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 4-40 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 04/03/2026 are acknowledged. Claims 21-30 remain withdrawn as being drawn to an unelected invention or specie. Claims under consideration in the instant office action are claims 4-20 and 31-40.
Applicants' arguments, filed 04/03/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 and 31-40 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 Ameta et al., Recent Advances in Improving the Bioavailability of Hydrophobic/Lipophilic Drugs and Their Delivery via Self-Emulsifying Formulations, Colloids Interfaces, 02/17/2023, 7(16), pp. 1-21).
Boba Tea Protein teaches a nutritional supplement comprising beta-alanine in an amount of 1.8 g or 15% (1.8g/11.85g=0.15) (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 claims 13, 32, and 37-40, Boba Tea Protein does not specifically teach the exact amounts claimed in instant claims 13, 32, and 37-40. 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 “The Examiner's reliance on the Boba Tea Protein reference is incorrect because the "nutritional supplement" referenced in Bob a Tea Protein provides serving sizes of 11. 85 grams of the nutritional supplement in one scoop or 23.7 grams in two scoops. Thus, the amount of beta-alanine in the nutritional supplement referenced in Boba Tea Protein is 15.2% (i.e., 1.8 grams contained in one 11.85 gram scoop or 3.6 grams in two scoops amounting to 23.7 total grams).” The Examiner respectfully disagrees since although beta-alanine is present in a lower amount at about 15%, the Boba Tea Protein reference does teach a composition comprising beta-alanine in an amount of 15%, 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). 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 “Modifying the amount of beta-alanine in the Boba Tea Protein nutrition supplement from 15 wt% to about 50 wt% - 80 wt% required by claim 4 means 3.3-5.3 folds of a daily dosage increase from 1.8 g to 5.94-9.54 g or from 3.6 g to 11.88-19.08 g per serving, which can cause significant paraesthesia side effect, thereby dissuading or prohibiting the amounts of beta-alanine as suggested by the Examiner. Accordingly, the ordinarily skilled artisan would have no motivation, and in fact would be discouraged from, increasing the amount of beta-alanine to the about 50 wt% - 80 wt% required by claim 4.” The Examiner respectfully disagrees since Applicant has not provided support that one of ordinary skill in the art would not be motivated to formulate a higher dosage of beta-alanine.
Applicant also argues that “The Examiner's reliance on Ameta is misplaced because Ameta only teaches improving the bioavailability of hydrophobic/lipophilic (i.e., water-insoluble) drugs, NOT hydrophilic (watersoluble) agents such as beta-alanine.” The Examiner respectfully disagrees since although Ameta focuses on lipophilic/hydrophobic drugs, Ameta does disclose that such emulsion methods can be applied to hydrophilic drugs (see Table 1), and lecithin is conventionally used in the efficient delivery of active therapeutic agents as further evidenced by Klang (pg. 55, right column 1st paragraph).
Applicant also argues that “While Applicant does not agree with the Examiner, in the interest of expediting prosecution, Applicant submits Exhibit A here showing that the Boba Tea Protein nutrition supplement causes paresthesia (see the highlighted text). By contrast, Example 4 describes a claimed composition does not cause parenthesis. As such, the claimed composition does exhibit this unexpected advantage over the prior art composition and thus supports the non-obviousness of claim 4.” The Examiner respectfully disagrees since Applicant has not provided a comparative that a composition of the prior art causes paresthesia. 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).
Conclusion
Claims 4-20 and 31-40 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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
