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 2-21 and 24-32 have been cancelled. Claims 52-54 have been newly added.
The petition to revive an unintentionally abandoned application was granted on 2/13/2026. No response to the non-final rejection dates 4/11/2025 was submitted, and the application was abandoned on 11/13/2025.
Applicant's arguments filed 1/12/2026 and 2/1/2026 have been fully considered but they are not persuasive.
Specification
Applicant’s 1/12/2026 response included both an amendment to the specification on page 1 (see page 6 of 1/12/2026 response) and a substitute specification that included this amendment. The substitute specification was accompanied by a replacement sequence listing in XML file format. This sequence listing was not accepted because it was in the wrong format. See Sequence Listing Report dated 1/13/2026. Applicant then submitted a new replacement sequence listing in ASCII text format on 2/1/2026. This was accompanied by a second substitute specification with a submission date of 2/1/2026.
Neither the substitute specification dated 1/12/2026 nor the substitute specification dated 2/1/2026 have been entered. Page 1 of the 1/12/2026 substitute specification is now erroneous with respect to the referenced sequence listing as the XML file is not the current sequence listing. The 2/1/2026 substitute specification has not been entered as it did not show all changes with respect to the immediate prior version of the specification. At least for example, it does not strike through or remove the sequence listing paragraph on page 1 referencing the XML format sequence listing added outside of the substitute specification on 1/12/2026 and within the substitute specification submitted 1/12/2026.
The current specification is the original specification submitted 3/16/2022 as amended on 1/12/2026 (as set forth in page 6 of the 1/12/2026 response). Applicant should submit a new substitute specification marking deletion of this added paragraph on page 1 and inserting the correct sequence listing paragraph. It should also include the added sequence identifiers at pages 68-69 for SEQ ID NOS: 137-142. These were added in the 2/1/2026 replacement sequence listing.
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, 22-23, 33, 34-42, and 46-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,780,916. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to antibodies and GLP-1 fusion proteins that are not patentably distinct from the antibodies and GLP-1 fusion proteins of the issued claims.
The light chain and heavy chain sequence pairs recited in instant claim 1 contain the complete light and heavy chains. As such, instant claim 1 is directed to antibodies with two full-length heavy chains and two full-length light chains having the recited sequences. See at least page 9, second to last paragraph, of the instant specification.
Note that the SEQ ID NOS. 67, 77, and 101-124 in the ‘916 patent and the instant application refer to the same sequences. Note that SEQ ID NOS: 103, 104, and 124 each contain five wild-card amino acid positions that are defined in the sequence listing.
Issued claim 1 is directed to an antibody that would include a conventional four chain antibody (two heavy chains, two light chains) as evidenced by the “tetra-chain” antibody in dependent claim 4. Those of ordinary skill in the art would have known that a complete antibody light chain comprises the VL and the light chain constant domain. Those of ordinary skill in the art would have known that a complete antibody heavy chain comprises the VH and the heavy chain constant domains. See at least issued claims 2-3.
Issued claims 1-3 would have clearly suggested to one of ordinary skill in art to fuse
SEQ ID NO: 67 to SEQ ID NO: 101 which corresponds to instant SEQ ID NO: 125.
Issued claims 1-3 would have clearly suggested to one of ordinary skill in art to fuse
SEQ ID NO: 67 to SEQ ID NO: 102 which corresponds to instant SEQ ID NO: 126.
Issued claims 1-3 would have clearly suggested to one of ordinary skill in art to fuse
SEQ ID NO: 77 to SEQ ID NO: 103 which corresponds to instant SEQ ID NOS: 127-129.
Issued claims 1-3 would have clearly suggested to one of ordinary skill in art to fuse SEQ ID NO: 77 to SEQ ID NO: 124 which corresponds to instant SEQ ID NOS: 130-131.
Issued claims 1-3 would have clearly suggested to one of ordinary skill in art to fuse SEQ ID NO: 77 to SEQ ID NO: 104) which corresponds to instant SEQ ID NOS: 132-135.
The issued claims would have clearly suggested to one of ordinary skill in art each of the light chain/heavy chain pairs recited in instant claim 1.
The pharmaceutical limitations of instant claims 46 and 51 with respect to the claimed antibodies are suggested by issued claims 13 and 18.
The limitations of instant claims 22-23 and 33 are met by issued claims 4-5.
With respect to instant claim 34, the antibodies of the instant claim would inherently possess this IC50. See Figure 2 of the ‘916 patent. The antibody in this figure has the same CDRs responsible for antigen binding as the instant claims and issued claims and has an IC50 within the claim limitations.
The fusion proteins of instant claims 35-42 and 52-54 are suggested by issued claims 6-12 and 25-27.
It would have been obvious to create the claimed fusion constructs using the antibodies meeting the limitations of instant claim 1 as suggested by the issued claims as set forth above. The linkers in instant claim 42 are found in issued claim 6. The GLP-1 fragments in instant claim 42 are found in issued claim 12. Again, the sequences corresponding to the recited sequence identifiers are the same in the issued patent and the instant application. See instant claims 51-52. With respect to instant claim 54, SEQ ID NO: 136 corresponds to the GLP-1 fragment of SEQ ID NO: 106 fused to the linker of SEQ ID NO: 111 fused to the light chain of SEQ ID NO: 125. See antibody V1W5 in instant claim 1 having SEQ ID NO: 125 and SEQ ID NO: 131. Instant claim 54 is directed to an embodiment that would have been suggested by issued claims 1-3 (for the V1W5 antibody) and claims 6, 11-12, and 25-27 for the GLP-1 fragment and linker portions.
The pharmaceutical limitations of instant claims 46 and 51 with respect to the claimed fusion constructs are suggested by issued claims 19 and 24.
The methods of instant claims 47-50 are suggested by issued claims 14-17 and 20-23. It would have been obvious to use the antibodies meeting the limitations of instant claim 1 as suggested by the issued claims as set forth above by administering them as set forth in issued claims 14-17 and 20-23. It would have been obvious to use the fusion constructs meeting the limitations of instant claim 35 as suggested by the issued claims as set forth above by administering them as set forth in issued claims 14-17 and 20-23. Note that the patent specification defines “treating” as recited in the instant claims as including “reducing severity.” See at least column 38, lines 1-21.
The instant claims are not patentably distinct from the instant claims. The claimed antibodies would have been obvious over the issued claims. The claimed fusion proteins would have been obvious over the issued claims. Applicant’s arguments are not persuasive. The claimed antibody sequences are suggested by the issued claims.
Claims 43-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,780,916 in view of Yie et al. (WO 2017/112824, of record).
The instant application does not share a priority claim with the ‘916 patent. There has been no restriction in the instant application and there is no bar against a double patenting rejection for instant claims 43-45.
The antibodies of the instant claims are suggested by the issued claims as set forth above.
The ‘916 claims are discussed above. They are not directed to a polynucleotide encoding an antibody, vector, or host cell.
Yie et al. discloses recombinant production of gastric inhibitor peptide receptor (GIPR) antibodies using polynucleotides encoding them, vectors, and host cells. See at least claims 19-21 and 29-40.
It would have been obvious to take the amino acid sequence for the GIPR antibodies suggested by the ‘916 claims as set forth above and produce a polynucleotide encoding each of them, a vector containing the polynucleotide, and a host cell containing the vector as suggested by Yie et al. thereby arriving at the invention of claims 43-45. One would have been motivated to do so in order to produce the antibodies recombinantly as suggested by Yie et al.
The instant claims are not patentably distinct from the ‘916 claims in view of Yie et al.
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.
Claim 50 is 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 GLP-1 fragments and reverse GLP-1 fragments as discussed below, does not reasonably provide enablement for all GLP-1 fragments encompassed by the claims. 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.
Claim 50 is directed to a method for treating simultaneously two or more recited diseases by administering the pharmaceutical composition of claim 46.
Page 62 of the specification defines “treatment” as comprising alleviation or prevention of at least one symptom or other aspect of a disorder, or reduction of disease severity. It includes cure. Claim 50 does not recite any particular therapeutic effect (e.g. stabilizing blood glucose levels) and as such must enable the breadth of what “treatment” encompasses.
The specification provides no evidence or reason to believe that administration of the claimed antibodies or fusion proteins containing the antibodies will cure any of the recited conditions. There are no known cures for non-alcoholic fatty liver disease (NAFLD) or diabetes or an obesity-related disease such as cirrhosis of the liver.
With respect to alleviating at least one symptom, one symptom of NAFLD is cirrhosis. There is no evidence or reason to believe that administration of the claimed antibodies or GLP-1 fusion proteins containing the antibodies will reverse cirrhosis.
With respect to alleviating at least one symptom, one symptom of diabetes is diabetic retinopathy with its associated loss of vision. There is no evidence or reason to believe that administration of the claimed antibodies or GLP-1 fusion proteins containing the antibodies will reverse vision loss.
With respect to alleviating at least one symptom, one symptom of obesity is arthritis and its associated joint damage. There is no evidence or reason to believe that administration of the
claimed antibodies or GLP-1 fusion proteins containing the antibodies will reverse any joint damage.
Individuals who are obese have an increased risk for high blood pressure, dyslipidemia, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea, cancer, mental illness and pain. However, these conditions are not related to GIPR or GLP-1 in a manner that one would expect them to be treated by administration of the claimed compositions.
The scope of the method claims is not enabled.
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.
Claims 35-54 are 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.
Claim 35 as amended is directed to a fusion protein. Claims 41-43 and 46 refer to the GLP-1 fusion protein of claim 35. These claims lack antecedent basis in claim 35 for a GLP-1 fusion protein.
Claims 37 is confusing in reciting “fusion protein further comprises.” It appears that “further” should have been deleted as in claim 36. Based on its dependency on claim 35, it implies that five (one in claim 35 and four in claim 37) reverse GLP-1 fragments could be fused. There are not five carboxy termini available for these fusions.
Claim 49 is confusing in reciting “reducing the severity of obesity” in a patient having obesity. As the preamble of claim 49 already recites “a method for losing body weight,” the claim does not make clear what “reducing the severity of obesity” means if it differs from losing body weight. The metes and bounds of the claim cannot be determined.
Claim 35 as amended is directed to a fusion protein. This is confusing. The complete product of the claim is not a fusion protein as the light and heavy chains of the antibody are not fused to each other and produced as a single protein. The antibodies of claim 1 have two separate chains. In the context of the instant claims, the product being claimed in claim 35 is a protein construct comprising the antibody of claim 1 wherein the GLP-1 fragment and/or reverse GLP-1 fragment is fused as recited in claim 35. The fusion protein portion of the construct is with reference to one or both ends (N-terminus and/or C-terminus) of one or both antibody chains (light chain and/or heavy chain). See section 7 on page 69 of the 3/16/2022 specification with respect to a construct where the antibody has GLP-1 or reverse GLP-1 fragments fused to it.
For example, claim 35 could be amended to recite:
A protein construct comprising the antibody of claim 1 and a GLP-1 fragment or a reverse GLP-1 fragment; wherein (a) the carboxy terminal of the GLP-1 fragment is fused with the amino terminal of a light chain or a heavy chain of the antibody or (b) the amino terminal of the reverse GLP-1 fragment is fused with the carboxy terminal of a light chain or a heavy chain of the antibody; wherein the GLP-1 fragment or the reverse GLP-1 fragment has a length of at least 20 amino acids and has biological activity of binding and activating GLP-1 receptor.
The dependent claims would need to be amended to refer to the “protein construct of claim 35” for proper antecedent basis. At least for example, dependent claims 36-39 would need to recite “fused via a peptide linker” for proper antecedent basis in claim 35. See for example, claim 40.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 22 depends upon claim 1 and recites that the antibody is a humanized GIPR antibody. The specification does not clearly identify any of the light chain/heavy chain pairs in claim 1 as being humanized antibody chains. However, this appears to be the case based on section 5 and 6 on pages 68-69 of the 3/16/2022 specification. It is noted that all of the heavy chains recited in claim 1 include human IgG2 (SEQ ID NO: 103) or human IgG4 (SEQ ID NO: 104) sequences. It is noted that all of the light chains recited in claim 1 include the human kappa (SEQ ID NO: 101) or human lambda (SEQ ID NO: 102) sequences. If all of the antibodies in claim 1 are humanized, then claim 22 does not further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Applicant’s response did not identify whether or not each of the antibodies in claim 1 are humanized antibodies.
Claim 33 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 33 depends upon claim 1. Claim 33 recites a variety of limitations that do not further limit the subject matter of claim 1. The sequence pairs in claim 1 are for the complete light and heavy chains. As set forth in the prior Office action, claim 1 does not encompass any fragments such as Fab fragments or any other antigen-binding fragments. Claim 1 is directed to antibodies with two full-length heavy chains and two full-length light chains having the recited sequences. See at least page 9, second to last paragraph, of the instant specification. As such, they cannot be a “double-chain antibody” as recited in claim 33. They must be “tetra-chain antibodies” and so this “tetra-chain” limitation in claim 33 does not further define the antibodies of claim 1. The antibodies of claim 1 cannot be murine antibodies for the same reason as set forth for claim 22 in the prior Office action. The specification does not disclose the antibodies in claim 1 as being human or chimeric sequences and applicant’s response did not identify them. However, if they are human antibodies, they cannot be chimeric antibodies, and if they are humanized antibodies they cannot be human antibodies. The claim includes mutually exclusive categories of antibodies. It is noted that all of the heavy chains recited in claim 1 have either human IgG2 (SEQ ID NO: 103) or human IgG4 (SEQ ID NO: 104) sequences. It is noted that all of the light chains recited in claim 1 have either the human kappa (SEQ ID NO: 101) or human lambda (SEQ ID NO: 102) sequences. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
As set forth in the prior Office action, U.S. Patent No. 11,780,916 was published 10 October 2023 and does not qualify as prior art under 102(a)(1). It is not by other (same inventors and applicant as the instant application) and does not qualify as prior art under 102(a)(2). It is the equivalent of WO 2019/179424 (of record, published 26 September 2019) and U.S. Patent Application Publication 2021/0061904 (of record, published 4 March 2021). These documents do not qualify as prior art under 102(a)(1) or 102(a)(2).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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