DETAILED ACTION
The receipt is acknowledged of applicant’s amendment filed 09/15/2025.
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Claims 17-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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. Withdrawn claims are improperly identified as either “Original”, “Previously Presented”, or “Currently Amended”. Applicants may correct the claims’ identifier in the next communication.
Claims 1-16 are subject of this office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
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 8 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites “particle size of 3 µm and 40 µm”. The claim recites the broad recitation “40 µm” and the claim also recites narrower recitation “3 µm”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The boundaries of coverage is not imposed by the disclosure. It is important that a person of ordinary skill in the art be able to interpret the metes and bounds of the claims so as to understand how to avoid infringement of the patent that ultimately issues from the application being examined. See MPEP § 2173.02.
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 1-30, 35-40, 43 of U.S. Patent No. 8,333,983. 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: 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, 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 1-8 of U.S. Patent No. 8,481,079. 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: 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 1-29 of U.S. Patent No. 8,741,329. 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: 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 1-5 of U.S. Patent No. 8,858,977. 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: 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 1-6 of U.S. Patent No. 8,900,615. 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: 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 1-8 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 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, 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: 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: 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: 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 is/are rejected under 35 U.S.C. 103 as being obvious over De Graaff et al. (US 2009/0081278), as optionally evidenced by the article by Tomic et al.(A rapid test to measure adhesion between optical fibers and ethylene-vinyl acetate copolymer (EVA)), both references are previously cited in PTO 892, and copy of the NPL previously provided.
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.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
De Graaff teaches a drug delivery system comprising one compartment comprising (i) a drug-loaded thermoplastic polymer core layer, (ii) a drug-loaded thermoplastic polymer layer cover the core, wherein said core layer is loaded with crystals of a first pharmaceutically active compound and cover layer is loaded with, crystals of the second pharmaceutically active compound. The delivery system can be in the form of a vaginal ring for contraception (abstract; ¶¶ 0018, 0020, 0031, 0061-0063). The drug delivery system allows to adjust, independently from one another, the release rate of two pharmaceutically active compounds, that are present in the crystalline state in the polymer, for example because they have a relatively poor solubility in ethylene vinyl acetate (EVA) polymers and/or require a relatively high drug load in the polymeric matrix in order to obtain the desired release profile (¶¶ 0022, 0094). A fraction of actives A and B will dissolve in the polymer until the saturation concentration is reached and simultaneous internal diffusion will level out the internal concentration gradient (¶ 0025). The diffusion length of the compound loaded in the core layer can be adjusted by varying the thickness of the covering layer. Thus by varying the intermediate layer thickness the release rate of the compound loaded in the core layer can be tuned up or down, by decreasing or increasing the cover layer thickness. Another possibility to change the release ratio drastically is to reverse the drug load in the core layer and cover layer. Instead of loading active A in the core layer and B in the intermediate layer, B can be loaded in the core layer and A in the intermediate layer. A further means to tune the release ratio is to make use of different polymer grades used for the intermediate layer (¶¶ 0067, 0068, 0089). The active compounds have a relatively poor solubility in EVA polymers and require a relatively high load in the polymeric matrix in order to obtain the desired release ratio. In a more specific embodiment of the invention, both pharmaceutically active compounds are steroids wherein the core comprises one steroid and cover comprises a second steroid (¶¶ 0081, 0083, 0087). The reference teaches Elvax as EVA polymer (¶ 0094) and Elvax has VA content between 18 and 40% as evidenced by Table 1 of the article by Tomic. The ring has cross section diameter between about 2.5 and 6 mm (¶ 0097). The amount of the drug in both core and cover is 45%, e.g. 20-35% (¶ 0101). The steroids are estradiol and progesterone, wherein estradiol is present in the core in a concentration between 3-70%, 3-27%, 9-27% 3-20%, 4.5-9%, and progesterone in the cover layer in a concentration of 10-70%, 5-35%, 35%, 35-60% (¶¶ 0133-0136; claims 23-36). Example 1 teaches EVA having vinyl acetate content of 28%.
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 cover layer comprising second active agent and second polymeric material as taught by the reference, 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, at least 15%, at least 20% or at least 25% as claimed by claim 2, the reference teaches 10-70%, 5-35%, 35%, 35-60% that all overlap 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 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 crystals.
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 5-35%, 35%, 35-60% 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 3-70%, 3-27%, 9-27% 3-20%, that overlap 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 particles 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 that 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, Graaff evidenced by Tomic teaches the EVA having VA content from 18-40% that overlaps with the claimed VA content, Graaff also teaches EVA having vinyl acetate content of 28%. 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 cover layer as claimed by claim 15 and the cross sectional diameter of the core as claimed by claim 16, the reference teaches cross sectional diameter of the ring between 2.5 and 6 mm that embrace the thickness of the cover when added to the diameter of the core. One having ordinary skill in the art would have determined the thickness of the cover layer and the diameter of the core from within that taught by the reference. 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.
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.
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).
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 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 particles 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 cover layer as claimed by claim 15 and the cross sectional diameter of the core as claimed by claim 16, the reference teaches thickness of the skin of 0.005-0.7 mm that overlaps with the claimed broadest 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 intended use. 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 09/15/2025 have been fully considered but they are not persuasive.
Claim Rejections - 35 U.S.C. 112
Applicants amendment had overcome 112/b rejections except for claim 8. Claim 8 remains rejected as set forth in this office action.
Double Patenting
US 8,333,983; 8,481,079; 8,741,329, 8,858,877; 8,900,615; 10,413,504 (items 26-32)
Applicants argue that each cited patent relies on a non-medicated skin functioning layer as a rate-limiting membrane. Drug release in those systems is modulated by skin thickness and partitioning from a core reservoir. By contrast, the present claimed inventions require that the outermost sheath is itself medicated with a contraceptive steroid at greater than or equal to 10 wt%. Applicant’s experimental data show that the release of sheath loaded steroid is independent of the sheath thickness, while the issued patents relies on the skin layer thickness for release of the active agents. The preset invention provides constant drug release.
In response to this argument, it is argued that the “comprising” language of the present claims permits the presence of the skin layer of the issued patents. Even if the present claims recite that “the sheath is the outer layer of the drug delivery device”, the sheath is only the outer layer of the two claimed layers of the device, however the device can comprise additional layer other than the core and sheath of the cited references, e.g. the skin layer of the device claimed by the issued patents, that are permitted by the present claims’ language.
Provisional Obviousness-Type Doule Patenting (Items 33-34, copending 18/729,979 and 18/730,049)
Applicants argue that ‘979 application does not require more than 10% steroid, and recites covering the device with drug containing layer. Application ‘049 does not recite outer medicated sheath as instantly claimed.
In response to this argument, it is argued that the “comprising” language of the present claims permits the presence of the skin layer of the issued patents. Even if the present claims recite that “the sheath is the outer layer of the drug delivery device”, the sheath is only the outer layer of the two claimed layers of the device, however the device can comprise additional layer other than the core and sheath, e.g. the skin layer of the device claimed by the issued patents, that are permitted by the present claims’ language. Further, ‘979 application recite core and sheath as claimed and steroid in a concentration 5-20% that overlaps with the claimed more than 10%. The ‘049 application recites at least 10% steroid as claimed.
Claim Rejections - 35 U.S.C. 103
De Graaff et al.
Applicants argue that De Graaf relies on a non-medicated skin as a rate-limiting membrane. Drug release is governed by skin thickness and partitioning. The claimed invention requires a medicated sheath with >10 wt% steroid. A person skilled in the art would not be motivated to medicate the outer skin, as this would eliminate its membrane function; indeed, the art teaches away. The EVA adhesion article is unrelated and cannot supply the missing motivation.
In response to this argument, it is argued that the reference clearly teaches overlapping amounts of the steroids: estradiol is present in the core in a concentration between 3-70%, 3-27%, 9-27% 3-20%, and progesterone in the cover layer in a concentration of 10-70%, 5-35%, 35%, 35-60% (¶¶ 0133-0136; claims 23-36). The “comprising” language of the present claims permits the presence of the skin non-medicated layer of the issued patents. Even if the present claims recite that “the sheath is the outer layer of the drug delivery device”, the sheath is only the outer layer of the two claimed layers of the device, however the device can comprise additional layer, e.g. the skin layer of the device taught by the reference, that are permitted by the present claims’ language. Therefore, the reference does not teach away from the present invention. "A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant. The degree of teaching away will of course depend on the particular facts; in general, a reference will teach away if it suggests that the line of development flowing from the reference's disclosure is unlikely to be productive of the result sought by the applicant." In re Gurley, 27 F.3d 551,553 (Fed. Cir. 1994). The reference does not teach away from a device comprising core and sheath comprising more than 10% steroid and the sheath is outer to the inner core as claimed.
Aarts et al.
Applicants argue that Aarts similarly discloses systems in which the skin is non-medicated and membrane-controlling. Even where ranges overlap for concentrations elsewhere, there is no teaching to place > 10 wt% contraceptive steroid in the outer sheath. Doing so would defeat Aarts’ design principle.
In response to this argument, it is argued that Aarts teaches 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%. The amounts taught by the reference overlap with the claimed amounts. The “comprising” language of the present claims permits the presence of the skin non-medicated layer of the issued patents. Even if the present claims recite that “the sheath is the outer layer of the drug delivery device”, the sheath is only the outer layer of the two claimed layers of the device, however the device can comprise additional layer, e.g. the skin layer of the device taught by the reference, that are permitted by the present claims’ language. Therefore, modifying the reference does not defeats the reference design principle. The reference does not teach away from a device comprising core and sheath comprising more than 10% steroid and the sheath is outer to the inner core as claimed.
Unexpected results
Applicants argue that Applicant’s experimental data show:
Release of the sheath-laded steroid is substantially independent of sheath thickness (200, 300, 400 um).
Progesterone concentration effect: 33.9 wt% P (AC400) in the sheath suppresses the initial E2 burst vs. 5 wt% P (AB400) at the same 400 um sheath and the same 0.39 wt% E2 in the core — the initial E2 release is much lower for AC400 than AB400.
Core-E2 loading effect: a ring (DC400) with ~25x more estradiol in the core than AB400s shows an initially higher E2 release, yet the same sheath-thickness independence persists — even as P concentration in the sheath remains 33.9 wt%.
In response to this argument, it is argued that:
No sheet thickness is claimed. Further, the cited references teach the instantly claimed steroid amount present in two layers of the device and teach the claimed polymers of each layer. Applicant did not compare the present claims with the devices of the prior art in order to establish criticality and superiority.
Suppression of E2 burst by progesterone concentration is expected from the devices of the prior art that comprises the claimed amount of steroids present in two different layers, absent evidence to the contrary. Note that the claims do not require progesterone in the sheath and E2 in the core, rather 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, each can be present in either the core or sheath.
Regarding higher E2 concentration accompanied with higher initial release yet the same sheath-thickness independence persists — even as P concentration in the sheath remains 33.9%, this is expected since the prior art teaches the same amount of steroids in each layer and the same claimed material of each layer. 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 regarding release of hormones 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.
Conclusion
THIS ACTION IS MADE FINAL. 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 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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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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