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
Claims 34, 35, 46 and 47 are objected to because of the following informalities: The phrase “wherein measurement electrode” should be “wherein the measurement electrode” as the measurement electrode as already been claimed in the independent claims. Appropriate correction is required.
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.
(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.
Claim(s) 30-40 and 42-52 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by O’Connell et al. (Pub. No.: US 2016/0220821 A1); hereinafter referred to as “O’Connell”.
Regarding claims 30 and 42, O’Connell discloses a closed-loop method (e.g. see [0168]) for treating a neuropsychiatric disorder (e.g. see [0080]) in a subject, the method comprising: i. positioning one or more stimulation electrodes at Brodmann Area 11, Brodmann Area 47, or a combination thereof of orbitofrontal cortex region of brain of the subject (e.g. see [0047], [0105]. Note: Both Brodmann Areas are disclosed and “and combinations thereof”); ii. positioning a measurement electrode at a secondary area of the brain of the subject (e.g. see [0167], “Stimulation element 150 can comprise one or more deep brain stimulation electrodes, such as electrodes model 3387 produced by Medtronic of Minneapolis, Minn. These electrodes can be bilaterally implanted such that the tips of the electrodes are positioned in a region where cells can be recorded during micro-recording mapping”. Note: The bilateral electrodes will be at separate locations and are also used for sensing in addition to stimulation); iii. applying electrical stimulation (e.g. see figure 3 steps 541, 542, [0159]-[0160]) only to Brodmann Area 11, Brodmann Area 47, or a combination thereof (e.g. see [0047], [0105]) via the one or more stimulation electrodes (e.g. see [0049], [0167]) in a manner effective to treat the neuropsychiatric disorder; iv. receiving an electrical signal from the secondary area of the brain (e.g. see [0167], “These electrodes can be bilaterally implanted such that the tips of the electrodes are positioned in a region where cells can be recorded during micro-recording mapping”) of the subject via the measurement electrode (e.g. see figure 3 step 543, [0159], “In STEP 543, diagnostic data 305 is gathered with one or more diagnostic tools (e.g. diagnostic data 305 gathered by diagnostic tool 300 of FIG. 1) during stimulation with the test stimulation parameters 106”); V. applying electrical signal metrics to a control algorithm that is tuned to a clinically relevant target (e.g. see [0089], [0168]); vi. modulating one or more programmed stimulation parameters according to the algorithm's control law (e.g. see [0089], [0168]); and vii applying the modulated electrical stimulation only to Brodmann Area 11, Brodmann Area 47, or a combination thereof via the one or more stimulation electrodes in a manner effective to treat the neuropsychiatric disorder (e.g. see figure 3 step 550, [0163], [0168]).
Regarding claims 31 and 43, O’Connell discloses the secondary area of the brain comprises locations within OFC (e.g. see [0047], [0105]), insula (e.g. see [0047], [0105]), dorsal cingulate (e.g. see [0047], [0105]), subgenual cingulate (e.g. see [0047], [0105]), dorsal cingulate (e.g. see [0047], [0105]), amygdala (e.g. see [0047], [0105]) and/or hippocampus (e.g. see [0047], [0105]) (Note: [0167] discloses the same electrodes are used for stimulation and sensing).
Regarding claims 32 and 44, O’Connell discloses the one or more stimulation electrodes are brain-penetrating electrodes (e.g. see [0147]).
Regarding claims 33 and 45, O’Connell discloses the the one or more stimulation electrodes are non-brain penetrating electrodes (e.g. see [0148]).
Regarding claims 34 and 46, O’Connell discloses the measurement electrode is a brain-penetrating electrode (e.g. see [0143]).
Regarding claims 35 and 47, O’Connell discloses the measurement electrode is a non-brain penetrating electrode (e.g. see [0143]).
Regarding claims 36 and 48, O’Connell discloses the method comprises applying electrical stimulation to Brodmann Area 11 (e.g. see [0047], [0105]. Note: Both Brodmann Areas are disclosed and “and combinations thereof”).
Regarding claims 37 and 49, O’Connell discloses the method comprises applying electrical stimulation to Brodmann Area 47 (e.g. see [0047], [0105]. Note: Both Brodmann Areas are disclosed and “and combinations thereof”).
Regarding claims 38 and 50, O’Connell discloses the method comprises applying electrical stimulation to Brodmann Area 11 and Brodmann Area 47 (e.g. see [0047], [0105]. Note: Both Brodmann Areas are disclosed and “and combinations thereof”).
Regarding claims 39 and 51, O’Connell discloses the neuropsychiatric disorder comprises depression, wherein applying the electrical stimulation treats depression (e.g. see [0080]).
Regarding claims 40 and 52, O’Connell discloses the neuropsychiatric disorder comprises anxiety, wherein applying the electrical stimulation treats anxiety (e.g. see [0150]. “Alternatively or additionally, the repositioning can be based on minimizing a neurological condition of the patient, such as a level of one or more of: paranoia; psychosis; anxiety; depression; and confusion”).
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.
Claim(s) 41 and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connell as applied to claim 30 above, and further in view of Lozano (Pub. No.: US 2010/0057159 A1).
Regarding claims 41 and 53, O’Connell teaches it is known to treat depression (see the rejection for claim 39) and anxiety (see the rejection for claim 40) but is silent as to the neuropsychiatric disorder is Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Post-Traumatic Stress Disorder (PTSD), Addiction, Anorexia, Obsessive-Compulsive Disorder (OCD), or Bipolar Disorder (BD), or chronic pain. Lozano teaches it is known to treat Major Depressive Disorder (MDD) (e.g. see [0050]), Generalized Anxiety Disorder (GAD) (e.g. see [0050], [0052], [0055]), Post-Traumatic Stress Disorder (PTSD) (e.g. see [0050]), Addiction (e.g. see [(0051]), Anorexia (e.g. see [0050]), Obsessive- Compulsive Disorder (OCD) (e.g. see [0047]), or Bipolar Disorder (BD) (e.g. see [0050]) or chronic pain (e.g. see [0004)) to improve targeting areas of the brain or optimize stimulation parameters for neurostimulation to treat neurological disorders or diseases, such as mood and/or anxiety disorders (e.g. see [0032]) and thus provide improvement or alleviation or providing remission of depression and/or anxiety or improvement in cognition and/or memory in the treated subjects (e.g. see [0058]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to treat the specific disorders as taught by Lozano in the method of O’Connell, since said modification would provide the predictable results of improving targeting areas of the brain or optimize stimulation parameters for neurostimulation to treat neurological disorders or diseases, such as mood and/or anxiety disorders (e.g. see [0032]) and thus provide improvement or alleviation or providing remission of depression and/or anxiety or improvement in cognition and/or memory in the treated subjects (e.g. see [0058]).
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792