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 . Claims included in the prosecution are claims 25, 26 and 29-46.
Claim Objections
Claim 25 is objected to because of the following informalities: “vinyl-acetate (EVA) intravaginal ring (IVR), wherein the ring contains at least two segments/fibers” should not be italicized. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: “(memory” in the third line should be recited as --- memory ---. Appropriate correction is required.
Claim 33 is objected to because of the following informalities: “in length” in the last line should be removed since it is repetitive. Appropriate correction is required.
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.
Claims 25, 26 and 29-46 are 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.
1. Claims 25 and 30-33 recite the term “segments/fibers.” The claims are indefinite since a segment and a fiber are not necessarily the same since a fiber has a particular structure that a segment does not necessarily need to have and it is unclear whether the claim comprises both a segment and a fiber or whether the terms are meant to mean the same thing.
2. Regarding claim 26, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
3. Regarding claims 30 and 32, the phrase "(28% vinyl acetate content)" renders the claim indefinite because it is unclear whether the limitation within the parenthesis is part of the claimed invention.
4. Claims 34-38 recite the limitation "rings.” There is insufficient antecedent basis for this limitation in the claim. The claims recite a plurality of rings and it is unclear what other ring the claims are referring to when claim 25 recites a singular ring.
5. Claim 45 recites the limitation "the device" in the first line. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether the claim is referring to the ring in claim 25 or is referring to an additional embodiment of the claimed invention.
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 25, 26 and 29-46 are rejected under 35 U.S.C. 103 as being unpatentable over Ron et al. (US 2008/0248017, Oct. 9, 2008) (IDS reference).
Ron et al. disclose a drug delivery device comprising two or more unitary segments. Each segment comprises a drug-permeable polymeric substance. Two or more segments may each contain a drug, preferably a different drug in each segment. The drug-permeable polymeric substance may be a thermoplastic polymer, such as an ethylene-vinyl acetate copolymer (EVA). The drug delivery device may be in the shape of a ring. The drug delivery device may have an overall diameter of from 40 mm to 80 mm, and a cross-sectional diameter of from 2 mm to 12 mm. The drug to be delivered may be an estrogenic compound and a progestational compound (¶ [0016]). Suitable estrogenic compounds include 17-β estradiol (¶ [0054]). Suitable progestational compounds include progesterone (¶ [0055]). The drug delivery device may be an intravaginal device (¶ [0002]). The release of the drug by a drug delivery device comprising EVA is determined to a large extent by the vinyl acetate content of the material. Preferably, the EVA has a vinyl acetate content of about 4 to 50% by weight. The release of the drug by a drug delivery device comprising EVA is also controlled by the surface area of the segment. For example, in order to increase the rate of release of the drug one could increase the length and/or circumference of the segment (¶ [0068]). Release rate is further dependent upon the initial concentration of the active substance in the polymeric matrix (¶ [0077]). The amount of drug incorporated in the drug delivery device varies depending on the particular drug, the desired therapeutic effect, and the time span for which the device provides therapy (¶ [0076]). Proportions suitable can range from about 0.01 to 50 parts by weight of the active substance (¶ [0077]). The drug delivery device may be used for relieving symptoms and signs associated with menopausal, perimenopausal, and post-menopausal women (¶ [0024]). A perimonopasual women have associated symptoms of estrogen deficiency, such as vasomotor flushes (¶ [0062]). The device may be designed to release drugs over 28 days (¶ [0157]).
Ron et al. differ from the instant claims insofar as not disclosing about 4 mg to about 8 mg progesterone and about 80 µg to about 160 µg 17β-estradiol is released per day.
However, Ron et al. disclose wherein release rate is dependent upon the initial concentration of the active substance in the polymeric matrix and wherein the amount of drug incorporated depends on the desired therapeutic effect and the time span for which the device provides therapy. Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed release rate depending on the therapeutic effect and time span of therapy desired. One of ordinary skill in the art would have had a reasonable expectation of success since Ron et al. disclose wherein the release of the drug is determined to a large extent by the vinyl acetate content, the surface area of the segment, and the initial concentration of the active substance in the polymeric matrix.
In regards to instant claims 31 and 33 reciting a particular segment length, Ron et al. disclose wherein the length of the segment affects rate of release of the drug. Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed length depending on the rate of release of the drug desired.
In regards to instant claim 1 reciting wherein the average in vivo plasma concentration of 17β-estradiol (E2) over a dosing interval (CAVG) is about 22 pg/mL to about 37 pg/mL and the limitations of instant claims 34-45, the properties recited are measured from intravaginal rings releasing either 4 mg or 8 mg progesterone per day (see paragraphs [0039] and [0059] and Tables 2 and 3 of the instant specification). Since it would have been obvious to one of ordinary skill in the art to have arrived at the claimed IVR through routine experimentation depending on the therapeutic effect and time span of therapy desired, the properties associated therewith, which are recited in claims 34-45, would have also been obvious.
Conclusion
Claims 25, 26 and 29-46 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1612
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