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 1-24, 30, and 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea, specifically a mental process, without significantly more. The claim(s) recite(s) “mapping the patient’s brain to determine a location for DBS electrode placement by identifying fiber tracts…”and “mapping the patient’s brain to determine programming of said DBS electrode by identifying fiber tracts…”. The limitations, under broadest reasonable interpretation, cover performance of the limitation in the mind, but for the recitation of generic computer components, and/or read on analyzing an image by visual inspection by a user. In this case, “mapping the patient’s brain…by identifying fiber tracts…” can be practically performed in the mind by a user/physician viewing the image of the brain, through visual inspection. If a claim limitation under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components (i.e. a processor), then it falls within the “mental processes” grouping of abstract ideas.
Following step 2A of the two-prong analysis, these judicial exceptions are not integrated into a practical application because the claim merely provides instructions to implement an abstract idea and makes no mention of whether a generic computer (i.e. “using a computer processor”) is used to do so (See MPEP 2106.05(f)). Furthermore, the claims as written do not include elements to 1) improve the functioning of a computer (See MPEP 2105.05(a)); 2) effect a particular treatment or prophylaxis (See MPEP 2106.04(d)(2)); 3) use a particular machine (See MPEP 2106.05(b)); or 4) use the judicial exceptions in a meaningful way beyond generally linking the use to a particular technological environment (See MPEP 2106.05(h)).
Following step 2B of the two-prong analysis, the additional element(s) (i.e. receiving a brain image, processing the brain image, implanting a DBS electrode) do not amount to significantly more than the judicial exception the computer is simply the tool used to perform the abstract idea of mapping the patient brain to determine location or programming of the DBS electrode by identifying fiber tracts (See MPEP 2106.05(f)).
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 30 and 31 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.
Claims 30 and 31 include the step of “generating an electrode placement map” and “generating an electrode programming map”. Claims 30 and 31 do not define further steps on how the “electrode placement map” and “electrode programming map” is generated. The specification paragraphs [0135-0143] discloses Tractography based Electrode Placement and Programming but the claims lack clarity on how the map is generated in each claim. It is suggested claims 30 and 31 provide further clarity to this step.
Claim Objections
Claim 2 is objected to because of the following informalities: line 3 recites “implanting a DBS electrode target” and it is suggested this be modified to “implanting a DBS electrode to target”. Appropriate correction is required.
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.
Claim(s) 1-14, 16, 17, 19, 20, 23, 24, 30, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chaturvedi et al. (2016/0067495) in view of Pouratian (2014/0171779) and further in view of Charles et al. (2020/0188672).
With respect to claims 1, 2, 30, and 31, Chaturvedi et al. teach of a deep brain stimulation system, method programmed to deliver electrical stimulation therapy to a tissue site within a brain of a patient with Parkinson’s disease [0038, 0040, 0041] where the electrodes 24, 26 are implanted in a brain region such as the subthalamic nucleus of the patient [0045]. Chaturvedi et al. teach of mapping the brain to determine location for electrode placement by receiving brain image for the patient [0061] including fiber tracts from the motor area to the subthalamic nucleus and the fiber tracts from the pre-supplementary motor area to the STN of the patient [0040, 0045, 0108] and implanting the electrode to the target location [0045]. Chaturvedi et al. teach of target therapy delivery for controlling a movement disorder of the patient by targeting specific regions [0045, 0046, 0061] based on the mapping results and clinical rating scale scores and avoiding other regions of tissue within brain [0067]. Chaturvedi et al. also teach of generating electrode programming map or placement map for treatment of the patient using DBS such that the implanted electrodes will target certain parts such as the fiber tract associated with the subthalamic nucleus of the patient and avoid target voxels of the map which negatively affect the overall efficacy score based on the mapping data [0067, 0133].
With respect to claims 1, 2, 23, 24, 30, and 31, Chaturvedi et al. teach of delivering electrical stimulation to one or more tissue sites in the cortex of the brain [0040] but do not explicitly teach of the supplementary motor area. In a similar field of endeavor Pouratian teaches of method for deep brain stimulation targeting therapy with the electrode placement in supplementary motor area [0068]. It is well known in the art to avoid direct or excessive stimulation of the pre-SMA, which can lead to disruptions in planning and inhibition of voluntary actions and potentially worsening motor hesitation. The combination of the references would map the brain to determine location of DBS electrode placement and implanting the electrode to the targeted fiber tracts from the SMA area to the STN while avoiding fiber tracts from the pre-supplementary area to avoid unwanted side effects and more precise treatment or stimulation delivery to the thalamic region [Pouratian, 0068].
With respect to claims 1, 2, 30, and 31, the references do not specify early-stage Parkinson’s. In a similar field of endeavor Charles et al. teach of deep brain stimulation in early stage Parkinson’s and administering the subject subthalamic nucleus deep brain stimulation by positioning a DBS electrode in the target region and applying electrical current [0015]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Charles et al. to modify the previous references to slow disease progression at an early stage and capture the underlying state of early PD motor symptoms [Charles, 0028, 0102].
With respect to claim 3, Chaturvedi et al. in view of Pouratian in view of Charles et al. teach of treating the patient by delivering the electrical current through DBS electrode by target therapy delivery within patient continuously [0051].
With respect to claims 4-6, Chaturvedi et al. in view of Pouratian in view of Charles et al. teach of the patient being a human and therefore male or female and the therapy system may also be applied to other mammalian or non-mammalian non-human patients [0039]. Charles et al. also teach of specifically male and female subjects [0015].
With respect to claim 7, Chaturvedi et al. in view of Pouratian in view of Charles et al. teach of performing the DBS on a chronic basis [0064].
With respect to claims 8-14, Chaturvedi et al. in view of Pouratian do not explicitly teach of the PD therapy administered with the STN-DBS. Charles et al. teach of administering a second PD therapy prior to STN-DBS, same time as STN-DBS, and after STN-DBS [0019]. Charles et al. teach of the different types of PD therapy selected from levodopa, carbidopa, and others [0016, 0019]. Charles et al. teach of slowing of motor symptom progression and lower stimulation parameters resulting from STN-DBS [0017]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Charles et al. to modify the previous references to slow disease progression at an early stage and capture the underlying state of early PD motor symptoms [Charles, 0028, 0102].
With respect to claim 17, Chaturvedi et al. in view of Pouratian in view of Charles et al. teach of performing a post-operative scan of the patient’s brain [0103].
With respect to claims 16, 19, 20, Chaturvedi et al. do not explicitly teach of the supplementary motor area. In a similar field of endeavor Pouratian teaches of method for deep brain stimulation targeting therapy with the electrode placement in supplementary motor area or primary motor cortex, premotor cortex, prefrontal cortex [0024, 0025, 0041, 0068]. Pouratian teaches of patient specific tractography data collected from diffusion-weighted brain imaging [0011, 0044]. It is well known in the art to avoid direct or excessive stimulation of the pre-SMA, which can lead to disruptions in planning and inhibition of voluntary actions and potentially worsening motor hesitation. The combination of the references would map the brain to determine location of DBS electrode placement and implanting the electrode to the targeted fiber tracts from the SMA area to the STN while avoiding fiber tracts from the pre-supplementary area to avoid unwanted side effects and more precise treatment or stimulation delivery to the thalamic region [Pouratian, 0068].
Claim(s) 15, 18, 21, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chaturvedi et al. in view of Pouratian in view of Charles et al. and further in view of Koch et al. (2023/0381512). The previous references do not explicitly teach of identifying the patient-specific location of the claimed tracts from a normative connectome. In a related field of endeavor Koch et al. teach of target identification via normative or custom brain activity templates (fig. 2, 0037) and connectome data (fig. 4, 0039) to identify patient-specific location of the tracts. Koch et al. also teach of determining which contacts or segments provide the maximal stimulation [0025]. Koch et al. also teach of using the intensity of the electric field to adjust the pulse shape [0264]. Chaturvedi et al. teach of determining a field shape for the contact that provides maximal stimulation or where the processor determines the shape of the electrical field based on physical characteristics of human tissue and known physical characteristics of the electrodes [0107]. Pouratian teaches of method for deep brain stimulation targeting therapy with the electrode placement in supplementary motor area or primary motor cortex, premotor cortex, prefrontal cortex [0024, 0025, 0041, 0068]. Pouratian teaches of patient specific tractography data collected from diffusion-weighted brain imaging [0011, 0044]. It is well known in the art to avoid direct or excessive stimulation of the pre-SMA, which can lead to disruptions in planning and inhibition of voluntary actions and potentially worsening motor hesitation. The combination of the references along with the Koch reference would map the brain to determine location of DBS electrode placement and implanting the electrode to the targeted fiber tracts from the SMA area to the STN while avoiding fiber tracts from the pre-supplementary area to avoid unwanted side effects and more precise treatment or stimulation delivery to the thalamic region [Pouratian, 0068]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Koch et al. to modify the previous references to ensure optimal target location for stimulation to model which surrounding white matter tracts are being stimulated by the implanted electrodes.
Conclusion
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BR
/BAISAKHI ROY/ Primary Examiner, Art Unit 3797
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