The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election of Group I, claims 1-6, 8, 10-13, 17, 22, 24, to SEQ ID NO: 159, (GRGDQPYQ)40 (SEQ ID NO: 3), in the reply filed on September 2, 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 7, 9, 14-16, 18-21, 23, 30-33 are canceled. Claims 25-29, 34 have been withdrawn from further consideration by the examiner because they are drawn to non-elected inventions. Claims 1-6, 8, 10-13, 17, 22, 24, to SEQ ID NO: 159, (GRGDQPYQ)40 (SEQ ID NO: 3), are under consideration.
Priority: This application is a 371 of PCT/US2021/020591, filed March 3, 2021, which claims benefit of provisional application 62/985179, filed March 4, 2020.
Failure to Comply with the Sequence Rules
Where the description of a patent application discusses a sequence of 4 or more amino acids or a sequence of 10 or more nucleic acids, reference must be made to the sequence by use of the sequence identifier preceded by “SEQ ID NO:” in the text of the description even if the sequence is also embedded in the text of the description of the patent application (see MPEP 2412.03). The sequence identifier may be used in either the drawing or the Brief Description of Drawings (see MPEP 2412).
Objection to the Specification:
The specification is objected to for failure to comply with the sequence rules for the reasons as given above. The specification refers to sequences without identifiers at: see at least
paragraphs 0019, 0046, 0047, 0098 (of the application publication).
The sequences must be in computer readable form (CRF) for search. See also MPEP
2422 for sequence compliance requirements. Appropriate correction is required.
Objection to the Drawings:
The drawings are objected to for failure to comply with the sequence rules for the reasons as given above. See at least Figs. 8C, 30A, 30B, 30C, 30D.
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.
The sequences must be in computer readable form (CRF) for search. See also MPEP
2422 for sequence compliance requirements. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-6, 8, 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by You et al. (WO 2018231834). You et al. teach a resilin-like polypeptide comprising GFP-His-(GRGDQPYQ)20 (at least paragraph 0118, Table 3). You et al. further teach a resilin-like polypeptide comprising GFP-His-(GRGDSPYS)80 (at least paragraph 0118, Table 3). Since You et al. teach a polypeptide comprising ten or more repeats of an amino acid sequence having the same structural features recited, the polypeptides of You et al. will necessarily have the phase separation properties recited in the instant claims. “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP 2112.01. Therefore, You et al. can be deemed to anticipate instant claims 1-6, 8, 10-11.
Claims 1-6, 8, 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chilkoti et al. (US 20120121709, cited as US 8470967 on IDS 01.05.23). Chilkoti et al. teach environmentally responsive proteins comprising at least ten sequences selected from GRGDSPYQ (SEQ ID NO: 48) (at least paragraphs 0008, 0053, p. 47 claim 21). Since Chilkoti et al. teach a polypeptide comprising ten or more repeats of an amino acid sequence having the same structural features recited, the polypeptides of Chilkoti et al. will necessarily have the phase separation properties recited in the instant claims. “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP 2112.01. Therefore, Chilkoti et al. can be deemed to anticipate instant claims 1-6, 8.
Regarding instant claim 10, Chilkoti et al. teach attaching the environmentally responsive protein to a polypeptide of interest, including therapeutics, polymers (at least paragraphs 0074-0075).
Claims 1-6, 8, 10, 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wu et al. (US 20210346570). Wu et al. teach a disordered protein comprising a resilin-like polypeptide comprising a number of repeating amino acid sequence motifs, the disordered protein comprising MSKGP-(GRGDQPYQ)n, where n greater than 5, including n is 20 (at least paragraphs 0005, 0118-0119, 0368, p. 38 claim 16). Since Wu et al. teach a polypeptide comprising ten or more repeats of an amino acid sequence having the same structural features recited, the polypeptides of Wu et al. will necessarily have the phase separation properties recited in the instant claims. “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP 2112.01. Therefore, Wu et al. can be deemed to anticipate instant claims 1-6, 8.
Regarding instant claim 10, Wu et al. teach additional structures, including proteins, enzymes, are embedded or localized with the disordered protein (DP) (at least paragraphs 154-0156).
Regarding instant claim 12, Wu et al. teach a disordered protein comprising the amino acid sequence of SEQ ID NO: 15 (p. 37), where SEQ ID NO: 15 has 100% sequence identity with instant SEQ ID NO: 3.
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, 8, 10-11, 13, 17, 22, 24 are rejected under 35 U.S.C. 103 as being unpatentable over You et al. (WO 2018231834) in view of Braisted et al. (US 6013763). The teachings of You et al. over at least instant claims 1-6, 8, 10-11 are noted above.
Regarding instant claims 13, 22, 24, You et al. disclose the systems comprising resilin-like polypeptides can be attached to a biomolecule of interest, including enzymes, therapeutic biologics, antigenic proteins, immunogenic proteins, GFP, GLP-1, etc. (at least paragraphs 0102-0104). Braisted et al. disclose protein A from Staphylococcus aureus binds with high affinity to a region of IgG (col. 1 lines 15-20). Braisted et al. disclose Z domain variants for therapeutic use in compositions comprising auxiliary agents (col. 42-44 section V). Braisted et al. disclose the Z domain of protein A has the amino acid sequence of SEQ ID NO: 4 (col. 4 lines 3-11), where SEQ ID NO: 4 has 100% sequence identity with instant SEQ ID NO: 159. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate and/or attach a Z domain variant derived from SEQ ID NO: 4 of Braisted et al. for the biomolecule of interest with the resilin-like polypeptides comprising -(GRGDQPYQ)20 and/or -(GRGDSPYS)80 of You et al. (instant claim 13) because You et al. disclose the systems comprising resilin-like polypeptides for production of an attached protein, including antigenic proteins, immunogenic proteins, etc. One of ordinary skill would have a reasonable expectation of success because methods for engineering resilin-like polypeptides comprising a protein of interest were known and disclosed in the prior art.
Regarding instant claim 17, since You et al. disclose a polypeptide comprising ten or more repeats of an amino acid sequence having the same structural features recited, the polypeptides of You et al. will necessarily have the property to enhance bioavailability of a molecule as recited in the instant claim. “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP 2112.01.
Claims 1-6, 8, 10, 11-12, 13, 17, 22, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Chilkoti et al. (US 20120121709, cited as US 8470967 on IDS 01.05.23) in view of Braisted et al. (US 6013763). The teachings of Chilkoti et al. over at least instant claims 1-6, 8, 10 are noted above.
Regarding instant claims 13, 22, 24, Chilkoti et al. disclose the environmentally responsive polypeptides are used as materials for delivery of proteins and/or purification of proteins (at least paragraphs 0061-0073). Chilkoti et al. disclose attaching the environmentally responsive protein to a polypeptide of interest, including therapeutics, polymers (at least paragraphs 0074-0075). Braisted et al. disclose protein A from Staphylococcus aureus binds with high affinity to a region of IgG (col. 1 lines 15-20). Braisted et al. disclose Z domain variants for therapeutic use in compositions comprising auxiliary agents (col. 42-44 section V). Braisted et al. disclose the Z domain of protein A has the amino acid sequence of SEQ ID NO: 4 (col. 4 lines 3-11), where SEQ ID NO: 4 has 100% sequence identity with instant SEQ ID NO: 159. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate and/or attach a Z domain variant derived from SEQ ID NO: 4 of Braisted et al. for the polypeptide of interest with the polypeptides comprising at least ten sequences of GRGDSPYQ (SEQ ID NO: 48) of Chilkoti et al. (instant claim 13) because Chilkoti et al. disclose the systems comprising environmentally responsive polypeptides for attaching to biomolecule of interest, including proteins, therapeutics, etc. One of ordinary skill would have a reasonable expectation of success because methods for engineering environmentally responsive polypeptides comprising a protein of interest were known and disclosed in the prior art.
Regarding instant claim 17, since Chilkoti et al. disclose a polypeptide comprising ten or more repeats of an amino acid sequence having the same structural features recited, the polypeptides of Chilkoti et al. will necessarily have the property to enhance bioavailability of a molecule as recited in the instant claim. “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP 2112.01.
Regarding instant claim 11, as noted above, Chilkoti et al. disclose an environmentally responsive protein comprising at least ten sequences of GRGDSPYQ (SEQ ID NO: 48) (at least paragraphs 0008, 0053, p. 47 claim 21). Chilkoti et al. disclose the design of the behavior of the polypeptides is tuned by adjusting the hydrophobicity of the residues comprising the repeating unit (at least paragraph 0120). Chilkoti et al. disclose that incorporating a glutamine (Q) significantly reduced the UCST of the biopolymer (at least paragraph 0120). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the recited repeat sequence GRGDSPYS by substituting another hydrophilic amino acid residue, serine (S), for the glutamine (Q) residue in the repeat sequence GRGDSPYQ of Chilkoti et al. because Chilkoti et al. disclose peptides that are similar to the recited peptides and disclose that the behavior of the polypeptides can be tuned and it is known that serine is also a hydrophilic amino acid residue.
Regarding instant claim 12, it is disclosed in the instant specification that instant SEQ ID NO: 3 comprises the repeat sequence (GRGDQPYQ)40. As noted above, Chilkoti et al. disclose an environmentally responsive protein comprising at least ten sequences of GRGDSPYQ (SEQ ID NO: 48) (at least paragraphs 0008, 0053, p. 47 claim 21). Chilkoti et al. disclose the design of the behavior of the polypeptides is tuned by adjusting the hydrophobicity of the residues comprising the repeating unit (at least paragraph 0120). Chilkoti et al. disclose that incorporating a glutamine (Q) significantly reduced the UCST of the biopolymer (at least paragraph 0120). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the recited repeat sequence GRGDQPYQ by substituting another hydrophilic amino acid residue, serine (S), for the glutamine (Q) residue in the repeat sequence GRGDQPYQ of Chilkoti et al. because Chilkoti et al. disclose peptides that are similar to the recited peptides and disclose that the behavior of the polypeptides can be tuned and it is known that serine is also a hydrophilic amino acid residue.
Claims 1-6, 8, 10, 12, 13, 17, 22, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (US 20210346570) in view of Braisted et al. (US 6013763). The teachings of Wu et al. over at least instant claims 1-6, 8, 10, 12 are noted above.
Regarding instant claims 13, 22, 24, Wu et al. disclose a disordered protein comprising a resilin-like polypeptide comprising a number of repeating amino acid sequence motifs, the disordered protein comprising MSKGP-(GRGDQPYQ)n, where n greater than 5, including n is 20 (at least paragraphs 0005, 0118-0119, 0368, p. 38 claim 16). Wu et al. disclose additional structures, including proteins, enzymes, adhesion molecules, are embedded or localized with the disordered protein (DP) (at least paragraphs 154-0156). Braisted et al. disclose protein A from Staphylococcus aureus binds with high affinity to a region of IgG (col. 1 lines 15-20). Braisted et al. disclose Z domain variants for therapeutic use in compositions comprising auxiliary agents (col. 42-44 section V). Braisted et al. disclose the Z domain of protein A has the amino acid sequence of SEQ ID NO: 4 (col. 4 lines 3-11), where SEQ ID NO: 4 has 100% sequence identity with instant SEQ ID NO: 159. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate and/or attach a Z domain variant derived from SEQ ID NO: 4 of Braisted et al. for the additional structure with the resilin-like polypeptides comprising MSKGP-(GRGDQPYQ)n of Wu et al. (instant claim 13) because Wu et al. disclose the systems comprising resilin-like polypeptides for embedding additional structures, including proteins, adhesion molecules, etc. One of ordinary skill would have a reasonable expectation of success because methods for engineering resilin-like polypeptides comprising a protein of interest were known and disclosed in the prior art.
Regarding instant claim 17, since Wu et al. teach a polypeptide comprising ten or more repeats of an amino acid sequence having the same structural features recited, the polypeptides of Wu et al. will necessarily have the property to enhance bioavailability of a molecule as recited in the instant claims. “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP 2112.01.
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 1-6, 8, 10-13, 17, 22, 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-19, 21-31 of copending Application No. 17908415 (‘415) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the ‘415 application claims are drawn to polypeptide comprising ten or more repeats of an amino acid sequence comprising GRGDQPYQ (see at least claims 18, 23-24 of the ‘415 application).
Regarding instant claim 11, the ‘415 application claim 24 recites the repeat sequence is GRGDSPYS.
Regarding instant claim 12, the ‘415 application claims 18, 23-24 recite the repeat sequence is 20-400, including 40, repeats of GRGDQPYQ.
Regarding instant claims 13, 17, 22, 24, the ‘415 application claims 18, 31 recite the polypeptide further comprises a binding polypeptide comprising a Z-domain of staphylococcal protein A.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 8, 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9, 14-15 of copending Application No. 17800700 (‘700) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the ‘700 application claims are drawn to a polypeptide comprising ten or more repeats of an amino acid sequence comprising (GRGDSPYQ)n (see at least claims 1, 9 of the ‘700 application).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 8, 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11591576 (‘576). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the ‘576 patent claims are drawn to a polypeptide comprising ten or more repeats of an amino acid sequence comprising (GRGDSPYQ)n (see at least claims 1, 9 of the ‘576 patent).
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marsha Tsay whose telephone number is (571)272-2938. The examiner can normally be reached M-F.
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/Marsha Tsay/Primary Examiner, Art Unit 1656