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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/31/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 2, the limitation “to provide navigation and positioning guidance” is not supported by the original disclosure. There is no disclosure to support how contour parameters provide the claimed benefit “to provide navigation and positioning guidance”.
Regarding claim 10, the recited limitations of the coupling pad material are not found or supported in the disclosure.
Regarding claim 12, the disclosure does not support the act of “re-positioning”.
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.
Claims 2-11 are 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.
Regarding claim 2, the limitation “to provide navigation and positioning guidance” is not supported by the original disclosure. There is no disclosure to support how contour parameters provide the claimed benefit “to provide navigation and positioning guidance”.
Regarding claim 10, the recited limitations of the coupling pad material are not found or supported in the disclosure.
Regarding claim 12, the disclosure does not support the act of “re-positioning”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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) 2-9 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rockweiler et al. (US 20160346568 A1), granted as (US Pat. No. 10,543,382 B2) prior publication as (WO2015/116512 A1), in view of Emery (US 2014/0257145 A1).
Regarding claim 2, Rockweiler et al. (‘568) teach a device for vulvovaginal rejuvenation and lubrication (see abstract), comprising: a head portion comprising an ultrasound transducer (see #34); and a coupling pad component (see #32), the coupling pad component comprising a support component and a coupling pad comprising a dome-shaped contour configured to engage tissue in or around a subject’s vagina and external genitalia (see [0032]; and Fig. 3), wherein the support component is configured to support the coupling pad and comprises a bottom surface configured to interface with and detachably connect to the head portion, and wherein a bottom surface of the coupling pad is configured to interface with the ultrasound transducer when the support component is detachably connected to the head portion, wherein the device is configured to deliver ultrasound energy through the coupling pad to the tissue in or around the subject’s vagina and external (see [0036]). However, Emery (‘145) from the same field of endeavor do teach a handle configured for maintaining the position of the device during use (see #100; and Fig. 1). It would be obvious to one of ordinary skill in the art to combine the invention of Rockweiler et al. with the features of Emery for the benefit of easier use and positioning by the user to maintain proper position.
Regarding claim 3, Rockweiler et al. (‘568) in view of Emery (‘145) teach the device of claim 2, wherein a top surface of the coupling pad comprises a dome-shaped contour (see Rockweiler et al. [0032]; and Fig. 3).
Regarding claim 4, Rockweiler et al. (‘568) in view of Emery (‘145) teach the device of claim 2, wherein the handle is configured for maintaining the position of the device during use via contouring to fit in a hand of the subject (see Emery #100; and Fig. 1).
Regarding claim 5, Rockweiler et al. (‘568) in view of Emery (‘145) teach the device of claim 2, further comprising a face of the transducer angled relative to the device body configured to be supported by an arm, wrist, or hand of the subject during use of the device (see Rockweiler et al. [0032]; and Fig. 3).
Regarding claim 6, Rockweiler et al. (‘568) in view of Emery (‘145) teach the device of claim 2, wherein the support component interfaces and detachably connects to the head portion via rounded edges and a tapered shape of the support component (see Rockweiler et al. [0032], [0036]; and Fig. 3),
Regarding claim 7, Rockweiler et al. (‘568) in view of Emery (‘145) teach the device of claim 2, wherein the support component and a face of the transducer are configured to interface in alignment with minimal offset to provide a sleek exterior of the device for user comfort (see Rockweiler et al. [0032]; and Fig. 3).
Regarding claim 8, Rockweiler et al. (‘568) in view of Emery (‘145) teach the device of claim 2, wherein body structures comprise silicon (see Rockweiler et al. [0032]). The combined invention of Rockweiler et al. with the features of Emery including a handle portion, would result in at least a portion of the handle portion comprising a silicon overmold capable of providing user comfort.
Regarding claim 9, Rockweiler et al. (‘568) in view of Emery (‘145) teach the device of claim 2, wherein the contour parameters include: (i) a shape of the dome-shaped contour including: oval nub, ridge, dome and round nub, (ii) height and shape of the dome-shaped contour including a dome with rounded edges, and (iii) a height of the coupling pad component above a support ring (see Rockweiler et al. [0032]; and Fig. 3).
Regarding claim 11, Rockweiler et al. (‘568) in view of Emery (‘145) teach the device of claim 2, wherein the tactile positioning of the device in the vulvovaginal area of the subject is configured to be performed by the subject (see Rockweiler et al. [0032]; and Fig. 3).
Regarding claim 12, Rockweiler et al. (‘568) in view of Emery (‘145) teach the device of claim 1, further comprising an alert mechanism configured to indicate insufficient contact between the device and the vulvovaginal area of the subject; wherein the alert mechanism is configured to prompt a further adjustment of the device configured to orient the device to the vulvovaginal area of the subject for the targeted ultrasound energy delivery; wherein the further adjustment includes one or more of the re-positioning of the device and applying more pressure on the vulvovaginal area of the subject via the device (see Rockweiler et al. [0040]).
Regarding claim 13, Rockweiler et al. (‘568) in view of Emery (‘145) teach the device of claim 12, wherein the alert mechanism includes one or more of spring-loaded features, magnetic snap fits, mechanical snap fits, elastic materials, adhesives, visual cues and audio cues (see Rockweiler et al. [0040]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rockweiler et al. (US 20160346568 A1), granted as (US Pat. No. 10,543,382 B2) prior publication as (WO2015/116512 A1), in view of Emery (US 2014/0257145 A1), as applied to claim 2 above, and further in view of Freiburg et al. (US 2016/0242736 A1)
Regarding claim 10, Rockweiler et al. (‘568) in view of Emery (‘145) teach the device of claim 2, wherein the coupling pad component is configured to minimize energy attenuation for maximizing therapeutic delivery of ultrasound energy (see Rockweiler et al. [0036]) but fail to teach the use of agarose in the material. However, Freiburg et al. (US 2016/0242736 A1) from the same field of endeavor do teach the use of agarose in the acoustic coupling material (see [0100]). It would be obvious to one of ordinary skill in the art to combine the invention of claim 2 with the features of Freiburg et al. for the benefit of providing acoustically attenuating properties to the acoustic coupling medium.
Response to Arguments
Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive. Not with standing that the limitations Applicant argues for are not supported by the disclosure, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK REMALY whose telephone number is (571)270-1491. The examiner can normally be reached Mon - Fri 9:00 - 6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK D REMALY/Primary Examiner, Art Unit 3797