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
Claims 4-30 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 10/23/2025 are acknowledged. Claims 21-30 remain withdrawn as being drawn towards a nonelected invention. Claims under consideration in the instant office action are claims 4-20.
Applicants' arguments, filed 10/23/2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
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, 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 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.
Claims 4-20 are rejected under 35 U.S.C. 103 as being unpatentable over Boba Tea Protein (“Passion Fruit Green Tea Composition”, as disclosed in IDS) in view of Scandiffio et al. (Protective Effects of (E)-β-Caryophyllene (BCP) in Chronic Inflammation, Nutrients, 2020, 12, pp. 1-24) as evidenced by .
Boba Tea Protein teaches a nutritional supplement comprising beta-alanine in an amount of 1.8 g or 27% (1.8g/6.67g=0.27) (see supplemental facts). Boba Tea Protein teaches L-citrulline which is an anti-inflammatory agent present in an amount of 3.0 g or 45% (3.0/6.67=0.45) (see supplemental facts). Boba Tea Protein teaches betaine which is an amphiphilic agent present in an amount of 1.25 g or 19% (1.25/6.67=0.19) as well as organic sunflower lecithin (see supplemental facts; other ingredients). Boba Tea Protein teaches caffeine, which is a stimulant present in an amount of 0.125 g or 13.9% (0.125/0.900=0.139) (see supplemental facts). Boba Tea Protein teaches organic tapioca maltodextrin, which serves as a coating agent (see other ingredients).
Boba Tea Protein does not teach a composition further comprising beta-caryophyllene as an anti-inflammatory agent.
Scandiffio et al. is drawn towards the protective effects of beta-caryophyllene (“BCP”) (see abstract). Scandiffio et al. teaches “The data accumulated so far both in in vivo and in vitro studies show that BCP is a good candidate in the treatment of chronic inflammation due to its specific molecular targets and very low toxicity.” (pg. 15, second paragraph).
It would have been obvious to one of ordinary skill in the art to formulate a composition further comprising beta-caryophyllene as an anti-inflammatory agent, as suggested by Scandiffio et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since Scandiffio et al. teaches beta-caryophyllene as an effective anti-inflammatory agent with very low toxicity, with a reasonable expectation of success absent evidence of criticality of the particular formulation.
With regards to the limitation claimed in instant claim 13, which claims “between about 70 wt. % and about 73 wt. % of the at least one compound selected from the group consisting of beta-alanine, an ester of beta-alanine, and a salt of beta-alanine; between about 0.5 wt. % and about 1 wt. % of the anti-inflammatory agent; between about 1 wt. % and about 5 wt. % of the amphiphilic agent; and between about 0. 1 wt.% and about 0.2 wt.% of the stimulant”, Boba Tea Protein does not specifically teach the exact amounts claimed in instant claim 13. Although Boba Tea Protein teaches beta-alanine present in an amount of 27%, it would have been obvious to one of ordinary skill in the art to increase the concentration of beta-alanine to increase muscle endurance, reduce muscle fatigue, and increase potential workload (see pg. 8). Additionally, one of ordinary skill in the art would have optimized the amount of beta-caryophyllene to achieve the desired amount of anti-inflammatory effect, and the amount of stimulant for muscle performance. It would be within the skill of an ordinary artisan to be able to modify the concentrations of the amphiphilic agent in order to obtain the desired bioavailability of the agents. It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant argues that “none of Baba Tea Protein, Scandiffio, Allerton, and Gioacchino teaches a composition comprising the amounts of beta-alanine (an ester of beta-alanine and/or a salt of beta-alanine), an anti-inflammatory agent, an amphiphilic agent, and a stimulant similar to or overlapping with those required by claim 4.” The Examiner respectfully disagrees since although the prior art does not explicitly disclose the recited ranges of the amount of beta-alanine, an anti-inflammatory agent, an amphiphilic agent, and a stimulant, Boba Tea Protein teaches beta-alanine present in an amount of 27%, and it would have been obvious to one of ordinary skill in the art to increase the concentration of beta-alanine to increase muscle endurance, reduce muscle fatigue, and increase potential workload (see pg. 8). Additionally, one of ordinary skill in the art would have optimized the amount of beta-caryophyllene to achieve the desired amount of anti-inflammatory effect, and the amount of stimulant for muscle performance. It would be within the skill of an ordinary artisan to be able to modify the concentrations of the amphiphilic agent in order to obtain the desired bioavailability of the agents. It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Applicant also argues that “skilled artisan would not have been motivated to modify the amounts of four agents (i.e., beta-alanine, the anti-inflammatory agent, the amphiphilic agent, and the stimulant) in the Baba Tea Protein composition with a reasonable expectation of success to arrive at the claimed composition.” The Examiner respectfully disagrees since Boba Tea Protein teaches beta-alanine present in an amount of 27%, and it would have been obvious to one of ordinary skill in the art to increase the concentration of beta-alanine to increase muscle endurance, reduce muscle fatigue, and increase potential workload (see pg. 8). Additionally, one of ordinary skill in the art would have optimized the amount of beta-caryophyllene to achieve the desired amount of anti-inflammatory effect, and the amount of stimulant for muscle performance. It would be within the skill of an ordinary artisan to be able to modify the concentrations of the amphiphilic agent in order to obtain the desired bioavailability of the agents.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant also argues that “the non-obviousness of claim 4 is supported by the unexpected results as detailed in the Specification.” The Examiner respectfully disagrees since although Applicant has demonstrated improved bioavailability over free unencapsulated beta-alanine, one of ordinary skill in the art would reasonably expect that amphiphilic agents, such as lecithin, would improve the bioavailability of active agents as evidenced by Ameta et al. (pg. 3, third paragraph). Applicant has not provided a comparative of the claimed composition and a formulation comprising an amphiphilic agent disclosed by the prior art such as the one disclosed by Boba Tea Protein.
Conclusion
Claims 4-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691