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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/28/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 01/28/2026 have been fully considered but are moot in view of a new grounds of rejection.
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.
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 13-18, 26, 28-30, 32-35, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Boggs, II et al. (US 2019/0151660) in view of Rooney et al. (US 2007/0150034) in view of Rajguru et al. (US 2017/0266443) in view of Flaherty et al. (US 2010/0152812).
In re claim 13, Boggs discloses a method for stimulating tissue [0088], comprising:
providing a stimulation device (Fig. 6C: 102);
placing a lead (112) within range of a target nerve [0009-0010, 0138],
wherein the lead is operatively attached to the stimulation device (Fig. 6C);
applying a first stimulation signal to the target nerve with the lead and the stimulation device (fig. 11A: peripheral nerve stimulation is applied within the dashed lines for FNS and SNS [0075]; [0057-0058, 0186]);
terminating the applying the first stimulation signal ([0144]: the first stimulation signal that was active prior to amputation surgery can be deactivated during surgery);
performing, after terminating the application of the first stimulation signal, a *subcutaneous surgery [0132-0133; 0144, 0058]; and
applying, after terminating the application of the first stimulation signal, a **second stimulation signal to the target nerve
([0144]: the first stimulation signal applied prior to surgery and “optionally turned off/deactivated during the surgery, and turned on/activated during and/or at some designated time following the surgery” implies a second stimulation signal),
directly activating excitable tissue of the target nerve ([0062]: electrical stimulation is delivered to electrode at the nerve so that nerve fibers i.e. tissue are activated; [0057, 0139-0140]) for a total therapy duration that comprises less than 60 minutes providing stimulation of the target nerve ([0167]: the total treatment period can range from minutes to hours; [0147]: target peripheral nerve may be stimulated to treat and/or prevent pain; [0139-0140, 0144]).
*Regarding the limitation “subcutaneous surgery”, although Boggs mentions the stimulation being applied before an amputation surgery, it is possible that the Applicant is referring to “subcutaneous” to imply a surgery specifically done under the skin rather than a surgery done around the skin to completely remove tissues or organs.
Therefore, at the time the instant application was filed it would be obvious to try performing, after terminating the application of the first stimulation signal, a subcutaneous surgery, where the subcutaneous surgery occurs primarily under the skin, because Boggs discloses that stimulation is used to evoke pain relief at desired regions [0186], which can include a variety of body parts including tissues and nerves [0133], and also because Boggs discloses a need for pain management before and after surgery [0005].
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.
Therefore, since at the time the instant invention was filed there was a need to perform subcutaneous surgery after terminating the application of the first stimulation signal and because there are only a finite number of places where stimulation can be performed to manage pain, one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success, especially because Boggs teaches performing surgery in various tissues and structures of the body to assist in pain management and relief in the desired locations.
**Regarding the limitations “a second stimulation”, Boggs discloses various ways that stimulation can be applied, for instance, “the therapeutic stimulation may be active prior to the amputation surgery, optionally turned off/deactivated during the surgery, and turned on/activated during and/or at some designated time following the surgery” [0144], which implies the following sequences of stimulation signals:
Electrical stimulation applied before surgery (first stimulation signal) and during surgery (second stimulation signal)
Electrical stimulation applied before surgery (first stimulation signal) and after surgery (second stimulation signal)
Therefore, the second stimulation signal can be either during surgery, or after surgery, and the second stimulation is a separate stimulation signal from the first stimulation signal since the first stimulation signal would have already been deactivated.
Boggs fails to explicitly disclose
placing a lead in close proximity to an injured target nerve,
applying a first stimulation signal to the injured target nerve with the lead and the stimulation device;
applying, after terminating the application of the first stimulation signal, a second stimulation signal to the injured target nerve,
directly activating excitable tissue of the injured target nerve for a total therapy duration that comprises less than 30 minutes using stimulation parameters for promoting healing of the injured target nerve.
Regarding the limitation, “placing a lead in close proximity to a target nerve”, Rooney teaches an analogous implantable lead [0009, 0020] used to provide stimulation [0009], and teaches placing the lead ([0020]: paddle lead) in close proximity to a target nerve [0020].
Rooney further teaches that PNS can involve a lead positioned proximate or in contact with the peripheral nerve [0020] that is responsible for pain sensation to treat pain [0020].
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 for stimulating tissue taught by Boggs, to provide placing a lead in close proximity to a target nerve, as taught by Rooney, because PNS can involve a lead positioned proximate or in contact with the peripheral nerve that is responsible for pain sensation to treat pain.
Regarding the limitation, “activating excitable tissue of the target nerve for a total therapy duration that comprises less than 30 minutes promoting healing of the target nerve”, Rajguru teaches
an analogous stimulation therapy system [0003] which is used to treat pain [0020], comprising directly activating excitable tissue of target nerve [0012-0014, 0119] for a total therapy duration that comprises less than 30 minutes promoting healing ([0271]: accelerating tissue healing promotes healing) of the target nerve ([0351-0353]: therapy can be applied to a target nerve for total duration of 20 minutes, and stimulation frequency is altered or paused; [0271]: stimulation may provide accelerated healing as well as nerve repair/regeneration).
Rajguru further teaches that pausing stimulation after a preset amount of time, for instance 10 minutes, can prevent habituation [0026], which would otherwise lead to decreased stimulation or a reduced response to stimulation [0354]. Rajguru also teaches that the total stimulation period can occur from 0 minutes to 100 minutes, depending on the symptoms needing to be treated [0352], and that stimulation may provide accelerated healing [0271] as well as nerve repair/regeneration [0271].
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 for stimulating tissue yielded by the proposed combination, to provide directly activating excitable tissue of the target nerve for a total therapy duration that comprises less than 30 minutes promoting healing of the target nerve, as taught by Rajguru, because the total stimulation duration can be adjusted based on the symptoms needing to be treated, and because stimulation may provide accelerated healing as well as nerve repair/regeneration of the target nerve.
Regarding the limitations,
placing a lead in close proximity to an injured target nerve,
applying a first stimulation signal to the injured target nerve…;
applying… a second stimulation signal to the injured target nerve,
directly activating excitable tissue of the injured target nerve….using stimulation parameters for promoting healing of the injured target nerve,
Flaherty teaches
placing a lead [0012] in close proximity to an injured target nerve [0012, 0058],
applying a first stimulation signal to the injured target nerve [0014];
applying a second stimulation signal to the injured target nerve ([0111]: treatments include providing multiple electromagnetic stimulation that changes polarity at a period of time),
directly activating excitable tissue of the injured target nerve using stimulation parameters for promoting healing of the injured target nerve
([0019]: nerve regeneration system administers a nerve regeneration treatment to the damaged nerve, which would directly activate tissue to promote healing of the injured nerve; [0084]: stimulation may be controlled such as frequency and amplitude to facilitate growth of nerves as a current goes through tissue).
Flaherty further teaches that nerve regeneration treatments restore signal transmission capabilities of nervous systems [0052] by restoring motor and sensory functions [0052] of damaged nerves [0052]. Flaherty further teaches that stimulation parameters may be adjusted [0029 based on monitored growth [0031, 0111].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify stimulating the target nerve yielded by the proposed combination, to instead place a lead in close proximity to an injured target nerve and stimulate the injured target nerve to promote healing of the injured target nerve, as taught by Flaherty, because nerve regeneration treatments restore signal transmission capabilities of nervous systems by restoring motor and sensory functions of damaged nerves while also adjusting stimulation parameters based on monitored growth.
In re claim 14, regarding the limitations, “applying the second stimulation signal after the subcutaneous surgery”, see in re claim 13 above.
In re claim 15, regarding the limitations, “applying a third stimulation signal during the subcutaneous surgery”, although Boggs discloses “applying electrical stimulation to one or more peripheral nerves throughout the body before, during, and/or after the amputation”, [0144] which would imply a third stimulation signal, Boggs doesn’t explicitly mention the third stimulation signal being applied during surgery. However, Boggs discloses “the present system is designed to deliver therapy to relieve pain before, during, and/or after amputation, and may also be applied in a combination of those times, either continuously or intermittently” [0144].
Therefore, at the time the instant application was filed it would be obvious to try to apply another stimulation signal (i.e. a third stimulation signal) during surgery, specifically after the second stimulation signal is applied during surgery, because Boggs discloses that the stimulation signal can be deactivated and activated [0144], and because the system aims to provide stimulation that decreases pain perception during an amputation surgery [0145, 0194]. Additionally, 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.
Since at the time the instant invention was filed there was a need to provide stimulation during surgery, and because there are only a finite number of times where stimulation signal can be applied, one of ordinary skill in the art could have pursued the known potential solutions of applying a third stimulation during the subcutaneous surgery with a reasonable expectation of success, especially because the stimulation signals in Boggs are able to be activated and deactivated before, after, and during surgery, and therefore could be activated and deactivated twice during surgery to result in a third stimulation signal.
In re claim 16, regarding the limitations, “applying the second stimulation signal during the subcutaneous surgery”, see in re claim 13 above.
In re claim 17, the proposed combination yield in re claim 13 above yields applying the first stimulation signal comprises applying the first stimulation signal for ten minutes, because providing the stimulation for a long period of time without stopping can lead to habituation which would decrease responsiveness to stimulation.
In re claim 18, regarding the limitations, “wherein applying the second stimulation signal comprises applying the second stimulation signal for ten minutes”, the combination of Boggs and Rajguru has been discussed above (in re claim 17).
It would have been obvious to modify the proposed combination in substantially the same way and for substantially the same reasons discussed above (in re claim 17).
In re claim 26, regarding the limitations, “a method for stimulating tissue, comprising:
providing a stimulation device;
placing a lead in close proximity to an injured target nerve,
wherein the lead is operatively attached to the stimulation device; and
applying a stimulation signal to the injured target nerve with the lead and the stimulation device,
directly activating excitable tissue of the injured target nerve for a total therapy duration that comprises less than 30 minutes using stimulation parameters for promoting healing of the injured target nerve,”
see in re claim 13 above.
In re claim 28, the proposed combination yields (all mapping directed to Boggs unless otherwise stated) wherein application of the stimulation signal to the target nerve occurs before surgery [0144].
In re claim 29, the proposed combination yields (all mapping directed to Boggs unless otherwise stated) wherein application of the stimulation signal to the target nerve occurs during surgery [0144].
In re claim 30, the proposed combination yields (all mapping directed to Boggs unless otherwise stated) wherein application of the stimulation signal to the target nerve occurs after surgery [0144].
In re claim 32, the proposed combination yields (all mapping directed to Boggs unless otherwise stated) further comprising dividing an input signal to a plurality of output signals through a corresponding plurality of electrodes extending from the lead ([0138]: each of the leads 112 may have one or more electrodes 116; [0139]: input signal of electrical stimulation outputted through the electrodes).
In re claim 33, the proposed combination yields (all mapping directed to Boggs unless otherwise stated) wherein the stimulation device utilizes a plurality of channels to deliver the stimulation signal ([0086]: leads are channels which provide electrical stimulation; [0138-0139]).
In re claim 34, the proposed combination yields (all mapping directed to Boggs unless otherwise stated) wherein the stimulation device utilizes a plurality of contacts to deliver the stimulation signal ([0168]: electrodes are contacts that deliver the stimulation signal; [0138-0139]).
In re claim 35, the proposed combination yields (all mapping directed to Boggs unless otherwise stated) wherein the stimulation signal applied has a frequency of between 2Hz and 100Hz ([0182]: frequency may be between any combination of two whole integers between 1 and 100Hz; [0205]: 100Hz provides maximum paresthesia coverage)
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the stimulation signal applied has a frequency of between 2Hz and 100Hz. 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 frequency is not disclosed as being crucial or unexpected. Further, a person of ordinary skill in the art would consider a frequency that would not harm the patient, which would include a frequency between 2Hz and 100Hz. Additionally, Boggs teaches that various stimulation frequency ranges can be applied [0182], and that higher frequencies (such as 100 Hz) may evoke sensations or comfortable paresthesia in regions of pain or in alternate target regions [0185].
Even if the proposed combination fails to yield wherein the stimulation signal applied has a frequency of between 2Hz and 100Hz, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the stimulation signal applied has a frequency of between 2Hz and 100Hz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In re claim 39, the proposed combination yields (all mapping directed to Boggs unless otherwise stated) wherein the stimulation signal applied has an amplitude between 1 mA and 2 mA ([0182]: range of intensities may be any two whole integers between 1 and 30 mA).
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the stimulation signal applied has an amplitude between 1 mA and 2 mA. 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 frequency is not disclosed as being crucial or unexpected. Further, a person of ordinary skill in the art would consider an amplitude that would not harm the patient, which would include an amplitude between 1 mA and 2 mA. Additionally, Boggs teaches that various range of intensities can be applied [0182], and that applying stimulation at the correct intensity will provide the patient with a comfortable tingling sensation [0147, 0186]. Boggs further teaches that the stimulation intensity being too high or low will lead to unwanted consequences [0184].
Even if proposed combination fails to yield wherein the stimulation signal applied has an amplitude between 1 mA and 2 mA, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the stimulation signal applied has an amplitude between 1 mA and 2 mA, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Boggs, II et al. (US 2019/0151660) in view of Rooney et al. (US 2007/0150034) in view of Rajguru et al. (US 2017/0266443) in view of Flaherty et al. (US 2010/0152812) in view of Erickson (US 2004/0210272).
In re claim 27, the proposed combination fails to yield wherein the stimulation device further comprises a pulse counter operatively counting a number of pulses generated by the stimulation device.
Erickson teaches a stimulation device [0016] for tissue stimulation [0002], wherein the stimulation device further comprises a pulse counter (fig. 5: 112; [0049]) operatively counting a number of pulses [0049] generated by the stimulation device [0045, 0049].
Erickson further teaches that the stimulation counter counts the pulses so that a determination can be made on the completion of a set of stimulation pulses or cycles [0049]. Erickson additionally teaches that the counter may be associated with individual stimulation sets in a multiple stimulation set device [0016].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the stimulation device yielded by the proposed combination, to provide wherein the stimulation device further comprises a pulse counter operatively counting a number of pulses generated by the stimulation device, as taught by Erickson, because doing so allows for a determination to be made regarding the completion of a set of stimulation pulses for each individual stimulation set in a multiple stimulation set device.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Boggs, II et al. (US 2019/0151660) in view of Rooney et al. (US 2007/0150034) in view of Rajguru et al. (US 2017/0266443) in view of Flaherty et al. (US 2010/0152812) in view of Hershey (US 2014/0081345).
In re claim 31, the proposed combination yields (all mapping directed to Boggs unless otherwise stated) wherein the stimulation signal comprises a biphasic waveform [0179] with controlled current [0178-0179].
The proposed combination fails to yield wherein the stimulation signal comprises a biphasic waveform with controlled current during a cathodic phase.
Hershey teaches a tissue stimulation system [0002, 0009], wherein a stimulation signal ([0036]: modulation energy; [0009-0010]) comprises a biphasic waveform [0036] with controlled current during a cathodic phase [0036].
Hershey further teaches that using a series of biphasic pulses with each biphasic pulse including a cathodic modulation pulse and an anodic recharge pulse prevents direct current transfer through tissue and avoids electrode degradation and cell trauma [0036].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the stimulation device yielded by the proposed combination, to provide wherein the stimulation signal comprises a biphasic waveform with controlled current during a cathodic phase, as taught by Hershey, because implementing a series of biphasic pulses with each biphasic pulse including a cathodic modulation pulse and an anodic recharge pulse prevents direct current transfer through tissue, which avoids electrode degradation and cell trauma.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Boggs, II et al. (US 2019/0151660) in view of Rooney et al. (US 2007/0150034) in view of Rajguru et al. (US 2017/0266443) in view of Flaherty et al. (US 2010/0152812) in view of Ostroff et al. (US 2017/0173328).
In re claim 36, the proposed combination fails to yield wherein the stimulation signal applied has a frequency of between 15Hz and 30 Hz.
Ostroff teaches a tissue stimulating device [0002, 0007] wherein a stimulation signal [0015] applied has a frequency of between 15Hz and 30 Hz ([0015]: between 30Hz and 10 Hz).
Ostroff further teaches that certain ranges may be effective at treating specific conditions [0015], and that for peripheral nerve field stimulation, most patients prefer the frequency to be between 20 and 50 Hz [0016].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the stimulation device yielded by the proposed combination, to provide wherein the stimulation signal applied has a frequency of between 15Hz and 30 Hz, as taught by Ostroff, because certain ranges of frequencies may be effective at treating specific conditions, for instance, most patients who receive peripheral nerve field stimulation prefer the frequency to be between 20 and 50 Hz.
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the stimulation signal applied has a frequency of between 15Hz and 30 Hz. 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 frequency is not disclosed as being crucial or unexpected. Further, a person of ordinary skill in the art would consider a frequency that would not harm the patient, which would include a frequency between 15Hz and 30 Hz. Additionally, Boggs teaches that various stimulation frequency ranges can be applied [0182].
Even if proposed combination fails to yield wherein the stimulation signal applied has a frequency of between 15Hz and 30 Hz, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the stimulation signal applied has a frequency of between 15Hz and 30 Hz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Boggs, II et al. (US 2019/0151660) in view of Rooney et al. (US 2007/0150034) in view of Rajguru et al. (US 2017/0266443) in view of Flaherty et al. (US 2010/0152812) in view of McGee et al. (US 2016/0213927).
In re claim 37, the proposed combination fails to yield wherein the stimulation signal applied has a frequency of 16Hz to 20 Hz.
McGee teaches an electrical stimulation system [0038-0039] that activates peripheral nerves [0038-0039] to treat pain [0039], wherein a stimulation signal applied [0082] has a frequency of 16Hz to 20 Hz ([0082]: low frequencies range from 5Hz - 20Hz).
McGee further teaches that applying low frequencies produces consistent motor activation and modulates pain processing [0082] without producing fatigue which could prevent pain relief [0082]. Furthermore, McGee teaches that stimulation parameters may be adjusted so they can be applied over prolonged periods of times without causing additional pain [0082].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the stimulation device yielded by the proposed combination, to provide wherein the stimulation signal applied has a frequency of 16Hz to 20 Hz, as taught by McGee, because applying stimulation at low frequencies produces consistent motor activation and modulates pain processing without producing fatigue which could prevent pain relief.
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the stimulation signal applied has a frequency of 16Hz to 20 Hz. 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 frequency is not disclosed as being crucial or unexpected. Further, a person of ordinary skill in the art would consider a frequency that would not harm the patient, which would include a frequency of 16Hz to 20 Hz. Additionally, Boggs teaches that various stimulation frequency ranges can be applied [0182].
Even if proposed combination fails to yield wherein the stimulation signal applied has a frequency of 16Hz to 20 Hz, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the stimulation signal applied has a frequency of 16Hz to 20 Hz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Boggs, II et al. (US 2019/0151660) in view of Rooney et al. (US 2007/0150034) in view of Rajguru et al. (US 2017/0266443) in view of Flaherty et al. (US 2010/0152812) in view of Parker (US 2013/0261697).
In re claim 38, the proposed combination fails to yield wherein the stimulation signal applied has an amplitude between 0.1 mA and 20 mA.
Parker teaches spinal cord modulation to inhibit pain [0024] wherein a stimulation signal applied [0081, 0130] has an amplitude between 0.1 mA and 20 mA [0081].
Parker further teaches that stimulation parameters may be varied while still obtaining beneficial results for patients [0081], and that the amplitude may be set an initial level to establish a therapeutic effect and then lowered to save power [0081]. Parker further teaches that modulation can be applied to peripheral nerves to address phantom limb pain [0129].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the stimulation device yielded by the proposed combination, to provide wherein the stimulation signal applied has an amplitude between 0.1 mA and 20 mA, as taught by Parker, because stimulation parameters such as intensity may be varied while still obtaining beneficial results for patients, and that the amplitude may be set an initial level to establish a therapeutic effect and then lowered to save power.
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the stimulation signal applied has an amplitude between 0.1 mA and 20 mA. 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 frequency is not disclosed as being crucial or unexpected. Further, a person of ordinary skill in the art would consider an amplitude that would not harm the patient, which would include an amplitude between 0.1 mA and 20 mA. Additionally, Boggs teaches that various range of intensities can be applied [0182], and that applying stimulation at the correct intensity will provide the patient with a comfortable tingling sensation [0147, 0186]. Boggs further teaches that the stimulation intensity being too high or low will lead to unwanted consequences [0184].
Even if proposed combination fails to yield wherein the stimulation signal applied has an amplitude between 0.1 mA and 20 mA, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the stimulation signal applied has an amplitude between 0.1 mA and 20 mA, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Richmond et al. (US 2002/0120309) discloses stimulators (abstract) implanted alongside injured nerves (abstract) to promote recovery of peripheral nerve injuries (abstract).
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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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796