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 § 112
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 5-8, 19, and 21-22 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.
The term “about” in claims 5-8, 19 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claimed ranges pertaining to voltage and amperages are rendered indefinite. For the purpose of advancing prosecution, the claimed ranges are interpreted without the term “about.”
The term “few” in claims 21 & 22 is a relative term which renders the claim indefinite. The term “few” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claimed range defined by the end point “a few seconds” is rendered indefinite. For the purpose of advancing prosecution, the term “few” is interpreted as 5 seconds.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8, 12-16, 19, and 21-22 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes and mathematical concepts groupings, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Under Step 1:
Independent claims 1 and 12 are directed to a system and a method; thus, the claims all fall under one of the four patent eligible categories.
Under Step 2A, Prong 1:
Claims 1 & 12 recite steps comprising compare the detrusor measurement; increase or decrease a level of the stimulation control signal until the detrusor pressure measurement is in the target detrusor pressure range. Under broadest reasonable interpretation, these limitations appear to be directed to mental processes because they can be performed in the mind or with pen and paper. A trained clinician can obtain patient measurement data; compare measurements by evaluating the data; and determine an increase or decrease in a level of the stimulation control signal by using observations and mental judgments. Accordingly, claims 1 & 12 are directed to a judicial exception including one or more abstract ideas under mental processes and mathematical concepts.
Under Step 2A, Prong 2:
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
Claim 1 includes an input/output, a feedback control circuit and steps of compare detrusor pressure measurements; and increase or decrease a level of the stimulation control signal; wherein the input/output and the feedback control circuit are generic computers and/or components, do not improve upon a technology, and only generally links the use of the judicial exception to a particular technological environment or field of use.
Claim 2 includes a feedback control circuit and steps of repeatedly increase or decrease the level of stimulation control signal until detrusor pressure measurement is in the target detrusor range, wherein the feedback control circuit is a generic computer and/or component, does not improve upon a technology, and only generally links the use of the judicial exception to a particular technological environment or field of use.
Claim 4 includes an electrical pulse generator, electrode array and steps of receiving the stimulation control signal; and applying the generated electrical pulses to an electrode array; wherein the electrical pulse generator and electrode array only generally links the use of the judicial exception to a particular technological environment or field of use, do not improve upon a technology, and do not apply or use the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition.
Claims 5-6, and 16 include a transdermal electrode array, an epidural electrode array and steps of a stimulation output comprising a voltage and an amperage between a predefined range, wherein the transdermal and epidural electrode arrays only generally links the use of the judicial exception to a particular technological environment or field of use, do not improve upon a technology, and do not apply or use the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition.
Despite the fact that the abstract ideas claimed are performed on a generic computer, the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, “[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.” Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for “anonymous loan shopping” was an abstract idea because it could be “performed by humans without a computer”). See MPEP 2106.04(a)(2)(III).
Furthermore, generic computers and/or components that perform abstract ideas are still abstract mental processes unless the claim limitation cannot be practically performed in the mind. As such, “input/ouput” and “feedback control circuit” appear to amount to nothing more than a suggestion to “apply it” on a computer; Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984.
Under Step 2B:
Claims 1-8, 12-16, 19, and 21-22 fail to include any additional elements that, alone or in combination, amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exception into a practical application, the additional elements of “electrical pulse generator”, “electrode array”, “transdermal electrode array”, “epidural electrode array” are well-understood, routine, and conventional activities previously known in the field of electrostimulation as indicated in the following references:
US Patent 6,058,331
See signal generator [col. 4:48-51] for electrical pulse generator.
See [col. 5:2-3] for epidural electrode array.
US 2011/0202107 A1
See electric current application section (6, [0041]) for electrical pulse generator.
See electrode (4, [0041]) for transdermal electrode array.
US 2017/0239470 A1
See implanted or external electrodes [0070] for epidural and transdermal electrode arrays.
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 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) 1-4, 7, 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over King (US Patent 6,058,331) in view of Wei (US Pre Grant Publication 2017/0239470 A1).
Regarding claims 1 & 12, King teaches a system and a method for controlling blood flow in a patient, comprising:
an input (80, Fig. 5) for receiving a signal indicative of a measurement ([col. 8:1]; telemetry unit 80 receives and transmits signals);
a feedback control circuit (68, Fig. 5) connected to receive the signal from the input and to deliver a stimulation control signal to an output ([col. 8:39-44]; microprocessor 68 receives sensed signal and determines stimulation control), the feedback control circuit configured to:
compare measurement to a target range ([col. 9:10-18], [col. 9:40-49], Fig. 7; oxygen measurement compared to minimum e.g. below 30 mm Hg and maximum values), wherein
if the comparison indicates that the measurement is below the target range, increase a level of the stimulation control signal until the measurement is in the target range ([col. 9:14-22], Fig. 7 & 8); stimulation parameters increased until oxygen level reaches target level e.g. above 30 mm Hg); and
if the comparison indicates that the measurement is above the target range, decrease a level of the stimulation control signal until the measurement is in the target range ([col. 9:40-49], Fig. 7; stimulation parameters reduced until requisite oxygen level reached),
but does not disclose,
a detrusor pressure (Pdet),
detrusor pressure during voiding,
as claimed.
However, Wei teaches a system and a method for controlling bladder dysfunctions with electrostimulation therapy. Wei is analogous to the claimed invention because it is reasonably pertinent to the problem of determining bladder dysfunctions using detrusor pressures. Wei further teaches,
a detrusor pressure (Pdet) ([0094]; pressure sensors include detrusor pressure sensor),
detrusor pressure during voiding ([0094]; detrusor pressure sensor configured to sense sensations related to voiding).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method, as taught by King, with a detrusor pressure (Pdet) and detrusor pressure during voiding, as taught by Wei. One of ordinary skill in the art would have been motivated to make these modifications to improve bladder dysfunction therapy by using detrusor pressures to sense and target various bladder functions (Wei, [0094]).
Regarding claims 2 & 13, King, in view of Wei, teaches the apparatus according to claims 1 and 12, and further teaches wherein the feedback control circuit stores an increment value ([col. 11:18-21], Fig. 6; signal size automatically adjusted by gradually increasing amplitude of pulses; memory unit 74 stores prior parameters of stimulation) and a lag time ([col. 9:59-62], Fig. 6; change timer) and (when the comparison indicates that the detrusor pressure measurement is below the target detrusor pressure range; only in claim 13) is configured to increase the level of the stimulation control signal until the detrusor pressure measurement is in the target detrusor pressure range by repeatedly increasing the level of the stimulation control signal by the increment value, waiting for the lag time, obtaining a new detrusor pressure measurement from the input and comparing the new detrusor pressure measurement to the target detrusor pressure range ([col. 9:60-64], Fig. 6; feedback sensor data compared to stored parameters; if physiological response is not met (lower than target), then stimulation parameters increased; change timer (lag time) counts down and resets after feedback sensor samples data again in step 410; cycle continues until target response is met).
Regarding claims 3 & 14, King, in view of Wei, teaches the apparatus according to claims 1 and 12, and further teaches wherein the stimulation control signal is continuously applied ([col. 4:62-65]; continuous electrical stimulation) and the level of the stimulation control signal is (iteratively; only claim 14) adjusted based on the detrusor pressure measurement ([col. 9:53-col. 10:7], Fig. 6; closed loop operation iteratively changes parameters until tissue physiology achieves preset goals).
Regarding claims 4 & 15, King, in view of Wei, teaches the apparatus according to claims 1 and 12, and further teaches comprising an electrical pulse generator (14, Fig. 4) connected to receive the stimulation control signal ([col. 4:48-51]; signal generator receives feedback instructions via antenna 24) and to generate electrical pulses ([col. 4:62-65]; electrical stimulation by way of pulses) and apply the generated electrical pulses to an electrode array (18, Fig. 4) ([col. 5:9-10]; lead 18, paddle having plurality of electrodes), wherein increasing the level of the stimulation control signal causes the electrical pulse generator to increase a voltage and/or a current and/or a frequency ([col. 9:18-24]; adjusts frequency as required to increase oxygen to a desired level; first, frequency of stimulation is increased) and/or a pulse width of generated electrical pulses.
Regarding claim 7, King, in view of Wei, teaches the apparatus according to claim 4, and further teaches wherein the stimulation control signal controls for a stimulation output comprising electrical pulses presented at a pulse frequency between about 5 Hz to 10 kHz ([col. 10:8-11]; repetition rates (frequency) 5-185 Hz).
Regarding claim 16, King, in view of Wei, teaches the apparatus according to claim 4, and further teaches wherein the electrode array is a transdermal electrode array or an epidural electrode array ([col. 5:2-3]; epidural electrodes).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over King (US Patent 6,058,331) in view of Wei (US Pre Grant Publication 2017/0239470 A1) and in further view of Sunagawa et al (US Pre Grant Publication 2011/0202107 A1).
Regarding claim 5, King, in view of Wei, teaches the apparatus according to claim 4, and further teaches the stimulation control signal controls for a stimulation output comprising a voltage between about 0.1 V to about 100 V ([col. 10:8-9]; amplitudes 0.1-20 volts) but does not disclose wherein the electrode array comprises a transdermal electrode array and a stimulation output comprising an amperage between about 0 mA to about 100 mA.
However, Sunagawa teaches a system and a method for blood pressure stabilization using transdermal stimulation. Sunagawa is analogous to the claimed invention because it is reasonably pertinent to the problem of using transdermal electrode arrays for therapeutic electrostimulation.
Sunagawa further teaches, wherein the electrode array comprises a transdermal electrode array (4, Fig. 1) ([0041]; electrode 4 preferably placed on the patient skin, [0062]; plurality of electrodes preferably placed within the same region of the patient body) and the stimulation control signal controls for a stimulation output comprising an amperage between about 0 mA to about 100 mA ([0026]; amperage values 10-60 mA).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system, as taught by King and Wei, wherein an electrode array comprises a transdermal electrode array and the stimulation control signal controls for a stimulation output comprising a voltage between about 0.1 V to about 100 V and an amperage between about 0 mA to about 100 mA, as taught by Sunagawa. One of ordinary skill in the art would have been motivated to make these modifications to improve electrostimulation therapy by using a non-invasive method to deliver electrostimulation through a transdermal patch (Sunagawa, [0009]).
Regarding claim 6, King, in view of Wei, teaches the apparatus according to claim 4, and further teaches wherein the electrode array comprises an epidural electrode array ([col. 5:2-3]; epidural electrodes) and the stimulation control signal controls for a stimulation output comprising a voltage between about 0.1 V to about 20 V ([col. 10:8-9]; amplitudes 0.1-20 volts), but does not teach,
and an amperage between about 0 mA to about 100 mA.
However, Sunagawa teaches,
and an amperage between about 0 mA to about 100 mA ([0026]; amperage values 10-60 mA).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by King and Wei, with a stimulation output comprising an amperage between about 0 mA to about 100 mA, as taught by Sunagawa. One of ordinary skill in the art would have been motivated to make these modifications to improve electrostimulation therapy by targeting spinal cord injuries with higher stimulation amperages (Sunagawa, [0057]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over King (US Patent 6,058,331) in view of Wei (US Pre Grant Publication 2017/0239470 A1) and in further view of Gerber (US Pre Grant Publication 2007/0027495 A1).
Regarding claim 8, King, in view of Wei, teaches the apparatus according to claim 4, but does not teach wherein the stimulation control signal controls for a stimulation output comprising electrical pulses having a pulse width between about 0.002 seconds to about 20 seconds.
However, Gerber teaches a system and a method for sensing and controlling urinary incontinence with electrostimulation. Gerber is analogous to the claimed invention because it is reasonably pertinent to the problem of controlling electrostimulation signal outputs.
Gerber further teaches wherein the stimulation control signal controls for a stimulation output comprising electrical pulses having a pulse width between about 0.002 seconds to about 20 seconds ([col. 10:9-10]; pulse width 10-5000 microseconds (0.00001-0.005 seconds)).
Gerber fails to explicitly recite a pulse width between 0.002 seconds to about 20 seconds. However, examiner submits that when claimed ranges overlap ranges disclosed by the prior art, a prima facie case of obviousness exists. See Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by King and Wei, with a stimulation output comprising electrical pulses having a pulse width between about 0.002 seconds to about 20 seconds, as taught by Gerber. One of ordinary skill in the art would have been motivated to make these modifications to improve neurostimulation therapy for bladder disorders by using stimulation parameters that are known in the art to effectively treat said disorders (Gerber, [0087]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over King (US Patent 6,058,331) in view of Wei (US Pre Grant Publication 2017/0239470 A1) and in further view of Gerber (US Pre Grant Publication 2007/0027495 A1) and Yakovlev et al (US Pre Grant Publication 2017/0095667 A1).
Regarding claim 19, King, in view of Wei and Gerber, teaches the apparatus according to claim 8, but does not disclose wherein the pulse width is between about 0.033 seconds to about 0.17 seconds.
However, Yakovlev teaches a system and a method for neuromodulation treatments of various conditions. Yakovlev is analogous to the claimed invention because it is reasonably pertinent to the problem of using electrostimulation of various pulse widths to treat patient disorders.
Yakovlev further teaches, wherein the pulse width is between about 0.033 seconds to about 0.17 seconds ([0075]; pulse width 1 microsecond (0.000001 seconds) – 50 milliseconds (0.05 seconds)).
Yakovlev fails to explicitly recite a pulse width between 0.033 seconds to about 0.17 seconds. However, examiner submits that when claimed ranges overlap ranges disclosed by the prior art, a prima facie case of obviousness exists. See Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by King, Wei, and Gerber, with a pulse width that is between about 0.033 seconds to about 0.17 seconds, as taught by Yakovlev. One of ordinary skill in the art would have been motivated to make these modifications to improve electrostimulation devices by enabling long duration pulses for additional therapeutic applications (Yakovlev, [0012]).
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over King (US Patent 6,058,331) in view of Wei (US Pre Grant Publication 2017/0239470 A1) and in further view of Davis et al (US Pre Grant Publication 2010/0010585 A1).
Regarding claims 21 & 22, King, in view of Wei, teaches the apparatus according to claims 2 and 13, but does not disclose wherein the lag time is between one second and a few seconds.
However, Davis teaches a system and a method for programming electrostimulation therapy based on patient posture. Davis is analogous to the claimed invention because it is reasonably pertinent to the problem of programming stimulation delay times for therapeutic treatments.
Davis further teaches, wherein the lag time is between one second and a few seconds ([0255]; delay time period 1 second – 5 minutes).
Davis fails to explicitly recite a lag time is between one second and a few seconds. However, examiner submits that when claimed ranges overlap ranges disclosed by the prior art, a prima facie case of obviousness exists. See Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by King and Wei, with a lag time is between one second and a few seconds, as taught by Davis. One of ordinary skill in the art would have been motivated to make these modifications to improve electrostimulation therapy by increasing the delay period between therapy to detect symptoms that the patient may not experience until they have been in a posture for an extended period of time (Davis, [0251]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 & 12 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 15 of U.S. Patent No. 12,268,878 in view of Wei (US Pre Grant Publication 2017/0239470 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the invention of U.S. Patent No. 12,268,878 with a detrusor pressure ([0094]; pressure sensors include detrusor pressure sensor) and a detrusor pressure during voiding ([0094]; detrusor pressure sensor configured to sense sensations related to voiding), as taught by Wei. The claimed invention does not include any structural elements that distinguish it from the invention of U.S. Patent No. 12,268,878, and claims 1 & 15 also include a limitation for measurements of bladder function; the claimed invention and the invention from U.S. Patent No. 12,268,878 both appear to be a signal processing device that does not require specific equipment to obtain either blood pressure or detrusor measurements from a patient. Furthermore, as the Supreme Court has explained, simple substitution of one known element for another known element supports a conclusion of obviousness; blood pressure (a known element) substituted for detrusor pressure (a known element). See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Instant Application 19/098,463
US Patent 12,268,878 B2
Claims 1 & 12
Claims 1 & 15
An apparatus for controlling bladder voiding control in a subject, the apparatus comprising:
An apparatus for controlling blood pressure in a subject, the apparatus comprising:
an input for receiving a signal indicative of a detrusor pressure (Pdet) measurement
an input for receiving a BP signal indicative of a blood pressure measurement;
a feedback control circuit connected to receive the signal from the input and to deliver a stimulation control signal to an output, the feedback control circuit configured to:
a feedback control circuit connected to a sensor to receive the BP signal from the input and to deliver a stimulation control signal to an output, the feedback control circuit configured to:
compare the detrusor pressure measurement to a target detrusor pressure range, wherein
compare the blood pressure measurement to a target blood pressure range, wherein
if the comparison indicates that the detrusor pressure measurement is below the target detrusor pressure range during voiding, increase a level of the stimulation control signal until the detrusor pressure measurement is in the target detrusor pressure range; and
if the comparison indicates that the blood pressure measurement is below the target blood pressure range increase a level of the stimulation control signal until the blood pressure measurement is in the target blood pressure range;
if the comparison indicates that the detrusor pressure measurement is above the target detrusor pressure range during voiding, decrease a level of the stimulation control signal until the detrusor pressure measurement is in the target detrusor pressure range.
and if the comparison indicates that the blood pressure measurement is above the target blood pressure range decrease a level of the stimulation control signal until the blood pressure measurement is in the target blood pressure range;
wherein the apparatus comprises a processor configured to receive a measurement of bladder function and to control blood pressure and at least one of bladder and bowel function by respectively applying a blood pressure stimulation signal and a bladder/bowel stimulation signal;
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brink et al (US 2017/0065821 A1) discloses a system and a method for treating bladder dysfunctions with electrostimulation [0025]; withhold delivery of stimulation (lag time) and detrusor muscle [0052].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWANE COLLARD whose telephone number is (571)272-6553. The examiner can normally be reached M-F 9 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWANE COLLARD/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
