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
Claims 1-3, 5-9, 11-21, 23-31 and 33-49 are pending in the Claim Set 4/02/2026.
Herein, claims 1-3, 5-9, 11-21, 23-31 and 33-49 are for examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/02/2026 has been considered by the examiner and an initialed copy of the IDS is included with the mailing of this office action.
Withdrawn Rejections
The rejection of claims 23-25 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the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention is withdrawn in view of Applicants amendment.
The rejection of claims 1-3, 5-9, 11-21, 23-31 and 33-39 under 35 U.S.C. 103(a) as being unpatentable over Bromley et al (WO2009/117152, cited in IDS) is withdrawn in view of applicants’ arguments.
Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The rejection of claims 1-3, 5-9, 11-21, 23-31 and 33-49 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 13-16, 24, 30, 32-33, 37, 42, 44-52 and 54-63 of copending Application No. 17/672, 894 (herein ‘894) is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘894 claims are directed to common subject matter.
Instant claims are directed to a composition comprising: an alcohol-soluble species; and a modified oil-in-water microemulsion including a modified oil phase and a modified polar continuous phase, where the alcohol-soluble species is solubilized in the modified oil phase, the modified oil phase comprising a phospholipid, a polyethylene glycol derivative, and an alcohol, and where the modified polar continuous phase comprises a sugar or sugar alcohol and water, wherein the alcohol-soluble species is chosen from dehydroepiandrosterone (DHEA), pregnenolone, and dienolylmethane, where the modified oil-in water microemulsion is visually clear, shelf-stable, ingestible and edible.
Similarly, ‘894 claims are directed to a composition comprising: an alcohol-soluble species; and a modified oil-in-water microemulsion including a modified oil phase and a modified polar continuous phase, where the alcohol-soluble species is solubilized in the modified oil phase, the modified oil phase comprising a phospholipid, a polyethylene glycol derivative, and an alcohol, and where the modified polar continuous phase comprises a sugar or sugar alcohol and water, wherein the alcohol-soluble species is chosen from dehydroepiandrosterone (DHEA), pregnenolone, and dienolylmethane, where the modified oil-in water microemulsion is visually clear, shelf-stable, ingestible and edible.
‘894 claims differ from instant claims for at least the reason that the Instant Claims are directed to different alcohol-soluble species such as dienolylmethane, however, both instant claims and the ‘894 claims are both directed to the identical alcohol-soluble species dehydroepiandrosterone, so that share common alcohol-soluble species, and they are both modified oil-in water microemulsion that are visually clear, shelf-stable, ingestible and edible.
Thus, Instant Claims and ‘894 claims are obviously directed to common subject matter. Therefore, the subject matter as instantly claimed is prima facie obvious in view of the ‘894 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Updated Rejection: copending Application No. 17972754 is Now U.S. Patent 12527804 (herein ‘804).
The rejection of claims 1-3, 5-9, 11-21, 23-31 and 33-49 on the ground of nonstatutory double patenting as being unpatentable over claims 1-53 of U.S. Patent 12527804 (herein ‘804), (Previously Rejected as Application No. 17972754), is made again and maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘804 claims are directed to common subject matter.
Instant claims are directed to a composition comprising: an alcohol-soluble species; and a modified oil-in-water microemulsion including a modified oil phase and a modified polar continuous phase, where the alcohol-soluble species is solubilized in the modified oil phase, the modified oil phase comprising a phospholipid, a polyethylene glycol derivative, and an alcohol, and where the modified polar continuous phase comprises a sugar or sugar alcohol and water, wherein the alcohol-soluble species is chosen from dehydroepiandrosterone (DHEA), pregnenolone, and dienolylmethane, where the modified oil-in water microemulsion is visually clear, shelf-stable, ingestible and edible.
Similarly, ‘’804 claims are directed to a composition comprising: an alcohol-soluble species; and a modified oil-in-water microemulsion including a modified oil phase and a modified polar continuous phase, where the alcohol-soluble species is solubilized in the modified oil phase, the modified oil phase comprising a phospholipid, a polyethylene glycol derivative, and an alcohol, and where the modified polar continuous phase comprises a sugar or sugar alcohol and water, wherein the alcohol-soluble species is chosen from dehydroepiandrosterone (DHEA), pregnenolone, and dienolylmethane, where the modified oil-in water microemulsion is visually clear, shelf-stable, ingestible and edible.
‘804 claims differ from instant claims for at least the reason that the ‘804 claims are directed to different alcohol-soluble species such as polyphenol, however, both instant claims and the ‘804 claims are both directed to the identical alcohol-soluble species dehydroepiandrosterone, so that share common alcohol-soluble species, they are both comprise modified oil-in water microemulsion that are visually clear, shelf-stable, ingestible and edible.
Thus, Instant Claims and ‘804 claims are obviously directed to common subject matter. Therefore, the subject matter as instantly claimed is prima facie obvious in view of the ‘804 claims.
Response to Arguments
Applicants argue that they believe the claims in the present application are patently distinct from the claims in the copending and commonly owned applications, and that the distinctions will become evident during continued prosecution of the application. Thus, Applicant requests the Examiner to hold these rejections in abeyance until the Examiner's other concerns with the application are resolved so the claims pending at that time may be examined regarding the Examiner's double patenting concerns.
Applicants’ arguments have been fully considered but they are not persuasive, because Applicants did not distinctly and specifically point out the supposed errors in the Double Patenting rejection. Applicant is reminded that a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. Furthermore, a request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP 37 CFR 1.111(b) and 714.02). Therefore, the Double Patenting rejection of record has been maintained as no action regarding these rejections has been taken by Applicants at this time.
With respect to the ‘894, Applicant is reminded that the instant application and the ‘894 application share the same patent term filing date, 9/4/2020. Applicant is reminded that benefit claims under 35 U.S.C. 119(e) and foreign priority claims under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) or (b) are not taken into account when determining the term of an issued patent (see 35 U.S.C. 154(a)(2) and (a)(3) ), and therefore, are not taken into account in determining the patent term filing date of an application.
Thus, since both the application under examination and the ‘894 application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicants can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application or includes a compliant terminal disclaimer in the application under 37 CFR 1.321 that obviates the rejection.
Conclusions
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicants are 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thurman Wheeler whose telephone number is (571)-270-1307. The examiner can normally be reached Monday-Friday 11:00am-5:00pm EST.
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/T.W./ Examiner, Art Unit 1619
/SARAH ALAWADI/ Primary Examiner, Art Unit 1619
