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 1-30 were originally filed April 13, 2022.
The preliminary amendment received April 13, 2022 amended claims 2, 6, 10-12, 16, 20, 25, and 29 and canceled claims 3, 7-9, 17, 21, 22, 26, and 30.
The amendment received March 10, 2025 amended claims 2, 4, and 5.
Claims 1, 2, 4-6, 10-16, 18-20, 23-25, and 27-29 are currently pending.
Claims 1, 2, 5, 6, and 12 are currently under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 2, 4-6, and 10-12) in the reply filed on March 10, 2025 is acknowledged.
Claims 13-16, 18-20, 23-25, and 27-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected methods, there being no allowable generic or linking claim.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 10, 2025.
Applicant’s election of SEQ ID NO: 5 (heparin binding domain of VEGF-a 125) for protein 1 (affinity for a growth factor or a growth factor receptor), two 6 amino-hexanoic acid spacers, SEQ ID NO: 25 (PDGF-BB) for protein 2 (affinity for an extracellular matrix protein). n = 2, binding the bipeptide to a polymer, and an amount sufficient to treat an injured tendon and/or ligament in the reply filed on March 10, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Please note: simply stating “with traverse” without a specific traversal is considered not distinctly and specifically pointing out any supposed errors.
Please note: it appears that the elections for proteins 1 and 2 have been reversed since protein 1 should have “affinity” for a growth factor or a growth factor receptor and protein 2 should have “affinity” for an extracellular matrix protein. It is unclear why applicants picked species for peptides 1 and 2 from claim 5 which only refers to a Markush group for peptide 2. Although, from the specification and the prior art, it appears that SEQ ID NO: 25 has been mischaracterized as having affinity for an extracellular matrix (protein 2, claim 5). At paragraphs 48 and 49 of the present specification, it appears that SEQ ID NO: 25 actually has “affinity for PDGF-BB” (i.e. growth factor). In addition, applicants mischaracterized the function of SEQ ID NO: 5 as having “affinity” for heparin while the specification clearly teaches “affinity for collagen” (see page 8).
Please note: the claims do not require two 6 amino-hexanoic acid spacers, therefore, the rejections of record do not require two 6 amino-hexanoic acid spacers.
Please note: the election of an amount sufficient to treat an injured tendon and/or ligament is a vague subgenus and not a single, specific species. Therefore, the vague subgenus was searched.
Please note: see page 8 and paragraphs 48 and 49 regarding the present SEQ ID NOs:.
SEQ ID NO: 1 – “affinity” for TGF-b1 (peptide 1)
SEQ ID NO: 2 – “affinity” for VEGF (peptide 1)
SEQ ID NO: 3 – “affinity” for BMP-2 (peptide 1)
SEQ ID NO: 4 – “affinity” for FGF (peptide 1)
SEQ ID NO: 25 – “affinity” for PDGF-BB (peptide 1)
SEQ ID NO: 5 – “affinity” for collagen (peptide 2)
SEQ ID NO: 6 – “affinity” for fibronectin (peptide 2)
SEQ ID NO: 7 – “affinity” for hyaluronan (peptide 2)
SEQ ID NO: 8 – “affinity” for heparin (peptide 2)
SEQ ID NO: 9 – “affinity” for hydroxyapatite (peptide 2)
Potential Rejoinder
Applicants elect 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.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3.
Priority
The present application is a 371 (National Stage) of PCT/US2020/057090 filed October 23, 2020 which claims the benefit of 62/926,180 filed October 25, 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 24, 2022 is being considered by the examiner.
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).
See paragraph 42/Table 1 (i.e. G8, G6, and (Ala-Pro)n which is 10-34 amino acids in length).
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 abstract of the disclosure is objected to because “method using” should read “method of using”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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. See paragraph 6.
Claim Objections
Claim 2 is objected to because of the following informalities: “a TGF-b1, VEGF, BMP-2, PDGF, or an FGF binding peptide” should read “a TGF-b1 binding peptide, a VEGF binding peptide, a BMP-2 binding peptide, a PDGF binding peptide, and an FGF binding peptide” (i.e. insertion of articles and “binding peptide” for each and utilization of “and” with the closed Markush group). Appropriate correction is required.
Claim 2 is objected to because of the following informalities: “a collagen, fibronectin, hyaluronan, hydroxyapatite, or a heparin binding peptide” should read “a collagen binding peptide, a fibronectin binding peptide, a hyaluronan binding peptide, a hydroxyapatite binding peptide, and a heparin binding peptide” (i.e. insertion of articles and “binding peptide” for each and utilization of “and” with the closed Markush group). Appropriate correction is required.
Claim 5 is objected to because of the following informalities: the conjunction “and” should be utilized with the closed Markush group. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “selected from” should read “selected from the group consisting of”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the conjunction “and” should be utilized with the closed Markush group (see second to last line). 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.
Claims 1, 5, 6, and 12 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. One of skill in the art would not be able to determine the scope of the present bipeptide. For example, it is unclear what the scope of “affinity” is (e.g. under what conditions, specific Kd, etc.). In light of claim 2, it appears that “affinity” refers to specific binding which may be a better term for the claims.
Claims 1, 2, 5, 6, and 12 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. One of skill in the art would not be able to determine the scope of the present bipeptide. For example, it is unclear how a “bi-peptide” can contain more than two peptides.
Claim 5 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. One of skill in the art would not be able to determine the scope of the present bipeptide. For example, it is unclear why SEQ ID NO: 25 is included in a Markush group for peptide 2 (e.g. “affinity” for an extracellular matrix protein) when the application clearly states that SEQ ID NO: 25 has “affinity” for PDGF-BB (peptide 1; “affinity” for a growth factor).
Claim 6 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. One of skill in the art would not be able to determine the scope of the present bipeptide. For example, it is unclear why limitations for a bipeptide contain method steps (e.g. binding, forming). The claim should contain limitations that clearly refer to the structure of the bipeptide (e.g. the bipeptide is bound to a polymer, etc.).
Claim 12 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. One of skill in the art would not be able to determine the scope of the present bipeptide. For example, it is unclear what amount is “sufficient to treat an injured tendon and/or ligament”.
Claim 5 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of SEQ ID NOs: 5-9 and 25 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: while SEQ ID NOs: 5-9 refer to peptide 2 (i.e. has “affinity” for ECM), SEQ ID NO: 25 actually refers to peptide 1 (i.e. has “affinity” for growth factor or growth factor receptor).
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim 6 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 6 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the Markush group refers to a bipeptide bound to a polymer; additional linkers, peptide 1, and/or peptide 2; concatamers; or linkers.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 5, 6, and 12 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Hubbell et al. WO 2019/094938 published May 16, 2019 and/or U.S. Patent 11,732,029 (effective filing date of November 13, 2017).
For present claims 1, 2, 5, 6, and 12, Hubbell teaches fusion polypeptides of a growth factor binding domain (SEQ ID NO: 1 which has 100% identity and the same length as present SEQ ID NO: 25) and a collagen binding peptide (i.e. ECM binding peptide) wherein linkers are present and the fusion polypeptide may have more than two peptides and be attached to a polymer and bipeptides at various dosages (please refer to the entire specification particularly the abstract; paragraphs 3-5, 11-13, 17, 20-22, 39, 73-80, 84, 89-92, 94-96, 100, 101, 125-131, 133-137, 140-142, 145-148). Hubbell also teaches growth factor binding peptides to VEGF, VEGF-A, PDGF, PDGF-BB, PDGF-CC, BMP, BMP-2, FGF, and FGF-2 (please refer to the entire specification particularly paragraphs 5, 20, 21, 80).
Therefore, the presently claimed bipeptide is anticipated by Hubbell.
Claims 1, 2, 6, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shanks et al. WO 2018/057522 published March 29, 2018.
For present claims 1, 2, 6, and 12, Shanks et al. teach PEGylated fusion polypeptides comprising a TGF-b1 antagonist, linkers, and collagen or heparin anchor domains (i.e. collagen binding or heparin binding) at therapeutically effective amounts (please refer to the entire specification particularly the abstract; pages 1-4, 6, 7, 10, 12, 15, 17, 18, 23, 24, 28, 29, 31-34).
Therefore, the teachings of Shanks et al. anticipate the presently claimed bipeptide.
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, 2, 5, 6, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hubbell et al. WO 2019/094938 published May 16, 2019 and/or U.S. Patent 11,732,029 (effective filing date of November 13, 2017) and Chung et al. WO 2008/150119 published December 11, 2008.
For present claims 1, 2, 5, 6, and 12, Hubbell teaches fusion polypeptides of a growth factor binding domain (SEQ ID NO: 1 which has 100% identity and the same length as present SEQ ID NO: 25) and a collagen binding peptide (i.e. ECM binding peptide) wherein linkers are present and the fusion polypeptide may have more than two peptides and be attached to a polymer and bipeptides at various dosages (please refer to the entire specification particularly the abstract; paragraphs 3-5, 11-13, 17, 20-22, 39, 73-80, 84, 89-92, 94-96, 100, 101, 125-131, 133-137, 140-142, 145-148). Hubbell also teaches growth factor binding peptides to VEGF, VEGF-A, PDGF, PDGF-BB, PDGF-CC, BMP, BMP-2, FGF, and FGF-2 (please refer to the entire specification particularly paragraphs 5, 20, 21, 80).
For present claims 1, 2, 5, 6, and 12, Chung et al. teach SEQ ID NO: 28 (100% identity and the same length as present SEQ ID NO:5) in polymers (please refer to the entire specification particularly the abstract; pages 1, 2, 5-7).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods 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 (e.g. genus of collagen binding peptide) for another (i.e. species of SEQ ID NO: 28/SEQ ID NO: 5) would have yielded predictable results (i.e. binding to collagen) to one of ordinary skill in the art at the time of the invention. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See WO 2018/101826 regarding the sequences in present claim 4.
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.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658