DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/29/2024 has been considered by the examiner.
US publication 20190038854 has been crossed out because the name and number do not match.
CA 2926987 A1 has been crossed out because the name and number do not match.
Status of the Claims
The claims filed 09/29/2023 are under consideration.
Claims 1-7, and 9-21 are pending.
Applicant’s election of polyoxyethanyl-α-tocopheryl sebacate (PTS) as solubilizer of Formula (I) in the reply filed on 02/27/2026 is acknowledged. The election refers to the PTS monomer as per specification, ¶ 0034 wherein r is 12. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant has indicated that claims 1-7, 9-10, 12-15, and 17-21 read on the elected species.
Claim 10 recites polyalcohol. The specification indicates term “polyalcohol” as used herein refers a compound having the general formula HOCH2(CHOH)xCH2OH (Spec, e.g., 0037). Polyethylene glycol does not appear to be a member of this genus. Thus, claim 10 is withdrawn as being directed to a non-elected species.
Claim 16 recites wherein the at least one compound of Formula (I) is PTS dimer.
Claim 17 recites wherein the at least one compound of formula (I) is a combination of PTS monomer and PTS dimer.
Since Applicant elected a PTS monomer, i.e., polyoxyethanyl-α-tocopheryl sebacate (PTS), claims 16 and 17 read on non-elected species, i.e., PTS dimer.
Claims 10-11 and 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/27/2026.
Claims 1-7, 9, 12-15, and 18-21 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 9 depends from cancelled claim 8. The skilled artisan cannot determine which claim the subject matter of claim 9 was intended to further limit.
Clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 9, 12, 13, 14, 15, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vegh, Journal of Natural Health Product Research, 2019 as evidenced by Sikorska, Neurobiology of Aging, 35, 2014.
Vegh teaches compositions comprising solubilized coq10 (UBISOL-Q10) and an ethanolic root extract of ashwagandha extract (ASH). See Vegh, e.g., pg. 21/23, Abstract P20.
UBISOL-Q10 is coenzyme-Q10 solubilized with PTS monomer, i.e., polyoxyethanyl-α-tocopheryl sebacate (PTS). See Sikorska, e.g., pg. 2330, ¶ spanning c1-c2. The polyethylene glycol has a molecular wight of 600 and UBISOL-Q10 is used in the present application. See Specification, e.g., 0046 and 00120.
Claims 2 and 3 are included here to the extent that these claims read on compositions comprising a combination of CoQ10, PTS, and ashwagandha extract. That is, an alcoholic extracted ashwagandha root extract water solubilized with at least one solubilizing agent of Formula (I) reads on compositions comprising PTS and ashwagandha extract.
Vegh anticipates the subject matter of instant claims 1-7, 9, 12, 13, 14, 15, and 21 as evidenced by Sikorska.
Claims 1-7, 9, 12, 13, 14, 15, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huggard, UWill Discover Abstracts, 2020 as evidenced by Sikorska, Neurobiology of Aging, 35, 2014.
Huggard teaches compositions comprising UBISOL-Q10 (solubilized CoQ10) and water solubilized ethanolic ashwagandha extract.
UBISOL-Q10 is coenzyme-Q10 solubilized with PTS monomer, i.e., polyoxyethanyl-α-tocopheryl sebacate (PTS). See Sikorska, e.g., pg. 2330, ¶ spanning c1-c2. The polyethylene glycol has a molecular wight of 600 and UBISOL-Q10 is used in the present application. See Specification, e.g., 0046 and 00120.
Claims 2 and 3 are included here to the extent that these claims read on compositions comprising a combination of CoQ10, PTS, and ashwagandha extract. That is, an alcoholic extracted ashwagandha root extract water solubilized with at least one solubilizing agent of Formula (I) reads on compositions comprising PTS and ashwagandha extract.
Huggard anticipates the subject matter of instant claims 1-7, 9, 12, 13, 14, 15, and 21 as evidenced by Sikorska.
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 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.
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 1-7, 9, 12, 13, 14, 15, 18, 20, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Sikorska, US 20160228387 A1 in view of Vegh, Journal of Natural Health Product Research, 2019.
Sikorska teaches s solubilized formulation of CoQ10 and PTS, i.e., polyoxyethanyl-a-tocopheryl sebacate for treating Parkinson’s disease (Sikorska, entire documents, e.g., Abstract, claims, and 0021-0038).
According to the elected species: Sikorska teaches polyethylene glycol molecular weight ranges from about 300 to about 5000 (Sikorska, e.g., 0025). The claimed r=12 corresponds to a polyethylene glycol having a molecular weight in the claimed range. Repeating section in the elected species corresponds to 44 g/mol (OCH2CH2), and 12 moles is 528 molecular weight (12 mol x 44 g/mol = 528 g). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. Additionally, Sikorska teaches wherein the solubilizer is UBISOL-Q10 which is the same solubilizer used in the present application examples.
The solubilizer improves absorption of CoQ-10 and improves the ability of CoQ-10 to cross the blood brain barrier (Sikorska, e.g., 0041).
Sikorska does not expressly teach the composition further comprising an alcohol extracted ashwagandha root extract.
Vegh teaches compositions comprising solubilized coq10 (UBISOL-Q10) and an ethanolic root extract of ashwagandha extract (ASH). See Vegh, e.g., Abstract, Title.
Vegh expressly teaches combining solubilized coq10 (UBISOL-Q10) and an ethanolic root extract of ashwagandha extract for treating Parkinson’s disease offers improved success in halting the progression of Parkinson’s disease (PD) compared to using either alone. Vegh provides an express suggestion to modify Sikorska’s compositions with an ethanolic root extract of ashwagandha extract for improved motor impairment and to slow progression of PD.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to combine the teachings of Sikorska and Vegh to arrive at a composition having the features of claims 1-3 with a reasonable expectation of success. The skilled artisan would have been prompted modify Sikorska’s water solubilized CoQ-10 compositions having a solubilizer of the elected species with an ethanolic root extract of ashwagandha by the express teachings of Vegh. The skilled artisan would have been motivated to to make this modification for improved motor impairment and slowed disease progression suggested by Vegh. The skilled artisan would have had a reasonable expectation of success because both documents teach water solubilized CoQ10 formulations for treating Parkinson’s disease.
Claims 2 and 3 are included here to the extent that these claims read on compositions comprising a combination of CoQ10, PTS, and ashwagandha extract. That is, an alcoholic extracted ashwagandha root extract water solubilized with at least one solubilizing agent of Formula (I) reads on compositions comprising PTS and ashwagandha extract.
Applicable to claims 4-5: PTS contains alpha tocopherol (Sikorska, e.g., 0022-0025).
Applicable to claims 6-7: polyethylene glycol is a polyether and polyalkylene glycol. Applicant has indicated the elected species reads on claims 6 and 7.
Applicable to claim 9: the claimed range significantly overlaps with the range recited in Sikorska, e.g., 0025).
Applicable to claims 12-15: The elected species taught by Sikorska. Applicant has indicated the elected species reads on claims 12-15.
Applicable to claim 18: Sikorska teaches a ratio within the claimed range, e.g., 1:2 (Sikorska, e.g., 0023, claim 12, and 15).
Applicable to claim 20: Sikorska teaches formulations containing 0.2 mg/mL (Sikorska, e.g., 0046)
Applicable to claim 21: Vegh teaches alcohol extract of ashwagandha root.
Accordingly, the subject matter of claims 1-7, 9, 12, 13, 14, 15, 18, 20, and 21 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 2-3 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Sikorska, US 20160228387 A1 in view of Vegh, Journal of Natural Health Product Research, 2019 as applied to claims 1-7, 9, 12, 13, 14, 15, 18, 20, and 21 above, and further in view of Borowy-Borowski, Journal of Drug Targeting, 2004.
The teachings of Sikorska and Vegh teach a composition according to claim 1 as enumerated above.
Applicable to claim 18: The teachings of Borowy-Borowski evidence the fact that 1:2 mol/mol is the same as about 1:3-1:4 wt/wt (Borowy-Borowski, e.g., pg. 418, c2). Borowy-Borowski teaches optimizing the amount of solubilizing carrier, e.g., PTS with lipophilic agents for water and lipid solubility over a wide range of temperatures. Thus, to the degree that 1:2 mol/mol is not about 1:3 by weight, it would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to optimize the ratio between lipophilic molecule such as CoQ10 using the teachings of Borowy-Borowski, e.g., 1:3-1:4 wt/wt for improved water solubility with a reasonable expectation of success.
Applicable to claims 2-3 and 19:
The combined teachings of Sikorska and Vegh do not expressly teach wherein the solubilizing agent to the alcohol ashwagandha root extract is within the ranges recited in claim 19. To the extent that claims 2-3 and 19 read on a water solubilized ashwagandha root extract:
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify compositions suggested by Sikorska and Vegh by formulating the alcohol ashwagandha root extract with the same solubilizer, e.g., PTS, in a ratio suggested by Borowy-Borowski, e.g., about 3:1 or 4:1, with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to improve the ashwagandha root alcohol extract’s solubility as shown in Borowy-Borowski with similar lipophilic agents. The skilled artisan may have further been motivated to make this modification to improve the ability of the ashwagandha root alcohol extract to cross the blood brain barrier in the same way observed by Sikorska for CoQ10. The skilled artisan would have seen this modification as the use of a known technique to improve the solubility, absorption, and brain exposure of similar active agents which are active beyond the blood brain barrier with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success because Borowy-Borowski reports success in solubilizing a number of diverse lipophilic agents and because the composition suggested by Sikorska and Vegh would have the solubilizing agent in it already.
Accordingly, the subject matter of claims 2-3 and 18-19 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
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