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 Objections
Claim 19-20, 23-24, 27-28, and 32 is/are objected to because of the following informalities:
In Claim 19, 24, and 28, “lateral from the brain midline” should read “lateral from a brain midline” as it is the first recitation of this limitation in the claim.
In Claim 20 and 23, “a brain” should read “the brain”, since the claims depends on claim 19 which already recites "brain”.
In Claim 32, “a brain” should read “the brain”, since the claims depends on claim 28 which already recites "brain”.
In Claim 27, “the patient” should read “a patient”, as it is the first recitation.
Appropriate correction is 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.
Claim 20 and 29 is/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. The claims recite, “acquiring a first image … from one of the first imaging system and a second imaging system …”, it is unclear because of the phrase “one of” as ordinarily it would be a selection from a plurality of alternatives. However, the claim use “and” between the two imaging systems, thereof it is unclear whether the second image acquired from first imaging system, second imaging system, or both. Such that the scope of the claim is indefinite.
Claim 23 and 32 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. The claims recite, “acquiring an image, representing a structure of a brain of the patient, that includes the target region from an imaging system;”. It is unclear as to whether the recited “image” is intended to be the same image previously acquired in another embodiment of the claimed subject matter, or a separate image acquired. Accordingly, the scope of the claim is unclear.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 19-23 and 28-32 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18-21 of U.S. Patent No. 12678638. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the patented claims primarily present the same scope of subject matter.
There was nothing precluding the method claims from being filed in the same application as the patented method, the instant claims are of the same scope or are at most an obvious modification thereof. The only substantive deviation from the claimed subject matter is that the instant claims recite a broader embodiment of the claimed invention recited. Although the claims are not identical, the differences in the instant claims recites a broader embodiment and are anticipated by the claims of the patented claims.
Claim 24-27 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12-15 of U.S. Patent No. 12678638. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the patented claims primarily present the same scope of subject matter.
There was nothing precluding the system claims from being filed in the same application as the patented system, the instant claims are of the same scope or are at most an obvious modification thereof. The only substantive deviation from the claimed subject matter is that the instant claims recite a broader embodiment of the claimed invention recited. Although the claims are not identical, the differences in the instant claims recites a broader embodiment and are anticipated by the claims of the patented claims.
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.
Claim(s) 19-20, 23-24, 28-29, and 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20220110694 A1 to Williams et al. (hereinafter “Williams”) in view of US 20080288018 A1 to Rezai et al. (hereinafter “Rezai”).
Regarding Claim 19, 24, and 28, Williams disclose a systems and methods of improving neuropsychiatric function in a patient (see Abstract, Para 02) comprising:
selecting a volume of influence having a center point within a target region (see Para 59: “target parcel is then selected (370) from the group of candidate parcels based on the target scores … the center for the target parcel is extracted (380) in order to more precisely determine TMS coil alignment”, Fig. 3) comprising the nucleus accumbens and the ventral internal capsule (see Para 40, 57) that is between seven millimeters (mm) to twelve mm lateral from the brain midline, between one mm to six mm anterior to the anterior commissure (AC), and between two mm above to two mm below the AC; and
delivering neuromodulation to the selected volume of influence (see Para 27-29: “apply transcranial magnetic stimulation to the target parcel using the transcranial magnetic stimulation device and/or neuronavigation device in order to treat major depressive disorder”).
Williams disclose the targeted structure is dorsolateral prefrontal cortex (DLPFC) for major depressive disorder, and suggest that there may even be other regions in the brain that would provide better stimulation targets for the patient. However, it fails to explicitly disclose the target region comprising the nucleus accumbens and the ventral internal capsule that is between seven millimeters (mm) to twelve mm lateral from the brain midline, between one mm to six mm anterior to the anterior commissure (AC), and between two mm above to two mm below the AC.
However, Rezai, disclose a methods of improving neuropsychological function in a patient having a neurocognitive disorder (see Abstract, Para 5-6), a target region comprising the nucleus accumbens and the ventral internal capsule (see Para 25: “positioning a delivery device in a target site of a ventral capsule/ventral striatum region of the brain … the ventral striatum (which includes nucleus accumbens)”, and Para 28-30) that is between seven millimeters (mm) to twelve mm lateral from the brain midline (see Para 25: “X--3 mm to 13 mm from the midline (medial lateral stereotactic region)”, between one mm to six mm anterior to the anterior commissure (AC), and between two mm above to two mm below the AC (see Para 25: “Y--5 mm behind AC to 10 mm in front of AC (Anterior-posterior stereotactic region) Z--13 mm above the AC-PC line to 7 mm below the AC-PC line (dorsal/ventral steretoactic region)”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed system and method of Williams by using the targeted region disclose by Rezai in order to predictably substitute one known target region for another for improved stimulation as suggested by Williams, thereby improving neuropsychiatric function in a patient with reasonable expectation of success. See MPEP 2143 and 2144.05.
Regarding Claim 20 and 29, Williams further teaches the modified method of claim above, wherein selecting the volume of influence comprises:
acquiring a first image, representing a structure of a brain of the patient, from a first imaging system (see Para 05: “Systems and methods for targeted neuromodulation … a structural magnetic resonance imaging (sMRI) scan”, and Para 53);
acquiring a second image, representing a connectivity of the brain, from one of the first imaging system and a second imaging system (see Para 05: “at least one functional magnetic resonance imaging (fMRI) scan of a patient's brain”, and Para 45: “the fMRI machine is capable of obtaining both structural and functional MRI images of a patient”);
determining a first utility value associated with directly modulating tissue within a region of interest for each of a plurality of voxels within the region of interest from the first image (see Para 05, 11-12, 16, 27-29; determination of a region of interest; quantify candidate parcel for direct stimulation; and Para 53-56: “a target identification process for generating an individualized stimulation target for a patient … other factors contribute to the score including (but not limited to) parcel depth, other functions of the parcel and/or surrounding brain structures, size, shape, and homogeneity of the parcel”);
determining a second utility value associated with indirectly modulating tissue outside of the region of interest by modulating tissue within the region of interest for each of the plurality of voxels from the second image (see Fig. 3, and Para 05, 11-12, 16, 27-29, and 54-56; determine of regions indirectly impacted (reference ROI) and how the connectivity in the brain needs to be taken into account; functional connectivity between two parcels is measured to quantify the impact from connectivity; element 350; extract relationship between candidate and reference which is the utility value associated of indirectly modulating tissue and modulating tissue);
determining an overall utility value for each of the plurality of voxels from at least the first utility value and the second utility value (see Fig. 3, and Para 05, 11-12, 16, 27-29, and 54-58: “a weighted average of the network connectivity scores for different networks can be used as an overall network connectivity score, where the weights are based on the relevance of particular networks to a condition at issue. In various embodiments, the functional connectivities are calculated on a per-voxel basis and averaged to get an overall parcel score”); and
determining the volume of influence from the overall utility value for each of the plurality of voxels (see Para 05, 59: “An individualized target parcel is then selected (370) … scored candidate parcel is selected” and Fig. 3-6).
Regarding Claim 23 and 32, Williams further teaches the modified method of claim above, wherein selecting the volume of influence comprises:
acquiring an image, representing a structure of a brain of the patient, that includes the target region from an imaging system (see Para 05: “a targeted neuronavigation system … a structural magnetic resonance imaging (sMRI) …”, and Para 16, 27, 29, 45);
determining a utility value for each of a plurality of voxels within the target region (see Para 53-56: “a target identification process for generating an individualized stimulation target for a patient … other factors contribute to the score including (but not limited to) parcel depth, other functions of the parcel and/or surrounding brain structures, size, shape, and homogeneity of the parcel”);
determining the volume of influence from the utility value for each of the plurality of voxels (see 54-59: “a weighted average of the network connectivity scores for different networks can be used as an overall network connectivity score, where the weights are based on the relevance of particular networks to a condition at issue. In various embodiments, the functional connectivities are calculated on a per-voxel basis and averaged to get an overall parcel score … individualized target parcel is then selected (370) from the group of candidate parcels based on the target scores”).
Regarding Claim 33 and 34, Rezai further teaches the modified method of claim above, wherein improving neuropsychiatric function comprises improving a psychiatric disorder or a neuropsychiatric disorder, an eating disorder (see Para 06: “present invention is directed to improving neuropsychological function in a patient suffering from a neurocognitive disorder … patient suffering from a psychiatric disorder or from improving neuropsychological behavior per se (i.e. in a patient not suffering from a neurocognitive disorder”, Para 22: “metabolic disorders”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed system and method of Williams in order to apply neuromodulation to improve psychiatric disorder or a neuropsychiatric disorder, including eating disorder. This would allow known neuromodulation technique to be used for treating a broader range of neuropsychiatric conditions with reasonable expectations of therapeutic benefit.
Claims 21, 25-26, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Rezai as applied to claim 19, 24, and 28 above, and further in view of WO 2013172981 A1 to Pascual-Leone et al. (hereinafter “Pascual-Leone”).
Regarding Claim 21, 25-26, and 30, Williams in view of Rezai teach the modified method and system as discussed above, but fails to specifically disclose delivering focused ultrasound. Rezai disclose delivering neuromodulation to the selected volume of influence comprises delivering focused ultrasound to the selected volume of influence ( see Para 45: “other modes of neuromodulation can be used such as light, magnetism, sound, pressure, and heat/cold”), where sound modality is disclosed but not specifically focused ultrasound.
Another reference, Pascual-Leone, disclose a method for identifying individual target sites for application of transcranial magnetic stimulation (TMS) to the patient's brain for treatment of depression and other disorders (see Summary), wherein delivering neuromodulation to the selected volume of influence comprises delivering focused ultrasound to the selected volume of influence ( see attached Doc: “additionally or alternatively to fMRI … brain stimulation techniques other than TMS may be used … focused ultrasound”), wherein the neuromodulation system is a deep brain stimulation system, focused neuromodulation system (see attached Doc: “brain stimulation techniques other than TMS may be used … focused ultrasound, … , deep brain stimulation …).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to apply focused ultrasound neuromodulation disclose by Pascual-Leone and motivated to modify the disclosed system and method of Williams in order to provide more precise and localized delivery of the sound energy to the selected volume (deep brain) of influence, thereby improving targeting while achieving expected effect.
Claims 22, 27, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Rezai as applied to claim 19, 24, and 28 above, and further in view of WO 2015073411 A1 to Moffitt et al. (hereinafter “Moffitt”).
Regarding Claim 22, 27, and 31, Williams in view of Rezai teach the modified method and system as discussed above. Rezai further teaches, wherein the volume of influence is a first volume of influence (see Para 36: “an activation signal is applied to a ventral striatum/ventral capsule region target site … in response to a detected bodily activity”), the method further comprising:
measuring feedback comprising one of a physiological parameter, a cognitive parameter, a psychosocial parameter, a behavioral parameter of the patient (see Para 36-37: “Non-limiting examples of suitable bodily activities include, for example, respiratory function … cognitive function, and any of the other neuropsychological functions described above …”);
determining an effectiveness of the neuromodulation according to the measured feedback (see Para 36: “detected bodily activity associated with the neuropsychological function … bodily activity of the body associated with the neuropsychological function being improved to produce a sensor signal …”).
However, the combination fails to disclose selecting a second volume of influence having a center point within the target region if the effectiveness of the neuromodulation fails to meet a threshold value.
Another reference, Moffitt, disclose a system and method system and method (see Abstract), where system is configured for the stimulation to be performed either in an open-loop mode or a closed-loop mode (see Para 14), selecting a second volume of influence having a center point within the target region if the effectiveness of the neuromodulation fails to meet a threshold value (see Para 71: “the system provides … evaluate stimulation paradigms (via evoked responses sensed by the system), search the stimulation parameter space … tries new paradigms and parameters until the system achieves or gets close to the input goal …”, and Para 16, 87).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to apply closed loop threshold based techniques disclosed by Moffitt and modify the disclosed system and method of Williams in order to combine known element for predictable results, thereby improve treatment effectiveness by permitting stimulation target to be modified.
Conclusion
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/I.J./ Examiner, Art Unit 3792
/JOHN R DOWNEY/ Primary Examiner, Art Unit 3792
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