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.
1. Claim 9 is 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.
Regarding claim 9, “the cumulative map” lacks antecedent basis since it has yet to be claimed. Correction is needed.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
2. Claim(s) 1-7 and 12-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Molnar (US 20090264789 A1).
In regards to claims 1, 18 and 20, Molnar discloses a method, comprising:
delivering a deep brain stimulation (DBS) therapy to a patient according to a first therapy program (Abstract discloses applying DBS therapy to a patient and Par. 0005 teaches a “first therapy program” with its own parameters);
receiving a logged event from a user or sensor indicative of an acute reduction in therapy (Par. 0074-0075 and Fig 16 teach receiving a sensor reading from a voice sensor and then reducing the intensity of the therapy)
automatically identifying a second therapy program for the DBS therapy to address the acute reduction in therapy; delivering the DBS therapy according to the second therapy program (Par. 0076 teaches that if the user wants less intensity, they can switch to a second therapy program that provides less intensity);
prompting the user to report whether the user likes or dislikes the DBS therapy delivered according to the second therapy program (Par. 0077 teaches the user can have access to a system that allows them to provide manual feedback and input on the different therapy programs, i.e. they can be prompted to make changes via this access if they are experiencing negative effects from a particular program); and
controlling the DBS therapy based on the report by choosing a third therapy program when the user does not like the second therapy program, reverting to the first therapy program when the user does not like the second therapy program, or continuing to deliver the DBS therapy according to the second therapy program when the user likes the second therapy program (Par. 0078 teaches that the system has multiple therapy programs that the user can switch between based on what they desire).
In regards to claims 2 and 3, Molnar discloses the method of claim 1, wherein the logged event is indicative of a symptom known to the user that may be experienced by the patient and that is known to potentially cause the acute reduction in therapy, wherein the automatically identified second therapy program is an accessible program for targeting the symptom (Par. 0074-0078 teach that the higher intensity stimulation can adversely affect speech fluency, i.e. cause negative symptoms of speech disturbances, and then they can choose a second therapy program that can lessen these effects).
In regards to claims 4 and 5, Molnar discloses the method of claim 1, wherein the logged event is indicative of a side effect known to the user that may be experienced by the patient and that is known to the user to potentially cause the acute reduction in therapy, wherein the automatically identified second therapy program is an accessible program for targeting the side effect Par. 0074-0078 teach that the higher intensity stimulation can adversely affect speech fluency and cause speech disturbance, i.e. cause a side effects, and then they can choose a second therapy program that can lessen these effects).
In regards to claim 6, Molnar discloses the method of claim 1, wherein the logged event from the user is indicative of an activity that corresponds to a set of symptoms that cause the first therapy to be suboptimal (Par. 0074-0075 teaches that activities such as lack of speech fluency or speech disturbances can be experienced and cited by the user during the first therapy program).
In regards to claim 7, Molnar discloses the method of claim 6, further comprising automatically requesting additional information when the logged event is received, wherein the additional information is requested using user-answered queries or is received via user-provided free text (Par. 0077 and 0084 teaches the user can be prompted for feedback about the efficacy of the therapy programs).
In regards to claim 12, Molnar discloses the method of claim 1, further comprising determining if a program limit has been reached the DBS therapy is delivered according to another therapy program, and only delivering the DBS therapy according to the other therapy program when a program limit has not been reached (Par. 0085 teaches having limits on the DBS therapy provided to the user).
In regards to claim 13, Molnar discloses the method of claim 1, wherein the user includes at least one of the patient or a caregiver for the patient (Par. 0077 teaches the user being a patient).
In regards to claims 14 and 19, Molnar discloses the method of claim 1, further comprising: receiving a report on the second therapy, by prompting the user or automatically sensing a detectable response, within a first time period after beginning to deliver the DBS therapy according to the second therapy, and continuing to deliver the DBS therapy according to the second therapy program when the report is good; and determining whether to continue to deliver the DBS therapy according to the second therapy program within a second time period after beginning to deliver the DBS therapy based on another report by prompting the user or automatically sensing the detectable response or another detectable response, wherein the second time period is longer than the first time period (Par. 0084 teaches prompting the user about how the therapy programs are going and Par. 0095 teaches that the system can employ automatic sensing and controlling the times the therapy is delivered).
In regards to claim 15, Molnar discloses the method of claim 14, wherein at least one of the first time period or the second time period depends on an event type for the logged event (Par. 0167 teaches that based on the side effects/logged event of the first therapy a second therapy can be used with different signal durations)
In regards to claim 16, Molnar discloses the method of claim 14, further comprising adding at least one prompt for the user to report on the second therapy within at least one time period longer than the second time period (Par. 0080-0081 teach a display or display like device that the patient can access and give inputs/make adjustments on the therapy programs provided, i.e. they can be prompted to make changes via this access if they are experiencing negative effects from a particular program).
In regards to claim 17, Molnar discloses the method of claim 1, further comprising receiving additional logged or sensed events and using the logged or sensed events to identify patterns of therapy reduction and develop event-related adjustments to the DBS therapy for the identified patterns (Par. 0078 and 0085-0086 teach automatic detection of the patients symptoms/side effects and then adjusting therapy based on these).
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.
2. Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar in view of Kaemmerer (US 20160250476 A1).
In regards to claims 8 and 9, Molnar discloses the method of claim 1, except for wherein a weighted summary map combines weights of clinical effects data into a cumulative score, and the second therapy program is automatically identified by altering the weights of symptoms in the clinical effects data, and identifying a program with a best estimated score, wherein the second therapy program is automatically identified by placing a side effect barrier on the cumulative map, the automatically identified second therapy program has a best estimated score remaining outside of a side effect region.
However, in the same field of endeavor, Kaemmerer teaches a DBS therapy system (Abstract) wherein the system can create a score of the best therapy program to choose from based on the programs side effects that they cause the patient (The Applicant discloses in their specification that the cumulative map is a weighted system that inputs side effects of a program and then uses it to help determine if a therapy program is the best option based on the scores/weights of the side effects input. Par. Par. 0131-0135 and 0127 of Kaemmerer teaches using weights and scores when determining if a program is the right option, these weights./scores given being indicative of side effects experienced) in order to quickly identify the therapy programs that may be efficacious (Par. 0131).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Molnar and modified them by having the system create a scoring of the best therapy programs for the patient, as taught and suggested by Kaemmerer, in order to quickly identify the therapy programs that may be efficacious (Par. 0131 of Kaemmerer).
3. Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar in view of Roberts (US 20110264034 A1).
In regards to claims 10-11, Molnar discloses the method of claim 1, except for it further comprising altering a workflow to simplify patient interaction when the logged event is repeatedly received, wherein the workflow is altered by introducing a schedule for delivering the DBS according to the second therapy schedule.
However, in the same field of endeavor, Roberts discloses a therapy modification system for DBS therapy (Abstract and Par 0020) wherein the therapy can be placed on a schedule that can match and address the users logged symptomatic condition, for example when bolus requests are repeated the system can create a maximum request on the schedule, i.e. when a logged event is repeatedly received (Par. 0031) in order to add ease of therapy delivery.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Molnar and modified them by having the system create a therapy schedule, as taught and suggested by Roberts, in order to add ease of therapy delivery.
Conclusion
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/S.L.C./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792