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 .
DETAILED ACTION
Status of Application, Amendments, and/or Claims
The Information Disclosure Statements (IDS) filed 24 March 2023 and 13 November 2024 have been entered. Applicant’s amendments of the abstract and specification filed 24 March 2023 have been entered.
Election/Restriction
In the reply received on 10 December 2025, Applicant elected the species of: A) wherein the peptide containing the amino acid sequence of SEQ ID NO: 42; and B) wherein the bone disease is osteoporosis.
Claims 1-16 are pending and under examination to the extent they read on the elected species.
Priority
Acknowledgment is made of Applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed for the foreign application (KR 10-2020-0125196, filed 09/25/2020); however, no English translation of the foreign application has been provided.
Should Applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oh et al. (US 2018/0311315 A1, Pub. Date: Nov. 1, 2018).
Oh teaches a method of treating a disease or metabolic syndrome, e.g., diabetes, comprising administering a conjugate or a composition containing the conjugate to a subject in need thereof [0210] [0211]. As evidenced by Jackuliak et al. (Int. J. Endocrinol., Vol. 2014, Article ID 820615, 10 pages), both type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) are associated with an increased risk of osteoporosis-associated fractures (p. 1, under section “1. Instruction”). Thus, the patients having diabetes meet the limitation as in need of prevention or treatment of a bone disease or osteoporosis. Oh teaches that the conjugate is represented by Chemical Formula 1: X-La-F, wherein X is a peptide having an amino acid sequence of any of SEQ ID NOs: 1-102, with its C-termini amidated; L is a polymer, e.g., polyethylene glycol or PEG with M.W. in the range of 1-100 kDa, or 10 kDa; and F is an IgG Fc region which is aglycosylated [0018-0024] [0199] [0202-0203] [0205-0206] [0268] [0482] [0506] [0554]. The amino acid sequence of SEQ ID NO: 42 disclosed in Oh is identical to the presently claimed amino acid sequence of SEQ ID NO: 42, in which amino acid residues at positions 16 and 20 form a ring (see sequence alignment). Oh teaches that the IgG Fc is in the form of a dimer, in which L is linked to X and F respectively via an amino or thiol group [0483] [0499].
Regarding claims 15-16, which recite wherein the pharmaceutical composition, when administered, reduces serum osteocalcin level, increases serum PINP level, or increases osteoblast differentiation, these properties/activities would reasonably be considered to be inherent since Oh teaches administering the same compound to the same subject as recited in the present claims. A compound and all of its properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)).
Therefore, Oh anticipates the instant claims.
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 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
1) claims 1-16 of U.S. Patent No. 10,370,426;
2) claims 1-24 of U.S. Patent No. 10,400,020;
3) claims 1-41 of U.S. Patent No. 10,981967; and
4) claims 1-34 of U.S. Patent No. 11,332,508.
Although the conflicting claims are not identical, they are not patentably distinct from each other. The claims of each of the above cited U.S. Patents recite a peptide or a conjugate thereof with the formula of the subject claims for treatment of a disease or metabolic symptom, e.g., diabetes, multiple sclerosis. As evidenced by Jackuliak et al. (cited above), and by Gupta et al. (CNS Drugs, 2014, Vol. 28:731-742), diabetes and multiple sclerosis are associated with increased risk of osteoporosis and fractures. Thus, the patients having diabetes or multiple sclerosis meet the limitation as in need of prevention or treatment of a bone disease or osteoporosis. Accordingly, the claims of each of the cited U.S. Patents anticipate or render obvious the claims of the instant application.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
5) claims 100, 125-137 and 140 of copending Application No. 17/282,661;
6) claims 62, 64, 69, 88-91, 93, 96 and 98 of copending Application No. 17/415,474;
7) claims 1, 3-6, 23-25, 30, 32, 34-35 and 63 of copending Application No. 17/416,880;
8) claims 4-15, 18 and 20-22 of copending Application No. 17/700,055;
9) claims 1-2, 4-5, 7, 10 and 16-18 of copending Application No. 17/766,137;
10) claims 27-28, 31-35 and 44-45 of copending Application No. 18/041,151;
11) claims 24 and 32-41 of copending Application No. 18/250,150;
12) claims 1-3, 6-16 and 18 of copending Application No. 18/565,628; and
13) claims 1-18 of copending Application No. 18/028,348.
Although the conflicting claims are not identical, they are not patentably distinct from each other. The claims of each of the above cited copending applications recite a peptide or a conjugate thereof with the formula of the subject claims for treatment of a disease or metabolic symptom, e.g., diabetes, multiple sclerosis. As evidenced by Jackuliak et al. (cited above), and by Gupta et al. (cited above), diabetes and multiple sclerosis are associated with increased risk of osteoporosis and fractures. Thus, the patients having diabetes or multiple sclerosis meet the limitation as in need of prevention or treatment of a bone disease or osteoporosis. Accordingly, the claims of each of the cited copending applications anticipate or render obvious the claims of the instant application.
This is a provisional nonstatutory double patenting rejection.
Conclusion
NO CLAIM IS ALLOWED.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Xiaozhen Xie, whose telephone number is 571-272-5569. The examiner can normally be reached on M-F, 8:30-5.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa L. Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/XIAOZHEN XIE/Primary Examiner, Art Unit 1674