DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. 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.
Information Disclosure Statement
The information disclosure statement filed 21 Dec, 2023 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. Thus, these references were not considered. It is possible that some of these references were not in the file wrapper of this application or any of the applications in the priority list – because they were not in English, it was not clear which citation some of these references referred to.
Specification
Applicant’s title gives a sequence which is not required for an embodiment to meet a claim limitation, making the title misleading. Appropriate correction is required.
Election/Restrictions
Applicant’s election without traverse of group II (method of stopping bleeding) using SEQ ID 3 in 1-3% aqueous solution for endoscopic demucosation in the reply filed on 30 March, 2026 is acknowledged.
The requirement is deemed proper and is therefore made FINAL.
Applicants elected endoscopic demucosation using SEQ ID 3. A search was conducted for this invention, and references rendering it obvious were found. As a result, claims 30-32 and 34-36 were examined and claims 16-23 were withdrawn from consideration.
Claims Status
Claims 16-23, 30-32, and 34-36 are pending.
Claims 30-32 have been amended.
Claims 34-36 are new.
Claims 16-23 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected election or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 30 March, 2026.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 30-32 and 34-36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yamamoto (US 6,319,260) in view of Ellis-Behnke et al (Nanomed. (2006) 2(4) p207-215, cited by applicants) and Gelain et al (Macromol. Biosci. (2007) 7 p544-551, cited by applicants).
Yamamoto discusses endoscopic mucosal resection (title). Prior systems use saline injected in the submucosal layer to lift the mucosal section, which is trapped by a snare and excised. However, the saline rapidly diffuses, leading to disappearance of the protrusion to be excised (column 1, line 40-54). An alternative adds epinephrine to the saline to prevent or minimize bleeding (column 1, line 55-58), which deals with that common complication (column 1, line 44-47). However, the material is emitted from the opening caused by excising the tissue, which causes the protrusion to disappear (column 1, line 65-column 2, line 3). To overcome this issue, a mucopolysaccharide solution is used, as it diffuses slowly and is too viscous to bleed out of an incision quickly (column 2, line 42-49). It is also used with a hemostatic or angiotonic material (column 2, line 25-26). The amount of the hemostatic or angiotonic material varies depending on what it is (column 3, line 56-60).
The difference between this reference and the examined claims is that this reference does not discuss SEQ IDs 1-3.
Ellis-Behnke et al discuss nano-hemostat solutions (title). Self assembling peptides form a barrier that achieves hemostasis immediately when applied to a wound in a number of different bleeding scenarios, including such difficult situations as femoral arterial bleeding and liver injury (abstract). The self assembling peptides were 1-4% (w/v) in water (4th page, 2nd column, 1st paragraph). All concentrations of one sequence were effective, but higher concentrations worked more rapidly (7th page, 2nd column, 3d paragraph). The proposed mechanism of action is that the material forms a barrier (8th page, 1st column, 4th paragraph). One sequence did not work; it fractured at the interface and in the gel, while gels formed from the other sequences flexed with the tissue (8th page, 2nd column, 1st paragraph). This reference discusses using self-assembling peptides for their hemostatic effects.
Gelain et al discuss self assembling peptides in the context of 3-d tissue culture, tissue repair, and regenerative therapies (abstract). Among the sequences discussed is the same sequence used by Ellis-Behnke et al (p547, 1st column, 4th paragraph) and Ac-KLDLKLDLKLDL-NH2 (p547, 1st column, 5th paragraph), identical with applicant’s elected sequence (SEQ ID 3). This reference discusses the sequence of Ellis-Behnke et al and applicant’s elected sequence for use for similar purposes.
Therefore, it would be obvious to use a self assembling peptide in the formulation of Yamamoto, as Ellis-Behnke et al shows that it works as a hemostatic agent, which Yamamoto states is useful in their invention. As these peptides gel, which is important for the invention of Yamamoto, an artisan in this field would attempt this modification with a reasonable expectation of success.
Furthermore, it would be obvious to substitute the sequences of Ellis-Behnke et al for the sequence of Gelain et al, as a substitution of one known element for another yielding expected results. As there is no evidence of record that the sequence of Gelain et al suffers from the problem of the sequence of Ellis-Behnke et al that failed, an artisan in this field would attempt this substitution with a reasonable expectation of success.
Yamamoto discusses injecting a formulation comprising a hemostatic agent submucosally to elevate an excision site for endoscopic removal. Ellis-Behnke et al and Gelain et al together render obvious using SEQ ID 3 of applicants in the invention as a hemostatic agent. Thus, the combination of references renders obvious claims 30-32.
Ellis-Behnke et al use 1-4% w/v solutions of the peptide, overlapping with the ranges of claims 34-36, rendering them obvious.
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.
first rejection
Claims 30-32 and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 16 and 17 of U.S. Patent No. 11,801,281.
Competing claim 16 describes excising a mucosal tissue section that has been elevated by infusion of a liquid comprising SEQ ID 2. Competing claim 17 describes a method identical with examined claim 32, save that the sequence is limited to SEQ ID 2 (identical to SEQ ID 2 of the examined claims). This claim describes applying a hemostatic agent comprising SEQ ID 2 to an endoscopic demucosation. While examined claims 34-36 describe concentration of peptide, competing claims 1 and 2 describe the formulation and concentration, with the concentration identical to that of the examined claims.
second rejection
Claims 30-32 and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 9, and 12 of copending Application No. 19/337,620 (US 20260083917) in view of Yamamoto (US 6,319,260).
Competing claims 1 and 3 describe a formulation that can comprise SEQ ID 1, identical with SEQ ID 1 of the examined claims. Competing claim 9 describes treating a wound in a mucous membrane to help it heal, comprising administering the formulation of competing claim 3, while competing claim 12 requires endoscopy to apply the material.
The difference between the competing claims and the examined claims is that the competing claims do not discuss endoscopic demucosation, or lifting the site for excision.
Yamamoto discusses endoscopic mucosal resection (title). Prior systems use saline injected in the submucosal layer to lift the mucosal section, which is trapped by a snare and excised. However, the saline rapidly diffuses, leading to disappearance of the protrusion to be excised (column 1, line 40-54). An alternative adds epinephrine to the saline to prevent or minimize bleeding (column 1, line 55-58), which deals with that common complication (column 1, line 44-47). However, the material is emitted from the opening caused by excising the tissue, which causes the protrusion to disappear (column 1, line 65-column 2, line 3). To overcome this issue, a mucopolysaccharide solution is used, as it diffuses slowly and is too viscous to bleed out of an incision quickly (column 2, line 42-49). It is also used with a hemostatic or angiotonic material (column 2, line 25-26). The amount of the hemostatic or angiotonic material varies depending on what it is (column 3, line 56-60).
Therefore, it would be obvious to add the formulation of the competing claims to the formulation of Yamamoto, to help the wound to heal, as described in the competing claims. As both deal with wounds to the mucous surface, an artisan in this field would attempt this modification with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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