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 .
Status of Application
Receipt of Applicant’s remarks and amended claims filed on December 31, 2025 is acknowledged.
Claims 1-23 are pending in this application.
Claims 1 and 13 have been amended.
No claims have been cancelled.
All claims are under examination in this application.
Withdrawn Rejections
Claim Rejections - 35 USC § 103
The rejection of claims 1-20 under 35 U.S.C. 103 as being unpatentable over Kiser et al. (US 2014/0209100) has been withdrawn in view of the amendment to claim 1 to recite “wherein the core and membrane are each made of an ethylene-vinyl acetate copolymer”.
The rejection of claims 21-23 under 35 U.S.C. 103 as being unpatentable over Kiser et al. (US 2014/0209100) as applied to claims 1-20 above, and further in view of Groenewegan (CN 1196930 A) has been withdrawn in view of the amendment to claim 1 to recite “wherein the core and membrane are each made of an ethylene-vinyl acetate copolymer”.
Newly Applied Objections/Rejections
Claim Objections
Claim 3 is objected to because of the following informalities: 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. It is suggested the claim be amended to recite “the amount of etonogestrel in the drug delivery system is from about 1 mg to about 75 mg”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 21-23 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 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”. 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 Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Groenewegan (US 5,989,581).
Groenewegan 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).
Regarding claims 2-6, while Groenewegan does not explicitly recite the total amount of etonogestrel or the ethinyl estradiol present in the ring. However, the instant claims and the disclosure of Groenewegan disclose overlapping dosage of each of the steroids over the same period of times, therefore, it would necessarily have the same total amounts of etonogestrel and ethinyl estradiol present.
Regarding claim 7, the poly(EVA) core may comprise 0.5-1% etonogestrel (column 4, lines 60-61).
Regarding claim 8, the poly(EVA) core may comprise 0.1-0.23% ethinyl estradiol (column 4, lines 61-62).
Regarding claims 9-12 and 15-18, 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).
Regarding claim 13, the ring is primarily designed for contraceptive use (column 3, lines 60-61).
Regarding claims 14 and 19-20, since Groenewegan discloses the same device recited in claim 1, it would necessarily have the same properties and functional limitations recited in the instant claims. Applicant’s 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 a ethylene-vinyl acetate copolymer with a 25 to 35% (column 4, lines 29-31).
Groenewegan, therefore, anticipates the rejected claims.
Conclusion
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.
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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