DETAILED ACTION
The receipt is acknowledged of applicants’ request for RCE and IDS filed 02/09/2026.
Claims 1, 7, 10-14, 17-20 are pending and subject of this office action.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/09/2026 has been entered.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 7, 10-14, 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Shalaby et al. (US 2008/0069850, IDS filed 04/30/2018, hereinafter Shalaby ‘850), Shalaby (US 6,413,539, IDS filed 12/15/2022, hereinafter Shalaby ‘539), and Xiang et al. (WO 2011/005839, 892 dated 10/29/2021).
Applicant Claims
Claim 1 is directed to an intravaginal device in a form of a contraceptive ring for a controlled release of a first bioactive agent and a second bioactive agent, wherein the device comprises:
a circular mesh having a perimeter, and
a polymeric ring around the perimeter of the circular mesh to provide a ring-surrounded mesh,
wherein the polymeric ring comprises a biostable elastomeric silicon-based amphiphilic polymeric matrix, the first bioactive agent, the second bioactive agent, and a plurality of absorbable microparticulates, each of the plurality of absorbable microparticulates comprising an ion-exchanging polymer,
wherein the ion-exchanging polymer forming the plurality of absorbable microparticulates comprises:
a polyester derived from cyclic monomers selected from the group consisting of lactides, glycolides, epsilon-caprolactone, trimethylene carbonate, para- dioxanone, and combinations thereof;
a polyester with acid end groups;
a polyester that degrades by hydrolysis;
or a combination thereof;
wherein the plurality of absorbable microparticulates are dispersed throughout the biostable elastomeric silicon-based amphiphilic polymeric matrix and are effective to modulate the release of the first bioactive agent and the second bioactive agent from the biostable elastomeric silicon-based amphiphilic polymeric matrix,
wherein the first bioactive agent and the second bioactive agent are dispersed in the biostable elastomeric silicon-based amphiphilic polymeric matrix,
wherein the first bioactive agent and the second bioactive agent are a non-hormonal contraceptive,
wherein the second bioactive agent is in the form of an organometallic complex,
wherein the organometallic complex provides at least one metal ion capable of acting as a reducing agent,
wherein the first bioactive agent is a reducing agent which reduces an oxidation state of the second bioactive agent, wherein the second bioactive agent provides a spermiostatic effect,
wherein the first bioactive agent comprises ascorbic acid;
wherein the second bioactive agent comprises ferrous gluconate;
wherein the polymeric ring is not fiber reinforced; and
wherein the polymeric ring becomes microporous as the plurality of absorbable microparticulates degrade when exposed to bodily fluid.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Shalaby ‘850 teaches intravaginal ring devices have multicomponent drug releasing substrates loaded with at least one bioactive agent and designed to effect contraception and to provide means to treat diseases caused by infectious micro-organisms, without compromising useful vaginal microflora in female patients (abstract). The reference teaches a multicomponent microbicidal contraceptive intravaginal ringed-mesh device comprising a ring matrix encircling a fibrous mesh adjoined thereto and held in the ring lumen and a polymeric coating covering the ringed-mesh construct, wherein each of the ring matrix and the polymeric coating comprise at least one drug-releasing polymeric substrate for independent controlled release of at least one contraceptive agent and at least one bioactive agent, wherein the ring matrix is silicone and the fibrous mesh is polyester, and wherein the ring contains at least one contraceptive agent and at least one bioactive agent. The fibrous mesh is porous. The ring contains at least one non-hormonal spermiostatic/spermicidal agent, and at least one potent non-hormonal bioactive agent. The ring matrix comprises at least one contraceptive agent and at least one bioactive agent, and wherein the ring matrix contains microparticulates of ferrous gluconate, ascorbic acid, glycine, and polyglycolic acid (¶¶ 0009-0015; claims). The polymeric ring contains hydrophilic polymer comprising a polyethylene glycol, and a relatively hydrophobic polymer silicone and the fibrous mesh comprises polyester, wherein the polyester fibrous mesh is chemically treated to create a polyanionic surface for repelling negatively charged sperms and immobilizing cationic bioactive agents comprising an absorbable, polyaxial copolyester. The ring is silicone polymer and comprises polymers selected from absorbable, polyaxial copolyester selected from epsilon-caprolactone, trimethylene carbonate, glycolide, l-lactide and p-dioxanone (¶ 0021). The ring is coated or uncoated (¶ 0027). The reference teaches in paragraph [0007] that melt blown is a known process of making fabric that obviously can be used for forming the mesh.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Shalaby ‘850 teaches microparticles comprising polyglycolic acid that is claimed by applicants as ion-exchange polymer, and further teaches absorbable polymer selected from epsilon-caprolactone, trimethylene carbonate, glycolide, l-lactide and p-dioxanone, which are ion exchange polymers, however, the reference does not explicitly teach ion-exchange polymers forming microparticles as claimed by claim 1.
While Shalaby ‘850 teaches ring made of silicone polymer, the reference is silent regarding amphiphilic silicone polymer as claimed by claim 1.
Shalaby ‘539 teaches absorbable or biodegradable polymeric hydrogels microparticles comprising polyglycolides that are self-solvating, absorbable polyester copolymers capable of selective, segmental association into compliant hydrogels upon contacting an aqueous environment, and provides uniform distribution of active agents. The reference teaches methods of using polyglycolides copolymers in hydrogel for therapeutic treatment of diseases such as infection of the vaginal tissues (abstract; col.9, lines 26-67; col.16, lines 1-30). The hydrogel is capable of controlled release of active agents (col.6, lines 33-53). The absorbable hydrogel and the active agent form ion exchange polymer are incorporated in less absorbable polymer (col.11, lines 50-57; col.12, lines 1-15; col.17, lines 37-40).
Xiang teaches amphiphilic silicone copolymer used for maintaining adhesion of drug delivery devices to moist environment and biological surfaces and does not dissolve in aqueous medium. The amphiphilic silicone polymer has reactive groups polymerized with hydrophilic or amphiphilic monomers, i.e. crosslinked (abstract; page1, lines 5-7; page 3, lines 7-33; page 4 lines 13-30).
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 vaginal ring comprising silicone ring encircling a porous mesh and the ring comprises microparticles comprising ferrous gluconate, ascorbic acid, glycine, and polyglycolic acid, and further comprises absorbable polymers selected from polyaxial copolyester selected from epsilon-caprolactone, trimethylene carbonate, glycolide, l-lactide and p-dioxanone as taught by Shalaby ‘850, and use polyglycolides ion exchange microparticles taught by Shalaby ‘539 as polyglycolic acid active agent and as absorbable polymers. One would have been motivated to do so because Shalaby ‘539 teaches absorbable polymeric microparticles comprising polyglycolides are self-solvating, absorbable polyester copolymers capable of selective, segmental association into compliant hydrogels upon contacting an aqueous environment, and provides uniform distribution of active agents, and teaches using polyglycolides copolymers in hydrogel for therapeutic treatment of diseases such as infection of the vaginal tissues. One would reasonably expected formulating vaginal ring comprising silicone ring encircling a porous mesh and wherein the ring comprises microparticles comprising ferrous gluconate, ascorbic acid, glycine, and polyglycolic acid, and further comprises absorbable polymers microparticles selected from polyaxial copolyester selected from epsilon-caprolactone, trimethylene carbonate, glycolide, l-lactide and p-dioxanone that are self-solvating, absorbable polyester copolymers capable of selective, segmental association into compliant hydrogels upon contacting an aqueous environment, and useful for treating vaginal infection, and further provides uniform distribution of active agents.
Further, it would have been obvious to one having ordinary skill in the art to provide a vaginal ring taught by the combination of Shalaby ‘850 and Shalaby ‘539 that comprises ring matrix of silicone polymer, and replace silicone polymer with crosslinked amphiphilic silicone copolymer used by Xiang. One would have been motivated to do so because Xiang teaches crosslinked amphiphilic silicone copolymer used for maintaining adhesion of drug delivery devices to moist environment and biological surfaces and does not dissolve in aqueous medium. One would reasonably expect formulating vaginal ring comprises amphiphilic silicone copolymer that adheres to the vaginal wall and does not dissolve in vaginal aqueous medium.
Regarding ion exchange polymers forming the microparticles claimed by claim 1, they are taught by combination of both Shalaby references as useful for treating vaginal infection as discussed above.
Regarding the limitation of claim 1 that “the microparticulate is effective to modulate the release of the active agent”, both Shalaby references teach release of the active agent upon solvation of the microparticulate and release of active agents to treat vaginal infection.
Regarding the “the amphiphilic silicone” as claimed by claim 1, it is taught by Xiang.
Regarding the first active agent is ascorbic acid and second active agent is ferrous gluconate that provides spermicidal effect as claimed by claim 1, they are taught by Shalaby ‘850.
Regarding the limitation of claim 1 that “the organometallic complex provides at least one metal ion capable of acting as a reducing agent”, Shalaby ‘850 teaches the claimed ferrous gluconate and ascorbic acid and it is expected to have the same function and property since materials and their properties are inseparable.
Regarding the limitation of claim 1 that the bioactive agent is dispersed in the polymeric matrix outside the microparticles as claimed by claim 1, Shalaby ‘850 teaches active agent dispersed in the ring matrix till contact body fluid, then released. This implies the active agent are outside the microparticles and dispersed in the polymer matrix till released. Further, combination of the cited references teaches the instantly claimed device made from the same materials including the same active agent and silicone elastomer matrix, and dispersion of the active agent in the polymeric matrix is expected from the prior art since materials and their properties are inseparable.
Regarding claim 1 that the ring is not fiber reinforced, Shalaby ‘850 teaches polymer that is not reinforced by any fibers.
Regarding the three active agents claimed by claims 1 and 18, Shalaby ‘850 teaches the claimed first, second and third non-hormonal active agents.
Regarding the limitation of claims 1 and 20 that the ring becomes porous as the microparticles degrade upon exposure to body fluid, Shalaby ‘539 teach release of active agent upon exposure to the body fluid and it is expected that the ring becomes porous as the microparticles degrade.
Regarding porous device as claimed by claim 7, Shalaby ‘850 teaches porous mesh, and the ring expected to be porous after degradation of microparticles and release of active agents.
Regarding the open-pore structure of the silicone polymer as claimed by claim 10, the combination of the cited references teaches silicone polymer and teaches porous polymer, hence porous silicone polymer is suggested.
Regarding crosslinked amphiphilic silicone matrix as claimed by claim 11, Xiang teaches crosslinked amphiphilic silicone polymer.
Regarding the microparticles claimed by claims 12-14, both Shalaby references teach lactide copolymer, and glycolide-caprolactone copolymer, and Shalaby ‘539 teaches polyglycolide. Applicants failed to show unexpected results obtained from any material of the microparticles over the other.
Regarding claim 17 that the bioactive agent provides a spermiostatic effect by mechanism of lipid peroxidation of sperm cell membrane, Shalaby ‘850 teaches same elements claimed as reducing agent and spermicidal agent, and the same elements claimed as bioactive agents, and it is expected to have the same mechanism of action as claimed since materials and their properties are inseparable.
Regarding material of the mesh as claimed by claim 19, Shalaby ‘850 teaches melt blown nonwoven mesh is a known in the art.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 02/09/2026 have been fully considered but they are not persuasive.
Rejections under 35 U.S.C. § 103
Applicants argue that Shalaby '850 repeatedly indicates that the rings are fiber-reinforced (e.g., with a reinforcing yarn) and that the reinforcing fibers are needed for achieving various purposes of those devices (see, for example, paragraph [0017]-[0019], Example 1 in paragraph [0036], and claim 14). Moreover, Applicant notes that Shalaby '850 claims priority to US. Application No. 11/667,933 which exclusively describes fiber reinforced devices.
In response to this argument, it is argued that Shalaby ‘850 teaches reinforcing the yarn around the mesh, and not enforcing the ring itself. Current claim 1 requires the polymeric ring is not fiber reinforced, and does not require the mesh is not reinforced, only the ring surrounding the mesh is not reinforced, and that what is taught by the reference. According to the present invention as disclosed in paragraph [0074] of the published application, applicants described “fiber-reinforced intravaginal device” as: “The device comprises a polymeric matrix in the shape of a ring, wherein the polymeric matrix is reinforced by a circular fiber that is fully embedded within the matrix.” This is not what described by Shalaby ‘850. Shalaby ‘850 rather teaches yarn around the mesh, and not embedded in the ring. Therefore, the ring taught by Shalaby ‘850 is not reinforced by fibers as claimed. same teaching of Shalaby ‘850 is disclosed by its prior application 11/667,933.
Applicants argue that the polyglycolide systems of Shalaby '539 only form hydrogels since they are block copolymers with PEG; this is what makes them a hydratable hydrogel. Meanwhile, the polyglycolide particles described in the current application are not block copolymers that contain PEG and so they do not form hydrogels.
In response to this argument, it is argued that the present claims do not exclude the presence of block copolymer comprising polyglycolide and PEG. Claim 1 recites “microparticles comprising a polyester derived from…..” The claims language permits the presence of block copolymer comprising PEG as long as polyester is present. The microparticles of Shalaby ‘539 achieved the release of active agents to the vaginal mucosa as applicant’s achieved.
Applicants argue that Shalaby '539 specifically prepares a composition that contains the drug and the particles. Shalaby '539 solubilizes the drug and then incubates with the particles and then removes the solvent. Meanwhile, present application mixes all the components together in a non-solubilized particulate form and then these are incorporated into the silicone which is then cured. All the materials remain as particulates in the silicone in the present application, unlike that described in Shalaby '539 in which the drug is coated onto the surface of the particles and is not in a particulate form.
In response to this argument, it is noted that applicants argue the process of making the present microparticles is different from the process of Shalaby. Applicant’s attention is directed to the scope of the present claims that are directed to a composition, and the process of making the composition does not impart patentability to the composition claims. Shalaby ‘539 is relied upon for solely teaching the use of the claimed polyester in microparticulate to deliver active agent to the vaginal mucosa. The presence of active agents in the particles is taught by Shalaby ‘850, and no need to be retaught by every secondary reference.
Applicants argue Xiang teaches an amphiphilic silicone that is designed for tissue adhesiveness for transdermal drug delivery. The Office is under the impression that the amphiphilic silicone is to make the ring adhere to the vaginal tissue. In the instant application, the physical construction of the ring and the size of the ring is what makes the ring stay in place; these are mechanical forces. As stated in the current application in [0012]: "Biostable amphiphilic elastomeric polymeric matrix refers to a non-absorbable polymeric construct that serves as a reservoir for release of a bioactive agent or agents." The choice of the amphiphilic silicone in the instant claims is so that the correct release profile can be obtained.
In response tot his argument, applicant’s attention is directed to the scope of the claims that are directed to a product, and all the elements of the claimed product are taught by 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 cited references, and reasonable expectation to achieve the present invention, as set forth in this office action. The reference satisfies the purpose for which it was applied.
The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, motivation to combine the references would have produced the claimed intravaginal device. Motivation to combine the references exists in the references themselves, with reasonable expectation to achieve the present invention, as set forth in this office action.
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art. See In re kerkhoven 205 USPQ 1069, 1072. All the elements of claimed product are taught by combination of the cited references. The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir 1983). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.
It has been held that it is obvious to combine prior art elements according to known methods to yield predictable results. A finding that the prior art included each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference, was held obvious by the court.
The rationale to modify the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art and the reason to modify the reference may often suggest what the applicant has done.
The obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. v. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir.1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
Finally, it is well established that the claims are given the broadest interpretation during examination. A conclusion of obviousness under 35 U.S.C. 103 (a) does not require absolute predictability, only a reasonable expectation of success; and references are evaluated by what they suggest to one versed in the art, rather than by their specific disclosure. In re Bozek, 163 USPQ 545 (CCPA 1969). Motivation to combine the references exists, as well as reasonable expectation to achieve the present invention. 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.
In the light of the foregoing discussion, the Examiner’s ultimate legal conclusion is that the subject matter as a whole as defined by the claims would have been prima facie obvious within the meaning of 35 U.S.C. 103 (a).
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 on Monday through Friday, 8:30 AM to 5:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/I.G./
/Isis A Ghali/Primary Examiner, Art Unit 1611