Prosecution Insights
Last updated: April 19, 2026
Application No. 18/053,588

ASSESSMENT DEVICE FOR VULVOVAGINAL REJUVENATION

Final Rejection §102§103
Filed
Nov 08, 2022
Examiner
KHANDKER, RAIHAN R
Art Unit
3771
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Madorra Inc.
OA Round
4 (Final)
64%
Grant Probability
Moderate
5-6
OA Rounds
2y 11m
To Grant
99%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allow Rate
100 granted / 157 resolved
-6.3% vs TC avg
Strong +60% interview lift
Without
With
+60.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
61 currently pending
Career history
218
Total Applications
across all art units

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
48.6%
+8.6% vs TC avg
§102
21.4%
-18.6% vs TC avg
§112
23.3%
-16.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 157 resolved cases

Office Action

§102 §103
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 . Response to Amendment This office action is responsive to the amendment filed on 01/23/2026. As directed by the amendment: claims 16-22 remain withdrawn and claims 27-28 have been added. Thus, claims 1-28 are presently pending in this application. Response to Arguments Applicant's arguments, see pages 7-11, filed 01/23/2026 with regards to the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Blurton et al (US 20160030083 A1), herein referenced to as “Blurton” have been fully considered but they are not persuasive. The applicant argues that Blurton does not disclose the limitations of claim 1. Specifically, they argue that Blurton does not disclose “assessing engagement between the tissue and a vulvovaginal device based on a shape of the transparent coupling pad”. They argue that Blurton is concerned with a different problem, namely pelvic support during child delivery and not vaginal rejuvenation as with the claimed invention. As indicated previously, the language is functional language and the claim is an apparatus claim and is to be limited by structural limitations. Blurton disclosing a different function of the device does not preclude the same structure from being used in the manner claimed (specifically “user to visually observe changes in tissue distension… by observing changes in the area of tissue against the pad 145 over time”. The language, " wherein a shape of the transparent coupling pad is further configured for assessing engagement between the tissue and the vulvovaginal rejuvenation device," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Blurton meets the structural limitations of the claim, and is capable of being used assess engagement between a separate vulvovaginal rejuvenation device and the introitus as the coupling pad is disclosed to conform its shape to complement the patient’s tissue surface (see [0142]) and then retaining that conformed shape (see [0142]) after the coupling pad is removed from the patient, which then can be used to assess fit on a separate device as the coupling pad can be removed from the current device. As such the rejection of the claims will be maintained. 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) 1-3, 5, 11, 15, and 26-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blurton et al (US 20160030083 A1), herein referenced to as “Blurton”. Claim 1 Blurton discloses: A handheld device 100 (see Figs. 1-4, [0125]) for visualizing quality of contact between a vulvovaginal rejuvenation device and an introitus, comprising: a handle 106 (see Figs. 1-4, [0130], a grip) configured for maintaining a position of the device 100 during use (see [0130], assist a user in holding in pressurized engagement); a head portion 102 (see Figs. 1-4, [0130]) comprising a translucent visualization window 104 (see Figs. 1-4, [0131] and [0137], the entirety of 102 is made of a transparent material, hence 104 is a translucent visualization window); and a transparent coupling pad 145 (see Figs. 1-4, [0141] and [0144], clear or translucent) configured to be attached (see [0147], loosely held via pressure to 102) to the head portion 102 and to engage a face 130 (see Figs. 1-4, [0131]) of the device 102 corresponding to the visualization window 104, the coupling pad 145 configured to contour and conform to tissue (see [0142], 145 is anatomically conformable structure) around a patient's vagina and external genitalia (see Figs. 1-4, [0142], the pad is conforming to tissue around the patient’s vagina and external genitalia, in this case tissue dorsal but “around” external genitalia), the transparent coupling pad 145 further configured to permit visualization (see [0144], the user can see through the pad, and through 102 which is attached to 145 to visually observe changes in tissue distension), through the transparent coupling pad 145 corresponding with the visualization window 104, of an interface between the coupling pad 145 and the tissue (see [0144], tissue contact against the pad) during use of the device (see [0144]); wherein a shape of the transparent coupling pad is further configured for assessing engagement between the tissue and the vulvovaginal rejuvenation device. The preamble, "for visualizing quality of contact between a vulvovaginal rejuvenation device and the introitus," merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Blurton meets the structural limitations of the claim, and is capable of being “used for visualizing quality of contact between a vulvovaginal rejuvenation device and the introitus”. This device is a fully translucent device with a coupling pad that is designed to observe tissue distension and changes of tissue contact with a coupling pad of the device (see [0144]). The language, " configured to conform to tissue in a user's vagina and external genitalia," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Blurton meets the structural limitations of the claim, and is capable of the conformable coupling pad to conform to tissue in a user’s vagina and external genitalia as it is explicitly disclosed that the coupling pad conforms to tissue (see [0142], such as a translucent clay-like polymer like silicone to retain a complementary shape to the patient’s tissue surface). The language, " wherein a shape of the transparent coupling pad is further configured for assessing engagement between the tissue and the vulvovaginal rejuvenation device," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Blurton meets the structural limitations of the claim, and is capable of being used assess engagement between a separate vulvovaginal rejuvenation device and the introitus as the coupling pad is disclosed to conform its shape to complement the patient’s tissue surface (see [0142]) and then retaining that conformed shape (see [0142]) after the coupling pad is removed from the patient, which then can be used to assess fit on a separate device as the coupling pad can be removed from the current device. Claim 2 Blurton discloses: The device of claim 1, see 102 rejection above. Blurton further discloses: wherein the visualization window 104 comprises a lens 104 + 145 (see [0137] and [0144], 104 and 145 are both translucent/transparent, and the 145 serves as a lens on top of 104), further wherein the coupling pad 145 is the lens (see [0137] and [0144]). Claim 3 Blurton discloses: The device of claim 2, see 102 rejection above. Blurton further discloses: wherein the lens 104 + 145 comprises markings or indicators 144 (see [0139], markings that make precise measurements of the tissue distension) allowing measurement of features seen therethrough. Claim 5 Blurton discloses: The device of claim 1, see 102 rejection above. Blurton further discloses: wherein the coupling pad 145 is detachably attached (see [0147], loosely held with pressure, see also [0142]) to the head portion 102. Claim 11 Blurton discloses: The device of claim 1, see 102 rejection above. Blurton further discloses: wherein the visualization window 102 comprises a surface area CA2 of about 3-7 cm2 (see Fig. 3, [0133], CA1 can be 3 cm2 and the ratio of CA2:CA1 can be 1 or greater than 1, so if the ratio is 1, or a 1:1 ratio, when CA1 is 3 cm2 CA2 is also cm2). Claim 15 Blurton discloses: The device of claim 1, see 102 rejection above. Blurton further discloses: wherein the coupling pad 145 comprises a translucent material (see [0144]). Claim 26 Blurton discloses: The device of claim 1, see 102 rejection above. The language, " wherein one or more of: a placement and a position of the device is configured to be adjusted to alleviate a presence of air bubbles based on the visualization through the coupling pad pursuant to quantifying a size of the air bubbles, further wherein a candidacy of the patient for vulvovaginal rejuvenation is determined based on the quantifying of the size of the air bubbles," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Blurton meets the structural limitations of the claim, and is capable of placing and positioning the device to reduce the presence of air bubbles by moving the handheld device to adjust the conformation to the tissue which would adjust the conformable coupling pad while the operator sees the size of air bubbles around the coupling pad. Furthermore, the operator can see through the transparent coupling pad the size of the air bubbles to determine if the patient is qualified for vulvovaginal rejuvenation. Claim 27 Blurton discloses: The device of claim 1, see 102 rejection above. Blurton further discloses: wherein the transparent coupling pad 145 is configured to be disposable (see [0217], single use type, discarded after use) between assessments of engagement between the tissue and the vulvovaginal rejuvenation device. The language, " configured to disposables between assessments of engagement between the tissue and the vulvovaginal rejuvenation device," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Blurton meets the structural limitations of the claim, and is capable of the transparent coupling pad to be disposed after use with assessment of engagement between the tissue and a vulvovaginal rejuvenation device as it cost effectively manufactured to be discarded after use (see [0217]). Claim 28 Blurton discloses: The device of claim 2, see 102 rejection above. The language, " wherein the coupling pad is configured to correspond to a size of an ultrasound device used in conjunction with the vulvovaginal rejuvenation device, wherein positioning and mechanical forces applied via the transparent coupling pad is configured to enhance assessment of engagement between the tissue and the vulvovaginal rejuvenation device," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Blurton meets the structural limitations of the claim, and is capable of the coupling pad configuring to correspond to a size of an ultrasound device used in the vulvovaginal rejuvenation device as the pad is can conform hence can correspond to a size of an ultrasound device and be pressed against tissue to enhance assessment of engagement between tissue and the vulvovaginal rejuvenation device via visual conformation. 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. 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. Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blurton. Claim 8 Blurton discloses: The device of claim 1, see 102 rejection above. Blurton does not explicitly disclose: wherein the coupling pad comprises a height of about 3-7 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Blurton to have the coupling pad comprises a height of about 3-7 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Perkins would not operate differently with the coupling pad comprises a height of about 3-7 mm. Further, applicant places no criticality on the range claimed, as the applicant recites several other ranges of coupling pad height including 2-8 mm, 5-7 mm, or about 6.5 mm (see [0029]), hence the range is not critical as there are broader and narrower ranges that are also acceptable ranges for the device. Claim(s) 4 and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blurton in view of Ouyang et al (US 20120289858 A1), herein referenced to as “Ouyang”. Claim 4 Blurton discloses: The device of claim 1, see 102 rejection above. Blurton does not explicitly disclose: the device further comprising a light configured to illuminate the visualization window. However, Ouyang in a similar field of invention teaches a handheld device 100 (see Figs. 1-7) with a head 120 (see Figs. 1-7) with a translucent visualization window aperture of 640 (see Fig. 6, [0120]) and a coupling pad 642 (see Fig. 6). Ouyang further teaches: comprising a light 630 + 632 (see [0120]) configured to illuminate the visualization window (see [0120], illuminates the targeted tissue for visual inspection). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blurton to incorporate the teachings of Ouyang and teach a device with a light configured to illuminate the visualization window. Motivation for such can be found in Ouyang as this allows even illumination of tissue for visual inspection (see [0120]). Claim 6 Blurton discloses: The device of claim 1, see 102 rejection above. Blurton does not explicitly disclose: wherein the device comprises a camera configured to provide image data captured through the visualization window, wherein the head portion of the handheld device is configured to receive the camera, wherein the camera is configured to allow viewing of at least a portion of the visualization window for visual assessment of engagement between the coupling pad and the patient's vagina and external genitalia. However, Ouyang in a similar field of invention teaches a handheld device 100 (see Figs. 1-7) with a head 120 (see Figs. 1-7) with a translucent visualization window aperture of 640 (see Fig. 6, [0120]), a handle 108 (see Figs. 1-7), and a coupling pad 642 (see Fig. 6). Ouyang further teaches: wherein the device 100 comprises a camera 640 (see Fig. 6, [0120]) configured to provide image data image and video capture (see [0121]) captured through the visualization window aperture of 640 (see [0120]), wherein the head portion 120 of the handheld device 100 is configured to receive the camera 640 (see Figs. 6-7, the camera 640 is received into 120, an elongated portion of 120 that is continuous with the handle 108), wherein the camera is configured to allow viewing of at least a portion of the visualization window for visual assessment of engagement between the coupling pad and the patient's vagina and external genitalia. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blurton to incorporate the teachings of Ouyang and teach a device with a camera configured to provide image data captured through the visualization window, wherein the head portion of the handheld device is configured to receive the camera. Motivation for such can be found in Ouyang as the image seen can be displayed to an external display and/or saved (see [0117]-[0121]). The language, " for visual assessment of engagement between the coupling pad and the patient’s vagina and external genitalia," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Blurton and Ouyang meets the structural limitations of the claim, and is capable of the camera having a visual assessment of engagement between the transparent coupling pad and the patient’s vagina and external genitalia when the coupling pad is contacting the patient’s tissue. Claim 7 The combination of Blurton and Ouyang teaches: The device of claim 6, see 103 rejection above. Ouyang further teaches: wherein the camera 640 is configured to send image data image and video capture (see [0041]) to a display 110 (see Figs. 1-2, [0041] and [0114]) associated with the device 100. Claim(s) 9-10, 12-14, and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blurton in view of Krone et al (US 20190060675 A1), herein referenced to as “Krone”. Claim 9 Blurton discloses: The device of claim 1, see 102 rejection above. Blurton does not explicitly disclose: wherein the coupling pad comprises a generally ovular shape. However, Krone in a similar field of invention teaches a handheld device 100 (see Figs. 1A-1C) with a head 110 (see Figs. 1A-1C) and a coupling pad 114 (see Figs. 1A-1C). Krone further teaches: wherein the coupling pad 114 comprises a generally ovular shape (see Figs. 1A-1C, 114 has an ovular shape, see also [0136], oval nub and dome). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blurton to incorporate the teachings of Krone and teach a device with the coupling pad has a generally ovular shape. Motivation for such can be found in Krone as an oval nub and dome is found to be more comfortable for device use (see [0136]). Claim 10 Blurton discloses: The device of claim 1, see 102 rejection above. Blurton does not explicitly disclose: wherein the coupling pad comprises a generally dome shaped configuration. However, Krone in a similar field of invention teaches a handheld device 100 (see Figs. 1A-1C) with a head 110 (see Figs. 1A-1C) and a coupling pad 114 (see Figs. 1A-1C). Krone further teaches: wherein the coupling pad 114 comprises a generally dome shaped configuration (see Figs. 1A-1C, 114 has an ovular dome shape, see also [0136], oval nub and dome). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blurton to incorporate the teachings of Krone and teach a device with the coupling pad has a generally dome shaped configuration. Motivation for such can be found in Krone as an oval nub and dome is found to be more comfortable for device use (see [0136]). Claim 12 Blurton discloses: The device of claim 1, see 102 rejection above. Blurton does not explicitly disclose: wherein the coupling pad is configured to be attached to the head portion via snap fit. However, Krone in a similar field of invention teaches a 100 handheld device (see Figs. 4A-4B) with a head portion 110 (see Fig. 4A) and a coupling pad 114 (see Fig. 4A, [0082], coupling pad). Krone further teaches: wherein the coupling pad 114 is configured to be attached to the head portion 110 via snap fit (see [0082], snaps, [0024] “snap sounds”). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blurton to incorporate the teachings of Krone and have the coupling pad be configured to be attached to the head portion via snap fit. Motivation for such can be found in Krone as this can alert the user that there is sufficient contact between the coupling pad and the feature locks via a snap sound (see [0024]). Claim 13 Blurton discloses: The device of claim 1, see 102 rejection above. Blurton does not explicitly disclose: wherein the coupling pad is configured to be attached to the head portion via magnetic connection. However, Krone in a similar field of invention teaches a 100 handheld device (see Figs. 4A-4B) with a head portion 110 (see Fig. 4A) and a coupling pad 114 (see Fig. 4A, [0082], coupling pad). Krone further teaches: wherein the coupling pad 114 is configured to be attached to the head portion 110 via magnetic connection magnets (see [0082]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blurton to incorporate the teachings of Krone and have coupling pad is configured to be attached to the head portion via magnetic connection. Motivation for such can be found in Krone as magnets are easy to use and easy to clean as they have a low profile (see [0194]). Claim 14 Blurton discloses: The device of claim 1, see 102 rejection above. Blurton further discloses: wherein a bottom surface the bottom surface of 145 (see Fig. 3) of the coupling pad 145 interfaces with the visualization window 104 (see Fig. 3) of the head portion 102 of the device 100, wherein the coupling pad 145 comprises a material configured to conform to the tissue (see [0142], such as a translucent clay-like polymer like silicone to retain a complementary shape to the patient’s tissue surface). Blurton does not explicitly disclose: wherein the coupling pad comprises a support ring having an opening filled with transparent material of the coupling pad and configured for enhanced visualization of the tissue interfacing with the coupling pad during use of the device. However, Krone in a similar field of invention teaches a 100 handheld device (see Figs. 4A-4B) with a head portion 110 (see Fig. 4A) and a coupling pad 114 + 3500 (see Figs. 4A and 35A-35D). Krone further teaches: wherein the coupling pad 114 + 3500 (see [0200], coupling pad molded into the support ring) comprises a support ring 3500 (see Figs. 35A-35D, [0200]) having an opening 3502 (see Figs. 35A-35D, [0200]) filled with material (see [0200], will be filled in by coupling pad material) of the coupling pad 114. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blurton to incorporate the teachings of Krone and teach a device with the coupling pad comprises a support ring having an opening filled with material of the coupling pad. Motivation for such can be found in Krone as the support ring can allow for connection to the head portion while maintaining comfort for the user (see [0202]). The combination of Blurton and Krone further teaches: that the material of the coupling pad is transparent (see [0141] and [0144] of Blurton, as combined, Krone adds a support ring but the coupling pad as a whole retains its transparent material). The language, " configured for enhanced visualization of the tissue interfacing with the coupling pad during use of the device.," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Blurton and Krone meets the structural limitations of the claim, and is capable of configured for enhanced visualization of the tissue interfacing with the coupling pad during use of the device (see [0144], the transparent material allows for visualization of the tissue interfacing with the coupling pad). Claim 23 Blurton further discloses: the device of claim 1, see 102 rejection above. Blurton further discloses: the device comprises: (i) a shape of the coupling pad 145, (ii) the handle 106, (iii) a shell the device of 102 + 106 forms a shell-like structure (see Figs. 1-4), (iv) a shape the shape of 1116, and (v) an angle the angle between 106 and 102 (see Fig. 3) between the handle 106 and the head portion 102 as the device 100 for visualizing quality of contact between the vulvovaginal rejuvenation device and the introitus, wherein the same or similar one of the shape of the coupling pad is further configured to assess engagement of the user’s tissue. The language, "for visualizing quality of contact between a vulvovaginal rejuvenation device and the introitus, wherein the same or similar one of the shape of the coupling pad is further configured to assess engagement of the user’s tissue " merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Blurton meets the structural limitations of the claim, and is capable of being used to visualizing the quality of contact engagement between a vulvovaginal rejuvenation device and the introitus and assess engagement of the user’s tissue using the same coupling pad as the coupling pad is disclosed to conform its shape to complement the patient’s tissue surface (see [0142]) and then retaining that conformed shape (see [0142]) after the coupling pad is removed from the patient, which then can be used to assess fit on a separate device as the coupling pad can be removed from the current device. Blurton does not explicitly disclose: wherein the device is an ultrasound treatment device. However, Krone in a similar field of invention teaches a 100 handheld device (see Figs. 4A-4B) with a head portion 110 (see Fig. 4A) and a coupling pad 114 (see Fig. 4A, [0082], coupling pad). Krone further teaches: wherein the device 100 is an ultrasound treatment device (see [0081], handheld ultrasound device). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blurton to incorporate the teachings of Krone and have the handheld visualization device be an ultrasound device. Motivation for such can be found in Krone as this allows for treatments such as vulvovaginal rejuvenation (see [0079]). Claim 24 The combination of Blurton and Krone teaches: the device of claim 23, see 103 rejection above. The language, " wherein the same or similar one of the coupling pad is configured for one or more of: (i) same or similar tissue coupling with the ultrasound treatment device as compared to the device for visualizing quality of contact between the vulvovaginal rejuvenation device and the introitus, (ii) visualization of the coupling pad tissue engagement under treatment conditions, and (iii) adjustment of positioning of the ultrasound treatment device to accommodate anatomy of the user," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Blurton meets the structural limitations of the claim, and is capable of the coupling pad having tissue coupling for visualizing the quality of contact between the device and the introitus by having a transparent coupling pad to see the contact with the tissue and the conformable material of the coupling pad can accommodate the anatomy of the user by flexibly conforming around the contacted tissue. Claim 25 The combination of Blurton and Krone teaches: the device of claim 23, see 103 rejection above. The language, " wherein the same or similar one of the shell is configured for re-creation of therapy and diagnosis of an issue with tissue engagement," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Blurton and Krone meets the structural limitations of the claim, and is capable of using the same device for diagnosis via visualization and therapy via ultrasound treatment. 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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 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, Darwin Erezo can be reached at 571-272-4695. 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. RAIHAN R. KHANDKER Examiner Art Unit 3771 /RAIHAN R KHANDKER/Examiner, Art Unit 3771 /DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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Prosecution Timeline

Nov 08, 2022
Application Filed
Oct 17, 2024
Non-Final Rejection — §102, §103
Jan 22, 2025
Response Filed
Mar 26, 2025
Final Rejection — §102, §103
May 30, 2025
Response after Non-Final Action
Jun 27, 2025
Request for Continued Examination
Jul 01, 2025
Response after Non-Final Action
Jul 15, 2025
Applicant Interview (Telephonic)
Jul 15, 2025
Examiner Interview Summary
Jul 18, 2025
Non-Final Rejection — §102, §103
Jan 23, 2026
Response Filed
Feb 20, 2026
Final Rejection — §102, §103 (current)

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Prosecution Projections

5-6
Expected OA Rounds
64%
Grant Probability
99%
With Interview (+60.0%)
2y 11m
Median Time to Grant
High
PTA Risk
Based on 157 resolved cases by this examiner. Grant probability derived from career allow rate.

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