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 .
Specification
The disclosure is objected to because of the following informalities:
“…A clip type setting structure 12 may have a clip structure that may clip locations like an outer ear part (e.g., earlobe and/or auricle) to provide a supporting force for arranging the setting structure 12 … “ para.[0045] needs to be corrected. A suggested correction is -- A clip type setting structure 12 may have a clip structure that may clip to locations like an outer ear part (e.g., earlobe and/or auricle) to provide a supporting force for arranging the setting structure 12 --.
Appropriate correction is required.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 7 “wherein the control module drives the coil structure for the electromagnetic stimulation when the ratio is greater than a threshold” needs to be corrected. A suggested correction is --wherein the control module drives the coil structure for the electromagnetic stimulation [[when]] based on the ratio ][[is]] being greater than a threshold-- to avoid conditional limitation recitation which would raise question as to what occurs when the condition is not met.
Claim 16 “wherein the stimulation controller drives the stimulation coil for the electromagnetic stimulation when the ratio is greater than a threshold” needs to be corrected. A suggested correction is -- wherein the stimulation controller drives the stimulation coil for the electromagnetic stimulation [[when]] based on the ratio [[is]] being greater than a threshold-- to avoid conditional limitation recitation which would raise question as to what occurs when the condition is not met.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement for the following reasons:
Please note that, USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process."). Consequently, a broad yet reasonable interpretation of each of claim 1 and claim 11 as explicitly, positively, specifically claimed encompasses migraine therapy sensing and stimulation device arranged on an ear of a subject targeting treatment of migraines in a subject or pain therapy sensing and stimulation device arranged on an ear of a subject targeting treatment of chronic pain in a subject.
Each of claim 1 and 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. More specifically, a broad yet reasonable interpretation of each of claim 1 and claim 11 as explicitly, positively, specifically claimed encompasses migraine therapy sensing and stimulation device arranged on an ear of a subject or pain therapy sensing and stimulation device arranged on an ear of a subject. However, the specification discloses sensing and stimulation device arranged on an ear of a subject configured for electromagnetic stimulation on the parasympathetic nerves in the ear to balance the stimulation of the sympathetic and parasympathetic nerves to achieve autonomic nervous system balance. Thus, each of claims 1 and 11 contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Dependent claims 2-10, 12-29 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112 first paragraph because the additional recited limitations fail to cure the 35 U.S.C. 112 first paragraph issue in their respective base claims. Consequently, dependent claims 2-10, 12-29 are also rejected under 35 U.S.C. 112 first paragraph based in their direct/indirect dependency on their respective base claims.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 recites “wherein the control module is configured to drive the coil structure for an eddy current induction measurement to an ear measurement area” which renders this claim unclear. More specifically, it is unclear as to what structure the eddy current are actually induced in i.e. is there an intermediate electrically conductive plate-like structure implicitly recited or whether blood or tissue fluid inside the ear measurement area is the biological conductor within which the eddy currents are induced by the coil. If an intermediate electrically conductive plate is being employed, than claim 1 would also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: conductive plate-like structure. Examiner suggests including implementation features and subject-matter of instant application specification as-filed [0048] to cure the notes issues.
Claim 11 recites “wherein the sensing controller is configured to drive the sensing coil for an eddy current induction measurement to an ear measurement area” which renders this claim unclear. More specifically, it is unclear as to what structure the eddy current are actually induced in i.e. is there an intermediate electrically conductive plate-like structure implicitly recited or whether blood or tissue fluid inside the ear measurement area is the biological conductor within which the eddy currents are induced by the coil. If an intermediate electrically conductive plate is being employed, than claim 11 would also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: conductive plate-like structure. Examiner suggests including implementation features and subject-matter of instant application specification as-filed [0048] to cure the notes issues.
Claim 1 recites “wherein the control module controls at least one parameter of the electromagnetic stimulation based on at least one measurement result of the eddy current induction measurement” which renders this claim unclear. More specifically, it is unclear as to in what way or implementation manner electromagnetic stimulation is based on at least one measurement result of the eddy current induction measurement i.e. impedance variation, magnetic flux variation or other values of the coil structure, and/or volume variation and/or component variation of biological tissue conductive portions inside the ear measurement area or something else. Additionally, it is unclear as to what direct/derived/indirect result of the eddy current induction measurement is being used here i.e. coil measurement impedance variation, magnetic flux variation or other values of the coil structure and/or biological tissue measurements such ear distribution variation, volume variation and/or component variation of biological tissue conductive portions inside the ear measurement area or something else. Examiner suggests including implementation features and subject-matter of instant application specification as-filed [0048] to cure the notes issues.
Claim 11 recites “wherein the stimulation controller controls at least one parameter of the electromagnetic stimulation based on at least one measurement result of the eddy current induction measurement” which renders this claim unclear. More specifically, it is unclear as to in what way or implementation manner electromagnetic stimulation is based on at least one measurement result of the eddy current induction measurement i.e. impedance variation, magnetic flux variation or other values of the coil structure, and/or volume variation and/or component variation of biological tissue conductive portions inside the ear measurement area or something else. Additionally, it is unclear as to what direct/derived/indirect result of the eddy current induction measurement is being used here i.e. coil measurement impedance variation, magnetic flux variation or other values of the coil structure and/or biological tissue measurements such ear distribution variation, volume variation and/or component variation of biological tissue conductive portions inside the ear measurement area or something else. Examiner suggests including implementation features and subject-matter of instant application specification as-filed [0048] to cure the notes issues.
Claim 6 recites “a low-frequency part” and “a high-frequency part” which render this claim unclear. More specifically, it is unclear as to “a low-frequency part” and “a high-frequency part” in the context used are with respect to what reference value. Additionally, it is unclear as to the recited term “a ratio of the low-frequency part to the high-frequency part” is representative or indicator of what biologic metric or nerve function i.e. heart rate variability, stress level, sympathetic nerve function, parasympathetic nerve function, autonomic nervous system balance, autonomic nervous system balance index or something else. If mere heart rate variability, it is unclear as to how this metric relates to eddy current induction measurement and the at least one measurement result of the eddy current induction measurement.
Claim 15 recites “a low-frequency part” and “a high-frequency part” which render this claim unclear. More specifically, it is unclear as to “a low-frequency part” and “a high-frequency part” in the context used are with respect to what reference value. Additionally, it is unclear as to the recited term “a ratio of the low-frequency part to the high-frequency part” is representative or indicator of what biologic metric or nerve function i.e. heart rate variability, stress level, sympathetic nerve function, parasympathetic nerve function, autonomic nervous system balance, autonomic nervous system balance index or something else. If mere heart rate variability, it is unclear as to how this metric relates to eddy current induction measurement and the at least one measurement result of the eddy current induction measurement.
Dependent claims 2-10 and 12-19 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 2-10 and 12-19 and 14-16 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-field at least para. [0040-0042], [0047-0048], [0061].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Contingently Allowable Subject-Matter
As per independent claims 1 and 11, independent claims 1 and 11 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action in addition to overcoming any other rejections/objections enumerated above.
As per dependent claims 2-10 and 12-19, dependent claims 2-10 and 12-19 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and by further including all of the limitations of the base claims and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
As per dependent claims 2-10 and 12-19, dependent claims 2-10 and 12-19 each is being objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
The following is a statement of reasons for the indication of allowable subject matter:
As per independent Claim 1, the prior art of record fails to disclose or render obvious eat worn sensing and stimulation device arranged on an ear of a subject, comprising… setting structure combined with the coil structure… configured to position the coil structure on the ear; and a control module coupled to the coil structure…wherein the control module controls at least one parameter of the electromagnetic stimulation based on at least one measurement result of the eddy current induction measurement including all the other features, structures, specific arrangement and combination of features and structures in independent Claim 1.
As per independent Claim 11, the prior art of record fails to disclose or render obvious a sensing and stimulation device arranged on an ear of a subject, comprising: a sensing module including… a sensing controller coupled to the sensing coil, wherein the sensing controller is configured to drive the sensing coil for an eddy current induction measurement … a stimulation module including…and a stimulation controller coupled to the stimulation coil, wherein the stimulation controller is configured to drive the stimulation coil for an electromagnetic stimulation to an ear stimulation area… wherein the stimulation controller controls at least one parameter of the electromagnetic stimulation based on at least one measurement result of the eddy current induction measurement including all the other features, structures, specific arrangement and combination of features and structures in independent Claim 11.
Prior art US 20210379374 A1 to Hamner et al. discloses systems and methods of treating migraine, cephalgia, headache, and other headache conditions through noninvasive peripheral nerve stimulation. More specifically, Hamner discloses a system for treating migraine in a patient that include, or consist essentially of a peripheral nerve stimulator including a pulse generator and at least two electrodes configured to deliver electrical neuromodulation, e.g., stimulation to a nerve, acupressure point, or meridian in the patient's limb or ear. In some embodiments, the stimulation is not delivered to the patient's head, but rather on the patient's ear, lower extremity, or upper extremity. The upper extremity neuromodulation, e.g., stimulation could be in some embodiments on the upper arm, spanning the upper arm and lower arm, or only below the elbow (e.g., only on one or more of the forearm, wrist, and/or finger(s)), and the stimulation devices can be configured accordingly. The neuromodulation, e.g., stimulation can be sufficient in some embodiments to reduce one or more of throbbing cranial pain, sensory sensitivity to light, sound, and smell, nausea, and dysfunction of autonomic, cognitive, emotional, and motor systems. In some embodiments, the neuromodulation, e.g., stimulation could be therapeutic (e.g., after the start of symptoms), and/or prophylactic/preventative (e.g., when the patient is not currently experiencing any symptoms). The system can also include one, two, or more sensors. The stimulator and/or the sensor could be implantable within a patient, or wearable without any implantable components. The stimulator and/or the sensor(s) could be percutaneous or transcutaneous in some embodiments.
Prior art WO 2011011748 A1 to Burnett et al. discloses system with a conductive coil within or along housing to generate magnetic field focused on target nerve near to the coil. A sensor attachable to skin surface near to target nerve or muscle for detecting electrical conduction on nerve or muscle stimulation, where sensor is one of titanium, silver, silicon, biocompatible polymers or suture material. A controller couples with the coil and sensor facilitating coil to generate magnetic field focused on target nerve while sensor attached to skin surface to sense it.
Prior art US 20190009087 A1 to Cakmak et al. discloses stimulation device where the supplementary motor area, premotor area, cerebellum and/or subthalamic nucleus are stimulated. More specifically, stimulation system that includes an electro-stimulation device where the supplementary motor area, premotor area and/or subthalamic nucleus are stimulated extra-cranially. The stimulation device includes at least one electrode, said at least one electrode being provided with a stimulation end configured to be directly attached to intrinsic auricular muscles of a human so as to establish a direct contact relation therewith, said stimulation end being operatively coupled with a sensor.
Non-patent literature prior art Magnetic nerve stimulation by Harry A. C. Eaton discloses non-invasive magnetic nerve stimulation based on magnetic stimulators ability to generate eddy currents in tissue by producing a high-amplitude, short-duration magnetic pulse from a small coil located near the tissue.
However, patentable subject-matter as now explicitly, positively and specifically recited by the Applicants in independent device claims 1 and 11 has neither been disclosed nor is rendered obvious by the prior art of record.
Additionally, as per dependent claims 2-10 and 12-19, dependent claims 2-10 and 12-19 would be contingently allowable based on their direct/indirect dependency on contingently allowable respective base claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 20130038322 A1 to Yamamoto discloses a sensor for measuring eddy currents. More specifically, an eddy current measuring sensor including a probe which is configured as a regular triangle and is provided with an excitation unit for applying a given AC excitation signal to a workpiece and a detection unit for detecting a detection signal occurring in an object to be measured responsive to the applied AC excitation signal, wherein the excitation unit is provided with exciting coils which are arranged on each side of the probe, while the detection unit is provided with detection coils which are arranged at each vertex of the probe.
Prior art US 2019/0353618 to Jinno et al. for disclosing an eddy current flaw detecting probe includes a plurality of excitation coils which are configured to generate an eddy current in an inspection target and a plurality of detection coils which are differentially connected to each other similar to that disclosed.
Prior art US 2023/0043106 to Gao et al. for disclosing an eddy current testing system for nondestructive testing of a pipeline, which belongs to the field of nondestructive testing technology.
Prior art US 2011/0304328 to Yamamoto for disclosing an eddy current sensor that includes an excitation coil that applies a predetermined alternating-current excitation signal to a measurement target component; and a detection coil that detects a detection signal, generated by eddy current, from the measurement target component to which the alternating-current excitation signal is applied similar to that disclosed.
Prior art US 20130038322 A1 to Yamamoto for disclosing a sensor for measuring eddy currents similar to that disclosed. More specifically, eddy current measuring sensor including a probe which is configured as a regular triangle and is provided with an excitation unit for applying a given AC excitation signal to a workpiece and a detection unit for detecting a detection signal occurring in an object to be measured responsive to the applied AC excitation signal, wherein the excitation unit is provided with exciting coils which are arranged on each side of the probe, while the detection unit is provided with detection coils which are arranged at each vertex of the probe.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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