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 .
DETAILED ACTION
Status of Claims
Note: The amendment of December 12th 2025 has been considered.
Claims 1 and 10 have been amended.
Claims 2-9 are cancelled.
Claims 1 and 10-18 are pending in the current application.
Claim 10 is withdrawn from consideration.
Claims 1 and 11-18 are examined in the current application.
Any rejections not recited below have been withdrawn.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 12th 2025 has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35 of the U.S. Code not included in this action can be found in a prior Office action.
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 and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over NPL Farayadi et al., “Effect of high frequency ultrasound on micromixing efficiency in microchannels” (from Chemical Engineering and Processing 77 (2014) 13-21) and NPL Giratkar et al., “Ultrasonic Studies of amino Acid in Aqueous Salt Solution at Different Temperatures” (from IJRVAT, Vol. V, Issue (3), September 2017: 41-45) in view of NPL Leong et al., “Ultrasonic encapsulation – A review” (from Ultrasonics Sonochemistry 35 (2017) 605-614) and NPL Spernath et al., “Microemulsions as carriers for drugs and nutraceuticals” (from Advances in Colloid and Interface Science 128-130(2006) 47-64).
Regarding claims 1, 11, 12, 14-18: Farayadi discloses mixing and dissolving hydrophilic active compositions, KIO3 and KI (i.e., known water soluble iodine supplements) in an aqueous medium, boric acid, H3BO3 buffer (an aqueous medium with a known antiseptic, antifungal additive to food, cosmetics and pharmaceuticals), followed by a treatment with an ultrasound vibrations at 1.7 MHz for a period of time (see Farayadi abstract; sections 1, 2.21 and 3.5-3.6). Giratkar discloses mixing and dissolving a different hydrophilic active compound (i.e., the hydrophilic polar amino acid, L-serine, a known cosmetics and nutraceutical additive, and an injectable pharmaceutical that may help with ocular disease) in distilled water/beverage (i.e., an aqueous medium), followed by a treatment with ultrasound vibrations at 2.0 MHz for a period of time (see Giratkar abstract; Introduction; Materials and Methods).
As to the method for improving the bioavailability of a hydrophilic active compound in solution in an aqueous medium by vectorization in the preamble of claim 1: Farayadi and Giratkar disclose treatment of active hydrophilic active ingredients with hydrophilic solutions for periods of time, at ultrasound frequencies that read on the claimed ultrasound frequencies, but fail to disclose the effect of the ultrasound on the bioavailability of the compounds; However, Leong and Spernath disclose the use of ultrasonic treatment to achieve encapsulation and thus bioavailability of active compounds is well known (see Leong whole document and Spernath whole document). Accordingly, the improved bioavailability observed by applicant clearly takes place in modified Farayadi. As set forth in MPEP §2112.01, "where...the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. See In re Brown, 59 CCPA 1036, 459 F.2d 531,173 USPQ 685 (1972)." In re Best, Bolton and Shaw 195 USPQ 430 (CCPA 1977).
As to the vectorization (i.e., encapsulation) of the hydrophilic active compound in the hydrophilic solution recited in claim 1: While Farayadi and Giratkar fail to disclose the vectorization (i.e., encapsulation) of the hydrophilic active compounds in the hydrophilic solution occurring during the ultrasound treatment, given the fact that Farayadi and Giratkar disclose ultrasound treatments of active hydrophilic active ingredients with hydrophilic solutions for periods of time, at ultrasound frequencies that read on the claimed ultrasound frequencies, it is examiner’s position that the vectorization of the hydrophilic active compound in the hydrophilic solution, would flow naturally from the ultrasound treatment disclosed in Farayadi and Giratkar which is recited in claim 1. As set forth in MPEP §2145, the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding claim 13: Giratkar recognizes that similarly to vitamin B9 (i.e., folate), L-serine metabolism is very important for development and the proper function of the central nervous system (see Giratkar page 41, bottom paragraph). Accordingly, it would have been obvious to a skilled artisan at the time the application was filed to have modified Giratkar and to treated an aqueous solution of B9 vitamin with ultrasound vibrations at 2.0 MHz, and thus arrive at the claimed limitations.
Response to Arguments
Applicant's arguments filed on December 12th 2025 have been fully considered but they are not persuasive.
Applicant argues the prior art references fail to render the claimed invention obvious, because the intent to vectorize and improve the bioavailability of the emulsion by ultrasound. The examiner respectfully disagrees.
While Farayadi discloses of using ultrasound to form the emulsion, It fails to disclose the vectorization (i.e., encapsulation) and improved bioavailability as the intent behind the ultrasound treatment. Leong and Spernath recognize that the claimed ultrasound parameters provide encapsulation, which will inherently provide a bioavailable product.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASSAF ZILBERING whose telephone number is (571)270-3029. The examiner can normally be reached on M-F 8:30-5:00.
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