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 the application
Receipt of applicant’s remarks and claim amendments filed on 12/05/2025 are acknowledged.
In light of claim amendments, previous 102 rejection is withdrawn.
However, applicants’ arguments for the previous 103 rejection are found not persuasive. Accordingly, the previous rejection is maintained and modified to address claim amendments. Please see the examiners response to applicants arguments below.
Response to Arguments
Applicants’ main argument is that while JP2019 is directed to methods and materials for occluding a pancreatic fistula, Ando is directed to a bone formation promoter. Applicant respectfully submits that a person of ordinary skill in the art at the time of filing would not have considered the disclosure of Ando that negatively or positively charged peptides can be used to promote bone growth to be relevant to the development of "[a] method of treating a digestive organ in a patient in which the digestive organ is at risk of a leak of digestive fluid", as recited in instant claim 8. Similarly, a person of ordinary skill in the art at the time of filing would not have considered the disclosure of Ando to be relevant to the treatment of pancreatic fistulae.
Claims require self-assembling peptides with the recited limitations, which reads the self-assembling peptides of Ando. Moreover, self-assembling peptides can have different utilities. In this case, utilities as shown in both JP2019 and Ando. However, Ando teaches advantages of their self-assembling peptides. Therefore, a skilled person in the art would be motivated to extrapolate or test the properties of self-assembling peptides of Ando in the method of JP2019, and arrive applicants method with a reasonable expectation of success.
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 17-22 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).
For claims 8 and 17-18:
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 between about 7 and 32 amino acids in length, The method wherein the self-assembling peptide solution forms a hydrogel under physiological conditions, thereby stop or closing leak pancreatic juice [see claim 1].
In the above, pancreas is a digestive organ. Since there are no structural characterizations of claimed self-assembling peptide, the recited property is expected in the self-assembling peptides of JP2019.
However, it appears that JP2019 is silent on applicants claimed self-assembling peptide, which is positively charged as a whole at physiological pH.
However, this can be cured by the teachings of Ando, which teaches the following self-assembling peptides:
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[see 0012].
Ando further provided 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].
Ando teach 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]. 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].
Therefore, one would be motivated to replace self-assembling peptides of JP2019 with self-assembling peptides of Ando, 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 peptides of Ando.
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 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.
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
THIS ACTION IS MADE FINAL. 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658