Prosecution Insights
Last updated: April 18, 2026
Application No. 18/037,795

Pharmaceutical Composition of GLP-1/GLP-2 Dual Agonists

Non-Final OA §103§112§DP
Filed
May 19, 2023
Examiner
KONOPELSKI SNAVEL, SARA ELIZABETH
Art Unit
1658
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Zealand Pharma A/S
OA Round
1 (Non-Final)
33%
Grant Probability
At Risk
1-2
OA Rounds
3y 3m
To Grant
63%
With Interview

Examiner Intelligence

Grants only 33% of cases
33%
Career Allow Rate
6 granted / 18 resolved
-26.7% vs TC avg
Strong +30% interview lift
Without
With
+30.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
53 currently pending
Career history
71
Total Applications
across all art units

Statute-Specific Performance

§101
7.7%
-32.3% vs TC avg
§103
27.3%
-12.7% vs TC avg
§102
18.3%
-21.7% vs TC avg
§112
25.7%
-14.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 18 resolved cases

Office Action

§103 §112 §DP
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 the species “CPD1OH” in the reply filed on 2/4/2026 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 1-21 are pending. Claims 16-21 are new. Priority The instant application is the 371 national stage entry of PCT/EP2021/086148 , filed 12/16/2021, which claims priority to the foreign application EP20214558.7 , filed 12/16/2020. The priority date of 12/16/2020 is acknowledged. Information Disclosure Statement The IDS’s submitted on 6/13/2023, 4/9/12024, 7/26/2024, 1/13/2025, 6/30/2025, 7/17/2025, and 11/12/2025 are under consideration. Any strikethrough is owed to a lack of a copy of the reference in the file wrapper. Nucleotide and/or Amino Acid Sequence Disclosures REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES Items 1) and 2) provide general guidance related to requirements for sequence disclosures. 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted: In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying: the name of the ASCII text file; ii) the date of creation; and iii) the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying: the name of the ASCII text file; the date of creation; and the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended). When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical. Specific deficiencies and the required response to this Office Action are as follows: Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Required response – Applicant must provide: A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of: A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); A copy of the amended specification without markings (clean version); and A statement that the substitute specification contains no new matter. See Pg 4, formula A ; Pg 5, formulas A and B ; Pg 6, CPD1OH and CPD1NH2 ; Pg 7, top paragraphs ; Pg 28 formula A ; Pg 29, Formula B and variants CPD10H and CPD1Nh2 on Pg 30; Pg 33, Formula A Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above. Required response – Applicant must provide: A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of: A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); A copy of the amended specification without markings (clean version); and A statement that the substitute specification contains no new matter. Specification The use of the term Kinetext (Pg 35, two instances), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term . Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Claim Objections Claims 1, 9, and 11 are objected to because of the following informalities: The claim lists an amino acid sequence with 4 or more specifically defined and enumerated residues and therefore requires a SEQ ID NO. However, no SEQ ID NO is listed in the claim. See MPEP 2422 and 37 C.F.R. 1.821. Appropriate correction is required. 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 appl icant regards as his invention. Claims 1-21 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 1 recites that [Ψ] indicates an L or D lysine residue in which an albumin binding moiety is conjugated to the GLP-1/GLP-2 dual agonist, and wherein said albumin binding moiety is [K([17-c a rboxy-heptadecanoyl]- isoGlu )]. This limitation can be interpreted in multiple ways, thus rendering its scope indefinite. The first interpretation is that Ψ is a lysine residue and the albumin binding moiety comprises [K([17-crboxy-heptadecanoyl]- isoGlu )], wherein the K residue is in addition to the one that occupies the Ψ position. Another interpretation would be that the lysine residue listed as part of [K([17-crboxy-heptadecanoyl]- isoGlu )] is the same lysine residue that occupies the Ψ position. Claim 9 also has this same issue ; further, by virtue of their dependency on claim 1, claims 2-21 are also hereby rejected for this same reasoning. For purposes of examination, the claim is being interpreted as there is only one lysine residue that occupies the Ψ position, which is where the albumin binding moiety attaches, thereby resulting in [K([17-crboxy-heptadecanoyl]- isoGlu )]. Claim 11 is also rejected because it recites two amino acid sequences with “Hy” at the N-terminus. Although the instant specification indicates that this is representative of hydrogen (see instant Pg 8, third paragraph), it’s unclear whether this appendage is representative of a typical peptide N-terminus that begins with “NH2” or if the “Hy” indicates there is an additional hydrogen attached. For purposes of examination, the sequences are being interpreted as having standard “NH2” N-termini. Further, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation about 15mg/mL , and the claim also recites about 2mg/mL which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. 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. 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) 1-5 and 9 -15 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen ( WO 2018/104561 A1, published 6/14/2018 , cited on IDS filed 6/13/2023 ) in view of Norton ( WO 2020086741 A1 , published 4/30/2020). Larsen teaches GLP-1/GLP-2 receptor agonists of the following formula: R1-X*-U-R2, which meets the limitations of the peptide of the general formula A as recited in claim 1, wherein where R1 is hydrogen; R2 is NH2 or OH; X * is a peptide of formula I: H-X2-EG-X5-F-X7-X8-E-X10-X11-TIL-X15-X16-X17-A-X19-X20-X21-FI-X24-WL-X27-X28-X29-KIT-X33 , wherein X2 is Aib ; X5 is T or S; X7 is T or S; X8 is S; X10 is L; X11 is A; X15 is D; X16 is Ψ; X17 is Q; X19 is A; X20 is R; X21 is D; X24 is A; X27 is I; X28 is Q, E, A, H, Y, L, K, R or S; X29 is H; and X33 is D; U is absent; Ψ is a residue of K conjugated to a substituent having the formula Z1-Z2, wherein Z1 is HOOC -(CH2) 16 (CO )- (17-carboxy-heptadecanoyl) and Z2 is Zs1 which is isoGlu (Pg 2, line 21 -Pg 3, line 29) . The above formula also reads on the general formula B of instant claim 9, wherein X2 is Aib ; X5 is T or S; X7 is T; X8 is S; X10 is L; X11 is A; X15 is D; X16 is Ψ; X17 is Q; X19 is A; X20 is R; X21 is D; X24 is A; X27 is I; X28 is Q, E, A, H, Y, L, K, R or S; X29 is H; and X33 is D . Larsen does not teach a composition with one or more of benzoate, benzalkonium chloride and/or benzyl alcohol and phosphate buffer. Norton teaches GLP-2 fusion proteins, methods of treatment, and compositions thereof (Abstract) . Norton teaches that such pharmaceutical compositions that can include preservatives such as benzoate, benzalkonium chloride and/or benzyl alcohol ([00130, 00138]) and buffers such as phosphate buffer ([00133]). Thus, Larsen teaches a GLP-1/GLP-2 peptide of the instant formula A of claim 1, and Norton teaches preservatives and buffers that can be used to make compositions of GLP-2 proteins. Therefore, regarding claims 1 and 9, it would be prima facie obvious to use the preservatives and buffer taught by Norton to make a composition of the GLP-1/GLP-2 peptide taught by Larsen . One skilled in the art would be motivated to do so and have a reasonable expectation of success because Norton established that such preservatives and buffers could be used for similar GLP-2 peptides. Regarding claim 2, Norton teaches intravenous administration of a composition is a solution in sterile isotonic aqueous buffer ([00136]). Regarding claim 3, Norton teaches the preservative benzoate ([00130]) . Regarding claim 4, Norton teaches the preservative benzalkonium chloride ([00138]). Regarding claim 5, Norton teaches the preservative benzyl alcohol ([00130]). Regarding claims 10 and 11, Larsen teaches the instant SEQ ID NO: 1 of claim 10 (Pg 11, 17 th sequence from the top) as well as the elected species CPD1OH (Table 1, Pg 69, compound 18). Regarding claims 12 and 13, Larsen teaches a composition wherein the concentration of the GLP-1/GLP-2 dual agonist is 2mg/mL (Pg 77, Example 3, first line) . Regarding claims 14 and 15, Norton teaches including isotonicity makers, such as sodium chloride, in the pharmaceutical composition ([00130]). Claim(s) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen ( WO 2018/104561 A1, published 6/14/2018 , cited on IDS filed 6/13/2023 ) and Norton ( WO 2020086741 A1 , published 4/30/2020), as applied to claim s 1-5 and 9-15 above, and further in view of Dimarchi ( AU 2012273364 A1 , published 1/16/2014). The teachings of Larsen and Norton have been set forth above. Larsen and Norton do not teach that the phosphate buffer is present at a concentration of from about 5-50mM. Dimarchi teaches GLP-1 peptide variants, methods of treatment, and compositions thereof (Abstract). Dimarchi teaches formulations of said compositions wherein a buffer such as phosphate buffer can have a strength (concentration) of at least 5mM to at least 50mM ([00226]). In summary , Larsen and Norton teach a composition comprising a GLP-1/GLP-2 peptide of the instant formula A, one or more preservatives selected from benzoate, benzalkonium chloride and/or benzyl alcohol, and phosphate buffer. Dimarchi teaches compositions comprising GLP-1 peptides and specific concentrations of phosphate buffer . Therefore, regarding claim 6 , it would be prima facie obvious to use the concentrations taught by Dimarchi to make a composition of the GLP-1/GLP-2 peptide taught by Larsen and Norton . One skilled in the art would be motivated to do so and have a reasonable expectation of success because Dimarchi established that such concentrations could be used for similar GLP- 1 peptides. Regarding claim 7, Dimarchi teaches the buffer can be sodium phosphate ([00224]). Regarding claim 8, Dimarchi teaches the pH of composition may be at least 6-9 ([00226]). Claim(s) 1- 5 , 9- 1 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen ( WO 2018/104561 A1, published 6/14/2018 , cited on IDS filed 6/13/2023 ) and Norton ( WO 2020086741 A1 , published 4/30/2020), as applied to claim s 1-5 and 9-15 above, and further in view of Xiong et al. ( CN 103405753 A , published 11/27/2013). The teachings of Larsen and Norton have been set forth above. Larsen and Norton do not teach specific concentrations of benzoate or benzyl alcohol. Xiong teaches pharmaceutical compositions comprising an insulinotropic peptide, isotonic agent, preservative, solvent, and buffer salt solution, wherein the insulinotropic peptide is GLP-1 or derivatives thereof (Abstract). Xiong teaches including hydroxyl butyl benzoate and/or benzyl alcohol at a concentration of 1-20mg/m L (Equivalent Abstract). In summary, Larsen and Norton teach a composition comprising a GLP-1/GLP-2 peptide of the instant formula A, one or more preservatives selected from benzoate, benzalkonium chloride and/or benzyl alcohol, and phosphate buffer. Xiong teaches compositions comprising GLP-1 peptides and specific concentrations of the preservatives benzoate and/or benzyl alcohol. Therefore, regarding claims 16 and 18, it would be prima facie obvious to use the concentrations taught by Xiong to make a composition of the GLP-1/GLP-2 peptide taught by Larsen and Norton. One skilled in the art would be motivated to do so and have a reasonable expectation of success because Xiong established that such concentrations could be used for similar GLP-1 peptides. Claim(s) 1- 5 , 9-15 , and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen ( WO 2018/104561 A1, published 6/14/2018 , cited on IDS filed 6/13/2023 ) and Norton ( WO 2020086741 A1 , published 4/30/2020), as applied to claim s 1-5 and 9-15 above, and further in view of Quay et al. ( US 20060210614 A1 , published 9/21/2006). The teachings of Larsen and Norton have been set forth above. Larsen and Norton do not teach a specific concentration of benzalkonium chloride. Quay teaches methods for treating metabolic diseases via intranasal delivery of an exenatide or GLP - 1, comprising an aqueous mixture a delivery enhancer, and the pharmaceutical formulations used therein (Abstract ; [0020] ). Quay teaches including benzalkonium chloride at a concentration of 0- 9 mg/mL ( Table 1, Pg 30 ). In summary, Larsen and Norton teach a composition comprising a GLP-1/GLP-2 peptide of the instant formula A, one or more preservatives selected from benzoate, benzalkonium chloride and/or benzyl alcohol, and phosphate buffer. Quay teaches compositions comprising GLP-1 peptides and specific concentrations of benzalkonium chloride . Therefore, regarding claim 17 , it would be prima facie obvious to use the concentration taught by Quay to make a composition of the GLP-1/GLP-2 peptide taught by Larsen and Norton. One skilled in the art would be motivated to do so and have a reasonable expectation of success because Quay established that such concentrations could be used for similar GLP-1 peptides. Claim(s) 1-5, 9-15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen (WO 2018/104561 A1, published 6/14/2018, cited on IDS filed 6/13/2023) and Norton ( WO 2020086741 A1 , published 4/30/2020), as applied to claims 1-5 and 9-15 above, and further in view of Carrington (CN 107108715 A, published 8/29/2017). The teachings of Larsen and Norton have been set forth above. Larsen and Norton do not teach that the CPD10H peptide is a chlorine salt. Carrington teaches glucagon peptide analogues with agonist activity towards GLP-1 receptor and glucagon receptor (Abstract). Carrington teaches pharmaceutically acceptable salts of the peptides include chlorine salts (Translation Pg 14, first paragraph) . In summary, Larsen and Norton teach a composition comprising a GLP-1/GLP-2 peptide of the instant formula A, one or more preservatives selected from benzoate, benzalkonium chloride and/or benzyl alcohol, and phosphate buffer. Carrington teaches GLP-1 peptides can be formulated a chlorine salts . Therefore, regarding claim 19, it would be prima facie obvious to generate a chlorine salt of the instant GLP-1/GLP-2 peptide taught by Larsen and Norton. One skilled in the art would be motivated to do so and have a reasonable expectation of success because Carrington established that such concentrations could be used for similar GLP-1 peptides. Claim(s) 1- 5, 9-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen ( WO 2018/104561 A1, published 6/14/2018 , cited on IDS filed 6/13/2023 ) and Norton ( WO 2020086741 A1 , published 4/30/2020), as applied to claim s 1-5 and 9-15 above, and further in view of Parshad ( EP 3628682 A1 , published 4/1/2020). The teachings of Larsen and Norton have been set forth above. Larsen and Norton do not teach the inclusion of D-mannitol in the composition nor a specific concentration of it. Parshad teaches stable liquid pharmaceutical formulations of GLP-2 analogues (Abstract). Parshad teaches including mannitol at a concentration of 20-360mM ([ 0059, 0062, 0063 ]). Parshad teaches that the mannitol is preferably D-mannitol ( [0057]). In summary, Larsen and Norton teach a composition comprising a GLP-1/GLP-2 peptide of the instant formula A, one or more preservatives selected from benzoate, benzalkonium chloride and/or benzyl alcohol, and phosphate buffer. Parshad teaches compositions comprising GLP- 2 peptides and specific concentrations D-mannitol . Therefore, regarding claim 20 , it would be prima facie obvious to use the concentration taught by Parshad to make a composition of the GLP-1/GLP-2 peptide taught by Larsen and Norton. One skilled in the art would be motivated to do so and have a reasonable expectation of success because Parshad established that such concentrations could be used for similar GLP-1 peptides. Claim(s) 1- 5, 9-15, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen ( WO 2018/104561 A1, published 6/14/2018 , cited on IDS filed 6/13/2023 ) and Norton ( WO 2020086741 A1 , published 4/30/2020), as applied to claim s 1-5 and 9-15 above, and further in view of Carrier ( CA 2708762 A1 , published 6/18/2009 ). The teachings of Larsen and Norton have been set forth above. Larsen and Norton do not teach a specific concentration of NaCl. Carrier teaches pharmaceutical formulations comprising insulinotropic peptide conjugates, including GLP-1 derivatives, and methods of administration (Abstract ; [00381]) ). Carrier teaches formulations wherein the concentration of NaCl is 100-200 mM sodium chloride ([0011, 0012, 0080]). In summary, Larsen and Norton teach a composition comprising a GLP-1/GLP-2 peptide of the instant formula A, one or more preservatives selected from benzoate, benzalkonium chloride and/or benzyl alcohol, and phosphate buffer. Carrier teaches compositions comprising GLP- 1 peptides and specific concentrations of NaCl . Therefore, regarding claim 21 , it would be prima facie obvious to use the concentration taught by Carrier to make a composition of the GLP-1/GLP-2 peptide taught by Larsen and Norton. One skilled in the art would be motivated to do so and have a reasonable expectation of success because Carrier established that such concentrations could be used for similar GLP-1 peptides. 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, 9-11, and 15 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-5 of U.S. Patent No. 10 , 905 , 745 B2 (‘745) in view of Norton ( WO 2020086741 A1 , published 4/30/2020) . Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter. Claim 1 of US ‘745 recites a dual agonist represented by the formula R1-X*-R2, wherein R1 is Hydrogen (Hy), C1-4 alkyl, acetyl, formyl, benzoyl, or trifluoroacetyl ; R2 is NH2 or OH; X* is a peptide H[ Aib ] EGSFTSELATILDψQAARDFIAWLIQHKITD , Ψ is an L or D Lys residue whose side chain is conjugated to a substituent of formula Z1-Z2 and Z1-Z2 is [17-carboxy-heptadecanoyl]- isoGlu -, or a pharmaceutically acceptable salt thereof. Dependent claims include additional variants of the peptide (claims 2 and 3) and pharmaceutical compositions comprising thereof (claims 4 and 5). US ‘745 does not teach specifically adding one or more preservatives selected from benzoate, benzalkonium chloride, and/or benzyl alcohol, nor does it teach that the composition comprises phosphate buffer. Norton teaches that pharmaceutical composition comprising GLP-2 fusion proteins can include preservatives such as benzoate, benzalkonium chloride and/or benzyl alcohol ([00130, 00138]) and buffers such as phosphate buffer ([00133]). Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Norton into US ‘745 , thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Norton teach es such preservatives and buffer can be used for similar GLP-2 peptide composition s . Thus, the claims are obvious in view of US ‘745. Claims 1, 9-11, and 15 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1- 2, 4-6, 9-12, 16-24, 27, 28, and 38-45 of U.S. Patent No. 11,395,847 B2 (‘ 847 ) in view of Norton ( WO 2020086741 A1 , published 4/30/2020) . Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter. Claim 1 of US ‘ 847 recites a g lucagon-like-peptide 1/glucagon-like-peptide 2 (GLP-1/GLP-2) dual agonist represented by the formula: R 1 —X*—U—R 2 , wherein: R 1 is hydrogen (Hy), C 1-4 alkyl, acetyl, formyl, benzoyl or trifluoroacetyl ; R 2 is NH 2 or OH; X* is a peptide of formula I: (I) (SEQ ID NO: 3) H-X2-EG-X5-F-X7-X8-E-X10-X11-TIL-X15-X16-X17-A- X19-X20-X21-FI-X24-WL-X27-X28-X29-KIT-X33, wherein: X2 is Aib or G; X5 is T or S; X7 is T or S; X8 is S, E or D; X10 is L, M, V or Ψ; X11 is A, N or S; X15 is D or E; X16 is G, E, A or Ψ; X17 is Q, E, K, L or Ψ; X19 is A, V or S; X20 is R, K or Ψ; X21 is D, L or E; X24 is A, N or S; X27 is I, Q, K, H or Y; X28 is Q, E, A, H, Y, L, K, R or S; X29 is H, Y or Q; X33 is D or E; U is absent or a sequence of 1-15 residues, each, independently, selected from K, k, E, A, T, I, L and Ψ; the molecule contains one and only one Ψ, wherein Ψ is a residue of K, k, R, Orn , Dap or Dab in which the side chain is conjugated to a substituent having the formula Z 1 — or Z 1 —Z 2 —, wherein Z 1 — is CH 3 —(CH 2 ) 10-22 —(CO)— or HOOC—(CH 2 ) 10-22 —(CO)—; and —Z 2 — is selected from —Z S1 —, —Z S1 —Z S2 —, —Z S2 —Z S1 —, —Z S2 —, —Z S3 —, —Z S1 —Z S3 —, —Z S2 —Z S3 —, —Z S3 —Z S1 —, —Z S3 —Z S2 —, —Z S1 —Z S2 —Z S3 —, —Z S1 —Z S3 —Z S2 —, —Z S2 —Z S1 —Z S3 —, —Z S2 —Z S3 —Z S1 —, —Z S3 —Z S1 —Z S2 —, —Z S3 —Z S2 —Z S1 —, or —Z S2 —Z S3 —Z S2 ; wherein Z S1 is isoGlu , β-Ala, isoLys , or 4-aminobutanoyl; Z S2 is -(Peg3) m -, wherein m is 1, 2, or 3; and Z S3 is a peptide sequence of 1-6 amino acid residues independently selected from the group consisting of A, L, S, T, Y, Q, D, E, K, k, R, H, F and G; and wherein at least one of X5 and X7 is T; or a pharmaceutically acceptable salt thereof. Wherein R1 is Hy, R2 is OH, X2 is Abi, X5 is T or S, X7 is T or S, X8 is S, X10 is L X11 is A, X15 is D, X16 is Ψ , X17 is Q, X19 is A, X20 is R, X21 is D, X24 is A, X27 is I, X28 is Q, E, A, H, Y, L, K, R, or S, X29 is H and X33 is D, Ψ is HOOC—(CH 2 ) 10-22 —(CO)— isoGlu , and U is absent reads on the instant formula A of claim 1. Dependent claims include additional species of the peptide (claims 2, 4 - 6, 9 - 12, 16 -24, 27, 28, 38-42), a pharmaceutical composition thereof (claim 43), and methods of treating (claims 44 and 45 ) ; the instant specification indicates that the instant peptides can be used to treat weight gain and obesity (see instant Pg 32, embodiment 30). US ‘847 does not teach specifically adding one or more preservatives selected from benzoate, benzalkonium chloride, and/or benzyl alcohol, nor does it teach that the composition comprises phosphate buffer. Norton teaches that pharmaceutical composition comprising GLP-2 fusion proteins can include preservatives such as benzoate, benzalkonium chloride and/or benzyl alcohol ([00130, 00138]) and buffers such as phosphate buffer ([00133]). Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Norton into US ‘847 , thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Norton teach es such preservatives and buffer can be used for similar GLP-2 peptide compositions . Thus, the claims are obvious in view of US ‘847. Claims 1, 2, 6 -1 2 , 14-15, and 19-21 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-4, 6-12, and 17-25 of U.S. Patent No. 12,576,025 B2 (‘025) in view of Norton ( WO 2020086741 A1 , published 4/30/2020) . Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter. Claim 1 of US ‘ 025 recites a n isotonic parenteral pharmaceutical composition, comprising: a. at least about 1 mg/mL of one or more GLP-1/GLP-2 dual agonist, wherein the one or more GLP-1/GLP-2 dual agonist is Hy-H[Aib]EGSFTSELATILD[K([17-carboxy-heptadecanoyl]-isoGlu)QAARDFIAWLIQHKITD-OH (CPD10H) (SEQ ID NO: 1) or any pharmaceutically acceptable salt thereof b. about 5 mM to about 50 mM of phosphate buffer component; and c. about 190 mM to about 240 mM of one or more tonicity agent, wherein said one or more tonicity agent comprises or consists of mannitol, wherein said composition further comprises a solvent, and wherein said composition has a pH of about pH 6.0 to about pH 8.2. Dependent claims include species and concentrations of the compositions components (claims1-4, 6-12, and 19-22) and methods of treating (claims 17, 18, 23-25 ); the instant specification indicates that the instant peptides can be used to treat weight gain and obesity (see instant Pg 32, embodiment 30). US ‘025 does not teach specifically adding one or more preservatives selected from benzoate, benzalkonium chloride, and/or benzyl alcohol. Norton teaches that pharmaceutical composition comprising GLP-2 fusion proteins can include preservatives such as benzoate, benzalkonium chloride and/or benzyl alcohol ([00130, 00138]). Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Norton into US ‘025 , thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Norton teach es such preservatives can be used for similar GLP-2 peptide compositions . Thus, the claims are obvious in view of US ‘025. Claim s 1, 2, 6-12, 14-15, and 19-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1, 2, 7-9, 11-13, 20, 22, and 37-42 of copending Application No. 19/236,746 (‘746 reference application; claim set filed 8/25/2025) in view of Norton ( WO 2020086741 A1 , published 4/30/2020) . Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter. Claim 1 of copending Application No. ‘746 recites an isotonic parenteral pharmaceutical composition, comprising: a. at least about 1 mg/mL of one or more GLP-1/GLP-2 dual agonist, wherein the one or more GLP-1/GLP-2 dual agonist is Hy-H[Aib]EGSFTSELATILD[K([17-carboxy-heptadecanoyl]-isoGlu)]QAARDFIAWLIQHKITD-OH (CPD1OH) (SEQ ID NO: 1) or a pharmaceutically acceptable salt thereof: b. about 1mM to about 200mM of buffer component; and c. about 1mM to about 500mM of one or more tonicity agent, wherein said one or more tonicity agent comprises a non-ionic tonicity agent, wherein the non-ionic tonicity agent is mannitol, wherein said composition further comprises a solvent, and wherein said composition has a pH of about pH 6.0 to about 8.2. Dependent claims include species and concentrations of the compositions components (claims 1, 2, 7-9, 11-13, 20, 22, and 38-42 ; phosphate buffer is specifically recited in claim 7 ) and methods of treating (claim 37); the instant specification indicates that the instant peptides can be used to treat weight gain and obesity (see instant Pg 32, embodiment 30). Copending Application No. ‘746 does not teach specifically adding one or more preservatives selected from benzoate, benzalkonium chloride, and/or benzyl alcohol. Norton teaches that pharmaceutical composition comprising GLP-2 fusion proteins can include preservatives such as benzoate, benzalkonium chloride and/or benzyl alcohol ([00130, 00138]). Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Norton into copending Application No. ‘746 , thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Norton teach es such preservatives can be used for similar GLP-2 peptide compositions . Thus, the claims are obvious in view of copending Application No. ‘746. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1, 9-11, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 7, 11-13, 15, 16, 19, 20, 24, and 26-32 of copending Application No. 17 / 834 , 062 (‘ 062 reference application; claim set filed 11/21/2025 ) in view of Norton ( WO 2020086741 A1 , published 4/30/2020). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter. Claim 1 of copending Application No. ‘ 062 recites a method of prophylaxis or treatment of (a) malabsorption, ulcers, short-bowel syndrome, cul-de-sac syndrome, inflammatory bowel disease, irritable bowel syndrome, pouchitis , celiac sprue, tropical sprue, hypogammaglobulinemic sprue, mucositis induced by chemotherapy or radiation therapy, diarrhea induced by chemotherapy or radiation therapy, low grade inflammation, metabolic endotoxemia, necrotising enterocolitis, primary biliary cirrhosis, hepatitis, fatty liver disease, or gastrointestinal side-effects of inflammatory conditions in a subject in need thereof, or (b) obesity, morbid obesity, obesity-linked gallbladder disease, obesity-induced sleep apnea, inadequate glucose control, glucose tolerance, dyslipidaemia , diabetes, pre-diabetes, metabolic syndrome or hypertension in a subject in need thereof; the method comprising administering a glucagon-like-peptide 1/glucagon-like peptide 2 (GLP-1/GLP-2) dual agonist, or pharmaceutically acceptable salt thereof, to the subject, wherein the GLP-1/GLP-2 dual agonist is represented by the formula: R 1 —X*—U—R 2 , wherein: R 1 is hydrogen (Hy), C 1-4 alkyl, acetyl, formyl, benzoyl or trifluoroacetyl ; R 2 is NH 2 or OH; X* is a peptide of formula I: (I) (SEQ ID NO: 3) H-X2-EG-X5-F-X7-X8-E-X10-X11-TIL-X15-X16-X17-A- X19-X20-X21-FI-X24-WL-X27-X28-X29-KIT-X33, wherein: X2 is Aib or G; X5 is T or S; X7 is T or S; X8 is S, E or D; X10 is L, M, V or Ψ; X11 is A, N or S; X15 is D or E; X16 is G, E, A or Ψ; X17 is Q, E, K, L or Ψ; X19 is A, V or S; X20 is R, K or Ψ; X21 is D, L or E; X24 is A, N or S; X27 is I, Q, K, H or Y; X28 is Q, E, A, H, Y, L, K, R or S; X29 is H, Y or Q; X33 is D or E; U is absent or a sequence of 1-15 residues, each, independently, selected from K, k, E, A, T, I, L and Ψ; the molecule contains one and only one Ψ, wherein Ψ is a residue of K, k, R, Orn , Dap or Dab in which the side chain is conjugated to a substituent having the formula Z 1 — or Z 1 —Z 2 —, wherein Z 1 — is CH 3 —(CH 2 ) 10-22 —(CO)— or HOOC—(CH 2 ) 10-22 —(CO)—; and —Z 2 — is selected from —Z S1 —, —Z S1 —Z S2 —, —Z S2 —Z S1 —, —Z S2 —, —Z S3 —, —Z S1 —Z S3 —, —Z S2 —Z S3 —, —Z S3 —Z S1 —, —Z S3 —Z S2 —, —Z S1 —Z S2 —Z S3 —, —Z S1 —Z S3 —Z S2 —, —Z S2 —Z S1 —Z S3 —, —Z S2 —Z S3 —Z S1 —, —Z S3 —Z S1 —Z S2 —, —Z S3 —Z S2 —Z S1 —, or —Z S2 —Z S3 —Z S2 ; wherein Z S1 is isoGlu , β-Ala, isoLys , or 4-aminobutanoyl; Z S2 is -(Peg3) m -, wherein m is 1, 2, or 3; and Z S3 is a peptide sequence of 1-6 amino acid residues independently selected from the group consisting of A, L, S, T, Y, Q, D, E, K, k, R, H, F and G; and wherein at least one of X5 and X7 is T; or a pharmaceutically acceptable salt thereof. Wherein R1 is Hy, R2 is OH, X2 is Abi, X5 is T or S, X7 is T or S, X8 is S, X10 is L X11 is A, X15 is D, X16 is Ψ , X17 is Q, X19 is A, X20 is R, X21 is D, X24 is A, X27 is I, X28 is Q, E, A, H, Y, L, K, R, or S, X29 is H and X33 is D, Ψ is HOOC—(CH 2 ) 10-22 —(CO)— isoGlu , and U is absent reads on the instant formula A of claim 1. Further, the instant specification teaches that the instant peptides can be used to treat (a) and (b) as described above (see instant Pg 32, embodiment 30). The methods of claims 2 are also taught in the instant specification (Pg 22, “Indications,” second paragraph). Dependent claims include species of the peptide (claims 3-7, 11-13, 15, 16, 19, 20, 24, 26-29 ) and additional methods of treating (c laims 2 and 30-32). Copending Application No. ‘062 does not teach specifically adding one or more preservatives selected from benzoate, benzalkonium chloride, and/or benzyl alcohol, nor does it teach that the composition comprises phosphate buffer. Norton teaches that pharmaceutical composition comprising GLP-2 fusion proteins can include preservatives such as benzoate, benzalkonium chloride and/or benzyl alcohol ([00130, 00138]) and buffers such as phosphate buffer ([00133]). Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Norton into copending Application No. ‘062, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Norton teach es such preservatives and buffer can be used for similar GLP-2 peptide compositions . Thus, the claims are obvious in view of copending Application No. ‘062. 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 FILLIN "Examiner name" \* MERGEFORMAT Sara E Konopelski Snavely whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-1841 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 9-6pm EST . 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, FILLIN "SPE Name?" \* MERGEFORMAT Melissa L Fisher can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-7430 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SARA E KONOPELSKI SNAVELY/ Examiner, Art Unit 1658 /FRED H REYNOLDS/ Primary Examiner, Art Unit 1658
Read full office action

Prosecution Timeline

May 19, 2023
Application Filed
Apr 01, 2026
Non-Final Rejection — §103, §112, §DP (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12577278
KRAS G12V Mutant Binds to JAK1, Inhibitors, Pharmaceutical Compositions, and Methods Related Thereto
2y 5m to grant Granted Mar 17, 2026
Patent 12486303
NOVEL USE OF PEPTIDE FOR INHIBITING FUNCTIONS AND EXPRESSIONS OF MULTIPLE DISEASE BIOMARKERS
2y 5m to grant Granted Dec 02, 2025
Patent 12441769
POLYPEPTIDE, PHOTORESIST COMPOSITION INCLUDING THE SAME, AND METHOD OF FORMING PATTERN USING THE SAME
2y 5m to grant Granted Oct 14, 2025
Study what changed to get past this examiner. Based on 3 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

1-2
Expected OA Rounds
33%
Grant Probability
63%
With Interview (+30.0%)
3y 3m
Median Time to Grant
Low
PTA Risk
Based on 18 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month