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
In response to the restriction requirement dated 15 December, 2025, Applicant elects, without traverse: Group I, encompassing claims 1-25, drawn to a composition. Non-elected Group II encompassing claim 26 is withdrawn. In response to the election of species, Applicant elects species C10-V2A2E2 for searching purposes. The elected species is encompassed by claims 1-25.
Applicant’s election in the reply filed on 18 December 2025 is acknowledged.
Claims 1-25, are hereby examined on the merits. Claim 26 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Priority
Acknowledgement is made of Applicant’s claim for priority to 63/364,047, filed 05/03/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/17/2023 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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) 1-16 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Stupp et al., hereinafter Stupp (Pub. No.: US2022/0056219 A1, published 02/24/2022).
Stupp teaches peptide amphiphiles comprising a hydrophobic segment, a structural peptide segment, a charged peptide segment and a host moiety [0003, line 3]. The hydrophobic segment comprises an 8-24 carbon alkyl chain (C8-C24), the structural peptide segment comprises V2A2, V3A3, V2A3 or V3A2 and the charged peptide segment comprises E2-4 [0004][0116] (see Fig 1c). Accordingly, the hydrophobic component comprises a single, linear alkyl chain or acyl chain ([0074], line 10). In some embodiments in Stupp, Stupp teaches that the peptide amphiphile further comprises a bioactive moiety wherein the bioactive moiety is typically a peptide [0117]. In some embodiments, the bioactive peptide amphiphile comprises C8-C24 V2A2 E2-4 backbone sequence linked to a bioactive moiety ([0007], last line). Stupp teaches that the selection of the bioactive moiety may depend on the desired use of the composition of peptide amphiphile [0119].
Stupp teaches that the peptide amphiphile molecules and compositions are synthesized using preparatory techniques well-known to those skilled in the art, preferably by standard solid-phase peptide synthesis, with the addition of a fatty acid in place of a standard amino acid at the N-terminus (or C-terminus) of the peptide, in order to create the lipophilic segment [0098].
Claims 1-14 is directed to the species of formula (I) elected by the Applicant, C10-V2A2E2.
Stupp teaches bioactive peptide amphiphile comprises the backbone sequence C8-C24 V2A2 E2-4 (see Stupp [0122][0129][0006][0007][0011]). With respect to the elected species, C10 V2A2 E2 is encompassed by the compound in Stupp [0122][0129][0006][0007][0011] as the disclosure of C8-C24 includes C10. The elected species is 100% identical to the peptide amphiphile taught by Stupp. Therefore, the disclosure of Stupp anticipates the claimed invention.
As noted, Stupp also teaches C16 V2A2 E2. The species search and examination was extended to include this species for the purpose of compact prosecution.
Claims 15 and 16 are directed to the composition of claim 1 wherein the peptide self-assembles to form a hydrogel at pH 5.0 and disassembles at a pH of 7.0.
Regarding claims 15 and 16, Stupp teaches hydrogel compositions of peptide amphiphile [0008]. Stupp teaches compositions of peptide amphiphile comprising a host moiety, peptide amphiphile comprising a guest moiety and one or more diluent peptide amphiphiles. The diluent peptide amphiphile comprises a hydrophobic segment, structural peptide segment, and a charged peptide segment and does not contain a host or guest moiety ([0003] lines 6-16). Stupp teaches that a hydrogel comprises one or more superstructures. In some embodiments , each super structure comprises one or more host peptide amphiphiles and one or more guest peptide amphiphiles . In some embodiments , at least one superstructure further comprises one or more bioactive peptide amphiphiles ([0008] lines 3-7). Stupp teaches that to induce self-assembly of an aqueous solution of peptide amphiphiles, the pH of the solution may be changed (raised or lowered) or multivalent ions, such as calcium, or charged polymers or other macromolecules may be added to the solution [0102].
Stupp recites a peptide amphiphile that is substantially identical to the fusion peptide as instantly claimed. Therefore, the claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). (See MPEP § 2112.01 (I)).
Claim Rejections - 35 USC § 103
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.
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) 17-25 are rejected under 35 U.S.C. 103 as being unpatentable over Stupp et al., hereinafter Stupp (Pub. No.: US2022/0056219 A1, published 02/24/2022) in view of Tadej Battelino et al., hereinafter Tadej (Tadej Battelino et al., Pediatr Diabetes. 2021;22:734–741).
Claims 17-21, 24 and 25 is directed to the hydrogel composition comprising glucagon or glucagon analog wherein the glucagon or glucagon analog is encapsulated within the hydrogel.
Stupp teaches peptide amphiphiles comprising a hydrophobic segment (8-24 carbon alkyl chain C8-C24), a structural peptide segment (V2A2, V3A3, V2A3 or V3A2) and the charged peptide segment E2-4 [0004][0116] (see Fig 1c). Accordingly, the hydrophobic component comprises a single, linear alkyl chain or acyl chain ([0074], line 10). The peptide amphiphile of Stupp is a 100% match to the peptide of formula (I) in the instant application. Stupp teaches that the peptide amphiphile further comprises a bioactive moiety wherein the bioactive moiety is typically a peptide [0117]. Stupp teaches that in some embodiments, the bioactive peptide amphiphile comprises a C8-24V2A2E2-4 backbone sequence linked to the BDNF mimetic peptide [0007]. Stupp teaches that the selection of the bioactive moiety may depend on the desired use of the composition of peptide amphiphile [0119]. Stupp teaches that the bioactive moiety in some embodiments is a growth factor or a growth factor mimetic. The term “mimetic” is an entity that mimics the activity of the bioactive moiety. In some embodiments of Stupp, the mimetic is a peptide sequence that mimics the receptor binding epitope of the bioactive moiety [0118].
Stupp teaches hydrogel compositions of peptide amphiphile [0008]. Stupp teaches that a hydrogel comprises at least one superstructure that further comprises one or more bioactive peptide amphiphiles ([0008] lines 3-7; Fig 2a, 2b, 2j, 2k). As shown in Fig 3F, Stupp teaches the localization of BDNF in the BDNF peptide amphiphile hydrogel.
Stupp does not teach the bioactive peptide is glucagon or a glucagon analog.
Tadej teaches glucagon is a well-established first-line treatment for hypoglycemia (see page 735, 3rd paragraph). An alternate treatment option is dasiglucagon, a next-generation glucagon analog. Like human glucagon, dasiglucagon comprises 29 amino acids (see page 735, 5th paragraph). Tadej teaches that dasiglucagon is rapid, effective, and reliable in restoring plasma glucose levels following insulin-induced hypoglycemia in children and adolescents with Type I Diabetes Melitus. Tadej teaches that the overall safety profile of dasiglucagon is similar to that of reconstituted lyophilized glucagon supporting the use of dasiglucagon to treat severe hypoglycemia in pediatric and adult individuals with diabetes (see Discussion, last paragraph).
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis). Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bioactive peptide amphiphile of Stupp, and introduce glucagon or glucagon analog dasiglucagon, as in the instant application. One motivated to do so would have a reasonable expectation of success as Stupp teaches that the selection of the bioactive moiety may depend on the desired use of the composition of peptide amphiphile [0119] wherein the bioactive moiety is typically a peptide [0117]. Thus, one would have recognized that applying the teaching of Stupp and modifying with glucagon or dasiglucagon as taught by Tadej, would have yielded predictable results and improved the desired function of the composition (See MPEP § 2143 I(A)(D)).
Claims 22 and 23 are directed to the hydrogel wherein the hydrogel is intact at pH 5 and the hydrogel disassembles at pH 7.
As discussed above, Stupp teaches hydrogel compositions of peptide amphiphile [0008]. Stupp teaches that a hydrogel comprises at least one superstructure that further comprises one or more bioactive peptide amphiphiles ([0008] lines 3-7; Fig 2a, 2b, 2j, 2k). Stupp teaches that to induce self-assembly of an aqueous solution of peptide amphiphiles, the pH of the solution may be changed (raised or lowered) or multivalent ions, such as calcium, or charged polymers or other macromolecules may be added to the solution [0102].
Stupp does not teach the bioactive peptide is glucagon or a glucagon analog.
Tadej teaches glucagon is a well-established first-line treatment for hypoglycemia (see page 735, 3rd paragraph). An alternate treatment option is dasiglucagon, a next-generation glucagon analog. Like human glucagon, dasiglucagon comprises 29 amino acids (see page 735, 5th paragraph). Tadej teaches that dasiglucagon is rapid, effective, and reliable in restoring plasma glucose levels following insulin-induced hypoglycemia in children and adolescents with Type I Diabetes Melitus. Tadej teaches that the overall safety profile of dasiglucagon is similar to that of reconstituted lyophilized glucagon supporting the use of dasiglucagon to treat severe hypoglycemia in pediatric and adult individuals with diabetes (see Discussion, last paragraph).
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis). Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bioactive peptide amphiphile of Stupp, and introduce glucagon or glucagon analog dasiglucagon, as in the instant application. One motivated to do so would have a reasonable expectation of success as Stupp teaches that the selection of the bioactive moiety may depend on the desired use of the composition of peptide amphiphile [0119] wherein the bioactive moiety is typically a peptide [0117]. Notably, Stupp teaches that to induce self-assembly of an aqueous solution of peptide amphiphiles, the pH of the solution may be raised or lowered [0102]. Thus, one would have recognized that applying the teaching of Stupp and modifying with glucagon or dasiglucagon as taught by Tadej, would have yielded predictable results and improved the desired function of the composition (See MPEP § 2143 I(A)(D)).
Stupp recites a peptide amphiphile that is substantially identical to the fusion peptide as instantly claimed. In this case, a peptide amphiphile hydrogel of Stupp, that is substantially identical to the instant claim is presumed to disassemble at pH 7 (about), and intact at pH 5 (about). Therefore, the claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). (See MPEP § 2112.01 (I)).
Conclusion
No claim is allowed.
Correspondence
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/ARCHANA VARADARAJ/ Examiner, Art Unit 1658 /LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654