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 June 10th 2026 has been considered.
Claims 1 and 10 have been amended.
Claims 2-9 are cancelled.
Claim 19 was added.
Claims 1, 10-19 are pending in the current application.
Claims 10 are withdrawn from consideration.
Claims 1 and 11-19 are examined in the current application.
Any rejections not recited below have been withdrawn.
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 11-19 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).
Regarding claims 1, 11, 12 and 14-19: 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 (i.e., micromixing) for a period of time sufficient to form microstructured reactors (i.e., microchannels) (see Farayadi abstract; sections 1, 2.21 and 3.5-3.6). Given the fact Farayadi discloses the formation of the microchannels using only hydrophilic constituents without oil and hydrocolloids, Farayadi discloses a vectorization without encapsulation of hydrophilic constituents by ultrasound treatment at vibrational frequency greater than 1 MHz, and without the addition of oil, stabilizer, and emulsifier when treated.
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 improved bioavailability of a hydrophilic active compound provided by the vectorization recited in claim 1: Farayadi discloses ultrasonic treatment of hydrophilic active ingredients with hydrophilic solutions for a period of time sufficient to form microstructured reactors (i.e., microchannels) at ultrasound frequencies that read on the claimed ultrasound frequencies (see Farayadi abstract; sections 1, 2.21 and 3.5-3.6),, but fail to disclose the effect of the ultrasound on the bioavailability of the compounds; However, in view of the fact Farayadi discloses forming microchannels (i.e., vectorization) by treating hydrophilic constituents with ultrasonic frequency similar to the claimed hydrophilic constituents and the claimed ultrasonic frequency, it is examiner’s position the improved bioavailability provided by the method recited in claim 1, would flow naturally from the ultrasound treatment of the hydrophilic constituents until microchannels are formed (i.e., until vectorization is achieved) without oil, stabilizer and emulsifier disclosed in Farayadi. 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 June 10th 2026 have been fully considered but they are not persuasive.
Applicant argues the prior art references fail to render the claimed invention obvious, because Farayadi and Giratkar fail to disclose vectorization, and Leong, Spernath also do not meet the amended claims, as they disclose encapsulation within emulsions, which comprise emulsifiers, stabilizers and oil. The examiner respectfully disagrees.
The current rejection does not rely on Leong and Spernath, as they disclose encapsulation within emulsions comprising stabilizers, emulsifiers and oils. Instead, the examined claims are rejected under 35 USC §103 over Farayadi and Giratkar, as 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 (i.e., micromixing) for a period of time sufficient to form microstructured reactors (i.e., microchannels) (see Farayadi abstract; sections 1, 2.21 and 3.5-3.6). Given the fact Farayadi discloses the formation of the microchannels using only hydrophilic constituents without oil and hydrocolloids, Farayadi discloses a vectorization without encapsulation of hydrophilic constituents by ultrasound treatment at vibrational frequency greater than 1 MHz, and without the addition of oil, stabilizer, and emulsifier when treated.
Applicant argues the prior art references fail to render the claimed invention obvious, because the prior art references fail to disclose vectorization using sonic energy to improve bioavailability of the hydrophilic constituents. The examiner respectfully disagrees.
While Farayadi fails to disclose improving bioavailability, Farayadi discloses forming microchannels (i.e., vectorization) by treating hydrophilic constituents with ultrasonic frequency similar to the claimed hydrophilic constituents and the claimed ultrasonic frequency. Accordingly, it is examiner’s position the improved bioavailability provided by the method recited in claim 1, would flow naturally from the ultrasound treatment of the hydrophilic constituents until microchannels are formed (i.e., until vectorization is achieved) without oil, stabilizer and emulsifier disclosed in Farayadi. 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).
Conclusion
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 ASSAF ZILBERING whose telephone number is (571)270-3029. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASSAF ZILBERING/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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