The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection.
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.
Claims 1, 13-14, 16, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bokil (US Patent Pub. No. 2020/0330750).
Regarding claims 1, 18 and 20, Bokil discloses methods of providing electrical neural modulation to a patient's brain… The methods involve differentially modulating two or more target regions of the brain… As the implantable pulse generators (IPGs) described herein include independent current sources, such differential modulation can be provided with a single IPG” (see Abstract). “The IPG case 12 also holds stimulation circuitry 31, which provides and controls electrical stimulation” (see paragraph 22; also see paragraph 29 which teaches the clinician interfacing with a computer, which has a processor and memory, for controlling and programming the stimulation circuitry 31). Paragraph 51 discusses the embodiment of Figure 7, in which an electrical stimulation signal is modulated from a first level (see waveform 702) to a second level (see waveform 704) over time (note that in paragraph 49 it discusses how “For example, according to one embodiment, a first one or more waveforms can be provided to the PV-GPe neurons using the first one or more electrodes, wherein the first one or more waveforms stimulate (i.e., excite) the PV-GPe cells”; and also in paragraph 50 in addressing Figure 6 it teaches that “cathodic and anodic waveforms can be interleaved or otherwise separated in time”). Paragraph 52 teaches that “When the remote target neural population C is excited using excitatory waveform 702 firing of the ultimate target neural population A will increase”, wherein the disclosed “target neural population C” is akin to the claimed first collateral neural population. Similarly, when the remote target neural population D is excited using waveform 704 firing of the ultimate target neural population B will increase, wherein the disclosed “target neural population D” is akin to the claimed second collateral neural population. Additionally, the claimed “target neural population” is interpreted as the combination of neural populations A and B. As taught by Bokil, neural populations A and C are distinct, neural populations B and D are distinct, and neural populations C and D are distinct, which reads on “wherein the first collateral neural population and the second collateral neural population are different than neurons of the target neural population”, and on “wherein modulating the electrical stimulation signal between the first level and the second level recruits the first collateral neural population and the second collateral neural population, which are different collateral neural populations”. Additionally, it is noted that Bokil teaches that “The effect on the ultimate neural targets (i.e., A and/or B) of applying waveforms to the remote neural targets (i.e., C and/or D) will depend on whether the neural projections 706/708 are excitatory or inhibitory” (see paragraph 51), which thereby teaches that this causes “the effect on the ultimate neural targets (i.e., A and/or B)”, which means that the electrical stimulation is at or above a therapeutic threshold for the target neural population throughout the delivery of electrical energy. Specifically regarding claims 18 and 20 for reciting controlling between a first level and a second level, and then from the second level to the first level, it is noted that Bokil teaches that “The cathodic and anodic waveforms can be interleaved” (see paragraph 50).
Regarding claim 13, Bokil teaches that “The cathodic and anodic waveforms can be interleaved” (see paragraph 50).
Regarding claim 14, Bokil teaches targeting neurons in the basal ganglia, which is generally at the top of the spinal cord, within the brain.
Regarding claim 16, it is noted that the IPG shown in Figure 1 is implantable.
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.
Claims 2-3 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Bokil in view of Dong et al. (NPL titled “Connectivity and Functionality of the Globus Pallidus Externa Under Normal Conditions and Parkinson’s Disease”, published March 2, 2021).
Bokil is described above with respect to claim 1. Bokil teaches that “For example, the A neurons may be PV-GPe neurons and the B neurons may be Lhx6-GPe neurons” (see paragraph 50). Also, since paragraph 49 teaches that “a first one or more waveforms can be provided to the PV-GPe neurons using the first one or more electrodes, wherein the first one or more waveforms stimulate (i.e., excite) the PV-GPe cells. Likewise, a second one or more waveforms can be provided to the Lhx6-GPe neurons using the second one or more electrodes”, then this teaches that there are distinct electrodes that target these distinct neuron types.
Dong teaches that “The reported overlap of Lhx6+ and PV+ neurons varies widely across laboratories and studies. Several studies have found that about 25% of Lhx6+ neurons are also PV+, while others show the overlapping percentage is up to 50%” (see page 3, right column around the middle of the page). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that the delivery of electrical stimulation to PV-GPe neurons and Lhx6-GPe neurons, as taught by Bokil, may be delivering electrical stimulation to the same nerve, or possibly to different nerves, since Dong teaches that different studies show different amounts of overlap between these two neuron types within the globus pallidus externa.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bokil alone.
As stated on page 2 of the previous Office action, the term “level” is used within the claims is defined in paragraph 26 of the application’s PGPUB 2024/0278018, which states the following:
In one or more examples, the modulation of the electrical stimulation signals may be suprathreshold therapeutic modulation. That is, processing circuitry may modulate an electrical stimulation signal between a first level and a second level over time. The term “level” generally refers to characteristic of the electrical stimulation signal indicative of the energy of the electrical stimulation signal. The term “level” may refer to the energy, amplitude, pulse width, or frequency. As described in more detail, the first level and the second level may also refer to electrode selection. The threshold may correspond to a therapeutic threshold, perception threshold, or any other threshold related to nerve activity.
Therefore, “level” in the claims refers to the energy, amplitude, pulse width, or frequency, or to electrode selection. As shown in Figure 7 of Bokil, the shows a first pulse width PWa in waveform 702 that is shorter than pulse width PWb in waveform 704, which is described as “long and low”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that this may be 5% longer than the pulse width of waveform 702, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Allowable Subject Matter
Claims 4-5, 7-12, 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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