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
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, 2, 7, 9-13, 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 20050216069 A1 to Cohen et al. (hereinafter, Cohen).
Regarding Claim 1, Cohen discloses a method for monitoring the fullness of a bladder of a patient, the method comprising inter alia:
fixedly positioning a bladder fullness monitoring apparatus (BFMA) between the patient's pubic bone and their bladder such that the BFMA is subjected to force from distension of the patient's bladder but is not substantially effected by force from tissue other than that from the bladder (paragraph [0049] “… the sensors comprise one or more mechanical sensors, such as pressure, force, motion or acceleration sensors, or an ultrasound transducer, which are preferably implanted on, in or in the vicinity of the bladder.”) (paragraph [0206] “A sensor lead (not shown) for a pressure or electrical sensor is advanced through the introducer to a desired position, e.g., in the retropubic space or between fascia and muscle. Following placement of the lead, it is secured to the fascia by a 3/0 nylon suture. Once the sensor has been properly secured, the lead stylet is withdrawn from the introducer, and the introducer is then removed.”) (Examiner notes the “retropubic space” is defined as the space located with the pubic bone and the urinary bladder);
the BFMA configured to generate an output signal corresponding to an amount of distension of the patient's bladder (paragraph [0049] “These sensors preferably generate signals responsive to motion, to intravesical or abdominal pressure, or to urine volume in the bladder, and are thus indicative of possible imminent incontinence.”);
generating the output signal in response to the amount of distension of the patient's bladder (paragraph [0188] “As described with reference to FIG. 5, the control unit preferably comprises a low-power, low-speed processor, which monitors … sensor signals continuously, and a high-speed processor, which turns on only when the low-speed processor detects an increase in … other activity.”); and
performing an electronically controlled function when the output signal exceeds a predetermined threshold (paragraph [0218] “The CPU is preferably programmed to distinguish between incontinence-related patterns and other signal patterns not associated with incontinence, such as signals generated when patient 31 wishes to pass urine voluntarily. Preferably, the CPU gathers long-term statistical information regarding the EMG and the signals from the other sensors, and analyzes the information to "learn" common signal patterns that are characteristic of patient 31. The learned patterns are used in refining decision criteria used by the CPU in determining whether or not to apply waveforms to the electrodes. For some applications, a handheld controller (not shown) receives an input from the patient whenever urine is unintentionally passed, and control unit 22 modifies signal analysis parameters and/or stimulation parameters responsive thereto, so as to reduce the likelihood of future incontinence.”).
Regarding Claim 2, Cohen discloses the method of claim 1, wherein fixedly positioned comprises suturing the BFMA to tissue adjacent the patient's bladder or public bone (paragraph [0206] “Following placement of the lead, it is secured to the fascia by a 3/0 nylon suture. Once the sensor has been properly secured, the lead stylet is withdrawn from the introducer…”).
Regarding Claim 7, Cohen discloses the method of claim 1, wherein the electronically controlled function comprises neuro-stimulation of the patient's neuroanatomy that controls or is involved in urination (paragraph [0066] “In a preferred embodiment, the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle of the patient. Typically, the control unit is adapted to configure the waveform so as to induce the relaxation of the bladder muscle responsive to analyzing the signal and determining that an urge event is imminent. In this case, the control unit is preferably adapted to configure the waveform to have (a) a frequency component between about 5 and 15 Hz, (b) a duration less than about 10 minutes, (c) an amplitude between about 0.5 and 5 V, and/or (d) a series of pulses having widths between about 0.05 and 1 ms, responsive to determining that an urge event is imminent.”).
Regarding Claim 9, Cohen discloses the method of claim 7, wherein the function comprises neuro-stimulation of the patient's neuroanatomy to initiate urination (paragraph [0066] “In a preferred embodiment, the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle of the patient. Typically, the control unit is adapted to configure the waveform so as to induce the relaxation of the bladder muscle responsive to analyzing the signal and determining that an urge event is imminent. In this case, the control unit is preferably adapted to configure the waveform to have (a) a frequency component between about 5 and 15 Hz, (b) a duration less than about 10 minutes, (c) an amplitude between about 0.5 and 5 V, and/or (d) a series of pulses having widths between about 0.05 and 1 ms, responsive to determining that an urge event is imminent.”).
Regarding Claim 10, Cohen discloses the method of claim 7, wherein the neuro-stimulation is performed by an implant associated with the BFMA (paragraph [0066] “In a preferred embodiment, the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle of the patient. Typically, the control unit is adapted to configure the waveform so as to induce the relaxation of the bladder muscle responsive to analyzing the signal and determining that an urge event is imminent. In this case, the control unit is preferably adapted to configure the waveform to have (a) a frequency component between about 5 and 15 Hz, (b) a duration less than about 10 minutes, (c) an amplitude between about 0.5 and 5 V, and/or (d) a series of pulses having widths between about 0.05 and 1 ms, responsive to determining that an urge event is imminent.”).
Regarding Claim 11, Cohen discloses the method of claim 10, wherein the implant comprises a pulse generator or other neuro-stimulation device (paragraph [0066] “In a preferred embodiment, the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle of the patient. Typically, the control unit is adapted to configure the waveform so as to induce the relaxation of the bladder muscle responsive to analyzing the signal and determining that an urge event is imminent. In this case, the control unit is preferably adapted to configure the waveform to have (a) a frequency component between about 5 and 15 Hz, (b) a duration less than about 10 minutes, (c) an amplitude between about 0.5 and 5 V, and/or (d) a series of pulses having widths between about 0.05 and 1 ms, responsive to determining that an urge event is imminent.”).
Regarding Claim 12, Cohen discloses the method of claim 1, wherein the BFMA is attached to one of the bladder wall or tissue connected to the bladder wall (paragraph [0206] “A sensor lead (not shown) for a pressure or electrical sensor is advanced through the introducer to a desired position, e.g., in the retropubic space or between fascia and muscle. Following placement of the lead, it is secured to the fascia by a 3/0 nylon suture. Once the sensor has been properly secured, the lead stylet is withdrawn from the introducer, and the introducer is then removed.”).
Regarding Claim 13, Cohen discloses the method of claim 1, wherein the BFMA is mechanically supported by the patient's public bone (paragraph [0206] “A sensor lead (not shown) for a pressure or electrical sensor is advanced through the introducer to a desired position, e.g., in the retropubic space or between fascia and muscle. Following placement of the lead, it is secured to the fascia by a 3/0 nylon suture. Once the sensor has been properly secured, the lead stylet is withdrawn from the introducer, and the introducer is then removed.”).
Regarding Claim 15, Cohen discloses the method of claim 1, wherein the electronic control of the function is performed by a controller operatively coupled to the BFMA (paragraph [0066] “In a preferred embodiment, the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle of the patient. Typically, the control unit is adapted to configure the waveform so as to induce the relaxation of the bladder muscle responsive to analyzing the signal and determining that an urge event is imminent. In this case, the control unit is preferably adapted to configure the waveform to have (a) a frequency component between about 5 and 15 Hz, (b) a duration less than about 10 minutes, (c) an amplitude between about 0.5 and 5 V, and/or (d) a series of pulses having widths between about 0.05 and 1 ms, responsive to determining that an urge event is imminent.”).
Regarding Claim 16, Cohen discloses the method of claim 15, wherein the controller is operatively coupled to or integral with an associated implant that performs the electronically controlled function (paragraph [0066] “In a preferred embodiment, the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle of the patient. Typically, the control unit is adapted to configure the waveform so as to induce the relaxation of the bladder muscle responsive to analyzing the signal and determining that an urge event is imminent. In this case, the control unit is preferably adapted to configure the waveform to have (a) a frequency component between about 5 and 15 Hz, (b) a duration less than about 10 minutes, (c) an amplitude between about 0.5 and 5 V, and/or (d) a series of pulses having widths between about 0.05 and 1 ms, responsive to determining that an urge event is imminent.”).
Regarding Claim 17, Cohen the method of claim 16, wherein implant comprises a pulse generator or other neuro-stimulation device (paragraph [0066] “In a preferred embodiment, the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle of the patient. Typically, the control unit is adapted to configure the waveform so as to induce the relaxation of the bladder muscle responsive to analyzing the signal and determining that an urge event is imminent. In this case, the control unit is preferably adapted to configure the waveform to have (a) a frequency component between about 5 and 15 Hz, (b) a duration less than about 10 minutes, (c) an amplitude between about 0.5 and 5 V, and/or (d) a series of pulses having widths between about 0.05 and 1 ms, responsive to determining that an urge event is imminent.”).
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) 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen in view of US 20180008185 A1 to Ramu et al. (hereinafter, Ramu).
Cohen discloses the method of claim 1 except for expressly discloses wherein the electronically controlled function includes causing a notification to be sent to the patient, wherein the notification is an alert to the patient of a degree of bladder fullness or a need to initiate urination, wherein the notification is sent to an external communication device, wherein the communication device is a cell phone. However, Ramu teaches alerting the user when the volume of the urinary bladder reaches a predetermined level (paragraph [0017] “The method could also include alerting a user when the volume of the urinary bladder reaches a predetermined level or monitoring the volume of the urinary bladder to calculate a rate of increase in the volume of the urinary bladder.”) and transmitting an alert to an external instrument, such as a cell phone (paragraph [0015] “In some embodiments, the implantable device also includes a communication module connected to the electronic circuitry for transmitting information related to the volume of the urinary bladder to an external instrument. The external instrument could be a smart phone, a cell phone, a watch-like device (iWatch, FitBit, etc), a computer or other electronic device. The external instrument could produce an audio, visual, or physical (small electronic shock, pinch, vibration) alert when the bladder reaches a pre-determined level.)”). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the method of Cohen to include the notification of bladder fullness to the cellphone of Ramu, as Ramu teaches the conventional and predictable step of alerting a user via a smartphone/cell phone so alert the user they need to head to the bathroom because the bladder is filling up (Ramu paragraph [0052]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen in view of US 20170368340 A1 to Possover.
Cohen discloses the method of claim 7 except for expressly disclosing wherein the neuroanatomy comprises a pudendal nerve. However, Possover teaches that the pudendal nerve induces relaxation of the bladder muscle (Possover paragraph [0007]). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the neuroanatomy of Cohn with the pudendal nerve of Possover and Possover teaches that stimulation of the pudendal nerve induces relaxation of the bladder muscle and aids the patient in reducing unwanted void and pain due to an overactive bladder (Possover paragraph [0007]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen in view of US 20140350348 A1 to Tee et al. (hereinafter, Tee).
Cohen discloses the method of claim 13 except for expressly disclosing wherein the BFMA includes a tissue conformable portion and said portion conforms to a contour of the pubic bone. However, Tee teaches at paragraph [0043] that small, flexible, small-cale sensors would allow for real-time passive pressure monitoring and would have overcome the challenges of frequency limits and lossy tissue environments. A skilled artisan would have recognized that a flexible pressure sensor would be configured to flex at least enough to conform to a contour of a pubic bone.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen in view of “Buyers’ guide Urodynamic systems to The National Health System (hereinafter, NHS)
Cohen discloses method of claim 1, further comprising calibrating the output signal (paragraphs [0226]-[0227]). Cohen discloses the claimed invention except for expressly disclosing calibrating the output signal to an amount of bladder distension or fullness, wherein the calibration comprises filling the bladder with a known amount of fluid using a bladder access device and measuring the output signal, wherein the bladder access device is a urinary drainage catheter. However, NHS teaches conducting filling and voiding cystometry the bladder, where the bladder may be filled actively by an infusion and during filling, and where the bladder and abdominal pressures are measured constantly using inserted catheters (page 6, Filling and void cystometry, second paragraph). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the calibration of Cohen to be performed by determining the output signal to an amount of distension or fullness, and filling the bladder with a known about of fluid via a catheter, as NHS teaches under Uroflowmetry (page 6) that knowing the bladder volume would have allowed studies to be performed and further teaches page 6, Filling and void cystometry, second paragraph that after filling and voiding using catheters, pressure can be determined.
Claim(s) 21-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen in view of WO 2010/0123907 A1 to Miesel et al. (hereinafter, Miesel).
Cohen discloses the method of claim 1 and where an orientation sensor is an accelerometers (acceleration sensor 78). Cohen discloses the claimed invention except for expressly disclose sensing an orientation including at least one of standing, sitting, sitting bent-over or lying down, performing another electronically controlled function based on the sensed orientation of the patient, wherein the other electronically controlled function is performed by a controller, wherein the controller adjusts the threshold based on the sensed orientation of the patient, the controlling selecting the fill status based on posture is a threshold adjustment based on orientation of the patient), wherein the controller gates out the output signal based on the sensed orientation patient, wherein the sensed orientation is sitting in a sitting bent-over position and the controller sends the patient an alert, wherein the alert comprises a message of a need to initiate urination, wherein the alert comprises a message to sit up.
However, Miesel teaches the claimed invention except for expressly disclose sensing an orientation including at least one of standing, sitting, sitting bent-over or lying down (page 4, lines 20-23), performing another electronically controlled function based on the sensed orientation of the patient (page 9, lines 9-18 “… thresholds, functions or tables used to control therapy delivery…” indicate a plurality of therapies based on a plurality of metrics), wherein the other electronically controlled function is performed by a controller (page 9, lines 9-18 “memory 34 … processor 32 …”), wherein the controller adjusts the threshold based on the sensed orientation of the patient (since the memory 34 stores tables that correlate fill levels with impedance values and postures (page 10, lines 4-5) and the impedance may vary depending on whether the patient is seated or lying down (page 2, lines 6-7), the controlling selecting the fill status based on posture is a threshold adjustment based on orientation of the patient), wherein the controller gates out the output signal based on the sensed orientation patient (controlled delivery of therapy based on determined posture is gating, page 2, lines 6-7), wherein the sensed orientation is sitting in a sitting bent-over position (page 2, lines 7-12, page 4, lines 17-23, it is noting sitting is inherently a bent-over position) and the controller sends the patient an alert (page 17, lines 6-10), wherein the alert comprises a message of a need to initiate urination (page 16, lines 20-27), wherein the alert comprises a message to sit up (col. 18, lines 7-9).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the system of Cohen to include the posture detection, respective therapies based on posture, gating and alerts of Miesel as Miesel teaches that posture must be considered in baller fullness measurements (page 2, lines 6-8), that thresholds and criteria should be adjusted by posture (page 9, lines 9-13) and further teaches that some advantages of such aspects of Miesel would alleviate suffering and allow patients to know when their bladder should be voided.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791