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
Applicant’s election without traverse of the method of Claims 1-4 in the reply filed on 10 February 2026 is acknowledged.
Status of the Claims
Claims 1-16, 19, 23, 24, and 29 are pending.
Claims 5-16, 19, 23, 24, and 29 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-4 are presented for examination and rejected as set forth in greater detail below.
Priority
The instant application is a National Stage entry of International application PCT/US2022/041269 filed 23 August 2022, which claims the benefit of Provisional U.S. application 63/237,078 filed 25 August 2021.
Claim Interpretation
Applicants claims are directed to methods of exposing a mineralized collagen glycosaminoglycan (MCGAG) scaffold with a solution containing each of EDC and N-hydroxysuccinimide (NHS), as well as a solution containing a crosslinking agent and an osteoprotegerin (OPG), OPG fragment, or an “equivalent of each thereof.” The examiner notes applicants have indicated that claim language indicating the inclusion of a component’s “equivalent thereof” “intends those having minimal homology while still maintaining desired structure or functionality similar to the reference protein, antibody, polypeptide, or nucleic acid…[f]or example, an equivalent intends at least about 70% homology or sequence identity…” (Specification [0055]. Claim 2 indicates he crosslinking agent is SPDP, Claim 3 PEGylated-SPDP, and Claim 4 the solution is to include phosphate-buffered saline.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-4 are 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. In particular, insufficient guidance is provided by applicants specification to determine which aspect of the “equivalent thereof” guidance provided is to be applied. Applicants Claim 1 indicates that “a solution comprising osteoprotegerin (OPG), an OPG fragment, or an equivalent thereof” is to be included in a solution used to contact the MCGAG scaffold which has been exposed to a solution of EDC and NHS. As applicants own specification has included two different, and in fact opposed, definitions of what an “equivalent thereof” may represent, it is unclear whether applicants intend the “equivalent” of the osteoprotegerin be one which has “minimal homology while still maintaining desired structure or functionality similar to the reference protein,” or whether the “equivalent” is one which represents “at least about 70% homology or sequence identity” to the reference osteoprotegerin.
Appropriate clarification is required.
Claim Rejections - 35 USC § 112(b)
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 1-4 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.
As set forth in greater detail above, two distinct and competing definitions of what an osteoprotegerin “equivalent” may represent are provided by applicants disclosure as originally filed. When a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention, or the claim remains indefinite under § 112. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).
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.
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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Harley (WO2019/194894), in view of Nataraj (U.S. PGPub. 2010/0266559), and Chung (U.S. PGPub. 2020/0140844).
Harley describes methods of forming a collagen glycosaminoglycan scaffold which may be mineralized by forming a mineralized scaffold, exposing the scaffold to a solution containing 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide and N-hydroxysuccinamide, then contacting that scaffold with a solution containing osteoprotegerin (OPG) or a fragment thereof to produce a OPG-bound scaffold, with Harley indicating that phosphate buffered saline (PBS) may serve as the solution for the OPG. [0054; 0109; 0118; 0128-29]. More particularly, Harley describes a method whereby a mineralized collagen glycosaminoglycan (MCGAG) scaffold is combined with a PBS solution containing each of the 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide and N-hydroxysuccinamide of the instant claims. [0142-43]. Harley indicates that OPG may be covalently bound to the MCGAG by crosslinking. [0215].
Despite reciting processes including the formation of a mineralized collagen glycosaminoglycan scaffold, the exposure of that scaffold to a PBS solution containing each of 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide and N-hydroxysuccinamide, then combining the MCGAG so treated to a solution combining PBS with an OPG to crosslink the OPG to the scaffold, Harley does not specifically indicate that a crosslinking agent, let alone any of the crosslinking agents specifically recited by each of Claims 2 and 3, may be used.
However, Nataraj indicates that biological implants may be conjugated with small peptides to provide biological activities to tissues where the implants are to be located, including as an osteogenic growth peptide the OPG of Harley and the present claims. [0131]. Nataraj indicates that heterobifunctional reagents can be employed as the conjugating agent for crosslinking the small proteins to the implants, [0166], but fails to identify either of the SPDP or pegylated SPDP of the instant claims as suitable conjugating agents. However, Chung indicates that each of the SPDP and PEGylated SPDP of the present claims were at the time known to be useful agents for crosslinking proteins and protein fragments to polymeric carrier materials. [0032].
It would have been prima facie obvious to one of ordinary skill in the art at the time the instant application was filed to have used a heterobifunctional crosslinking agent to covalently attach a protein such as OPG to an implantable scaffold such as is described by the process of Harley. This is because Harley indicates that proteins such as OPG may be covalently crosslinked to a MCGAG scaffold, and that heterobifunctional crosslinking agents are taught by Nataraj as crosslinking agent suitable for covalently linking proteins including OPG to bioimplants. The use of SPDP or PEGylated SPDP as such a heterobifunctional crosslinking agent appears, by the teachings of Chung, little more than the selection of a element known in the art to be useful for the purpose for which it is being chosen; namely, the capacity to crosslink peptides to polymeric substrates for implantation. See KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)) (indicating that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.”); see also Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)(holding that generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use).
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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