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 .
Election/Restriction
Newly submitted claims 16-18 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The method of treating asthma and COPD as described in claims 16-18 comprises the generation of electrical pulses directed to a region of the spinal cord between the C7 and T6 vertebrae, while the originally claimed device and method for treating respiratory conditions comprises neuromodulation that targets a region of the spinal cord between the T1 and T4 vertebrae. Since the added claims have a scope that comprises of a different type of method (originally treating respiratory conditions, now treating asthma and COPD) and different target vertebrae (originally between T1 and T4, now between C7 and T6), this constitutes as new matter and is subject to restriction.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 16-18 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
The amendment filed on Feb. 28, 2026 has been entered. Claims 1-15 remain pending in the application. Applicant’s amendments to the claim objections and 112(b) rejections previously set forth in the Non-Final Office Action mailed Dec. 04, 2025 have overcome each and every rejection.
Response to Arguments
Claim objections
Applicant amended claims 1, 3, and 6-7 to eliminate the informalities from originally filed claims 1, 3, and 6-7. This successfully overcomes the previous claim objections and the objections are withdrawn.
35 U.S.C. § 112(b)
Applicant amended claim 1 to eliminate the indefinite language from originally filed claim 1. This successfully overcomes the previous rejection under 35 U.S.C. 112(b) and the rejection is withdrawn.
35 U.S.C. § 103
Applicant’s arguments with respect to claims 1-2, 4-12, and 14-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior art rejection of record for any teaching or matter specifically challenged in the argument. The below response addresses arguments still relevant to the new ground of rejections set forth below.
Regarding claims 1 and 10, applicant is reminded that the evidence relied upon should establish that the differences in results are in fact unexpected and unobvious of both statistical and practical significance. Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. In the previous rejection mailed December 4, 2025, the inclusion of the terminology “about” when referencing the ranges of frequency, amplitude, and pulse width created grounds for lack of criticality. Upon Applicant’s amendment, the new grounds of evidence allow for further lack of criticality. While Applicant does provide association of criticality with this range, there is no evidentiary support that this is critical considering that the prior art suggests that these ranges, although broader, would still work for these conditions. Conclusory statements that results of these claimed values were unexpected, are unsupported by objective factual evidence. These statements were considered but were not found to be of substantial evidentiary value. Please see MPEP 716.01(c) for more information.
For these reasons, Applicant has not provided an unexpected result associated with criticality in this range.
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.
Claims 1-5, 10, and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simon et. al, (US 20130238049 A1, published 09/12/2013, hereinafter known as Simon.
Regarding claim 1, Simon discloses a device for treating respiratory conditions (“treatment of a variety of diseases and disorders…such as asthma, COPD, etc.” [0029]), the device comprising:
a processing circuitry (pulse generator may be implemented using…a processor” [0130]) having non-transitory computer readable storage media storing instructions which (“computer memories for the storage of executable computer programs” [0128]), when executed by the processing circuity, cause the processing circuitry to:
initiate a signal to generate electrical pulses (“objective of the invention is to produce and apply electrical impulses that interact with the signals of one or more nerves to achieve the therapeutic result of bronchodilation” [0066]) directed to a region of the spinal cord column (“methods involve high-frequency modulation …which is applied to the patient's spinal cord region” [0138]), the electrical pulses providing a neuromodulation that prevents bronchoconstriction (the stimulation…will not cause bronchoconstriction” [0034]), the neuromodulation having an amplitude ranging from 0.5 mAmp to 2.5 mAmp (“modulation signal may have a peak voltage amplitude…about 0.2 volts to about 40 volts” [0132]), a frequency ranging from 350 Hz to 500 Hz (“the frequency may be about 1 Hz or greater” [0132]), and a pulse width ranging from 240 µs to 350 µs (“modulation signal may have a pulse width…about 1 microseconds to about 1000 microseconds” [0132]).
Regarding claim 2, Simon discloses the neuromodulation stimulates a dorsal spinal cord region causing bronchodilation or preventing bronchoconstriction (“the stimulator produces a correspondingly selective physiological response in an individual patient, such as bronchodilation” [0039]).
The limitation of the neuromodulation stimulating a dorsal spinal cord region is disclosed by Simon through intended use. It is well known in the art that the dorsal spinal cord region directly impacts the lungs, so for a limitation in which bronchodilation is caused it can be assumed that the dorsal spinal cord region will be targeted. Further, Simon discloses “the devices and methods of the present invention can be applied to other tissues and nerves of the body”, which can then include the dorsal spinal cord region as well [0066].
Regarding claim 3, Simon discloses the neuromodulation targets parasympathetic and sympathetic ganglia between the T1 and T4 vertebrae.
The limitation of the targeting of parasympathetic and sympathetic ganglia between the T1 and T4 vertebrae is disclosed by Simon through intended use. It is well known in the art these ganglia and vertebrae directly impact the lungs. Further, Simon discloses “the devices and methods of the present invention can be applied to other tissues and nerves of the body”, which can then include the aforementioned ganglia and vertebrae as well [0066].
Regarding claims 4 and 14, Simon discloses providing the neuromodulation to mitigate symptoms associated with moderate and severe asthma, and chronic obstructive pulmonary disease (COPD) (“present invention involves devices and methods for the treatment of a variety of diseases and disorders that are primarily or at least partially driven by an imbalance in neurotransmitters in the brain, such as asthma, COPD” [0029]).
Regarding claims 5 and 15, Simon discloses the neuromodulation prevents onset of asthma attacks without drug intervention (“method and devices of the present invention are therefore particularly useful for providing substantially immediate relief of acute symptoms associated with bronchial constriction such as asthma attacks”, the device does not use any type of medication or drug, merely electrical stimulation, [0065]).
Regarding claim 10, Simon discloses a method of treating respiratory conditions, the method comprising:
providing a pulse generator configured for neuromodulation (“may be achieved using pulse generator” [0130]); and
programming the pulse generator to generate electrical pulses (“objective of the invention is to produce and apply electrical impulses that interact with the signals of one or more nerves to achieve the therapeutic result of bronchodilation” [0066]) directed to a region of the spinal cord (“methods involve high-frequency modulation…which is applied to the patient's spinal cord region” [0138]), the electrical pulses providing the neuromodulation to prevent bronchoconstriction (the stimulation…will not cause bronchoconstriction” [0034]), the neuromodulation having an amplitude ranging from 0.5 mAmp to 2.5 mAmp (“modulation signal may have a peak voltage amplitude…such as about 0.2 volts to about 40 volts” [0132]), a frequency ranging from 350 Hz to 500 Hz (“the frequency may be about 1 Hz or greater” [0132]), and a pulse width ranging from 240 µs to 350 µs (“modulation signal may have a pulse width…about 1 microseconds to about 1000 microseconds” [0132]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Lu (US 20190381313 A1, published 12/19/2019).
Regarding claim 12, Simon discloses the neuromodulation causes bronchodilation or prevents bronchoconstriction.
However, Simon does not disclose the neuromodulation stimulates a dorsal spinal cord region.
Lu teaches methods for improving, and/or regulating, and/or restoring respiration in a subject with a respiratory deficiency…the methods involve neuromodulating the cervical spinal cord (Abstract). The epidural stimulation is applied to the dorsal column and in certain embodiments to the lateral portion of the dorsal column…the epidural stimulation is alternatively or additionally applied to a dorsal root ([0297] & [0298]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the stimulation of the dorsal spinal cord region of Lu with the device and method for treating respiratory conditions of Simon because the dorsal region of the spinal cord aids in the regulation of breathing.
Claims 1, 6-9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lu in view of Simon.
Alternatively regarding claim 1, Lu discloses
a processing circuitry (“control module…may contain a processor” [0359]) having non-transitory computer readable storage media storing instructions which (“control module may include or be operably coupled to memory to store instructions for controlling the signal generation module” [0359]), when executed by the processing circuity, cause the processing circuitry to:
initiate a signal to generate electrical pulses (“Stimulation pulses are applied to electrodes (which typically are cathodes) with respect to a return electrode…to induce a desired area of excitation of electrically excitable tissue in one or more regions of the spine” [0366]) directed to a region of the spinal cord column (“stimulation of the spinal cord is utilized to facilitate stimulation of and/or maintenance of respiratory function” [0281]).
However, Lu does not disclose a device for treating respiratory conditions the device comprising:
electrical pulses providing neuromodulation that prevents bronchoconstriction,
the neuromodulation having an amplitude ranging from 0.5 mAmp to 2.5 mAmp a frequency ranging from 350 Hz to 500 Hz, and a pulse width ranging from 240 µs to 350 µs.
Simon teaches devices, systems and methods for treating a variety of diseases and disorders that are primarily or at least partially driven by an imbalance in neurotransmitters in the brain, such as asthma, COPD, and the like [0029]. The stimulation…will not cause bronchoconstriction… the stimulator produces a correspondingly selective physiological response in an individual patient, such as bronchodilation [0034] & [0039]. Modulation signal may have a peak voltage amplitude…about 0.2 volts to about 40 volts [0132]. The frequency may be about 1 Hz or greater [0132]. Modulation signal may have a pulse width…about 1 microseconds to about 1000 microseconds [0132].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the treatment of asthma and COPD, and modulation signal ranges for amplitude, frequency, and pulse width of Simon with the treatment device for restoring respiratory function of Lu because this device can be particularly useful for providing substantially immediate relief of acute symptoms associated with bronchial constriction such as asthma attacks, COPD exacerbations and/or anaphylactic reactions [0232].
Regarding claim 6, Lu discloses one or more leads (“any number of one or more leads may be employed” [0366]) configured to be implanted in an epidural space of the spinal canal, each of the one or more leads including electrical contacts for releasing the electrical pulses inside the epidural space between the T1 and T4 vertebrae (“methods described involve epidural electrical stimulation of the thoracic spine (e.g., spinal cord) or a region of the thoracic spine (spinal cord) of the subject to modulate and/or induce respiration… regions include, a region selected from the group consisting of…T1-T4” [0295]).
Regarding claim 7, Lu discloses the one or more leads are temporary percutaneous leads configured to be removed from the epidural space after completion of a spinal cord stimulation trial (“any number of one or more leads may be employed…the system comprises a temporary implanted device by percutaneous insertion of leads” [0366] & [0397]).
Regarding claim 8, Lu discloses wherein the one or more leads are permanent leads (“epidural stimulation is applied via a permanently implanted electrode array” [0085]).
Regarding claim 9, Lu discloses a pulse generator connected to the one or more leads (“any number of one or more leads may be employed, [0366]), and pulse generator housing the processing circuitry having the non-transitory computer readable storage media (“magnetic nerve stimulator comprises two parts: a high current pulse generator…and a stimulating coil… a voltage (power) source charges a capacitor via charging circuitry under the control of control circuitry (e.g., a microprocessor) that accepts information such as the capacitor voltage, power set by the user, etc.” [0383]).
Regarding claim 11, Lu discloses activating the pulse generator after implantation inside a patient (“subdural stimulation is accomplished by the implantation of subdural electrodes… system permits attending medical personnel to select the various pulse output options after implant…the system employs fully implanted elements” [0331] & [0358]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Lu and further in view of DiLorenzo (US 20200268536 A1, published 08/27/2020).
Regarding claim 13, Simon does not disclose wherein the neuromodulation targets parasympathetic and sympathetic ganglia between the T1 and T4 vertebrae.
Lu teaches the methods involve epidural electrical stimulation of the thoracic spine (e.g., spinal cord) or a region of the thoracic spine (spinal cord) of the subject to modulate and/or induce respiration… regions include, a region selected from the group consisting of…T1-T4 [0295].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the targeting of specific vertebrae of Lu with the device and method for treating respiratory conditions of Simon because the T1-T4 vertebrae primarily control organs and muscles in the chest, such as the lungs.
While Simon in view of Lu teaches the targeting of specific vertebrae, Simon in view of Lu still does not disclose wherein the neuromodulation targets parasympathetic and sympathetic ganglia.
DiLorenzo teaches a method and apparatus for physiological modulation, including…respiratory, and other modulation, for the purposes of treating disorders…including asthma (Abstract). By altering the level of sympathetic nervous system activity, or the level of parasympathetic nervous system activity, or the ratio of sympathetic to parasympathetic nervous system activity…the level of activity of the immune system may be modulated [0055].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the modulation of the parasympathetic nervous system and sympathetic nervous system of DiLorenzo with the device and method for treating respiratory conditions by targeting vertebrae T1-T4 of Simon in view of Lu, because both polarities of modulation have efficacy in the treatment of disease (DiLorenzo, [0055]).
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office Action. THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/F.M.K./Patent Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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