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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1, 11 and 20 recite systems and method comprising: processing circuitry configured to:
receive information of a therapy program for an implantable medical device, wherein the information includes therapy parameters values and a therapy schedule defining delivery of therapy by the implantable medical device,
determine, based on the therapy parameter values and the therapy schedule of the therapy program, a recharge interval value for a power source of the implantable medical device,
compare the determined recharge interval value to a range of possible values of the determined recharge interval value for each bin of a plurality of bins, wherein each bin of the plurality of bins correlates ranges of the possible values of the determined recharge interval value to a plurality of predefined possible suggested recharge interval values, and
based on the comparison, select the suggested recharge interval value from the plurality of predefined possible suggested recharge interval values that corresponds to the bin in which the determined recharge interval value resides, and
generate, for output to a user and for the therapy program, an indication of the suggested recharge interval value, wherein the output includes a prompt on a user interface of a computing device indicating the suggested recharge interval value.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claims 1 and 20 are directed to system and claim 11 is a method to perform the steps, and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1, 11 and 20 recite:
receive information of a therapy program for an implantable medical device, wherein the information includes therapy parameters values and a therapy schedule defining delivery of therapy by the implantable medical device,
determine, based on the therapy parameter values and the therapy schedule of the therapy program, a recharge interval value for a power source of the implantable medical device,
compare the determined recharge interval value to a range of possible values of the determined recharge interval value for each bin of a plurality of bins, wherein each bin of the plurality of bins correlates ranges of the possible values of the determined recharge interval value to a plurality of predefined possible suggested recharge interval values, and
based on the comparison, select the suggested recharge interval value from the plurality of predefined possible suggested recharge interval values that corresponds to the bin in which the determined recharge interval value resides, and
generate, for output to a user and for the therapy program, an indication of the suggested recharge interval value, wherein the output includes a prompt on a user interface of a computing device indicating the suggested recharge interval value.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Therefore, claims 1, 8, and 15 recite an abstract idea of a mental process.
Claims 1, 11 and 20 recite the abstract idea of a mental process. The limitations as drafted in the claims, under its broadest reasonable interpretation, covers performance of the claimed steps in the mind or manually by a clinician, but for the recitation of a generic processor. For example, a clinician can
receive information of a therapy program,
determine a recharge interval value for a power source of the implantable medical device,
compare the determined recharge interval value to a range of possible values of the determined recharge interval value for each bin of a plurality of bins, wherein each bin has a plurality of predefined possible suggested recharge interval values by looking up a database,
based on the comparison, select the suggested recharge interval value and
generate an indication of the suggested recharge interval value.
Further, dependent Claims 2-10 and 12-19 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claims 1, 8 and 15 recite the additional elements of a “processor”. Based on a review of the originally filed specifications and the claims the processor is recited at a high level of generality performing the function of generic data processing such that they amount to no more than mere instructions to simply implement the abstract idea using generic computer components. See MPEP 2106.05(b) and (f).
Accordingly, the additional elements do not integrate the abstract idea into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to integration of the abstract idea into a practical application, “processor” that is used to perform the claimed steps amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic components cannot provide an inventive concept. These additional elements are well‐understood, routine (For example Torgerson (U.S. Patent Application Publication Number: US 2010/0114252 A1, hereinafter “Torgerson”- APPLICANT CITED) Burnes et al (U.S. Patent Application Publication Number: US 2010/0114215 A1, hereinafter “Burnes”- APPLICANT CITED), Davis et al (U.S. Patent Application Publication Number: US 2011/0106213 A1, hereinafter “Davis-APPLICANT CITED) all teach implantable medical devices that are configured to provide stimulation and that comprise processors and displays for outputting results of the computation by the processor) and conventional limitations that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. Therefore, the claims are not patent eligible.
Additionally while the dependent claims 10 and 19 recite controlling, by the processing circuitry, the implantable medical device to deliver electrical stimulation therapy to one or more of a sacral nerve or tibial nerve for incontinence therapy according to the therapy program, the claims do not positively recite the implantable medical device, electrodes and stimulation generator as being part of the claimed system and do not positively recite any steps to provide stimulation based on the suggested recharge interval that was determined. These additional elements are well‐understood, routine and conventional limitations that do not amount to significantly more.
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.
Claims 1, 8, 9, 11 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson (U.S. Patent Application Publication Number: US 2010/0114252 A1, hereinafter “Torgerson”- APPLICANT CITED) in view of Burnes et al (U.S. Patent Application Publication Number: US 2010/0114215 A1, hereinafter “Burnes” - APPLICANT CITED).
Regarding claims 1 and 11, Torgerson teaches a system (e.g. Figs 1,2, [0022]) and method comprising:
processing circuitry (e.g. 30 Fig.2, [0032]) configured to:
receive information of a therapy program (e.g. [0033]) for an implantable medical device, wherein the information includes therapy parameters values (e.g. [0032], [0037]: processor controls signal generator to deliver therapy according to a therapy program and controls charge pump to discharge delivery of pulse based on the selected therapy program) and a therapy schedule (e.g. Fig. 4, [0050]): time between pulses) defining delivery of therapy by the implantable medical device,
determine, based on the therapy parameter values and the therapy schedule of the therapy program, a recharge interval for a power source of the implantable medical device value (e.g. Fig. 4, [0072],[0073], [0082]: minimum required recharge frequency may be based on the minimum voltage level of power source 34 necessary to ensure charge pump 44 will be able to charge to a level required by the selected therapy program during the time interval 64 between pulses),
determine, for the therapy program, a suggested recharge interval value (e.g. [0084]: minimum required recharge frequency) from a plurality of predefined possible suggested recharge interval values (e.g. [0084]: minimum required recharge frequency, recharge frequency typically used when power source 34 is allowed to deplete to the lower power source voltage level), and
generate, for output to a user and for the therapy program, an indication of the suggested recharge interval value (e.g. [0084], 102 Fig. 8: generate report).
Torgerson does not specifically teach that the suggested recharge interval value corresponds to different respective ranges of possible values of the determined recharge interval value.
In a similar field of endeavor, Burnes teaches an implantable medical device (e.g. [0002] Fig.1) and further teaches scheduling a regular recharge interval (e.g. [0012]: rechargeable source may be recharged, periodically (such as once a day).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Torgerson with having a plurality of predefined possible suggested recharge values corresponding to different respective ranges of possible values of the determined recharge interval value in order to provide the predictable results of ensuring that the charging of the power source occurs on a periodic basis. (Note: Applicant’s originally filed specifications describe the suggested recharge interval value corresponds to regular calendar dates e.g. [0006], [0026]).
Regarding claims 8, 9 and 18, Torgerson in view of Burnes teaches the claimed invention as discussed above and Torgerson further teaches automatically or in response to user input, receive updated information for the therapy program via communication with the implantable medical device; and update, based on the updated information, the determined recharge interval value and the processing circuitry is configured to generate, for output, a prompt on a user interface of a computing device indicating the suggested recharge interval value (e.g. [0084],[0085]: user may decide to continue using eth same program or change the program and therefore will receive updated information and thus update the determined recharge interval value).
Claims 2-7, 9 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson (U.S. Patent Application Publication Number: US 2010/0114252 A1, hereinafter “Torgerson”- APPLICANT CITED) in view of Burnes et al (U.S. Patent Application Publication Number: US 2010/0114215 A1, hereinafter “Burnes”- APPLICANT CITED) and further in view of Davis et al (U.S. Patent Application Publication Number: US 2011/0106213 A1, hereinafter “Davis” - APPLICANT CITED).
Regarding claims 2 and 12, Torgerson in view of Burnes teaches the claimed invention as discussed above except for each bin of a plurality of bins correlates each range of the different respective ranges of the possible values of the determined recharge interval value to the plurality of predefined possible suggested recharge interval values, and wherein to determine the suggested recharge interval value, the processing circuitry is configured to: compare the determined recharge interval value to the range of the possible values of the determined recharge interval value for each bin of the plurality of bins, and based on the comparison, select the suggested recharge interval value from the plurality of predefined possible suggested recharge interval values that corresponds to the bin in which the determined recharge interval value resides.
In a similar field of endeavor, Davis teaches a plurality of bins wherein each bin correlates each range of different respective ranges of the possible values of the determined recharge interval value to the plurality of predefined possible suggested recharge interval values (e.g. 1010 Fig. 10) and the processing circuitry is configured to: compare the determined recharge interval value to the range of the possible values of the determined recharge interval value for each bin of the plurality of bins, and based on the comparison, select the suggested recharge interval value from the plurality of predefined possible suggested recharge interval values that corresponds to the bin in which the determined recharge interval value resides (e.g. Fig. 10 shows a user interface of a programmer providing predicted longevity values and corresponding scenarios, for a given program or group of programs, with different duty cycles so the user can toggle the battery longevity scenarios 801 and so the processor is configured to compare the determined recharge interval value for say 100% to the range of the possible values of the determined recharge interval value for each bin of the plurality of bins as shown in the graph and based on the comparison, select a suggested recharge interval value from the plurality of predefined possible suggested recharge interval values that corresponds to the bin in which the determined recharge interval value resides as claimed). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Torgerson in view of Burnes with the teachings of Davis in order to provide the predictable results of providing a better estimate of power consumption to the user.
Regarding claims 3-5 and 13-15, Torgerson in view of Burnes teaches the claimed invention as discussed above and Torgerson further teaches that the therapy program comprises a first therapy program and a second therapy program (e.g. [0075]: new programs are tested and stored) But they do not specifically teach first and second different indications for the first and second programs and that the processing circuitry is configured to output an indication of a transition between the first therapy program and the second therapy program and the first therapy program includes a first therapy schedule defining delivery of therapy by the implantable medical device and the second therapy program includes a second therapy schedule defining delivery of therapy by the implantable medical device, the first therapy schedule different than the second therapy schedule.
In a similar field of endeavor, Davis teaches a display to show different indications for different therapy programs and a transition between therapy programs which comprise different therapy schedules (e.g. 1010 Fig. 10 shows a user interface of a programmer providing predicted longevity values and corresponding scenarios, for a given program or group of programs, with different duty cycles so the user can toggle the battery longevity scenarios 801 and view the transition between programs). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Torgerson in view of Burnes with the teachings of Davis in order to provide the predictable results of in order to provide the predictable results of helping the clinician choose between programs.
Regarding claims 6 and 16, Torgerson in view of Burnes teaches the claimed invention as discussed above except for at least some ranges of the possible values of the determined recharge interval value include an upper bound value and a lower bound value, and wherein the suggested recharge interval value correlating to each range of the at least some ranges is lower than the lower bound value for the at least some ranges of the respective ranges.
Davis teaches ranges of recharge interval value that include an upper bound value and a lower bound value, and wherein the suggested recharge interval value correlating to each range of the at least some ranges is lower than the lower bound value for the at least some ranges of the respective ranges (e.g.1010 Fig.10). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Torgerson in view of Burnes to include a suggested recharge interval value for at least some of the ranges lower than the lower bound value for at least some ranges in order to provide the predictable results of ensuring that the power source will contain enough power at any time of the stimulation schedule.
Regarding claims 7 and 17, Torgerson in view of Burnes teaches the claimed invention as discussed above except for receiving input of a user-defined recharge interval value different than the plurality of predefined suggested possible recharge interval values, and generate, for output based on the input of the user-defined recharge interval value, an indication of the user-defined recharge interval value.
Davis teaches a display to show different indications for different therapy programs (e.g. 1010 Fig. 10 shows a user interface of a programmer providing predicted longevity values and corresponding scenarios, for a given program or group of programs, with different duty cycles so the user can toggle the battery longevity scenarios 801 and view the transition between programs). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Torgerson in view of Burnes to allow the clinician to input a recharge interval value different than the plurality of predefined suggested possible recharge interval values, and generate, for output based on the input of the user-defined recharge interval value, an indication of the user-defined recharge interval value in order to provide the predictable results of providing more flexibility for the clinician to customize the therapy.
Regarding claim 20, Torgerson teaches a system (e.g. Figs 1,2, [0022]) and method comprising:
processing circuitry (e.g. 30 Fig.2, [0032]) configured to:
receive information of a therapy program (e.g. [0033]) for an implantable medical device, wherein the information includes therapy parameters values (e.g. [0032], [0037]: processor controls signal generator to deliver therapy according to a therapy program and controls charge pump to discharge delivery of pulse based on the selected therapy program) and a therapy schedule (e.g. Fig. 4, [0050]): time between pulses) defining delivery of therapy by the implantable medical device,
determine, based on the therapy parameter values and the therapy schedule of the therapy program, a recharge interval for a power source of the implantable medical device value (e.g. Fig. 4, [0072],[0073], [0082]: minimum required recharge frequency may be based on the minimum voltage level of power source 34 necessary to ensure charge pump 44 will be able to charge to a level required by the selected therapy program during the time interval 64 between pulses),
determine, for the therapy program, a recharge interval value (e.g. [0084]: minimum required recharge frequency) from a plurality of predefined possible suggested recharge interval values (e.g. [0084]: minimum required recharge frequency, recharge frequency typically used when power source 34 is allowed to deplete to the lower power source voltage level), and
Torgerson does not teach comparing the determined recharge interval value to a range of possible values of the determined recharge interval value for each bin of a plurality of bins, wherein each bin of the plurality of bins correlates ranges of the possible values of the determined recharge interval value to a plurality of predefined possible suggested recharge interval values, and based on the comparison, select the suggested recharge interval value from the plurality of predefined possible suggested recharge interval values that corresponds to the bin in which the determined recharge interval value resides.
In a similar field of endeavor, Burnes teaches an implantable medical device (e.g. [0002] Fig.1) and further teaches scheduling a regular recharge interval (e.g. [0012]: rechargeable source may be recharged, periodically (such as once a day).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Torgerson with having a plurality of predefined possible suggested recharge values corresponding to different respective ranges of possible values of the determined recharge interval value in order to provide the predictable results of ensuring that the charging of the power source occurs on a periodic basis. (Note: Applicant’s originally filed specifications describe the suggested recharge interval value corresponds to regular calendar dates e.g. [0006], [0026]).
Further, in a similar field of endeavor, Davis teaches a plurality of bins wherein each bin correlates each range of different respective ranges of the possible values of the determined recharge interval value to the plurality of predefined possible suggested recharge interval values (e.g. 1010 Fig. 10) and the processing circuitry is configured to: compare the determined recharge interval value to the range of the possible values of the determined recharge interval value for each bin of the plurality of bins, and based on the comparison, select the suggested recharge interval value from the plurality of predefined possible suggested recharge interval values that corresponds to the bin in which the determined recharge interval value resides (e.g. Fig. 10 shows a user interface of a programmer providing predicted longevity values and corresponding scenarios, for a given program or group of programs, with different duty cycles so the user can toggle the battery longevity scenarios 801 and so the processor is configured to compare the determined recharge interval value for say 100% to the range of the possible values of the determined recharge interval value for each bin of the plurality of bins as shown in the graph and based on the comparison, select a suggested recharge interval value from the plurality of predefined possible suggested recharge interval values that corresponds to the bin in which the determined recharge interval value resides as claimed). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Torgerson in view of Burnes with the teachings of Davis in order to provide the predictable results of providing a better estimate of power consumption to the user.
Claims 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson (U.S. Patent Application Publication Number: US 2010/0114252 A1, hereinafter “Torgerson” - APPLICANT CITED) in view of Burnes et al (U.S. Patent Application Publication Number: US 2010/0114215 A1, hereinafter “Burnes” - APPLICANT CITED) and further in view of Fried et al (U.S. Patent Application Publication Number: US 2021/0121708 A1, hereinafter “Davis”).
Regarding claims 2 and 12, Torgerson in view of Burnes teaches the claimed invention as discussed above and while Torgerson teaches that therapy system 2 may be useful in stimulation applications applications may be targeted to a variety of disorders such as incontinence (e.g. [0026]), they do not specifically teach control the processing circuitry to deliver electrical stimulation therapy to one or more of a sacral nerve or tibial nerve for incontinence therapy according to the therapy program.
In a similar field of endeavor, Fried teaches an implanted neurostimulator configured to deliver electrical stimulation therapy to one or more of a sacral nerve or tibial nerve for incontinence therapy according to the therapy program (e.g. [0129], [0130] Figs.10A, B, 11). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Torgerson in view of Burnes to be used to treat incontinence by stimulating the sacral/ tibial nerve as taught by Fried in order to provide the predictable results of providing relief and improving the health of the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Padly et al (U.S. Patent Application Publication Number: US 2010/0076516 A1, hereinafter “Padly”) teaches a system and method for preventing excessive power drainage and indicating the remaining discharge time of the power source of an implantable medical device for delivering a therapeutic output to a patient, which would result in damage to the power source and/or medical device and/or injury (e.g. Abstract, Fig. 5).
Rondoni et al (U.S. Patent Application Publication Number: US 2009/0273318 A1, hereinafter “Rondoni”) teaches a system and method for estimating a time to recharge a rechargeable power source of an implantable medical device by applying measured parameters relating to the implantable medical device and an external charging device are applied to a model of recharging performance (e.g. Abstract, Fig.12).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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