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 . 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.
Election/Restrictions
Applicant's election with traverse of a hydrogel formed by mixing a DMSO solution of the peptide with PBS and ATP in the reply filed on 4 Feb, 2026 is acknowledged. The traversal is on the ground(s) that the claims have unity of invention. This is not found persuasive because there was only an election of species. Note that MPEP 1893.03(d) limits unity of invention analysis to electing an invention (i.e. restriction), rather than species.
The requirement is still deemed proper and is therefore made FINAL.
Applicant elected a hydrogel formed by a specific product by process step. A search was conducted for this invention, and references rendering it obvious were found. As a result, claims 1 and 4-7 were examined and claims 2, 3, and 8-17 were withdrawn from consideration.
Claims Status
Claims 1-17 are pending.
Claims 1 and 6 have been amended.
Claims 2, 3, and 8-17 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4 Feb, 2026.
Examiner’s Note
Many of the claims have product by process limitations. It is expected that the ionic crosslinking will partition the ions between the hydrogel and the supernatant, with the more highly charged anions partitioning more into the hydrogel and the less highly charged compounds into the supernatant. Non-charged, hydrophilic molecules would be expected to wash out or partition into the supernatant.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim gives a peptide sequence, without the appropriate SEQ ID number. The MPEP states that "37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application” (MPEP 2422.03). Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities: there are numerous places describing the sequence of a polypeptide of the invention, but no SEQ ID number is described with each listing. The MPEP states that "37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application” (MPEP 2422.03).
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 4-7 are rejected under 35 U.S.C. 101 because they read on a judicial exception (natural phenomenon).
The Supreme Court has given a three part test for eligibility under this statue
1) Is the claim drawn to a process, machine, manufacture, or composition of matter?
2a) Does a judicial exception apply?
2b) If a judicial exception applies, is there anything beyond the judicial exception?
Applying the test:
Applicant is claiming a peptide hydrogel, a composition of matter, passing the first part.
2a) Applicant states that the material is made by mixing the peptide PFKLSLHL with buffer (spec, p3, line 19-23). Jia et al (Amino Acids (2018) 50 p229-239) states that this peptide occurs naturally in royal jelly (p230, 1st column, 2nd paragraph). Wu et al (Food. Chem. (2015) 173 p1111-1118) shows that adenosine diphosphate, one of the gelling agents used by applicants, occurs naturally in royal jelly (compare fig 1, p1113, bottom of page with fig 2, p1115, all of the page). By its name, royal jelly is a gel, and comprises all the ingredients that applicant states are required to generate the gel, so this natural product reads on the claims.
2b) The natural product, by itself, reads on the claims, so there can be nothing beyond the judicial exception. Thus, the claims are patent ineligible.
Claim Rejections - 35 USC § 103
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.
first rejection
Claim(s) 1, 4, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Jia et al (Amino Acids (2018) 50 p229-239) in view of Kumar et al (US 20200000875, cited by applicants) and Santos Cabrera et al (Biochemistry (2014) 58 p4857-4868, cited by applicants).
Jia et al discuss Jelleine-1, a broad spectrum antimicrobial peptide with the sequence PFKLSLHL (identical to the sequence of the examined claims) that was isolated from royal jelly (p230, 1st column, 2nd paragraph). It also had excellent antifungal properties (table 1, p232, bottom of page), and almost no hemolytic activity (fig 2, p233, 2nd column, middle of page). The antifungal activity was demonstrated in an in vivo mouse model (p234, 2nd column, 2nd paragraph), and had minimal toxicity (p234, 2nd column, 3d paragraph).
The difference between this reference and the examined claims is that this reference does not discuss a hydrogel formulation.
Kumar et al discuss self assembling antibacterial peptide hydrogels (title). These comprise charges at the terminus, alternating hydrophobic and hydrophilic amino acids, and a signaling domain that can be any sequence (paragraph 10). While the examples used alternating Ser and Leu residues as the alternating block, and lysines at either end as the charged block and the signaling domain (table 1, paragraph 39), this pattern also matches that of Jelleine-1 (N-terminal amine for positive charge, FKLSLH for alternating hydrophobic and hydrophilic residues, and L for the signaling sequence). Jelling of the sequences is useful for topical applications on infected wounds, for hemostasis and wound healing (paragraph 46). Jelling is induced merely by mixing a solution of the peptides in 10x PBS, which forms hydrogels within seconds (paragraph 43). This reference discusses jelling of antimicrobial peptide sequences.
Santos Cabrera et al discuss simulations to understand the mechanism of action of Jelleine-1 (title). This sequence has a tendency to aggregate in small clusters in water (p4865, 1st column, 1st paragraph). This reference shows that the peptide forms aggregates.
Therefore, it would be obvious to use the peptide of Jia et al in the jelling protocol of Kumar et al, to generate a system for topical antimicrobial treatment for rapid hemostasis and wound healing, as described by Kumar et al. As the antimicrobial peptide of Jia et al has the features that Kumar et al states are important for this activity, and Santos Cabrera et al teaches that the sequence aggregates by itself to some extent, an artisan in this field would attempt this process with a reasonable expectation of success.
Jia et al discuss the peptide of the examined claims as a useful, broad spectrum antimicrobial peptide. Kumar et al renders obvious making a gel out of it with phosphates. Thus, the combination of references renders obvious claims 1 and 4.
The temperature and method steps described in claims 6 and 7 have not been demonstrated by applicants to form a different gel than that of Kumar et al (after washing). The MPEP states that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (MPEP 2113). Thus, the combination of references renders these claims obvious.
second rejection
Claim(s) 1 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Jia et al (Amino Acids (2018) 50 p229-239) in view of Kumar et al (US 20200000875, cited by applicants), Santos Cabrera et al (Biochemistry (2014) 58 p4857-4868, cited by applicants), and Cattaneo et al (Blood (2011) 117(7) p2102-2112).
The teachings of Jia et al, Kumar et al, and Santos Cabrera et al were given above, and will not be repeated here. Please note that these references render obvious claims 1, 4, 6, and 7.
The difference between these references and the remaining claim is that these references do not discuss adenosine diphosphate.
Cattaneo discusses the platelet P2Y12 receptor for adenosine diphosphate (title). Adenosine diphosphate agonizes platelet activity, amplifies the platelet response induced by other agonists, and stabilizes platelet aggregates (p2102, 1st column, 1st paragraph). In patients with defects in this receptor, (either chemical or genetic) see an antithrombotic effect (abstract), showing that the aggregation promotes hemostasis. This reference teaches adenosine diphosphate assists with platelet function.
Therefore, it would be obvious to add adenosine diphosphate to the formulation of Kumar et al and Jia et al, to improve the hemostasis effect that Kumar et al states is part of the purpose of the gels. As this is a well known effect of adenosine diphosphate, an artisan in this field would attempt this addition with a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 4-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, and 8-10 of copending Application No. 18/270,395 (US 20250345492) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims render obvious the examined claims.
Competing claim 1 describes a small genus of peptides, with the peptide of the examined claims explicitly excluded. This exclusion means that the competing claims do not anticipate the examined claims, but it does not prevent them from rendering the examined claims obvious. Competing claim 3 requires a hydrogel, while competing claims 4 and 8-10 list the same limitations as examined claims 4-7, rendering them obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658