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 .
Summary
Claims 48-67 are pending in this office action. Claims 1-47 are cancelled. All pending claims are under examination in this application.
Priority
The current application was filed on September 19, 2023 is a 371 of PCT/IL2022/050309 filed on March 20, 2022. The 371 claims domestic priority to provisional patent application 63/163,887 filed on March 21, 2021.
Information Disclosure Statement
Receipt of the Information Disclosure Statement on January 4, 2026 is acknowledged. A signed copy of the document is attached to this office action.
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.
Claims 48-56 and 61-66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rapaport (WO2009/072119A2).
Rapaport is considered the closest prior art as it teaches amphiphilic peptide matrices for treatment of osteoporosis (see title). Furthermore, Rapaport discloses that the present invention provides methods for prevention, prevention of progression, and treatment of osteoporosis and pre-osteoporotic conditions comprising direct administering to osteoporetic bone of a composition comprising amphiphilic peptides and peptide matrices thereof, useful in promoting biomineralization, local osteoporetic medications and inducing bone repair (see abstract).
Regarding instant claim 48, Rapaport teaches a dermatological composition. The necessary citations of Rapaport that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 48
Rapaport Citations
A dermatological composition comprising at least one amphiphilic peptide comprising,
Rapaport discloses methods for prevention, prevention of progression, and treatment of osteoporosis and pre-osteoporotic conditions comprising direct administering to osteoporetic bone of a composition comprising amphiphilic peptides and peptide matrices thereof, useful in promoting biomineralization, local osteoporetic medications and inducing bone repair (see abstract).
alternating hydrophobic/hydrophilic amino acid residues, or a derivative or a salt thereof wherein the peptide comprises 1-20 pairs of hydrophobic-hydrophilic alternating amino acid residues wherein the hydrophilic amino acid residue is selected from the group consisting of Glu, Asp, Tyr, Ser, Thr, Ser(PO4). Thr(PO4). and Tyr(PO4), and the hydrophobic amino acid residue is selected from the group consisting of Phe, Leu, lie, Val, Trp, and Ala, and wherein said peptide has no more than 10% positively charged amino acid residues, and
Rapaport provides a method for the treatment,
prevention or prevention of progression of osteoporosis and pre-osteoporotic condition said method comprising administering to a subject in need of such treatment a therapeutically effective amount of a pharmaceutical composition comprising at least one amphiphilic peptide comprising at least 2 dyads of alternating hydrophobic/hydrophilic amino acid residues, or a derivative or a salt thereof, capable of forming a b-sheet structure and promoting biomineralization, wherein the peptide comprises:
i. 2-20 pairs of hydrophobic-hydrophilic alternating amino acid residues wherein
the hydrophilic amino acid residue is selected from the group consisting of: a
negatively charged amino acid, a hydroxyl-containing amino acid, and a phosphorylated-hydroxyl-containing amino acid; and
ii. no more than 10% positively charged amino acid residues.
(see pages 8-9, page 8 lines 30-34, page 9 lines 1-8)
Rapaport discloses the hydrophobic amino
acid is selected from the group consisting of Phenylalanine (Phe), Leucine (Leu), Isoleucine
(Ile), Valine (Val) and Alanine (Ala). According to certain embodiments the hydrophobic
20 amino acid is Phe or Leu. According to some embodiments the hydrophilic amino acid is selected from the group consisting of: Glutamic acid (Glu), Aspartic acid (Asp), Tyrosine (Tyr), Serine (Ser), Threonine (Tor), Phosphoserine (Ser(PO4)), Phosphotyrosine (Thr(PO4)), and Phosphotyrosine (Tyr(PO4)) (see page 9, lines 17-23).
a dermatologically acceptable carrier, wherein the dermatological composition is a soft tissue filler composition.
Rapaport discloses the term "physiologically acceptable carrier" or "diluent" or "excipient" refers to an aqueous or non-aqueous fluid that is well suited for pharmaceutical preparations.
Furthermore, the term "a pharmaceutically acceptable carrier or excipient" refers to at least
one carrier or excipient and includes mixtures of carriers and or excipients (see page 25, lines 24-27). Additionally, Rapaport discloses that the peptide composition is injected with a canulla and soft tissue is closed after disinfection (see Example 11C).
Regarding instant claim 49, Rapaport teaches wherein the at least one amphiphilic peptide has 2 to 40 amino acids, or wherein the at least one amphiphilic peptide further comprises at least one terminal Pro residue. Please see the citations and discussion within instant claim 48. Rapaport discloses the following polypeptide which meets the claim limitations of instant claim 49 (see page 11, line 14):
Glu-(Phe-Glu)5-Pro
Regarding instant claim 50, Rapaport teaches wherein the at least one amphiphilic peptide comprises an amino acid sequence according to Formula I:
X-(hydrophobic-hydrophilic)n-B (Formula I) or a salt thereof,
wherein n designates an integer of 1 to 20, hydrophobic designates a hydrophobic amino acid residue selected from the group consisting of Phe, Leu, lie, Val, Trp, and Ala, hydrophilic designates a hydrophilic amino acid residue selected from the group consisting of Glu, Asp, Tyr, Ser, Thr, Ser(PO4). Thr(PO4), and Tyr(PO4), X designates Pro, Pro-hydrophilic or the peptide's amino terminus, and B designates Pro or the peptide's carboxy terminus; or wherein the at least one amphiphilic peptide comprises an amino acid sequence of any of the following formulae X-(Phe-Glu)n-B, X-(Phe-Asp)n-B, X-(Leu-Glu)n-B, and X-(Leu- Asp)n-B, or a salt thereof; or wherein the at least one amphiphilic peptide comprises at least one modification selected from a modification of the amino terminus X and a modification of the carboxy terminus B. Please see the citations and discussion within instant claim 48. Rapaport discloses the following polypeptide which meets the claim limitations of instant claim 50 (see page 12, line 21):
Pro-(Phe-Asp)3-Pro
Regarding instant claim 51, Rapaport teaches wherein the modification comprises acetylation of the amino terminus, amidation of the carboxy terminus, or a combination thereof. Rapaport discloses the following polypeptide which meets the claim limitations of instant claim 51 (see page 12, line 6):
Ac-Pro-Asp-(Phe-Asp)5-Pro-NH2
Regarding instant claim 52, Rapaport teaches wherein the at least one amphiphilic peptide comprises a sequence selected from the group consisting of the correct designated polypeptide. Rapaport discloses the following polypeptide which meets the claim limitations of instant claim 52 (see page 11, line 14):
Glu-(Phe-Glu)5-Pro
Regarding instant claim 53, Rapaport teaches wherein the at least one amphiphilic peptide comprises a sequence as set forth in SEQ ID NO: 1, or a salt thereof. Rapaport discloses the following generic polypeptide which meets the claim limitations of instant claim 53 (see page 10, line 24):
Pro-(Asp-Phe)n-Asp-Pro wherein n is an integer of 3-9 (n=5)
Regarding instant claims 54 and 55, Rapaport teaches formulated for intradermal or subcutaneous administration or formulated for use in 3D bioprinting of an artificial tissue. Rapaport discloses the formulation of a single subcutaneous administration of a hydrogel (see Example 11D).
Regarding instant claim 56, Rapaport teaches the dermatological composition further comprising at least one of hyaluronic acid, collagen, gelatin, elastin, laminin, and fibronectin. Rapaport discloses the use of hyaluronic acid (see claim 27).
Regarding instant claim 61, Rapaport teaches a pre-filled syringe comprising the dermatological composition of claim 48. Rapaport discloses that the compositions are injected using a syringe.
Regarding instant claim 62, Rapaport teaches a dermatological composition comprising at least one amphiphilic peptide comprising alternating hydrophobic/hydrophilic amino acid residues, or a derivative or a salt thereof, wherein the peptide comprises 1-20 pairs of hydrophobic-hydrophilic alternating amino acid residues wherein the hydrophilic amino acid residue is selected from the group consisting of Glu, Asp, Tyr, Ser, Thr, Ser(PO4), Thr(PO4), and Tyr(PO4), and the hydrophobic amino acid residue is selected from the group consisting of Phe, Leu, lle, Val, Trp, and Ala, and wherein said peptide has no more than 10% positively charged amino acid residues, and a dermatologically acceptable carrier, wherein the dermatological composition is a cosmetic composition. Please see the citations and discussion within instant claim 48 for the necessary rejection text.
Regarding instant claim 63, Rapaport teaches the dermatological composition of claim 62, wherein the at least one amphiphilic peptide has 2 to 40 amino acids; or wherein the at least one amphiphilic peptide comprises at least one terminal Pro residue; or wherein the at least one amphiphilic peptide comprises an amino acid sequence according to Formula I: X-(hydrophobic-hydrophilic)n-B (Formula I) or a salt thereof, wherein n designates an integer of 1 to 20, hydrophobic designates a hydrophobic amino acid residue, hydrophilic designates a hydrophilic amino acid residue, X designates Pro, Pro-hydrophilic or the peptide's amino terminus, and B designates Pro or the peptide's carboxy terminus; or wherein the at least one amphiphilic peptide comprises an amino acid sequence of any of the following formulae X-(Phe-Glu)n-B, X-(Phe-Asp)n-B, X-(Leu-Glu)n-B, and X-(Leu- Asp)n-B, or a salt thereof; or wherein the at least one amphiphilic peptide comprises at least one modification selected from a modification of the amino terminus X and a modification of the carboxy terminus B. Please see the citations and discussion within instant claims 49-50 for the necessary rejection text.
Regarding instant claim 64, Rapaport teaches the dermatological composition of claim 62, wherein the at least one amphiphilic peptide comprises a sequence selected from the group consisting of the appropriate polypeptide. Please see the citations and discussion within instant claim 52 for the necessary rejection text.
Regarding instant claim 65, Rapaport teaches wherein the at least one amphiphilic peptide comprises a sequence as set forth in SEQ ID NO: 1, or a salt thereof. Please see the citations and discussion within instant claim 53 for the necessary rejection text.
Regarding instant claim 66, Rapaport teaches the formulated for topical administration in the form of a hydrogel. Please see the citations and discussion within instant claim 55 for the necessary rejection text.
Allowable Subject Matter
Claims 57-60 and 67 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The 35 U.S.C. §103 rejection has been withdrawn from the record due the arguments submitted on December 24, 2025 and the Rule 132 Declaration of Dr. Hanna Rapaport (co-inventor). The arguments supported the unobvious nature of the instant claims as it pertains to the dermatological application of the invention, and the Declaration disclosed new data that showed the present invention is superior to the prior art of record.
Response to Arguments
Applicant's arguments filed December 24, 2025 have been fully considered but they are not persuasive.
The Applicant’s claim amendments were sufficient to address the claim objections. Therefore, the claim objections from the Non-Final Rejection dated October 3, 2025 are withdrawn from the record.
The Applicant’s claim amendments did not necessitate a new ground of rejection.
Applicant Argument: The Applicant argues that the Rapaport reference does not qualify as 35 U.S.C. §102 art because it fails to teach or even suggest the use of its composition as a soft tissue filler or a cosmetic composition.
Examiner’s Rebuttal: The Examiner respectfully disagrees. The Examiner does submit that the Rapaport reference is in the field of osteoporosis. However, Rapaport discloses the identical composition. Therefore, the identified claims are anticipated. "Arguments that the alleged anticipatory prior art is ‘nonanalogous art’ or ‘teaches away from the invention’ or is not recognized as solving the problem solved by the claimed invention, [are] not ‘germane’ to a rejection under section 102." Twin Disc, Inc. v. United States, 231 USPQ 417, 424 (Cl. Ct. 1986) (quoting In re Self, 671 F.2d 1344, 213 USPQ 1, 7 (CCPA 1982)). See also State Contracting & Eng’ g Corp. v. Condotte America, Inc., 346 F.3d 1057, 1068, 68 USPQ2d 1481, 1488 (Fed. Cir. 2003) (The question of whether a reference is analogous art is not relevant to whether that reference anticipates. A reference may be directed to an entirely different problem than the one addressed by the inventor, or may be from an entirely different field of endeavor than that of the claimed invention, yet the reference is still anticipatory if it explicitly or inherently discloses every limitation recited in the claims).
A reference is no less anticipatory if, after disclosing the invention, the reference then disparages it. The question whether a reference "teaches away" from the invention is inapplicable to an anticipation analysis. Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The prior art was held to anticipate the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed."). See Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(claimed composition that expressly excluded an ingredient held anticipated by reference composition that optionally included that same ingredient); see also Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Claimed composition was anticipated by prior art reference that inherently met claim limitation of "sufficient aeration" even though reference taught away from air entrapment or purposeful aeration.) [see M.P.E.P. §2131.05].
Applicant Argument: The Applicant argues that the 35 U.S.C. §103 rejection fails to present a prima facie case for obviousness.
Examiner’s Rebuttal: Both the arguments and the Rule 132 Declaration of Dr. Hanna Rapaport (co-inventor) submitted on December 24, 2025 were sufficient to withdraw the 35 U.S.C. §103 rejection from the record (see Allowable Subject Matter).
Therefore, the 35 U.S.C. §102(a)(1) rejection is maintained for instant claims 48-56 and 61-66.
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 JOHN W LIPPERT III whose telephone number is (571)270-0862. The examiner can normally be reached Monday - Thursday 9:00 AM - 5:00 PM.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615