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.
Status of the Claims
The claims filed 09/16/2026 are under consideration.
Claims 1, 4-7, 9-13, 15-18 and 20-21 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)).
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 Thus, claim 10 remains withdrawn as being directed to a non-elected species.
Claims 16-17 have been rejoined since claim 1 is free of the art.
The elected species of PTS monomer has been expanded to include the species PTS dimer.
Claim 1 allowable. The restriction requirement only between species 1 and species 2, as set forth in the Office action mailed on 12/29/2025, has been reconsidered in view of the allowability of claims to the elected species pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the species election requirement of 12/29/2025 is partially withdrawn. Claims 16-17, directed to PTS dimer and PTS monomer and PTS dimer, are no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim. However, claims 10 and 11, directed to wherein the hydrophilic moiety in Formula (I) is a polyalcohol and wherein the hydrophobic moiety is cholesterol remain withdrawn from consideration because they do not require all the limitations of an allowable claim.
In view of the above noted partial withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 10-11 remain 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.
Claim 10 is not eligible for rejoinder since claim 1 is no longer generic to polyalcohol.
Claim 11 is not eligible for rejoinder at least because claim 1 is no longer generic to cholesterol.
Claims 10 and 11 should be canceled to facilitate allowance since they are not eligible for rejoinder.
Claims 1, 4-7, 9, 12-13, 15-18, and 20-21 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.
Withdrawn
The rejection of claim 9 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 has been withdrawn because of Applicant’s amendment.
The rejection of claims 1-7, 9, 12, 13, 14, 15, and 21 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 has been withdrawn because of Applicant’s amendment.
Vegh does not teach the composition comprising a water solubilized alcohol extracted ashwagandha root extract including the ratio as required by amended claim 1.
The rejection of claims 1-7, 9, 12, 13, 14, 15, and 21 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 has been withdrawn because of Applicant’s amendment.
Huggard does not teach the composition comprising a water solubilized alcohol extracted ashwagandha root extract including the ratio as required by amended claim 1.
The rejection of claims 1-7, 9, 12, 13, 14, 15, 18, 20, and 21 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 has been withdrawn because of Applicant’s amendment.
Sikorska alone or further in view of Vegh does not teach the composition comprising a water solubilized alcohol extracted ashwagandha root extract including the ratio as required by amended claim 1.
The rejection of claims 2-3 and 18-19 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 has been withdrawn because of Applicant’s amendment.
Sikorska alone or further in view of Vegh and Borowy-Borowski does not expressly teach the composition comprising a water solubilized alcohol extracted ashwagandha root extract including the ratio as required by amended claim 1.
Even in view of Borowy-Borowski, there is insufficient guidance for the skilled artisan to have modified Sikorska and Vegh by separately solubilizing the ashwagandha extract with the selected solubilizing agent in the recited ratio.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 does not include all the limitations of claim 1 from which it depends because claim 4 allows for hydrophobic groups beyond α-tocopherol as required in claim 1, e.g., cholesterol, 7-dehydrocholesterol, campesterol, sitosterol, ergosterol, stigmasterol, etc.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 does not further limit the subject matter since claim 1 already requires α-tocopherol.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 does not include all the limitations of claim 1 from which it depends because claim 6 allows for polyethers beyond polyethylene glycol required by claim 1.
Claim 6 also fails to further limit the subject matter of claim 1 from which it depends because claim 6 recites a genus broader than polyoxyethanyl required by claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 does not include all the limitations of claim 1 from which it depends because claim 7 allows for polyalkylene glycols beyond polyethylene glycol required by claim 1.
Claim 7 also fails to further limit the subject matter of claim 1 from which it depends because claim 7 recites a genus broader than polyoxyethanyl required by claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 does not include all the limitations of claim 1 at least because claim 1 requires that n is 8.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 does not include all the limitations of claim 1 at least because claim 1 requires that n is 8.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 is dependent on improper claims 6 and 7. Claim 9 should depend on claim 1 since claims 6 and 7 fail to further limit/include all the limitations of claim 1 from which they depend. The phrase “polyalkylene glycol is a” and “having” should be deleted so that the claim recites “the polyethylene glycol has an average molecular weight from about 300 to about 500 or about 400 to about 1000” to properly further limit claim 1.
Clarification is required.
Conclusion
Claims 1, 15-18, and 20-21 are allowable.
Claims 4-7, 9, and 12-13 are rejected.
Claims 10-11 remain withdrawn and are ineligible for rejoinder.
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.
Correspondence
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
/SUSAN T TRAN/Primary Examiner, Art Unit 1615
