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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on July 22, 2026 has been entered.
Status of Application
Receipt of Applicant’s remarks and amended claims filed on June 18, 2026 is acknowledged.
Claims 1-2, 4-5, and 7-23 are pending in this application.
Claims 1, 4-5, 9, 13, 15-17, and 21 have been amended.
Claims 3 and 6 have been cancelled.
All claims are under examination in this application.
Withdrawn Objections/Rejections
Claim Objections
The objection to claim 3 because the claim recites “the amount of etonogestrel in the drug delivery system is from about 1 mg etonogestrel to about 75 mg etonogestrel”; the additional recitations of etonogestrel is unnecessary and redundant has been withdrawn in view of the cancellation of the claim
Claim Rejections - 35 USC § 112
The rejection of claims 21-23 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 because claim 1, from which claims 21-23, ultimately depend recite the core and membrane are each made of an ethylene-vinyl acetate copolymer, however, the rejected claims recite the “core and the membrane are each independently made of a thermoplastic polymer or an elastomer” has been withdrawn in view of the amendment to claim 21 to remove the “core and the membrane are each independently made of a thermoplastic polymer or an elastomer” recitation.
Claim Rejections - 35 USC § 102
The rejection of claims 1-21 under 35 U.S.C. 102(a)(1) as being anticipated by Groenewegen (US 5,989,581) has been withdrawn in view of the amendments to claim 1 to recite the “core comprises ethinyl estradiol in an amount from about 0.1 mg to about 2.5 mg and etonogestrel from about 8 mg to about 9 mg” and the period of time of 21 days has been deleted from the claim.
Newly Applied Objections/Rejections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, the claim recites “delivers less than an average of 0.013 per day”. The amount has no units. However, after a review of the instant claim set and the previous claim set, the units have been removed from the claim. The previous claim set dated December 31, 2025 recited “mg” as units. For purposes of continued examination of this application, the claim has been interpreted to recite “0.013 mg”. Appropriate correction is required.
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, 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.
Claims 1-2, 4-5, and 7-23 are rejected under 35 U.S.C. 103 as being unpatentable over Groenewegen (US 5,989,581) in view of Kiser et al. (US 2014/0209100).
Groenewegen discloses a drug delivery device in a ring-shaped form suitable for vaginal administration, for the simultaneous release of a progestogenic steroid and an estrogenic steroid compound in a fixed physiological ratio over a prolonged period of time The drug delivery system comprises at least one compartment comprising a thermoplastic polymer core containing the mixture of the progestogenic and estrogenic compounds and a thermoplastic polymer skin (abstract).
The drug delivery system for at least two steroidal compounds (such as a progestogen and an estrogen) are preferably for etonogestrel and ethinyl-estradiol (column 2, lines 28-34).
The thermoplastic polymer core is ethylene-vinyl acetate copolymer (poly-EVA) (column 2, lines 55-57).
The thermoplastic polymer (poly-EVA) is used for the core, as well as the skin (membrane) (column 3, line 32-34).
The device is loaded so as to allow over a period of 21 days an average release rate of 95 to 145 mg etonogestrel and 10-20 mg ethinyl estradiol per 24 hours in situ (column 4, lines 12-15).
Groenewegen does not disclose a time period over 21 days or the total amount of each steroid within the device.
Kiser discloses an intravaginal drug delivery device (IVDs), such as a ring (abstract) which can comprise poly(ethylene co-vinyl acetate) (EVA) (paragraph 0037).
The device comprises a rate controlling membrane over the drug containing core (paragraph 0061).
Contraceptive agents, hormones, and estrogen receptor modulators may be delivered with the device (paragraph 0032).
Ethyl estradiol and etonogestrel are disclosed (paragraph 0034; claim 29; Example 4).
The amount of drugs in the device range from 1 mg to 2000 mg. The drug is present in an amount ranging from about 0.01% w/w to about 50% w/w, where w/w refers to the weight ratio of the drug to the total weight of the device (paragraph 0035).
The devices are adapted to delivery pharmaceutically effective amounts of each drug (paragraph 0035).
The device capable of providing sustained delivery of one or more vaginally administrable drugs in a substantially zero order release profile. The devices exhibit a substantially zero order release profile of the drug over at least one day or the devices exhibit a substantially zero order release profile of the drug over at least several days (e.g., over at least 2, 3, 4, 5, or 6 days), over at least a week, over at least one month, or over more than a month (e.g., over at least 45, 60, or 90 days) (paragraph 0036).
The devices exhibit release rates of about 5 mg, about 10 mg, about 25 mg, about 50 mg, about 75 mg, about 100 mg, about 150 mg, about 200 mg, about 500 mg, about 750 mg, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 10 mg, about 15 mg, about 20 mg, about 30 mg, about 40 mg, about 50 mg of drug per day and ranges between and including any two such values (paragraph 0036).
Regarding claims 2, and 4-5, while Groenewegen does not explicitly recite the total amount of etonogestrel or the ethinyl estradiol present in the ring, the ranges recited in the instant claims are within those customarily found in intravaginal delivery devices (vaginal rings), as shown by Kiser. The instant claims and the disclosure of Groenewegen and Kiser disclose overlapping dosage of each of the steroids over the same intervals of times, therefore, it would have been obvious to one of ordinary skill in the art to adjust the total load of the steroids in the device based on the time interval sought for delivery of the etonogestrel and ethinyl estradiol to the patient.
Regarding claim 7, Groenewegen discloses the poly(EVA) core may comprise 0.5-1% etonogestrel (column 4, lines 60-61).
Regarding claim 8, Groenewegen discloses the poly(EVA) core may comprise 0.1-0.23% ethinyl estradiol (column 4, lines 61-62).
Regarding claims 9-12 and 15-18, Groenewegen discloses the vaginal ring allows for delivery over a period of 21 days an average release rate of 95 to 145 mg etonogestrel and 10-20 mg ethinyl estradiol per 24 hours in situ (column 4, lines 12-15). Applicant is directed above to the teachings of Kiser regarding drug loading and delivery past the 21 days detailed by Groenewegen.
Regarding claim 13, the ring is primarily designed for contraceptive use inside the vagina (column 3, lines 60-61), while not explicitly taught, the skilled artisan would understand that after a prolonged period of time, the device is to be removed.
Regarding claims 14 and 19-20, since Groenewegen and Kiser disclose the same device recited in claim 1, it would necessarily have the same properties and functional limitations recited in the instant claims. Applicants’ attention is directed to MPEP 2112.01 which discloses "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
Regarding claim 21, the core body and skin (membrane) is advantageously comprised of an ethylene-vinyl acetate copolymer with a 25 to 35% (column 4, lines 29-31), the skin (membrane) is comprised of 5-15% vinyl acetate content (column 4, lines 20-22).
Regarding claim 22, the example of Groenewegen discloses the preparation of a ring comprising:
57-75 parts of etonogestrel;
12-16 parts of ethinyl estradiol;
5 parts of magnesium stearate;
9904-9926 parts of Evatane 28-25 (EVA copolymer), which is about 99% EVA copolymer. It is the position of the Examiner that 99% reads on “about 92%” recited in the instant claim.
Regarding claim 23, Example 2 of Groenewegen additionally discloses the core is coextruded with Evatane 1020 VN3 which is interpreted as the skin (membrane). Based on the thickness of the membrane, the skilled artisan would be able to adjust and optimize the percentage and total weight of the membrane within the total formulation.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have optimized and adjusted the amounts of the steroids within the ring in order to provide extended and sustained delivery via the device. Applicant’s attention is directed to MPEP 2141.03 which states "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397.
Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-5, 7-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/240284. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and copending claims recite a drug delivery device comprising a core of ethinyl estradiol and etonogestrel with a membrane covering said core. Both devices are additionally disclosed to deliver 0.013 mg per day of ethinyl estradiol over a period of time ranging from 21 days to 3 months. The release profile of etonogestrel is disclosed in dependent claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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