DETAILED ACTION
The receipt is acknowledged of applicant’s IDS and amendment, both filed 01/14/2026.
Claims 101-104, 129-130, 153-154, 165, 167-170 previously presented. Claim 169 is currently canceled. Claims 172-178 are currently added.
Claims 101-104, 129-130, 153-154, 165, 167-168, 170, 172-178 are currently pending.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 .
Election/Restrictions
Currently amended claims 101-104, 129-130, 170 as well as newly submitted claims 172-178 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the currently amended claims 101-104, 129-130, 170 and new claims 172-178 require barrier that is a “spherical cap shape” that was not required before in the examined claims. Claims 153-154, 165, 167 and 168 do not require the cap shaped barrier. Claims 153-154, 165, 167-168 have been already examined on the merit.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 101-104, 129-130, 170 and new claims 172-178 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 153-154, 165, 167-168 are examined on the merit.
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 153-154, 165, 167-168 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 101-121, 128-130, 165-168 of copending Application No. 17/331,119 (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 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: intravaginal ring device comprising a saddle-shaped, circular or flat ring made of thermoplastic elastomer wherein the ring encircles a curved or flat, non-resorbable barrier, wherein the barrier is a metal barrier, polymeric barrier, combination metal and polymer barrier, or a barrier made with perforated film, wherein the barrier is attached to the ring and said metal and polymer barrier and said perforated film optionally contains active ingredients; and wherein said barriers or perforated film is not fully occlusive to allow the passage of uterine secretions. Therefore, the claims are not patentably distinct from the instant claims, and the copending claims anticipate the current claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 153-154, 165 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Gray Jr. et al. (US 2017/0020718, IDS filed 03/28/2024), Ron et al. (US 2008/0286322, previously cited on PTO 892), Dunn et al. (US 4,589,880, IDS filed 06/20/2025) and Austin et al. (US 5,771,900, previously cited on PTO 892).
Applicant Claims
Claim 153 is directed to An intravaginal ring device comprising a flat, circular or oval ring made with a segmented uncoated thermoplastic elastomer, excluding copolymeric silicone, with a removal tab, wherein the ring contains one or more active ingredients; and, wherein the ring encircles a curved, non-resorbable polymeric barrier which is attached to the ring; and wherein the ring covers the cervix when inserted into a subject.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Gray teaches an intravaginal ring (IVR) device or construct comprising polymeric biostable, uncoated elastomeric polymeric matrix ring encircling a mesh, that reads on the claimed barrier, and used for variety of strategies to address women's health issues inclusive of contraception, infertility, sexually transmitted infections, and the need to develop improvement inclusive of development of intravaginal drug release devices that would assist in improving patience compliance and efficiency of drug administration. The ring comprises active agent including spermicidal agent (abstract; ¶¶ 0005-0009, 0024, 0034-0036, 0058-0064). The elastomeric polymeric matrix comprises polyethylene vinyl acetate copolymer and polyurethane (¶¶ 0012-0014, 0057). The shape of the vaginal ring may vary from tubular perfect circle to ellipse to a ribbon (4 0022). The active spermicidal agent comprises at least one other bioactive agent that provides a spermiostatic effect, with a reducing agent in the form of metal ions, such as iron, copper, zinc or cobalt; and in the form of inorganic salt such as copper sulfate, copper gluconate, etc. (¶¶ 0034, 0038, 0081-0083). Both the ring and the mesh may comprise bioactive agent (¶¶ 0060-0064). The mesh has pores, i.e. perforated (¶¶ 0065-0066). The mesh is mixed with copper material, or the mesh comprises metal ion impregnated fibers (¶¶ 0067-0071). The reference teaches the active agents present in two different portion of the ring or in different layers of the ring (¶ 0098), i.e. suggesting two different segments of the ring.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Gray suggests the active agents present in two different portions of the ring or in different layers of the ring (¶ 0098), that what suggests different segments of the ring, the reference does not explicitly teach two active agents present in two different segments as claimed by claim 153.
Gray does not teach curved barrier to cover the cervix or removable tab as claimed by claim 153.
Ron teaches intravaginal ring that is less expensive and easy to produce for delivering multiple active agents simultaneously for prolonged period of time. The ring comprises two or more segments comprising two or more active agents. The device used to provide contraception, and treatment of ovarian disorder and discomfort associated with menopause. The segments forming the ring are made of uncoated thermoplastic polymers mixed with the active agents. The thermoplastic polymer is ethylene vinyl acetate copolymer (abstract; ¶¶ 0015-0018; Figure 1).
Dunn teaches intravaginal spermicide-releasing contraceptive barrier formed from thermoplastic polymer. The barrier comprises curved dome shaped diaphragm supported around its rim or outer periphery with resilient polymeric ring. Both dome and ring can be made of the same polymer, e.g. polyurethane, to provide softness and flexibility of the dome and resilience of the ring. The curved dome barrier acts as a physical barrier to most sperms. The intravaginal barrier comprises spermicides and other active agents that are controllably released (abstract; col.2, lines 6-68; col.3, lines 1-10; col.4, lines 11-30; figures).
Austin teaches contraceptive device/diaphragm comprising rim surrounding a membrane that reads on the claimed barrier. The device comprises small finger dome (16) that projects from the membrane which is grasped by the wearer to remove the device. The device comprises a dome shaped membrane (12) attached to the rim that fits snuggly around the cervix covering it (abstract; col.2, lines 26-61; col.3, line 50 till col.4, line 44; col.5, lines 31-35, 57-67; col.6, lines 1-10, 35-47; figures and claims).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
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 intravaginal ring comprising ring encircling a mesh that may comprises one or more active agents indifferent portions or different layers of the ring as taught by Gray, and use segmented ring taught by Ron comprising two or more segments comprising different active agents One would have been motivated to do so because Ron teaches segmented ring is less expensive and easy to produce for delivering multiple active agents simultaneously for prolonged period of time, and useful for contraception, and treatment of ovarian disorders and discomfort associated with menopause. One would reasonably expect formulating intravaginal ring comprising segmented ring and mesh wherein the segments of the ring comprise two or more active agents that provide contraception and treatment of other disorders while the ring is inexpensive and easy to produce that are produced for prolonged time and can be delivered simultaneously.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide intravaginal ring comprising segmented ring encircling a mesh barrier and the ring comprises one or more active agents in different segments as taught by the combination of Gray and Ron, and further design the barrier as dome shaped as taught by Dunn or Austin. One would have been motivated to do so because Dunn teaches dome shaped barrier acts as physical barrier for most sperms and provides controlled release of spermicides and other active agents, and because Austin teaches dome shaped membrane (12) attached to the rim of the ring fits snuggly around the cervix covering it. One would reasonably expect formulating intravaginal ring comprising segmented ring encircling dome shaped barrier that fits snuggly and comfortably around the cervix while delivering spermicides in a controlled manner to successfully provide contraception.
Furthermore, one having ordinary skill in the art would have attached an element to remove the intravaginal ring to the above intravaginal ring taught by combination of Gray, Ron and Dunn, such as taught by Austin for ease and convenience of removal of the intravaginal ring when needed.
Regarding thermoplastic polymers claimed by claim 154, they are taught by Gray and Ron that teach ethylene vinyl acetate copolymer, and Dunn that teaches polyurethane.
Regarding the active agents claimed by claim 165, all the references teach spermicide agents that prevent pregnancy and also have antibacterial effects.
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 167-168 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Gray Jr. et al. (US 2017/0020718, IDS filed 03/28/2024) and the article by Clark et al. (“Engineering a segmented dual-reservoir polyurethane intravaginal ring for simultaneous prevention of HIV transmission and unwanted pregnancy” previously provided).
Applicant Claims
Claim 167 is directed to an intravaginal ring device comprising a saddle-shaped, flat-shaped, circular-shaped, or oval-shaped ring made with a non-segmented or segmented uncoated thermoplastic elastomer, excluding copolymeric silicone,
wherein the ring encircles a curved or flat, non-resorbable metal barrier, polymeric barrier, combination metal and polymer barrier or a barrier made with perforated film,
wherein said thermoplastic elastomer has at least two discrete reservoirs, wherein each of the at least two discrete reservoirs contain an active ingredient, and
wherein the barrier is attached to the ring and said metal and polymer barriers and said perforated film contains one or more active ingredients;
wherein said barrier[[s]] or perforated film is not fully occlusive to allow the passage of uterine secretions.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The teaching of Gray are previously discussed in this office action.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Gray teaches delivery of active agent from different portions or different layers of the intravaginal ring, the reference does not explicitly teach two or more reservoirs contain different active agent as claimed by claim 167.
Clark teaches that there are two main approaches being explored to increase user demand for HIV pre-exposure prophylaxis (PrEP), to either increase device duration or to make devices that are multifunctional and satisfy more than one user need. Clark teaches a segmented dual-reservoir polyurethane intravaginal ring for simultaneous prevention of HIV transmission and unwanted pregnancy, wherein the dual-reservoir intravaginal ring that delivers the HIV-1 reverse transcriptase inhibitor tenofovir and the contraceptive levonorgestrel for 90 days. These tenofovir-eluting segments and coaxially extruded levonorgestrel eluting segments were joined by induction welding to form rings that released tenofovir and levonorgestrel for 90 days. This system represents a significant advance in vaginal drug delivery technology, and is the first in a new class of long-acting multipurpose prevention drug delivery systems for women to control their productive health (see the entire document, and in particular; abstract; introduction; and conclusion).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
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 intravaginal ring comprising ring encircling a mesh that comprises one or more active agents in different portions of the ring as taught by Gray, and improve the ring by introducing two reservoirs in the ring comprising two different active agents, e.g. antiviral and levonorgestrel as taught by Clark. One would have been motivated to do so because Clark teaches using both antiviral and levonorgestrel meet user demand for HIV pre-exposure prophylaxis and contraception, while also increasing patient adherence, and satisfying more than one user need, and provides long-acting multipurpose drug delivery systems for women to control their productive health. One would reasonably expect formulating intravaginal ring encircling a barrier wherein the ring comprises two reservoir comprising two different active agents wherein the intravaginal ring increases patient adherence, and satisfying more than one user need, and provides long-acting multipurpose drug delivery systems for women to control their productive health.
Regarding the active agents claimed by claim 168, both references teach spermicide agents that prevent pregnancy and Clark teaches contraceptive agent, e.g. levonorgestrel.
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 01/14/2026 have been fully considered but they are not persuasive. Applicant argument is focused on the claims amendment to recite “spherical cap shaped” that was not presented by original presentation. Meanwhile, applicant maintains the claims that does not require the spherical cap that been examined previously. Accordingly, the claims that are directed to spherical cap have been withdrawn from further consideration, and claims that do not require the spherical can and previously examined are examined on the merit. Therefore, applicants argument regarding the spherical cap are moot in view of the new rejection necessitated by the amendment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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./