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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/15/2026 has been entered.
Status of the application
Receipt of applicant’s remarks and claim amendments filed on 07/15/2026 are acknowledged.
In light of claim amendments and arguments, previous 103 rejection is withdrawn.
However, to address applicants arguments and claim amendments, a new grounds of rejection is made. The rejection is based on the different interpretation of the previously applied art and newly found prior art, which provides an explanation of the rejection.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8 and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2019508175 A (herein after JP2019) in view of Ando (US 2017/0119825 A1), Suganuma (US 2018/0344861 A1) and Fujimoto (WO 2019142886 A1; see applicants filed IDS dated 08/19/2022).
For claim 8:
JP2019 teaches a method for stopping pancreatic leak or closing pancreatic juice, comprising administering to the leak or pancreatic juice an effective amount of a self-assembling peptide solution, wherein the self-assembling peptide is in between about 7 and 32 amino acids in length, wherein the self-assembling peptide solution forms a hydrogel under physiological conditions, thereby stop or close the leak of pancreatic juice [see claim 1].
In the above, the pancreas is a ‘digestive organ’ and ‘self-assembling peptide’ read applicants claimed ‘self-assembling peptide’.
Differences between JP2019 and instant claim are as follows:
(i) JP2019 is silent on self-assembling peptide having positively charged as a whole at physiological pH and its associated property; and
(ii) JP2019 is silent on self-assembling peptide has a charge from +1 to +4 at the physiological pH.
With regard to (i) of above, the following art and the reasoning cure this deficiency:
Ando teaches the following self-assembling peptides:
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[see 0012].
Ando provides species for the above generic formula in SEQ ID NOs:1-19, wherein these self-assembling peptides are positively charged as a whole [see page 3-4] in pH range of 5.5-7.5 [see 0036 and Table 1].
Ando further teaches sequences, for example, SEQ ID NOs: 1-8 and 14, which are identical to applicants SEQ ID NOs:1, 5-11 and 17.
Suganuma teaches self-assembling peptides and their compositions, wherein self-assembling peptides represented by SEQ ID NOs: 1-4 are identical to applicants self-assembling peptides, represented by SEQ ID NOs:1-4, these have +1, +2 and +4 overall charges on the peptide. Suganuma further teaches applications of peptide compositions, which include cosmetics, such as a skin care article and a hair care article; a cell culture substrate to be used for drug development screening, regenerative medicine, or the like, and drugs and medical instruments, such as a pressure ulcer preparation, a bone filling injection material, an injection material for cosmetic surgery, an auxiliary material for ophthalmic surgery, a synthetic vitreous, an intraocular lens, a joint lubricant, an eye drop, a drug delivery system (DDS) substrate, a carrier for cell delivery, a hemostatic material, and an occlusive agent; a lubricating humectant; a desiccant; a coating agent for a medical instrument or the like; and a material for preventing the outflow of a liquid, a gas, or the like [see 0061-0062].
SEQ ID NO:1 of Suganuma is identical to SEQ ID NO:1 of Ando.
Fujimoto also teaches self-assembling peptides and their composition, wherein self-assembling peptides are represented by SEQ ID NOs: 1-16 [see abstract and page 9], wherein SEQ ID NOs: 1-4, 5-8 and 13-15 are identical to applicants SEQ ID NOs: 1 ,8, 6, 7, 5, 10, 11, 12, 13 and 2. Fujimoto further teaches use of self-assembling peptides, for example, as a cell culture substrate, a hemostatic material, a bone filler, a drug delivery substrate, an artificial vitreous body, an ophthalmologic surgery auxiliary material, cosmetics, smoking articles etc. [see Background of the Invention].
SEQ ID NO: 1-8 of Fujimoto is also identical to SEQ ID NO: 1-8 of Ando.
In the above teachings, some self-assembling peptide sequences are common among Ando, Suganuma and Fujimoto and it appears that self-assembling peptides can have different utilities. Since Ando teaches advantages of self-assembling peptides and, Suganuma and Fujimoto teach that self-assembling peptides can have multiple utilities, and so, a skilled person in the art would be motivated to replace self-assembling peptides in JP2019 with self-assembling peptides of Ando, Suganuma and Fujimoto.
With regard to (ii) of above, Ando teaches self-assembling peptide(s) having a net charge of +2 at neutral pH [see Table 1].
Ando further teaches that the charges of self-assembling peptides in a neutral region are not balanced, whereas static attraction and repulsion suitable for formation of a gel are balanced, resulting in forming a transparent and stable gel in a neutral region [0038]. In addition, the self-assembling peptides are high biological safe and capable of forming beta-sheet structure at neutral pH [see 0010, 0011 and 0018].
Therefore, one would be motivated to replace self-assembling peptides of JP2019 with self-assembling peptides of Ando, Suganuma and Fujimoto because Ando teaches that their self-assembling peptides are biological safe and capable of forming beta-sheet structure at neutral pH and arrive at applicants claimed method with a reasonable expectation of success.
For claim 19:
Since absence of sequence structural characterizations, the sequences of JP2019 are expected show similar physical properties, or at least in the peptides of Ando, since peptides of Ando are identical to applicants sequences.
For claim 20:
Ando teach self-assembling peptide having the following amino acid sequence:
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[see 0012].
For claim 21:
Ando further teaches sequences, for example, SEQ ID NOs: 1-8 and 14, which are identical to applicants SEQ ID NOs:1, 5-11 and 17.
Ando further teaches that their self-assembling peptides are high biological safe and capable of forming beta-sheet structure at neutral pH [see 0010, 0011 and 0018].
In light of advantages of self-assembling peptides of Ando, one would be motivated to replace self-assembling peptides of JP2019 and arrive at applicants method with a reasonable expectation of success.
For claim 22:
JP2019 teaches leak in the pancreas fluid, wherein pancreas is digestive organ.
For claim 23:
See For Claim 8 above.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, self-assembling peptides in treating pancreatic fistula and applicants individual sequences etc, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed method with a reasonable expectation of success.
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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