DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/9/2024 has been considered by the examiner.
Status of the Claims
Claims 2, 3, 6-9, 11-20, 22-25, 29, 30, 32-34, 37, 43, and 48-50 have been canceled by preliminary amendment. Claims 1, 4, 5, 10, 21, 26-28, 31, 35, 36, 38-42, and 44-47 are pending and under current examination.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 1, 26-28, 31, 35, 36, 38-42, and 44-47 in the reply filed on 1/2/2026 is acknowledged.
Claims 4, 5, 10, and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/2/2026.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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, 26-28, 31, 35, 36, 38-42, and 44-47 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0397692A1 (“hereafter, “Variano”) in view of US 5,972,372 (hereafter, “Saleh”) and “Archer” (“Efficacy of the 1-year (13-cycle) segesterone acetate and ethinyl estradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials”, Lancet Glob Health, 2019; 7: e1054-64).
The instant claims are drawn to a method comprising (a) inserting into the vagina of the female a vaginal ring system, which is further specified in the claims, and retaining the ring system in the vagina for 364 consecutive days and wherein the method achieves a serum sample as claimed. It is noted that “approximately” is defined at paragraph [0086] of the specification as filed.
Variano teaches an intravaginal ring system applied to prevent pregnancy [in a female of reproductive potential] wherein the system is comprised of segesterone acetate and ethinyl estradiol and is configured for thirteen 28-day product use cycles (see abstract, in particular). Variano’s ring comprises two cylindrical cores, the first core comprising segesterone acetate, the second core comprising segesterone acetate and ethinyl estradiol. The ring body is made of a cured silicone elastomer comprising platinum, and the cores are made of a silicone material. Example 12 for instance discloses a clinical trial in which the ring is applied for 364 days divided into 13 cycles, each cycle involving 21 consecutive days of exposure and 7 days of device removal. Variano’s system includes a silicone elastomer ring body including a first core and a second core, each comprising respective elastomers impregnated with respective active agents of segesterone acetate and ethinyl estradiol (see [0039] and [0040] for instance). The cylindrical cores are inserted into a channel (see [0091]); the vaginal system comprises one or more channels adapted to receive at least oen core (see [0202] and [0204])(limitations “a” and “b” as in claim 1).
Regarding claim 1, component i, Variano teaches the silicone elastomer to have a platinum concentration from approximately 1 to 15 ppm or in certain embodiments from 2 to 10 ppm (see [0264]), a range including the instantly claimed range of approximately 3 to 10 ppm platinum concentration (further limitation of claim 42). Variano teaches the elastomer to include a hydride/vinyl ratio from approximately 1:2 to 5:1, in some embodiments from 1:1.5 to 3:1 (see [0266]), ranges including substantially the same values and overlapping the range recited in claim 1.
Further regarding claim 1 component ii, Variano’s ring body cores may be made of condensation cure silicone elastomers and may comprise one or more of said elastomeric cores (see [0218]). The condensation cure silicone elastomer may be prepared from components including a dibutyltin dilaurate (see [0220] last line) and may in some embodiments include silica in combination (“a viscosity agent” as in claim 1ii)(see [0219] and [0221]). Diatomaceous earth, cellulose, talc, and/or silica may be included to increase viscosity (see [0217]). The first core contains from approximately 40 to 60% by mass of segesterone acetate (see [0213]), a range including the instantly recited “approximately 50% segesterone acetate by mass”.
Further regarding claim 1 component iii, Variano’s embodiments encompass the claimed features. Variano teaches two cores containing segesterone acetate and another containing segesterone acetate and ethinyl estradiol (see [0009]). Variano specifies a combination core which may comprise from approximately 30 to 50 or approximately 50% by mass of segesterone acetate in combination with 5 to 20% and more particularly 10 to 14% and more particularly still approximately 12% of ethinyl estradiol (see [0215]).
As to claim 1 component iv, Variano specifies an embodiment in which 103 mg of segesterone acetate and 17.4 mg of ethinyl estradiol are included in the cores of the ring system (see end of [0209]).
As to the “volume ratio of about 11:18” recited in claim 1, this term is interpreted to recite a ratio which is volume of a first cylindrical core : volume of a second cylindrical core wherein said ratio is about 11:18. Variano does not use the term “volume ratio” as recited in claim 1, however Variano describes the same shape and size parameters which correspond to the same volume ratio. Variano specifies that its vaginal system is a ring-shaped structure suitable for insertion to the vagina with the cores suitable for containment with said ring (see [0194]) and the ring’s cross-sectional diameter is approximately 3 mm to 10 mm and more specifically approximately 8.4 mm (see [0199])(limitation of claims 38 and 41). The ring has an interior diameter approximately 40 mm (see [0198])(limitation of claims 38 and 40) and an overall diameter of approximately 56 mm (see [0197])(limitations of claims 38 and 39) wherein sizing is an important component in the system design for practical use purposes (see [0201]). The ring body has channels adapted to receive the cores for instance on opposing sides of the ring body or in closer proximinty to each other (see [0202]). Variano teaches the same recovery profile as instantly claimed (see Variano claim 1 and [0300])(limitation of claim 26). As to the cores themselves, the first core may be from 1 to 5 mm in diameter and 9 to 13 mm in length and the second core from 1 to 5 mm in diameter and from 16 to 20 mm in length (see [0214] and [0215])(limitations of claims 27 and 28). Each of the two channels have diameter of approximately 3 mm (see [0207])(limitation of claim 31) and first and second channel lengths of approximately 27 mm (see [0207])(limitation of claim 35) and are substantially parallel (see [0276])(limitation of claim 36). The silicone elastomer ring body has shore A hardness of approximately 25 to 30 and a mean fatigue parallel to the cores of approximately 85% and a mean fatigue perpendicular to the cores of approximately 98% (see [0030])(limitation of claim 44). The first core is impregnated with a first amount of segesterone acetate particles having the same particle size distribution instantly claimed (see [0039]) as well as second core components and particle size disbribution the same s instantly claimed (see [0040])(limitation of claim 45). At least 75% of the segesterone acetate comprises polymorphic form I and up to 25% is polymorphic form II (see [0046] and [0047])(limitations of claims 46 and 47).
A resulting volume ratio between these first and second cores appears to be the same or substantially the same as about 11:18 as instantly recited (see also [0226] and [0227] of the instant specification as filed illustrating the overlapping dimensions and therefore volume ratios of first and second cores).
Variano’s Example 12 discloses ring application for a 1-year trial, divided into 13 cycles each involving 21 consecutive days of exposure plus 7 days of device removal, however Variano does not teach retaining the ring for 364 consecutive days without any removal nor does Variano specify the segesterone acetate or ethinyl estradiol concentration in serum as a function of 364 day time as in claim 1. Variano does not teach 80-90 days of consecutive use followed by removal as in claim 4.
Saleh cures this deficiency by teaching that a pharmaceutically effective amount is an amount sufficient to result in contraception for a predetermined time period which may be about a year (see column 7, lines 30-34), and Archer provides rationale for the serum concentration claimed.
Like Variano, Saleh is directed to intravaginal ring devices with drug-containing cores in their respective cylindrical channels (see Saleh abstract, in particular). It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to perform routine optimization procedures as to the duration of vaginal ring exposure and specifically to increase it to a time period of about a year based on Saleh’s delineation of the state of the art including this time period, with a reasonable expectation of success. Moreover, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to perform routine optimization procedures with respect to achieved serum concentration of segesterone acetate and/or ethinyl estradiol active agents over the aforementioned time period; one would have been motivated to do so to achieve the desired end result of contraception efficacy alongside reduced undesired side effects.
Like Variano, Archer teaches contraception using segesterone acetate and ethinylestradiol vaginal systems (see title, in particular). Archer specifies that ovulation is likely when segesterone acetate serum levels drop below 100 pmol/L (page e1057, column 1, 8 lines from the bottom of the page).
Therefore, regarding the effects recited in claim 1, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to adjust the amount and release properties of Variano and Saleh’s vaginal ring systems to achieve a serum concentration of above 100 pmol/L. One would have been motivated to do so since Archer teaches this as the minimum necessary to prevent ovulation thereby achieving desired contraceptive effects.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/ Primary Examiner, Art Unit 1617