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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/04/2025 has been entered.
Status of the application
Receipt of applicant’s remarks and claim amendments filed on 12/04/2025 are acknowledged.
In light of claim amendments and arguments, the previous 102 rejection is withdrawn.
However, applicants’ arguments for the previous 103 rejections are found not persuasive. Accordingly, the previous rejection is maintained and modified to address claim amendments. Please see the examiners response to applicants below.
Response to Arguments
Applicants main argument is that the anticue task as required by amended claim 1 is a specialized cognitive assessment tool that specifically measures inhibitory control and control of impulsivity. Jonker's burrowing test does not disclose or suggest this specific measurement methodology. While Jonker concludes that "NWT-03 has a positive effect on cognition and may be used for the treatment of neurodegenerative diseases," Jonker, paragraph [0097], this general statement about cognition based on burrowing behavior does not disclose or teach improving inhibitory control and improving control of impulsivity as measured by an anticue task as now recited by amended claim 1.
As explained in the modified rejection below, the cited new limitation in the claim 1, which is anticue task, is known in the art to measure a specific desired parameter(s) in a subject, see newly cited prior art in the rejection below. Previously cited art teaches same drug, i.e., NWT-03 (aka subtilisin A hydrolysate lysozyme), to a subject to improve cognitive function, as explained above. So, if anticue task is applied to the teachings of Jonker, the results should match to applicants shown data, since same drug is applied to the subject to improve cognitive functioning.
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 1, 4-5, 12-14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Jonker (WO 2017/144443 A1) in view of Adam (Acta Psychologica, 2015, 161, 137-144).
For claim 1:
Jonker teacehs a functional test on male mice by administering NWT-03 (aka subtilisin A hydrolysate lysozyme) by using burrowing test [see Examples 8 and 9], wherein the test comprising the following:
The mice were habituated to the procedure a week prior to the test by placement of the burrow tube into the home cage. After two baseline measurements the burrow test was performed. The mouse was placed in a cage with the burrow tube containing 200 g of food pellets. The difference between the burrowing behavior at the start (t = 9 weeks) and the end (t = 21 weeks) of the treatment was determined.
It was found that the mice fed with a high fat diet (group 1) and those fed with a high fat diet in combination with NWT-02 burrowed substantially the same amount of material (-2.1 gram and -2.5 gram respectively) at the beginning and the end of the test (figure 1). Mice fed with a high fat diet containing NWT-03 burrowed 12.7 gram on average, whereas the mice fed with a high fat diet comprising both NWT-02 and NWT-03 burrowed 25.2 grams on average.
It is concluded that NWT-03 has a positive effect on cognition and may be used for the treatment of neurodegenerative diseases. This effect is synergistically enhanced by the addition of NWT-02.
In the above NWT-03 is subtilisin A hydrolysate lysozyme [see preparative method in Example 3, wherein Alcalase is also known as subtilisin A]. The high burrowing behavior is nothing but improving cognitive function, specifically improving control of impulsivity and improve inhibitory control etc.
The above disclosure of Jonker is interpreted applicants “method of improving cognitive function in a subject by administering subtilisin A hydrolysate lysozyme”, since results showed improving in the burrowing behavior.
The difference is that Jonker is silent on anticue task in their disclosure.
First, anticue task is a cognitive test or task to measure a specific desired parameter in a subject, and which is known in the art, see below. Second, previously cited prior art teaches same drug, i.e., NWT-03 (aka subtilisin A hydrolysate lysozyme), to a subject to improve cognitive function, as explained above. Finally, if anticue task is applied to the teachings of Jonker, the results should match to applicants shown data, since same drug is applied to the subject to improve cognitive functioning.
In addition, Adam teaches anticue test and its advantages measuring improvement in inhibitory control and control of impulsivity [see sections Abstract, General Discussion and Conclusion].
Therefore, one would be motivated to use anticue task in light of its advantages for measuring desired parameters.
For claims 4-5:
Jonker teaches a male mouse for their in vivo animal experiments [see example 8], wherein mouse before the treatment is interpreted as a healthy subject.
Jonker is silent on healthy human subject. However, the shown data in mouse model can be extended to human subject, which is a known common practice in the art, absent evidence to the contrary.
For claims 12-13:
Jonker teaches that in the preparative example, a maximum molecular weight of less than 10 kDa with the peptide distribution of 46% < 500Da, 23% 500-1000Da, 32% >1000Da. The degree of hydrolysis of 21% [see Example 3].
For claim 14:
It is not clear about daily dose amounts of subtilisin A hydrolysate lysozyme from the disclosure of Jonker. However, these amounts are considered as a result effective variables and so, a skilled person in the art would determine the optimal dose amounts through a routine titration of experimentation.
For claim 16:
Jonker further teach that their composition comprising subtilisin A hydrolysate lysozyme can be mixed with food stuff [see lines 21-26 in page 5; line 34 in page 7 to line 4 in page 8].
For claim 17:
Jonker is silent on human male subject of at least 60 years old. However, the shown data in mouse model can be extended to human subject in need thereof, which is a known common practice in the art.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components in the composition and their use in improving cognitive functioning, and known measuring tests for a desired parameters 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 modify or extrapolating the teaching the art to a desired subject 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.
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
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658