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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in India on 05/23/2022. It is noted, however, that applicant has not filed a certified copy of the 202221029471 application as required by 37 CFR 1.55.
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 12-14 are 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.
Regarding claim 12, the claim requires a “mole excess ratio” which renders the claim indefinite because it is unclear what the subject of the “excess” is intended to refer to. For the sake of examination, the claim will be interpreted as requiring a mol ratio of 1:30:50 RSF:PEI:carbodiimide.
Regarding claims 13-14, the claims are rendered indefinite because they directly depend on claim 12, which is indefinite as described above.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumar (ACS Applied Polymer Materials 2022, 4, pp. 4699-4708).
Regarding claim 6, Kumar teaches a composition containing 6 wt% RSF, 15.2% PEI, and 76.7% of polymeric surfactant (p. 4702, right column, continued paragraph).
Regarding claim 7, Kumar teaches the prevention of interchain RSF interactions via the formation of a dual coronal shell around the RSF (p. 4700, right column, first full paragraph).
Regarding claims 8-9, Kumar teaches that the RSF liquid behaves like a liquid above 45°C and like a soft solid at 25°C (p. 4705, Conclusions section).
Regarding claim 10, Kumar teaches that the RSF liquid retains its conformations for at least 8 months (p. 4705, Conclusions section).
Regarding claim 11, Kumar teacehs that the RSF liquid undergoes a structural transition from silk I to silk II upon treatment with glutaraldehyde at 50°C (p. 4705, Conclusions section).
Allowable Subject Matter
Claims 12-14 are rejected as indefinite under 35 USC 112(b) as described above, but contain subject matter which would be allowable pending the resolution thereof.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is designated as the teachings of Niu (Polymers 2021, 13, pp. 1-15) in view of Perriman (US 2021/0060174 A1), cited in the rejections of claims 1-5, above.
Regarding claim 6, Niu as modified by Perriman teaches the claimed combination of RSF, PEI, and polymeric surfactant, as described above. However, neither of the prior art documents contemplate a viscoelastic liquid with the specifically claimed composition of 6 wt% RSF, 15 wt% of PEI, and 77 wt% of a PEG-based polymeric surfactant. Niu teaches only up to 10% of PEI based on the weight of silk fibroin (c.f. p. 6, Figure 2(B) and first paragraph, near top-of-page). Furthermore, Niu indicates that, above 6% of PEI based on the weight of silk fibroin, the zeta potential of the cationized polymer remains constant, implying that further addition of PEI would be unnecessary (p. 6, first paragraph, near top-of-page). Perriman fails to cure this deficiency within Niu; while Perriman teaches the chemical cationization of proteins ([0207]), optionally with polyethylenimine ([0040]), the experimental process only involves a particular ratio of cationizing compound with respect to the number of anionic sites within the polymer (c.f. p. 19, Table 10), instead of a particular mass percentage range. It therefore would not have been obvious to one of ordinary skill in the art to have combined RSF, PEI, and polymeric surfactant in the claimed compositional amounts.
Regarding claims 12-14, Niu teaches the cationization of silk fibroin using PEI at a pH ranging from 5.0 to 6.0 (p. 3, section 2.2 Preparation of Cationized Silk Fibroin Solution) and teaches the storage/incubation of the resulting solution at 4°C. Furthermore, polyethyleneimine inherently contains primary, secondary, and tertiary amines. However, Niu fails to disclose the specific mol ratio requirements as claimed. By contrast, Niu discloses the amount of PEI included per mass of the silk fibroin (p. 3, section 2.2 Preparation of Cationized Silk Fibroin Solution). Niu additionally teaches the molecular weight of the PEI (1,800 kDa, Abstract), but fails to disclose the molecular weight of the silk fibroin. As a result, the mol ratio of these two components cannot be determined, and therefore the teachings of Niu fail to disclose the claimed compositional limitation. Perriman fails to cure this deficiency; it likewise only teaches the mol ratio of protein and cationizing compound (p. 19, Table 10 and p. 9, [0086]).
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks, filed January 20, 2026, with respect to objections to claims 1 and 3-11, 112(b) rejections of claims 1-5 and 13, and 35 USC 103 rejections of claims 1-5 have been fully considered and are persuasive. Said objections and rejections have been withdrawn.
Applicant's remaining arguments have been fully considered but they are not persuasive.
Applicant states that claim 12 has been amended to depend on claim 6 in an effort to overcome the 112(b) rejection thereof, however this amendment does not resolve the indefiniteness issue of record. Therefore, the 112(b) rejection of claim 12 has been maintained.
Regarding 35 USC 102(a)(1), applicant asserts that the previously applied reference, Kumar, does not qualify as prior art under 35 USC 102(B)(1)(A). However, a document may only be excepted as prior art under 35 USC 102(b)(1)(A) if (1) the disclosure is made one year or less before the effective filing date of the claimed invention; and (2) the disclosure is made by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor (i.e., an inventor-originated disclosure). See MPEP 2153.01(a).
However, if the application names fewer joint inventors than a publication (e.g., the application names as joint inventors A and B, and the publication names as authors A, B and C), it would not be readily apparent from the publication that it is an inventor-originated disclosure and the publication would be treated as prior art under AIA 35 U.S.C. 102(a)(1) unless there is evidence of record that an exception under AIA 35 U.S.C. 102(b)(1) applies. See MPEP 2153.01(a). In this case, the application names Sharma and Kumar as inventors (i.e., the application includes Inventors A and B), while the prior art document names Joseph, Chaudhari, and Nisal in addition to Sharma and Kumar (i.e., the prior art document includes Inventors A, B, C, D, and E). It is therefore not readily apparent from the publication that it is an inventor-originated disclosure. Furthermore, there is no additional evidence of record that pertaining to inventor-origination, and therefore the 102(b)(1) exception does not apply.
Conclusion
THIS ACTION IS MADE FINAL. 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 JOSHUA CALEB BLEDSOE whose telephone number is (703)756-5376. The examiner can normally be reached Monday-Friday 8:00 a.m. - 5:00 p.m. EST.
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/JOSHUA CALEB BLEDSOE/Examiner, Art Unit 1762
/ROBERT S JONES JR/Supervisory Patent Examiner, Art Unit 1762
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