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 1-50 were originally filed July 25, 2023.
Claims 1-50 are currently pending.
Claims 1-4, 7-11, 20, 23, 31, and 32 are currently under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-24, 31-35, and 40-45) in the reply filed on March 16, 2026 is acknowledged.
Claims 25-30, 36-39, and 46-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected methods, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 16, 2026.
Applicant’s election without traverse of heparin sulfate (about 20 kDa), fetuin A isoform 1 (SEQ ID NO: 1) (about 20% functionalized), heparin sulfate conjugated with a single chain, non-phosphorylated fetuin A isoform 1 (SEQ ID NO: 1), follistatin, and a single use medical device as the species in the reply filed on March 16, 2026 is acknowledged.
Claims 5, 6, 12-19, 21, 22, 24, 33-35, and 40-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 16, 2026.
Potential Rejoinder
Applicant elected claims directed to a product. If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The present application is a 371 (National Stage) of PCT/US2022/013706 filed January 25, 2022 which claims the benefit of 63/191,839 filed May 21, 2021 and 63/141,977 filed January 26, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on July 25, 2023 and March 16, 2026 are being considered by the examiner.
Specification
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.
Claim Objections
Claim 1 is objected to because of the following informalities: “one or more single chain, non-phosphorylated AHSG molecule or fragment” should read “one or more single chain, non-phosphorylated AHSG molecule(s) or a fragment” (see lines 2-4). Appropriate correction is required.
Claim 7 is objected to because of the following informalities: “one or more single chain, non-phosphorylated AHSG molecule or fragment” should read “one or more single chain, non-phosphorylated AHSG molecule(s) or a fragment”. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: “one or more single chain, non-phosphorylated AHSG molecule or fragment” should read “one or more single chain, non-phosphorylated AHSG molecule(s) or a fragment” (see lines 2 and 4). Appropriate correction is required.
Claim 20 is objected to because of the following informalities: “one or more sulphated GAGs” should read “one or more sulphated GAG(s)” (see lines 3-4). Appropriate correction is required.
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.
Claim 9 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation at least 80% sequence identity, and the claim also recites at least 90%, at least 95%, or at least 99% which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 1-4, 7-11, 20, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Hachim et al., 2019, Glycosaminoglycan-based biomaterials for growth factor and cytokine delivery: Making the right choices, Journal of Controlled Release, 313: 131-147 and Daily et al. U.S. Patent Application Publication 2016/0161492 published June 9, 2016.
For present claims 1-4, 7-11, 20, and 31, Hachim et al. teach utilizing sulphated GAGs including heparan/heparin sulfate as peptide drug delivery systems wherein the peptide drug is covalently conjugated to the GAG (please refer to the entire reference particularly the abstract; Figures 1, 3; Table 1; sections 2, 3).
However, Hachim et al. do not teach fetuin fragments (SEQ ID NO: 1).
For present claims 1-4, 7-11, 20, and 32, Daily et al. teach fetuin SEQ ID NO: 61 (368mer) which has 100% identity to present SEQ ID NO: 1 (350mer) and fragments thereof as therapeutics/peptide drugs (please refer to the entire specification particularly the abstract; paragraphs 2, 7, 20, 24, 25, 31, 36, 37).
All the claimed elements were known in the prior art (i.e. sulphated GAG as peptide delivery systems; fetuin as a peptide drug) and one skilled in the art could have combined the elements as claimed by known methods (i.e. utilization of sulphated GAGs as a peptide delivery system) with no change in the respective functions and the combination would have yielded predictable results (i.e. increasing half-life and delivery of peptide drugs) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. one peptide drug) for another (i.e. fetuin) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilization of sulphated GAGs as a peptide delivery system) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1-4, 7-11, 20, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al., 2014, Molecular engineering of glycosaminoglycan chemistry for biomolecule delivery, Acta Biomaterialia, 10: 1705-1719 and Daily et al. U.S. Patent Application Publication 2016/0161492 published June 9, 2016.
For present claims 1-4, 7-11, 20, and 32, Miller et al. teach utilizing sulphated GAGs including heparan/heparin sulfate as peptide drug delivery systems wherein the peptide drug is covalently conjugated to the GAG (please refer to the entire reference particularly the abstract; Sections 2.2, 3, 3.1, 3.2, 3.3, 4, 4.1; Figures 3, 4).
However, Miller et al. do not teach fetuin fragments (SEQ ID NO: 1).
For present claims 1-4, 7-11, 20, and 32, Daily et al. teach fetuin SEQ ID NO: 61 (368mer) which has 100% identity to present SEQ ID NO: 1 (350mer) and fragments thereof as therapeutics/peptide drugs (please refer to the entire specification particularly the abstract; paragraphs 2, 7, 20, 24, 25, 31, 36, 37).
All the claimed elements were known in the prior art (i.e. sulphated GAG as peptide delivery systems; fetuin as a peptide drug) and one skilled in the art could have combined the elements as claimed by known methods (i.e. utilization of sulphated GAGs as a peptide delivery system) with no change in the respective functions and the combination would have yielded predictable results (i.e. increasing half-life and delivery of peptide drugs) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. one peptide drug) for another (i.e. fetuin) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilization of sulphated GAGs as a peptide delivery system) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1-4, 7-11, 20, 23, 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Hachim et al., 2019, Glycosaminoglycan-based biomaterials for growth factor and cytokine delivery: Making the right choices, Journal of Controlled Release, 313: 131-147; Daily et al. U.S. Patent Application Publication 2016/0161492 published June 9, 2016; and Goodman et al. U.S. Patent 2019/0365830 published December 5, 2019.
For present claims 1-4, 7-11, 20, 23, 31, and 32, Hachim et al. teach utilizing sulphated GAGs including heparan/heparin sulfate as peptide drug delivery systems wherein the peptide drug is covalently conjugated to the GAG (please refer to the entire reference particularly the abstract; Figures 1, 3; Table 1; sections 2, 3).
However, Hachim et al. do not teach fetuin fragments (SEQ ID NO: 1).
For present claims 1-4, 7-11, 20, 23, 31, and 32, Daily et al. teach fetuin SEQ ID NO: 61 (368mer) which has 100% identity to present SEQ ID NO: 1 (350mer) and fragments thereof as therapeutics/peptide drugs (please refer to the entire specification particularly the abstract; paragraphs 2, 7, 20, 24, 25, 31, 36, 37).
However, Hachim et al. do not teach follistatin.
For present claims 1-4, 7-11, 20, 23, 31, and 32, Goodman et al. teach utilizing fetuin A and follistatin as therapeutics (please refer to the entire specification particularly paragraphs 113 and 143).
All the claimed elements were known in the prior art (i.e. sulphated GAG as peptide delivery systems; fetuin as a peptide drug; follistatin as a peptide drug) and one skilled in the art could have combined the elements as claimed by known methods (i.e. utilization of sulphated GAGs as a peptide delivery system) with no change in the respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. one peptide drug) for another (i.e. fetuin, follistatin) would have yielded predictable results (i.e. increasing half-life and delivery of peptide drugs) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilization of sulphated GAGs as a peptide delivery system) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1-4, 7-11, 20, 23, 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al., 2014, Molecular engineering of glycosaminoglycan chemistry for biomolecule delivery, Acta Biomaterialia, 10: 1705-1719; Daily et al. U.S. Patent Application Publication 2016/0161492 published June 9, 2016; Goodman et al. U.S. Patent 2019/0365830 published December 5, 2019.
For present claims 1-4, 7-11, 20, 23, 31, and 32, Miller et al. teach utilizing sulphated GAGs including heparan/heparin sulfate as peptide drug delivery systems wherein the peptide drug is covalently conjugated to the GAG (please refer to the entire reference particularly the abstract; Sections 2.2, 3, 3.1, 3.2, 3.3, 4, 4.1; Figures 3, 4).
However, Miller et al. do not teach fetuin fragments (SEQ ID NO: 1).
For present claims 1-4, 7-11, 20, 23, 31, and 32, Daily et al. teach fetuin SEQ ID NO: 61 (368mer) which has 100% identity to present SEQ ID NO: 1 (350mer) and fragments thereof as therapeutics/peptide drugs (please refer to the entire specification particularly the abstract; paragraphs 2, 7, 20, 24, 25, 31, 36, 37).
However, Miller et al. do not teach follistatin.
For present claims 1-4, 7-11, 20, 23, 31, and 32, Goodman et al. teach utilizing fetuin A and follistatin as therapeutics (please refer to the entire specification particularly paragraphs 113 and 143).
All the claimed elements were known in the prior art (i.e. sulphated GAG as peptide delivery systems; fetuin as a peptide drug; follistatin as a peptide drug) and one skilled in the art could have combined the elements as claimed by known methods (i.e. utilization of sulphated GAGs as a peptide delivery system) with no change in the respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. one peptide drug) for another (i.e. fetuin, follistatin) would have yielded predictable results (i.e. increasing half-life and delivery of peptide drugs) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilization of sulphated GAGs as a peptide delivery system) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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.
/AMBER D STEELE/Primary Examiner, Art Unit 1658
Prosecution Insights