DETAILED ACTION
Applicant’s amendments and remarks, filed March 23, 2026, are fully acknowledged by the Examiner. Currently, claims 18-40 are pending with claims 1-17 cancelled, and claims 18, 21, 24, 27, 29, 34, 36 and 39 amended. Applicant’s updated to paragraph [0001] of the Specification have obviated the previously-filed objection. Applicant’s amendments to the claims have obviated the previously-filed rejections under 35 U.S.C. 112(b). The following is a complete response to the March 23, 2026 communication.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 18-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16, 39 and 47 of U.S. Patent No. 8,961,511 B2 in view of Ingle et al. (US Pat. No. 6,216,704 B1).
Regarding instant claim 18, the Examiner is of the position that a majority of the limitations set forth therein can be found in patented claim 16 and further including the limitations set forth in parent claims 1, 9 and 15. In particular, the Examiner finds that the follow correlation exists between instant claim 18 and patented claims 16/15/9/1.
Instant Application – Claim 18
US Pat. No. 8,961,511 B2
A method for non-invasively remodeling a therapeutic zone within a target tissue including a submucosa and a muscularis underlying a mucosal epithelium of female genital tissue in at least one of an introitus and a vagina;
heating the target tissue in a portion of the vagina extending from the introitus inwardly to a location 1 cm in from the introitus;
the heating does not substantially affect the mucosal epithelium and the heating includes heating the therapeutic zone within the target tissue to between 40 degrees C and 45 degrees C;
wherein the remodeling of the therapeutic zone within the target tissue includes tightening the target tissue.
1: A method for remodeling a therapeutic zone within a target tissue, the target tissue comprising tissue underlying an epithelium of female genital tissue comprising at least one of vulva, introitus and vagina tissue
1: heating the target tissue … wherein the heating includes heating a portion of the vagina extending from the introitus inwardly to a location from 1 cm to 3.5 cm in from the introitus
16: wherein the reverse thermal gradient ranges from a low temperature of 0 degrees C. to 10 degrees C. at the epithelium to a high temperature of 45 degrees C. to 80 degrees C. in the underlying target tissue
1: remodeling the therapeutic zone of target tissue
While the combination of patented claims 16/15/9/1 provide for the various limitations as noted in the table above, the Examiner has failed to find that these claim provide for the limitations of a) contacting the mucosal epithelium with a treatment tip at a plurality of contact sites, the treatment tip including an energy delivery element, b) the heating includes delivering energy by radiofrequency energy at the plurality of contact site, c) the heating is controlled by a feedback control including at least one thermal sensor, such that a temperature of the target tissue does not go higher than a predetermined temperature. The Examiner, however is of the position that these features are provided in the prior art by the teaching of Ingle.
Ingle provides for an exemplary manner of remodeling female genital tissue where an apparatus including an energy delivery element (12) on a treatment tip (tip of the shaft 42) is contacts various sites of target tissue (see at least figure 6 where the tip with 12 contacts various sites when placed in the vagina at V). Ingle further provides an exemplary manner of heating such tissue including the delivery of radiofrequency energy by the energy delivery element (see col. 18; 8-21) and for the heating to be controlled by a feedback controller including at least one thermal sensor, such that a temperature of the target tissue does not go higher than a predetermined temperature (see col. 12; 37-47 and col. 18; 22-30).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to have utilized an energy treatment device as in Ingle including the treatment tip, energy delivery element and temperature feedback controller to provide for an exemplary manner of applying radiofrequency energy to the mucosal epithelium of the at the claimed tissue location. The combination of patented claims readily provide for the focus of treatment with Ingle merely being relied upon to teach a known treatment device and thermal controller for accomplishing treatment in a similar location within the female genital tissue. The Examiner finds that one of ordinary skill would believe the apparatus of Ingle to work with a reasonable expectation of success to carry out the steps providing in instant claim 18.
Regarding instant claim 19, see patented claim 9;
Regarding instant claims 20-22, the Examiner is of the position that such would be obvious results of the treatment provided by the combination of limitations set forth in the rejection of claim 18 above, and wherein each manner of remodeling would represent one of a known number of options of treatment that would result from the heat treatment of the mucosal epithelium of the body as prescribed in both claim 18 as well as disclosed in Ingle.
Regarding instant claim 23, see patented claim 1.
Regarding instant claim 24, the Examiner is of the position that a majority of the limitations set forth therein can be found in patented claim 39 and further including the limitations set forth in parent claim 35. In particular, the Examiner finds that the follow correlation exists between instant claim 24 and patented claims 39/35.
Instant Application – Claim 24
US Pat. No. 8,961,511 B2
A method for non-invasively remodeling a therapeutic zone within a target tissue including a submucosa and a muscularis underlying a mucosal epithelium of female genital tissue in a vagina
heating the target tissue in a portion of the vagina circumferentially around a substantially complete circumferential sections of a vaginal wall from 1 o'clock to 11 o'clock, wherein an aspect closest to a urethra is at 12 o'clock,
wherein the heating does not substantially affect the mucosal epithelium,
wherein the remodeling of the therapeutic zone within the target tissue includes tightening the target tissue.
35: A method for remodeling a therapeutic zone within a target tissue, the target tissue comprising tissue underlying an epithelium of female genital tissue comprising at least one of vulva, introitus and vagina tissue
35: heating the target tissue … wherein the heating includes heating a portion of the vagina circumferentially around its wall from 1 o'clock to 11 o'clock, wherein the aspect closest to the urethra is at 12 o'clock
39: cooling the epithelium
35: remodeling the therapeutic zone of target tissue
While the combination of patented claims 39/35 provide for the various limitations as noted in the table above, the Examiner has failed to find that these claim provide for the limitations of a) contacting the mucosal epithelium with a treatment tip, the treatment tip including an energy delivery element that is radially curved, b) the heating includes delivering energy by radiofrequency energy at the plurality of contact sites, c) the heating is controlled by a feedback control including at least one thermal sensor, such that a temperature of the target tissue does not go higher than a predetermined temperature, and wherein the heating includes heating the therapeutic zone within the target tissue to between 40 degrees C and 45 degrees C. The Examiner, however is of the position that these features are provided in the prior art by the teaching of Ingle.
Ingle provides for an exemplary manner of remodeling female genital tissue where an apparatus including an energy delivery element (12) on a treatment tip (tip of the shaft 42) is contacts various sites of target tissue (see at least figure 6 where the tip with 12 contacts various sites when placed in the vagina at V). Ingle further provides an exemplary manner of heating such tissue including the delivery of radiofrequency energy by the energy delivery element (see col. 18; 8-21) and for the heating to be controlled by a feedback controller including at least one thermal sensor, such that a temperature of the target tissue does not go higher than a predetermined temperature (see col. 12; 37-47 and col. 18; 22-30) and wherein the heating includes heating the target tissue to between 40 degrees C and 45 degrees C (See col. 15; 19-27).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to have utilized an energy treatment device as in Ingle including the treatment tip, energy delivery element and temperature feedback controller to provide for an exemplary manner of applying radiofrequency energy to the mucosal epithelium of the at the claimed tissue location. The combination of patented claims readily provide for the focus of treatment with Ingle merely being relied upon to teach a known treatment device and thermal controller for accomplishing treatment in a similar location within the female genital tissue. The Examiner finds that one of ordinary skill would believe the apparatus of Ingle to work with a reasonable expectation of success to carry out the steps providing in instant claim 18.
Regarding instant claim 25, see patented claim 39;
Regarding instant claims 26-28, the Examiner is of the position that such would be obvious results of the treatment provided by the combination of limitations set forth in the rejection of claim 18 above, and wherein each manner of remodeling would represent one of a known number of options of treatment that would result from the heat treatment of the mucosal epithelium of the body as prescribed in both claim 24 as well as disclosed in Ingle.
Regarding instant claim 36, the Examiner is of the position that a majority of the limitations set forth therein can be found in patented claim 47 and further including the limitations set forth in parent claim 43. In particular, the Examiner finds that the follow correlation exists between instant claim 36 and patented claims 47/43.
Instant Application – Claim 36
US Pat. No. 8,961,511 B2
A method for non-invasively remodeling a therapeutic zone within a target tissue including a submucosa and a muscularis underlying a mucosal epithelium of female genital tissue in at least one of a vulva and an introitus,
heating the target tissue in a portion of the vulva radiating outward from the introitus to Hart's line,
wherein the heating does not substantially affect the mucosal epithelium,
wherein the remodeling of the therapeutic zone within the target tissue includes tightening the target tissue.
43: A method for remodeling a therapeutic zone within a target tissue, the target tissue comprising tissue underlying an epithelium of female genital tissue comprising at least one of vulva, introitus and vagina tissue
43: heating the target tissue … the heating includes heating a portion radiating outward from the introitus to Hart's line
47: cooling the epithelium
43: remodeling the therapeutic zone of target tissue
While the combination of patented claims 47/43 provide for the various limitations as noted in the table above, the Examiner has failed to find that these claim provide for the limitations of a) contacting the mucosal epithelium with a treatment tip at a plurality of contact sites, b) the heating includes delivering energy by radiofrequency energy at the plurality of contact sites, c) the heating is controlled by a feedback control including at least one thermal sensor, such that a temperature of the target tissue does not go higher than a predetermined temperature, and wherein the heating includes heating the therapeutic zone within the target tissue to between 40 degrees C and 45 degrees C. The Examiner, however is of the position that these features are provided in the prior art by the teaching of Ingle.
Ingle provides for an exemplary manner of remodeling female genital tissue where an apparatus including an energy delivery element (12) on a treatment tip (tip of the shaft 42) is contacts various sites of target tissue (see at least figure 6 where the tip with 12 contacts various sites when placed in the vagina at V). Ingle further provides an exemplary manner of heating such tissue including the delivery of radiofrequency energy by the energy delivery element (see col. 18; 8-21) and for the heating to be controlled by a feedback controller including at least one thermal sensor, such that a temperature of the target tissue does not go higher than a predetermined temperature (see col. 12; 37-47 and col. 18; 22-30) and wherein the heating includes heating the target tissue to between 40 degrees C and 45 degrees C (See col. 15; 19-27).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to have utilized an energy treatment device as in Ingle including the treatment tip, energy delivery element and temperature feedback controller to provide for an exemplary manner of applying radiofrequency energy to the mucosal epithelium of the at the claimed tissue location. The combination of patented claims readily provide for the focus of treatment with Ingle merely being relied upon to teach a known treatment device and thermal controller for accomplishing treatment in a similar location within the female genital tissue. The Examiner finds that one of ordinary skill would believe the apparatus of Ingle to work with a reasonable expectation of success to carry out the steps providing in instant claim 18.
Regarding instant claim 37, see patented claim 47;
Regarding instant claims 38-40, the Examiner is of the position that such would be obvious results of the treatment provided by the combination of limitations set forth in the rejection of claim 18 above, and wherein each manner of remodeling would represent one of a known number of options of treatment that would result from the heat treatment of the mucosal epithelium of the body as prescribed in both claim 36 as well as disclosed in Ingle.
Allowable Subject Matter
Claims 29-35 are allowed.
Response to Arguments
Applicant's arguments filed March 23, 2026 have been fully considered but they are not persuasive.
Applicant argues with respect to the rejection of claim 18 on the grounds of non-statutory double patenting in view of Ingle (US Pat. No. 8,961,511) on page 10 of the Remarks. Therein, Applicant contends that the cited portion of the Ingle reference fails to “explicitly disclose the temperature range 40 degrees C to 45 degrees C as disclosed in independent claim 18” given that the cited portion of Ingle provides a high temperature range of “45 degrees C to 80 degrees C” in claim 16. This is not persuasive.
With respect to the analysis of the claim requirement in independent claim 18 of “the heating includes heating the therapeutic zone within the target tissue to between 40 degrees C and 45 degrees C”, the Examiner notes that MPEP 804(II)(B)(2) discusses anticipated analysis with respect to double patenting doctrine, and specifically recites that “the claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by 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, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993).
The Examiner further references MPEP 2131.03 to support that the claimed range in the Ingle reference provides anticipation of the range set forth in independent claim 18 with sufficient specificity to support the rejection. Applicant’s own disclosure provides not criticality associated with the value of 40-45 degrees C that would render the overlap in the ranges in patented claim 16 and instant claim 18 as non-anticipatory. Thus, the Examiner maintains that the rejection of claim 18 for obviousness-type double patented in view of US Pat. No. 8,961,511 remains tenable.
Applicant further argues with respect to the rejection of claims 24 and 36 for obviousness-type double patenting with respect to Ingle (US Pat. No. 8,961,511) in view of Ingle on pages 10-11 of the Remarks. Applicant argues that Ingle fails to provide for “heating the target tissue to between 40 degrees C and 45 degrees C” given that Ingle provide for a target zone temperature of “above about 60 C and often to a temperature at or about 70 C”. Applicant continues on page 11 that the target zone 32 in Ingle is heaters to a temperature above 40-45 degrees C and, in particular, heats the area of tissue 32 to above 60 degrees C.
This is not persuasive. The Examiner notes that the cited portion of column 15 of Ingle provides heating of tissue up to 45 degrees C. Further, Applicant correctly notes that the area of tissue at 32 is subsequently heated to higher temperatures above 60 degrees C. The Examiner however, finds that each of claims 24 and 36 only require “heating the target tissue …” such that the “heating includes heating the therapeutic zone within the target tissue to between 40 degrees C and 45 degrees C”. Neither claims 24 or 36 require that the heating of the therapeutic zone within the target tissue to the claims 4-0-45 degrees C temperature range is what specifically provides for the remodeling of the therapeutic zone. Rather, each of claims 24 and 36 can be interpreted to only require the tissue within that the therapeutic to achieve the claimed temperature and does not require the tissue in the therapeutic zone to be, for example, maintained at such a temperature to achieve the claimed remodeling.
As such, the Examiner is of the position that the disclosure in col. 15 of Ingle that teaches heating tissue to values that achieve the claimed 40-45 degrees C readily cures the noted deficiency in the combination of claims 39/35 of US 8,961,511 B2 with respect to claim 24 and in the combination of claims 47/43 of US Pat. No. 8,961,511 B2 with respect to claim 36, given that such contemplates that target tissue within the therapeutic zone is indeed heated to a temperature ranging from 40-45 degrees C.
Conclusion
THIS ACTION IS MADE FINAL. 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 RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794