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
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) 1-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 11,931,572) in view of Hamner et al. (US 2021/0252278).
Zhang discloses a stimulation system comprising providing a first and second electrical energy source with first and second electrical fields, directing the first and second energy towards the excitable tissue at an angle from one another, and wherein the first electric field overlaps with the second electric field at the excitable tissue so as to alter a physiological function of the excitable tissue (e.g. Col. 2, line 29-45). Examiner considers the first electric field and second electric field to originate for respective first and second positions spaced from the patient since the positions must be different positions to produce the distinct fields that will overlap.
Zhang discloses the invention as claimed but discloses use of skin electrodes for applying electrical energy, and fails to teach the use of microwave energy. Hamner teaches that it is known to provide transcutaneous stimulation of a patient with any of electrical energy, mechanical energy, magnetic energy, ultrasound energy, radiofrequency energy, thermal energy, light energy (infrared or UV), and/or microwave energy. Since Hamner teaches the interchangeability of these energy delivery forms, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Zhang with trying any of the listed energy deliver forms since Hamner teaches their interchangeability and also because this represents a finite list of alternatives the selection of any of them would be obvious to try, including use of a microwave antenna since an antenna is a known and even necessary component for delivery of microwave energy. Examiner considers applicant’s newly amended claim language “produce oscillatory forces on cell membranes in the excitable tissue by means of electrostriction” to be sufficiently anticipated by the combined teachings of Zhang and Hamner because the new limitation amounts to an intended result. Examiner considers the active steps of applying the first and second overlapping microwave electric fields to necessarily produce the electrostriction and oscillatory forces on cell membranes. Examiner was unable to determine from Applicant’s specification any disclosure of specific variables or otherwise that cause the electrostriction, if Applicant believes this result is tied to a specific variable, angle, overlap etc. then applicant must claim those specifics.
With regard to claim 2, the combination of Zhang in view of Hamner teaches the invention as claimed but fails to specifically teach each of the first microwave energy and the second microwave energy is transmitted in pulse durations ranging from 1-2ms. Hamner teaches that it is known to use various pulse widths, including pulse widths up to 0.5ms and contemplates selection of pulse widths to treat different nerve fibers (e.g. paragraph 79). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse width of Zhang in view of Hamner from between 0.5ms to between 1ms and 2ms as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With regard to claims 3, the combination of Zhang in view of Hamner sets forth use of microwave energy from a first and second source for treatment, but fails to explicitly teach the specific means for applying microwave energy being an emitting field element, microwave field generator, microwave dipolar antenna, microwave patch antenna, microwave waveguide, an antenna employing dielectric matching layers to the body surface of the patient, an exposed coaxial cable, a skin contacting electrode, and a wholly tissue implanted antenna-electrode system, and the first and second positions of the wave emitting devices being spaced apart from the patient. All of the above microwave delivery sources are well known in the art and the selection of any of these well known delivery sources would be within the level of ordinary skill in the art as they all reliably deliver microwave energy to a target location of a patient in medical applications. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Zhang in view of Hamner with selection any of the above microwave devices since selecting one of the microwave delivery devices would provide the predictable results of providing reliable known techniques for delivering microwave energy for medical applications. Further the selection of an exemplary emitting field element would also be spaced apart from the patient.
With regard to claim 4, the combination of Zhang in view of Hamner sufficiently teaches that the applied therapy would microwave energy. The very fact that it is microwave energy would inherently meet the claim limitation of the frequency range being between 300MHz to 300GHz. 300MHz to 300GHz is the widely accepted microwave frequency band. Frequencies below this range fall into the radiofrequency (RF) band. Frequencies above this range fall into the infrared (IR) frequency band. Alternatively, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Zhang in view of Hamner with the first and second microwave energy being within the frequency range of 300 MHz to 300 GHz, since such a modification would provide the predictable results of using a known frequency range for providing the previously disclosed microwave energy delivery.
With regard to claim 5, Zhang discloses the invention as claimed but fails to teach the first microwave energy and the second microwave energy is tuned to a different carrier frequency. However, Hamner teaches that it is known to select either the same frequency or different frequency (e.g. paragraph 19 and 70) for providing the predictable results of targeting different tissue types and wave shaping the resultant waveform/field. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Zhang with tuning the microwave energy of the first and second microwave energies to different frequencies since such a modification would provide the predictable results of targeting different tissue types and providing for wave shaping the resultant waveform/field.
With regard to claims 6 and 8, Zhang in view of Hamner disclose the invention as claimed but fail to teach the angle between the first and second microwave energy being between 10 and 80 degrees. It would have been obvious to one having ordinary skill in the art at the time the invention was made to select an angle between 10 to 80 degrees to ensure a desired amount of coverage of the target tissue while also providing for the overlap of the electric fields to provide therapy to the target tissue.
With regard to claim 7 and 19, Zhang discloses the use of multiple electrode pairs, for example four pairs, for creating the interferential field (see Fig. 1B shows pairs 122A, 124A, 122B, 124B; see Col. 9, line 57-60). It is contemplated that the combination of Zhang in view of Hamner would maintain the number of electrode pairs and the electrode pairs would be replaced with microwave emitters. The combination would therefore result in at least four microwave emitters with associated microwave fields that overlap.
With regard to claims 9, Zhang discloses the stimulation can be applied to a spinal cord region which would include at least a spinal nerve (e.g. Col. 6, line 21-31; Fig. 1B).
With regard to claims 10-11, Zhang discloses the invention as claimed but fails to teach the microwave energy of the first and second microwave sources is pulsed at a repetition rate in the range of physiological rhythms and the alteration of the physiological function is the capture of an irregular heart rhythm similar to a pacemaker, wherein the excitable tissue is an area of an infarction in a heart and the alteration of the physiological function is physiologic change at a cellular level that increases the functionality of cardiac cells selected from the group consisting of an increase of myocardial blood flow through vasodilation, an arrest of arrhythmias, an arrest of aberrant beats or any combination. Hamner teaches that the stimulation can be timed to changes in heart rate and/or rhythm and trigger on for example tachycardia (e.g. paragraph 138). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Zhang with the microwave energy of the first and second microwave sources is pulsed at a repetition rate in the range of physiological rhythms and the alteration of the physiological function is the capture of an irregular heart rhythm similar to a pacemaker, wherein the excitable tissue is an area of an infarction in a heart and the alteration of the physiological function is physiologic change at a cellular level that increases the functionality of cardiac cells selected from the group consisting of an increase of myocardial blood flow through vasodilation, an arrest of arrhythmias, an arrest of aberrant beats or any combination since such a modification would provide the predictable results of applying the therapy modality for treating and arresting typical cardiac conditions like arrhythmias.
With regard to claim 12, the combination of Zhang in view of Hamner as applied to claim 11 above discloses the invention as claimed but fails to teach the excitable tissue is an area of an infarction in a heart and the alteration of a physiological function is an alteration leading to a reduction of ischemic tissues that might otherwise undergo necrosis selected from the group consisting of increased bioelectrical activity, improved tissue metabolism, increased blood flow and any combination. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Zhang in view of Hamner with the excitable tissue is an area of an infarction in a heart and the alteration of a physiological function is an alteration leading to a reduction of ischemic tissues that might otherwise undergo necrosis selected from the group consisting of increased bioelectrical activity, improved tissue metabolism, increased blood flow and any combination since such a modification would provide the predictable results of treating a specific cardiac condition like ischemia and since it has been shown by Zhang in view of Hamner that cardiac targeted stimulation is possible through trasncutaneously applied energy delivery.
With regard to claim 13, Examiner considers any stimulation provided in response to an arrhythmia such as tachycardia to alter the physiological function and arrest of the arrhythmia as being initiation of an action event.
With regard to claim 14, Zhang discloses providing at least one microwave source capable of producing a first microwave energy beam with a first electric field and a second microwave energy beam with a second electric field, directing the first microwave energy beam towards a nerve bundle within the patient and directing the second microwave energy beam towards the nerve bundle at an angle from the first microwave energy, wherein the first electric field overlaps with the second electric field at the nerve bundle as to provide a desired neurostimulation effect from the nerve bundle (e.g. Col. 2, line 29-45). Zhang additionally discloses the frequencies of the first and second fields can be tuned or varied such that various beat frequencies (the difference between the two (or more) frequencies) are optimized for various tissue types (e.g. paragraph 30). Zhang fails to disclose the neurostimulation is done with first and second microwave energy beams. Hamner teaches that it is known to provide transcutaneous stimulation of a patient with any of electrical energy, mechanical energy, magnetic energy, ultrasound energy, radiofrequency energy, thermal energy, light energy (infrared or UV), and/or microwave energy. Since Hamner teaches the interchangeability of these energy delivery forms, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Zhang with trying any of the listed energy deliver forms since Hamner teaches their interchangeability and also because this represents a finite list of alternatives the selection of any of them would be obvious to try. Examiner considers applicant’s newly amended claim language “produce oscillatory forces on cell membranes in the excitable tissue by means of electrostriction” to be sufficiently anticipated by the combined teachings of Zhang and Hamner because the new limitation amounts to an intended result. Examiner considers the active steps of applying the first and second overlapping microwave electric fields to necessarily produce the electrostriction and oscillatory forces on cell membranes. Examiner was unable to determine from Applicant’s specification any disclosure of specific variables or otherwise that cause the electrostriction, if Applicant believes this result is tied to a specific variable, angle, overlap etc. then applicant must claim those specifics.
With regard to claim 15-16, Zhang discloses the selective tuning of the stimulation profiles to achieve desired activity at the target site. Such tuning also includes use of frequencies in the range as small as 1-2kHz (e.g. Col. 12, line 6-63). It is noted that Applicant’s specification details the selective nature of targeting A, B, and C fibers is achieved by using lower frequency stimulation in the range of 1-50kHz. Therefore, Examiner has interpreted Zhang’s disclosure of using a stimulation profile with a frequency within that range to also include the selective ability to target different fiber types.
With regard to claim 17, Zhang discloses the concept of tuning the stimulation to have a carrier frequency and a pulse modulation frequency for the first and second energy delivery (e.g. Col. 7, line 1-17; disclosure of a carrier wave and beat frequency).
With regard to claim 18, Zhang discloses the nerve bundle is a vertebral region of a back of the patient and the neurostimulation effect is a reduction of pain (e.g. Fig. 1b shows the vertebral column of a patient, Col. 9, line 39-40; Col. 1, line 16-51).
With regard to claim 20, Zhang in view of Hamner disclose the invention as claimed but fails to teach the first, second, and third microwave energy are symmetrically disposed in a plane that contains the deep tissue. Zhang discloses that the locations of the electrode pairs is a consideration along with energy parameters like amplitude and frequency, for steering the field to a particular target tissue site. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Zhang in view of Hamner with the first, second, and third microwave energy are symmetrically disposed in a plane that contains the deep tissue since such a modification would provide the predictable results of ensuring efficacy of steering the field to the desired target tissue site.
With regard to claim 21, the combination of Zhang in view of Hamner disclose the invention as claimed but fail to teach the use of a microwave antenna spaced from the skin of the patient. Similar to claim 3, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of Zhang in view of Hamner with use of a microwave antenna spaced apart from the skin since such a modification would involve the simple substitution of one known microwave energy delivery source with another (microwave antenna) and such a simple substitution would be within the level of ordinary skill in the art.
Response to Arguments
Applicant’s arguments, see Remarks, filed 11/20/2025, with respect to claims 4 and 6-8 have been fully considered and are persuasive. The 112b rejection of claims 4 and 6-8 has been withdrawn.
Examiner agrees with applicant’s arguments regarding the 112b rejections of claims 4 and 6-8. Examiner has interpreted these as a Markush group and as such the limitations are alternative limitations and only one species of the Markush group must be taught or anticipated by the prior art.
Applicant argues that a word search of Zhang and Hamner fail to disclose a single occurrence of the word “antenna”. Examiner does not disagree with this. However; Applicant previously claimed the modality for delivering microwave energy in previous claim 3. Examiner also previously and currently considers the modality for delivering the microwave energy to be obvious to one having ordinary skill in the art at the time the invention was made to select any of the known microwave delivery modalities.
Applicant has presented arguments related to the newly amended claim limitation regarding the oscillatory forces on cell membranes and electrostriction means. Examiner has addressed this in the body of the rejection above. Examiner considers applicant’s newly amended claim language “produce oscillatory forces on cell membranes in the excitable tissue by means of electrostriction” to be sufficiently anticipated by the combined teachings of Zhang and Hamner because the new limitation amounts to an intended result. Examiner considers the active steps of applying the first and second overlapping microwave electric fields to necessarily produce the electrostriction and oscillatory forces on cell membranes. Examiner was unable to determine from Applicant’s specification any disclosure of specific variables or otherwise that cause the electrostriction, if Applicant believes this result is tied to a specific variable, angle, overlap etc. then applicant must claim those specifics.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO 2011/113875 – Roman et al. teaches the use of an external microwave antenna. The concept of an external microwave antenna is well known in the art.
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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/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794