. Plasma leptin was significantly reduced by JD5037, the reduction being progressively greater the higher the pretreatment level (Figure 5F).” (See page 173, first column).
Tam also demonstrates that JD5037 decreases Leptin secretion from adipocytes, stating, “Furthermore, 24 hr incubation of differentiated 3T3 L1 adipocytes with different CB1R agonists increased leptin in the culture medium, which was inhibited by 100 nM JD5037 (Figure 6B).” (See page 173, second column and Figure 6B).
Tam demonstrates that treating DIO mice with JD5037 restored weight loss to control levels, thus demonstrating detecting a resultant improvement in the obesity of the subject
Thus, Tam teaches treating obesity in a subject by partially inhibiting circulating leptin in the mice wherein the circulating leptin levels appear to be reduced in the range of 50-70%.
Tam does not teach that: (1) the subject is a person, (2) the inhibiting step is performed under thermoneutral conditions, (3) titrating down the levels of leptin of the person to effect leptin sensitization without effecting weight gain.
It would have been prima facie obvious to one of ordinary skill in the art prior to the day the claimed invention was filed to modify the method of treating obesity in a subject taught by Tam such that the subject is a person, the inhibiting step is performed at thermoneutral conditions, and further titrating down the levels of leptin of the person to effect leptin sensitization without effecting weight gain, with a reasonable expectation of success.
Since DIO mice are art accepted animal models for human obesity, there would have been motivation to apply the method to a person who has obesity and there would have been a reasonable expectation of success based on the positive results demonstrated in the DIO mouse. Furthermore, although Tam does not explicitly teach that the inhibiting step is performed under thermoneutral conditions, it appears that the method was performed under normal (i.e., thermoneutral) conditions. Nevertheless, it would have been prima facie obvious to one of ordinary skill in the art prior to the day the invention was claimed to perform the method under normal (thermoneutral) conditions for convenience and there would have been a reasonable expectation of success based on the position result demonstrated by Tam. Furthermore, although Tam does not teach titrating down the levels of leptin of the person to effect leptin sensitization without effecting weight gain, it would have been a matter of routine optimization of the method taught by Tam to perform titration of leptin levels of the person in order to determine the effective levels of leptin of the person to effect leptin sensitization without effecting weight gain. It is prima facie obvious for one ordinarily skilled in the art to perform routine optimization. As noted in In re Aller, 105 USPQ 233 at 235,
More particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the instant claims are prima facie obvious over Tam.
It is noted that Tam provides evidence that partial reduction of leptin in obese subjects would lead to weight loss and glucose tolerance (e.g., see Figures 2 (E, J-M), 3 (F-G), 4-5, etc.) was not unexpected prior to the effective filing date of the claimed invention.
Claims 1-5, 13-14, 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tam et al. (Cell Metabolism, 2012; of record – cited in 02/08/2026 IDS; hereinafter “Tam”), as applied to claims 1-5, 15-20 in the rejection above, in view of Roh et al. (Exp Anim (2018) vol. 67(2): 229-237; published online 16 January 2018; of record).
Tam teaches treating Diet Induced Obesity (DIO) mice by administering JD5037 to the mice, which results in partial inhibiting circulating leptin in the mice wherein the circulating leptin levels appear to be reduced in the range of 50-70% compared to controls as indicated in the rejection above.
Tam does not teach inhibiting circulating leptin by knocking down leptin expression using CRISPR/Cas9.
Roh teaches successfully using CRISPR/Cas9 to knock down leptin expression in mouse cells (e.g., see abstract, page 231 under “Results”, etc.).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior the day the claimed invention was filed to further modify the method of Tam by using CRISPR/Cas9 to knock down expression of leptin with a reasonable expectation of success. It is noted that one rationale to use the CRISPR/Cas9 system to knock down leptin levels is that it would have been a matter of simple substitution of one known element for another (leptin knock down using CRISPR/Cas9 instead of JD5037) to obtain predictable results. The positive results of Roh demonstrating CRISPR/Cas9 inhibition of leptin provides the basis for a reasonable expectation of success.
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.
Claims 1-5, 13-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating obesity in a person in need thereof wherein the method comprises partially inhibiting circulating leptin 30%-90% by administering an agent that inhibits circulating leptin to said person in need thereof, does not reasonably provide enablement for treating diabetes. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988).
Wands states on page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
The nature of the invention
The claims are broadly drawn to a method of treating obesity or diabetes comprising partially inhibiting circulating leptin by 3-90% in a person in need thereof. Thus, the invention is in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., lnc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The breadth of the claims
The claims are broad with respect to using any means for partially inhibiting circulating leptin in a person in need thereof. Furthermore, it is noted that treating “diabetes” broadly encompasses treating all types of diabetes (e.g., type I and type II, which are very etiologically distinct types of diabetes).
The unpredictability of the art and the state of the prior art
The prior art teaches partially inhibiting circulating leptin level in an mouse model of obesity by administering JD5037 to said mouse, and also teaches using CRISPR/Cas9 to knock down leptin expression in mouse cells (e.g., see Tam and Roh references as indicated in the rejection(s) above). The prior art does not appear to teach treating diabetes by partially inhibiting circulating leptin levels in a subject in need thereof.
Working Examples and Guidance in the Specification
The specification provides working examples the utilize an animal model for obesity, specifically a mouse, wherein the obese mouse is treated with three different antibodies that are specific for leptin, as well as treating the obese mouse with CRISPR/Cas9 system as well a CRE/loxP system that reduces circulating leptin levels in the mouse. There are no examples presented demonstrating treatment of diabetes in a subject in need thereof.
Quantity of Further Experimentation Required
As indicated above, the claimed encompass treating any type of diabetes in a subject in need thereof, which includes treating type I and type II diabetes. Type I diabetes is an autoimmune disorder where the immune system destroys insulin-producing beta cells in the pancreas, while type II diabetes is a metabolic condition wherein a subject’s cells become resistant to insulin. Therefore, an effective treatment for one type of diabetes may not be an effective treatment for another type of diabetes. Since there is no evidence found in the prior demonstrating treatment of diabetes by inhibiting circulating leptin levels in a subject in need thereof, additional experimentation is required. Considering that the lack of evidence with respect to treating diabetes in view of the fact that the claims encompass treating type I and type II diabetes which different causes, the additional experimentation would require de novo experimentation without a guarantee of success, and further considering that any positive results (i.e., successful treatment of diabetes in a subject) would amount to a significant advancement in the state of the art, the additional experimentation required is considered undue.
Level of the skill in the art
The level of the skill in the art is deemed to be high.
Conclusion
Considering the nature of the invention, the breadth of the claims, the unpredictable nature of the invention as recognized in the prior art, the limited amount of working examples and guidance provided, and the high degree of skill required to practice the invention, it is concluded that the specification does not provide an enabling disclosure for the entire scope encompasses by the instant claims. Therefore, additional experimentation is required before one of skill in the art could make and use the claimed invention. The amount of additional experimentation required to perform the broadly claimed invention is undue.
Furthermore, in In re Vaeck, 947 F.2d 488,495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the Court ruled that a rejection under 35 U.S.C. 112, first paragraph for lack of enablement was appropriate given the relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims. Such is the case here where there is a relatively incomplete understanding in the biotechnological field involved, as described above, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims.
Therefore, it is appropriate to reject the claims under 35 USC 112(a) for not being enabled to their full scope. It is noted that amending the claims to, for example, a method of treating obesity in a person in need thereof wherein the method comprises partially inhibiting circulating leptin 30%-90% by administering an agent that inhibits circulating leptin to said person in need thereof would obviate this rejection.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11760799. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 1 is drawn to method of treating obesity or diabetes comprising partially inhibiting circulating leptin by 30-90% in a person in need thereof.
Claim 4 of the ‘799 patent is drawn to a method of reducing leptin levels in a human subject, comprising administering an effective amount of the antibody of claim 1 (i.e., an antibody that binds human leptin) to said subject.
Claim 4 of the ‘799 patent does not teach partial inhibition of circulating leptin by 30-90%. It is noted that the instant claims do not require any particular amount of inhibitor to the person, thus since claim 4 of the patent teaches administering leptin inhibitor to a person it meets the broad requirement of claims 1-3 (which encompass administering any amount of any leptin inhibitor), and the resultant inhibition of circulating leptin levels is an inherent feature of performing treatment. It is also noted that using the specification of the ‘799 patent as a dictionary to define broad claim 4 including obvious variations thereof, the specification discloses “Antibody treatment leads to an effective 40% reduction of circulating leptin levels, sufficient to achieve a significant degree of leptin sensitization.” (See column 6, lines 32-34). Furthermore, it also would have been a matter of routine optimization to perform additional experimentation to determine the most effective amount of the antibody to achieve the optimum inhibition of circulating leptin levels. As noted in In re Aller (as indicated above), it is prima facie obvious for one ordinarily skilled in the art to perform routine optimization.
Terminal Disclaimer
The terminal disclaimer filed on 03/26/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11732037 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments with respect to non-statutory double patenting rejection have been fully considered and in view of the filing of a proper terminal disclaimer, are persuasive. The rejection has been withdrawn.
However, upon further consideration of the claims beyond the elected invention (using CRISPR/Cas9) and upon consideration of the IDS filed 02/08/2026, new grounds of rejection are set forth for the reasons indicated above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/ Primary Examiner, Art Unit 1637
Prosecution Insights