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 07/17/2026 are acknowledged.
However, applicants’ arguments for the previous 103 rejection are found not persuasive. Accordingly, the previous rejections are maintained and modified to address newly added claims. Please see the examiners response to applicants arguments below.
Response to Arguments
Applicants’ main argument is that Shashidhar's general reference to the anti-aging benefits of a crude Cordyceps extract fails to provide any meaningful teaching, motivation, or roadmap to target the specific, independent pathology of sarcopenia using the isolated dipeptide cFP. Goto likewise does not disclose any muscle-related use of cFP. Goto generally concerns HSP expression, sleep improvement, anti-stress activity, and autonomic nerve adjustment. It does not report myoblast differentiation, myoblast fusion, muscle growth, increased muscle mass, or treatment of sarcopenia.
Sarcopenia is age-related progressive loss of muscle mass, strength and function. There are several causes of sarcopenia, and some causes include physical inactivity, obesity, chronic diseases like kidney disease, loss of mobility, insulin resistance and reduction in hormone levels etc. So, in other words there are several root causes for sarcopenia.
Cited Shashidhar identified various pharmaceutical advantages of a supplement from Cordyceps sinensis. Some of its utilities include treating aging, kidney or liver related diseases, and hyperlipidemia etc. All these diseases or symptoms are linked to sarcopenia.
Further, Shashidhar identified or shortlisted cFP as one of the bioactive peptides in Cordyceps sinensis.
At least based on the above reasoning, a skilled person in the art would be motivated to explore and identify individual active ingredients and their utilities through routine experimentation.
As an additional support, the rejection also provided teachings from Goto, which also identified cFP and its utilities, such as sleep improvement and anti-stress agent. These are also typical symptoms of sarcopenia.
A combination of prior art references is only proper if a person of ordinary skill in the art (POSA) at the time of the invention, faced with the same problem, would have been motivated to combine their teachings with a reasonable expectation of success. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Here, the technical fields and problems addressed by the references are not distinct from that of the present claimed invention.
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 6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Shashidhar (Journal of Functional Foods, 2013, 5, 1013-1030) in view of Goto (US 2019/0201395 A1).
Shashidhar teaches a food supplement from the bioactive principles from Cordyceps sinensis, and its health benefits, wherein proteins are one of the bioactive principles and one of the protein is cyclo-(Phe-Pro) [see abstract and section 4.4 in page 1018]. Shashidhar further teaches that Cordyceps and its products containing major active ingredients recently claimed treating against various conditions, such as aging [see second paragraph in right column in page 1014].
In the above, treating aging falls within the definition of applicants elected sarcopenia.
Difference is that Shashidhar is silent on exemplifying cyclo-(Phe-Pro) in treating sarcopenia. This can be cured with the following reasoning:
Art identified that cyclo-(Phe-Pro) is one of the component in the bioactive principles of Cordyceps sinensis, and which is used as a food supplement and useful to treat aging, as evidenced from the teachings of Shashidhar. Also food supplement can have multiple utilities including protecting aging or muscle loss [sarcopenia]. Therefore, it is obvious to identify the properties of individual components in the extract of Cordyceps sinensis and take advantage in treating various conditions, such as sarcopenia.
In addition to above, Goto teaches that cyclo-(Phe-Pro) as a sleep improvement and anti-stress agent [see claims], which may contribute towards lowering the muscle loss in a subject.
For claims 8-10:
Claimed limitations are nothing but properties of c(Phe-Pro).
A compound and all of its properties are generally inseparable. In re Papsech, 315 F2d. 381, 137 USPQ 43, (CCPA 1963).
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
In light of above teachings, a skilled person in the art immediately envision that cyclo-(Phe-Pro) can have multiple utilities, since its parent extract showed several medical advantages, and therefore, would be motivated to choose cyclo-(Phe-Pro) and explore its other advantages, which are closely related to sleep disorders and anti-stress etc., and arrive at applicants method with a reasonable expectation of success.
The motivation to combine the art or motivation to modify the art can arise from the expectation that the prior art elements will perform their expected function(s) to achieve their expected results when modified or 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
Prosecution Insights