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 1-26 were originally filed February 17, 2023.
The preliminary amendment received February 17, 2023 amended claims 1, 4-17, 19-21, and 24 and cancelled claims 22, 23, 25, and 26.
The amendment received December 9, 2025 amended claims 1, 3, 4, 6-11, 15-17, 19, and 20.
Claims 1-21 and 24 are currently pending.
Claims 1-6 and 17-20 are currently under consideration.
Election/Restrictions
Applicant’s election of Group I (claims 1-20) in the reply filed on December 9, 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)).
Claims 21 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method and a nonelected polynucleotide, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 9, 2025.
Applicant’s election of SEQ ID NO: 3 as the “Q block”, SEQ ID NO: 14 (12 “spacers”; 9 with valine, 2 with alanine, and 1 with glutamic acid) as the “spacer”, no “K block”, and SEQ ID NO: 16 as the final polypeptide in the reply filed on 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: applicants neglected to designate the domains in SEQ ID NO: 16 (see below).
Claims 7-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.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 December 9, 2025.
Please note: claim 7 is withdrawn because the “Q block” is not present at the N- or C-terminus of SEQ ID NO: 16; claims 8-11 and 16 are withdrawn because a “K block” was not elected; claim 12 is withdrawn because SEQ ID NO: 16 contains additional amino acids (see below); claim 13 is withdrawn because SEQ ID NO: 16 has additional amino acids between the “Q block” and “spacer” (see below); claim 14 is withdrawn because it is unclear what a “Q sequence tract” is; and claim 15 is withdrawn because the elected spacer is 12 repeats.
Priority
The present application is a 371 (National Stage) of PCT/EP2021/072863 filed August 17, 2021 which claims foreign priority to EP 20191629.3 filed August 18, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on February 17, 2023 and December 17, 2025 are being considered by the examiner.
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. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the specific domains of present SEQ ID NO: 1 and SEQ ID NO: 16 as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d) (i.e. the specific domains of SEQ ID NO: 1 and SEQ ID NO: 16; see below). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
SEQ ID NO: 1
Underlined: “spacer”/ELP repeats/VPGXG (SEQ ID NO: 12)
Bold: “Q block”/transglutaminase inhibitor (SEQ ID NO: 3)
Bold and italics: deleted in SEQ ID NO: 16 and replaced with “Q block”/transglutaminase inhibitor (SEQ ID NO: 3)
Met Gly His Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Ala Gly
Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Glu Gly Val Pro Gly Ala Gly Ser Gly Asp
Gln Met Met Leu Pro Trp Pro Ala Val Ala Leu Ser Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Ala Gly Val Pro Gly Val
Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly
Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Glu Gly Val Pro Gly Ala Gly Ser Gly Asp Gln Met Met Leu
Pro Trp Pro Ala Val Ala Leu Ser Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val
Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Glu Gly
Val Pro Gly Ala Gly Ser Gly Asp Gln Met Met Leu Pro Trp Pro Ala
Val Ala Leu Ser Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Glu Gly Val Pro Gly Ala
Gly Ser Gly Asp Gln Met Met Leu Pro Trp Pro Ala Val Ala Leu Ser
Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Ala Gly
Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Glu Gly Val Pro Gly Ala Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Ala Gly Val Pro Gly Val
Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly
Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Glu Gly Val Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val
Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Glu Gly
Val Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Glu Gly Val Pro Gly Ala
Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Ala Gly
Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Glu Gly Val Pro Gly Ala Gly Ser Gly Gly
Ser Lys Gly Ser Ser Gly Val Pro Gly Val Gly Val Pro Gly Val Gly
Val Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Glu Gly Val Pro Gly
Ala Gly Ser Gly Gly Ser Lys Gly Ser Ser Gly Val Pro Gly Val Gly
Val Pro Gly Val Gly Val Pro Gly Ala Gly Val Pro Gly Val Gly Val
Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly
Glu Gly Val Pro Gly Ala Gly Ser Gly Gly Ser Lys Gly Ser Ser Gly
Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Ala Gly Val
Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly
Val Gly Val Pro Gly Glu Gly Val Pro Gly Ala Gly Ser Gly Gly Ser
Lys Gly Ser Ser Gly Val Pro Gly Trp Leu Asp Ser Leu Glu Phe Ile
Ala
SEQ ID NO: 16
Underlined: “spacer”/ELP repeats/VPGXG (SEQ ID NO: 12)
Bold: “Q block”/transglutaminase inhibitor (SEQ ID NO: 3)
Met Gly His Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Ala Gly
Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Glu Gly Val Pro Gly Ala Gly Ser Gly Asp
Gln Met Met Leu Pro Trp Pro Ala Val Ala Leu Ser Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Ala Gly Val Pro Gly Val
Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly
Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Glu Gly Val Pro Gly Ala Gly Ser Gly Asp Gln Met Met Leu
Pro Trp Pro Ala Val Ala Leu Ser Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val
Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Glu Gly
Val Pro Gly Ala Gly Ser Gly Asp Gln Met Met Leu Pro Trp Pro Ala
Val Ala Leu Ser Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Glu Gly Val Pro Gly Ala
Gly Ser Gly Asp Gln Met Met Leu Pro Trp Pro Ala Val Ala Leu Ser
Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Ala Gly
Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Glu Gly Val Pro Gly Ala Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Ala Gly Val Pro Gly Val
Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly
Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Glu Gly Val Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val
Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Glu Gly
Val Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Glu Gly Val Pro Gly Ala
Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Ala Gly
Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Glu Gly Val Pro Gly Ala Gly Ser Gly Asp
Gln Met Met Leu Pro Trp Pro Ala Val Ala Leu Ser Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Ala Gly Val Pro Gly Val
Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly
Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Glu Gly Val Pro Gly Ala Gly Ser Gly Asp Gln Met Met Leu
Pro Trp Pro Ala Val Ala Leu Ser Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val
Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Glu Gly
Val Pro Gly Ala Gly Ser Gly Asp Gln Met Met Leu Pro Trp Pro Ala
Val Ala Leu Ser Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val
Pro Gly Ala Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro
Gly Val Gly Val Pro Gly Val Gly Val Pro Gly Val Gly Val Pro Gly
Val Gly Val Pro Gly Val Gly Val Pro Gly Glu Gly Val Pro Gly Ala
Gly Ser Gly Asp Gln Met Met Leu Pro Trp Pro Ala Val Ala Leu Ser
Gly Val Pro Gly Trp Leu Asp Ser Leu Glu Phe Ile Ala
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
See page 8, lines 1 and 9; page 18 (A2V8E1); page 25, lines 35-37; page 26, lines 8 and 9; and page 30, lines 16, 17, 22, and 31.
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.
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings.
See Figure 1a.
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, 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. See page 14, lines 24 and 25.
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: “selected from” should read “selected from the group consisting of” (see lines 2 and 12). Appropriate correction is required.
Claims 1, 4, 5, 6, and 18 are objected to because of the following informalities: the arbitrary name “Q-block” or “Q block” should read “transglutaminase inhibitor”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “and/or” between vii and viii should be “and”. Appropriate correction is required. Alternatively, applicants may wish to change the singular with a combination (see dependent claim 5) to keep the and/or conjunctions.
Claims 1, 17, 18, and 19 are objected to because of the following informalities: the arbitrary “spacer” should read “ELP”. Appropriate correction is required.
Claims 1 and 18 are objected to because of the following informalities: the arbitrary “K-block” should read “a spacer comprising at least one lysine”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: “selected from” should read “selected from the group consisting of”. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: “Ala:Val:Glu being used for X is” should read “Ala:Val:Glu for X is”. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: “spacer sequences are comprised in spacer sequence multimers” should read “spacer sequences”. Appropriate correction is required. Claims 18 and 19 would also have to be amended to delete multimers. Alternatively, the “plurality of spacer sequences” of claim 1 could be called spacer sequence multimers.
Claim 19 is objected to because of the following informalities: “multimer” should read “multimers”. 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 1-6 and 17-20 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.
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, claims 1 and 20 recites the broad recitation “comprising”, and the claim also recites “essentially consisting of” 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 4 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 sequence. For example, it is unclear if “is” is open, closed, etc. Utilization of comprising, consisting of, etc. is suggested.
Claim 20 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 20 recites the broad recitation ≥ (i.e. greater than or equal to), and the claim also recites “more than” 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 1-6 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kiyotaka et al. JP 2007-197434 published August 9, 2007 and MacEwan et al., 2014, Applications of elastin-like polypeptides in drug delivery, J Control Release, 190: 314-330.
For present claims 1-6 and 17-19, Kiyotaka et al. teach transglutaminase inhibitors/”Q block” of SEQ ID NOs: 59 (present SEQ ID NO: 3), 51 (present SEQ ID NO: 4), 43 (present SEQ ID NO: 5), 50 (present SEQ ID NO: 6), 41 (present SEQ ID NO: 7), 47 (present SEQ ID NO: 8), 39 (present SEQ ID NO: 9), and 44 (present SEQ ID NO: 10) with linkers or spacers and as fusion polypeptides wherein more than one transglutaminase inhibitor may be present and can be either the same or different (please refer to the entire specification particularly Tables 1-8; paragraphs 5, 7, 8, 10, 19, 20, 30-32, 66-77).
For present claims 1-6 and 17-19, MacEwan et al. teach ELP multimers/”spacer” for drug delivery including polypeptides comprising VPGXG wherein X is any amino acid other than P/Pro/proline; X is V/Val/valine, A/Ala/alanine and/or E/Glu/Glutamic acid; various multimer lengths including 27, 36, 90, 100, 110, 240, 5-240, etc.; varying X (i.e. different ratios) for desired functions/structures; and multimers of the same or different VPGXG (please refer to the entire reference particularly the abstract; Introduction; 2.1; 2.2; 2.5; Tables 1-4).
All the claimed elements (i.e. transglutaminase inhibitors/”Q block” of present SEQ ID NO: 3-10 and ELP of VPGXG, VPGVG, VPGAG, and/or VPGEG) 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 (i.e. transglutaminase inhibitors; structure of ELP/VPGXG multimers) and the combination would have yielded predictable results (i.e. ability of ELP/VPGXG multimers to act as carriers for drug delivery) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because the substitution of one known element (e.g. genus of linker, genus of spacer, genus of fusion polypeptide) for another (i.e. species of ELP/VPGXG wherein X is V, A, and/or E) would have yielded predictable results (i.e. drug delivery) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. adding ELP/VPGXG wherein X is V, A, and/or E to a polypeptide) 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).
Allowable Subject Matter
Polypeptides with at least 90% identity to SEQ ID NOs: 1 or 16 are free of the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent 6,127,166 (VPGVG; column 14; SEQ ID NO: 27)
U.S. Patent 5,250,516 (VPGVG; throughout specification)
U.S. Patent 5,854387 (VPGXG – SEQ ID NO: 9; VPGVG – SEQ ID No: 1; and VPGEG – SEQ ID NO: 10)
U.S. Patent 8,846,624 (VPGAG – SEQ ID NO: 2)
U.S. Patent 10,385,115 (VPGXG – SEQ ID NO: 19)
WO2008033847 (VPGAG, VPGEG, and VPGVG)
EP1422242 (SEQ ID NO: 2 – VPGVG, SEQ ID NO: 13 VPGEG)
U.S. Patent Application 20130197359 (VPGXG – SEQ ID NO: 1, VPGVG – SEQ ID NO: 6, VPGAG – SEQ ID NO: 7)
U.S. Patent Application Publication 20090098110 (VPGXG, VPGVG, VPGAG)
WO 20010187267 (VPGVG)
WO 2017168183 (VPGXG, VPGVG, VPGEG)
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.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658