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
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/US2020/033869 filed 05/20/2020, which claims the benefit of the priority of US Provisional application 62/850,513 filed 05/20/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 28-30, 32-35, 77-80, 83-84, 86-89 are pending. Claims 30 is amended. Claims 1-27, 31, 36-76, 81-82, 85 are canceled.
Claims 28-30, 32-35, 78-80, 83-84, and 86-89 are being examined on the merits in this office action.
Drawings - Withdrawn
The objection to the drawings is withdrawn in view of the amended drawings.
Claim Rejections - 35 USC § 112 - Withdrawn
The rejection of claim 30 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn in view of the amended claim.
Claim Objections
Claims 32 and 80 are objected to because of the following informalities:
Claim 32 recites “sequences presented in Table 3. Since Table 3 comprises three sequences, these sequences should be recited in the claims and the “Table 3” should be deleted. Examiner suggests amending claim 32 to recite “The hydrogel of claim 28, wherein the amino acid sequence of the self-aggregating peptides comprises any one selected from SEQ ID NOs: 11-13”.
Claim 80 contains an improper line break on line 2-3. The claim should be amended accordingly.
Appropriate correction is required.
Claim Rejections - 35 USC § 102 - Maintained
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.
Claims 28-30, 78-80, 83-84, 86-89 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horii et al. (US 2009/0162437A1 – hereinafter “Horii”, cited and enclosed in the previous office action).
Regarding claim 28, Horii teaches a hydrogel that comprises a modified self-assembling peptide ([0015]; claims 41-43), that the peptide comprises beta sheets (claim 27, 32, 36, 37; [0010, 0193, 0196, 0228, 0243-0244]), that the peptide is derived from laminin [0132, 0247, 0253, 0256, 0261-0265]. Examiner notes that the instant claims (claim 29) recite that the non-amyloid protein is laminin. Thus the teachings of Horii anticipate the instant claims.
Regarding clam 29, Horii teaches that the peptide is derived from laminin [0132, 0247, 0253, 0256, 0261-0265].
Regarding claim 30, Horii teaches a hydrogel that comprises a modified self-assembling peptide ([0015]; claims 41-43, that the peptide comprises beta sheets (claim 27, 32, 36, 37; [0010, 0193, 0196, 0228, 0243-0244]).
Regarding claim 78, Horii teaches the peptides may be chemically synthesized or purified from natural or recombinant sources, and the amino- and carboxy-termini of the peptides may be protected [0208], using F-moc chemistry [0209, 0398, 0399].
Regarding claim 79, Horii teaches that the peptides are incubated in a solution of NaCl and the peptides are referred to herein as peptide hydrogels or peptide hydrogel matrices [0208, 0320].
Regarding claim 80, Horii teaches a hydrogel that comprises a modified self-assembling peptide ([0015]; wherein the protein is a growth factor (claim 47, 49, 50; [0244-0245, 0272-0273]).
Regarding claim 83, Horii teaches a hydrogel that comprises a modified self-assembling peptide ([0015]; claims 42-48), and that the hydrogel comprises an additional peptide (claims 51-52), or comprises one or more self-assembling peptides [0238]. This reads on a plurality of peptides.
Regarding claim 84, Horii teaches the invention comprises peptide mixtures or comprises a mix one or more unmodified self-assembling peptides together with one or more modified self-assembling peptides of the present invention [0238, 0242, 0410].
Regarding claim 86, Horii teaches a pH of about 6-8 [0347-0349].
Regarding claim 87-88, Horii teaches invention comprises electrolytes such as NaOH, KCl, NaCl, saline (NaCl-aqueous), phosphate buffered saline (PBS-aqueous) [0124, 0126]. Thus a composition that comprises other electrolytes other than NaCl, would read on claim 88.
Regarding claim 89, Horii teaches sizes including 10 μm in size [0127, 0129, 0131, 0133].
Claim Rejections - 35 USC § 103 – Maintained
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 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 32-35 remain rejected under 35 U.S.C. 103 as being unpatentable over Horii et al. (US 2009/0162437A1 – hereinafter “Horii”, cited and enclosed in the previous office action) as applied to claim 28 above, and further in view of Carr et al. (WO2017184590-A1 – hereinafter “Carr”, cited and enclosed in the previous office action).
The teachings of Horii are disclosed above and incorporated herein by reference.
Horii does not teach the sequence recited in claims 32-35.
Carr teaches sequences that include the sequence LLFYL (See Page 205, 2nd row), sequence LLVYL (See Page 255, 3rd row). The sequence read on the sequence of claims 32-35.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the sequence of Carr in the hydrogel of Horri since Carr teaches using them in hydrogels [00297]. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using the peptides of Carr in the hydrogels of Horii since Carr teaches that such peptides for use in hydrogels [00297]. The disclosures render obvious claims 32-35.
Response to Arguments
Applicant's arguments filed 08/05/2025 have been fully considered but they are not persuasive.
Applicant Arguments
Applicant argues that the beta-sheet-forming sequences derived from nonamyloid proteins self-assemble independently, forming nano-scale fibers. In contrast, Horii discloses a design principle in which peptides are formed by covalently linking a self-assembling domain e.g., alternating hydrophobic/hydrophilic residues) with a non-self-assembling functional domain.
Examiner’s Response
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that Horii teaches a hydrogel that comprises a modified self-assembling peptide ([0015]; claims 41-43), that the peptide comprises beta sheets (claim 27, 32, 36, 37; [0010, 0193, 0196, 0228, 0243-0244]), that the peptide is derived from laminin [0132, 0247, 0253, 0256, 0261-0265]. Examiner notes that the instant claims (claim 29) recite that the non-amyloid protein is laminin. Examiner notes that Horii teaches all the limitations of the claimed invention. Further, applicant argument that the beta-sheet-forming sequences derived from nonamyloid proteins self-assemble independently, forming nano-scale fibers is unpersuasive since Horii similarly teaches that the peptide self-assembles to form nanofibers [0010]. Examiner notes that Applicant argument that the peptides of Horii are formed by covalently linking a self-assembling domain is unpersuasive since Horii teaches a hydrogel generated from self-assembling peptides which are derived from laminin which is a non-amyloid protein. Horii teaches all the limitations of the instant invention. The arguments are unpersuasive and the rejection is maintained.
Conclusion
No claims are allowed.
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 Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LI N KOMATSU/Primary Examiner, Art Unit 1658