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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/07/2026 has been entered.
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/KR2019/018316 filed 12/23/2019, which claims the benefit of the priority of Korean Patent Application No. 10-2018-0167698 filed 12/21/2018.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1, 5-6, 8-9, 23-25, 30, 32, 34-37, 41-43, 61-64 are pending. Claims 1, 5-6, 8-9, 23-25, 30, 32, 34-37, 41-42, 61-63 are amended. Claims 2-4, 7, 10-22, 26-29, 31, 33, 38-40, 46-60 are canceled. Claim 64 is withdrawn. Claims 1, 5-6, 8-9, 23-25, 30, 32, 34-37, 41-43, 61-63 are being examined on the merits in this office action.
Claim Rejections Withdrawn
The rejection of claims 1-6, 8-9, 23-25, 30, 32, 35-37, 41-43, and 61-63 under 35 U.S.C. 103 as being unpatentable over DiMarchi et al. (WO2016/049190A1 – hereinafter “DiMarchi”) in view of Oh et al. (WO2017116204A1 – hereinafter “Oh”) and Jin et al. (KR20180090760A – hereinafter “Jin”) is withdrawn in view of the claim amendments.
The rejection of claims 34 under 35 U.S.C. 103 as being unpatentable over DiMarchi et al. (WO2016/049190A1 – hereinafter “DiMarchi”) in view of Oh et al. (WO2017116204A1 – hereinafter “Oh”) and Jin et al. (KR20180090760A – hereinafter “Jin”), as applied to claim 1 above, and further in view of Choi et al. (US20180291077A1 – hereinafter “Choi”) is withdrawn in view of the claim amendments.
The rejection of claims 1, 5, 23, 25, 30, 32, 35-37, 40-43, and 61-62 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 100, 125-129, 131-134, and 136 of copending Application No. 17/282,661 is withdrawn in view of the claim amendments.
Claim Objections - New
Claim 25 is objected to because of the following informalities: Claim 25 comprises the status identifier “previously presented”. However, claim 25 has been amended and should contain the identifier “currently amended”. All "currently amended" claims must include markings to indicate the changes made relative to the immediate prior version of the claims: underlining to indicate additions, strike-through or double brackets for deletions (see 37 CFR 1.121(c) (See MPEP 714, 1893.01(a)(4)). Appropriate correction is required.
Claim Rejections - 35 USC § 112 - New
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 1, 5-6, 8-9, 23-25, 30, 32, 34-37, 41-43, 61-63 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 the limitation "…wherein the combination pharmaceutical composition…" in line 12. It is unclear what composition is being referred to in this claim since the claim is drawn to a preparation. Additionally, there is no combination pharmaceutical composition previously recited. There is insufficient antecedent basis for this limitation in the claim.
Additionally, claim 1 is drawn to a combination preparation comprising long-acting conjugate of insulin and long-acting conjugate of an isolated peptide. It is the Examiner’s understanding that the recited preparation comprises both the isolated peptide and insulin, i.e. the isolated peptide and insulin are combined. However, the claim further recites that the first and second preparation are separate preparations that are administered simultaneously or sequentially. It is unclear if the preparation is a combination (or mixture) of both the isolated peptide and insulin or if the preparation is simply a kit that comprises two separate preparations of the isolated peptide and insulin. The dependent claims do not clear up the ambiguity and are thus rejected as well.
Claim Rejections - 35 USC § 101/112 - New
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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 5-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product and a method and only a single invention is required.
Claims 5-6 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 5 is directed to a product and a method and only a single invention is required. Examiner notes that the wherein clause is an active method step. Therefore, the metes and bounds of the claim are unknown making the claim indefinite.
Claim 6 depends on claim 5 and is also rejected.
Claim Rejections - 35 USC § 103 - New
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 1, 5-6, 8-9, 23-25, 30, 32, 35, 37, 41-43, 61-63 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (EP3156066B1 – hereinafter “Kim”) in view of Oh et al. (WO2017116204A1 – hereinafter “Oh”).
Kim teaches a pharmaceutical composition for use in a method of the prevention or treatment of diabetes mellitus comprising:
a long-acting insulin analogue conjugate in which an insulin analogue is linked to an immunoglobulin Fc region via a non-peptidyl polymer linker; and
a long-acting insulinotropic peptide conjugate in which an insulinotropic peptide is linked to an immunoglobulin Fc region via a non-peptidyl polymer linker [0024-0027], wherein the long-acting insulin analogue conjugate and the long-acting insulinotropic peptide conjugate may be administered simultaneously, sequentially or reversely, and may be administered simultaneously in a proper combination of effective doses and that the long-acting insulin analogue conjugate and the long-acting insulinotropic peptide conjugate may be stored separately in individual containers, and then administered simultaneously, sequentially or reversely [0094], wherein the material capable of prolonging in vivo half-life of the corresponding analogue or peptide by formation of the conjugate may be the biocompatible material or carrier according to the present disclosure, which may be an immunoglobulin Fc region [0036]. Kim teaches that composition has the effect of lowering blood glucose and reducing weight gain which can be induced by single administration of insulin [0092].
Kim does not teach that the long-acting insulinotropic peptide comprises the amino acid sequence of SEQ ID NO: 42-43, 96-97.
Oh teaches a peptide having activity against glucagon receptor, Glucagon-like peptide-1 receptor, and Glucose-dependent insulinotropic polypeptide receptor, that the peptide is derived from a native GLP-1, native GIP, or native exendin-4 amino acid sequence, that the peptide has the Formula 1. SEQ ID NO: 103 (claims 1, 3-4). Oh teaches that the pharmaceutical composition for preventing or treating metabolic syndrome, comprising the peptide of any one of claims 1 to 13 and specifically for treating disorders of glucose tolerance, hypercholesterolemia, dyslipidemia, obesity, diabetes (claims 20-21). Oh teaches SEQ ID NO: 43 (Example 1 on page 22). Examiner notes that this sequence is 100% identical to the instant SEQ ID NO: 42. Oh teaches that the peptide have a glycemic control and weight loss effect, there are no side effects such as vomiting and nausea (Page 6, last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Kim and use a better insulinotropic peptide such as the one taught by Oh since the peptide had both glycemic control and weight loss effect. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using the insulinotropic peptide of Oh, since the peptide had both glycemic control and weight loss effect, with no side effects such as vomiting and nausea. The disclosures render obvious claim 1.
Regarding claims 5-6, Kim teaches that the composition is administered to subjects suffering from diabetes mellitus (claim 2; [0017, 0019, 0027, 0097, 0103]), who are known to need insulin.
Regarding claims 8-9, Kim teaches molar ratio of long-acting insulinotropic peptide conjugate:insulin analogue conjugate may be in the range of 1:0.01~1:50 [0032, 0138].
Regarding claim 23, Oh teaches specifically the peptide of SEQ ID NO: 64 YXQGTFTSDYSKYLDEKRAKEFVQWLLDHHPSSGQPPPSC (SEQ ID NO: 42), wherein X is AIB (Example 1). Examiner notes that this sequence is 100% identical to the instant SEQ ID NO: 42. Oh teaches that the peptide have a glycemic control and weight loss effect, there are no side effects such as vomiting and nausea (Page 6, last paragraph). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Kim and use a better insulinotropic peptide such as the one taught by Oh since the peptide had both glycemic control and weight loss effect.
Regarding claim 24, Oh teaches that the amino acids 16 and 20 from the N-terminus in the general formula form a ring with each other (Page 11). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Kim and use a better insulinotropic peptide such as the one taught by Oh since the peptide had both glycemic control and weight loss effect.
Regarding claim 25, Oh teaches that the peptide C-terminus is amidated (claim 18). It would have been obvious to modify the sequence of Kim and amidate it at the C-terminus as taught by Oh since both references teach similar analogs in a composition with insulin.
Regarding claim 30, Kim teaches Analog 2 (See Table 3), which has the sequence
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236
802
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and is identical to the instant SEQ ID NO: 126.
Regarding claim 32, Kim teaches Analog 8 (See Table 3), which has the sequence
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233
826
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and is identical to the instant SEQ ID NO: 142.
Regarding claim 35, Kim teaches Analog 1 (See Table 3) which has the sequence
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227
785
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and this sequence is identical to the instant Formula 4 and 5.
Regarding claim 36, 41, 63, Kim teaches insulin analogue conjugate and the insulinotropic peptide conjugate may be represented by the following formula: X-La-F wherein X is an insulin analogue or an insulinotropic peptide, L is a linker, a is 0 or a natural number (when a is 2 or higher, each L is independent), F is an FcRn binding material, specifically immunoglobulin Fc region [0063-0064], that the insulin analogue or the insulinotropic peptide is linked to a biocompatible material or a carrier via a covalent bond or a non-covalent bond [0033], wherein the immunoglobulin Fc region is an IgG Fc (claim 6; [0067, 0076-0079]).
Regarding claim 42, Kim teaches wherein the immunoglobulin Fc region is aglycosylated (claim 6; [0074-0075).
Regarding claim 43, Kim teaches that the immunoglobulin Fc region of the present disclosure may include 1) a CH1 domain, a CH2 domain, a CH3 domain and a CH4 domain, 2) a CH1 domain and a CH2 domain, 3) a CH1 domain and a CH3 domain, 4) a CH2 domain and a CH3 domain, 5) a combination of one or more domains and an immunoglobulin hinge region (or a portion of the hinge region), and 6) a dimer of each domain of the heavy-chain constant regions and the light-chain constant region [0066].
Regarding claim 61, Kim teaches wherein the non-peptidyl polymer linker is a polyethylene glycol (claims 4-5).
Regarding claim 62, Kim teaches that the composition is a pharmaceutical composition [0016-0018], that the composition may be in a form of a therapeutic kit for diabetes [0095].
Claims 34 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Claims 1, 5-6, 8-9, 23-25, 30, 32, 35, 37, 41-43, 61-63 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (EP3156066B1 – hereinafter “Kim”) in view of Oh et al. (WO2017116204A1 – hereinafter “Oh”) as applied to claim 1 above, and further in view of Choi et al. (US20180291077A1 – hereinafter “Choi”).
The teachings of Kim and Oh are disclosed above and incorporated herein by reference. Even though Kim teaches proinsulin, Kim does not teach the proinsulin sequence as recited in the instant claim 34.
Choi teaches insulin analogs and methods of preparing (Abstract) and that the analogs have the sequence including the sequence of SEQ ID NO: 46 (See Table 1, Analog 21) which is 100% identical to the instant SEQ ID NO: 168. Choi teaches that the A-chain and the B-chain may be interlinked by a disulfide bond [0065, 0077].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Kim and use the insulin analog of Choi since Choi teaches that the insulin may possess in vivo blood glucose level-controlling capability equivalent or corresponding to that of native insulin [0067]. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success modifying the insulin analogue of Kim with the teachings of Choi, since they possess the in vivo blood glucose level-controlling capability. The disclosures render obvious claims 34 and 36.
Response to Arguments
Applicant’s arguments, see Applicant Arguments, filed 07/07/2026, with respect to the rejection(s) of claim(s) 1, 5-6, 8-9, 23-25, 30, 32, 34-37, 41-43, 61-63 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kim et al.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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