DETAILED ACTION
Notice of Pre-AIA or AIA Status
As previously set forth: 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
As previously set forth: Applicant’s election of Group I, spider silk fibroin having a thiol group, hydropathy of 0.22, polycarbonate block copolymer, maleimide, in situ, alternatively bonded, DMSO solvent in the reply filed on 11/14/25 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Claims 7, 16-20, 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/species, there being no allowable generic or linking claim.
Priority
As previously set forth: The foreign priority is not in English, the claims thusly have an effective date of the filing of the PCT: 3/16/21
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/26/26 has been considered by the examiner.
Response to Arguments
Applicant argues Kazantsev does not disclose the configuration wherein the second segment is covalently bonded via a thiol group in an artificial structural protein.
The Examiner agrees, and now includes Kaplan (which was previously used over the same limitation in a dependent claim) to address such. As such arguments herein are found moot.
Applicant argues Kaplan discloses silk fibroin but the silk fibroin is a component stabilized by beta sheet formation in a PEG body, thus the covalent bonding is not met.
The Examiner disagrees. Kaplan discloses silk fibroin is a known polypeptide that can be used for biomaterial hydrogels, the same use as Kazantsev. That it is used differently is moot, one has a reasonable expectation that it will function as a polypeptide in Kazantsev. Arguments therein are thusly not found persuasive.
Applicant argues the ODP rejections should be withdrawn because the amendments are not met.
The Examiner disagrees. The new thiol requirements are met by claim 15 and claim 19, respectively, in the ODP’s, and, the artificial protein limitations are met by elements previously set forth. Arguments herein are thusly not persuasive.
Claim Rejections - 35 USC § 112
Rejection over Claims 1, and its dependents, 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 is overcome by amendment.
Rejection over Claim 4, and its dependents, 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 is overcome by amendment.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13, 14, and their dependents, are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 13, 14 have the limitations “derived from an artificial protein” and “artificial structural protein”, respectively. These no longer limit claim 1 due to amendment. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
Rejection over Claim(s) 1, 4-6, 9-10 under 35 U.S.C. 102a1 as being anticipated by Kazantsev (US 2018/0043030) is overcome, claim 14 has been amended into claim 1.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-6, 8-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kazantsev in view of Kaplan (US 2013/0287742) as evidenced by Sigma Aldrich-lysozyme.
Elements of Kazantsev and Kaplan are as previously set forth, reiterated below in italics. The references are combined for claim 1 because Claim 14 has been amended therein. Regarding amended claim 4, Ex 9 uses chicken egg lysozyme, which as evidenced by Sigma Aldrich has a MW of 14.3 kDa, and a PEG-dinorbonene having MW 3.8 kDa. This is a ratio of 27:100 embracing that of claim 4 (x/3.8 = 100/14.3, x=27)
Kazantsev discloses degradable thio-ene polymers and methods of making (title). See the formula of [0210] -S-Ct-X-Ct-S-C-C-Y-C-C-. Therein X is a polypeptide (meeting the first segment of claim 1), Ct-S is a thiol link, C-C is another linker group and Y is a polymer such as a polycarbonate (meeting the second segment of claim 1) [0210]. This formula repeats, creating the polymer (meeting the synthetic polymer of claim 1). The other formulas of Kazantesev all include a polypeptide segment and one or more polymer segments, see [0061], [0065], [0206], ect.
Thus, the only element picked from a list is the polycarbonate. Polycarbonate must implicitly (since it was elected) have a plasticizing function for the polypeptide segment.
Kazantsev includes elements as set forth above. Kazantsev discloses copolymers comprising a polypeptide segment, and, a polymer segment wherein the polymer may be a polycarbonate. The polymer may also be a polyethylene glycol [0210]. The composition is used as degradable polymer biocompatible hydrogel (title, abstract). Kazantsev discloses using polypeptides but does not disclose the use of artificial spider silk fibroin or the hydrophobicity thereof.
Kaplan disclose silk fibroin and PEG biomaterials (title). Said biomaterials may be a hydrogel [0011, 0060], thus akin to the use of Kazantsev. The silk fibroin of Kaplan is a type of polypeptide. The silk fibroin and PEG are chemically crosslinked/reacted together to form the hydrogel. Though a different reaction one can see that the silk fibroin is a known polypeptide that can be used for biomaterial hydrogels, the same use as Kazantsev.
It would have been obvious to one of ordinary skill in the art to use in Kazantsev the use of a silk fibroin as the polypeptide, as taught by Kaplan, since it is recognized in the art of biomaterial hydrogels reacted with polymers to be suitable for the intended use thereof. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), wherein the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination.
Since Kazantsev discloses polyethylene glycol and polycarbonate to both be suitable therein one has a reasonable expectation that the silk fibroin would equally work for use in Kazantsev’s invention.
Further, the silk fibroin may be derived from a spider [0045]. Since the same species of polypeptide is disclosed as instantly claimed the hydropathy index is expected to be embraced by the reference.
Elements above meet claims 1-3, 5-6, 13-16.
In the -S-Ct-X-Ct-S-C-C-Y-C-C- repeat unit of [0210] group (also in any other formula above) the C-C can be said to be a plurality of molecular groups of the second segment that are linked together, as required by claim 9
Regarding claim 8: Kazantsev includes elements as set forth above. See the formula of [0210] -S-Ct-X-Ct-S-C-C-Y-C-C-. This formula repeats, creating the polymer (meeting the synthetic polymer of claim 1).
Though picking the combination of the above formula of [0210] and polycarbonate is from a list of possible combinations, it has been held that though a specific embodiment is not taught as preferred makes it no less obvious, also, that the mere fact that a reference suggests a multitude of possible combinations does not in and of itself make any one of those combinations less obvious, see Merck v. Biocraft, 10 USPQ2d 1843 (Fed Cir 1985)
The above formula repeats, thus creating/embracing the alternative bonding of claim 8.
Regarding claims 10-12: In the -S-Ct-X-Ct-S-C-C-Y-C-C- repeat unit of [0210] group C-C can be said to be a plurality of molecular groups of the second segment that are linked together, as required by claim 9, these molecular groups can comprise a linker such as maleimide (Table 2), this maleimide attaches to the thiol group of the polypeptide (the S of the X-Ct-S is a thiol) meeting claims 10-12.
Rejection over Claim(s) 8, 11-12 under 35 U.S.C. 103 as being unpatentable over Kazantsev (US 2018/0043030) is amended into the above rejection, due to amendment.
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, 13-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 10, 3, 7, 14, 15 of copending Application No. 18/294011 (reference application).
Elements of this rejection are as previously set forth, reiterated below in italics. Regarding the amendments: claim 15 of ‘011 discloses the use of thiol and the artificial structural protein are met by claims 13-16 of ‘011 as previously set forth.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘011 meets instant claims 1, 8, claim 2 of ‘011 meets instant claim 2, claim 10 of ‘011 meets instant claim 3, claim 3 of ‘011 meets instant claim 4, claim 5 of ‘011 meets instant claims 5, 6, claim 15 of ‘011 meets instant claims 9-10 and claim 14 of ‘011 meets instant claims 13-16.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5-6, 8-10, 14-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, 7, 19, 14 of copending Application No. 18/294005 (reference application).
Elements of this rejection are as previously set forth, reiterated below in its entirety in italics. Regarding the amendments: claim 19 of ‘005 disclose the use of thiol groups and the artificial structural protein is met by claims 14-16 of ‘005
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘005 meets instant claims 1, 8, claim 2 of ‘005 meets instant claim 2, claim 10 of ‘005 meets instant claim 3, claim 7 of ‘005 meets instant claims 5,6, claim 19 of ‘005 meets instant claims 9, 10, claim 14 of ‘005 meets instant claims 14-16.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALICIA BLAND whose telephone number is (571)272-2451. The examiner can normally be reached Mon - Fri 9:00 am -3:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curt Mayes can be reached at 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALICIA BLAND/ Primary Examiner, Art Unit 1759
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