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 .
Election/Restrictions
Applicant’s election of Group II, drawn to dulaglutide, in the reply filed on 7/7/2026 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)).
Claim Status
Claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, and 59-65 are pending. Claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, and 59 are amended. Claims 60-65 are new. Claims 1, 3-4, 6-7, 9-19, 21-35, 37, 39, 43, 46, and 49-58 are cancelled.
Priority
The instant application claims priority to the provisional application 63/491,758, filed 3/23/2023. The priority date of 3/23/2023 is acknowledged.
Information Disclosure Statement
The IDS filed on 9/2/2025 is under consideration.
Claim Objections
Claim 59 is objected to because of the following informalities: Line 1 currently recites “Dulaglutide produced a method comprising the steps of”. Amend the claim such that it reads “Dulaglutide produced by a method comprising the steps of” (emphasis added). Appropriate correction is required.
Claim Interpretation
The claims are being interpreted as product-by-process claims. See more in art rejections below and MPEP 2113.
Claim Rejections - 35 USC § 112
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 62-64 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.
Claims 62-64 each recite features of dulaglutide that are inherent to the dulaglutide structure recited in claim 59 (a dimer, a linker SEQ ID NO: 3, and the human IgG4 Fc fragment, respectively, which collectively are equivalent to SEQ ID NO: 4). The scope of each of these claims is indefinite as it is unclear whether the recitations of claims 62-64 merely refer back to the structure of dulaglutide as recited in claim 59 or whether the claims further comprise the additional features recited.
For purposes of examination, claims 62-64 are being interpreted as referring to the dulaglutide structure as recited in claim 59.
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.
Claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, and 62-64 are 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.
Claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, and 47-48 depend from claim 59, which is sequentially after them.
Claims 62-64 recite structural features of dulaglutide that are inherent to claim 59. Therefore, they do not further limit claim 59.
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.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, 59-60, and 62-65 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wang (US20220000984A1, published 1/6/2022), as evidenced by CAS (CAS 923950-08-7, accessed on 9/1/2026).
Wang teaches GLP-1 fusion proteins, conjugates, and pharmaceutical compositions thereof (Abstract). One GLP-1 receptor agonist taught by Wang is dulaglutide ([0011, 0059]).
As evidenced by CAS, dulaglutide comprises a dimer of two GLP-1 monomers linked via a linker having an amino acid sequence identical to SEQ ID NO: 3 to human immunoglobulin 4 Fc fragment; in other words, dulaglutide is equivalent to the instant SEQ ID NO: 4
Per MPEP 2113, unless an unobvious structural limitation is provided by the process limitation, patentability of product-by-process claims are based on the product itself. As Wang discloses dulaglutide, the teachings of the prior art appear to meet the limitations recited in the instant claim. “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983), emphasis added.
Thus, claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, 59, and 62-65 are anticipated.
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.
Claim(s) 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, 59-65 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US20220000984A1, published 1/6/2022) in view of Jensen et al. (Absorption, metabolism and excretion of the GLP-1 analogue semaglutide in humans and nonclinical species. European Journal of Pharmaceutical Sciences, 104 (2017) 31-41).
The teachings of Wang have been set forth above. Wang does not explicitly teach dulaglutide wherein clipped dulaglutide does not have His-Gly residues at the N-terminus.
Jensen teaches peptide degradation and beta-oxidation are common metabolic pathways both in animals and humans and are not confined to specific organs. Two enzymes are known to be involved in native GLP-1 degradation: DPP-4 and NEP. DPP-4, which is found in plasma as a soluble enzyme and within various body compartments, is responsible for the inactivation of GLP-1 via truncation of the N-terminal dipeptide sequence, His-Ala (Pg 40, left column, 2nd paragraph).
Based on these teachings, it would be prima facie obvious to substitute a known element for another to obtain predictable results. Jensen taught that GLP-1 degradation is common in response to administration, as DPP-4 is found widespread through the plasma in various parts of the body; this results in the N-terminal truncation of His-Ala of semaglutide. One skilled in the art would recognize that a related GLP-1, dulaglutide, would similarly be cleaved by DPP-4 upon its administration to an individual. Further, one would reasonably expect that dulaglutide would have its two N-terminal amino acids, His-Gly, removed by DPP-4, thus resulting in some amount of dulaglutide without said N-terminal amino acids. Thus, claim 61 is rendered obvious.
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 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, and 59-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,576,950B2 (US ‘950). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the method claims of US ‘950 anticipates the instant claims.
Claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, and 59-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,890,325B2 (US ‘325). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the method claims of US ‘325 anticipates the instant claims.
Claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, and 59-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-12, and 14-17 of copending Application No. 17/795,797 (‘797 reference application; claim set filed 3/18/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the method claims of copending Application No. ‘797 anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, and 59-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-51 of copending Application No. 18/149,982 (‘982 reference application; claim set filed 2/8/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the method claims of copending Application No. ‘982 anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, and 59-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/409,277 (‘277 reference application; claim set filed 1/10/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the method claims of copending Application No. ‘277 anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, and 59-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 19/593,114 (‘114 reference application; claim set filed 6/3/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the method claims of copending Application No. ‘114 anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, and 59-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8-21, and 31 of copending Application No. 19/691,511 (‘511 reference application; claim set filed 5/28/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the method claims of copending Application No. ‘511 anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, and 59-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-56 of copending Application No. 19/141,221 (‘221 reference application; claim set filed 6/19/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the method claims of copending Application No. ‘221 anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, and 59-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 19/141,739 (‘739 reference application; claim set filed 6/20/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the method claims of copending Application No. ‘739 anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, and 59-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 40-42 of copending Application No. 19/143,256 (‘256 reference application; claim set filed 11/26/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the method claims of copending Application No. ‘256 anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 5, 8, 20, 36, 38, 40-42, 44-45, 47-48, and 59-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-36 and 41-53 of copending Application No. 17/438,692 (‘692 reference application; claim set filed 4/3/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of copending Application No. ‘692 anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa L 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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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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