DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the application
Receipt of applicant’s remarks and claim amendments filed on 12th Jan 2026 are acknowledged.
In light of claim amendments, previous Claim Objections and 112(b) rejection are withdrawn.
However, applicants’ arguments for the previous 103 rejection are found not persuasive. Accordingly, the previous rejection is maintained. Please see the examiners response to applicants below.
With regard to nonstatutory double patenting rejections, since applicants offer no direct arguments against the rejections of record nor has a Terminal Disclaimer been filed over the pending rejections. Also, applicants mentioned that ‘previous nonstatutory double patenting rejections be held in abeyance until allowable claims have been identified in the subject application’, and accordingly, the rejections are maintained.
Response to Arguments
Applicants main argument is that office failed to provide that the skilled artisan has a reasonable expectation of success or that the claimed invention as a whole is predictable. Further, Applicant submits that the Examiner's assertions are improperly derived from a hindsight analysis of Applicant's own disclosure and cannot be considered a valid demonstration of prima facie obviousness.
Boyce teaches treating MCR-4 mediated diseases, such as early onset of obesity, insulin resistance, and diabetes due to leptin deficiency, by administering MCR-4 agonists. Dong teaches applicants MCR-4 agonist, and further teach the MCR-4 agonist suppresses food intake. The “suppresses food intake” is interpreted as lowering sugar levels and which is nothing but treating diabetes, specifically insulin resistance diabetes, absent evidence to the contrary. So, the combination reads applicants claimed invention.
Based on the above, first, the combination of the teachings of cited art reads applicants claimed invention. Second, there is a reasonable expectation of success to arrive at applicants claimed invention since there is a nexus between the teachings of cited art as explained above. So, a skilled person in the art would be motivated to extrapolate the teachings of Dong into the teachings of Boyce and treat insulin resistance, also since suppressing food intake directly related to controlling diabetics, and arrive at applicants invention with a reasonable expectation of success. Applicants simply comment that there is no reasonable expectation of success, but failed to explain why?
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
Applicants show how each cited reference differ from the instant invention, but the obviousness test under 35 U.S.C. 103 is whether the invention would have been obvious in view of the prior art taken as a whole. In re Metcalf et al. 157 U.S.P.Q. 423.
Applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-2, 4-5, 9, 13-14, 21, 23-24 and 28-29 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Boyce et al. (WO 03/099818 A1) in view of Dong et al. (US 8,563,000 B2) and Hung et al. (Diabetology & Metabolic Syndrome, 2019, 5 pages).
Regarding claim 1, Boyce et al. disclose administering by intraperitoneal (ip) injection an effective amount of a MCR-4 agonist to 9-10 week old ob/ob mice (subject in need of treating insulin resistance) that display early onset of obesity, insulin resistance, and diabetes due to leptin deficiency. See paragraph [0246-0248]. With regard to the limitation “treating insulin resistance in a subject in need thereof” recited in the preamble and the limitation “to treat said insulin resistance in said subject in need thereof” recited in the body of the claim, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Boyce et al. also teach that the administration results in a significant reduction in food intake. See paragraph [0247].
Regarding claims 5 and 21, the mice display early onset of obesity (the subject is obese). See paragraph [0246].
Regarding claim 9, the mice displayed diabetes due to leptin deficiency (type II diabetes). See paragraph [0246]. Ob/ob mice that are leptin deficient exhibit metabolic signatures consistence with Type II diabetes phenotype as evidenced by Hung et al. See the §Introduction.
Regarding claims 13 and 28, Boyce et al. teach the MC4-R agonist was administered by intraperitoneal (ip) injection. [0246-0252].
Regarding claims 14 and 29, Boyce et al. teach the administration is twice daily. See paragraph [0247-0252].
Regarding claim 21, Boyce et al. teach the MCR4 agonist was administered in an amount effective to reduce the body weight of the mice. See paragraph [0248].
The difference is that Boyce et al. do not teach the Melanocortin 4 receptor agonist is an agonist selected from generic formula (IV) and also the list of agonists set forth in claim 2.
However, Dong et al. teach the compound Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2 (elected species; see compound B; SEQ ID NO: 13). Dong et al. the compound Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2 teach selectively binds to the Melanocortin 4 receptor (Ki). See Table 2B. Dong et al. further teach the compound suppresses food intake. See Figures 2B and col. 121, lines 23-58.
At the time the invention was made, it would have been obvious to the artisan of ordinary skill in the art to substitute Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2 taught Dong et al. for the melanocortin 4 receptor agonist of Boyce et al. because Ac-D- Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2 is an agonist selective melanocortin 4 receptor. The artisan of ordinary skill in the art would have been motivated to select Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2 with a reasonable expectation of success because it suppresses food intake as demonstrated by Dong et al.
Therefore, at the time the invention was made, the claimed invention was prima facie obvious to the artisan of ordinary skill.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed method with a reasonable expectation of success.
Non-statutory Double Patenting Rejection
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, 2, 5, 13, 14, 21, 24, 28 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US 9,155,777 B2 in view of Dong et al. (US 8,563,000 B2; 2013 filed May 25, 2007).
Regarding claims 1 and 2, US 9,155,777 B2 claims a method of treating insulin resistance in a subject in need thereof, comprising peripheral administration of an effective amount of Ac-Arg-c(Cys-D-Ala-His-D-Phe-Arg-Trp-Cys)-NH2 (SEQ ID NO:50) or a pharmaceutically acceptable salt thereof (melanocortin 4 receptor agonist) to treat said insulin resistance in said subject. See claims 1-10.
US 9,155,777 B2 does not claim the receptor is Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2.
Dong et al. teach the compound Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2 (elected species; see compound B; SEQ ID NO: 13). Dong et al. teach selectively binds to the Melanocortin 4 receptor (Ki). See Table 2B. Dong et al. further teach the compound suppresses food intake. See Figures 2B and col. 121, lines 23-58.
Regarding claim 5, US 9,155,777 B2 claims the subject is obese. See claim 2.
Regarding claim 13, US 9,155,777 B2 claims the peripheral administration is oral, subcutaneous, intraperitoneal, intramuscular, intravenous, rectal, transdermal or intranasal. See claim 4.
Regarding claim 14, US 9,155,777 B2 claims the administration is continuous, hourly, four times daily, three time daily, twice daily, once daily, once every other day, twice weekly, once weekly, once every two weeks, once a month, or once every two months. See claim 5.
Regarding claim 21, US 9,155,777 B2 claims the method reduces the body weight of said subject in need thereof. See claim 6.
Regarding claim 24, US 9,155,777 B2 claims the subject is obese. See claim 7.
Regarding claim 28, US 9,155,777 B2 claims the administration is continuous, hourly, four times daily, three time daily, twice daily, once daily, once every other day, twice weekly, once weekly, once every two weeks, once a month, or once every two months. See claim 8.
Regarding claim 29, US 9,155,777 B2 claims the administration is continuous, hourly, four times daily, three time daily, twice daily, once daily, once every other day, twice weekly, once weekly, once every two weeks, once a month, or once every two months. See claim 9.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 2, 4 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US 9,155,777 B2 in view of Dong et al. (US 8,563,000 B2; 2013 filed May 25, 2007).
US 9,155,777 B2 claims a method of treating insulin resistance in a subject in need thereof, comprising peripheral administration of an effective amount of Ac-Arg-c(Cys-D-Ala-His-D-Phe-Arg-Trp-Cys)-NH2 (SEQ ID NO:50) or a pharmaceutically acceptable salt thereof (melanocortin 4 receptor agonist) to treat said insulin resistance in said subject. See claims 1-10.
US 9,155,777 B2 does not claim the receptor is Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2.
Dong et al. teach the compound Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2 (elected species; see compound B; SEQ ID NO: 13). Dong et al. teach selectively binds to the Melanocortin 4 receptor (Ki). See Table 2B. Dong et al. further teach the compound suppresses food intake. See Figures 2B and col. 121, lines 23-58.
It would have been obvious to substitute Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2 taught Dong et al. for Ac-Arg-c(Cys-D-Ala-His-D-Phe-Arg-Trp-Cys)-NH2 (SEQ ID NO:50) claimed in US. Patent No. 9,155,777 B2 because Ac-D- Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2 is an agonist selective for the melanocortin 4 receptor. The artisan of ordinary skill in the art would have been motivated to select Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2 with a reasonable expectation of success because it suppresses food intake as demonstrated by Dong et al.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US 9,155,777 B2 in view of Goldstein (“Insulin Resistance as the Core Defect in Type 2 Diabetes Mellitus”, Am J Cardiol, 2002, 3G-10G).
US 9,155,777 B2 claims a method of treating insulin resistance in an obese subject in need thereof, comprising peripheral administration of an effective amount of Ac-Arg-c(Cys-D-Ala-His-D-Phe-Arg-Trp-Cys)-NH2 (SEQ ID NO:50) or a pharmaceutically acceptable salt thereof (melanocortin 4 receptor agonist) to treat said insulin resistance in said subject. See claims 1-10.
US 9,155,777 B2 does not claim the subject is suffering from type 2 diabetes.
Goldstein teaches insulin resistance is the major contributor to the pathogenesis of type 2 diabetes. See the abstract.
It would have been obvious to administer an effective amount of Ac-Arg-c(Cys-D-Ala-His-D-Phe-Arg-Trp-Cys)-NH2 (SEQ ID NO:50) that is claimed to treat insulin resistance to a subject with type 2 diabetes because a subject with type 2 diabetes has insulin resistance.
Claims 1, 2, 4, 5, 9, 13, 14, 21, 23, 24, 28 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of US 9,439,943 B2.
Regarding claims 1, 2, 4, 21 and 23, US 9,439,943 B2 claims a method of treating insulin resistance in a subject in need thereof, comprising peripheral administration of an effective amount of Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH.sub.2 (SEQ ID NO:278) or a pharmaceutically acceptable salt thereof to treat said insulin resistance in said subject. US 9,439,943 B2 claims the method reduces the body weight of said subject in need thereof. See claims 1-17.
Regarding claims 5 and 24, US 9,439,943 B2 claims the subject is obese. See claims 2 and 12.
Regarding claims 13 and 28, US 9,439,943 B2 claims the peripheral administration is oral, subcutaneous, intraperitoneal, intramuscular, intravenous, rectal, transdermal or intranasal. See claim 4 and 13.
Regarding claims 14 and 29, US 9,439,943 B2 claims the administration is continuous, hourly, four times daily, three time daily, twice daily, once daily, once every other day, twice weekly, once weekly, once every two weeks, once a month, or once every two months. See claims 5-8 and 14-17.
Regarding claim 9, US 9,439,943 B2 claims the subject suffers from Type II diabetes. See claim 10.
Although the claims at issue are not identical, they are not patentably distinct from each other
Claims 1, 2, 4, 5, 9, 13, 14, 21, 23, 24, 28 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US 9,827,286 B2.
Regarding claims 1, 2, 4, 21, 23, US 9,827,286 B2 claims a method of treating insulin resistance in a subject in need thereof, comprising peripheral administration of a pharmaceutical composition comprising an effective amount of Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2 (SEQ ID NO:278) or a pharmaceutically acceptable salt thereof (melanocortin receptor 4 agonist), and a pharmaceutically acceptable carrier to treat said insulin resistance in said subject. See claim 1-10. With respect to claim 21, US 9,827,286 B2 claims administering the same compound with the same mode of administration encompassed by the claims to the same patient population as claimed, thus the effect of reducing body weight is inherent because it is a result that naturally flow from the administration of an effective amount of Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2 (SEQ ID NO:278) or a pharmaceutically acceptable salt thereof.
Regarding claims 5 and 24, US 9,827,286 B2 claims the subject is obese. See claim 4.
Regarding claim 9, US 9,827,286 B2 claims the subject suffers from Type II diabetes. See claim 7.
Regarding claims 13 and 28, using the specification of the issued patent as a dictionary it is evident the scope of peripheral administration claimed includes oral, subcutaneous, intraperitoneal, intramuscular, intravenous, rectal, transdermal and intranasal forms of administration. See col. 107, lines 4-12. MPEP 804(II)(B)(1) states,” The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02 (emphasis added).” Therefore, it would have been prima facie obvious at the time the invention was made to have administer Hydantoin(C(O)-(Arg-Gly))-c(Cys-Glu-His-D-Phe-Arg-Trp-Cys)-NH2 (SEQ ID NO:278) or a pharmaceutically acceptable salt thereof by oral, subcutaneous, intraperitoneal, intramuscular, intravenous, rectal, transdermal and intranasal forms of administration because the scope of peripheral administration includes the claimed forms of administration..
Regarding claims 14 and 29, using the specification of the issued patent as a dictionary it is evident the scope of administration includes administration that is continuous, hourly, four times daily, three times daily, twice daily, once daily, once every other day, twice every other day, once weekly, once every two week, once a month or once every two months or longer. See col. 103,lines 47-53. MPEP 804(II)(B)(1) states,” The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02 (emphasis added).”. Therefore, it would have been obvious the administration is continuous, hourly, four times daily, three times daily, twice daily, once daily, once every other day, twice every other day, once weekly, once every two week, once a month or once every two months or longer because the scope of administration includes continuous, hourly, four times daily, three times daily, twice daily, once daily, once every other day, twice every other day, once weekly, once every two week, once a month or once every two months or longer administration periods.
Although the claims at issue are not identical, they are not patentably distinct from each other.
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 SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658