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 12 is 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.
Regarding claim 12, it recites the limitation, “the delivery of electromagnetic radiation”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 5-10, 15, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simon et al. (US 20130310909 A1) (hereon referred as Simon).
Regarding claim 1, Simon teaches an apparatus for promoting recovery after an acute injury to the central nervous system in a subject (“treating various central nervous system disorders…traumatic brain injury”, paragraph [0074]) comprising:
At least one array of at least one effector in proximity to a lesion (“induced electrical current…towards the surface of the patient’s skin…array of electric field”, paragraph [0125]) in the central nervous system of a subject, wherein the array is configured to generate electrical or magnetic fields in the lesion promptly after acute injury and stimulate neurons or nerves (“electrical impulses are applied through the electrodes of the stimulation device to one or more selected nerves”, paragraph [0062]) in the central nervous system either within the lesion or connected to the lesion via neuronal pathways.
Regarding claims 2 and 3, Simon teaches the effector being an electropermanent magnet and/or an electrode (“electrodes or magnetic stimulator coil…produce an electric current and/or an electric field within the patient”, paragraph [0021]).
Regarding claim 5, Simon teaches the array defining an extent and magnitude of delivery of electromagnetic fields to the lesion (“shape an elongated electric field…given depth of stimulation in the patient…a field in which the magnitude of the field in some direction may exhibit more than one spatial maximum”, paragraph [0124]).
Regarding claim 6, Simon teaches the lesion being in the brain (“electrical stimulation of a vagus nerve…activation of brainstem and brain functions”, paragraph [0058]).
Regarding claim 7, Simon teaches a method for promoting recovery after an acute injury to the central nervous system (“treating various central nervous system disorders…traumatic brain injury”, paragraph [0074]) in a subject comprising:
Generating an electromagnetic field in a lesion via an apparatus with an array of at least one effector (“induced electrical current…towards the surface of the patient’s skin…array of electric field”, paragraph [0125]) promptly after the acute injury to stimulate neurons or nerves (“electrical impulses are applied through the electrodes of the stimulation device to one or more selected nerves”, paragraph [0062]) in the central nervous system either within the lesion or connected to the lesion via neuronal pathways.
Regarding claims 8-10, Simon teaches the electromagnetic field being applied within one hour, within four hours, or within 72 hours after the acute injury (“for an acute treatment…therapy may consist of…treatment at the onset of symptoms…treatment every hour”, paragraph [0014]).
Regarding claim 15, Simon teaches the apparatus delivering electromagnetic fields to deep lesions (“stimulator comprises a source of electrical power…configured to stimulate a deep nerve”, paragraph [0019]).
Regarding claim 17, Simon teaches the injury being vascular (“electrical energy is applied in a patient to a target region within or around the carotid sheath…called the carotid neurovascular bundle”, paragraph [0053]).
Regarding claim 18, Simon teaches the injury being traumatic (“to treat a wide range of central nervous system disorders including…traumatic brain injury”, paragraph [0074]).
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 4, 12, 13, and 16 are rejected under 35 U.S.C. 103 as being obvious over Simon in view of Weinberg (US 20170128738 A1).
Regarding claim 4, Simon teaches all the limitations of claim 1, but does not teach the array being configured to create an image of the lesion.
However, Weinberg teaches an apparatus for promoting recovery after an acute injury to the central nervous system (“magnetizable particles could be introduced into the central nervous system”, paragraph [0012]) comprising at least one array that is configured to create an image of the lesion (“one or more particles are used to visualize the subject’s underlying anatomy…using fast magnetic pulse sequences produced by the at least one coil…may employ MRI or magnetic particle imaging methods”, paragraph [0020]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the apparatus of Simon with Weinberg and configure at least one array to create an image of the lesion in order to help visualize the area and assist in the diagnosis of the acute injury.
Regarding claim 12, Simon teaches all the limitations of claim 7, but does not teach an image of the lesion being collected by the apparatus being used in planning the delivery of electromagnetic radiation to the lesion.
However, Weinberg teaches a method of an image of the lesion being collected by the apparatus being used in planning the delivery of electromagnetic fields to the lesion (“images of the subject’s anatomy including the at least one cell may be obtained using magnetic resonance imaging techniques and a location of the at least one magnetizable particle may be superimposed on an image of the subject’s anatomy”, paragraph [0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Simon with Weinberg and use an image of the lesion to plan the delivery of electromagnetic fields in order to visualize the delivery of electromagnetic treatment onto the lesion and accurately treat the targeted region.
Regarding claim 13, Simon teaches all the limitations of claim 7, but does not teach the apparatus being used in assessing the delivery of electromagnetic fields to the lesion.
However, Weinberg teaches the apparatus being used in assessing the delivery of electromagnetic fields to the lesion (“the effect of this stimulation may be measured via MRI techniques…or via optical techniques…or by observing the behavioral responses of an animal or human”, paragraph [0018]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Simon with Weinberg and assess the delivery of electromagnetic fields and ensure that the results are thoroughly assessed and evaluated.
Regarding claim 16, Simon teaches all the limitations of claim 7, but does not teach the apparatus delivering magnetic particles or other magnetically-actuated devices fields to the lesion.
However, Weinberg teaches a method of positioning magnetic particles or other magnetically-actuated devices fields to the lesion (“apparatus and method for stimulating one or more cells within a subject’s brain by one or more magnetizable particles under the influence of at least one coil”, abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Simon with Weinberg and provide magnetic particles or other magnetically-actuated devices to the lesion of the subject in order to treat acute injury and stimulate neurons in the central nervous system.
Claim 11 is rejected under 35 U.S.C. 103 as being obvious over Simon in view of Wagner et al. (US 20150025421 A1) (hereon referred as Wagner).
Regarding claim 11, Simon teaches all the limitations of claim 7, but does not teach a medication being administered to the subject while the electromagnetic field is applied.
However, Wagner teaches a medication being administered to the subject while the electromagnetic field is applied (“interventions that are given in conjunction with the therapies…alter the pain medication a patient is receiving relative to the patient’s response to the tuned stimulation”, paragraph [0118]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Simon with Wagner and provide the patient medication while applying electromagnetic stimulation for treating acute injuries or pain in the patient.
Claim 14 is rejected under 35 U.S.C. 103 as being obvious over Simon in view of Sandyk et al. (US 20040181115 A1) (hereon referred as Sandyk).
Regarding claim 14, Simon teaches all the limitations of claim 7, but does not teach the apparatus being used during transport of the subject.
However, Sandyk teaches an apparatus that delivers electromagnetic fields (“patient is to be treated with electromagnetic fields”, paragraph [0032]) during transport of the subject (“device…can be transported anywhere for selective activation at the convenience of the patient”, paragraph [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Simon with Sandyk and allow for the apparatus to deliver electromagnetic fields during transport, providing the patient treatment at any given moment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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