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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 29 May 2026. As directed by the amendment: claims 1, 3, 9-11, 18-22 have been amended, claim 14 has been canceled, and claim 25 has been added. Thus, claims 1-13 and 15-25 are presently pending in this application.
Response to Arguments
Objection to the Specification
Applicant’s arguments, see Remarks, filed 29 May 2026, with respect to the objections to the specification have been fully considered and are persuasive in light of the amendments to the specification. The objections to the specification have been withdrawn.
Objections to Claims 3, 9-10, 18 and 20
Applicant’s arguments, see Remarks, filed 29 May 2026, with respect to the objections to the claims have been fully considered and are persuasive in light of the amendments to the claims. The objections to the claims have been withdrawn.
35 U.S.C. §112(b) rejection of claims 14, 19 and 21-22
Applicant’s arguments, see Remarks, filed 29 May 2026, with respect to the 35 U.S.C. §112(b) rejections of claims 14, 19 and 21-22 have been fully considered and are persuasive in light of the amendments to the claims. The 35 U.S.C. §112(b) rejections of claims 14, 19 and 21-22 have been withdrawn.
35 U.S.C. §112(d) rejection of claim 14
Claim 14 has been canceled. Therefore, the rejection of claim 14 under 35 U.S.C. 112(d) has been rendered moot.
35 U.S.C. §102(a)(1) rejection of claims 1-2. 4-6. 9-12. 14-15 and 18-24
Applicant’s arguments, see Remarks, filed 29 May 2026, with respect to the rejections of claims 1 and 11 under 35 U.S.C. 102 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Li et al. (US 20170246458 A1), hereinafter Li, in view of Karst et al. (US 20170259066 A1, previously cited), hereinafter Karst.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-2, 4-12, and 15-25 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 20170246458 A1), hereinafter Li, in view of Karst et al. (US 20170259066 A1, previously cited), hereinafter Karst.
Regarding claim 1, Li discloses a method comprising:
generating, by a system (Fig. 1, paragraph [0026], implantable deep brain stimulator 10) comprising a processor (Fig. 2, paragraph [0028], processing module 111), a first stimulation at a first frequency and a second stimulation at a second frequency that is different than the first frequency (paragraph [0030], "As shown in FIGS. 4-6, the variable frequency stimulation pulse 150 includes at least two alternate electrical stimulation pulse trains 152 at different frequencies");
sending, by the system, the first stimulation to an electrode for application to a first location in a region of a brain of a patient to trigger an excitation period for a first set of neural elements in the region of the brain (paragraph [0030], "The at least two electrical stimulation pulse trains 152 can alternately stimulate the target nerve tissue") to treat at least one symptom of a malady (paragraph [0034], "Clinical trials show that the electrical stimulation therapy at high frequency from about 90 Hz to about 400 Hz can improve the motor symptoms of Parkinson patients"), wherein the first stimulation is a single pulse (Fig. 7, first pulse train 152); and
after a time to ensure the first set of neural elements has entered a refractory period as a result of the single pulse (Fig. 7, paragraph [0040], time space 154), sending, by the system, the second stimulation to the electrode for application to a second location in the region of the brain to trigger an excitation period for a second set of neural elements in the region of the brain (paragraph [0030], "The at least two electrical stimulation pulse trains 152 can alternately stimulate the target nerve tissue") to treat the at least one symptom of the malady and at least another different symptom of the malady (paragraph [0034], "the electrical stimulation therapy at from about 10 Hz to about 90 Hz can depress and discourage some non-motor symptoms, such as dysarthria, dyskinesia or freezing of gait");
Li does not explicitly disclose that the first set of neural elements is not excited by the second stimulation.
However, Karst teaches systems and methods for disrupting the pathological oscillation of Parkinson's disease (PD) (paragraph [0021]) wherein a first set of neural elements is not excited by a second stimulation after a first stimulation is applied (paragraph [0046], "neurons excited with a first burst are unable to be excited again until after neuronal refractory period 501 passes. … By delivering second bursts 304 and 404 within neuronal refractory period 501, a distinct neural population (relative to the neural population targeted by first bursts 302 and 402) is targeted with second bursts 304 and 404. For example, a neural population within first tissue volume 220 will not be activated by second burst 304. Rather, second burst 304 will activate the neural population in the 'shell' of second tissue volume 222 that surrounds first tissue volume 220").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li with the teachings of Karst so that the first set of neural elements is not excited by the second stimulation, because doing so allows stimulation to be delivered to a very specific region using only one or two electrode contacts while still disrupting pathologic oscillation (Karst, paragraph [0037]).
Regarding claim 2, the method of claim 1 is obvious over Li and Karst, as explained above. Although LI further discloses that the durations of the first stimulation and second stimulation can be different (paragraph [0036]), Li does not explicitly disclose applying the first stimulation to the first location in the region of the brain at least twice before the second stimulation is applied to the second location.
However, Karst further teaches applying the first stimulation to the first location in the region of the brain at least twice before the second stimulation is applied to the second location (Fig. 4, paragraph [0045], "stimulation may be applied simultaneously at first and second contacts 206 and 208"; paragraph [0042], "stimulation is delivered using two contacts, such as first and second contacts 206 and 208, in a random pattern, in a pseudo-random pattern, in an in-sequence pattern, or substantially simultaneously") before the second stimulation is applied to the second location (Fig. 4, paragraph [0046], "second bursts 304 and 404 are delivered within a neuronal refractory period 501 after respective first bursts 302 and 402").
Regarding claim 4, the method of claim 1 is obvious over Li and Karst, as explained above. Li further discloses positioning a DBS lead in the region of the brain of the patient (paragraph [0054], "step (S10), implanting the lead 12 in a brain of the patient") wherein the DBS lead comprises at least one electrode contact to deliver the first stimulation to the first location and the second stimulation to the second location (paragraph [0027], "The lead 12 includes at least one stimulation contactor"; paragraph [0054], "at least one stimulation contactor of the lead 12 contact with target nerve tissue of the patient directly").
Regarding claim 5, the method of claim 1 is obvious over Li and Karst, as explained above. Li further discloses that the first location and the second location are proximal to one another or identical (paragraph [0030], "The at least two electrical stimulation pulse trains 152 can alternately stimulate the target nerve tissue").
Regarding claim 6, the method of claim 1 is obvious over Li and Karst, as explained above. Li further discloses that the first set of neural elements and the second set of neural elements are at least one of overlapping, contiguous, or proximal to one another (paragraph [0030], "The at least two electrical stimulation pulse trains 152 can alternately stimulate the target nerve tissue").
Regarding claim 7, the method of claim 1 is obvious over Li and Karst, as explained above. Li further discloses that the first frequency is less than 100 Hz (paragraph [0034], "one electrical stimulation pulse train 152 can have a first frequency from about 50 Hz to about 80 Hz") and the second frequency is greater than 100 Hz (paragraph [0034], "the other one electrical stimulation pulse trains 152 can have a second frequency from about 100 Hz to about 150 Hz").
Regarding claim 8, the method of claim 1 is obvious over Li and Karst, as explained above. Li further discloses that the first frequency is an integer multiple of the second frequency (paragraph [0041], "50 Hz and 150 Hz"; paragraph [0084], "a first frequency 10 Hz and a second frequency 70 Hz"; paragraph [0037], "The order of the at least two electrical stimulation pulse trains 152 in each pulse train period 151 can be from high frequency to low frequency, from low frequency to high frequency, or at random as long as each electrical stimulation pulse train 152 has a certain time ratio in each pulse train period 151").
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a first frequency that is an integer multiple of the second frequency, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 9, the method of claim 1 is obvious over Li and Karst, as explained above. Li further discloses that the malady is Parkinson's disease (paragraphs [0034], [0058]), the at least one symptom is at least one or tremor or rigidity (paragraph [0070], "motor symptoms, such as tremors and rigidity"), and the at least another different symptom is a gait problem (paragraph [0034], freezing of gait).
Regarding claim 10, the method of claim 1 is obvious over Li and Karst, as explained above. Li does not explicitly disclose modulating, by the system, at least one of a polarity, an amplitude, the first frequency or the second frequency, a pulse width, and a stimulation location of each of the first stimulation and the second stimulation in response to receiving feedback.
However, Karst further teaches modulating, by the system, at least one of an amplitude (Fig. 3, paragraphs [0039]-[0040]), a pulse width (paragraph [0041]), and a stimulation location (Fig. 2, first tissue volume 220 and second tissue volume 222) of each of the first stimulation and the second stimulation in response to receiving feedback (paragraph [0048], "signals recorded by bipolar recording electrodes may be used in a feedback scheme, where the burst patterns delivered by first and/or second contacts 206 and 208 are adjusted based on detected changes in neuronal activity").
Regarding claim 11, Li discloses a system comprising:
a signal generator (Fig. 1, paragraph [0026], pulse generator 11) configured to generate a first stimulation at a first frequency and a second stimulation at a second frequency that is different than the first frequency, wherein the first stimulation is a single pulse (paragraph [0030], "As shown in FIGS. 4-6, the variable frequency stimulation pulse 150 includes at least two alternate electrical stimulation pulse trains 152 at different frequencies"; Fig. 7, first pulse train 152); and
at least one DBS lead configured to be positioned within a region of the patient's brain (paragraph [0054], "step (S10), implanting the lead 12 in a brain of the patient") comprising a first set of neural elements and a second set of neural elements (paragraph [0027], "The lead 12 is configured to apply the electrical stimulation pulses 15 to the target nerve tissue of the patient"; paragraph [0030], "The at least two electrical stimulation pulse trains 152 can alternately stimulate the target nerve tissue"), the at least one DBS lead configured to:
apply the first stimulation to a first location in the region of the brain to trigger an excitation period for the first set of neural elements to treat at least one symptom of a malady (paragraph [0034], "Clinical trials show that the electrical stimulation therapy at high frequency from about 90 Hz to about 400 Hz can improve the motor symptoms of Parkinson patients"), and
after a time to ensure the first set of neural elements enters a refractory period as a result of the single pulse (Fig. 7, paragraph [0040], time space 154), apply the second stimulation to a second location in the region of the brain to trigger an excitation period for only the second set of neural elements to treat the at least one symptom of the malady and at least another symptom of the malady (paragraph [0034], "the electrical stimulation therapy at from about 10 Hz to about 90 Hz can depress and discourage some non-motor symptoms, such as dysarthria, dyskinesia or freezing of gait").
Li does not explicitly disclose that the first set of neural elements is not excited by the second stimulation.
However, Karst teaches systems and methods for disrupting the pathological oscillation of Parkinson's disease (PD) (paragraph [0021]) wherein a first set of neural elements is not excited by a second stimulation after a first stimulation is applied (paragraph [0046], "neurons excited with a first burst are unable to be excited again until after neuronal refractory period 501 passes. … By delivering second bursts 304 and 404 within neuronal refractory period 501, a distinct neural population (relative to the neural population targeted by first bursts 302 and 402) is targeted with second bursts 304 and 404. For example, a neural population within first tissue volume 220 will not be activated by second burst 304. Rather, second burst 304 will activate the neural population in the 'shell' of second tissue volume 222 that surrounds first tissue volume 220").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li with the teachings of Karst so that the first set of neural elements is not excited by the second stimulation, because doing so allows stimulation to be delivered to a very specific region using only one or two electrode contacts while still disrupting pathologic oscillation (Karst, paragraph [0037]).
Regarding claim 12, the system of claim 11 is obvious over Li and Karst, as explained above. Although LI further discloses that the durations of the first stimulation and second stimulation can be different (paragraph [0036]), Li does not explicitly disclose applying the first stimulation to the first location in the region of the brain at least twice before the second stimulation is applied to the second location.
However, Karst further teaches applying the first stimulation to the first location in the region of the brain at least twice before the second stimulation is applied to the second location (Fig. 4, paragraph [0045], "stimulation may be applied simultaneously at first and second contacts 206 and 208"; paragraph [0042], "stimulation is delivered using two contacts, such as first and second contacts 206 and 208, in a random pattern, in a pseudo-random pattern, in an in-sequence pattern, or substantially simultaneously") before the second stimulation is applied to the second location (Fig. 4, paragraph [0046], "second bursts 304 and 404 are delivered within a neuronal refractory period 501 after respective first bursts 302 and 402").
Regarding claim 15, the system of claim 11 is obvious over Li and Karst, as explained above. Li further discloses that the first set of neural elements and the second set of neural elements are overlapping (paragraph [0030], "The at least two electrical stimulation pulse trains 152 can alternately stimulate the target nerve tissue").
Regarding claim 16, the system of claim 11 is obvious over Li and Karst, as explained above. Li further discloses that the first frequency is less than 100 Hz (paragraph [0034], "one electrical stimulation pulse train 152 can have a first frequency from about 50 Hz to about 80 Hz") and the second frequency is greater than 100 Hz (paragraph [0034], "the other one electrical stimulation pulse trains 152 can have a second frequency from about 100 Hz to about 150 Hz").
Regarding claim 17, the system of claim 11 is obvious over Li and Karst, as explained above. Li further discloses that the first frequency is an integer multiple of the second frequency (paragraph [0041], "50 Hz and 150 Hz"; paragraph [0084], "a first frequency 10 Hz and a second frequency 70 Hz"; paragraph [0037], "The order of the at least two electrical stimulation pulse trains 152 in each pulse train period 151 can be from high frequency to low frequency, from low frequency to high frequency, or at random as long as each electrical stimulation pulse train 152 has a certain time ratio in each pulse train period 151").
Regarding claim 18, the system of claim 11 is obvious over Li and Karst, as explained above. Li further discloses that the malady is Parkinson's disease (paragraphs [0034], [0058]), the at least one symptom is at least one or tremor or rigidity (paragraph [0070], "motor symptoms, such as tremors and rigidity"), and the at least another different symptom is a gait problem (paragraph [0034], freezing of gait).
Regarding claim 19, the system of claim 11 is obvious over Li and Karst, as explained above. Li further discloses that the region of the brain is the subthalamic neighborhood (paragraph [0080], "After applying a first variable frequency stimulation pulse of frequencies 60 Hz & 130 Hz, amplitude 2.7 V, and pulse width 60 μs, on left subthalamic nucleus and applying a second variable frequency stimulation pulse of frequencies 60 Hz & 130 Hz, amplitude 2.7 V, and pulse width 60 μs, on right subthalamic nucleus, both the rigidity and the freezing of gait are obviously improved").
Regarding claim 20, the system of claim 11 is obvious over Li and Karst, as explained above. Li does not explicitly disclose modulating, by the system, at least one of a polarity, an amplitude, the first frequency or the second frequency, a pulse width, and a stimulation location of each of the first stimulation and the second stimulation in response to receiving feedback.
However, Karst further teaches modulating, by the system, at least one of an amplitude (Fig. 3, paragraphs [0039]-[0040]), a pulse width (paragraph [0041]), and a stimulation location (Fig. 2, first tissue volume 220 and second tissue volume 222) of each of the first stimulation and the second stimulation in response to receiving feedback (paragraph [0048], "signals recorded by bipolar recording electrodes may be used in a feedback scheme, where the burst patterns delivered by first and/or second contacts 206 and 208 are adjusted based on detected changes in neuronal activity").
Regarding claim 21, the system of claim 11 is obvious over Li and Karst, as explained above. Li further discloses that the at least one DBS lead has at least one contact configured to deliver the first stimulation to the first location and at least one contact configured to deliver the second stimulation to the second location (paragraph [0030], "The at least two electrical stimulation pulse trains 152 can alternately stimulate the target nerve tissue"; paragraph [0054], "at least one stimulation contactor of the lead 12 contact with target nerve tissue of the patient directly").
Regarding claim 22, the system of claim 11 is obvious over Li and Karst, as explained above. Li further discloses that the at least one DBS lead has one contact configured to deliver the first stimulation to the first location and the second stimulation to the second location, wherein the first location and second location are the same location (paragraph [0027], "The lead 12 includes at least one stimulation contactor"; paragraph [0054], "at least one stimulation contactor of the lead 12 contact with target nerve tissue of the patient directly").
Regarding claim 23, the system of claim 11 is obvious over Li and Karst, as explained above. Li further discloses that the first set of neural elements and the second set of neural elements are at least one of overlapping, contiguous, or proximal to one another (paragraph [0030], "The at least two electrical stimulation pulse trains 152 can alternately stimulate the target nerve tissue").
Regarding claim 24, the system of claim 11 is obvious over Li and Karst, as explained above. Li further discloses that the first location and the second location are proximal to one another or identical (paragraph [0030], "The at least two electrical stimulation pulse trains 152 can alternately stimulate the target nerve tissue").
Regarding claim 25, the method of claim 1 is obvious over Li and Karst, as explained above. Li further discloses that the single pulse is from a continuous train of pulses (paragraph [0040], "As shown in FIG. 7, in one embodiment of the fourth kind of variable frequency stimulation pulse 150, the plurality of electrical stimulation pulse trains 152 can be continuous or non-continuous. There can be a time space 154 between adjacent two electrical stimulation pulse trains 152. As shown in FIG. 8, in one embodiment of the fifth kind of variable frequency stimulation pulse 150, the plurality of pulse train periods 151 can be continuous or non-continuous").
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 20170246458 A1), hereinafter Li, in view of Karst et al. (US 20170259066 A1, previously cited), hereinafter Karst, and further in view of Moffitt (US 8180445 B1, previously cited).
Regarding claim 3, the method of claim 1 is obvious over Li and Karst, as explained above. Neither Li nor Karst explicitly discloses generating the first stimulation at a first polarity; and generating the second stimulation at an opposite polarity of the first polarity.
However, Moffitt teaches a neurostimulation system (Abstract) for deep brain stimulation (column 11, line 10) wherein generating a first stimulation and a second stimulation comprises:
generating the first stimulation at a first polarity (Fig. 6, column 11, lines 22-24, cathodic pulse 102); and
generating the second stimulation at an opposite polarity of the first polarity (Fig. 6, column 11, lines 24-25, anodic pulse 104).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li and Karst with the teachings of Moffitt so that generating the first stimulation and the second stimulation further comprises generating the first stimulation at a first polarity; and generating the second stimulation at an opposite polarity of the first polarity, because doing so prevents net DC charge transfer through the tissue (Moffitt, column 11, lines 25-26).
Regarding claim 13, the system of claim 11 is obvious over Li and Karst, as explained above. Although Karst further discloses that the stimulation may be applied simultaneously using a bipolar configuration (paragraph [0045]), neither Li nor Karst explicitly discloses that the first stimulation has a first polarity and the second stimulation has an opposite polarity than the first stimulation.
However, Moffitt teaches a neurostimulation system (Abstract) for deep brain stimulation (column 11, line 10) wherein the first stimulation has a first polarity (Fig. 6, column 11, lines 22-24, cathodic pulse 102) and the second stimulation has an opposite polarity than the first stimulation (Fig. 6, column 11, lines 24-25, anodic pulse 104).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li and Karst with the teachings of Moffitt so that the first stimulation has a first polarity and the second stimulation has an opposite polarity than the first stimulation, because doing so prevents net DC charge transfer through the tissue (Moffitt, column 11, lines 25-26).
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 CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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