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 .
Status of Claims
Claims 1-24 are currently pending in this application.
Specification
The disclosure is objected to because of the following informalities:
“extremeties” in paragraph [0003], line 3 should read “extremities”
“Parkinson’s diseases” in paragraph [0031], line 1 should read “Parkinson’s disease
Appropriate correction is required.
Claim Objections
Claims 3, 9, 10, and 20 are objected to because of the following informalities:
Claim 3:
A comma should be added after “claim 1”
The comma after “stimulation” in line 2 should be omitted
“at opposite polarity” in line 4 should read “at an opposite polarity”
Claim 9:
“the at least the other symptom” in line 3 should read “the at least another symptom”, in alignment with claim 1.
a comma should be added after “gait problem” in line 4
Claim 10: “pulse-width” in line 3 should read “pulse width”
Claim 18:
“the at least the other symptom” in line 3 should read “the at least another symptom”, in alignment with claim 1.
a comma should be added after “gait problem” in line 4
Claim 20: “pulse-width” in line 2 should read “pulse width”
Appropriate correction is required.
Claim Interpretation
Claims 9 and 18 recite “wherein the at least [another] symptom is an axial problem, a gait problem and/or a balance problem”. Parent claims 1 and 11 recite that the second stimulation is applied “to treat the at least one symptom of the malady and/or at least another symptom of the malady”. Under their broadest reasonable interpretations, claims 1 and 11 can be interpreted such that the second stimulation is applied to treat only the at least one symptom of the malady, and not the at least another symptom of the malady. Thus, in claims 9 and 18, the limitation that “the at least [another] symptom is an axial problem, a gait problem and/or a balance problem” is not necessarily required.
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.
Claims 14 and 19 are 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.
Claim 14 recites “The system of claim 11, wherein the at least one DBS lead of the patient is previously implanted in the brain of the patient”. The term “previously implanted” is unclear as to when the implantation occurred. There is no other event to compare the time of the implantation to. Furthermore, the at least one DBS lead recited in claim 11 is not “of the patient”; rather, it is of the system of claim 11.
Claim 19 recites the limitation "the subthalamic neighborhood" in line 1. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear as to what “the subthalamic neighborhood” is referring to. The term is not commonly used in the art of deep brain stimulation. “Subthalamic” can be interpreted such that the region of the brain recited in claim 19 is somehow related to the subthalamus, but “neighborhood” does not provide clear boundaries for the region. The subthalamic neighborhood is mentioned in the specification (paragraphs [0032], [0034], [0046]), but these also do not clearly define the boundaries of the region.
Claims 21 and 22 recite the limitation "the DBS lead". There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the DBS lead” will be interpreted as “the at least one DBS lead” in alignment with claim 11.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 recites “at least one DBS lead configured to be positioned within a region of the patient’s brain”. Claim 14 recites “The system of claim 11, wherein the at least one DBS lead of the patient is previously implanted in the brain of the patient”. It is unclear as to how claim 14 further limits the system of claim 11, because “implanted in the brain of the patient” and “positioned within a region of the patient’s brain” are synonymous.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-2, 4-6, 9-12, 14-15, and 18-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karst et al. (US 20170259066 A1), hereinafter Karst.
Regarding claim 1, Karst discloses a method comprising:
generating, by a system (Fig. 1, paragraph [0025], stimulation system 100) comprising a processor (Fig. 1, paragraph [0025], controller 151), a first stimulation (Fig. 3, paragraph [0039], first burst 302) at a first frequency (paragraph [0033], pulse frequency, intra-burst frequency, or inter-burst frequency) and a second stimulation (Fig. 3, paragraph [0039], second burst 304) at a second frequency (paragraph [0033], pulse frequency, intra-burst frequency, or inter-burst frequency);
sending, by the system, the first stimulation to an electrode (Fig. 3, paragraph [0039], first contact 206) 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 (Fig. 2, paragraph [0041], first tissue volume 220; paragraph [0039], "activating only neurons that are relatively close to first contact 206") to treat at least one symptom of a malady (paragraph [0033], "stimulation programs to treat the patient's disorder(s)"); and
after a time to ensure the first set of neural elements has entered a refractory period (paragraph [0046], "second bursts 304 and 404 are delivered within a neuronal refractory period 501 after respective first bursts 302 and 402"; paragraph [0033], delay between a first and second burst), 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 (Fig. 2, paragraph [0041], second tissue volume 222; paragraph [0039], "Subsequently, a second burst 304 of stimulation is provided at a higher amplitude, activating neurons within a larger region") to treat the at least one symptom of the malady and/or at least another symptom of the malady (paragraph [0033], "stimulation programs to treat the patient's disorder(s)"),
wherein the first set of neural elements is not excited by the second stimulation (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.").
Regarding claim 2, Karst discloses the method of claim 1, as explained above. Karst further discloses applying the first stimulation to the first location in the region of the brain at least twice (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, Karst discloses the method of claim 1, as explained above. Karst further discloses positioning a DBS lead in the region of the brain of the patient (Fig. 2, paragraph [0036], "stimulation lead 202 is a DBS lead implanted into a patient's brain"; paragraph [0035], "stimulation lead 202 that may be used, for example, with neurostimulation system 100") wherein the DBS lead comprises at least one electrode contact (Fig. 2, paragraph [0035], first contact 206, second contact 208) to deliver the first stimulation (Fig. 3, paragraph [0039], first burst 302) to the first location (Fig. 2, paragraph [0041], first tissue volume 220; paragraph [0039], "activating only neurons that are relatively close to first contact 206") and the second stimulation (Fig. 3, paragraph [0039], second burst 304) to the second location (Fig. 2, paragraph [0041], second tissue volume 222; paragraph [0039], "Subsequently, a second burst 304 of stimulation is provided at a higher amplitude, activating neurons within a larger region").
Regarding claim 5, Karst discloses the method of claim 1, as explained above. Karst further discloses that the first location and the second location are proximal to one another (Fig. 2, paragraph [0046], first tissue volume 220 and second tissue volume 222 are near each other).
Regarding claim 6, Karst discloses the method of claim 1, as explained above. Karst further discloses that the first set of neural elements and the second set of neural elements are at least one of overlapping (Fig. 2, second tissue volume 222 overlaps first tissue volume 220), contiguous (Fig. 2, paragraph [0046], first tissue volume 220 and second tissue volume 222 share the border between them), or proximal to one another (Fig. 2, paragraph [0046], first tissue volume 220 and second tissue volume 222 are near each other).
Regarding claim 9, Karst discloses the method of claim 1, as explained above. Karst further discloses that the malady is Parkinson's disease (paragraph [0021]), and wherein the at least one symptom is tremor (paragraph [0022], essential tremor).
Regarding claim 10, Karst discloses the method of claim 1, as explained above. Karst further discloses 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]).
Regarding claim 11, Karst discloses a system (Fig. 1, paragraph [0025], stimulation system 100) comprising:
a signal generator (Fig. 1, paragraph [0025], pulse generating circuitry 152) configured to generate a first stimulation at a first frequency and a second stimulation at a second frequency a first stimulation (Fig. 3, paragraph [0039], first burst 302) at a first frequency (paragraph [0033], pulse frequency or intra-burst frequency) and a second stimulation (Fig. 3, paragraph [0039], second burst 304) at a second frequency (paragraph [0033], pulse frequency or intra-burst frequency); and
at least one DBS lead configured to be positioned within a region of the patient's brain (Fig. 2, paragraph [0036], "stimulation lead 202 is a DBS lead implanted into a patient's brain"; paragraph [0035], "stimulation lead 202 that may be used, for example, with neurostimulation system 100") comprising a first set of neural elements (Fig. 2, paragraph [0041], first tissue volume 220) and a second set of neural elements (Fig. 2, paragraph [0041], second tissue volume 222), 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 (Fig. 2, paragraph [0041], first tissue volume 220; paragraph [0039], "activating only neurons that are relatively close to first contact 206") to treat at least one symptom of a malady (paragraph [0033], "stimulation programs to treat the patient's disorder(s)"), and
after a time to ensure the first set of neural elements enters a refractory period (paragraph [0046], "second bursts 304 and 404 are delivered within a neuronal refractory period 501 after respective first bursts 302 and 402"; paragraph [0033], delay between a first and second burst), 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 (Fig. 2, paragraph [0041], second tissue volume 222; paragraph [0039], "Subsequently, a second burst 304 of stimulation is provided at a higher amplitude, activating neurons within a larger region") to treat the at least one symptom of the malady and/or at least another symptom of the malady (paragraph [0033], "stimulation programs to treat the patient's disorder(s)"),
wherein the first set of neural elements is not excited by the second stimulation (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.").
Regarding claim 12, Karst discloses the system of claim 11, as explained above. Karst further discloses applying the first stimulation at least twice (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 14, Karst discloses the system of claim 11, as explained above. Karst further discloses that the at least one DBS lead of the patient is previously implanted in the brain of the patient (paragraph [0036], "a DBS lead implanted into a patient's brain").
Regarding claim 15, Karst discloses the system of claim 11, as explained above. Karst further discloses that the first set of neural elements and the second set of neural elements are overlapping (Fig. 2, second tissue volume 222 overlaps first tissue volume 220).
Regarding claim 18, Karst discloses the system of claim 11, as explained above. Karst further discloses that the malady is Parkinson's disease (paragraph [0021]), and wherein the at least one symptom is tremor (paragraph [0022], essential tremor).
Regarding claim 19, Karst discloses the system of claim 11, as explained above. Karst further discloses that the region of the brain is the subthalamic neighborhood (paragraph [0036], "first and second contacts 206 and 208 are positioned within a subthalamic nucleus (STN) 212 of the patient").
Regarding claim 20, Karst discloses the system of claim 11, as explained above. Karst further discloses the generator is configured to modulate 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]).
Regarding claim 21, Karst discloses the system of claim 11, as explained above. Karst further discloses that the DBS lead has at least one contact configured to deliver the first stimulation to the first location (Fig. 2, paragraphs [0043]-[0044], first contact 206 delivers first burst 402 to first tissue volume 230) and at least one contact configured to deliver the second stimulation to the second location (Fig. 2, paragraphs [0043]-[0044], second contact 208 delivers second burst 404 to second tissue volume 232).
Regarding claim 22, Karst discloses the system of claim 11, as explained above. Karst further discloses that the DBS lead has one contact configured to deliver the first stimulation to the first location and the second stimulation to the second location (Fig. 2, paragraph [0039], first contact 206), wherein the first location and second location are the same location (Fig. 2, paragraph [0046], first tissue volume 220 and second tissue volume 222 include the same location).
Regarding claim 23, Karst discloses the system of claim 11, as explained above. Karst further discloses that the first set of neural elements and the second set of neural elements are at least one of overlapping (Fig. 2, second tissue volume 222 overlaps first tissue volume 220), contiguous (Fig. 2, paragraph [0046], first tissue volume 220 and second tissue volume 222 share the border between them), or proximal to one another (Fig. 2, paragraph [0046], first tissue volume 220 and second tissue volume 222 are near each other).
Regarding claim 24, Karst discloses the system of claim 11, as explained above. Karst further discloses that the first location and the second location are proximal to one another (Fig. 2, paragraph [0046], first tissue volume 220 and second tissue volume 222 are near each other).
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 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Karst et al. (US 20170259066 A1), hereinafter Karst, in view of Moffitt (US 8180445 B1).
Regarding claim 3, Karst discloses the method of claim 1, as explained above. Although Karst further discloses that the stimulation may be applied simultaneously using a bipolar configuration (paragraph [0045], Karst does not explicitly disclose 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 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, Karst discloses the system of claim 11, as explained above. Although Karst further discloses that the stimulation may be applied simultaneously using a bipolar configuration (paragraph [0045], Karst does not explicitly disclose 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 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 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).
Claims 7-8 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Karst et al. (US 20170259066 A1), hereinafter Karst, in view of Cleland et al. (US 20230381522 A1), hereinafter Cleland.
Regarding claim 7, Karst discloses the method of claim 1, as explained above. Although Karst further discloses that the stimulation parameters include an intra-burst frequency of 130 Hz (paragraph [0033]), Karst does not explicitly disclose that the first frequency is less than 100 Hz and the second frequency is greater than 100 Hz.
However, Cleland teaches systems and methods for deep brain stimulation (paragraph [0040], system 100), wherein pulses of a first frequency less than 100 Hz (paragraph [0027], tonic frequency of 50 Hz) are interleaved with pulses of a second frequency greater than 100 Hz (paragraph [0026], priming frequency of 400 Hz or 200 Hz; paragraph [0025]).
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 Karst with the teachings of Cleland so that the first frequency is less than 100 Hz and the second frequency is greater than 100 Hz, because the higher frequency component facilitates lower frequency signals to stimulate nerve tissue, lowers the threshold for depolarization of nerve fibers, and lowers the impedance of the stimulated tissue, which allows for better penetration of the electric field into the neural tissue (Cleland, paragraph [0023]).
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 less than 100 Hz and a second frequency greater than 100 Hz, for the purpose of selectively stimulating different sets of neural elements, 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.
Regarding claim 8, Karst discloses the method of claim 1, as explained above. Karst does not explicitly disclose that the first frequency is an integer multiple of the second frequency.
However, Cleland teaches systems and methods for deep brain stimulation (paragraph [0040], system 100), wherein the first frequency is an integer multiple of the second frequency (paragraph [0026], "the burst frequency of the priming frequency signal component can be an integer multiple (M) of the tonic signal frequency"; paragraphs [0026]-[0027], a priming frequency of 400 Hz or 200 Hz is an integer multiple of a tonic frequency of 50 Hz).
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 Karst with the teachings of Cleland so that the first frequency is an integer multiple of the second frequency, because the higher frequency component facilitates lower frequency signals to stimulate nerve tissue, lowers the threshold for depolarization of nerve fibers, and lowers the impedance of the stimulated tissue, which allows for better penetration of the electric field into the neural tissue (Cleland, paragraph [0023]).
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 a 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 16, Karst discloses the system of claim 11, as explained above. Although Karst further discloses that the stimulation parameters include an intra-burst frequency of 130 Hz (paragraph [0033]), Karst does not explicitly disclose that the first frequency is less than 100 Hz and the second frequency is greater than 100 Hz.
However, Cleland teaches systems and methods for deep brain stimulation (paragraph [0040], system 100), wherein pulses of a first frequency less than 100 Hz (paragraph [0027], tonic frequency of 50 Hz) are interleaved with pulses of a second frequency greater than 100 Hz (paragraph [0026], priming frequency of 400 Hz or 200 Hz; paragraph [0025]).
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 Karst with the teachings of Cleland so that the first frequency is less than 100 Hz and the second frequency is greater than 100 Hz, because the higher frequency component facilitates lower frequency signals to stimulate nerve tissue, lowers the threshold for depolarization of nerve fibers, and lowers the impedance of the stimulated tissue, which allows for better penetration of the electric field into the neural tissue (Cleland, paragraph [0023]).
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 less than 100 Hz and a second frequency greater than 100 Hz, for the purpose of selectively stimulating different sets of neural elements, 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.
Regarding claim 17, Karst discloses the system of claim 11, as explained above. Karst does not explicitly disclose that the first frequency is an integer multiple of the second frequency.
However, Cleland teaches systems and methods for deep brain stimulation (paragraph [0040], system 100), wherein the first frequency is an integer multiple of the second frequency (paragraph [0026], "the burst frequency of the priming frequency signal component can be an integer multiple (M) of the tonic signal frequency"; paragraphs [0026]-[0027], a priming frequency of 400 Hz or 200 Hz is an integer multiple of a tonic frequency of 50 Hz).
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 Karst with the teachings of Cleland so that the first frequency is an integer multiple of the second frequency, because the higher frequency component facilitates lower frequency signals to stimulate nerve tissue, lowers the threshold for depolarization of nerve fibers, and lowers the impedance of the stimulated tissue, which allows for better penetration of the electric field into the neural tissue (Cleland, paragraph [0023]).
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 a 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).
Conclusion
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/CHRISTINE SISON/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796