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 .
Response to Arguments
Applicant’s arguments filed 07/07/2025 have been fully considered but are not persuasive or are moot in view of new grounds of rejection.
Applicant argues, “Linden discloses delivering low frequency stimulation energy to intentionally elicit an effect (paresthesia) in the patient to identify those peripheral nerves most sensitive to aberrancy and to then target them with high frequency pain-relieving stimulation energy. As such, Linden teaches trialing electrical stimulation at multiple locations to identify on-target effects. Linden 1 Office Action, p. 6 cannot be relied on to teach "determining that the application of the electrical stimulation energy at the first location does not cause the off-target effect" and "applying electrical stimulation energy at the first location," as presently claimed, since Linden teaches applying electrical stimulation energy only at locations that exhibit an effect, and not at any location that does not elicit the effect.”
Examiner respectfully disagrees. Under broadest reasonable interpretation, the recited “determining whether application of the electrical stimulation energy at the first location causes an off-target effect in the subject” does not prevent on-target effects to be detected as well as preventing certain off-target effects. For instance, although Linden identifies on-target effects such as reducing pain and inducing paresthesia [0331], Linden is also focused on minimizing off-target effect, such as unintentional stimulation of non-target tissue [0331].
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 6-8, and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Hamdy (US 2008/0009810) in view of Su et al. (US 2018/0304075) in view of Linden et al. (US 2020/0306528)
In re claim 1, Hamdy discloses a method [0001] comprising:
via a nasal [0052] or oral cavity [0052], positioning an elongate member (fig. 1: 12) carrying a conductive element (14) in a lumen of a pharynx of a human subject (fig 2; [0052]) such that the conductive element is positioned at a first location [0012, 0014];
applying electrical stimulation energy at the first location via the conductive element ([0014]: applying electrical pulses capable of inducing pharyngeal stimulation to electrodes located on the surface of a catheter)
after applying the electrical stimulation energy at the first location ([0011-0013]: electrodes are provided in a position suitable for applying electrical pharyngeal stimulation which provides recovery from dysphagia) obtaining first data characterizing a cortical excitability of the subject ([0042]: delivers a stimulus capable of activating the swallowing reflex; [0046] shows change in pharyngeal cortical excitability following intraluminal pharyngeal electrical stimulation; fig. 3).
applying electrical stimulation energy at the first location to improve a cortical excitability of a human patient suffering from dysphagia, thereby improving a swallowing function of the patient and treating the dysphagia ([0042]: delivering stimulation at a position capable of activating the swallowing reflex; [0046]: change in pharyngeal cortical excitability occurs from stimulation).
Hamdy fails to disclose
…determining whether application of the electrical stimulation energy at the first location causes an off-target effect in the subject,
the off-target effect comprising at least one of stimulation of a facial nerve of the subject, stimulation of a trigeminal nerve of the subject, or motor activity of an upper esophageal sphincter of the subject;
positioning the elongate member in the lumen such that the conductive element is positioned at a second location;
applying electrical stimulation energy at the second location via the conductive element and determining whether application of the electrical stimulation energy at the second location causes the off-target effect in the subject;
after applying the electrical stimulation energy at the second location, obtaining second data characterizing the cortical excitability of the subject;
comparing the cortical excitability of the first data to the cortical excitability of the second data;
determining that the cortical excitability characterized by the first data is greater than the cortical excitability characterized by the second data;
determining that the application of the electrical stimulation energy at the first location does not cause the off-target effect;
based on the greater cortical excitability and the lack of the off-target effect at the first location, identifying the first location as a preferred treatment location for delivering electrical stimulation energy; and
applying electrical stimulation energy at the first location to improve a cortical excitability of a human patient suffering from dysphagia, thereby improving a swallowing function of the patient and treating the dysphagia.
Su teaches a system for positioning and placing implantable electrodes for neurological stimulation [0020], and teaches
determining whether application of an electrical stimulation energy at a first location via a conductive element ([0027]: lead is used to provide stimulation) causes an off-target effect in the subject ([0021]: EMG responses after stimulation is measured to determine response to an intended target site and may be repositioned to avoid undesirable side effects, therefore the first target site is interpreted as a first location)
applying electrical stimulation energy at the second location via the conductive element and determining whether application of the electrical stimulation energy at the second location causes the off-target effect in the subject ([0021]: next position where EMG is compared to a previous position to provide desired therapy while reducing undesirable side effects);
comparing a cortical excitability of a first data to a cortical excitability of a second data ([0021]: EMG responses for multiple positions may be compared to determine an appropriate position);
determining that the cortical excitability characterized by the first data is greater than the cortical excitability characterized by the second data ([0021]: comparing the EMG response of the various locations and determining whether the first location has a high EMG response at the target site and a low EMG response remote from the target site);
determining that the application of the electrical stimulation energy at the first location does not cause the off-target effect ([0021]: occurs when a low EMG response remote from the target site is detected; [0068]: low EMG detected at a site remote from a stimulation site avoids side effects associated with stimulating unintended sites);
based on the greater cortical excitability and the lack of the off-target effect at the first location, identifying the first location as a preferred treatment location for delivering electrical stimulation energy ([0021]: first location would be preferred if the EMG response at the target site is high and the EMG response remote from the target site is low);
wherein determining whether application of the electrical stimulation energy at the first location or the second location caused the off-target effect in the subject comprises obtaining feedback from the subject [0027]; and
applying electrical stimulation energy at the first location to improve a cortical excitability of a human patient ([0021]: determined appropriate position is selected for delivering stimulation therapy to reduce undesirable side effects; [0026-0027]).
Su further teaches that that comparing EMG responses between different positions ensures that a target site is selected that reduces undesirable side effects [0026-0027] such as patient discomfort [0027].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method taught by Hamdy, to provide determining whether application of the electrical stimulation energy at the first location causes an off-target effect in the subject, positioning the elongate member in the lumen such that the conductive element is positioned at a second location; applying electrical stimulation energy at the second location via the conductive element and determining whether application of the electrical stimulation energy at the second location causes the off-target effect in the subject; after applying the electrical stimulation energy at the second location, obtaining second data characterizing the cortical excitability of the subject; comparing the cortical excitability of the first data to the cortical excitability of the second data; determining that the cortical excitability characterized by the first data is greater than the cortical excitability characterized by the second data; determining that the application of the electrical stimulation energy at the first location does not cause the off-target effect; based on the greater cortical excitability and the lack of the off-target effect at the first location, identifying the first location as a preferred treatment location for delivering electrical stimulation energy; wherein determining whether application of the electrical stimulation energy at the first location or the second location caused the off-target effect in the subject comprises obtaining feedback from the subject; and applying electrical stimulation energy at the first location to improve a cortical excitability of a human patient, as taught by the comparison of the EMG responses of Su, because comparing responses between different positions ensures that a target site is selected that reduces undesirable side effects such as patient discomfort.
Linden teaches a medical apparatus [0003] for delivering enhanced stimulation [0003] while avoiding undesired effects [0003] and teaches
determining whether application of electrical stimulation energy at a first location causes an off-target effect in a subject ([0331]: first instance that stimulation is delivered to target tissue is used to detect whether non-target tissue is stimulated),
the off-target effect comprising of stimulation of a facial nerve of the subject ([0367]: trigeminal nerve tissue may be a target, but a facial nerve may be targeted instead),
positioning an elongate member (fig. 4C: any one of filament 1701a or 1701b) in a lumen ([0420]: lead 265 includes lumen 208 where filaments 1701 can be inserted into) such that a conductive element is positioned at a second location ([0420]: filaments 1701 allow lead 265 to advance through tissue and includes stimulation elements 260; [0331]: position of 260 can be adjusted i.e. moved to a second location to minimize unintentional stimulation of non-target tissue);
applying electrical stimulation energy at the second location via the conductive element and determining whether application of the electrical stimulation energy at the second location causes the off-target effect in the subject [0331];
after applying the electrical stimulation energy at the second location, obtaining second data characterizing efficacious treatment of the subject ([0331]: patient informs clinician of sensation of paresthesia coverage to characterize efficacious treatment of the subject to determine if the position of the stimulation element needs to be adjusted).
Linden further teaches that preventing an off-set effect minimized unintentional stimulation and optimizes efficacious treatment [0331], and various target areas can be selected [0367].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method the proposed combination, to provide wherein the off-target effect comprising of stimulation of a facial nerve of the subject, as taught by Linden, because preventing an off-set effect minimizes unintentional stimulation and optimizes efficacious treatment, and various target areas can be selected which would include various positions for off-target effects to be measured.
The proposed combination would further yield wherein the cortical excitability of Hamdy is compared between a first position and a second position, as taught by Su, and a determination of an off-target effect comprising of stimulation of a facial nerve of a subject and determined by patient feedback is used to determine whether the first location is where electrical stimulation energy should be applied to improve a cortical excitability of a human patient suffering from dysphagia, thereby improving a swallowing function of the patient and treating the dysphagia.
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the off-target effect comprising at least one of stimulation of a facial nerve of the subject, stimulation of a trigeminal nerve of the subject, or motor activity of an upper esophageal sphincter of the subject. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed off-target effect is not disclosed as being crucial or unexpected, and because the off-target effect could have been any of the three recited off-target effects depending on the desired target.
In re claim 3, the proposed combination yields (all mapping directed to Hamdy unless otherwise stated) wherein obtaining at least one of the first data characterizing a cortical excitability or the second data characterizing the cortical excitability includes:
stimulating the subject's neural tissue via transcranial magnetic stimulation (TMS) ([0081]: transcranial stimulation (sTMS) of the cerebral cortex is achieved using a magnetic stimulator), and
detecting a pharyngeal electromyographic (EMG) response to the stimulation ([0083]: EMG (electromyographic) responses were recorded from the pharynx).
In re claim 4, the proposed combination yields (all mapping directed to Hamdy unless otherwise stated) wherein stimulating the subject's neural tissue comprises stimulating one or more regions of the subject's swallow motor cortex ([0093]: transcranial magnetic stimulation was performed over the swallowing motor cortex).
In re claim 6, the proposed combination yields (all mapping directed to Hamdy unless otherwise stated) wherein detecting the pharyngeal EMG response includes obtaining a motor-evoked potential (MEP) parameter ([0083]: Pharyngeal MEPs were recorded).
In re claim 7, the proposed combination yields (all mapping directed to Hamdy unless otherwise stated) wherein the MEP parameter includes an MEP amplitude and/or an MEP latency ([0086]: using 100% of stimulator output and the hemisphere evoking the greatest pharyngeal MEP amplitude was identified).
In re claim 8, the proposed combination fails to yield further comprising:
obtaining first baseline data characterizing a cortical excitability of the subject before applying the electrical stimulation energy at the first location;
obtaining second baseline data characterizing a cortical excitability of the subject before applying the electrical stimulation energy at the second location;
comparing the cortical excitability associated with the first data to the cortical excitability associated with the first baseline data; and
comparing the cortical excitability associated with the second data to the cortical excitability of the second baseline data.
Su teaches
obtaining first baseline data characterizing a cortical excitability of the subject before applying the electrical stimulation energy at the first location ([0059]: EMG response may be determined to be evoked with reference to a baseline EMG and would be before delivering stimulation);
obtaining second baseline data characterizing a cortical excitability of the subject before applying the electrical stimulation energy at the second location [0059];
comparing the cortical excitability associated with the first data to the cortical excitability associated with the first baseline data ([0059]: each EMG response would be compared with a baseline EMG before stimulation); and
comparing the cortical excitability associated with the second data to the cortical excitability of the second baseline data [0059].
Su further teaches that there are different ways to detect if an EMG response has been evoked [0059], including by comparing the EMG response with a baseline obtained prior to delivering any stimulation [0059].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method the proposed combination, to provide obtaining first baseline data characterizing a cortical excitability of the subject before applying the electrical stimulation energy at the first location; obtaining second baseline data characterizing a cortical excitability of the subject before applying the electrical stimulation energy at the second location; comparing the cortical excitability associated with the first data to the cortical excitability associated with the first baseline data; and comparing the cortical excitability associated with the second data to the cortical excitability of the second baseline data, as taught by Su, because are different ways to detect if an EMG response has been evoked, including by comparing the EMG response with a baseline obtained prior to delivering any stimulation.
In re claim 20, the proposed combination fails to yield wherein the off-target effect comprises motor activity of a hand of the subject.
At the time the instant application was filed it would be obvious to try to provide wherein the off-target effect comprises motor activity of a hand of the subject. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed off-target effect is not disclosed as being crucial or unexpected, and because the target of Hamdy is to stimulate a location that improves a cortical excitability of a human patient suffering from dysphagia, therefore, anything that isn’t directed to that (e.g. motor activity of a hand) could have been considered as an off-target effect that would indicate the position of the stimulation location needs to be modified.
In re claim 21, the proposed combination fails to yield wherein the off-target effect comprises a change in cardiac activity of the subject.
At the time the instant application was filed it would be obvious to try to provide wherein the off-target effect comprises a change in cardiac activity of the subject. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed off-target effect is not disclosed as being crucial or unexpected, and because the target of Hamdy is to stimulate a location that improves a cortical excitability of a human patient suffering from dysphagia, therefore, anything that isn’t directed to that (e.g. a change in cardiac activity) could have been considered as an off-target effect that would indicate the position of the stimulation location needs to be modified.
In re claim 22, regarding the limitation, “wherein determining that the application of the electrical stimulation energy at the first location did not cause the off-target effect in the subject comprises measuring an electromyographic (EMG) signal from the subject”, see the proposed combination yielded in re claim 1 above (Hamdy [0083]: EMG responses are recorded; Su [0027]: EMG signals are used to avoid undesirable side effects).
In re claim 23, regarding the limitations, “wherein determining whether application of the electrical stimulation energy at the first location or the second location caused the off-target effect in the subject comprises obtaining feedback from the subject”, see the proposed combination yielded in re claim 1 above.
In re claim 24, the proposed combination fails to yield wherein the second position is spaced apart from the first position along a longitudinal dimension of the pharynx.
Su teaches that the stimulation electrode may be moved along different stimulation sites [0051], including along an axial length of a lead [0044] based on a feedback signal [0044], and also due to the stimulation lead being moved along an axis [0049].
The proposed combination would yield wherein the first and second positions are spaced apart along a longitudinal dimension of the pharynx, as taught by the first and second positions of Su being spaced apart in various ways as desired.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method the proposed combination, to provide wherein the second position is spaced apart from the first position along a longitudinal dimension of the pharynx, as taught by Su, because the position can be moved along various directions based on feedback signals.
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the second position is spaced apart from the first position along a longitudinal dimension of the pharynx. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed second position and first position spacing is not disclosed as being crucial or unexpected, and because one of ordinary skill in the art at the time the instant application was filed would have considered multiple positions for applying stimulation, including two that were spaced apart from one another along a longitudinal dimension of the pharynx.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hamdy (US 2008/0009810) in view of Su et al. (US 2018/0304075) in view of Linden et al. (US 2020/0306528) in view of Errico et al. (US 2015/0073505).
In re claim 5, the proposed combination fails to yield
wherein stimulating the subject's neural tissue comprises stimulating one or more of
the subject's caudal sensory motor cortex,
anterior insula,
premotor cortex,
frontal operculum,
anterior cingulate cortex,
prefrontal cortex,
anterolateral parietal cortex,
posterior parietal cortex,
precuneus,
superiomedial temporal cortex,
posterior cingulate cortex,
putamen, or
caudal nuclei.
Errico teaches a nerve stimulation system [0029] for electrical stimulation of one or more nerves of a patient [0028] and wherein an insula (which would include anterior insula) is important for swallowing [0090].
Therefore, it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method the proposed combination, to provide wherein stimulating the subject's neural tissue comprises stimulating the anterior insula, as taught by Errico, because the insula, which includes the anterior insula, is known to be directed to swallowing, therefore, stimulating it could be used to treat dysphagia.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Su et al. (US 2014/0378941) discloses systems for screening effective therapies using cortical evoked potentials (abstract), and teaches screening different stimulation sites for effective therapy locations based on a comparison of cortical evoked potential locations [0041].
Mattila et al. (US 2022/0133200) discloses a non-invasive measurement [0003] of an electromyogram (EMG) [0003] between locations on a skin [0003] to compare electrical potential differences [0003] between the locations [0003].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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