DETAILED ACTION
The receipt is acknowledged of applicant’s IDS and amendment filed 11/17/2025.
Claims 101-130 and 165-168 are pending. Claims 122-127 and 166 are previously withdrawn from further consideration as directed non-elected species.
Note: withdrawn claim 166 is incorrectly identified as (Previously Presented). correction of the claim’s identifier is requested in next communicating.
Claims 101-121, 128-130, 165, 167-168 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Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 .
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 101-121, 128-130, 165, 167-168 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 101-104, 129-130, 153-154, 165-171 of copending Application No. 18/561,377 (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, 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 present claims anticipate the copending 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 101-104, 114, 120, 128-130, 167-168 are rejected under 35 U.S.C. 103 as being unpatentable over Gray Jr. et al. (US 2017/0020718) combined with Austin et al. (US 5,771,900), both references are of record.
Applicant Claims
Claim 101 is directed to an intravaginal ring (TVR) device comprising:
a saddle-shaped ring made with an uncoated thermoplastic elastomer, the saddle-shaped ring comprising a non-planar sinusoidal shape, and
a curved, non-resorbable barrier having a non-planar sinusoidal shaped circumferential edge,
wherein the saddle-shaped ring is coupled to the curved, non-resorbable barrier, wherein the curved non-resorbable barrier is a metal barrier, polymeric barrier, combination metal and polymer barrier, or a barrier made with perforated film,
wherein the curved, non-resorbable barrier is attached to the saddle shaped ring, and wherein the saddle shaped ring contains an active ingredient; and
wherein the curved non-resorbable barrier allows the passage of uterine secretions through the curved, non-resorbable barrier.
Claim 168 is directed to an intravaginal ring (IVR) device comprising:
a saddle-shaped ring made with an uncoated thermoplastic elastomer, wherein the elastomer comprises ethylene vinyl acetate (EVA) copolymer, the saddle-shaped ring comprising a non-planar sinusoidal shape, and
a curved, non-resorbable barrier having a non-planar sinusoidal shaped circumferential edge,
wherein the saddle shaped ring is coupled to the curved, non-resorbable barrier,
wherein the curved, non-resorbable barrier is a metal barrier, polymeric barrier, combination metal and polymer barrier, or a barrier made with perforated film,
wherein the curved non-resorbable barrier is attached to the saddle shaped ring, and wherein the saddle shaped ring contains an active ingredient,
wherein the curved, non-resorbable allows the passage of uterine secretions through the curved, non-resorbable barrier.
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, that is attached to the ring. The ring is 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 (¶ 0022). The active spermicidal agent comprises at least one other bioactive agent 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 can have pore sizes ranging from below 100 to greater than 100 micron (¶¶ 0065-0066). The mesh can be fibrous woven or non-woven electrospun material mixed with woven copper material, or the mesh comprises metal ion impregnated fibers (¶¶ 0067-0071). The reference teaches fiber material in the construct/device, that implies it can be in the mesh or the ring, that can be monofilament or multifilament polymers comprising fibers made of copper and/or polyethylene, and active agent (¶¶ 0017, 0073). The reference teaches two different portion of the ring or in different layers of the ring (¶ 0098), i.e. forming two different segments of the ring.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Gray teaches shape of the vaginal ring may vary from perfect circle to ellipse to a ribbon, the reference however does not explicitly teach sinusoidal shaped ring and curved, barrier as instantly claimed by claim 101 and 168.
Austin teaches contraceptive device/diaphragm comprising rim surrounding a membrane that reads on the claimed barrier. The membrane is attached to the rim along its periphery. The rim is formed with a curvilinear profile to provide advantageous precise fit and cling to the anatomy of the women, and provides comfort of the user. The device comprises small dome projects from the membrane which is grasped by the wearer to remove the device. The principles of the invention may be advantageously used to provide a contraceptive diaphragm having a contoured shape and improved construction to facilitate insertion and removal, and improve adherence of the diaphragm within the anatomy of a woman. The rim defined loop that is elliptical in shape and rim is not planar. The rim has sinusoidal S shape formed of three arcs, each having different radii and alternating aspects or orientations (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 a IVR comprising outer ring surrounding a barrier membrane as taught by Gray wherein in the ring can be ellipt in shape, and reshape the ring of Gray having a barrier attached to the ring into a sinusoidal non planar S shape having a curved barrier attached to its rim as taught by Austin. One would have been motivated to do so because Austin teaches curvilinear sinusoidal S shape of the ring facilitates insertion and removal of the ring and provides advantageous precise fit and cling to the anatomy of the women, thus provides comfort of the user, and improves adherence of the device within the anatomy of a woman. One would reasonably expect formulating IVR surrounding a barrier mesh membrane having non-planar sinusoidal S shape and curved barrier wherein the IVR that is easy to insert and to remove, and have a precise fit into the anatomy of the woman while being comfortable to the user.
Regarding the limitation of claims 101 and 168 that the barrier is not fully occlusive, the mesh taught by Gray is porous mesh.
Regarding curved, non-resorbable barrier as claimed by claims 101 and 168, Austin teaches device/diaphragm comprising rim surrounding a membrane, and the membrane is attached to the rim along its periphery. The cited references teaches the same materials of the barrier that are non-resorbable, e.g. metal.
Regarding the thermoplastic elastomer claimed by claims 102-104 and 168, Gray teaches ethylene vinyl acetate copolymer.
Regarding claim 114 that the barrier is combination of metal and polymer and the barrier is attached to the ring, Gray teaches the mesh is polymeric fibers and can further comprises copper. Gray and Austin both teach a ring attached with a mesh membrane.
Regarding claim 120 that the mesh comprises spermiostatic metals Gray teaches the mesh comprises spermiostatic agents include metals, e.g. copper.
Regarding claim 128 that the device comprises a removal tab, tag or string, Austin teaches small dome projects from the membrane which is grasped by the wearer to remove the device that reads on the claimed tab or tag.
Regarding the ring contains two or more segments as claimed by claim 129, Gray teaches different portions or different layers of the ring comprise different active agents, implying formation of two different segments, Austin further teaches the rim has sinusoidal S shape formed of three arcs, each having different radii and alternating aspects or orientations implying more than two segments.
Regarding the property of the claimed vaginal ring as claimed by claim 130, Gray combined with Austin teaches a IVR substantially identical to the claimed ring, and the ring taught by combination of the prior art is expected to have the claimed less distortion after storage or insertion for at least 14 days when compared to an IVR made with silicone copolymer. Determination distortion of IVR is not part of the claimed IVR. It is only an in-vitro diagnostic test that is expected to provide the same results obtained from two similar delivery devices tested under the same circumstances, and the recitation of in-vitro test does not impart patentability to claims directed to device. The burden is on applicants to show that the claimed testing process resulted in novel and unobvious difference between the claimed product and prior art product since the Patent Office does not have the facilities for preparing the claimed materials and comparing them with the prior art inventions. See In re Best, 562 F.2 1252, 195 USPQ 430 (CCPA 1977); and In re Fitzgerald et al., 619 F.2d 67, 205 USPQ 594 (CCPA 1980).
Regarding the claimed pore size of the mesh of 100-150 µm as claimed by claim 167, Gray teaches less than 100 µm to more than 100 µm that overlaps with the claimed pore size. 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]. Note that applicants failed to show any unexpected results obtained from the claimed pore size of the mesh.
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 105-113, 115-119, 121 and 165 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Gray and Austin as applied to claim 101-104, 114, 120, 128-130, 167-168 above, and further in view of Shalaby et al. (US 2010/0062039, of record).
Applicant Claims
Claim 105-113, 115-119, 121 and 165 further recite the material of the mesh.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teachings of Gray and Austin are previously discussed in this office action.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Gray suggests woven and non-woven porous fibrous material for the mesh barrier layer, and suggests combination of porous fibrous layer with metallic spermiostatic agents in the mesh, the reference however does not explicitly teach polyolefins as claimed as claimed by claims 105-113, 115-119, 121 and 165.
Shalaby teaches intravaginal device comprising ring surrounding a mesh for securing contraception relying on biomechanical, pharmacological and biochemical means wherein the mesh is used as spermiostatic net. The mesh is biostable non-woven, meltblown porous polyolefin fibers including polyethylene and polypropylene, and comprises spermiostatic agents. The mesh comprises multifilament slow absorbing yarn (abstract; ¶¶ 0001, 0007, 0010-0012, 0014, 0017, 0025, 0026).
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 IVR surrounding a barrier mesh of woven or nonwoven fibrous porous membrane having non-planar sinusoidal S shape as taught by the combination of Gray and Austin, and use polyolefin comprising polyethylene and polypropylene to make the mesh as taught by Shalaby. One would have been motivated to do so because Shalaby teaches such a mesh secures contraception relying on biomechanical, pharmacological and biochemical means. One would reasonably expect formulating IVR surrounding a barrier mesh having non-planar sinusoidal S shape wherein the mesh is made of polyethylene or polypropylene wherein the IVR secures contraception and spermiostatic effect.
Regarding mesh materials as claimed by claims 105, 106, 115 and 116, Shalaby teaches polyethylene and polypropylene polymers forming the mesh,
Regarding mono- or multi-filaments claimed by claims 107, 111, 117 and 119, Gray teaches both mono- and multi-filaments, and Shalaby teaches multi-filaments.
Regarding spermiostatic agents claimed by claims 108-110, 118 and 121, Gray teaches copper sulfate.
Regarding the property of the claimed vaginal ring as claimed by claim 165, the combination of Gray, Austin and Shalaby teaches a IVR substantially identical to the claimed ring, and the ring taught by combination of the prior art is expected to have the claimed less distortion after storage or insertion for at least 14 days when compared to an IVR made with silicone copolymer. Determination distortion of IVR is not part of the claimed IVR. It is only an in-vitro diagnostic test that is expected to provide the same results obtained from two similar delivery devices tested under the same circumstances, and the recitation of this in-vitro test does not impart patentability to claims directed to device. The burden is on applicants to show that the claimed testing process resulted in novel and unobvious difference between the claimed product and prior art product since the Patent Office does not have the facilities for preparing the claimed materials and comparing them with the prior art inventions. See In re Best, 562 F.2 1252, 195 USPQ 430 (CCPA 1977); and In re Fitzgerald et al., 619 F.2d 67, 205 USPQ 594 (CCPA 1980).
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 11/17/2025 have been fully considered but they are not persuasive.
Double Patenting
The examiner acknowledges Applicant’s intention to consider filing a Terminal Disclaimer to obviate double patenting rejection once the outstanding rejections have been withdrawn, and upon re-evaluated the double patenting rejection in view of the allowable claims. Therefore, the double patenting rejection is maintained.
Rejections under 35 U.S.C. §103
Applicants argue that the claimed IVR device includes a saddle-shaped ring comprising a non-planar sinusoidal shape and a curved, non-resorbable barrier having a non-planar sinusoidal shaped circumferential edge, and this unique configuration allows for reduced ring distortion over time that occurs with intravaginal ring devices and enables for a better fit and more comfort for subjects using the device. See instant specification at
¶
[0003] and [0004]. The claimed non-planar sinusoidal shape of the saddle-shaped ring, which can be achieved both prior to and after insertion, enables the claimed IVR device to achieve improvements over the prior art, such as improved fit and comfort for users of the claimed IVR.
In response to this argument, it is argued that all the elements of the claimed IVR is taught by combination of the cited references as set forth in this office action. Any benefits or advantages applicants achieved would be expected from the IVR of the prior art that has non-planar sinusoidal shape and a curved non-resorbable barrier having a non-planar sinusoidal shaped circumferential edge, absent evidence to the contrary.
Applicants argue that a person skilled in the art would readily appreciate that the claimed invention relates to an intravaginal ring device that intentionally allows the passage of uterine secretion. To the contrary, a traditional diaphragm - such as the ones described in Austin - is intended to be fully occlusive to prevent any passage of uterine secretion. As described in the specification, the barrier of the intravaginal ring device is a mesh. See, e.g., ¶ [0012], [0062], [0063], and [0064]. The specification states that the barrier mesh "has pores that range in size from about 100-150 pm." Id. at ¶ [0062]. The specification states that the "pore size of the polymer mesh, metal mesh or perforated film can be measured microscopically." Id. at ¶ [0064]. A skilled artisan would readily understand that with the device allows for secretions to pass through the mesh, and not occlusive. To arrive at the claimed invention, a skilled artisan would have to modify the teachings of Gray. As described herein, the claimed invention provides for a better fit and reduced ring distortion over time - which is not taught in the cited art.
In response to this argument, the examiner respectfully disagrees because in construing the rejection, the examiner adopted from Austin only the sinusoidal shape of the ring and the curved attached membrane to modify the shape of IVR and porous barrier of Gary into sinusoidal ring and curved barrier. The rejection did not replace the porous barrier of Gray with occlusive membrane of Austin. One having ordinary skill in the art would have shaped the ring and barrier of Gray to the sinusoidal shape taught by Austin because Austin teaches such a shape is of the ring facilitates insertion and removal of the ring and provides advantageous precise fit and cling to the anatomy of the women, thus provides comfort of the user, and improves adherence of the diaphragm within the anatomy of a woman. Any benefit applicants achieved would be expected from combination of the cited references. It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. As such, the examiner respectfully submits that there is motivation to combine the Gray and Austin.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., pore sizes) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicants argue that Shalaby does not cure the deficiencies of Gray or Austin, alone or in combination. Shalaby relates to an intravaginal ring device which is "ringed, flat mesh encircled with a fiber-reinforced composite ring." Shalaby also does not teach or suggest a saddle-shaped ring comprising a non-planar sinusoidal shape and a curved, non-resorbable barrier having a non-planar sinusoidal shaped circumferential edge, as claimed. The Office relies on Shalaby for disclosing a "mesh compris[ing] [a] multifilament slow absorbing yarn".
In response to this argument, it is argued that Shalaby is relied upon for solely teaching material of the mesh made of polyolefin comprising polyethylene and polypropylene. The reference satisfies the purpose for which it was applied. If Shalaby was to teach IVR having the claimed shape, the reference would have been considered for anticipation.
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./