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 § 102
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 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) 1-4, 6-9, 13-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20090222058 to Craggs.
Regarding claims 1 and 14. Craggs discloses an electrostimulation device/method (abstract, para 0067, etc. “wearable neuromodulation device”) for stimulating a pelvic floor (abstract, para 0004, 0012, 0067, 0125 “configured to apply stimulating [] rectum, [] vagina”) comprising: an electrode (para 0071-0080, 0123, “stimulation electrode 8a-8d”) configured for intimate contact with vaginal or rectal mucosa floor (abstract, para 0004, 0012, 0067, 0125); a sensor for detecting urinary related activity, wherein said urinary related activity includes at least one of an increase of intra-abdominal pressure, pelvic floor contraction, and electromyographic activity of the pelvic floor (para 0078 “pressure sensors 12, 13”, para 0033 “at least one sensor to detect one or more conditions indicating bladder overactivity”, also see para 0014, 0018, 0077); a processor configured to receive signals from said sensor, and in response to detection of said urinary related activity by said sensor, induce electrostimulation of a pelvic floor by said electrode (para 0033 “in response to said detection, using said means for applying electrical stimulation signals”, para 0083-0085 “microprocessor/processor”); a laterally protruding rim configured to support a vagina wall at a level of a bladder neck above a pubis (para 0067 “bulb portion 3”).
Regarding claim 2. Craggs discloses the device of claim 1, wherein the sensor includes a pressure sensor and said urinary related activity is an increase in intra-abdominal pressure (para 0018, 0079).
Regarding claim 3. Craggs discloses the device of claim 1, wherein the processor and electrode are configured to respond to said sensor sensing increased activity of pelvic floor muscles by stimulating the pelvic floor muscles with positive feedback (para 0081 “device 1 responds to the increased EMG signals and/or pressure by providing appropriate stimulation to the pudendal nerves. This causes immediate reflex suppression of the bladder overactivity, direct motor activation of the sphincters and the prevention of incontinence”).
Regarding claim 4. Craggs discloses the device of claim 3, wherein said positive feedback suppresses a voiding reflex (para 0014 “prevent incontinence”).
Regarding claim 6. Craggs discloses the device of claim 1, wherein the laterally protruding rim is flexible (para 0069 “sleeve 5 is of moulded soft medical grade silicone rubber, para 0130”).
Regarding claim 7. Craggs discloses the device of claim 1, wherein the device is configured for use in strengthening the pelvic floor and for use in treating mild to moderate pelvic floor prolapse (para 0016, “device may also be used as an early intervention tool, to prevent the deterioration of muscles after paralysis”; para 0039 “prevent muscle wastage”, para 0129).
Regarding claim 8. Craggs discloses the device of claim 1, further including a wireless communication module for sending data to an external computer and receiving signals from the external computer to adjust stimulation parameters (abstract, para 0022, 0024, etc. “communicate with an external device”).
Regarding claim 9. Craggs discloses the device of claim 1, further comprising an elastic body which is reversibly deformed by an increase in intra-abdominal pressure (para 0015-0018 “the device can be formed from a material, such as soft or spongy silicone rubber, that can be suitably profiled so that it can be worn comfortably by a patient. The provision of such a highly wearable, comfortable device, can promote patient compliance”).
Regarding claim 13. Craggs discloses the device of claim 1, further comprising one or more additional sensors, wherein the one or more additional sensors are selected from a group consisting of: accelerometer, position, tilt, photoplethysmography, bioimpedance, ultrasonographic electromyography, and any combination thereof (para 0018, 0033, 0078).
Regarding claim 15. Craggs discloses the method of claim 14, further comprising: repeating said sensing and electrostimulation to create a reflex to automatically contract the pelvic floor on increase of intra-abdominal pressure (para 0014).
Regarding claim 16. Craggs discloses the method of claim 14, wherein said electrostimulating reduces at least one of frequency of urination, inhibition of stress urinary incontinence, inhibition of fecal incontinence and urgency of urination (para 0081 “device 1 responds to the increased EMG signals and/or pressure by providing appropriate stimulation to the pudendal nerves. This causes immediate reflex suppression of the bladder overactivity, direct motor activation of the sphincters and the prevention of incontinence”).
Regarding claim 17. Craggs discloses the method of claim 14, further comprising: repeating said sensing and electrostimulation to strengthen pelvic floor muscles (para 0039 “a method of preventing muscle wastage comprises providing a wearable neuromodulation device for insertion into a pelvic orifice of a human body, the wearable neuromodulation device comprising means for applying electrical stimulation signals selectively to stimulate pudendal nerves through the wall of a rectum or vagina of the human body and applying a burst of said electrical pulses.”).
Regarding claim 18. Craggs discloses the method of claim 14, further comprising: controlling the electrostimulation by a processor is connected to at least one pressure sensor and at least one electrode para 0033 “in response to said detection, using said means for applying electrical stimulation signals”, para 0083-0085 “microprocessor/processor”).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20090222058 to Craggs.
Regarding claim 10. Craggs discloses the device of claim 9, wherein the reversible deformation is a reversible reduction of an anteroposterior diameter of the body by at least 5% when the intra-abdominal pressure increases by at least 1/10 bar (para 0015-0018 “the device can be formed from a material, such as soft or spongy silicone rubber, that can be suitably profiled so that it can be worn comfortably by a patient. The provision of such a highly wearable, comfortable device, can promote patient compliance”). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Claim(s) 5 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20090222058 to Craggs in view of CA2653442C to Pelger et al.
Regarding claim 5. Craggs discloses the device of claim 1, but fails to disclose wherein a length of the device is adaptable to fit a length of a vagina and wherein the laterally protruding rim is adaptable to fit a width of a vagina.
Pelger, from a similar field of endeavor teaches wherein the longitudinal positional of this ring on the probe may be adjustable (description). It would have been obvious to a person skilled in the art to modify the disclosure of Craggs with the teachings of Pelger to provide the predictable result of allowing the position of the device to be adjustable as desired (Description).Also see MPEP KSR rationals and In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) .
Regarding claim 11. Craggs discloses the device of claim 9, but fails to disclose wherein the body has an axially compressible region.
Pelger, from a similar field of endeavor teaches wherein the longitudinal positional of this ring on the probe may be adjustable (description). It would have been obvious to a person skilled in the art to modify the disclosure of Craggs with the teachings of Pelger to provide the predictable result of allowing the position of the device to be adjustable as desired (Description).Also see MPEP KSR rationals ((E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (A) Combining prior art elements according to known methods to yield predictable results; and In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20090222058 to Craggs in view of US 20180264259 to Billard.
Regarding claim 12. Craggs discloses the device of claim 1, but fails to disclose wherein the laterally projecting rim is configured to support a bladder neck.
Billard, from a similar field of endeavor teaches a body configured to support a vagina wall at a level of a bladder neck above a pubis, wherein the body includes a lateral projection which is configured to support a bladder neck (balloon 4, fig 1, para 0053, 0055). It would have been obvious to a person skilled in the art to modify the disclosure of Craggs with the teachings of Billard, because doing so would provide support the vagina wall at a level of a bladder neck above a pubis, providing the predictable result of providing support at a bladder neck.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20090222058 to Craggs in view of US 20190126039 to Yoo et al. (hereinafter “Yoo”).
Regarding claim 19. Craggs discloses the method of claim 18, but fails to disclose wherein the processor further comprises an artificial intelligence (Al) module configured for determining when there is a high chance of an imminent urine or fecal leak.
Yoo from a similar field of endeavor teaches the device to include an artificial intelligence program operated by the processor to help adjust, use the stimulator (para 0113). It would have been obvious to a person skilled in the art to modify the disclosure of Craggs with the teachings of Yoo to use artificial intelligence to provide the predictable result of improving operation of the device.
Regarding claim 20. Craggs as modified by Yoo renders obvious the method of claim 19, further comprising: instructing the at least one electrode to provide electrostimulation in response to said determining (para 0033 “in response to said detection, using said means for applying electrical stimulation signals”, para 0083-0085 “microprocessor/processor”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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/SANA SAHAND/Examiner, Art Unit 3796
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