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 Application
The amendment and election of 16 June 2026 are entered.
Claims 1-5, 7, 10, 12, 14-15, 19, 25-26, 28-30, 32, 33, 43-45, 48, 50, 57, 62, 64, 65, 67-70, 74, 78, and 79 are pending. Claims 26, 29, 32, 33, 43-45, 48, 50, 57, 62, 64, 65, 67-70, 74, 78, and 79 are withdrawn. Claims 1-5, 7, 10, 12, 14-15, 19, 25, 28, and 30 are being examined on the merits.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-5, 7, 10, 12, 14-15, 19, 25-26, and 28-30) in the reply filed on 19 June 2026 is acknowledged. The traversal is on the ground(s) that there is no search burden present to search Group IV along with Group I. This is not found persuasive because search burden is not a consideration for restriction of national stage applications filed under 35 U.S.C. 371(c). See MPEP 823 and 1893.03(d).
The requirement is still deemed proper and is therefore made FINAL.
Claims 32, 33, 43-45, 48, 50, 57, 62, 64, 65, 67-70, 74, 78, and 79 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 19 June 2026.
Applicant’s election without traverse of the species where X is abaloparatide, Y is a non-releasable linker, and Z is DE20 in the reply filed on 16 June 2026 is acknowledged.
Claim 29 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 16 June 2026.
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). The Asp10-Cys as found in Scheme I requires a SEQ ID NO, as it contains more than 4 specifically enumerated L-amino acids.
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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 19 and 28 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.
In claims 19 and 28, the indefinite language is DE 10 or DE20. The claim is indefinite because it is amenable to multiple plausible interpretations: The language could represent 10 or 20 repeats of D-glutamic acid. The language could represent 10 or 20 repeats of an Asp-Glu dipeptide. The language could represent a mix of Asp or Glu residues as long as the sequence is less than 10 or 20 amino acids.. Ex parte Kenichi Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (precedential) “hold[s] that if a claim is amenable to two or more plausible constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite.”
Please note that claim 29 is withdrawn but would be subject to the same rejection if under examination.
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 1-5, 7, 10, 12, 14-15, 19, 25, 28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Low et al. (WO 2018/102616 A1, published 6 July 2018, hereafter referred to as ‘616) and Parikh et al. (J. Endocrine Society 4:A54, published April-May 2020, hereafter referred to as Parikh).
The ‘616 application discloses a compound X-Y-Z, where X is an agent that modulates activity of a parathyroid hormone receptor (PTHr), Z is a bone-targeting molecule, and Y is a linker between X and Z (see e.g. [0008]). ‘616 further discloses that X can be abaloparatide (see e.g. [0009], SEQ ID NO: 3). The Y can be a portion of PTHrP, including residues 35-46 (see e.g. [0010]). ‘616 discloses that Z is a series of acidic amino acid residues including 10 or 20 total residues (see e.g. [0011]). The ‘616 application mentions spinal fusion treatment with BMP-2 and BMP-7 (see e.g. [0006]). The assembled X-Y-Z is also claimed as part of a more limited subgenus of X-Y-Z compounds, including where X is a compound with at least 80% identity to abaloparatide, Y is a sequence with at least 80% identity to residues 35-46 of PTHrP, and Z is at least 4 or more acidic amino acids (see e.g. claims 2-6). This reasonably leads to a construct of SEQ ID NO: 2. The ‘616 application further claims use of the compound to treat a bone-related disease (see e.g. claim 13).
The difference between the ‘616 application and the claimed invention is that while ‘616 discloses an overlapping X-Y-Z compound and use in a bone-related disease, it does not disclose or suggest treating a spinal fusion in a patient in need thereof.
The Parikh art suggests usage of abaloparatide for augmentation of spinal fusion in patients (see e.g. entire document).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the compound of ‘616 utilizing a modified abaloparatide with a bone-targeting acidic oligopeptide could have been utilized in place of abaloparatide in the Parikh art to treat spinal fusion in subjects in need thereof. The rationale comes from ‘616 already teaching constructs containing abaloparatide for use in bone-related diseases and the Parikh art suggesting that abaloparatide can be used in treatment of spinal fusions to promote bone growth. There would have been a reasonable expectation of success because Parikh already shows use of abaloparatide to treat spinal fusions, such that one would expect that an abaloparatide-based compound containing additional bone-targeting residues would have been as or more effective in treatment of spinal fusions. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claim 2, the linker of ‘616 is a non-releasable linker.
With respect to claims 3 and 4, as noted above ‘616 utilizes abaloparatide.
With respect to claims 5, 7, 10, 12, 14, 15, and 19, ‘616 uses an acidic oligopeptide reasonably leading to 20 D-Glu residues.
With respect to claim 25, the linker of ‘616 contains an amide bond.
With respect to claims 28 and 30, as noted above ‘616 leads to the claimed compound including one matching SEQ ID NO: 2.
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 1-5, 7, 10, 12, 14-15, 19, 25, 28, and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/184,400 in view of Low et al. (WO 2018/102616 A1, published 6 July 2018) and Parikh et al. (J. Endocrine Society 4:A54, published April-May 2020).
The ‘400 application claims a compound with the structure X-Y-Z, where X is a PTHR1 agonist of at least 80% identity to SEQ ID NO: 3, Y is a non-cleavable peptide linker, and Z is a peptide of 6-35 residues selected from Glu, Asp, or combinations thereof (see e.g. claim 1). SEQ ID NO: 3 is abaloparatide.
The difference between ‘400 and the claimed invention is that the ‘400 application does not claim a method of treating spinal fusion.
The relevance of ‘616 and Parikh is set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the compound of ‘400 in a manner similar to that found by combining ‘616 and Parikh in order to provide a method of treating spinal fusions. The rationale comes from ‘616 disclosing an overlapping compound and Parikh showing that abaloparatide is useful for treating spinal fusions. There would have been a reasonable expectation of success given the overlapping compositions claimed by ‘400 and found in ‘616. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claims 2-5, 7, 10, 12, 14-15, 19, 25, 28, and 30, as set forth above ‘616 in view of Parikh provide for these claim limitations. Additionally, the ‘400 compound generally overlaps with the limitations regarding the X, Y, and Z features as claimed.
This is a provisional nonstatutory double patenting rejection.
2. Claims 1-5, 10, 12, 14, and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 3, 5, 12, and 16 of U.S. Patent No. 10,960,054 B2 in view of Parikh et al. (J. Endocrine Society 4:A54, published April-May 2020).
The ‘054 patent claims a compound X-Y-Z, where X is abaloparatide, Y is a linker, and Z is a bone-targeting molecule (see e.g. claim 1). ‘054 further claims the linker as a non-releasable linker, in particular a polypeptide of residues 35-46 of PTHrP (see e.g. claims 2, 3, and 5). Z is claimed as a series of glutamic acid residues (see e.g. claim 12). See also claims 13-15. The compound is claimed as being useful in treating bone fracture (see e.g. claim 16).
The difference between ‘054 and the claimed invention is that the ‘054 patent does not claim a method of treating spinal fusion.
The relevance of Parikh is set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the compound of the ‘054 patent already shown to be useful for bone fractures and containing abaloparatide in a method of treating spinal fusion as suggested by Parikh for the base abaloparatide. The rationale comes from the common abaloparatide present in ‘054 and Parikh, such that one of ordinary skill in the art would seek to utilize bone-targeting variants and expect the same or better efficacy. There would have been a reasonable expectation of success because of the overlapping abaloparatide presence in both ‘054 and Parikh. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claim 2, ‘054 claims a non-releasable linker as set forth above.
With respect to claims 3 and 4, ‘054 claims abaloparatide as set forth above.
With respect to claims 5, 10, 12, and 14, ‘054 claims multiple Glu residues as set forth above.
With respect to claim 25, ‘054 claims a non-releasable oligopeptide as set forth above.
3. Claims 15, 19, 28, and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 3, 5, 12, and 16 of U.S. Patent No. 10,960,054 B2 and Parikh et al. (J. Endocrine Society 4:A54, published April-May 2020) as applied to claim 1 above, and further in view of of Low et al. (WO 2018/102616 A1, published 6 July 2018).
The relevance of ‘054 and Parikh is set forth above.
The difference between the claims of ‘054 in view of Parikh and the claimed invention is that neither ‘054 nor Parikh provide for D-Glu residues.
The relevance of ‘616 is set forth above, including the use of D-Glu as the Z element.
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 method of ‘054 and Parikh by utilizing D-Glu for the Z moiety. The rationale comes from ‘616 using D-Glu for overlapping compositions, as well as the art recognizing that D-Glu acidic oligopeptides are useful for targeting to bone (as evidence, see Nielsen and Low, Current Osteoporosis Reports 18:449-459, published 29 August 2020). There would have been a reasonable expectation of success because the skilled artisan is only altering the L-Glu sequence to D-Glu. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached Mon-Thurs 7-5.
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 (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.
/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658
Prosecution Insights