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 .
Status of the Claims
Claims 1-47 were originally filed January 18, 2023.
The amendment received April 20, 2023 amended claims 6, 18, 20, 22, 33, 34, 37, 38, and 42-47; canceled claims 8-10, 12-16, 24, 25, 36, and 39-41; and added new claims 48-52.
The amendment received February 21, 2024 canceled claims 1-46 and added “new” claims 47-52 and new claims 53-76. Please note: the claim status identifiers do NOT match with the previous claim set.
The “amendment” received February 21, 2024 canceled claims 1-4, 33, and 35-41. Please note: this claim set is apparently the amended claim set for KR 10-2021-0032692. In the future, please do NOT submit claim sets alone as the Office will treat individual claims sets as being the claim set to prosecute.
The amendment received April 19, 2024 canceled claim 76 and added “new” claim 74. Please note: claim 74 can not be new since claim 74 was added in the amendment received February 21, 2024.
The amendment received January 24, 2025 amended claims 47, 48, 60, 62, and 75.
The amendment received June 27, 2025 amended claims 47-60, 62-70, and 74 and canceled claim 61.
The amendment received December 18, 2025 amended claim 47.
The amendment received August 4, 2026 amended claims 47, 49, 53, and 70 and canceled claim 54.
Claims 47-53, 55-60, and 62-75 are currently pending.
Claims 47, 48, 52, 60, 63-65, 70, 71, and 74 are currently under consideration.
Election/Restrictions
Applicants elected, without traverse, Group I (claims 47-74) in the reply filed on January 24, 2025. 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 Claim 75 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim.
Applicants elected, without traverse, GLP-1/exendin 4 hybrid (species of GLP-1 analog), SEQ ID NO: 15 (species of first Fc), GLP-2 (species of GLP-2 analog), SEQ ID NO: 16 (species of second Fc), SEQ ID NO: 39 (species of linker), and MG12-8 (SEQ ID NOs: 30 and 36; species of complete bispecific fusion protein) as the species in the reply filed on January 24, 2025. 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)). Claims 49-51, 53-59, 62, 66-69, 72, and 73 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
Please note: GLP-1 is present SEQ ID NO: 2 without the C-terminal glycine; exendin 4 is present SEQ ID NO: 4, and GLP-2 is present SEQ ID NO: 18.
Please note: the election of MG12-8 (SEQ ID NOs: 30 and 36; species of complete bispecific fusion protein) does not correlate with the election of, at least, A (i.e. GLP-1/exendin 4 hybrid; SEQ ID NO: 2/GLP-1 and residues 1-31 of SEQ ID NO: 30 do not correlate – residue 2 of SEQ ID NO: 30 is Gly while residue 2 of SEQ ID NO: 2 is Ala, the Arg is missing between residues 29 and 30 of SEQ ID NO: 30 – i.e. residue 30 of SEQ ID NO: 2 or, alternatively, various mutations are present for exendin 4), C (i.e. GLP-2; the following mutations are present in SEQ ID NO: 36 compared to SEQ ID NO: 18 – A2G, N16G, and L17Q), or D (species of linker; (G4S)3EPKSSDKTHTCPPCP/SEQ ID NO: 39 is not the same as the linker in SEQ ID NO: 30). Therefore, only claims that read on the species of A-D have been examined.
SEQ ID NO: 19 is a human GLP-2 mutant (A2G, N16G, and L17Q) which was not elected (i.e. GLP-2 was elected).
SEQ ID NO: 11 differs from GLP-1 of SEQ ID NO: 2 at residues A2G and deletion of Arg at residue 30 which was not elected (i.e. GLP-1 was elected).
Election can not be changed mid-prosecution. Election by original presentation prevails.
Priority
The present application is a 371 (National Stage) of PCT/KR2021/003128 filed March 12, 2021 which claims foreign priority to Korea 10-2020-0030727 filed March 12, 2020.
Specification
The amendment filed August 4, 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: withdrawn claim 53 reads “wherein the tandem repeat of GLP-1/Exendin 4 hybrid comprises the amino acid sequence of SEQ ID NO: 1”. However, SEQ ID NO: 1 is human GLP-1 mutant A2G and not a GLP-1/Exendin 4 hybrid.
Applicant is required to cancel the new matter in the reply to this Office Action.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3.
Declaration Under 37 CFR § 1.132
The declaration under 37 CFR 1.132 filed August 4, 2026 was considered. However, the amendments received August 4, 2026 caused the withdrawal of the prior art rejections of record. In addition, it is respectfully noted that the declaration and the data provided are not commensurate in scope with the present claims (i.e. data is for PG-102/MG12-8 which is SEQ ID NO: 30 and SEQ ID NO: 36 which are not part of the presently examined claims). Furthermore, the data provided does not provide sequences for any of the polypeptides.
Withdrawn Rejections
The rejection of claim 60 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 (new matter) is withdrawn in view of originally filed claim 19.
The rejection of claim 60 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 is withdrawn in view of originally filed claim 19.
The rejection of claims 47, 48, 60, 64, 65, 70, and 71 under 35 U.S.C. 103 as being unpatentable over Sung et al. U.S. Patent Application Publication 2017/0362293 published December 21, 2017 and Guan et al. WO 2018/009778 published January 11, 2018 is withdrawn in view of the amendment received August 4, 2026.
The rejection of claims 47, 48, 52, 60, 64, 65, 70, and 71 under 35 U.S.C. 103 as being unpatentable over Sung et al. U.S. Patent Application Publication 2017/0362293 published December 21, 2017; Guan et al. WO 2018/009778 published January 11, 2018; and Gan et al., 2015, GLP-1-Exendin-4/IgG4 (Fc) Fusion Protein as a Novel Drug for Diabetes Treatment, Exp. Clin. Endocrinol. Diabetes, 123: 371-375 is withdrawn in view of the amendment received August 4, 2026.
The rejection of claims 47, 48, 52, 60, 63-65, 70, 71, and 74 under 35 U.S.C. 103 as being unpatentable over Sung et al. U.S. Patent Application Publication 2017/0362293 published December 21, 2017; Guan et al. WO 2018/009778 published January 11, 2018; Gan et al., 2015, GLP-1-Exendin-4/IgG4 (Fc) Fusion Protein as a Novel Drug for Diabetes Treatment, Exp. Clin. Endocrinol. Diabetes, 123: 371-375; and Jin et al. WO 2020/231199 published November 19, 2020 (effective filing date of May 14, 2019) is withdrawn in view of the amendment received August 4, 2026.
The rejection of claims 47, 60, 63-65, 70, 71, and 74 under 35 U.S.C. 103 as being unpatentable over Sung et al. U.S. Patent Application Publication 2017/0362293 published December 21, 2017 and Jin et al. WO 2020/231199 published November 19, 2020 (effective filing date of May 14, 2019) is withdrawn in view of the amendment received August 4, 2026.
New Rejections Necessitated by Amendment
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 47, 48, 52, 60, 63-65, 70, 71, and 74 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. One of skill in the art would not be able to determine the scope of the present fusion polypeptide. For example, it is unclear how the “at least one of the GLP-1 receptor agonist and the GLP-2 receptor agonist is a tandem repeat of a GLP-1 receptor agonist” (i.e. how can the GLP-2 receptor agonist be a GLP-1 receptor agonist).
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.
Claims 47, 48, 52, 60, 63-65, 70, 71, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Sung et al. U.S. Patent Application Publication 2017/0362293 published December 21, 2017; Guan et al. WO 2018/009778 published January 11, 2018; Gan et al., 2015, GLP-1-Exendin-4/IgG4 (Fc) Fusion Protein as a Novel Drug for Diabetes Treatment, Exp. Clin. Endocrinol. Diabetes, 123: 371-375; Jin et al. WO 2020/231199 published November 19, 2020 (effective filing date of May 14, 2019); Hou et al., 2007, High-Level Expression of Fusion Protein Containing 10 Tandem Repeated GLP-1 Analogs in Yeast Pichia pastoris and Its Biological Activity in a Diabetic Rat Model, Biosci Biotechnol Biochem, 71(6): 1462-1469; and Sasaki et al. U.S. Patent Application Publication 2005/0164930 published July 28, 2005.
For present claims 47, 48, 52, 60, 63-65, 70, and 71, Sung et al. teach GLP-1-hybrid Fc and GLP-2 (present SEQ ID NO: 18)-hybrid Fc and utilizing linkers wherein the hybrid can have different origins (i.e. isotype) (please refer to the entire specification particularly 1, 4, 6-8, 13-18, 21-54, 60, 61, 63-66, 76, 77, 79, 90, 100, 137, 139, 140, 142; Table 1; Examples).
For present claims 47, 48, 52, 60, 63-65, 70, and 71, Hou et al. teach 10 tandem repeats of GLP-1 analogues which are functional (please refer to the entire reference particularly the abstract).
For present claims 47, 48, 52, 60, 63-65, 70, and 71, Sasaki et al. teach 2-30 tandem repeats of GLP-2 which are functional (please refer to the entire specification particularly the abstract; paragraphs 1-9, 24, 25).
However, Sung et al. do not teach that the GLP-1-hybrid Fc and GLP-2-hybrid Fc are linked/dimerized.
For present claims 47, 48, 52, 60, 63-65, 70, and 71, Guan et al. teach linking GLP-1 and GLP-2 via linking agents to create dual agonists (please refer to the entire specification particularly the abstract; paragraphs 4, 24-38, and 49; Examples; claims).
However, Sung et al. do not teach a GLP-1/exendin-4 hybrid.
For present claims 47, 48, 52, and 71, Gan et al. teach a GLP-1-exendin-4/IgG4 (Fc) fusion protein that is a potent long acting GLP-1 receptor agonist wherein exendin-4 is present SEQ ID NO: 4 (please refer to the entire reference particularly the abstract; discussion).
However, Sung et al. do not teach Fc of present SEQ ID NOs: 15 or 16 or linkers of present SEQ ID NO: 39.
For present claims 63, 71, and 74, Jin et al. teach SEQ ID NOs: 3 (present SEQ ID NO: 15), 4 (present SEQ ID NO: 16), and 18 (present SEQ ID NO: 18), additional linkers of claim 74, GLP-1E-NTIG, GLP-1/exendin-4, GLP-2-2G-NTIG, and GLP-1 and GLP-2 with knobs-in-holes (KIH) (please refer to the entire specification particularly the abstract; pages 8, 9, 11, 12, 20-22, 27-29, 34, 35).
The claims would have been obvious because a particular known technique (i.e. making bispecific antibodies; dimerization of Fc; making tandem repeats of GLP-1 and GLP-2) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because the substitution of one known element (GLP-1; GLP-2; one Fc; genus of linker) for another (GLP-1-exendin-4 fusion polypeptide; GLP-1 tandem repeats; GLP-2 tandem repeats; Fc of SEQ ID NOs: 15 or 16; linker of SEQ ID NO: 39) would have yielded predictable results (GLP-1 receptor agonist; GLP-2 receptor agonist; prolonging half-life of attached polypeptide and ability to dimerize with another Fc) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 47, 60, 63-65, 70, 71, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Sung et al. U.S. Patent Application Publication 2017/0362293 published December 21, 2017; Jin et al. WO 2020/231199 published November 19, 2020 (effective filing date of May 14, 2019); Hou et al., 2007, High-Level Expression of Fusion Protein Containing 10 Tandem Repeated GLP-1 Analogs in Yeast Pichia pastoris and Its Biological Activity in a Diabetic Rat Model, Biosci Biotechnol Biochem, 71(6): 1462-1469; and Sasaki et al. U.S. Patent Application Publication 2005/0164930 published July 28, 2005.
For present claims 47, 60, 63-65, 70, 71, and 74, Sung et al. teach GLP-1-hybrid Fc and GLP-2 (present SEQ ID NO: 18)-hybrid Fc and utilizing linkers wherein the hybrid can have different origins (i.e. isotype) (please refer to the entire specification particularly 1, 4, 6-8, 13-18, 21-54, 60, 61, 63-66, 76, 77, 79, 90, 100, 137, 139, 140, 142; Table 1; Examples).
For present claims 47, 48, 52, 60, 63-65, 70, and 71, Hou et al. teach 10 tandem repeats of GLP-1 analogues which are functional (please refer to the entire reference particularly the abstract).
For present claims 47, 48, 52, 60, 63-65, 70, and 71, Sasaki et al. teach 2-30 tandem repeats of GLP-2 which are functional (please refer to the entire specification particularly the abstract; paragraphs 1-9, 24, 25).
However, Sung et al. do not teach KiH Fc of present SEQ ID NOs: 15 or 16 or linkers of present SEQ ID NO: 39.
For present claims 63, 70, 71, and 74, Jin et al. teach SEQ ID NOs: 3 (present SEQ ID NO: 15), 4 (present SEQ ID NO: 16), and 18 (present SEQ ID NO: 18), additional linkers of claim 74, GLP-1E-NTIG, GLP-1/exendin-4, GLP-2-2G-NTIG, and GLP-1 and GLP-2 with knobs-in-holes (KIH) (please refer to the entire specification particularly the abstract; pages 8, 9, 11, 12, 20-22, 27-29, 34, 35).
The claims would have been obvious because a particular known technique (i.e. making bispecific antibodies; making tandem repeats of GLP-1 and GLP-2; dimerization of Fc via KiH) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because the substitution of one known element (GLP-1; GLP-2; one Fc; genus of linker) for another (GLP-1 tandem repeats; GLP-2 tandem repeats; Fc of SEQ ID NOs: 15 or 16; linker of SEQ ID NO: 39) would have yielded predictable results (activity of GLP-1 and GLP-2; prolonging half-life of attached polypeptide and ability to dimerize with another Fc) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 47, 48, 52, 60, 63-65, 70, 71, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Sung et al. U.S. Patent Application Publication 2017/0362293 published December 21, 2017; Gan et al., 2015, GLP-1-Exendin-4/IgG4 (Fc) Fusion Protein as a Novel Drug for Diabetes Treatment, Exp. Clin. Endocrinol. Diabetes, 123: 371-375; Jin et al. WO 2020/231199 published November 19, 2020 (effective filing date of May 14, 2019); Hou et al., 2007, High-Level Expression of Fusion Protein Containing 10 Tandem Repeated GLP-1 Analogs in Yeast Pichia pastoris and Its Biological Activity in a Diabetic Rat Model, Biosci Biotechnol Biochem, 71(6): 1462-1469; and Sasaki et al. U.S. Patent Application Publication 2005/0164930 published July 28, 2005.
For present claims 47, 48, 52, 60, 63-65, 70, 71, and 74, Sung et al. teach GLP-1-hybrid Fc and GLP-2 (present SEQ ID NO: 18)-hybrid Fc and utilizing linkers wherein the hybrid can have different origins (i.e. isotype) (please refer to the entire specification particularly 1, 4, 6-8, 13-18, 21-54, 60, 61, 63-66, 76, 77, 79, 90, 100, 137, 139, 140, 142; Table 1; Examples).
For present claims 47, 48, 52, 60, 63-65, 70, and 71, Hou et al. teach 10 tandem repeats of GLP-1 analogues which are functional (please refer to the entire reference particularly the abstract).
For present claims 47, 48, 52, 60, 63-65, 70, and 71, Sasaki et al. teach 2-30 tandem repeats of GLP-2 which are functional (please refer to the entire specification particularly the abstract; paragraphs 1-9, 24, 25).
However, Sung et al. do not teach a GLP-1/exendin-4 hybrid.
For present claims 47, 48, 52, 60, 63-65, 70, 71, and 74, Gan et al. teach a GLP-1-exendin-4/IgG4 (Fc) fusion protein that is a potent long acting GLP-1 receptor agonist wherein exendin-4 is present SEQ ID NO: 4 (please refer to the entire reference particularly the abstract; discussion).
However, Sung et al. do not teach KiH Fc of present SEQ ID NOs: 15 or 16 or linkers of present SEQ ID NO: 39.
For present claims 47, 48, 52, 60, 63-65, 70, 71, and 74, Jin et al. teach SEQ ID NOs: 3 (present SEQ ID NO: 15), 4 (present SEQ ID NO: 16), and 18 (present SEQ ID NO: 18), additional linkers of claim 74, GLP-1E-NTIG, GLP-1/exendin-4, GLP-2-2G-NTIG, and GLP-1 and GLP-2 with knobs-in-holes (KIH) (please refer to the entire specification particularly the abstract; pages 8, 9, 11, 12, 20-22, 27-29, 34, 35).
The claims would have been obvious because a particular known technique (i.e. making bispecific antibodies; GLP-1 tandem repeats; GLP_2 tandem repeats; dimerization of KiH Fc) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because the substitution of one known element (GLP-1; GLP-2; one Fc; genus of linker) for another (tandem repeat of GLP-2; tandem repeat of GLP-2; GLP-1-exendin-4 fusion polypeptide; Fc of SEQ ID NOs: 15 or 16; linker of SEQ ID NO: 39) would have yielded predictable results (GLP-1 receptor agonist; GLP-2 receptor agonist; prolonging half-life of attached polypeptide and ability to dimerize with another Fc via KiH) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
Linkers made up of glycine and serine as recited in present claim 74 are exceedingly common in the prior art. See, for example, Chichili et al., 2012, Linkers in the structural biology of protein-protein interactions, Protein Science, 22: 153-167.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Park et al., 2016, Exendins and exendin analogs for diabetic therapy: a patent review (2012-2015), Expert Opinion on Therapeutic Patents, 26(7): 833-842.
Klein et al., 2012, Progress in overcoming the chain association issue in bispecific heterodimeric IgG antibodies, mAbs, 4(6): 653-663.
Godar et al., 2018, Therapeutic bispecific antibody formats: a patent applications review (1994-2017), Expert Opinion on Therapeutic Patents, 28(3): 251-276.
Xu et al., 2015, Production of bispecific antibodies in “knobs-into-holes” using a cell-free expression system, mAbs, 7(1): 231-242.
Shatz et al., 2013, Knobs-into-holes antibody production in mammalian cell lines reveals that asymmetric afucosylation is sufficient for full antibody-dependent cellular cytotoxicity, mAbs, 5(6): 872-881.
WO 2007/039140 (English equivalent for KR 20080064840)
EP 3 241 850 (English equivalent for KR 20160083810)
Hou et al., 2007, Oral administration of a fusion protein containing eight GLP-1 analogues produced in Escherichia coli BL21(DE3) in streptozotocin-induced diabetic rats, Biotechnol Lett, 29: 1439-1446.
CN 101525386 exendin 4 tandem repeat
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Future Communications
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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