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 .
Status of Claims
The amendments and arguments filed on 04/10/2026 are acknowledged and have been fully
considered. Claim 19 is cancelled. Claims 1, 17, 18, and 25 are currently amended. Claims 1-18, 20-25 and 36 are now pending and will be examined on the merits herein.
Objections/Rejections Withdrawn
Objections and/or rejections not reiterated from previous Office Action are hereby withdrawn.
The following rejections and/or objections are either reiterated or newly applied, and constitute the
complete set presently being applied to the instant application.
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) 1-18, 20-25 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).
Regarding claims 1-14, 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). 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]. Specifically, Stupp teaches 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. As noted, Stupp also teaches C16 V2A2 E2. The species search and examination is extended to include this species for the purpose of compact prosecution.
Stupp does not teach -comprising 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 specifically teaches that the selection of the bioactive moiety depends on the desired use of peptide amphiphile [0119] wherein the bioactive moiety is a peptide [0117]. Thus, one would have recognized that applying the teaching of Stupp and modifying with glucagon or dasiglucagon (i.e. glucagon analog) as taught by Tadej, would have yielded predictable results and improved the desired function of the composition (See MPEP § 2143 I(A)(D)).
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)).
Stupp does not teach -comprising glucagon or glucagon analog.
The teachings in Tadej and the obviousness rationale have been set forth above.
Claims 17, 18, 20, 21, 24 and 25 are 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 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.
Regarding the limitation in claim 17, ‘encapsulated withing the hydrogel’, Stupp specifically teaches that the hydrogel may comprise a BDNF mimetic peptide as the bioactive moiety , which may facilitate infiltration of neuronal cells within the hydrogel (i.e. encapsulated).
Regarding the limitation in claim 18, ‘wherein R1…isopropyl’, Stupp teaches “ amino acid analog ” refers to a natural or unnatural amino acid where one or more of the C – terminal carboxy group , the N - terminal amino group and side – chain bioactive group has been chemically blocked , reversibly or irreversibly , or otherwise modified to another bioactive group . For example , aspartic acid- ( beta - methyl ester ) is an amino acid analog of aspartic acid [0055].
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.
The teachings in Stupp have been set forth above.
As discussed, 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)).
Claim(s) 1-18, 20-25, 36 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) further in view of Li Zhao et al., hereinafter Zhao (Li Zhao et al., Glucose Oxidase-Based Glucose-Sensitive Drug Delivery for Diabetes Treatment, Polymers 2017, 9, 255).
Regarding claim 36, the teachings in Stupp and Tadej have been set forth above.
The combined teachings in Stupp and Tadej teach hydrogel comprising glucagon or glucagon analog.
Stupp and Tadej do not teach glucose oxidate (GOx).
Zhao teaches glucose oxidase-incorporated hydrogels (see section 3.1, page 7). Specifically, Zhao teaches that pH-sensitive hydrogels and microgels with chemically or physically cross-linked structures have potential applications in glucose-sensitive drug delivery based on Gox (see page 11, 2nd paragraph).
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 and GOx, as in the instant application. One motivated to do so would have a reasonable expectation of success as Stupp teaches that the bioactive moiety is typically a peptide [0117] (i.e. glucagon or glucagon analog). 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]. Zhao specifically teaches that pH-sensitive hydrogels have potential applications in glucose-sensitive drug delivery based on Gox (see page 11, 2nd paragraph). Therefore, combining the teaching in Zhao, directed to glucose sensitive drug delivery and incorporation of Gox, one would have recognized that applying the teaching of Stupp and Tadej and Zhao, would have yielded predictable results and improved the specific function of the composition (See MPEP § 2143 I(A)(D)).
Response to Arguments
Applicant's arguments filed 04/10/2026 have been fully considered but they are not persuasive.
Applicant argues that the combination of Stupp and Tadej do not teach each and every element of independent claims 1 and 17. However, the rejection of record was that it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Stupp, specifically disclosing a bioactive peptide, and to incorporate glucagon or glucagon analog as the bioactive peptide, drawings from the teachings in Tadej. Specifically, that it would be 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, 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].
Applicant argues that in the independent claims 1 and 17, glucagon or glucagon analog are separate from the formula (I) and is not covalently attached to the peptide of formula (I). The Examiner would like to remind the Applicant, that the claims do not recite glucagon or glucagon analog as being separate or not covalently attached. As noted in MPEP §2111.01 (II) “Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment." Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004). Next, the transitional phrase ‘comprising’ in claims 1 and 17, is inclusive or open-ended and does not exclude additional, unrecited elements (Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) ("Comprising" is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim. See MPEP§ 2111.03 (I)).
Applicant argues that a person of ordinary skill in the art would not have modified Stupp in view of Tadej, because references are directed to different fields of endeavor. It has been held that a prior art reference must either be in the field of the inventor' s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the Examiner would like to reiterate that Stupp teaches peptide amphiphiles for a wide range of biomedical applications such as drug release ([0093], line 12). Stupp teaches that suitable bioactive moieties can be selected from peptides or mimetics ([0118], line 2). The bioactive moiety in Stupp, comprises the claimed peptide amphiphile. Tadej teaches glucagon, which is a peptide with therapeutic benefit. The combined prior art, teach the composition comprising glucagon or glucagon analog, in the context of the inventive concept of the instant application i.e. drug release.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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