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 .
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/12/2025 has been entered.
DETAILED ACTION
Claims 1, 2, 6-9, 13-30, 32, 33, 37-42, 44-52 and 54-63 are pending in the Claim Set filed 6/12/2025.
Claim 1 has been amended.
Claims 7-9, 17-23, 25-29 and 38-41 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 3-5, 10-12, 31, 34-36, 43, 46, 53 and 64-91 are canceled.
Herein, claims 1, 2, 6, 13-16, 24, 30, 32, 33, 37, 42, 44-52 and 54-63.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/15/2025 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Withdrawn Rejections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 1, 6, 13-16, 24, 30, 32, 33, 37, 42, 44-52 and 54-63 under 35 U.S.C. 103 as being unpatentable over Bromley et al (WO2009/117152) cited in IDS filed 8/2/22022) is withdrawn in view of applicants arguments.
Double Patenting Rejections are Maintained
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, 2, 6, 13-16, 24, 30, 32, 33, 37, 42, 44-52 and 54-63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-50 of copending Application No. 17967267 (herein ‘267) is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘267 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 ethonal, and where the modified polar continuous phase comprises a sugar or sugar alcohol and water, wherein the alcohol-soluble species is chosen from testosterone, dehydroepiandrosterone (3-betahydroxyandrosteron-5-en-17-one), dihydrotestosterone, 7-ketodehydroepiandrosterone, pregnenolone, androstenedione, androstenediol, progesterone, estradiol, estrone, estriol, cortisol, and combinations thereof, where the modified oil-in water microemulsion is visually clear, shelf-stable ingestible and edible.
Similarly, ‘267 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.
‘267 claims differ from instant claims for at least the reason that the ‘467 claims are directed to different alcohol-soluble species such as dienolylmethane, however, both instant claims and the ‘267 claims are both directed t 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 ‘267 claims are obviously directed to common subject matter.
Accordingly, it would have been prima facie obvious to one of skill in the art to provide the balloon catheter of Instant claims in view of the subject matter as recited in the ‘267 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Application 17/972,754 has been issued as an allowance: Now USP 12527804, claims 1-60 (renumbered)
Claims 1, 2, 6, 13-16, 24, 30, 32, 33, 37, 42, 44-52 and 54-63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-60 of U.S. Patent No. 12527804 (herein ‘804).
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘267 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 ethanol, and where the modified polar continuous phase comprises a sugar or sugar alcohol and water, wherein the alcohol-soluble species is chosen from testosterone, dehydroepiandrosterone (3-betahydroxyandrosteron-5-en-17-one), dihydrotestosterone, 7-ketodehydroepiandrosterone, pregnenolone, androstenedione, androstenediol, progesterone, estradiol, estrone, estriol, cortisol, and combinations thereof, where the modified oil-in water microemulsion is visually clear, shelf-stable ingestible and edible.
Similarly, ‘804 Patent 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 ethanol, 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 Patent claims differ from instant claims for at least the reason that the ‘804 Patent claims are directed to different alcohol-soluble species such as polyphenol, however, both instant claims and the ‘804 Patent claims are both directed to the identical alcohol-soluble species dehydroepiandrosterone, so that they 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 Patent claims are obviously directed to common subject matter.
Accordingly, it would have been prima facie obvious to one of skill in the art to provide the balloon catheter of Instant Claims in view of the subject matter as recited in the ‘804 Patent claims.
.
Response to Arguments
Applicants state in the reply filed 6/12/2025 that Application No. 17967267 (‘267) is not presently under substantive examination. However, the Examiner would like to point out that a Non-Final rejection was mailed 10/03/2025 in the ‘267 application. Further, applicant is reminded that a provisional double patenting rejection is appropriate as long as the conflicting application and claims are co-pending regardless of whether prosecution has started or not.
Applicants state in the reply filed 6/12/2025 that Application No. 17972754 (‘754) is not presently under substantive examination. However, the Examiner would like to point out that an issue of Allowance was granted for Application No. 17972754 (‘754) that is NOW USP 12527804. Applicants filed Terminal Disclaimers directed to the Double Patenting Rejection of Applications 17/967,267 (filed 11/26/2024) and 17/672,894 (filed 7/16/2025) (Instant Application).
Therefore, Applicants’ arguments that there is not presently substantive examination for ‘267 and ‘753 applications is not persuasive.
Applicants in the reply filed 6/12/2025 request to hold the Double Patenting Rejections in abeyance (See reply at pages 25-27).
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 ‘267, Applicant is reminded that the instant application and the ‘267 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 ‘267 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, applicant 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.
Claim Rejections - 35 USC § 112
(Rejection is maintained and made again)
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 rejection of claim 2 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 is maintained and made again.
Claim 2 recites: The composition of claim 1, the modified oil phase further comprising an oil.
claim 1 recites: a modified oil phase which encompasses and oil; thus, claim 1 already has an oil. Applicant is reminded that a claim in dependent form must further limit or add a limitation to the claim upon which it depends.
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.
Response to Arguments
Applicants state in the reply filed 6/12/2025 that it is possible that the modified oil phase can lack an oil. Applicants refer to para. [0078] in the specification where it states: when a MO/W microemulsion includes 0% oil, 57 % to 63 % sugar or sugar alcohol by weight is preferred.
Applicant’s arguments have been fully considered but they are not persuasive. While applicant is correct in that ‘modified oil phase’ may not comprise an oil, the rejection under 112d is made because ‘modified oil phase’ is reasonably interpreted to encompasses an oil being present in the ‘modified oil phase’. Thus, where the oil is present, the addition of an oil in claim 2 would not further limit or add a limitation to the claim from which it depends. Thus, in the instant case, the ‘modified oil phase’ as recited in claim 1 is interpreted to comprise an oil, then claim 2 fails to further limit claim 1 because claim 1 already comprises and oil.
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.
Claim 2 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 is indefinite in reciting that the modified oil phase “further comprising an oil” because it is unclear what is encompasses by the phrase. Base claim 1 recites a “modified oil phase”, which is reasonably interpreted to already comprise an oil making it unclear whether claim 2 is referring to the oil already present in the ‘modified oil phase’, or whether additional oil is being added to the “modified oil phase” and whether the added oil is the same or different from the oil that is already present in the ‘modified oil phase’, or if some other meaning is contemplated by the phrase. As written, one skilled in the art would not be reasonably apprised of the metes and bounds of the claim.
Conclusions
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THURMAN WHEELER whose telephone number is (571)-207-1307. The examiner can normally be reached Monday-Friday 10:00am-6:00pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.W./ Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619