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 § 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 1-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1
The claims are drawn to a system.
Step 2A, Prong 1
Claim 1 recites the limitation of calculating at least one condition of the patient related to treatment of a voiding disorder. This limitation, given its broadest, reasonable interpretant, amounts to a clinician looking at a set of data and determining, in their mind, a condition of a patient. This is a mental process abstract idea.
Step 2A, Prong 2
The claims do not include any additional elements that amount to integration of the abstract idea into a practical application. Claim 1 includes the additional elements of a whiteboard device; a processor; memory; a display on the whiteboard device for displaying a first set of information; and “causing the whiteboard device to perform at least one treatment oepriaotn”, which is defined as broadly as simply issuing an alert or alarm (see Claim 5). The whiteboard device, processor and memory are generically claimed that they amount to generic computer implementation of the abstract idea. Displaying data on a display for review amounts to the insignificant extra-solution activity of data gathering and display; and issuing an alarm in response to a determined condition amounts to the insignificant, post-solution activity of data reporting or display. Generic computer implementation and insignificant, extra-solution activity do not amount to integration of the abstract idea into a practical application.
Step 2B
The claims do not include any additional elements that amount, alone or in combination, to significantly more than the abstract idea itself. Claim 1 includes the additional elements of a whiteboard device; a processor; memory; a display on the whiteboard device for displaying a first set of information; and “causing the whiteboard device to perform at least one treatment oepriaotn”, which is defined as broadly as simply issuing an alert or alarm (see Claim 5). The whiteboard device, processor and memory are generically claimed that they amount to generic computer implementation of the abstract idea. Displaying data on a display for review amounts to the insignificant extra-solution activity of data gathering and display; and issuing an alarm in response to a determined condition amounts to the insignificant, post-solution activity of data reporting or display. Generic computer implementation and insignificant, extra-solution activity do not amount, alone or in combination, to significantly more than the abstract idea itself.
Claims 2 and 20-22 only add limitations that generically link the abstract idea to another technological environment of field of use. Particularly, Claims 20-22 do not correlate the provided therapy to the decision outcomes from the calculations in Claim 1.
Claims 3-8, 10, 14-17, 19, 23 and 25 only further define the insignificant, extra-solution activity of data gathering and display.
Claims 9 and 18 only further define the abstract idea of mental calculations/decision making.
Claims 11-13 introduce the abstract idea of organizing human activity, such as setting schedules.
Claim 24 requires initiating a scheduled neurostimulation treatment but this is simply a whiteboard providing an indication that a treatment needs to be delivered. This is equivalent to a clinician prescribing a treatment but does not actually require the device itself to actively provide a treatment. Applicant has only claimed the whiteboard and not the neurostimulation device. Thus the final outcome of the claimed invention is issuing an alert to provide a treatment, which is not a particular prophylaxis.
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.
Claim 9 is 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. Claim 9 recites an algorithm that “calculates answers based upon patient data including at least a ‘fall risk score’ which relates to a patent’s risk of falling.”
When addressing computer-implemented functional claim limitations, MPEP §2161.01 states: “Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.”
Claim 9 sets forth the intended result of calculating answers but fails to disclose any particular algorithm or steps that are used to produce said answers. This is a functional result without sufficiently describing the steps taken to produce said result.
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.
Claims 1-4, 15, 16, 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni et al. (2007/0252714) in view of Monovoukas et al. (2014/0213936).
Regarding Claims 1, 3 and 15, Rondoni discloses a system comprising an external programmer 16 having a memory 102 (par. [0033, 0080]) and processor 100 (par. [0080]) wherein the programmer 16 receives a first set of information about the patient, such as voiding logs (Abstract). Rondoni further discloses the voiding logs are displayed and then reviewed to diagnose a patient and to adjust stimulation therapy (a treatment operation), see Abstract, par. [0094-0095], Fig. 13. Rondoni does not disclose that the programmer is a whiteboard device. However, Monovoukas, in the same field of endeavor of patient monitoring using a medical device, shows that whiteboard devices are equivalent structures to computing devices known in the art (par. [0050]). Therefore, because computing devices (devices with a processor and user interface) and whiteboard devices were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute a whiteboard device for a computing device such as a programmer having a processor and user interface.
In regard to Claim 2, Rondoni discloses the system treats urinary incontinence (par. [0002-0005]).
Regarding Claim 4, Rondoni discloses providing visual display of the voiding log as well as audible notification of a voiding event (par. [0093]).
With regard to Claim 16, Rondoni discloses tracking a voiding log as well as the effect of therapy on said log and thus make adjustments base don the log and delivered therapy (par. [0012]).
In regard to Claim 23, Rondoni disclose providing a list of therapy programs to a user for selection (par. [0041]).
With regard to Claim 25, Rondoni discloses a sensor 26 that detects moisture (wetness), see par. [0035]).
Claims 1-10, 18-21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (2016/0263376) in view of Monovoukas et al. (2014/0213936).
Regarding Claims 1 and 3, Yoo discloses a system comprising an external programmer 70 having a memory and processor (not shown but present since it obtains and processes information) wherein the programmer 70 receives a first set of information about the patient (sensed data ), see par. [0230]. Yoo further discloses the sensed data can be displayed and then reviewed to diagnose a patient and to adjust stimulation therapy (a treatment operation), see par. [0230]. Yoo does not disclose that the programmer is a whiteboard device. However, Monovoukas, in the same field of endeavor of patient monitoring using a medical device, shows that whiteboard devices are equivalent structures to computing devices known in the art (par. [0050]). Therefore, because computing devices (devices with a processor and user interface) and whiteboard devices were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute a whiteboard device for a computing device such as a programmer having a processor and user interface.
With regard to Claim 2, Yoo discloses treating urinary incontinence (par. [0167]).
Regarding Claims 4-6, Yoo discloses providing audio-visual feedback and alarms related to the provision of therapy (par. [0231]).
In regard to Claim 7, Yoo discloses providing audio-visual feedback and alarms related to the provision of therapy (par. [0231]) as well as obtaining patient historical data and obtaining/processing information from the patient or caregiver (par. [0230]).
Regarding Claim 8, Yoo discloses utilizing a voiding log/diary to track voiding events (par. [0193, 0200]) but is silent regarding the exact labels claimed. However, the claim does not establish a functional relationship to the device and simply states that these labels are displayed with no clear tie-in to the function or control of the system This is non-functional descriptive material. Therefore, the printed material has no patentable weight (see MPEP §2111.05). If Applicant were to tie the printed words into a function, the Examiner notes picking the word “bladder” instead of “urinate” or “void-urine” or some other indicator that the patient urinated is an obvious variant of what Yoo teaches. Yoo is concerned with tracking when a person voids, what type of voiding event and the frequency of voiding to control therapy. The claimed words are obvious variants of the type of information encompassed by a typical voiding diary.
With regard to Claim 9, Yoo discloses providing therapy in response to questions posed by the device (par. [0469]).
Regarding Claims 10 and 18, Yoo discloses updating a historical data record with usage/compliance information (par. [0230]).
In regards to Claims 19 and 20, Yoo discloses providing transcutaneous electrical nerve stimulation (Abstract, par. [0012]).
With regard to Claim 21, Yoo discloses targeting the posterior tibial nerve or saphenous nerve (par. [0030, 0038]).
Regarding Claim 24, Yoo discloses providing stimulation according to a schedule (par. [0202, 0412]).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (2016/0263376) in view of Monovoukas et al. (2014/0213936), further in view of Bondell et al. (US Patent 5,074,317).
Regarding Claims 11-13, Yoo discloses providing scheduled delivery of stimulation that can be adjusted based on a voiding log/diary but fails to disclose prompting a user to go to the bathroom. However, Bondell, in the same field of endeavor of treating urinary incontinence, discloses providing prompts to a user to visit the bathroom, such as right before bed or first thing in the morning, for the purpose of ensuring a voluntary voiding event as part of a daily schedule, thus avoiding involuntary wetting (col. 6, line 28 – col. 7, line 34; col. 9, lines 20-24). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Yoo and Monovoukas combination to include providing prompts to a user to visit the bathroom, as taught and suggested by Bondell, for the purpose of ensuring a voluntary voiding event as part of a daily schedule, thus avoiding involuntary wetting.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (2016/0263376) in view of Monovoukas et al. (2014/0213936), further in view of Rondoni et al. (2007/0252714) .
Regarding Claim 14, Yoo discloses tracking voiding event using a log or diary but fails to disclose automatically creating the log with a sensor. However, Rondini, in the same field f endeavor of treating incontinence, discloses automatically creating a log using sensor data for the purpose of quickly and accurately accounting for voiding events without having to keep a manual diary (Abstract, par. [0006, 0012]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Yoo and Monovoukas combination to include automatically generating a log from sensor data, as taught and suggested by Rondoni, for the purpose of quickly and accurately accounting for voiding events without having to keep a manual diary.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (2016/0263376) in view of Monovoukas et al. (2014/0213936), further in view of John (PGPUB 2008/0058773).
In regard to Claim 17, Yoo and Monovoukas disclose all of the claimed invention except for providing an alert based on an upcoming scheduled therapy event. However, in the same field of endeavor of control of therapy events in an implantable device, John discloses issuing an alert to an upcoming event such as application of a stimulus for the purpose of preventing unnecessary stimulation at the wrong time; resource depletion; reduction in chance of developing tolerance due to overstimulation, etc. (par. [0006-0013]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Yoo and Monovoukas combination to include alerting to an upcoming therapy event, as taught and suggested by John, for the purpose of preventing unnecessary stimulation at the wrong time; resource depletion; reduction in chance of developing tolerance due to overstimulation, etc.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (2016/0263376) in view of Monovoukas et al. (2014/0213936), further in view of Forsell (PGPUB 2012/0116774).
Regarding Claim 22, Yoo discloses controlling amplitude/strength, starting and stopping of stimulation but fails to disclose doing so with voice commands. However, int eh same field of endeavor of implantable medical devices and concerned with the common problem of device control, Forsell discloses utilizing voice commands to control the device, which would provide the benefit of easy, hands-free control (par. [0015]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Yoo and Monovoukas combination to include voice command controls, as taught and suggested by Forsell, for the purpose of easy, hands-free control.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLEN PORTER whose telephone number is (571)270-5419. The examiner can normally be reached Mon - Fri 9:00-6:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALLEN PORTER/Primary Examiner, Art Unit 3796
Prosecution Insights