DETAILED ACTION
The receipt is acknowledged of applicant’s after final amendment filed 02/13/2026; and request for RCE filed 02/26/2026.
Claims 1-22 are pending.
Claims 17-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/16/2025.
Claims 1-16 are subject of this office 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/26/26 has been entered.
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 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,413,504. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims and the current claims are directed to common subject matter that is covered by the issued claims as follows: drug delivery system consisting of: a core comprising a first polymeric material and a first active ingredient, and a sheath comprising a second polymeric material and a second active ingredient dispersed and/or incorporated in the second polymeric material, wherein the first active ingredient and second active ingredient is a steroid, and wherein the steroid is a contraceptive agent. The issued claims anticipate the pending claims.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,596,103. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims and the current claims are directed to common subject matter that is covered by the issued claims as follows: drug delivery system comprising only two layers: a core comprising a first polymeric material and a first active ingredient, and a sheath comprising a second polymeric material and a second active ingredient dispersed and/or incorporated in the second polymeric material, wherein the first active ingredient and second active ingredient is a steroid, and wherein the steroid is a contraceptive agent. The issued claims anticipate the pending claims.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 10, 11, 17, 19, 21, 22, 24, 26-28 of copending Application No. 18/729,979 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed and claimed in the referenced copending applications and would be covered by any patent granted on the copending applications since the referenced copending applications and the instant application are claiming common subject matter as follows: drug delivery system comprising only: a core comprising a first polymeric material and a first active ingredient, and a sheath comprising a second polymeric material and a second active ingredient dispersed and/or incorporated in the second polymeric material, wherein the first active ingredient and second active ingredient is a steroid, and wherein the steroid is a contraceptive agent. The copending claims and current claims anticipate each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/730,049 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed and claimed in the referenced copending applications and would be covered by any patent granted on the copending applications since the referenced copending applications and the instant application are claiming common subject matter as follows: drug delivery system comprising only: a core comprising a first polymeric material and a first active ingredient, and a sheath comprising a second polymeric material and a second active ingredient dispersed and/or incorporated in the second polymeric material, wherein the first active ingredient and second active ingredient is a steroid, and wherein the steroid is a contraceptive agent. The copending claims and current claims anticipate each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
It is noted that numerous patents and copending applications of Applicants encompass the same or similar subject matter of the instant application. Applicant should review all subject matter which are same or similar and amend the claims or submit terminal disclaimers for each and every one considered to contain similar subject matter.
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 1-16 are rejected under 35 U.S.C. 103 as being obvious over Aarts et al. (US 2016/0296467, previously cited on PTO 892).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Applicant Claims
Claim 1 is directed to a drug delivery system comprising:
- a core comprising a first polymeric material and a first active ingredient, and
- a sheath comprising a second polymeric material and a second active ingredient dispersed and/or incorporated in the second polymeric material in a concentration of at least 10 wt% based on the weight of the sheath, wherein the first active ingredient and second active ingredient is a steroid, and wherein the steroid is a contraceptive agent, and
- wherein the sheath is the outer layer of the drug delivery system, and
- wherein the drug delivery system does not comprise more than the first and second
active ingredient and that the drug delivery system only consists of a single core and a
single sheath completely surrounding said core.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Aarts teaches vaginal ring drug delivery system comprising (i) a core comprising a first thermoplastic polymer and a first therapeutic agent, wherein the first therapeutic agent is dissolved in the first thermoplastic polymer, and (ii) a skin surrounding the core comprising a second thermoplastic polymer and a second therapeutic agent, wherein the second therapeutic agent is in solid form (abstract; ¶¶ 0030, 0059; claims). The vaginal ring drug delivery systems comprising the first therapeutic agent in the core and the second therapeutic agent in the skin surrounding the core, can be described as a hybrid between a reservoir type system and a matrix system or alternatively an enhanced matrix-type system, wherein the first thermoplastic polymer of the core and the second thermoplastic polymer of the skin are different polymers. The therapeutic agent loaded in the core will behave like a reservoir type system and will be released in a near zero order fashion typical for reservoir systems, while the therapeutic agent loaded in the skin will exhibit a release profile more akin to a matrix-type system. It is this hybrid configuration that allows certain embodiments of the described vaginal ring drug delivery systems to meet the necessary release criteria needed to achieve the desired therapeutic effect. In certain embodiments, of the vaginal ring drug delivery systems described herein the second therapeutic agent is loaded into the skin such that the second therapeutic agent is dispersed uniformly though out the skin (¶¶ 0062, 0063). The thickness of the skin is determined by the concentration of the second therapeutic agent and the desired release rate of the second therapeutic agent. Suitable thicknesses of the skin can range from 5-700 μm, i.e. 0.005-0.7 mm (¶ 0067). The thermoplastic material used for the first and second layer is ethylene vinyl acetate copolymer. The first thermoplastic polymer is EVA with vinyl acetate content 28% or greater, e.g. 28-40%, 33%. The second thermoplastic polymer is EVA with vinyl acetate content 28% or greater, e.g. 28-40%, 33%. Sometimes the second thermoplastic polymer is EVA with vinyl acetate content 28% or less, e.g. 9-28%, 9-18% (¶¶ 0077, 0080-0084). The first active agent in the core in present in concentration of 0.1-30%, and the second active agent in the skin is present in concentration of 5-50% (¶¶ 0092, 0093, 0096). The active agent can be contraceptive steroid, e.g. estradiol and progesterone (¶¶ 0117, 0118). The steroid can be estrogen dissolved in the core or progesterone in crystalline form (¶¶ 0121-0123). Claim 22of the reference and claims depending from claim 22 are directed to a vaginal ring comprising only two layers: core and skin, wherein the core and skin comprise different active agent and different vinyl acetate copolymer.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012) &
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
The reference does not teach a single embodiment with the claimed concentration of the second active ingredient as claimed by claim 1. As such, the instant prior art does not appear to provide sufficient specificity, i.e., involves some “picking and choosing” to give rise to anticipation. See, Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). That being said, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect.... the combination is obvious”. KSRv. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). Consistent with this reasoning, it would have obvious to have selected the various combinations of features claimed from within the prior art disclosure, specifically the amount of the second active ingredient from that taught and claimed by the reference.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide vaginal ring having core comprising first active agent and first polymeric material and skin layer comprising second active agent and second polymeric material as taught by the references, and select the concentration of the first and second active agent from within the concentrations taught by reference. One would have been motivated to do so because the reference teaches concentrations overlapping with the claimed concentrations that are suitable for contraception. One would reasonably expect successfully formulating the claimed vaginal ring comprising the claimed concentrations of the claimed active agents.
Regarding the claimed concentrations of the second active agent of at least 10% as claimed by claim 1, and at least 15%, at least 20% or at least 25% as claimed by claim 2, the reference teaches 5-50% that overlaps with the claimed concentrations especially in view of the expression “at least” of the claims. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding the limitation of claim 1 that “wherein the drug delivery system does not comprise more than the first and second active ingredient and that the drug delivery system only consists of a single core and a single sheath completely surrounding said core”, the reference teaches by virtue of claims 22 and the claims depending from claim 22 a vaginal ring comprising only one core and one skin layer surrounding the core as claimed.
Regarding claim 3 that the second active ingredient is dispersed and/or incorporated in the second polymeric material in the form of particles, such as crystals, the reference teaches the active ingredient in the cover is dispersed in solid form.
Regarding claim 4 that the second active ingredient is dispersed and/or incorporated in the second polymeric material in a concentration below the percolation threshold of said second active ingredient in the sheath, the reference teaches the same second active ingredients in the same concentration, therefore expected to be present below the percolation threshold as claimed.
Regarding claim 5 that the second active ingredient is dispersed and/or incorporated in the second polymeric material in a concentration of 40 wt% or below based on the weight of the sheath, preferably in a concentration of 35 wt™% or below, the reference teaches 5-50% that overlap with the claimed concentrations. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding claim 6 that wherein the first active ingredient is dispersed and/or incorporated and/or dissolved in the first polymeric material in a concentration above 5 wt% based on the weight of the core, preferably at least 10 wt% based on the weight of the core, preferably at least 15 wt% based on the weight of the core and even more preferred at least 20 wt% based on the weight of the core, the reference teaches the first active agent is dissolved in the core in a concentration of 10-40%, that overlaps with the claimed concentration. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding claim 7 that the at least one first active ingredient is dispersed and/or incorporated in the first polymeric material in the form of particles, such as crystals, the reference teaches the first active agent can be in form of particles or dissolved.
Regarding the size of the particles as claimed by claim 8 as determined by laser diffraction, one having ordinary skill in the art would have determined the particle size of the active agent based on the desired release profile. The determination of the particle sizes by laser diffraction is not part of the claimed composition.
Regarding claim 9 that the first active ingredient is dissolved in the first polymeric material in a concentration below the saturation concentration of said first active ingredient at 25°C, the reference teaches the claimed first active ingredient, and its concentration is expected to be below the saturation concentration of specific active agent since materials and their properties are inseparable.
Regarding the first polymeric material and/or second polymeric material as claimed by claim 10 that is selected from thermoplastic elastomer, e.g. ethylene-vinyl acetate (EVA) copolymers, low-density polyethylene, polyurethanes, and styrene-butadiene copolymers, the reference teaches at least EVA.
Regarding the first and second polymeric material are ethylene-vinyl acetate copolymer and their vinyl acetate contents as claimed by claims 11 and 12, the reference teaches the EVA having VA content from 19-40% that overlaps with the claimed VA content. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding claim 13 that the contraceptive agent is estrogen or progesterone, the reference teaches both estrogen and progesterone.
Regarding claim 14 that the first active agent is estradiol and the second active agent is progesterone, this is taught by the reference.
Regarding the thickness of the sheath as claimed by claim 15 of 0.05-3 mm, and the cross sectional diameter of the core as claimed by claim 16 of between 2-8 mm, the reference teaches thickness of the skin layer of 0.005-0.7 mm that overlaps with the claimed thickness of 0.05-3 mm. One having ordinary skill in the art would have determined the cross sectional diameter of the core based on the desired release rate and the drug being released. Applicants failed to show unexpected results obtained from specific thickness or diameter.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 02/26/2026 have been fully considered but they are not persuasive.
Double Patenting
Applicants argue that cited patents and applications are directed to multilayered delivery designs wherein the external layer is often non-medicated layer depletion layer. Amended claim 1 recites “consisting of” language that limits the claimed drug delivery device to the only two claimed layers: core and sheath.
In response to this argument, it is noted that the amendment made to the claims had only overcome the double patenting rejections over issued patents and copending applications that require more than the two claimed layers. The maintained double patenting rejection are over patents and application(s) reciting claims that are directed to device comprising only two layers: core and sheath as claimed.
Claim Rejections - 35 U.S.C. 103
Aarts et al.
Applicants argue that mended claim 1 requires a drug delivery system that consists of only two layers (a single core and a single sheath completely surrounding the core) and that does not comprise more than the first and second active ingredients. Aarts describes delivery systems that include a "skin" surrounding the core and, in certain embodiments, a skin having multiple sublayers. The reference does not teach nor suggest the claimed two-layer system in which the medicated sheath is the sole layer surrounding the core. Applicants argue that the cited art emphasizes the use of an external skin/membrane, including non-medicated and/or depletion layers, to control diffusion length and tune release. A person skilled in the art would not have been motivated to remove that release-controlling skin/membrane and instead rely on a two-layer structure in which the outermost sheath itself is medicated with ≥10 wt% steroid. Doing SO would be contrary to the design principles of the cited systems.
In response to this argument, it is argued that Aarts teaches more than one embodiments, one of the embodiments comprises more than one core layer, and second embodiment comprises only one core and a skin layer surround the core completely, and both of the core and skin comprises active agents, claims 22 and 26-29 of the reference. Further, paragraph [0122] of the reference teaches steroid is present in “…..the core, or a layer of the core….” This teaching implies the core can be only one core layer. Aarts teaches only one skin layer that is medicated, and comprises active agent in concentration of 5-50% that overlaps with the claimed amounts. The disclosure of desirable alternatives does not necessarily negate a suggestion for modifying the prior art to arrive at the claimed invention. In In re Fulton, 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir. 2004). In Ruiz v. A.B. Chance Co., 357 F.3d 1270, 69 USPQ2d 1686 (Fed. Cir. 2004), The court found motivation to combine the references to arrive at the claimed invention in the “nature of the problem to be solved” because each reference was directed “to precisely the same problem.” Id. at 1276, 69 USPQ2d at 1690. The court also rejected the notion that “an express written motivation to combine must appear in prior art references….” Id. at 1276, 69 USPQ2d at 1690.
Applicant argue that the experimental data submitted previously on September 15, 2025 further demonstrate unexpected results consistent with the claimed two-layer, medicated-sheath design, including that the release of the sheath-loaded steroid is substantially independent of sheath thickness over the tested range (e.g., 200, 300, and 400 µm), and that higher sheath steroid loading can suppress an initial burst. These results support the non-obviousness of the claimed subject matter.
In response to this arguments, the examiner maintains the arguments in the final office action, and further emphasizes that the cited references teach the instantly claimed thickness of the sheath layer and teaches the steroid amount present in two layers of the device and teach the claimed polymers of each layer. Applicant did not compare the presently claimed device with the devices of the prior art in order to establish criticality and superiority. The data provided by applicants is expected since the prior art teaches the same structure of the device, the same amount of steroids in each layer and the same claimed material of each layer and same thickness of the sheath. The results applicants achieved are not unexpected superior results over the prior art, absent comparative data in record. It is the examiner's position that the data in the specification are not unexpected results and therefore cannot rebut prima facie obviousness. The examiner directs applicant's attention to MPEP 716.02 (a). "A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness...of the claims at issue." In re Corkhill, 711 F.2d 1496, 266 USPQ 1006 (Fed.Cir. 1985). In Corkhill, the claimed combination showed an additive result when a diminished result would have been expected. Furthermore, the MPEP states, "Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967). Further, the data shown by applicants does not commensurate in scope of the claims because applicants tested core comprising E2 and sheath comprising 33.9% progesterone and claim 1 recites any steroid in either core or sheath, and claim 13 recites that the contraceptive agent is estrogenic steroid and/or progestational steroid in each layer.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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