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 1-16 were originally filed November 28, 2023.
The preliminary amendment received November 28, 2023 amended claims 2-4 and 8-16.
The amendment received June 12, 2026 amended claims 1-6, 9-12, and 14; canceled claims 15 and 16; and added new claim 17.
Please note: the text of canceled claims should not be present. See MPEP § 714 C (C).
Claims 1-14 and 17 are currently pending.
Claims 1, 2, 12, and 13 are currently under consideration.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-13) in the reply filed on June 12, 2026 is acknowledged. The traversal is on the grounds that Kanjana et al. no longer reads on the claimed peptide since SEQ ID NO: 18 has been deleted. This is not found persuasive because at the time of the Lack of Unity, SEQ ID NO: 18 was part of the present claims. The Lack of Unity cannot reasonably be relitigated after each claim amendment. Furthermore, Kanjana et al. still reads on (C)mX1X2X3(X4)nX5(C)o. Kanjana et al. teach SEQ ID NO: 1 GLHTSATNLYLH wherein m and o are 0, X1 is H, X2 is T, X3 is S, X4 is ATNLYL (n is 6), and X5 is H wherein the peptide is a 12mer. Please also refer to the art rejections of record below for additional prior art which may be utilized to break Unity of Invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 14 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected polynucleotide and a nonelected method, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on June 12, 2026.
Applicant’s election of SEQ ID NO: 16, a multimer, and low surface energy polymer (LSEP) in the reply filed on June 12, 2026 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 elect the charge, function, and a helix forming potential for SEQ ID NO: 16. Therefore, only SEQ ID NO: 16 was searched.
Please note: applicants elected the subgenus of multimer, therefore only the subgenus was searched.
Please note: applicants elected the subgenus of LSEP, therefore only the subgenus was searched.
Claims 3-11 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 June 12, 2026.
Potential Rejoinder
Applicants 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/EP2022/084762 filed December 7, 2022 which claims foreign priority to Germany 10 2021 133 427.6 filed December 16, 2021.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome any rejection of record because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 28, 2023 is being considered by the examiner.
Drawings
No drawings are present.
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 paragraphs 40 and 42 and Tables 3 and 4.
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 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: it appears that two commas are present – please review lines 11 and 12 (X5). Appropriate correction is required.
Claim 2 is objected to because of the following informalities: a single conjunction should be present (i.e. and/or after (iii) only). Appropriate correction is required.
Claim 12 is objected to because of the following informalities: “selected from the group of” should read “selected from the group consisting of”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: a single conjunction of “and” should be utilized with the closed Markush group of “selected from the group consisting of”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: “composed of at least one” is unnecessary since the Markush group contains copolymers and mixtures. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: the full name should be present with the first recitation of the acronym (i.e. “low surface energy polymer (LSEP)”). Appropriate correction is required.
Claim 13 is objected to because of the following informalities: “(multimer)” should be removed or amended (e.g. parentheses potentially cause confusion regarding what is actually required by the claim). Appropriate correction is required.
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.
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, 2, 12, and 13 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 presently claimed peptide. For example, it is unclear if (a) and (b) are open, closed, etc. (see “4 to 50 amino acids”, “has”, “specified in”).
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 presently claimed peptide. For example, it is unclear if the plastic surface is required by the claim or if the “capable of adhesion” is simply a function of the peptide (i.e. the plastic surface is not a structural requirement).
Claim 13 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 presently claimed peptide. For example, it is unclear if the peptide or polypeptide is simply a composition comprising two or more peptides or polypeptides or if both the peptide and the polypeptide must be a multimer (i.e. dimer, trimer, etc. wherein a structural change is present).
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.
Claims 1, 2, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taden et al. DE 10 2012 110 664 published May 8, 2014 (see translation for the below citations).
For present claims 1, 2, 12, and 13, Taden et al. teach multimers and peptides comprising various peptides within the scope of (C)mX1X2X3(X4)nX5(C)o including RSIVTFSLRQNR wherein m and o are 0, R is X1, S is X2, I is X3, VTFSKLQN is (X4)8, and R is X5 (please refer to the entire specification particularly paragraphs 3, 4, 24, 51, 52; Tables 1 and 2).
Therefore, the teachings of Taden et al. anticipate the presently claimed peptides.
Claims 1, 2, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taden et al. WO 2014/072313 published May 15, 2014 (see translation for the below citations).
For present claims 1, 2, 12, and 13, Taden et al. teach multimers and peptides comprising various peptides within the scope of (C)mX1X2X3(X4)nX5(C)o including RSIVTFSLRQNR wherein m and o are 0, R is X1, S is X2, I is X3, VTFSKLQN is (X4)8, and R is X5 (please refer to the entire specification particularly pages 1, 3, 6, 7; Tables 1 and 2).
Therefore, the teachings of Taden et al. anticipate the presently claimed peptides.
Claims 1, 2, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balaoing et al., 2015, Laminin Peptide-Immobilized Hydrogels Modulate Valve Endothelial Cell Hemostatic Regulation, PLoS ONE, 10(6): e0130749 (16 pages).
For present claims 1, 2, 12, and 13, Balaoing et al. teach peptide(s) of (C)mX1X2X3(X4)nX5(C)o including RKRLQVQLSIRT wherein m and o are 0, R is X1, L is X2, Q is X3, VQLSIR is (X4)6, and T is X5 and cysteine can be added to the N-terminus bound to plastic polymers (please refer to the entire reference particularly the abstract; Material and Methods).
Therefore, the teachings of Balaoing et al. anticipate the presently claimed peptide.
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.
Claims 1, 2, 12, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/564,736 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 18/564,736 (reference application) are drawn to peptides of (C)mX1X2X3(X4)nX5(C)o including SEQ ID NO: 16 (i.e. 100% identity and the same length as present SEQ ID NO: 16).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 12, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/492,505 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 19/492,505 (reference application) are drawn to peptides of (C)mX1X2X3(X4)nX5(C)o including SEQ ID NO: 16 (i.e. 100% identity and the same length as present SEQ ID NO: 16).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 12, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/128,006 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 19/128,006 (reference application) are drawn to peptides of (C)mX1X2X3(X4)nX5(C)o including SEQ ID NO: 19 (i.e. 100% identity and the same length as present SEQ ID NO: 16).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 12, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,494,622. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 10,494,622 are drawn to peptides of (C)mX1X2X3(X4)nX5(C)o including SEQ ID NO: 4 MKKLFKTIVTLSLLISGTLLFSQSAAA wherein m and o are 0, X1 is K, X2 is L, X3 is F, (X4)n is KTIVTLSLLISGTLLFSQSAA, and X5 is A.
Claims 1, 2, 12, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,803,183. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 9,803,183 are drawn to peptides of (C)mX1X2X3(X4)nX5(C)o including SEQ ID NO: 2 MAKPLSKGGILVKKVLIAGAVGTAVLFGTLSSGIPGLPAADA wherein m and o are 0, X1 is K, X2 is P, X3 is L, (X4)n is SKGGILVKKVLIAGAVGTAVLFGTLSSGIPGLPAAD, and X5 is A.
Claims 1, 2, 12, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,065,991. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 10,065,991 are drawn to peptides of (C)mX1X2X3(X4)nX5(C)o including SEQ ID NOs: 9-19 including SEQ ID NO: 9 SRARLFVVTYHK wherein m and o are 0, X1 is R, X2 is L, X3 is F, (X4)n is VVTYH, and X5 is K.
Claims 1, 2, 12, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,046,961. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 11,046,961 are drawn to peptides of (C)mX1X2X3(X4)nX5(C)o including SEQ ID NO: 6 MTLTKLKMLSMLTVMIASLFSSQALA wherein m and o are 0, X1 is K, X2 is M, X3 is L, (X4)n is SMLTVMIASLFSSQAL, and X5 is A.
Claims 1, 2, 12, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,157,870. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 12,157,870 are drawn to peptides of SEQ ID NOS: 2-7 including SEQ ID NO: 3 RSVCRGIKLCRRRGGCYYKCTNRPY wherein m and o are 0, X1 is R, X2 is S, X3 is V, (X4)n is CRGIKLCRRRGGCYYKCTNRP, and X5 is Y.
Subject Matter Free of the Prior Art*
*see the above Double Patenting Rejections
Peptides comprising amino acid sequences with at least 90% identity to SEQ ID NOs: 16, 17, 19, 20, 21, or 22 are free of the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Regarding peptides bound to plastics:
Zhang et al, 2020, Diminution of Phagocytosed Micro/Nanoparticles by Tethering with Immunoregulatory CD200 Protein, Scientific Reports, 10: 8604 (13 pages).
Clauder et al., 2020, Peptide-mediated surface coatings for the release of wound-healing cytokines, J Tissue Eng Regen Med, 14: 1738-1748.
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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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
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