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 .
Response to Arguments
Applicant’s amendments filed 3/26/2026 appear to overcome the objections to claims 34-35 and 46-47 and the objections are therefore withdrawn.
Applicant’s arguments and amendments filed 3/26/2026 with respect to the rejections under 35 U.S.C. § 102 are persuasive, and merit new grounds for rejection in view of Goldwasser et al. (Pub. No.: US 2014/0148872 A1).
Goldwasser teaches specific electrical stimulation targeting of Brodmann Area 11 as set forth in [0237] to provide targeting of Brodmann Area 11 of the orbitofrontal cortex, which can be advantageous for modulating executive control and decision making (e.g. see [0237]) in systems/methods for treating anxiety/stress disorders (e.g. see [0022]-[0024], [0217]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use electrical stimulation targeting of Brodmann Area 11 as taught by Goldwasser in the system/method of O’Connell, since said modification would provide the predictable results of targeting of Brodmann Area 11 of the orbitofrontal cortex, which can be advantageous for modulating executive control and decision making (e.g. see [0237]) and for treating anxiety/stress disorders (e.g. see [0022]-[0024], [0217]).
Applicant’s arguments, see pages 7-10, filed 3/26/2026, with respect to the rejection(s) of claim(s) 30-53 under O’Connell alone have been fully considered and are persuasive. In particular, the applicant’s arguments regarding undue experimentation of O’Connell are persuasive and the examiner agrees that O’Connell is not fully enabling of the newly amended claim scope alone. However, as noted above, the new grounds for rejection in view of Goldwasser illustrate that electrical stimulation of the orbitofrontal cortex (specifically Brodmann Area 11) for neuromodulation/neuropsychiatric applications is known as taught by Goldwasser and is therefore enabling when taken in combination with O’Connell. Therefore, as this rejection is brought in response to Applicant’s amendments, this rejection is made final.
Claim Objections
Claims 30 and 42 are objected to because of the following informalities: “orbitofrontal cortex region of brain” should be “orbitofrontal cortex region of the brain” or orbitofrontal cortex region of a brain”. 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) 30-40, 42-52, 102, and 103 is/are rejected under 35 U.S.C. 103 as being unpatentable over by O’Connell et al. (Pub. No.: US 2016/0220821 A1); hereinafter referred to as “O’Connell”. in view of Goldwasser et al. (Pub. No.: US 2014/0148872 A1); hereinafter referred to as “Goldwasser”.
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: 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 of orbitofrontal cortex region of brain of the subject (e.g. see [0047], [0105]. Note: Both Brodmann Areas and the orbitofrontal cortex region are disclosed and “and combinations thereof”) via one or more stimulation electrodes (e.g. see [0049], [0167]) in a manner effective to treat the neuropsychiatric disorder (e.g. see [0080]), wherein the one or more stimulation electrodes are positioned 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 and the orbitofrontal cortex region are disclosed and “and combinations thereof”); receiving an electrical signal from the secondary area of the brain (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) of the subject via a 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”) positioned at the secondary area of the brain (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); applying electrical signal metrics to a control algorithm that is tuned to a clinically relevant target (e.g. see [0089], [0168]); modulating one or more programmed stimulation parameters according to the algorithm's control law (e.g. see [0089], [0168]); and 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]).
O’Connell teaches 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 of orbitofrontal cortex region of brain of the subject (e.g. see [0047], [0105]. Note: Both Brodmann Areas and the orbitofrontal cortex region are disclosed and “and combinations thereof”) via one or more stimulation electrodes (e.g. see [0049], [0167]) in a manner effective to treat the neuropsychiatric disorder (e.g. see [0080]). Goldwasser further reinforces the specific electrical stimulation targeting of Brodmann Area 11 as set forth in [0237] to provide targeting of Brodmann Area 11 of the orbitofrontal cortex, which can be advantageous for modulating executive control and decision making (e.g. see [0237]) in systems/methods for treating anxiety/stress disorders (e.g. see [0022]-[0024], [0217]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use electrical stimulation targeting of Brodmann Area 11 as taught by Goldwasser in the system/method of O’Connell, since said modification would provide the predictable results of targeting of Brodmann Area 11 of the orbitofrontal cortex, which can be advantageous for modulating executive control and decision making (e.g. see [0237]) and for treating anxiety/stress disorders (e.g. see [0022]-[0024], [0217]).
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”).
Regarding claims 102 and 103, O’Connell discloses positioning the one or 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 and the orbitofrontal cortex region are disclosed and “and combinations thereof”); and positioning the measurement electrode at the 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).
Claim(s) 41, 53, 100 and 101, is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connell and Goldwasser as applied to claims 30 and 42 above, and further in view of Lozano (Pub. No.: US 2010/0057159 A1).
Regarding claims 41, 53, 100 and 101, 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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