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 9-11 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.
Claim 9 recites the limitation "the measured position". There is insufficient antecedent basis for this limitation in the claim.
Claims 10-11 are rejected due to their dependence on indefinite claim 9.
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.
Claims 1-12, 15 and 20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Stolen et al. (PGPUB 2019/0351234).
Regarding Claims 1, 7, 8 and 20, Stolen discloses applying non-destructive electrical stimulation via a spinal cord stimulator to a patient that exhibits orthostatic intolerance during posture changes (see par. [0005, 0073]). Therefore, the patient was previously determined as having orthostatic intolerance before the implant of the device 444 and the application of stimulation via electrodes 454(Fig. 4) is to address the orthostatic intolerance issues associated with the posture changes. Specifically, Stolen discloses measuring a blood pressure demand event an controlling stimulation to address/correct the patient’s blood pressure (Abstract; par. [0073]_
In regard to Claim 2, Stolen also discloses heart rate can be used to control therapy (par. [0079]).
With regard to Claim 3, Stolen discloses changes in heart rate, such as quantified by heart rate turbulence, can also be sued to control therapy (par. [0079, 0083-0084]).
Regarding Claim 4, Stolen discloses sensing heart rate form a heart rate sensor, such as cardiac sensing electrodes (par. [0094]).
With regard to Claim 5, Stolen discloses the sensors can all be noninvasive in some embodiments (par. [0129]).
In regard to Claim 6, Stolen discloses the sensors are integrated in a wired or wireless fashion with the stimulator to control the stimulator in a closed-loop manner (par. [0129]).
With regard to Claims 9-12, Stolen discloses measuring posture and posture changes which are positional measurements and controlling therapy to treat orthostatic intolerance due to the posture/positional changes (par. [0023, 0073, 0078]).
Regarding Claim 15, Stolen discloses therapy can be delivered to a dorsal horn (par. [0039]).
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.
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.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Stolen et al. (PGPUB 2019/0351234) in view of Thakur et al. (2018/0064350).
Regarding Claim 13, Stolen discloses that the system can help a patient that has orthostatic intolerance due to posture changes but fails to disclose changing the posture of an individual using a tilt table. However, in the same field of endeavor of assessing and treating orthostatic intolerance, Thakur discloses clinical assessment of the presence or absence of orthostatic intolerance involves strapping a patient to a tilt table and monitoring the patient’s transition between supine and vertical positions (par. [0021]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Stolen reference to include utilizing a tilt table to screen for orthostatic intolerance, as taught and suggested by Thakur, for the purpose of identifying the need to provide medical intervention to a patient with a compromised baroreflex response.
In regard to Claim 14, Stolen discloses posture and measured data can be input via a user interface and wirelessly transmitted the data to another device (par. [0129, 0140]; Fig. 3).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Stolen et al. (PGPUB 2019/0351234) in view of Phillips et al. (2022/0111208). Stolen discloses applying spinal cord stimulation but fails to disclose the specific og how the lea dis implanted. However, in the same field of endeavor of regulating blood pressure with electrical stimulation, Phillips discloses longitudinally aligning an implantable electrode array along the T11-L1 vertebral levels, wherein the electrode array is bipolar (has cathodes and anodes) for the purpose of effectively regulating the blood pressure of a patient. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Stolen reference to include longitudinally implanting the electrode array and providing a bipolar array, as taught and suggested by Phillips, for the purpose of effectively regulating the blood pressure of a patient.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Stolen et al. (PGPUB 2019/0351234) in view of Park et al. (2007/0299476). Stolen discloses all of the claimed invention except for delivery of stimulation not perceptible by the patient. However, in the same field of endeavor of nerve stimulation, Park discloses applying sub-perception threshold stimulation for the purpose of providing pain free stimulation ot a user (par. [0111]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Stolen reference to include sub-perception stimulation as taught and suggested by Park, for the purpose of increasing patient comfort by providing pain free stimulation.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Stolen et al. (PGPUB 2019/0351234). Stolen discloses situation can be provided to a dorsal hprn but fails to disclose targeting two dorsal horns. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include targeting two dorsal horns instead of one, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. One having ordinary skill in the art would have a reasonable expectation of success in targeting multiple areas at once wherein each area alone is identified as being a beneficial target.
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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