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 .
Any References cited but not appearing in any current Form 892 may be found in previous Form 892’s or IDS’s.
Response to Amendment
The amendment to the claims filed on 05/06/2026 is acknowledged. In the amendment, claim 1 and claim 9 are amended. Claims 2-5 and 30 are cancelled. Claims 10-29 are withdrawn. Claims 1 and 6-9 are currently pending for examination.
The cancellation of claim 2 renders moot the objection to claim 2.
The amendment of claim 9 overcomes the 112b rejection with regard to claim 9.
Response to Arguments
Applicant’s arguments, see page 3, filed 05/06/2026, with respect to the rejection(s) of claim(s) 1 under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly cited Pope (US 2012/0097171) in view of newly cited Baum (US 2023/0017712).
Drawings
The drawings are objected to because Fig. 1C includes a description instead of numerical reference characters. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because it includes the legal phraseology “comprising”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pope (US 2012/0097171) in view of Baum (US 2023/0017712).
Regarding claim 1, Pope discloses a contraceptive device (10) ([0020], intravaginal deice 10, Fig. 1; [0024], the device may possibly act as a contraceptive device; capable of intended use) configured for insertion into the vagina of a female reproductive system of a subject ([0023]), the contraceptive device comprising: a torus-shaped ([0020], silicon rubber tubing; Fig. 1, tubular ring is torus shaped) flexible body ([0020], flexible silicon rubber tubing); and at least one bioactive agent having spermicidal or spermiostatic properties coupled to the elastomeric body ([0023]-[0024], copper present in the device acts as a pathogen inhibitor and possibly a contraceptive device; [0025], copper wire embedded in the flexible material), 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 ([0021], [0023]-[0024], device inserted in the vagina; capable of intended use), wherein the at least one bioactive agent is copper ([0020]-[0021] and [0023]-[0024]) and wherein the copper is coupled into the flexible body as one or more segments (14) (Fig. 1, [0023], 0025], copper wire embedded in the flexible material is a segment that is a bioactive agent).
Pope does not explicitly disclose that the flexible body is an elastomeric body.
Baum teaches an analogous contraceptive device ([0059]-[0060], [0085]-[0087], intravaginal ring) configured for insertion into the vagina of a female ([0060], [0087], capable of intended use), the contraceptive device comprising an elastomeric body ([0192]-[0193], the elastomeric material of the drug delivery device disclosed herein may comprise silicones).
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 flexible body of the contraceptive device of Pope is an elastomeric body as taught by Baum in order to provide an improved device that is non-resorbable (Baum, [0193]).
Regarding claim 6, Pope in view of Baum discloses the invention as described above with regard to claim 1.
Pope further discloses wherein the at least one bioactive agent coupled to the body further comprises one or more vaginal-health-promoting agents ([0017], additional medicinal substances such as antibiotic formulations; [0025], antibiotic formulations added to the device; capable of intended use).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pope (US 2012/0097171) in view of Baum (US 2023/0017712) as applied to claim 6 above, and in further view of Friend (US 2021/0275347).
Regarding claim 7, Pope in view of Baum discloses the invention as described above with regard to claim 6.
Pope in view of Baum does not disclose 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.
Friend teaches an analogous 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 analogous 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, spermiostatic metals and/or metal salts and is thus capable of intended use), wherein the at least one bioactive agent 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), 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 above description pertaining to ascorbic acid being an acidifying agent).
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 Pope in view of Baum are selected from the group consisting of acidifying agents, vaginal microbiota, prebiotics, or a combination thereof, as taught by Friend, in order to provide an improved contraceptive device that has a spermiostatic agent (Friend, [0089]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pope (US 2012/0097171) in view of Baum (US 2023/0017712) and in view of Friend (US 2021/0275347), as applied to claim 7 above, and in further view Moench (US 2012/0070476).
Regarding claim 8, Pope in view of Baum and in further view of Friend discloses the invention as described above with regard to claim 7.
Pope in view of Baum and in further view of 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 comprises an analogous acidifying agent ([0023]-[0024]) 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 Pope in view of Baum and in further view of Friend 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]).
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pope (US 2012/0097171) in view of Baum (US 2023/0017712, as applied to claim 6 above, and in view of Gray (US 2017/0020718) and in further view of Faulkner (US 2021/0401806).
Regarding claim 7, Pope in view Baum discloses the invention as described above with regard to claim 7.
Pope in view of Baum does not disclose 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.
Gray teaches an analogous 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 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), wherein the at least one bioactive agent further comprises one or more vaginal-health-promoting agents ([0078], Lactobacillus strain; capable of intended use) wherein the one or more vaginal-health-promoting agents are selected from the group consisting of acidifying agents, vaginal microbiota ([0078], At least one bioactive agent is a probiotic strain. For example, the probiotic strain may be a strain of Lactobacillus [vaginal microbiota as evidenced by claim 9]; NOTE: thus there is thus disclosed an embodiment with two probiotics [as at least one bioactive agent is a probiotic strain indicating that more than one bioactive agent may be a probiotic strain] with two strains of Lactobacillis [vaginal microbiota]), prebiotics, or a combination thereof.
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 agents of the contraceptive device of Pope in view of Baum are selected from the group consisting of acidifying agents, vaginal microbiota, prebiotics, or a combination thereof, as taught by Gray, in order to provide an improved contraceptive device that provides.
Regarding claim 9, Pope in view Baum, and in further view of Gray discloses the invention as described above with regard to claim 7.
Gray further discloses wherein the vaginal microbiota are a strain of Lactobacillus ([0078]).
Gray does not explicitly disclose wherein the vaginal microbiota are Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus reuteri, Bifidobacterium longum, or a combination thereof.
Faulkner teaches a vaginal ring ([0051]) with analogous vaginal microbiota ([0043], [0051], disclosed compositions) wherein the vaginal microbiota are Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus reuteri, Bifidobacterium longum, or a combination thereof ([0043]).
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 microbiota of the contraceptive device of Pope in view of Baum and in further view of Gray are Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus reuteri, Bifidobacterium longum, or a combination thereof, as taught by Faulkner, in order to provide an improved contraceptive device that exert positive health effects (Faulkner, [0043]) and that treat and prevent vaginal infections (Faulkner, [0007]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bechgaard (US 2013/0042873) discloses a contraceptive device that is a ring that includes copper ([0040]).
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.
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/G.M./Examiner, Art Unit 3786
/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
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