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 .
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, 11-17, and 19 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), in view of Barnard et al. (US 2013/0289411 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]); but fail to explicitly teach a handle configured for maintaining the position of the device. 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. Rockweiler et al. fail to explicitly teach a coupling pad with reservoirs for providing lubrication. However, Barnard et al. (‘411) from the same field of endeavor do teach coupling pad with reservoirs for providing lubrication (see [0050]; and Fig. 3). It would be obvious to one of ordinary skill in the art to combine the invention of Rockweiler et al. with the features of Barnard et al. for the benefit of easier and more efficient release of the coupling fluid while performing the procedure.
Regarding claim 3, Rockweiler et al. (‘568) in view of Emery (‘145) in view of Barnard et al. (‘411) 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) in view of Barnard et al. (‘411) 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) in view of Barnard et al. (‘411) 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) in view of Barnard et al. (‘411) 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) in view of Barnard et al. (‘411) 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) in view of Barnard et al. (‘411) 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) in view of Barnard et al. (‘411) 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) in view of Barnard et al. (‘411) 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) in view of Barnard et al. (‘411) teach the device of claim 2, 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) in view of Barnard et al. (‘411) 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]).
Regarding claim 14, Rockweiler et al. (‘568) in view of Emery (‘145) in view of Barnard et al. (‘411) teach the device of claim 2, wherein the self-lubrication is maintained by releasing a lubricant from the convex dome-shaped contour of the coupling pad (see Barnard et al. [0050]; and Fig. 3).
Regarding claim 15, Rockweiler et al. (‘568) in view of Emery (‘145) in view of Barnard et al. (‘411) teach the device of claim 14, wherein the lubricant is contained in pre-formed pockets along an outer portion of the convex dome-shaped contour of the coupling pad (see Barnard et al. [0050]; and Fig. 3).
Regarding claim 16, Rockweiler et al. (‘568) in view of Emery (‘145) in view of Barnard et al. (‘411) teach the device of claim 15, wherein the pre-formed pockets are 0.5-3mm in diameter and comprise a shape of one or more of: circles, spheres, ellipsoids and ellipses (see Barnard et al. [0050]; and Fig. 3).
Regarding claim 17, Rockweiler et al. (‘568) in view of Emery (‘145) in view of Barnard et al. (‘411) teach the device of claim 14, wherein the convex dome-shaped contour of the coupling pad is an outer portion of the coupling pad, wherein the lubricant released from the convex dome shaped contour of the coupling pad has greater lubricity than a material in an inner portion of the coupling pad (see Barnard et al. [0050]; and Fig. 3).
Regarding claim 19, Rockweiler et al. (‘568) in view of Emery (‘145) in view of Barnard et al. (‘411) teach the device of claim 14, wherein releasing the lubricant is performed by an additive configured to be driven out of the convex dome-shaped contour of the coupling pad via sonophoresis during delivery of ultrasound energy to the vulvovaginal area of the subject (see Barnard et al. [0050]; and Fig. 3).
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), in view of Barnard et al. (US 2013/0289411 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) in view of Barnard et al. (‘411) 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. (‘736) 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.
Claim(s) 18 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), in view of Barnard et al. (US 2013/0289411 A1), as applied to claim 14 above, and further in view of Freiburg et al. (US 2016/0242736 A1) in view of Lo et al. (US Pat. No. 7,815,575 B2).
Regarding claim 18, Rockweiler et al. (‘568) in view of Emery (‘145) in view of Barnard et al. (‘411) teach the device of claim 14, but fail to explicitly teach the use of agarose or coconut oil in the material. However, Freiburg et al. (‘736) 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 14 with the features of Freiburg et al. for the benefit of providing acoustically attenuating properties to the acoustic coupling medium. However, Lo et al. (‘575) from the same field of endeavor do teach the use of coconut oil in the acoustic coupling material (see col. 13, lines 33-40). It would be obvious to one of ordinary skill in the art to combine the invention of claim 14 with the features of Lo et al. for the benefit of enhanced biocompatibility.
Claim(s) 20 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), in view of Barnard et al. (US 2013/0289411 A1), as applied to claim 14 above, and further in view of Lo et al. (US Pat. No. 7,815,575 B2).
Regarding claim 20, Rockweiler et al. (‘568) in view of Emery (‘145) in view of Barnard et al. (‘411) teach the device of claim 14, but fail to explicitly teach wherein releasing the lubricant to maintain the self-lubrication is provided by at least a portion of the convex dome-shaped contour of the coupling pad configured to undergo a phase change from solid to liquid at a range near body temperature and 85 degrees Fahrenheit to form a layer of lubrication. However, Lo et al. (‘575) from the same field of endeavor do teach the use of coconut oil in the acoustic coupling material (see col. 13, lines 33-40). It would be obvious to one of ordinary skill in the art to combine the invention of claim 14 with the features of Lo et al. for the benefit of enhanced biocompatibility.
Response to Arguments
Applicant’s arguments with respect to claim(s) 2-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
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
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