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
In response to the restriction requirement dated 6 April, 2026, Applicant elects, without
traverse: Group I, claims 112-130. In response to the Request for Election of Species Applicant elects, without traverse, the following species:
1. "GIPR antagonist GIP peptide" species:
EGTFISEYSIAibLEKIKQQEFVEWLLAQKPSSGAPPPS-C16-diacid/18K; SEQ ID
NO:6; GIP(3-30)+Cex(31-39) [D9E;A13Aib;M14L;D15E;H18K;D21E;N24E] (as
recited in claims 125(i) and 128).
2. "GLP-1 receptor agonist" species: semaglutide (as recited in claims 115 and 116).
3. "linker" species: no linker, i.e., said fatty acid molecule is attached directly to the side
chain amino group of the amino acid residue at position 18 of SEQ ID NO:39 (as
recited in claim 123).
4. "fatty acid" species: COOH(CH2)14C0- (i.e., C16-diacid, (as recited in claim 122).
Consistent with the elections above, Applicant submits that claims 112-123 and 125-130 are either generic or read on the elected species.
Applicant's election in the reply filed on 29 June 2026 is acknowledged. Claims 112-123 and 125-130 are hereby examined on the merits. Claims 124 and 131 are withdrawn from further consideration pursuant to 37 CFR l.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Priority
The instant application filed 11/30/2023 is a National Stage entry of PCT/EP2022/065826 , International Filing Date: 06/10/2022 claims foreign priority to 21178712.2, filed 06/10/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 5/9/2024, 8/12/2025, 10/31/2025, 4/7/2026 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 120 is objected to because of the following informalities: SEQ ID NO: 2 is repeated twice, as (b) and as (t). Appropriate correction is required.
Claim 125 is objected to because of the following informalities: ‘(bb)’ is repeated twice. Appropriate correction is required.
Claim 126 is objected to because of the following informalities: Claim 126 depends on claim 112 and recited ‘dyslipidemia’ which is already present in claim 112. Examiner recommends removing ‘dyslipidemia’ from claim 126.
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.
Claims 114, 116, 120, 125, 126, 128-130 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.
Regarding claim 114, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Here, it is unclear whether the claim recites broadly a GLP-1 peptide, or narrowly, a protease-resistant analog of hGLP-1.
Regarding claim 116, which is dependent on the independent claim 112, the independent claim recites the limitation ‘functional variant thereof wherein said variant has 1, 2 or 3 individual amino acid substitutions at any amino acid residue’. Since claim 116 also recites the same limitation of claim 112, it is unclear if the dependent claim is limited by a total of 3 individual amino acid substitutions or if the dependent claim can incorporate the 3 additional substitutions from the independent claim as well.
Dependent claims 120, 125, 128-130 incorporate the indefiniteness as noted above.
Regarding claim 116, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Here, it is unclear whether the claim recites (a) a variant broadly, or a variant narrowly having 1-2 amino acid substitutions.
Regarding claim 126, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In the instant case, it is unclear if the claim recites broadly, breathing problems, or narrowly sleep apnea and asthma…binge eating.
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 112-123 and 125-130 , rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claim 112 is directed to a method of treatment comprising administering a GIP consisting of SEQ ID NO: 39. Applicant reduces to practice Compound I (SEQ ID NO: 6 with a C16-diacid attached to the K16 side chain) and Compound II (SEQ ID NO: 12 with a C18 diacid attached to the K16 side chain) (see page 55). Applicant does not reduce to practice a method of treating, comprising a functional variant, wherein said variant has 1, 2, or 3 individuals amino acid substitutions at any amino acid residue of SEQ ID NO: 39. Applicant does not teach all possibilities of amino acid, at position 18, that attach to a fatty acid.
Claim 113 is directed to a method of reducing food intake comprising administering a GIP consisting of SEQ ID NO: 39. As noted above, Applicant reduces to practice Compound I (SEQ ID NO: 6 with a C16-diacid attached to the K16 side chain) and Compound II (SEQ ID NO: 12 with a C18 diacid attached to the K16 side chain) (see page 55). Applicant does not reduce to practice a method of treating comprising a functional variant of SEQ ID NO: 39 and does not teach all possibilities of amino acid, at position 18, that attach to a fatty acid.
Claim 115 is directed to GLP-1 receptor agonists. Applicant reduces to practice the method with Liraglutide (Fig 1). Applicant does not reduce to practice functional variants or the recited sequences excluding liraglutide.
Claims 116, 119 is directed to the method of claim 112, comprising a variant. Applicant does not reduce to practice variants.
Claim 123 is directed to the method of claim 112. Here, Applicant has reduced to practice fatty acid attached to position K18 (see page 55). Applicant does not reduce to practice variants at position 18 that attach to a fatty acid molecule.
Regarding claims 125, 128, 129, 130, Applicant does not reduce to practice variants and amino acid residues at position 18, in the variants, that attach to the fatty acid.
The written description requirement for “a peptide” may be satisfied through sufficient description of a representative number of species of peptide, by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that the Applicant was in possession of the claimed genus of peptides. A “representative number of species” means that the species that are adequately described are representative of the entire genus. See MPEP 2163. The
peptide SEQ ID NO: 6 and SEQ ID NO: 12 described in the specification is not representative of the full variation of peptides comprising fatty acid, attached to several possibilities of amino acid residue at position 18, as recited in the claim. A skilled artisan is unable to predict the peptides that would collectively present a core structure sufficient for the method of treatment as claimed. Thus, the
specification fails to satisfy the written description requirement of 35 USC 112 (a) with respect to claims
112-123 and 125-130.
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.
Claims 112-123 and 125-130 is/are rejected under 35 U.S.C. 103 as being obvious over Sparre-Ulrich, AH et al., hereinafter Ulrich (Sparre-Ulrich, AH et al.,WO2020/115048A1; International Filing date 3 Dec 2019) in view of Jens Juul Holst, hereinafter Holst (Holst, JJ., Cell Reports Medicine, 100284, May 18, 2021).
The applied reference has a common Applicant and Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, Ulrich teaches GIP peptide analogs for use in a method of treating obesity (see page 91; lines 9-10) wherein obesity related disorders may be one of dyslipidemia (see page 91; line 27). Specifically, Ulrich teaches subcutaneous administration of GIP analogs (1-10 nmol/kg) to 2-3 Göttingen minipigs (see page 104; line 32); intravenous administration in Wistar rats (see page 105; line 5) (i.e. administration). GIP analogs for e.g., are listed in Table IA (see page 108-117). Ulrich teaches AT673 (page 137, line 21 (also below).
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The sequence of AT673 is 100 % identical to instant SEQ ID NO: 39 or a functional variant thereof wherein the GIP peptide analog comprises C16-diacid (i.e. fatty acid) at Lys-18.
Ulrich does not teach administering GLP-1 receptor agonist.
Holst teaches that combinations of a GLP-RA with GIP agonists, as well as with GIP antagonists, have beneficial metabolic effects and cause body weight losses beyond those elicited by either of the two components alone. Notably, Holst teaches, that various attempts have been made to antagonize the actions of GIP to prevent fat accumulation, and among the most successful so far is the development of monoclonal antibodies against the GIP receptor, which prevents weight gain in animal models, including non-human primates, and potentiates weight loss induced by GLP-1 (page 1, 3rd paragraph).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the GIP peptide of Ulrich, with a GLP-1 receptor agonist as suggested in Holst, as both molecules are directed to reduce body weight and improve metabolic parameters (see first paragraph in Holst). One motivated to do so would have a reasonable expectation of success Holst discloses studies specifically directed to the combination of GIPR antagonist antibodies conjugated to GLP-1 peptide that decrease weight in obese mice and monkeys (1st paragraph, lines 1-4). Thus, one would have recognized that applying the teaching
of Ulrich to the method of Holst, would have yielded predictable results and improved the clinical benefit of the method of treatment (See MPEP § 2143 l(A)(D)).
Regarding claim 113, as noted in the obviousness rationale above, the combined teachings of Ulrich and Holst, read on the instant claim limitations.
Regarding claim 114, Holst teaches development of monoclonal antibody directed against the human and/or the murine GIP receptor conjugated with a GLP-1 peptide analog (stabilized against DPP-4) (i.e. protease resistant) (Main text, lines 3-5).
Regarding claim 115, Ulrich teaches GLP-1 receptor agonist SEQ ID NO: 22 (see page 86, SEQ ID NO: E).
Ulrich does not teach administering GLP-1 receptor agonist and GIP.
Holst teaches that combinations of a GLP-RA with GIP agonists, as well as with GIP antagonists, have beneficial metabolic effects and cause body weight losses beyond those elicited by either of the two components alone. Notably, Holst teaches, liraglutide, is approved for obesity. Holst teaches, that most recently, a second-generation GLP-1RA, semaglutide, has shown surprisingly strong weight-reducing effects when used in a higher dose, resulting in weight losses of close to 20% of body weight (1st paragraph, last 5 lines).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the GIP peptide of Ulrich, with a GLP-1 receptor agonist as suggested in Holst, as both molecules are directed to reduce body weight and improve metabolic parameters (see first paragraph in Holst). One motivated to do so would have a reasonable expectation of success Holst discloses studies specifically directed to the combination of GIPR antagonist antibodies conjugated to GLP-1 peptide that decrease weight in obese mice and monkeys (1st paragraph, lines 1-4). Thus, one would have recognized that applying the teaching
of Ulrich to the method of Holst, would have yielded predictable results and improved the clinical benefit of the method of treatment (See MPEP § 2143 l(A)(D)).
Regarding claim 116, the obviousness rationale has been set forth above (i.e. f and g).
Regarding claim 117, Holst teaches semaglutide as noted above.
Regarding claim 118, embodiments of the specification disclose ‘triple acting’ as triple agonist of the GLP-1 receptor and two additional receptors (page 41, line 3) and ‘dual-acting’ as GLP-1 receptor agonist is a GLP-1R/glucagon dual agonist (page 41, line 7-8). Specifically, Holst teaches GIP-GLP-1 co-agonist tirzepatide (i.e. dual acting) (see paragraph 4, line 6).
Regarding claim 119, Ulrich teaches AT673 as noted in the rejection under claim 112 (i.e. (a),(b),(d).
Ulrich does not teach (e) or (f) as recited in the claim in a single embodiment.
However, Ulrich specifically teaches that in the GIP peptide analogue or a functional variant thereof, x1 is E or glutaric acid (page 19, line 26) (i.e. (e)). Ulrich discloses that it may be advantageous to substitute E in position 3 (i.e. the first amino acid from the N-terminus) with glutaric acid, since glutaric acid has no amino group and therefore the N-terminal pyroGlu formation is not possible. PyroGlu formation may be an unwanted side reaction for glutamic acid. Substitution with glutaric acid in position 3 may also increase the potency. Glutaric acid is naturally produced in the body during the
metabolism of some amino acids, including lysine and tryptophan (see page 20, line 5). Additionally, Ulrich teaches the sequence shown below (see page 68, line 26) (i.e. (f)).
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Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute residues X1, X2 or both, as specifically suggested in the GIP peptide of Ulrich. One motivated to do so would have a reasonable expectation of success as Ulrich discloses said substitutions to generate an array of GIP peptides, which would have yielded predictable results and improved the clinical benefit of the method of treatment (See MPEP § 2143 l(A)(D)).
Regarding claim 120, Ulrich teaches AT615 (i.e. (a)); AT616 (i.e. (b)); AT665 (i.e. (c)); AT666(i.e. (d)); AT667 (i.e. (e)); AT673 (i.e. (f)); AT674 (i.e. (g)); AT693 (i.e. (h)); AT694 (i.e. (i)); AT673 plus 1 substitution (i.e. (j)); AT695 plus 1 substitution (i.e. (k)); AT696 plus 1 substitution (i.e. (l)); AT693 plus 1 substitution (i.e. (m)); AT616 plus 1 substitution (i.e. (o)); AT616 plus 1 substitution (i.e. (p)); AT635 plus 2 substitutions (i.e. (q)); AT615 plus 1 substitution (i.e. (r)); AT668 plus 1 substitution (i.e. (s)); AT673/674/695 plus 1 substitution (i.e. (u)); AT673/674/695 plus 1 substitution (i.e. (v)). See Table IA (see page 108-117).
Regarding claim 121, the rejection has been set forth above.
Regarding claim 122, the rejection has been set forth above.
Regarding claim 123, the GIP peptide composition as disclosed in Ulrich has been noted above, meeting the limitations of the claim.
Regarding claim 125, the rejection has been noted above in the rejection under claim 120. Additionally, Ulrich teaches linkers, wherein the fatty acid molecule is attached to an amino acid residue via a linker such that a carboxyl group forms an amide bond with an amino group of the linker (see page 158, line 23).
Regarding claim 126, as noted in the rejection under claim 112, Ulrich teaches for e.g. obesity, dyslipidemia.
Regarding claim 127, the rejection is noted above.
Regarding claim 128, Ulrich teaches AT673 as noted in the rejection under claim 112. See Table IA (see page 108-117).
Regarding claim 129, Ulrich teaches AT695 plus 1 substitution as noted in the rejection under claim 120 and applying the motivation to combine rationale under claim 112. See Table IA (see page 108-117).
Regarding claim 130, Ulrich teaches AT696 plus 1 substitution as noted in the rejection under claim 120 and applying the motivation to combine rationale under claim 112. See Table IA (see page 108-117).
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.
1. Claims 112-123 and 125-130 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 86-91, 94-95, 97-99, 101-105, 107-108 of copending Application No. 17/776976 in view of Sparre-Ulrich, AH et al., hereinafter Ulrich (Sparre-Ulrich, AH et al.,WO2020/115048A1; International Filing date 3 Dec 2019) further in view of .
This is a provisional nonstatutory double patenting rejection.
The teachings of Ulrich and Holst have been set forth above.
Regarding claim 112, reference application ‘976 recites a GIP analog which reads on SEQ ID NO: 39 in the instant claim.
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Reference Application ‘976 does not teach a method of treatment as instantly claimed.
Ulrich teaches GIP peptide analogs for use in a method of treating obesity (see page 91; lines 9-10) wherein obesity related disorders may be one of dyslipidemia (see page 91; line 27). Specifically, Ulrich teaches subcutaneous administration of GIP analogs (1-10 nmol/kg) to 2-3 Göttingen minipigs (see page 104; line 32); intravenous administration in Wistar rats (see page 105; line 5) (i.e. administration). GIP analogs for e.g., are listed in Table IA (see page 108-117). Ulrich teaches AT673 (page 137, line 21 (also below).
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The sequence of AT673 is 100 % identical to instant SEQ ID NO: 39 or a functional variant thereof wherein the GIP peptide analog comprises C16-diacid (i.e. fatty acid) at Lys-18. Holst teaches that combinations of a GLP-RA with GIP agonists, as well as with GIP antagonists, have beneficial metabolic effects and cause body weight losses beyond those elicited by either of the two components alone. Notably, Holst teaches, that various attempts have been made to antagonize the actions of GIP to prevent fat accumulation, and among the most successful so far is the development of monoclonal antibodies against the GIP receptor, which prevents weight gain in animal models, including non-human primates, and potentiates weight loss induced by GLP-1 Ras (page 1, 3rd paragraph).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the GIP peptide of the reference application ‘976, with a GLP-1 receptor agonist as suggested in Holst, as both molecules are directed to reduce body weight and improve metabolic parameters (see first paragraph in Holst). One motivated to do so would have a reasonable expectation of success as Holst discloses studies specifically directed to the combination of GIPR antagonist antibodies conjugated to GLP-1 peptide that decrease weight in obese mice and monkeys (1st paragraph, lines 1-4). Thus, one would have recognized that applying the teaching of the reference application ‘976 to the method of Ulrich and Holst, would have yielded predictable results and improved the clinical benefit of the composition (See MPEP § 2143 l(A)(D)).
Regarding claim 113, as noted in the obviousness rationale above, the combined teachings of the reference application’976 and Ulrich and Holst, read on the instant claim limitations.
Regarding claim 114, Holst teaches development of monoclonal antibody directed against the human and/or the murine GIP receptor conjugated with a GLP-1 peptide analog (stabilized against DPP-4) (i.e. protease resistant) (Main text, lines 3-5).
Regarding claim 119, reference application ‘976 teaches Formula A (i.e. (a),(b),(d), (e), (f).
Regarding claim 120, reference application ‘976 teaches the sequences in claim 97.
Regarding claim 121, see claim 99.
Regarding claim 122, see claim 99
Regarding claim 123, see claim 100.
Regarding claim 125, see claim 101.
Regarding claim 126, Ulrich teaches for e.g. obesity, dyslipidemia.
Regarding claim 127, the rejection is noted above.
Regarding claim 128, see claim 101 (i).
Reference application ‘976 does not teach 18K.
Ulrich teaches that GIP peptide is modified by attaching at least one fatty acid molecule at one or more amino acid residues at positions 3 to 29 of SEQ ID NO XX, or said functional variant thereof (see page 3, lines 20-23).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the GIP peptide with fatty acid at K18 as Ulrich discloses. One motivated to do so would have a reasonable expectation of success as the peptides in Ulrich are GIP receptor antagonist peptides comprising peptide sequences that read on the sequence in the reference application ‘976 (See MPEP § 2143 l(A)(D)).
Regarding claim 129, see claim 101 (i).
Regarding claim 130, see claim 101 (j).
2. Claims 112-123 and 125-130 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12297250 in view of Sparre-Ulrich, AH et al., hereinafter Ulrich (Sparre-Ulrich, AH et al.,WO2020/115048A1; International Filing date 3 Dec 2019) further in view of Jens Juul Holst, hereinafter Holst (Holst, JJ., Cell Reports Medicine, 100284, May 18, 2021.
The teachings of Ulrich and Holst have been set forth above.
Regarding claim 112, reference patent ‘250 teaches a method of treating comprising administering a GIP analog (see claim 17).
Reference patent does not teach GLP receptor agonist.
The teachings of Ulrich and Holst provide the obviousness rationale as noted above.
Regarding claim 113, the rejection is noted above.
Regarding claim 114, Holst teaches development of monoclonal antibody directed against the human and/or the murine GIP receptor conjugated with a GLP-1 peptide analog (stabilized against DPP-4) (i.e. protease resistant) (Main text, lines 3-5).
Regarding claim 115, Ulrich teaches GLP-1 receptor agonist SEQ ID NO: 22 (see page 86, SEQ ID NO: E).
Regarding claim 116, the obviousness rationale has been set forth above (i.e. f and g).
Regarding claim 117, Holst teaches semaglutide as noted above.
Regarding claim 118, embodiments of the specification disclose ‘triple acting’ as triple agonist of the GLP-1 receptor and two additional receptors (page 41, line 3) and ‘dual-acting’ as GLP-1 receptor agonist is a GLP-1R/glucagon dual agonist (page 41, line 7-8). Specifically, Holst teaches GIP-GLP-1 co-agonist tirzepatide (i.e. dual acting) (see paragraph 4, line 6).
Regarding claim 119, reference patent ‘250 teaches SEQ ID NO: 81 (see claim 4-9, 11-17).
Regarding claim 120-123, 125, reference patent ‘250 teaches claims 1-17.
Regarding claim 126, reference patent ‘250 teaches for e.g. obesity.
Regarding claim 127, the rejection is noted above.
Regarding claim 128, see claim 11-15 (SEQ ID NO: 174).
Regarding claim 129, see claim 11-15 (SEQ ID NO: 174).
Regarding claim 130, see claim 11-15 (SEQ ID NO: 174).
Reference patent ‘250 does not teach linker in the same embodiment.
Ulrich teaches linkers, wherein the fatty acid molecule is attached to an amino acid residue via a linker such that a carboxyl group of the fatty acid molecule forms an amide bond with an amino group of the linker (see page 158, line 23).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the GIP peptide in the reference patent ‘250 with fatty acid using a linker. One motivated to do so would have a reasonable expectation of success as the peptides in Ulrich are GIP receptor antagonist peptides comprising peptide sequences that read on the sequence in the reference patent ‘250 (See MPEP § 2143 l(A)(D)).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to the applicant’s disclosure: WO2021110845A1.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 5712707430. 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.
/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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