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 .
DETAILED ACTION
Claims 1-3, 8, 10, 11, 17, 19, 21, 22, 24, 26-28, 31, 32 and 34-37 are currently pending and amendments to the claims filed on 06/03/2026 are acknowledged.
Election/Restriction
Applicant's election without traverse of Group I, claims 1-3, 8, 10, 11, 17, 19, 21, 22, 24, and 26-28 in the Reply filed on 06/03/2026 is acknowledged. By way of applicant’s election, claims 31, 32 and 34-37 have been withdrawn from further consideration. Therefore, claims 1-3, 8, 10, 11, 17, 19, 21, 22, 24, and 26-28 are examined on the merits to which the following grounds of rejections are applicable. Since the election was made without traverse, the requirement is still deemed proper and is therefore made FINAL.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/03/2026 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
Claim Objections
Claim 21 is objected to a minor informality under 37 CFR 1.75.
There is no conjunction word “and” or “or” between (a) and (b) in claim 21. Appropriate correction is requested.
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 1 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 1 recites “reservoir-type ring composition” in line 2. However, claim 1 is indefinite in the recitation of the term "type” because it was unclear what “type” of reservoir in vaginal ring was intended to convey. That is, it is not clear how close it has to resemble an reservoir in the ring for the artisan to know when they are infringing or not, and thus, this term extends the scope of the expression so as to render it indefinite. See case law. The addition of the word “type” to an otherwise definite expression (e.g., Friedel-Crafts catalyst) extends the scope of the expression so as to render it indefinite. Ex parte Copenhaver, 109 USPQ 118 (Bd. Pat. App. & Inter. 1955).
Appropriate correction is requested.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-3, 8, 10, 11, 17, 19, 21, 22, 24 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over De Graaff et al. (US2015/0157561A1) in view of Devin et al. (US2015/0136143A1, IDS of 06/03/2026) as evidenced by Boyd et al., “The ins and outs of drug-releasing vaginal rings: a literature review of expulsions and removals”, Expert Opinion on Drug Delivery, 2020, vol. 17, no. 11. Pp. 1519-1540.
Applicant claims the below claim 1 filed on 06/03/2026:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a cosmetic research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from skin moisturizer — without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
De Graaff discloses an intra-vaginal drug delivery system comprising (i) a core comprising a first thermoplastic polymer such as EVA 28, and a first therapeutic agent, wherein the first therapeutic agent is dissolved in the first thermoplastic polymer, and the core reads on the claimed core and (ii) a skin surrounding the core comprising a second thermoplastic polymer such as EVA 15 or 18 and a second therapeutic agent (e.g., abstract, [0064]), and the skin reads on the claimed sheath; the first therapeutic agent is steroid wherein the steroid includes levonorgestrel (e.g., [0076]-[0077]); anti-microbial drug such as dapivirine can be incorporated into in the skin portion (e.g., [0094]); EVA28 in the core is used in an amount of about 99% (e.g., Table 2), and although the prior art does not expressly the claimed range, it would be optimized depending on the intended purpose, amounts of other ingredients, etc., and EVA 16 is used in an amount of about 73% to about 91% (Table 1a) which overlaps the claimed range of about 70%-about 85%; and the ring has an outer diameter of between 50 and 60 mm that overlaps the instant range of about 53-57mm and a cross-sectional diameter is between about 2.5 to 5 mm that overlaps the instant range of about 3.8 to 4.5mm (e.g., [0091]). MPEP 2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); and the ring is effective to treat and/or prevent AIDS, chlamydia, herpes and gonorrhoea (e.g., [0092]-[0093]) (instant claim 1, in part); EVA18 is used in an amount of about 82% to about 91% (e.g., Table 1b) that about 82% is close enough to the instant range about 80%. In this respect, please see MPEP 2144.05(I): “Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (instant claim 2); the instant intravaginal ring does not comprise antioxidant and EVA28 does not comprise an antioxidant (instant claim 3); the ring further comprises magnesium stearate in an amount of 0.1% that is within the claimed range of about 0.0% to 0.2% (e.g., [0123] and Table 1a) (instant claim 8); the therapeutic agent loaded in the core will behave like a reservoir type system and will be released in a near zero order fashion (e.g., [0049])(instant claim 10); the ring is stable at room temperature (e.g., [0095]) and the thickness of the skin is 100-500 microns (e.g., [0058]) that overlaps the instant range of about 100 to about 300 microns (instant claim 19, in part); the first/second therapeutic agents are uniformly distributed in core and skin (instant claim 24); the therapeutic agent is micronized (instant claim 26); and the second therapeutic agent can be in crystal form (e.g., [0057]) (instant claim 28);
However, De Graaff does not disclose selection of levonorgestrel and dapivirine among drugs as claimed; the amount of active agents of instant claims 1 and 17; weight of ring of instant clam 19; and release profile of instant claim 11. The deficiencies are cured by Devin.
Devin discloses intravaginal rings containing dapivirine in combination with contraceptive compound levonorgestrel (e.g., abstract and [0026]) for e.g., treating HIV infection such as AIDS; the rings contain a core (=reservoir) and a sheath (e.g., [0068]); the ring comprises an EVA polymer (e.g., [0023] and [0075]); the release rates can be modified by changing the thickness of the rate-controlling sheath and/or the length of the drug-loaded core, and reservoir rings were developed to provide controlled (that is, constant daily) release rates ([0008]) ; less than about 7 mg (= 7000 microgram) dapivirine is released in vitro from the ring during an initial 24 hour period of release (e.g., [0011]) and the release amount of less than about 7000 microgram overlaps the instant range (c) of about 2500-about 6500 microgram (= about 2.5 – 6.5mg) (instant claims 1 and 11); the dapivirine is present in the ring in an amount of about 10 to about 800mg including about 100mg, about 150 mg, about 200mg etc. (e.g., [0027] and claims 37-38 of prior art) and the contraceptive compound is present in an amount of about 10 to about 800mg or about 10 to about 100mg including about 50mg (e.g., claims 50, 51, and 55 of prior art). Both amounts overlap the claimed ranges. MPEP 2144.05 noted above (instant claim 17), and Devin does not expressly teach about 5% to about 20% of levonorgestrel and about 70% to about 80% of dapivirine of instant claim 1, Devin discloses the dosage amount (mg) as noted above, and therefore, the amounts (%) of active agents would be optimized depending on the intended purpose, relationship with other ingredients, etc. It would have been obvious to modify the teaching of De Graaff with the amounts of levonorgestrel and dapivirine of Devin in order to provide therapeutically effective amounts and the amounts of Devin overlap the instant range, and thus the ordinary artisan would have optimized the amounts with the claimed amounts without undue experimentation (instant claim 1 – amounts of active ingredients).
It would have been obvious to specifically select the combination of levonorgestrel and dapivirine among various drugs of De Graaff for the vaginal ring in order to enhance the treatment of infection, e.g., HIV and/or AIDS as taught by Devin.
The applied art alone or in combination do not teach the weight of the ring of instant claim 19. However, that ring weight would depend on the amounts of active ingredients, polymers, excipients etc. and therefore the ordinary artisan would have optimized the weight of rings from the teachings of the applied art, in the absence of criticality evidence (instant clam 19 – ring weight).
Although the applied art alone or in combination does not expressly teach the hardness and retention time compared to a silicone ring, it is generally known that silicone is softer and more flexible while EVA polymer has a stiffer structure as evidenced by Boyd (see, e.g., sections 2.3.1 and 2.3.2 on pages 1522-1524), and therefore, the mechanical properties including hardness of the ring using EVA would have been increased by certain ranges compared to using silicone ring. Further, since the combination of De Graaff/Devin teach the same or very similar vaginal ring, the properties such as retention time of instant claim 21 and increased stability of levonorgestrel of instant claim 27 compared to a silicone ring would be implicit. This is because the claimed features are a natural result of the combination of elements. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). (inherency is limited when applied to obviousness and is present only when the limitation at issue is the “natural result” of the combination of prior art elements; quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)) (instant claims 21-22 and 27).
In light of the foregoing, the claimed invention is obvious over De Graaff in view of Devin.
Conclusion
All examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613
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