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 .
Claims 13, 15, 17, 19, 21, and 23 have been cancelled.
Election/Restrictions
Applicant’s election of the GIPR antibody where CDRL1 comprises SEQ ID NO: 702; CDRL2 comprises SEQ ID NO: 859; CDRL3 comprises SEQ ID NO: 1016; CDRH1 comprises SEQ ID NO: 1173; CDRH2 comprises SEQ ID NO: 1330; and CDRH3 comprises SEQ ID NO: 1487 in the reply filed on 11/5/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The set of elected CDRs are recited in claim 14. These CDRs are found in the light chain variable region comprising SEQ ID NO: 74 and the heavy chain variable region comprising SEQ ID NO: 231 in claim 16. These CDRs are found in the light chain of SEQ ID NO: 388 and the heavy chain of SEQ ID NO: 545 in claim 18.
Claims 20, 22, and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to method of administering a nonelected GIPR antibody, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/5/2025.
Claims 1-12, 14, 16, and 18 are under consideration.
Drawings
Applicant submitted drawings on 5/6/2022 that differ from the drawings of PCT/US2020/059647. See at least changes in shading. It is unclear if these were supposed to be replacement drawings. Clarification is requested.
Specification
The substitute specification filed 4/7/2023 has been entered. This substitute specification changes the header at the top of each page. It includes the specification amendments to page 1 that were submitted on 5/6/2022. Applicant indicated in the 11/5/2025 response that Tables 6-10 on pages 439-589 have sequence identifiers inserted to replace placeholder references. See for example, “a723” was replaced by “3164” in Table 6 for the VL of 2G10.303. Sequence identifiers were also inserted in paragraphs [0299, 0303, 0307, and 0308] of Example 1.
It is noted that WO 2021/092545 (the instant application is a 371 of PCT/US2020/059647) and 62/932,381 (the provisional application to which priority is claimed) do not recite these sequence identifiers in Tables 6-10 or Example 1. Provisional application 62/932,381 is not in sequence compliance.
It is noted that the 4/7/2023 remarks state that a substitute sequence listing was submitted; however, this is not the case. The 5/6/2022 sequence listing remains the only sequence listing in this application. Clarification is requested.
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 1-12, 14, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over either of Yie et al. (U.S. Patent No. 10,294,303) or Yie et al. (U.S. Patent Application Publication 2017/0275370) in view of Wolfe et al. (WO 2015/095354, of record).
Yie et al. (U.S. Patent No. 10,294,303) and Yie et al. (U.S. Patent Application Publication 2017/0275370) are equivalent documents. The ‘303 patent will be referenced.
Claims 1-14 of the ‘303 patent recite a GIPR antibody having the characteristics recited in instant claims 1-12, 14, 16, and 18. SEQ ID NOS: 702, 859, 1016, 1173, 1330, 1487, 74, 231, 388, and 545 in the ‘303 patent are identical to instant SEQ ID NOS: 702, 859, 1016, 1173, 1330, 1487, 74, 231, 388, and 545. The elected CDRs in instant claim 14 are found in issued claims 1 and 13 and meet the antigen binding protein limitations of instant claims 1 and 3. The limitations of instant claims 4-12 are found in issued claims 2-10, respectively. The sequences of issued claim 11 are found in instant claim 16. The sequences of issued claim 12 are found in instant claim 18. Issued claim 14 is directed to a pharmaceutical composition. The antibodies are GIPR antagonists. Methods of treating metabolic diseases and disorders by administering the antigen binding protein are disclosed. See at least title and abstract. See also column 1, lines 35-51, and column 35, lines 48-65. The reference does not disclose treating Cushing’s syndrome.
Wolfe et al. discloses treating Cushing’s syndrome with an anti-GIP antagonist antibody. Cushing’s syndrome is associated with prolonged exposure to abnormally high levels of cortisol. Food-induced Cushing’s syndrome occurs when the adrenal glands are abnormally responsive to gastric inhibitory polypeptide (GIP). Reducing GIP binding to the GIP receptor (GIPR) in adrenal cells will reduce or prevent the increase in GIP-induced cortisol secretion after food intake. See at least abstract; claims; and paragraphs [0008, 0016, 0067, and 0118].
It would have been obvious to administer the antibodies of Yie et al. to treat Cushing’s syndrome, a disorder associated with elevated cortisol levels, as taught by Wolfe et al. Wolfe et al. makes clear that reducing GIP binding to its receptor (GIPR) would be beneficial. While Wolfe et al. uses antibodies that bind GIP itself, one of ordinary skill in the art would have understood that anti-GIPR antagonistic antibodies would have achieved the same reduction in GIP binding to its receptor. These antibodies are taught by Yie et al. See in particular claim 10 of Yie et al. One would have been motivated to do so in order to provide additional therapeutic methods.
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 1-12, 14, 16, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,294,303 in view of Wolfe et al. (WO 2015/095354, of record).
The correspondence of the ‘303 claims to the instant claims is set forth above. The claims do not recite methods of treating conditions such as Cushing’s syndrome.
Wolfe et al. is applied as above.
It would have been obvious to administer the claimed antibodies of the ‘303 patent to treat Cushing’s syndrome, a disorder associated with elevated cortisol levels, as taught by Wolfe et al. thereby arriving at the method of the instant claims. Wolfe et al. makes clear that reducing GIP binding to its receptor (GIPR) would be beneficial. While Wolfe et al. uses antibodies that bind GIP itself, one of ordinary skill in the art would have understood that anti-GIPR antagonistic antibodies would have achieved the same reduction in GIP binding to its receptor. These antibodies are claimed in the ‘303 patent. See in particular claim 10 of the ‘303 patent. One would have been motivated to do so in order to provide additional therapeutic methods.
Note that the ‘303 patent and the instant application have a common applicant (Amgen) and common inventors (Lloyd and Sivits, Jr.). They do not share common priority. As such, there is no prohibition against double patenting.
Claims 1-3 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15-18 of U.S. Patent No. 11,046,774 in view of Wolfe et al. (WO 2015/095354, of record).
Issued claim 1 is directed to a method of treating a subject with a metabolic disorder by administering an antagonist antibody that specifically binds to amino acids 1-139 of human GIPR. Note that this corresponds to the entire extracellular domain of GIPR. See at least column 4, lines 47-50. The claims do not recite Cushing’s syndrome.
Wolfe et al. is applied as above.
It would have been obvious to practice the claimed method in the ‘774 patent to treat Cushing’s syndrome, a disorder associated with elevated cortisol levels, as taught by Wolfe et al. thereby arriving at the method of the instant claims. Wolfe et al. makes clear that reducing GIP binding to its receptor (GIPR) would be beneficial. While Wolfe et al. uses antibodies that bind GIP itself, one of ordinary skill in the art would have understood that anti-GIPR antagonistic antibodies would have achieved the same reduction in GIP binding to its receptor. These antibodies are claimed in the ‘774 patent. One would have been motivated to do so in order to provide additional therapeutic methods.
Note that the ‘774 patent and the instant application have a common applicant (Amgen) and common inventors (Lloyd and Sivits, Jr.). They do not share common priority. As such, there is no prohibition against double patenting.
Claims 1-5, 12, 14, 16, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,252,540 in view of Wolfe et al. (WO 2015/095354, of record).
SEQ ID NOS: 702, 859, 1016, 1173, 1330, 1487, 74, 231, 388, and 545 in claim 1 of the ‘540 patent are identical to instant SEQ ID NOS: 702, 859, 1016, 1173, 1330, 1487, 74, 231, 388, and 545. The sequences correspond to the elected antibody as recited in instant claims 14, 16, and 18. Issued claim 5 is directed to a method of making these antibodies. With respect to instant claims 3-4 and 12, the antibodies produced by the method of the ‘540 patent would have these properties as evidenced by the claims of U.S. Patent No. 10,294,303. The claims do not recite methods of treating conditions such as Cushing’s syndrome.
Wolfe et al. is applied as above.
It would have been obvious to administer the antibodies produced by the recombinant method of the ‘540 patent to treat Cushing’s syndrome, a disorder associated with elevated cortisol levels, as taught by Wolfe et al. thereby arriving at the method of the instant claims.
Wolfe et al. makes clear that reducing GIP binding to its receptor (GIPR) would be beneficial. While Wolfe et al. uses antibodies that bind GIP itself, one of ordinary skill in the art would have understood that anti-GIPR antagonistic antibodies would have achieved the same reduction in GIP binding to its receptor. These antibodies are claimed in the ‘540 patent. One would have been motivated to do so in order to provide additional therapeutic methods.
Note that the ‘540 patent and the instant application have a common applicant (Amgen) and common inventors (Lloyd and Sivits, Jr.). They do not share common priority. As such, there is no prohibition against double patenting.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-21, 23-28, 32, and 34 of copending Application No. 19/027,327 (8/26/2025 claim set) in view of Wolfe et al. (WO 2015/095354, of record).
Co-pending claims 19-21, 23-28, 32, and 34 provide antagonistic anti-GIPR antibodies having the properties of instant claims 1-12. Instant claims 1-12 are not limited to any particular anti GIPR antibody.
Wolfe et al. is applied as above.
It would have been obvious to administer the claimed antibodies of the ‘327 application to treat Cushing’s syndrome, a disorder associated with elevated cortisol levels, as taught by Wolfe et al. thereby arriving at the method of the instant claims. Wolfe et al. makes clear that reducing GIP binding to its receptor (GIPR) would be beneficial. While Wolfe et al. uses antibodies that bind GIP itself, one of ordinary skill in the art would have understood that anti-GIPR antagonistic antibodies would have achieved the same reduction in GIP binding to its receptor. These antibodies are claimed in the ‘327 application. See in particular claim 28 of the ‘327 application. One would have been motivated to do so in order to provide additional therapeutic methods.
Note that the 19/027,327 application and the instant application have a common applicant (Amgen) and common inventors (Lloyd and Sivits, Jr.). They do not share common priority. As such, there is no prohibition against double patenting.
The 19/027,327 is senior to the instant application.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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