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 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Claims 7, 16-20, 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/species, there being no allowable generic or linking claim.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
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 5/2/24, 10/18/22, 9/2822, 9/26/22 have been considered by the examiner.
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, and its dependents, 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 1 has the limitation “one or a plurality of second segments” along with “the second segment”. This combination makes it unclear as to whether the “the second segment” limitations that follow are only for one second segment, or, if it applies to “one or a plurality” of second segments.
Claim 4, and its dependents, 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 4 has the limitation “a molecular weight is a value within a range of 1 to 70 when a molecular weight of the first segment is 100”
It is unclear how the second segment can have a MW of 1. The only element with MW of 1 is hydrogen but use of hydrogen as the second segment is not disclosed/embraced by the specification. The second segment is disclosed in claims 5-6 to be various polymers. These cannot have a MW of 1. It is unclear if this is meant to be a ratio and/or if it is a translation error. The examiner requests clarification.
It is noted that the limitation is being treated as only needing to be met when the MW of the first segment is 100. If the MW of the first segment has any other MW the claim limitation bears no weight.
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.
Claim(s) 1, 4-6, 9-10 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kazantsev (US 2018/0043030).
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.
As such, elements above anticipate claim 1. Claim 4 only comes into play when the MW of the first segment is 100, since the MW is not disclosed to be 100 the limitation of bears no weight and the claim is met. Elements above meet claims 5 and 6. 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, these molecular groups can comprise a linker, meeting claim 10.
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.
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.
Claim(s) 8, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kazantsev (US 2018/0043030).
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. 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.
Claim(s) 2-3, 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kazantsev in view of Kaplan (US 2013/0287742).
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 thusly meet claims 2-3, 13-16
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). 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). 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
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/ALICIA BLAND/ Primary Examiner, Art Unit 1759