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 § 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.
Claims 1-9 and 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea (US 2016/0089540 A1) in view of Hadlock et al (US 2019/0022383 A1, hereinafter “Hadlock”).
Regarding claims 1 and 11, Bolea discloses a neuromodulation system and method to improve sleep disordered breathing (pars 0002-0004) comprising: a processor (par 0135); and a non-transitory computer readable medium storing executable instructions executable by the processor (par 0135) to: direct delivery of a stimulating neuromodulation signal to an ansa cervicalis that stimulates activation of the ansa cervicalis innervating one or more infrahyoid muscles (pars 0167-0169, where activation of site D includes stimulation of the ansa cervicalis nerve and innervating the sternohyoid).
Bolea discloses the claimed invention as detailed above, but does not explicitly disclose direct delivery of a blocking neuromodulation signal to the ansa cervicalis that blocks activation of efferent fibers that innervate one or more suprahyoid muscles, the blocking neuromodulation signal mitigating undesirable retrograde efferent activation of the one or more suprahyoid muscles. Hadlock is analogous art in regard to known methods for electrical neurostimulation of dysfunctional nerves. Hadlock discloses it was known in the art to provide total control of a nerve including stimulation resulting in a blockade to avoid undesirable signals (par 0045). Applied to the invention of Bolea, the features of Hadlock would provide means for direct delivery of a blocking neuromodulation signal to the ansa cervicalis that blocks activation of efferent fibers that innervate one or more suprahyoid muscles, the blocking neuromodulation signal mitigating undesirable retrograde efferent activation of the one or more suprahyoid muscles as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Hadlock in the invention of Bolea, since such a modification would provide the predictable results of prevention of propagation of triggered signals and resultant discomfort as known in the art.
Regarding claims 2 and 12, Bolea discloses direct delivery of a stimulating neuromodulation signal to hypoglossal nerve that stimulates activation of a genioglossus muscle (par 0127).
Regarding claims 3 and 13, Bolea discloses the claimed invention as detailed above, but does not explicitly disclose direct delivery of a blocking neuromodulation signal to a hypoglossal nerve that blocks activation of efferent fibers that innervate a styloglossus muscle, a hyoglossus muscle, or both, the blocking neuromodulation signal mitigating undesirable efferent activation of the styloglossus muscle, the hyoglossus muscle, or both. Hadlock is analogous art in regard to known methods for electrical neurostimulation of dysfunctional nerves. Hadlock discloses it was known in the art to provide total control of a nerve including stimulation resulting in a blockade to avoid undesirable signals (par 0045). Applied to the invention of Bolea, the features of Hadlock would provide means for direct delivery of a blocking neuromodulation signal to a hypoglossal nerve that blocks activation of efferent fibers that innervate a styloglossus muscle, a hyoglossus muscle, or both, the blocking neuromodulation signal mitigating undesirable efferent activation of the styloglossus muscle, the hyoglossus muscle, or both as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Hadlock in the invention of Bolea, since such a modification would provide the predictable results of prevention of propagation of triggered signals and resultant discomfort as known in the art.
Regarding claims 4 and 14, Bolea discloses direct delivery of a stimulating neuromodulation signal to a glossopharyngeal nerve that stimulates activation of efferent fibers of the glossopharyngeal nerve (par 0171).
Regarding claims 5 and 15, Bolea discloses the claimed invention as detailed above, but does not explicitly disclose direct delivery of a blocking neuromodulation signal to a glossopharyngeal nerve that blocks activation of afferent fibers of the glossopharyngeal nerve, the blocking neuromodulation signal mitigating undesirable sensory effects. Hadlock is analogous art in regard to known methods for electrical neurostimulation of dysfunctional nerves. Hadlock discloses it was known in the art to provide total control of a nerve including stimulation resulting in a blockade to avoid undesirable signals (par 0045). Applied to the invention of Bolea, the features of Hadlock would provide means for direct delivery of a blocking neuromodulation signal to a glossopharyngeal nerve that blocks activation of afferent fibers of the glossopharyngeal nerve, the blocking neuromodulation signal mitigating undesirable sensory effects as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Hadlock in the invention of Bolea, since such a modification would provide the predictable results of prevention of propagation of triggered signals and resultant discomfort as known in the art.
Regarding claims 6 and 16, Bolea discloses direct delivery of a stimulating neuromodulation signal to a hypoglossal nerve that stimulates a genioglossus muscle (par 0162).
Bolea discloses the claimed invention as detailed above, but does not explicitly disclose direct delivery of a blocking neuromodulation signal to the hypoglossal nerve that blocks activation of efferent fibers that innervate a styloglossus muscle, a hyoglossus muscle, or both, the blocking neuromodulation signal mitigating undesirable efferent activation of the styloglossus muscle, the hyoglossus muscle, or both. Hadlock is analogous art in regard to known methods for electrical neurostimulation of dysfunctional nerves. Hadlock discloses it was known in the art to provide total control of a nerve including stimulation resulting in a blockade to avoid undesirable signals (par 0045). Applied to the invention of Bolea, the features of Hadlock would provide means for direct delivery of a blocking neuromodulation signal to the hypoglossal nerve that blocks activation of efferent fibers that innervate a styloglossus muscle, a hyoglossus muscle, or both, the blocking neuromodulation signal mitigating undesirable efferent activation of the styloglossus muscle, the hyoglossus muscle, or both as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Hadlock in the invention of Bolea, since such a modification would provide the predictable results of prevention of propagation of triggered signals and resultant discomfort as known in the art.
Regarding claims 7 and 17, Bolea discloses direct delivery of a stimulating neuromodulation signal to a glossopharyngeal nerve that stimulates activation of efferent fibers of the glossopharyngeal nerve (par 0171).
Bolea discloses the claimed invention as detailed above, but does not explicitly disclose direct delivery of a blocking neuromodulation signal to the glossopharyngeal nerve that blocks activation of afferent fibers of the glossopharyngeal nerve, the blocking neuromodulation signal mitigating undesirable sensory effects. Hadlock is analogous art in regard to known methods for electrical neurostimulation of dysfunctional nerves. Hadlock discloses it was known in the art to provide total control of a nerve including stimulation resulting in a blockade to avoid undesirable signals (par 0045). Applied to the invention of Bolea, the features of Hadlock would provide means for direct delivery of a blocking neuromodulation signal to the glossopharyngeal nerve that blocks activation of afferent fibers of the glossopharyngeal nerve, the blocking neuromodulation signal mitigating undesirable sensory effects as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Hadlock in the invention of Bolea, since such a modification would provide the predictable results of prevention of propagation of triggered signals and resultant discomfort as known in the art.
Regarding claims 8 and 18, Bolea discloses direct delivery of a stimulating neuromodulation signal to a hypoglossal nerve that stimulates activation of a genioglossus muscle (par 0161) and direct delivery of a stimulating neuromodulation signal to a glossopharyngeal nerve that stimulates activation of efferent fibers of the glossopharyngeal nerve (par 0171).
Bolea discloses the claimed invention as detailed above, but does not explicitly disclose direct delivery of a blocking neuromodulation signal to the hypoglossal nerve that blocks activation of efferent fibers that innervate a styloglossus muscle, a hyoglossus muscle, or both, the blocking neuromodulation signal mitigating undesirable efferent activation of the styloglossus muscle, the hyoglossus muscle, or both; nor direct delivery of a blocking neuromodulation signal to the glossopharyngeal nerve that blocks activation of afferent fibers of the glossopharyngeal nerve, the blocking neuromodulation signal mitigating undesirable sensory effects. Hadlock is analogous art in regard to known methods for electrical neurostimulation of dysfunctional nerves. Hadlock discloses it was known in the art to provide total control of a nerve including stimulation resulting in a blockade to avoid undesirable signals (par 0045). Applied to the invention of Bolea, the features of Hadlock would provide means for direct delivery of a blocking neuromodulation signal to the hypoglossal nerve that blocks activation of efferent fibers that innervate a styloglossus muscle, a hyoglossus muscle, or both, the blocking neuromodulation signal mitigating undesirable efferent activation of the styloglossus muscle, the hyoglossus muscle, or both; as well as direct delivery of a blocking neuromodulation signal to the glossopharyngeal nerve that blocks activation of afferent fibers of the glossopharyngeal nerve, the blocking neuromodulation signal mitigating undesirable sensory effects as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Hadlock in the invention of Bolea, since such a modification would provide the predictable results of prevention of propagation of triggered signals and resultant discomfort as known in the art.
Regarding claims 9 and 19, Bolea discloses direct delivery of a stimulating neuromodulation signal to a neural site that stimulates activation of a palatoglossus muscle, a palatopharyngeus muscle, or both (par 0171).
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Hadlock, further in view of Park et al (US 2003/0153953 A1, hereinafter “Park”).
Regarding claims 10 and 20, Bolea in view of Hadlock discloses the claimed invention (see rejection of claim 1 above), but does not explicitly disclose direct delivery of a stimulating neuromodulation signal to the phrenic nerve to stimulate activation of the diaphragm. Park is analogous art in regard to monitoring and treatment methods for obstructive sleep disorders (pars 0025-0026). Park discloses it was known in the art to direct delivery of a stimulating neuromodulation signal to the phrenic nerve to stimulate activation of the diaphragm (par 0065). Applied to the invention of Bolea in view of Hadlock, the features of Park would provide means for direct delivery of a stimulating neuromodulation signal to the phrenic nerve to stimulate activation of the diaphragm as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Park in the invention of Bolea in view of Hadlock, since such a modification would provide the predictable results of use of improved breathing via additional effective conventional means for treating obstructive sleep disorders as known in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Kent (US 2020/0069947 A1). The present disclose generally relates to systems and methods for active titration of one or more cranial or peripheral nerve stimulators to treat obstructive sleep apnea. The active titration can be accomplished in an automated fashion by a closed-loop process. The closed-loop process can be executed by a computing device that includes a non-transitory memory storing instructions and a processor to execute the instructions to perform operations. The operations can include defining initial parameters for the one or more cranial or peripheral nerve stimulators for a patient; receiving sensor data from sensors associated with the patient based on a stimulation with the one or more cranial or peripheral stimulators programmed according to the initial parameters; and adjusting the initial parameters based on the sensor data. Pars 0005, 0031, 0036, 0049 disclose known methods for stimulating the ansa cervicalis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lindsey G Wehrheim whose telephone number is (571)270-5181. The examiner can normally be reached Monday - Friday 9 a.m. - 5 p.m. EST.
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Lindsey G Wehrheim
Primary Examiner
Art Unit 3799
/LINDSEY G WEHRHEIM/Primary Examiner, Art Unit 3799
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