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 § 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 1, 6, 8, 10, 11, 13, and 14 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.
In re claim 1, the limitation “a method for identifying effective placement of at least one lead,” is unclear. Specifically, the limitation implies that the method described will be used to identify where lead placement is most effective. This is unclear as the method is used to test different stimulation parameters used for electrode configurations and the patient identifies which is working the most effectively as the different combinations are being tested.
For examination purposes, claim 1 will be interpreted as a method that tests different electrode combinations and fractionalizations based on lead placement so that the patient can determine which combination works best for them.
In re claim 6, the limitation “the first program is configured to fractionalize about 1/3” and “the fourth program is configured to fractionalize about 1/3,” is unclear. Specifically, the usage of the word “about” which implies that the fractionalization values need to be around 1/3 but do not have to be exactly 1/3.
For examination purposes, the limitation “about” will be analyzed as the fractionalizations can be approximately 1/3 within a reasonable range, for this application, the range 30-40% is used.
In re claim 8, see above (In re claim 6).
In re claim 11, the limitation “spacing S corresponding to a number of electrodes that are not one of the NA anodic electrodes or one of the NC cathodic electrodes, where S=NT – (NA + NC),” is unclear. Specifically, whether the spacing corresponds to only the number of inactive electrodes or if spacing corresponds to where the inactive electrodes are located relative to the cathodic/anodic electrodes.
For examination purposes, the limitation “S” will be interpreted as the number of inactive electrodes that are used on a percutaneous lead.
In re claim 13, see above (In re claim 11).
In re claim 14, see above (In re claim 11).
Claim Rejections - 35 USC § 102/103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 1-9, 15, 17-20 are rejected under 35 U.S.C. 102(a)(1)/103 as being unpatentable over Rao et al. (US 2019/0148009).
In re claim 1, Rao discloses a method for identifying effective placement of at least one lead having a plurality of electrodes (fig 3: 12, 26), the method comprising:
testing each of the plurality of electrodes (26; [0039] “The IPG may also be operated to modify the stimulation parameters” [0050] “the processor generates new stimulation sets in response to the user operation”) with equal amounts of cathodic energy (fig 10a) by implementing at least two preset programs ([0044, 0060]),
wherein each of the at least two preset programs is configured to control delivery of neuromodulation ([0056]: “display screen allows the clinician to… define the configuration and orientation of the leads”) to deliver neuromodulation energy using a different set of active electrodes [0062] from the plurality of electrodes,
wherein for each of the at least two preset programs [0044, 0060]:
the active electrodes include at least two cathodic electrodes and at least two anodic electrodes [0070];
a total cathodic contribution ([0014] “total current on the electrodes for the same polarization must always equal 100 percent”) for the neuromodulation energy is evenly* fractionalized across each of the at least two cathodic electrodes (fig 8a, fig 9a); and
a total anodic contribution for the neuromodulation energy is evenly* fractionalized across each of the at least two anodic electrodes (fig 8a, 9a).
*Regarding the limitation “evenly”, Rao discloses two electrode combinations wherein the neuromodulation energy is fractionalized within 1% across the cathodes and anodes. Rao further discloses these currents as split equally as explained in the spec [0070, 0073]. Furthermore, the Applicant uses 33, 33, and 34% (fig. 13) to mean an even split. However, insofar as this is not explicitly disclosed, claim 1 is alternatively rejected under 35 U.S.C. 103, as follows:
It would have been obvious to one of ordinary skill in the art to provide evenly fractionalized across the anodes or electrodes with the percentages being within 1% as taught by Rao, and further disclosed by the Applicant, as evenly fractionalizing energy across an odd number of electrodes would provide slight variation in the amount of energy being sent to the electrodes.
In re claim 2, Rao discloses wherein *four preset programs [0060] are implemented to test each of the plurality of electrodes with the equal amounts of cathodic energy (Fig 8a, 9a, and 10a; [0060]; four combinations are shown, however only three combinations of electrodes are shown being test with equal amounts of cathodic energy)
However, insofar as the limitation regarding “four” is not explicitly disclosed, it would be obvious to one of ordinary skill in the art to modify which electrodes are being tested with equal amounts of cathodic energy while testing different electrode combinations, which would yield each of the four preset programs testing each of the plurality of electrodes, because doing so helps determine which electrodes provide the best neuromodulation energy to the user.
In re claim 3, Rao discloses wherein
the at least one lead includes eight electrodes [0043], and
the active electrodes in each of the four preset programs include two cathodic electrodes where 50% of the total cathodic contribution for the neuromodulation energy is provided using each of the cathodic electrodes (fig 10a, [0081]; see In re claim 2 above),
each of the four preset programs including different cathodic electrodes than the other ones of the four preset programs ([0060]; see In re claim 2 above).
In re claim 4, regarding the limitations, “wherein the four preset programs include:
a first program configured to test electrode 1 and electrode 2 with 50% of the total cathodic contribution for the neuromodulation energy;
a second program configured to test electrode 3 and electrode 4 with 50% of the total cathodic contribution for the neuromodulation energy;
a third program configured to test electrode 5 and electrode 6 with 50% of the total cathodic contribution for the neuromodulation energy; and
a fourth program configured to test electrode 7 and electrode 8 with 50% of the total cathodic contribution for the neuromodulation energy,”
for substantially the same reasons as discussed In re claim 2 above.
It would have been obvious to one of ordinary skill in the art at the time the instant invention was filed to yield the above recited limitations because Rao discloses the amount of fractionalized energy or total contribution as being changeable based on different electrode combinations and feedback (fig 8a, fig 9a, and fig 10a, [0071]).
Additionally, it also would have been obvious to one of ordinary skill in the art at the time the instant invention was filed because you can test different electrode configurations, amount of total contribution or fractionalizations to each cathode or anode, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum features or workable ranges involves only routine skill in the art. One having ordinary skill in the art would know to optimize the electrode combinations and amount of energy fractionalized or contributed for the cathodes and anodes. In re Aller, 105 USPQ 233.
In re claim 5, regarding the limitation “wherein:
the first program is configured to fractionalize 50% of the total anodic contribution to each of electrode 7 and electrode 8;
the second program is configured to fractionalize 50% of the total anodic contribution to each of electrode 7 and electrode 8;
the third program is configured to fractionalize 50% of the total anodic contribution to each of electrode 1 and electrode 2; and
the fourth program is configured to fractionalize 50% of the total anodic contribution to each of electrode 1 and electrode 2,”
see In re claim 4 above for substantially the same reasons.
In re claim 6, regarding the limitations, “wherein:
the first program is configured to fractionalize about 1/3 of the total anodic contribution to each of electrode 6, electrode 7 and electrode 8;
the second program is configured to fractionalize 25% of the total anodic contribution to each of electrode 1, electrode 6, electrode 7 and electrode 8;
the third program is configured to fractionalize 25% of the total anodic contribution to each of electrode 1, electrode 2, electrode 3 and electrode 8; and
the fourth program is configured to fractionalize about 1/3 of the total anodic contribution to each of electrode 1, electrode 2 and electrode 3,”
see In re claim 4 above for substantially the same reasons.
In re claim 7, regarding the limitations “wherein at least one of the four programs has two anodic electrodes wherein 50% of the total anodic contribution for the neuromodulation energy is provided using each of the two anodic electrodes,”
see In re claim 5 above for substantially the same reasons.
In re claim 8, regarding the limitations, “wherein at least one of the four programs has three anodic electrodes, wherein:
about 1/3 of the total anodic contribution for the neuromodulation energy is provided using each of the three anodic electrodes,”
see In re claim 6 above for substantially the same reasons.
In re claim 9, regarding the limitations “wherein at least one of the four programs has four anodic electrodes, wherein 25% of the total anodic contribution for the neuromodulation energy is provided using each of the four anodic electrodes,”
see In re claim 6 above for substantially the same reasons.
In re claim 15, Rao discloses wherein the at least two preset programs are implemented one preset program at a time [0060].
In re claim 17, see above (In re claim 1).
Rao also discloses:
a non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to perform a method [0018]
In re claim 18, see above (In re claim 1).
Rao also discloses:
A system, comprising:
a neural stimulator connected to at least one lead having a plurality of electrodes [0017],
wherein the neural stimulator is configured to store at least two preset programs [0055, 0060]
In re claim 19, see above (In re claim 2 and In re claim 3).
Rao also discloses wherein: the neural stimulator is configured to store four preset programs [0060]
In re claim 20, see above (In re claim 4).
Claim Rejections - 35 USC § 103
Claims 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rao et al. (US 2019/0148009) in view of Kothandaraman (US 2011/0257707).
In re claim 10, Rao discloses wherein:
the plurality of electrodes includes NT electrodes [0037];
the at least one lead is (fig 3: 26):
one percutaneous lead with the NT electrodes on the one percutaneous lead (fig 3: 26, [0037]);
two or more percutaneous leads with the NT electrodes equally distributed among the two or more percutaneous leads such that each of the two or more percutaneous leads have an equal number of electrodes (fig 3, [0037]); or
a paddle lead with the NT electrodes arranged in rows and columns on the paddle lead [0037];
Rao lacks wherein
the active electrodes include NC cathodic electrodes, where NC is NT /4; and
the total cathodic contribution for the neuromodulation energy is evenly fractionalized across each of the NC cathodic electrodes to deliver fractionalized cathodic energy FC to each of the NC cathodic electrodes,
wherein FC = -100 / NC
Kothandaraman teaches a neurostimulation system that allows the user to start with a stimulation parameter set and switch to a different stimulation parameter set (abstract). Kothandaraman also teaches wherein one percutaneous lead has eight electrodes, two of which are cathodes and two of which are anodes (fig 9). The total contribution is evenly fractionalized across the two cathodes where the fractionalized cathodic energy is negative 50, and evenly fractionalized across the two anodes where the fractionalized anodic energy is positive 50 (fig 9).
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Rao by using an electrode configuration as taught by Kothandaraman wherein one of the eight electrode percutaneous leads has all of the fractionalized cathodic energy going to NC electrodes because doing so would satisfy the above equations such that both cathodic electrodes are located on one lead and have 50% of the fractionalized energy delivered to them.
In re claim 11, Kothandaraman discloses wherein the active electrodes include NA anodic electrodes, wherein NA depends on a maximum cathodic electrode to anodic electrode spacing S corresponding to a number of electrodes that are not one of the NA anodic electrodes or one of the NC cathodic electrodes, where S = NT– (NA + NC) (fig 9; S is equal to four inactive electrodes when there are two anodic and two cathodic electrodes on one eight electrode lead).
In re claim 12, Kothandaraman discloses wherein NA, NC and S are adjustable via user input (fig 8, fig 9; [0060]).
In re claim 13, Kothandaraman discloses wherein NA = NC when S is NT /2 (fig 9, as seen In re claim 11 above).
In re claim 14, regarding the limitation “wherein NA = NC + (NT/2-S) when S is less than NT/2,” it would have been obvious at the time the instant invention was filed that more than two anodes would need to be fractionalized on one lead, as seen in Rao (fig 8a: right lead), while two cathodes were fractionalized evenly on one lead, as seen by Kothandaraman (fig 9) because doing so yields results that satisfy the above equation.
Additionally, it would have been obvious to one of ordinary skill in the art at the time the instant invention was filed because different electrodes configurations and fractionalizations could be tested on one or two leads, to calculate the number of anodic electrodes there would be if there were less inactive electrodes. One having ordinary skill in the art would know to optimize for different anodic and cathodic electrode configurations on one lead. In re Aller, 105 USPQ 233.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Rao et al. (US 2019/0148009) in view of Polefko et al. (US 8,781,592).
In re claim 16, Rao lacks:
wherein at least two of the at least two preset programs are concurrently implemented.
Polefko teaches a spinal cord stimulation system wherein the electrode lead has multiple channels and when more than one channel is available, each channel can be programmed to provide its own stimulation to its configured electrodes (col 4, ln 27-36).
It would be obvious to one of ordinary skill at the time the instant invention was filed to modify the system of Rao with the ability to stimulate multiple different electrode configurations at the same time as taught by Polefko, as running multiple configurations at once would cover more tissue area.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Moffitt et al. (US 2010/0057162) discloses a neurostimulation system that uses a paddle lead comprising a plurality of electrodes with spacing between the columns of electrodes to optimize spacing between the anodes and cathodes (abstract, [0012]). Moffitt also discloses electrode configurations wherein the current can be evenly fractionalized between the cathodes and anodes (fig 10a).
Woods et al. (US 2005/0245987) teaches a method for selecting spinal cord stimulation (SCS) stimulation parameter sets initially testing four stimulation sets to find the highest ranked. Then, the clinician uses a steering table to identify other optimal stimulation parameters (abstract).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796