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 .
DETAILED ACTION
This application is a 371 of PCT/EP2022/065143.
The amendment filed on July 21, 2026 has been entered.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1, 5-8, 29, 32, and 34) and the species (A)(1) SEQ ID NO:1 and (B) hydrogel in the reply filed on July 21, 2026 is acknowledged. The traversal is on the ground(s) that claim 1 has been amended to recite a hydrogel comprising a silk polypeptide and urea, which is not disclosed by WO 2006/008163 (“Scheibel”). This is found persuasive. However, Bae (WO 2014/084567 – form PTO-892. English transition of WO 2014/084567. Retrieved on September 24, 2026 – form PTO-892) discloses a hydrogel comprising silk fibroin, a silk polypeptide, and urea, wherein the concentration of the silk polypeptide in the hydrogel ranges from 0.01 to 30% by weight (abstract, page 3 and Preparation Example 1 and 2 a page 6). Therefore, the technical feature linking Groups I and III and the species does not constitute a special technical feature as defined by PCT Rule 13.2, as it does not define a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11, 13, 15, 17-19, 21, and 24-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 July 21, 2026.
Claim Status
Claims 1, 5-8, 11, 13, 15, 17-19, 21, 24-26, 29, 32, and 34 are pending.
Claims 11, 13, 15, 17-19, 21, and 24-26 are withdrawn.
Claims 1, 5-8, 29, 32, and 34 are under examination.
Foreign Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 7, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 29 is objected to because said claims depend from non-elected claim, claim 11. However, in order to expedite prosecution, the subject matter of claim 11has been incorporated into claim 29. Appropriate correction, incorporating the limitations of claim 11 into claim 29 is requested.
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 6 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 6 recites the limitations “(before neutralization)” and “(after neutralization)”. The metes and bounds of the limitations in the context of the above claims are not clear. The usage parentheses renders the claims indefinite because it is unclear whether the limitation(s) enclosed in the parentheses are part of the claimed invention or is a representative condition for the recited hydrogel. See MPEP § 2173.05(d).
Claim 8 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 8 recites the limitations “(SEQ ID NO:1)”, “(SEQ ID NO:2)”, and “(SEQ ID NO:7). The metes and bounds of the limitations in the context of the above claims are not clear. The usage parentheses renders the claims indefinite because it is unclear whether the limitation(s) enclosed in the parentheses are part of the claimed invention or is a representative sequence for the recited silk polypeptides. See MPEP § 2173.05(d).
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.
Claim(s) 1, 29, 32, and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bae (WO 2014/084567 – form PTO-892. English transition of WO 2014/084567. Retrieved on September 24, 2026 – form PTO-892).
Regarding claim 1, Bae discloses a hydrogel comprising silk fibroin, a silk polypeptide, and urea, wherein the concentration of the silk polypeptide in the hydrogel ranges from 0.01 to 30% by weight (abstract, page 3 and Preparation Example 1 and 2 a page 6).
Regarding claims 29 and 34, MPEP 2113 states that “ [P]product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.”. In the instant case, the structure of the claimed hydrogel implied is the same whether the hydrogel is obtained from the method of claim 11 or by the method of Bae as long as the resulting product has the structural limitations recited in the claims (a hydrogel comprising silk fibroin, a silk polypeptide, and urea, wherein the concentration of the silk polypeptide in the hydrogel ranges from 0.01 to 30% by weight).
Regarding claim 29, Bae discloses a method of making a hydrogel comprising a silk polypeptide and urea, wherein the concentration of the silk polypeptide in the hydrogel ranges from 0.01 to 30% by weight (abstract and page 3).
Regarding claims 32 and 34, Bae discloses a hydrogel composition comprising a silk polypeptide and urea, wherein the concentration of the silk polypeptide in the hydrogel ranges from 0.01 to 30% by weight (abstract and page 3).
Therefore, the reference of Bae anticipates claims 1, 29, 32, and 34.
Claim(s) 1, 6, 29, 32, and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (CN 106580842-A – form PTO-892. English transition of CN 106580842-A –. Retrieved on September 24, 2026 – form PTO-892).
Regarding claim 1, Wang discloses a hydrogel comprising silk fibroin, a silk polypeptide, and urea, wherein the concentration of the silk polypeptide in the hydrogel is 20%, which falls within the recited range of 0.5 to 30% by weight (abstract, page 3 and claim 2).
Regarding claim 6, Wang discloses that the hydrogel has a pH of 7.4, which falls within the recited range of 5.5 to 11 (page 5).
Regarding claims 29 and 34, MPEP 2113 states that “ [P]product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.”. In the instant case, the structure of the claimed hydrogel implied is the same whether the hydrogel is obtained from the method of claim 11 or by the method of Wang as long as the resulting product has the structural limitations recited in the claims (a hydrogel comprising silk fibroin, a silk polypeptide, and urea, wherein the concentration of the silk polypeptide in the hydrogel falls within the range of 0.5 to 30% by weight).
Regarding claim 29, Wang discloses a method of making a hydrogel comprising a silk polypeptide and urea, wherein the concentration of the silk polypeptide in the hydrogel falls within the range of 0.5 to 30% by weight (abstract and page 3).
Regarding claims 32 and 34, Wang discloses a hydrogel composition comprising a silk polypeptide and urea, wherein the concentration of the silk polypeptide in the hydrogel falls within the range of 0.5 to 30% by weight (abstract and page 3).
Therefore, the reference of Wang anticipates claims 1, 6, 29, 32, and 34.
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.
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.
Claim(s) 1, 5, and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bae (WO 2014/084567 – form PTO-892. English transition of WO 2014/084567. Retrieved on September 24, 2026 – form PTO-892) and Scheibel (US 8,034,897 – form PTO-892).
Regarding claim 1, Bae discloses a hydrogel comprising silk fibroin, a silk polypeptide, and urea, wherein the concentration of the silk polypeptide in the hydrogel ranges from 0.01 to 30% by weight (abstract, page 3 and Preparation Example 1 and 2 a page 6).
Bae does not disclose a hydrogel comprising a concentration of 8 M to 10 M of urea and a silk polypeptide having at least two identical repetitive subunits comprising of module C having the amino acid sequence of SEQ ID NO:1.
Regarding claim 5, the concentration of urea in the hydrogel of Bae is 10% by weight, which is equivalent to a concentration of 1.71 M (abstract, page 3 and Preparation Example 1 and 2 at page 6).
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It would have been well within the knowledge of one having ordinary skill in the art to vary and optimize the concentrations of urea, such as double the concentration of the urea, by using standard techniques and protocols to denature and dissolve the silk polypeptide. Further, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”, see MPEP 2144.
Regarding claims 7-8, Scheibel discloses a spider silk polypeptide having at least two identical repetitive subunits comprising of module C having the amino acid sequence of SEQ ID NO:5 (Column 7, lines 3-14). The module C of SEQ ID NO:5 of Scheibel has 100% sequence identity to the module C having the amino acid sequence of SEQ ID NO:1 of the instant application (see the sequence alignment below). Scheibel discloses hydrogels comprising silk spider proteins (Column 3, lines 24-42). Scheibel discloses that spider silk polypeptides have high tensile strength and elasticity (Column 1lines 34-56).
Therefore, in combining the above references, it would have been obvious to one having ordinary skill in the art before the time the claimed invention was effectively filed to modify the hydrogel of Bae by (1) replacing the silk polypeptide with the spider silk polypeptide of Scheibel and (2) to optimize the concentration of urea. One having ordinary skill in the art would have been motivated to (1) to use the spider silk polypeptide of Scheibel because spider silk polypeptides have high tensile strength and elasticity and (2) to optimize the concentration of urea in order to fully denature and dissolve the silk polypeptide. One of ordinary skill in the art would have had a reasonable expectation of success since Bae discloses a hydrogel comprising a silk polypeptide and urea and Scheibel discloses a hydrogel comprising a spider silk polypeptide.
Therefore, the above references render claims 1, 5, and 7-8 prima facie obvious.
Conclusion
Claims 1, 5-8, 11, 13, 15, 17-19, 21, 24-26, 29, 32, and 34 are pending.
Claims 11, 13, 15, 17-19, 21, and 24-26 are withdrawn.
Claims 1, 5-8, 29, 32, and 34 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm.
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/YONG D PAK/Primary Examiner, Art Unit 1652
US-13-117-274-5
Filing date in PALM: 2011-05-27
Sequence 5, US/13117274
Patent No. 8034897
GENERAL INFORMATION
APPLICANT: Thomas Scheibel et al.
TITLE OF INVENTION: Recombinant Spider Silk Proteins
FILE REFERENCE: VOSS-P0008-02-US
CURRENT APPLICATION NUMBER: US/13/117,274
CURRENT FILING DATE: 2011-05-27
PRIOR APPLICATION NUMBER: PCT/EP2005/007968
PRIOR FILING DATE: 2005-07-21
PRIOR APPLICATION NUMBER: US 60/590,196
PRIOR FILING DATE: 2004-07-22
NUMBER OF SEQ ID NOS: 55
SEQ ID NO 5
LENGTH: 35
TYPE: PRT
ORGANISM: Artificial sequence
FEATURE:
OTHER INFORMATION: Module C (ADF-4)
Query Match 100.0%; Score 192; Length 35;
Best Local Similarity 100.0%;
Matches 35; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GSSAAAAAAAASGPGGYGPENQGPSGPGGYGPGGP 35
|||||||||||||||||||||||||||||||||||
Db 1 GSSAAAAAAAASGPGGYGPENQGPSGPGGYGPGGP 35
