DETAILED 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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-9) in the reply filed on 01/26/2026 is acknowledged.
Claims 10-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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 01/26/2026.
Applicant's election with traverse of Species B1 and subspecies B1a in the reply filed on 01/26/2026 is acknowledged. The traversal is on the ground(s) that all the species and subspecies share the same function, namely they are capable of releasing an effective amount of copper ion into the vaginal region, cervical region and endometrial region of the female reproductive system and that in addition searching for/examining these species/subspecies would be no burden for Examiner as species and subspecies falling within one generic category would likely be classified together owing to their significant overlap in function.
This is not found persuasive because though all species and subspecies may release copper ion they do so in various different ways. As indicated in the Restriction Requirement of 11/21/2025 page 6, Figs. 4A-E depict a copper layer coating and Fig. 7A-C depicts an internal copper wire. These species are mutually exclusive and are not obvious variants based on the current record. The subspecies B1a-B1e are independent because they are mutually exclusive in that they each depict a different number and/or location of copper coating segments. In addition the subspecies are not obvious variants of each other based on the current record. There is a serious search and examination burden for at least the reasons as set forth at page 7 of the Restriction Requirement.
The requirement is still deemed proper and is therefore made FINAL.
Response to Amendment
The amendment to the claims filed on 01/26/2026 has been entered. Claims 1-29 are pending with claims 9-29 having been withdrawn. Claim 30 has been added.
Claim Objections
Claim 2 objected to because of the following informalities: It recites “wherein the at least bioactive agent” but it appears it should recite –wherein the at least one bioactive reagent--. Appropriate correction is required.
.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 9 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.
Claim 9 recites “wherein the vaginal microbiota are Lactobacillus Lactobacillis crispatus”. This recitation is indefinite because it is not clear whether the duplicate word “Lactobacillis” is a typographical error or whether the recitation was intended to recite – Lactobacillus, Lactobacillis crispatus--. In other words it is not clear whether the recitation intended to list the genus Lactobacillis in addition to the species or just list the various species. For the purposes of examination, it will be interpreted as listing the genus in addition to the species i.e. – Lactobacillus, Lactobacillis crispatus…--.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gray (US 2017/0020718).
Regarding claim 1, Gray discloses a contraceptive device configured ([0022], contraceptive device is a vaginal ring) for insertion into the vagina of a female reproductive system of a subject ([0022], capable of intended use), the contraceptive device comprising: a torus-shaped elastomeric body ([0022], tubular ring is torus-shaped; [0005], intravaginal ring contains a biostable hydrophilic elastomeric polymeric matric and is thus elastomeric) ; and at least one bioactive agent ([0005]; [0036]; [0081], the intravaginal ring comprises an elastomeric polymeric matrix and at least one bioactive agent is a non-hormonal contraceptive in the form of an organometallic complex that provides at least one metal ion capable of acting as a reducing agent) having spermicidal or spermiostatic properties coupled to the elastomeric body ([0055], the bioagent is a non-hormonal contraceptive; [0036], [0052]; first and second bioactive reagents are used and the second bioactive agent provides a spermiostatic effect; [0081], the non-hormonal contraceptive in the form of an organometallic complex provides at least one metal ion capable of acting as a reducing agent which reducing agent includes copper and thus copper [the first bioagent] is also having spermicidal or spermiostatic properties as it is a contraceptive and as it is an example given as a bioactive agent in claim 2 of the current application), wherein the contraceptive device is configured to release an effective amount of the at least one bioactive agent into the vaginal region, cervical region, and endometrial region of the female reproductive system when the contraceptive device is positioned into the vaginal region of the female reproductive system ([0056], [0081], [0034], [0036], the intravaginal device provides controlled release of at least one bioactive agent which is a metal ion reducing agent that may be copper; capable of intended use).
Regarding claim 2, Gray discloses the invention as described above.
Gray further discloses wherein the at least bioactive agent is a copper-containing agent ([0081], [0034], [0037], [0038], the first bioactive reagent/reducing agent may comprise metal ions and the metal ion may comprise copper).
Regarding claim 3, Gray discloses the invention as described above with regard to claim 2.
Gray further discloses wherein the copper-containing agent is copper, a copper alloy, a copper salt, or a combination thereof ([0081], [0038], copper).
Regarding claim 4, Gray discloses the invention as described above with regard to claim 3.
Gray further discloses wherein the copper-containing agent is copper ([0081], [0038], copper).
Regarding claim 5, Gray discloses the invention as described above with regard to claim 4.
Gray further discloses wherein the elastomeric body is dotted with the copper as a plurality of inclusions and the surface of the copper is in contact with the environment of the vaginal region of the female reproductive system (Per Applicant’s specification [0033], [0060] inclusions 320 are embedded with an elastomeric body and dispersed throughout the elastomeric body wherein the surface of the inclusions is partially exposed or not exposed; [0035], [0036]-[0037]; [0053]; [0081], the intravaginal ring comprises a polymeric matrix having a first bioactive agent [metal ion of copper] that reduces the oxidation state of a second bioactive agent and that is a non-hormonal contraceptive [per [0081] organometallic complex is a non-hormonal contraceptive with least one metal ion thus the metal ion is a contraceptive] and it follows that ions within a matrix are separate inclusions within the matrix and are thus a plurality of inclusions in contact with a vaginal region both by way of being a part of the ring matrix that is in contact with the environment of the vaginal region of the female reproductive system[which may include the space within the vaginal region] and by way of the release in a controlled delivery of the bioactive agent which is a reducing agent; Additionally, see [0073], the device is a fiber-reinforced intravaginal device for the controlled release of at least one bioactive agent and the device comprises a polymeric matrix in the shape of a ring reinforced by fiber made from copper and is capable of achieving contraception and thus the copper fibers area plurality of inclusions and the surface of the copper is in contact with the environment of the vaginal region of the female reproductive system as the fibers are reinforcing the ring). As to claim 5, the limitation, “wherein the elastomeric body is dotted with the copper” is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (emphasis added). Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Gray may be silent as to the process used to provide the plurality of copper inclusions [multiple occurrences copper ions in the polymeric matrix as described above and/or copper fibers reinforcing the ring], the apparatus disclosed is the same as claimed.
Regarding claim 6, Gray discloses the invention as described above with regard to claim 1.
Gray further discloses wherein the at least one bioactive agent further comprises one or more vaginal-health-promoting agents ([0078], a strain of Lactobacillus [vaginal microbiota]).
Regarding claim 7, Gray discloses the invention as described above with regard to claim 6.
Gray further discloses wherein the one or more vaginal-health-promoting agents are selected from the group consisting of acidifying agents (NOTE: ascorbic acid is listed in applicant’s specification at [0037] as an acidifying agent; [0034], D-ascorbic acid is the reducing agent in Gray which per Applicant’s spec is an acidifying agent ), vaginal microbiota ([0078], a strain of Lactobacillus [vaginal microbiota]), prebiotics, or a combination thereof.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-4, 6-7 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friend (US 2021/0275347).
Regarding claim 1, Friend discloses a contraceptive device (embodiment of Fig. 1) ([0022], [0062], ring has an active agent to prevent pregnancy) configured for insertion into the vagina of a female reproductive system of a subject ([0054], it is intravaginal), the contraceptive device comprising: an elastomeric body ([0005], the intravaginal device has a flat, circular or oval ring made with thermoplastic elastomer thus it is elastomeric) ; and at least one bioactive agent having spermicidal or spermiostatic properties coupled to the elastomeric body ([0022], the active agent is a non-hormonal contraceptive; [0005], the ring may contain one or more non-hormonal spermiostatic agents), wherein the contraceptive device is configured to release an effective amount of the at least one bioactive agent into the vaginal region, cervical region, and endometrial region of the female reproductive system when the contraceptive device is positioned into the vaginal region of the female reproductive system ([0022], [0055], [0061], the device is inserted in the vagina and contains non-hormonal contraceptive, spermiotastic metals and/or metal salts and is thus capable of intended use).
Friend, in an embodiment of Fig. 1, does not explicitly disclose a torus-shaped body.
Friend in an embodiment of Fig. 7 teaches an analogous contraceptive device having a torus-shaped body (Fig. 7; ([0005]; [0022]; see annotated Fig. 7 below which shows cross-sections of a circular embodiment of the ring portion of the device where the bottom have has half a circle and the top half has half a circle cross section which either alone or together are torus-shaped as they resemble or are a torus).
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It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the elastomeric body of the contraceptive device of Friend in an embodiment of Fig. 1 is a torus-shaped body, as taught by Friend in an embodiment of Fig. 7, in order to provide an improved contraceptive device that facilitates providing active ingredients in discrete reservoirs (Friend, [0022]).
Regarding claim 2, Friend as combined discloses the invention as described above with regard to claim 1.
Friend further discloses wherein the at least bioactive agent is a copper-containing agent ([0013], the intravaginal ring device has a metal barrier that is copper and copper is a copper-containing agent, thus at least one bioactive agents having spermicidal or spermiostatic properties [copper] is coupled to the elastomeric body [ring]).
Regarding claim 3, Friend as combined discloses the inventio as described above with regard to claim 2.
Friend further discloses wherein the copper-containing agent is copper (see explanation above with regard to claim 2) , a copper alloy, a copper salt, or a combination thereof.
Regarding claim 4, Friend discloses the invention as described above with regard to claim 3.
Friend further discloses wherein the copper-containing agent is copper (see explanation with regard to claim 2).
Regarding claim 6, Friend discloses the invention as described above with regard to claim 1.
Friend further discloses wherein the at least one bioactive agent coupled to the body further comprises one or more vaginal-health-promoting agents ([0022], agents to treat or prevent bacterial, fungal and/or viral infections and treat sexually transmitted infections are one or more vaginal-health promoting agents; [0018], ascorbic acid; [0039], in some embodiments the ascorbic acid is part of the ring and in other it is part of the barrier thus it is coupled to the body in either way; NOTE: ascorbic acid is listed in applicant’s specification at [0037] as an acidifying agent).
Regarding claim 7, Friend discloses the invention as described above with regard to claim 6.
Friend further discloses wherein the one or more vaginal-health-promoting agents are selected from the group consisting of acidifying agents, vaginal microbiota, prebiotics, or a combination thereof (see description above with regard to claim 6, with regard to ascorbic acid being an acidifying agent).
Regarding claim 30, Friend discloses the invention as described above with regard to claim 4.
Friend further discloses wherein the copper is coupled to the elastomeric body as one or more segments ([0013], the intravaginal ring has a metal barrier comprising copper and the metal barrier is mono- or multi-filament polymer; NOTE: a mono- or multi-filament of copper is one or more segments coupled to the elastomeric body [ring]).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray (US 2017/0020718) as applied to claim 7 above, in view Moench (US 2012/0070476).
Regarding claim 8, Gray discloses the invention as described above with regard to claim 7.
Gray does not disclose wherein the acidifying agent is lactic acid.
Moench teaches an analogous intravaginal device ([0030], [0031], tubular device contacting vagina) comprising an analogous bioactive agent that has an analogous acidifying agent wherein the acidifying agent is lactic acid ([0030]; [0023]; reservoir portion contains L-lactic acid).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the one or more vaginal-health-promoting agents of the contraceptive device of Gray that is an acidifying agent is lactic acid, as taught by Moench, in order to provide an improved contraceptive device that reduces pathogenic infection at a vaginal epithelial surface (Moench, [0024]).
Regarding claim 9, Gray in view of Moench discloses the invention as described above with regard to claim 8.
Gray further discloses wherein the vaginal microbiota are Lactobacillus Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus reuteri, Bifidobacterium longum, or a combination thereof ([0078], a strain of Lactobacillus which is a part of the genus per 112f analysis above).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friend (US 2021/0275347) as applied to claim 7 above, in view of Moench (US 2012/0070476).
Regarding claim 8, Friend discloses the invention as described above with regard to claim 7.
Friend does not disclose wherein the acidifying agent is lactic acid.
Moench teaches an analogous intravaginal device ([0030], [0031], tubular device contacting vagina) comprising an analogous bioactive agent that has an analogous acidifying agent wherein the acidifying agent is lactic acid ([0030]; [0023]; reservoir portion contains L-lactic acid).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the vaginal-health-promoting agent of the contraceptive device of Friend is an acidifying agent that is lactic acid, as taught by Moench, in order to provide an improved contraceptive device that reduces pathogenic infection at a vaginal epithelial surface (Moench, [0024]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA MCCARTHY whose telephone number is (408)918-7594. The examiner can normally be reached Monday - Friday, 7:00-3:30 PT.
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/G.M./Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786