DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group II, claims 10-20, in the reply filed on 3/12/2026 is acknowledged. The traversal is on the ground(s) that Group II is used by the method of Group I. This is not found persuasive because the restriction is based on Group I (classified in A61L 2430/34) and Group II (C07K 2319/70) are listed in different CPC classification demonstrating search burden. The relationship between Group I and Group II as argued by applicant is not a reason to make restriction decision.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/12/2026.
Claim Status
Claims 1-20 are pending.
Claims 1-9 are withdrawn; the election having been made on 3/12/2026 with traverse.
Claims 10-20 have been examined.
Priority
This application is a CIP of PCT/US22/15468 02/07/2022
PCT/US22/15468 has PRO 63/146,471 02/05/2021
The provisional application does not disclosed any peptide sequences of SEQ ID NOs: 1-7; thus, the prior art date of this application is the effective filing date of PCT/US22/15468 on 02/07/2022.
Information Disclosure Statement
There is no IDS of record.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 10 is rejected under 35 U.S.C. 101 because the claim encompasses a natural product composition.
The eligibility of patent subject is further analyzed as follows.
Step 1. The claim is directed to a composition.
Step 2A-Prone 1 (NO judicial exception is cited). The claim requires a linear polypeptide comprising multiple repeated peptide sequences linked to a crosslinker. A naturally-occurring linear elastin polypeptide comprises multiple repeated peptide motifs evidenced by Schrader et al. (J Biol Chem. 2018 Aug 14;293(39):15107–15119) shown as follows (p15109, Fig 2). The linear polypeptide comprises inherent crosslinkers of amino acid residues for cross-linking domains of a monomer molecule tropoelastin described in the abstract.
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Step 2A prong 2 (whether the claim as whole integrates the recited judicial exception into a practical application of the exception): No, there is nothing in the claim to integrate the judicial exception (JE) into any particular practical application. The crosslinker is inherent in the naturally-occurring elastin polypeptide.
Step 2B inventive concept (evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim): No, there is nothing in the claim that causes it to amount to significantly more than the JE. Again, the claim is drawn to a composition of a linear polypeptide monomer comprising a crosslinker and multiple linear repeated peptide sequences. Crosslinkers of amino acid residues exist in a naturally-occurring linear elastin polypeptide. Because claim 10 fails to satisfy eligibility of patent subject, claim 10 is rejected under 35 U.S.C. 101 as a natural elastin polypeptide.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10-14 and 16-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification failed to provide a representative number of a polypeptide monomer sequence comprising a plurality of amino acid repeats and a linker effective as a nano spring.
The specification disclosed a recombinant ankyrin containing 6 ankyrin repeat proteins [0011] and SEQ ID NOs: 1-4 and 6-7 in the sequence listing. However, the limited disclosure is insufficient to represent the entire genus of a polypeptide monomer sequence comprising a plurality of amino acid repeats and a linker effective as a “nano spring” in the claims. An elastin polypeptide comprises peptide repeats known in the art may be used for medical implant with a function of “nano spring”, but a combination of the disclosed examples and common knowledge known in the art is still insufficient to support the entire genus of a polypeptide monomer sequence comprising a plurality of amino acid repeats connected to a crosslinker effective as a “nano spring” in the claims.
The specification failed to establish a correlation between a polypeptide sequence and the function of “nano spring”. The examiner did not find sufficient evidence for the limited disclosure in the SPEC together with common knowledge able to establish correlation of a polypeptide sequence and the function of “nano spring”.
Thus, 10-14 and 16-20 are rejected under 35 U.S.C. 112(a). the rejection may be overcome by distinctly claiming the polypeptide sequence effective as a nano spring.
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 11 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.
Claim 11 is unclear with respect to the phrase “the receptor of the first crosslinker” for a number of reasons.
Claim 10 does not refers to “a receptor” in the first crosslinker, rendering the term in claim 11 lack of antecedent basis.
Although the specification disclosed biotin bound to streptavidin, it is improper to import claim limitations from the specification. See MPEP 2111.01.
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 10, 13-15, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Knoff et al. (Macromolecules 2020, 53, 3464−3471).
Claim 1 is drawn to a polypeptide monomer composition comprising a crosslinker linked to repeat component comprising a plurality of amino acid repeats linearly connected.
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Knoff et al. teach an ankyrin repeat protein of NI6C with 100% identity to the instant SEQ ID NO: 7 (elected species) as follows (Fig. S1 and legend). Knoff et al. teach a P cross-linker attached to both N and C termini to form P-NI6C-P (p3465, col 2, para 2; p3466, Fig 2, legend). Knoff et al. further teach NI6C exhibits spring-like nanomechanics, extending 11 times its folded length before returning to its original solenoid conformation (p3467, col 2, last para),
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reading on effective as a nano spring, reading on claims 10-11 and 13-15.
With respect to claim 20, Knoff et al. show a biopolymer hydrogel composition comprising a plurality of polypeptide monomer composition as follows (p3465, Fig 1).
Claims 1 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Urry et al. (Phil. Trans. R. Soc. Lond. B (2002) 357, 169–184).
Claim 1 is drawn to a polypeptide monomer composition comprising a crosslinker linked to repeat component comprising a plurality of amino acid repeats linearly connected.
Urry et al. teach that an elastin protein contains dynamic, non-random, regularly repeating structures that exhibit dominantly entropic elasticity by means of a damping of internal chain dynamics on extension (Abstract). Urry et al. teach internal lysine amino acids in elastin protein serving as a crosslinker (p173, col 1, Preparation of natural materials). Urry et al. teach an elastin protein contains multiple repeats of GVGVP (p171, col 2, para 2). Urry et al. further show calculation of elastic modulus of the elastin polypeptide containing multiple repeats of GVGVP (p175, col 2, last two para to p176, para 1-2; Fig 5), reading on the property of effective as a nano spring.
Claims 10, 16-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al. (Proc Natl Acad Sci U S A. 2014 Aug 5;111(31):11269-74.).
Claim 1 is drawn to a polypeptide monomer composition comprising a crosslinker linked to repeat component comprising a plurality of amino acid repeats linearly connected.
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Sun et al. teach “Synthesis of bioactive protein hydrogels by genetically encoded SpyTag-SpyCatcher chemistry” (Title). Sun et al. show various elastin fusion protein construct via SpyTag-SpyCatcher crosslinking to form hydrogel as follows (p11270, Fig. 1). Sun et al. show a crosslinker of the core ELP can be SpyTag or SpyCatcher and the other crosslinker is RGD to link a second ELP. Sun et al. teach the ELP polypeptide comprising a mixture of VPGVG and VPGEG repeated motifs (p11269, col 2, Engineered Protein Design), reading on claims 10, 16-18, and 20.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1. Claims 10-15 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Knoff et al. as applied to claims 10, 13-15, 20 and further in view of Moll et al. (Proc Natl Acad Sci U S A. 2002 Nov 12;99(23):14646-51.) and Gonzalez et al. (J Biol Chem. 1997 Apr 25;272(17):11288-94.).
Claim 12 is drawn to the first linker comprising a streptavidin polypeptide and claim 11 is drawn to biotin bound to the first crosslinker.
Knoff et al. teach attachment of crosslinkers to both N- and C- termini of an ankyrin repeat protein of NI6C (the elected species of SEQ ID NO: 7) for self-assembling to form hydrogel (p3465, col 1, last para and Figure 1).
Knoff et al. did not teach a linker as streptavidin to facilitate self-assembling of monomer polypeptide to form hydrogel.
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Moll et al. teach the use of streptavidin fusion to a self-assembling protein able to maintain self-assembling capability of the protein as well as streptavidin binding to biotin (Abstract; p14648, Fig. 1-2 and 4-5). Furthermore, Gonzalez et al. is cited to show biotin binding induces an increase in protein tightness of streptavidin (structural cooperativity) leading, in turn, to a higher thermostability at dose-dependent manner shown above (Abstract; p11290, Table I). Gonzalez et al. further suggest biotin binding able to regulate a streptavidin’s tetramer structure with two models shown as follows (p11293, Fig 6).
Because (a) Moll et al. teach the use of streptavidin fusion to a self-assembling protein able to maintain self-assembling capability of the protein as well as streptavidin binding to biotin (Abstract; p14648, Fig. 1-2 and 4-5), and (b) Gonzalez et al. suggest biotin binding modulates streptavidin’s structure and increases thermostability of streptavidin (Abstract; p14648, Fig. 1-2 and 4-5), one of ordinary skill in the art would have found it obvious to beneficially fusion Knoff’s self-assembling ankyrin repeat protein of NI6C to a streptavidin protein to facilitate self-assembling and regulation of conformation change and stability of the assembled hydrogel in response to biotin.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Knoff’s hydrogel composition comprising an ankyrin repeat protein of P1-NI6C-P2 with P1 and P2 crosslinkers (p3465, col 2, para 2) and (ii) Moll et al. in view of Gonzalez et al. because (a) Knoff et al. a hydrogel composition comprising a self-assembling ankyrin repeat protein flanked by a linker (p3465, col 1, last para and Figure 1), (b) Moll et al. teach the use of streptavidin fusion to a self-assembling protein able to maintain self-assembling capability of the protein as well as streptavidin binding to biotin (Abstract; p14648, Fig. 1-2 and 4-5), and (c) Gonzalez et al. is cited to show biotin binding induces an increase in protein tightness of streptavidin (structural cooperativity) leading, in turn, to a higher thermostability at dose-dependent manner (Abstract; p11290, Table I) and further suggest biotin binding able to regulate a streptavidin’s tetramer structure (p11293, Fig 6). The combination would have reasonable expectation of success because streptavidin fusion to a self-assembling protein of ankyrin repeat protein is expected to form a tetramer of streptavidin fusion to ankyrin repeat protein and biotin is expected to modulate the structure of the streptavidin fusion protein in hydrogel as suggested by Moll et al. in view of Gonzalez et al.
With respect to claim 11, Gonzalez et al. show biotin binding modulates streptavidin’s structure and increases thermostability of streptavidin.
With respect to claim 12 and 19, Moll et al. teach the use of streptavidin fusion to a self-assembling protein able to maintain self-assembling capability of the protein as well as streptavidin binding to biotin (Abstract; p14648, Fig. 1-2 and 4-5). Gonzalez et al. show biotin binding induces an increase in protein tightness of streptavidin (structural cooperativity) leading, in turn, to a higher thermostability at dose-dependent manner shown above (Abstract; p11290, Table I). Gonzalez et al. suggest biotin binding modulates streptavidin’s structure and increases thermostability of streptavidin (Abstract; p14648, Fig. 1-2 and 4-5), reading on modulates the mechanical properties of the biopolymer of Knoff’s hydrogel composition.
With respect to claim 20, Moll et al. teach streptavidin self-assembling to a tetramer (p11293, Fig 6). Thus a chimeric polypeptide of (streptavidin)-(P1-ankyrin repeat protein of NI6C-P2) would at least form a tetramer due to tetramerization of the streptavidin domain.
Claims 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Knoff et al. in view of Moll et al. and Gonzalez et al. as applied to claims 10-15, 19-20, and further in view of Sun et al. (Proc Natl Acad Sci U S A. 2014 Aug 5;111(31):11269-74.).
Claims 16-18 are drawn to a second crosslinker linked to the chimeric protein of streptavidin fusion to an ankyrin repeat protein (P1-NI6C-P2) via P1 or P2 linker.
Knoff et al. in view of Moll et al. and Gonzalez et al. teach a monomer fusion protein of streptavidin fusion to an ankyrin repeat protein (P1-NI6C-P2) via P1 or P2 linker in a hydrogel composition.
Knoff et al. in view of Moll et al. and Gonzalez et al. did not teach the second P linker further linked to a SpyCatcher or SpyTag.
Similarly Sun et al. teach “Synthesis of bioactive protein hydrogels by genetically encoded SpyTag-SpyCatcher chemistry” (Title). Sun et al. show fusion of SpyTag or SpyCatcher to a hydrogel-generating protein comprising repeated motifs to form hydrogel network via site-specific crosslinking between SpyTag and SpyCatcher (p11270, Fig. 1). Because Sun et al. teach beneficial fusion of SpyTag or SpyCatcher to a hydrogel-generating protein comprising repeated motifs for site-specific crosslinking to form hydrogel network, one of ordinary skill in the art would have found it obvious to combine the hydrogel-generating protein taught by Knoff et al. in view of Moll et al. and Gonzalez et al. with Sun’s SpyTag and SpyCatcher to generate a fusion for the same purpose of generating a hydrogel, reading on claims 16-18.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Knoff et al. in view of Moll et al. and Gonzalez et al. with (ii) Sun et al. because (a) Knoff et al. in view of Moll et al. and Gonzalez et al. teach a protein comprising streptavidin fusion to an ankyrin repeat protein (P1 linker-NI6C-P2 linker) for generating a hydrogel and (b) Sun et al. show fusion of SpyTag or SpyCatcher to a hydrogel-generating protein comprising repeated peptide motifs to form hydrogel network via site-specific crosslinking between SpyTag and SpyCatcher (p11270, Fig. 1). The combination would have reasonable expectation of success because both Knoff et al. and Sun et al. teach a composition comprising a protein having repeated peptide motifs to form a hydrogel.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 10, 12, 16-17, and 20 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-4 and 15 of copending Application No. PCT/US22/15468 (the ‘468 application, 02/07/2022).
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
14-May-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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