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 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 21-32 recite a system and therefore is a product.
Claims 33-39 recite a method and therefore a process.
Claim 40 recite a non-transitory computer-readable medium and therefore a product.
Therefore, the claims fall within the statutory categories.
Step 2A, Prong 1:
Claims 21, 33, and 40 recite limitations of:
“determine a first therapeutic window for an electrode combination for a first period of time, the first therapeutic window representing a first range of values for a stimulation parameter that at least partially defines stimulation therapy for a patient during the first period of time”,
“determine a second therapeutic window for the electrode combination for a second period of time different than the first period of time, the second therapeutic window representing a second range of values for the stimulation parameter that at least partially defines stimulation therapy for the patient during the second period of time”, and
“generate…a representation of the first therapeutic window and the second therapeutic window.”
The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitation in the mind except for the recitation of “a processing circuitry” in claims 21, 33, and 40, “a user interface” in claims 21, 33, and 40, and “non-transitory computer-readable medium” in claim 40.
For the limitation of “user interface”, all steps recited in claims 21, 33, and 40 are being performed by the “processing circuitry”, not the “user interface” and “user interface” is not part of the claimed system rather part of a user device (Fig. 3 which illustrates different parts of processor 310, processing circuitry, and user interface 302). That is, other than reciting that “a processing circuitry” and “a non-transitory computer-readable medium” are performing these tasks, nothing in the claim precludes the steps from practically being performed in the human mind or being considered as methods of organizing human activity.
MPEP 2106.04(a)(2)(II) states that the sub-grouping "managing personal behavior or relationships or interactions between people" include social activities, teaching, and following rules or instructions and MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. For example, aside from the recitations of “a processing circuitry” and “a non-transitory computer-readable medium” language, the claim encompasses the user analyzing physiological signals in response to therapy to determine and provide therapeutic parameters.
Step 2A Prong 2:
The claims recite “a processing circuitry” and “a non-transitory computer-readable medium” to perform the abstract steps. These components read on a computer implemented system and method and are recited at a high level of generality, i.e., as a generic processor, performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
As discussed with respect to Step 2A Prong 2, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification in [0165] does not provide any indication that the computer is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim, as a whole, amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Dependent claims 22-31 and 34-39 further limit the abstract idea already indicated in independent claims 21 and 33 and they are ineligible for the same reasons provided for claims 21 and 33 above.
For these reasons, there is no inventive concept in the claims and thus they are ineligible.
Claim Rejections - 35 USC § 102
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 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.
Claims 21, 24-30, 33, 35-38 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bradley (US 2003/0139781).
Regarding claims 21, 33, and 40, Bradley discloses the claimed system, related method, and computer readable medium comprising processing circuitry configured to (e.g. Figure 10):
determine a first therapeutic window for an electrode combination for a first period of time, the first therapeutic window representing a first range of values for a stimulation parameter that at least partially defines stimulation therapy for a patient during the first period of time (e.g. measurement of electrical field at non-activated electrodes resulting from application of stimulus to the activated electrodes at step 84 of Figure 10)
determine a second therapeutic window for the electrode combination for a second period of time different than the first period of time, the second therapeutic window representing a second range of values for the stimulation parameter that at least partially defines stimulation therapy for the patient during the second period of time (e.g. comparison of previously saved electric field data as disclosed in step 88 of Figure 10); and
generate, for display via a user interface, a representation of the first therapeutic window and the second therapeutic window (e.g. graphic displace as displaced in [0054]).
Regarding claims 24 and 35, Bradley additionally discloses wherein the electrode combination comprises a first electrode combination of a plurality of electrode combinations, and wherein each electrode combination of the plurality of electrode combinations comprises at least one electrode disposed at different positions around a perimeter of a lead implanted in the patient (e.g. group of electrodes as taught in step 82 of Figure 10).
Regarding claim 25, Bradley additionally discloses wherein the processing circuitry is further configured to: compare the first therapeutic window to the second therapeutic window (e.g. comparison step 88 of Figure 10); based on the comparison between the first therapeutic window and the second therapeutic window, determine a change in a physiological state or a change in a disease progression of the patient (e.g. analyze differences in the data to determine whether the electrode orientation has changed as disclosed in step 90 of Figure 10); and generate, for display via the user interface, an indication of the change in physiological state or the change in disease progression of the patient (e.g. comparison on the graphic display as taught in [0054] and initiating corrective action as needed as taught in step 92 of Figure 10).
Regarding claims 26 and 36, Bradley additionally discloses determining a trend between the first therapeutic window and the second therapeutic window or a change in an amplitude between the first therapeutic window and the second therapeutic window (e.g. mapping lead migration over time as taught in [0068]).
Regarding claim 27, Bradley additionally discloses wherein the system is configured to: determine one or more of an increase in the trend of the first therapeutic window or a decrease in the amplitude of the first therapeutic window over the first period of time; and based on the one or more of the increase in the trend of the first therapeutic window or the decrease in the amplitude of the first therapeutic window, generate, for display via the user interface, an indication of worsening disease progression (e.g. as taught in [0066] – [0068]).
Regarding claims 28 and 37, Bradley additionally discloses wherein the processing circuitry is configured to: identify a change between the first therapeutic window and the second therapeutic window; based on the change between the first therapeutic window and the second therapeutic window, determine to propose an adjustment of the stimulation parameter; and generate, for output via the user interface, an indication of the proposed adjustment of the stimulation parameter (e.g. proposed adjustment of stimulation based on newly located electrodes as disclosed in [0069]).
Regarding claims 29 and 38, Bradley additionally discloses wherein the processing circuitry is further configured to
determine a third therapeutic window for a second electrode combination different from the first electrode combination for the first period of time, the third therapeutic window representing a third range of values for the stimulation parameter for the patient during the first period of time; determine a fourth therapeutic window for the second electrode combination for the second period of time, the fourth therapeutic window representing a fourth range of values for the stimulation parameter for the patient during the second period of time (e.g. testing of more groups of electrodes as taught in step 85 of Figure 10);
identify a change between the third therapeutic window and the fourth therapeutic window (comparison as taught in step 88 of Figure 10);
compare the change between the third therapeutic window and the fourth therapeutic window to a change between the first therapeutic window and the second therapeutic window (e.g. analysis of all data as taught in step 90 of Figure 10);
determine the lead has moved based on the comparison between the change between the third therapeutic window and the fourth therapeutic window and the change between the first therapeutic window and the second therapeutic window (e.g. tracking of lead migration as taught in [0068]); and
generate, for display via the user interface, an indication that the lead has moved (e.g. display of results as taught in [0054]).
Regarding claim 30, Bradley additionally discloses wherein the processing circuitry is configured to: determine the lead has moved by determining the lead has rotated (e.g. lead migration or postural changes in [0064]).
Claims 21-24, 33-35 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moffitt et al (US 2012/0303087).
Regarding claims 21, 33, and 40, Moffitt discloses the claimed system, related method, and computer readable medium comprising processing circuitry configured to (e.g. Figure 8):
determine a first therapeutic window for an electrode combination for a first period of time, the first therapeutic window representing a first range of values for a stimulation parameter that at least partially defines stimulation therapy for a patient during the first period of time (e.g. first targeted tissue region 324(1) as disclosed in Figures 13 and 14 for use during sleep; [0156]);
determine a second therapeutic window for the electrode combination for a second period of time different than the first period of time, the second therapeutic window representing a second range of values for the stimulation parameter that at least partially defines stimulation therapy for the patient during the second period of time (e.g. second target region 324(2) for moderately aggressive therapy; [0156]).
generate, for display via a user interface, a representation of the first therapeutic window and the second therapeutic window (e.g. bar maps as shown in Figures 15A-15C).
Regarding claim 22, Moffitt additionally discloses wherein the stimulation parameter is a stimulation amplitude (e.g. amplitudes shown in the graphs of Figure 15A-15C).
Regarding claims 23 and 34, Moffitt additionally discloses wherein the representation of the first therapeutic window and the second therapeutic window comprises a bar graph of magnitude values over time, and wherein the bar graph includes a first bar representing the first therapeutic window at a first time and a second bar representing the second therapeutic window at a second time (e.g. amplitudes shown in the graphs of Figure 15A-15C).
Regarding claim 24 and 35, Moffitt additionally discloses wherein the electrode combination comprises a first electrode combination of a plurality of electrode combinations, and wherein each electrode combination of the plurality of electrode combinations comprises at least one electrode disposed at different positions around a perimeter of a lead implanted in the patient (e.g. electrodes E1 – E8 as shown in Figure 15).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/ Primary Examiner, Art Unit 3792