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 06/18/2026 have been fully considered but are not persuasive or are moot in view of a new grounds of rejection.
Applicant argues, “Flaherty's Field of the Invention states that it "relates generally to systems and methods for causing nerve cells to regenerate and, more particularly, to systems and methods for promoting nerve regeneration in the central and peripheral nervous systems of mammals" (Flaherty 0002). In other words, when a reference is actually in the nerve-regeneration field, it says so and addresses regeneration-specific problems. Flaherty's Background discusses damaged or severed nerves, the limits of natural regeneration, surgical nerve grafting, and the need for an improved nerve regeneration system that can optimize treatment parameters without invasive exploratory techniques (Flaherty 0004- 0010)…. Flaherty therefore supports Applicant's narrower field-of-endeavor framing: the relevant field is injured-nerve regeneration or healing, not electrical stimulation generally.”
Applicant further argues that Boggs, Rooney, and Rajguru are nonanalogous art.
In response to applicant's argument that Boggs, Rooney, and Rajguru are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
In this case, Rooney, Rajguru, and Flaherty are considered analogous to Boggs, as discussed below:
Boggs is directed to delivering electrical stimulation to treat pain [0002], and is further directed to providing electrical stimulation to a peripheral nerve [0023-0025].
Rooney is directed to delivering electrical stimulation to tissue and nerves [0015] to alleviate pain [0015]. Furthermore, Rooney teaches that stimulation can involve a lead positioned proximate or in contact with the peripheral nerve [0020] that is responsible for pain sensation to treat pain [0020].
Therefore, Rooney is in the same field of the inventor’s endeavor and reasonably pertinent to the particular problem with which the inventor was concerned, since Rooney is directed to treating pain through electrical stimulation.
Similarly, Rajguru also teaches treating pain [0020] by stimulating a target nerve [0021], and 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]. Thus, Rajguru is also in the same field of the inventor’s endeavor and reasonably pertinent to the particular problem with which the inventor was concerned.
Finally, Flaherty is directed to promoting nerve regeneration in peripheral nervous systems [0002, 0052], and does so through nerve regeneration treatments [0052] which include stimulating a damaged nerve [0012].
Furthermore, Flaherty teaches that nerve regeneration treatments restore signal transmission capabilities of nervous systems [0052] by restoring motor and sensory functions [0052] of damaged nerves [0052].
Thus, Flaherty is also in the same field of the inventor’s endeavor and reasonably pertinent to the particular problem with which the inventor was concerned.
Applicant argues, “the rejection is the product of impermissible hindsight reconstruction. Even under the flexible obviousness framework of KSR, "a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Rather, the Office must identify an articulated reason, with rational underpinning, that would have led a person of ordinary skill in the art to combine the teachings in the manner claimed.”
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
For instance, Rooney is used to teach “placing a lead in close proximity to a target nerve” to treat pain (Rooney: [0020]).
Rajguru is used to teach “activating excitable tissue of the target nerve for a total therapy duration that comprises less than 30 minutes promoting healing of the target nerve” because the total stimulation period can occur from 0 minutes to 100 minutes, depending on the symptoms needing to be treated (Rajguru: [0352]), and that stimulation may provide accelerated healing (Rajguru: [0271]) as well as nerve repair/regeneration (Rajguru: [0271]).
Flaherty is used to teach,
placing a lead [0012] in 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 provide placing the lead in proximity to an injured target nerve once an injured target nerve is detected, and stimulating 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.
The proposed combination would yield wherein during the surgery of Boggs, an injured target nerve is detected, and therefore stimulation would be provided to the injured target nerve to promote healing.
Applicant argues, “Boggs therefore supplies, at most, a pain-treatment sequence for creating comfortable sensations or pain relief in connection with amputation. It does not supply the claimed purpose of stimulating an injured target nerve using parameters selected to promote healing of that injured nerve.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As discussed above, the proposed combination is used to yield the limitations directed to the injured target nerve.
Applicant argues, “But Rajguru's specific timing disclosure is directed to stimulation through glabrous skin at parameters that "overcome or avoid habituation" of the targeted tissue, including a 10-minute stimulation interval followed by an automatic pause or stop (Rajguru 0351). Rajguru's broad list of possible conditions states generally that stimulation may be used for many different purposes, including atrophy prevention, nerve repair/regeneration, chronic pain, phantom pain, and tissue healing (Rajguru 0271)….Moreover, Rajguru teaches away from using its timing protocol for the purpose of promoting healing of an injured target nerve. Rajguru's 10-minute stimulation interval followed by a pause is expressly designed to "overcome or avoid habituation of the targeted tissue to the stimulation" (Rajguru 0351).”
Examiner respectfully states that although Rajguru may have a different purpose for providing a 10-minute stimulation interval followed by an automatic pause or stop (e.g. overcome or avoid habituation) than the instant invention, it is merely used to teach that the total therapy duration may be adjusted as needed, since Rajguru 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].
Regardless, regarding the limitation, “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”, at the time the instant application was filed it would be obvious to try to provide 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. 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 total therapy duration time is not disclosed as being crucial or unexpected, and also as evidenced by Rajguru as discussed above.
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, “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”, at the time the instant application was filed it would be obvious to try to provide 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. 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 total therapy duration time is not disclosed as being crucial or unexpected, and also as evidenced by Rajguru, which teaches a 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), and 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].
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 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 provide placing the lead in proximity to an injured target nerve once an injured target nerve is detected, and stimulating 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.
The proposed combination would yield wherein during the surgery of Boggs (see above), an injured target nerve is detected, and therefore stimulation would be provided to the injured target nerve to promote healing.
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.
Claims 13 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 2010/0152812) in view of Rooney et al. (US 2007/0150034) [in view of Rajguru et al. (US 2017/0266443)].
In re claim 13, Flaherty discloses a method [0002] for stimulating tissue [0012-0013], comprising:
providing a stimulation device [0011-0015];
placing a lead [0012] in proximity to an injured target nerve [0012, 0058],
wherein the lead is operatively attached to the stimulation device [0011-0012];
applying a first stimulation signal to the injured target nerve with the lead and the stimulation device [0014, 0133];
terminating the applying the first stimulation signal ([0133-0137]: nerve treatment regimen is started and then a determination is made to modify treatment regimen, which would terminate the first stimulation signal; fig. 7; [0063]);
applying, after terminating the application of the first stimulation signal, a second stimulation signal to the injured target nerve ([0133-0137]: modified stimulation signal after treatment is modified is a second stimulation signal applied; fig. 7),
directly activating excitable tissue of the injured target nerve for a total therapy duration that comprises less than 60 minutes ([0111]: therapeutic treatments, including energy stimulation, may be done for less than one hour) 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; [0023]).
Flaherty fails to disclose
placing a lead [0012] in close proximity to an injured target nerve,
performing, after terminating the application of the first stimulation signal, a subcutaneous surgery; and
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 Flaherty, 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 limitations, “performing, after terminating the application of the first stimulation signal, a subcutaneous surgery”, Flaherty teaches that multiple electrical signals may be administered [0054] and adjusted [0054, 0133-0137] over time [0115]. Therefore, if the method of Flaherty would take place over several weeks or even months, and a patient needed subcutaneous surgery in between treatment sessions, then they would receive the subcutaneous surgery after terminating application of a stimulation signal.
In other words, at the time the instant application was filed it would be obvious to try to provide performing, after terminating the application of the first stimulation signal, a subcutaneous surgery, because the process of Flaherty may take place over an extended period of time, and a patient may require a surgery during that period of time.
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 times when surgery may be performed, one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success, especially because a person who needed subcutaneous surgery would receive the subcutaneous surgery even if it was during the treatment method of Flaherty (yielding stimulation to occur before and after the surgery).
“Regarding the limitation, “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”, at the time the instant application was filed it would be obvious to try to provide 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.
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 total therapy duration time is not disclosed as being crucial or unexpected, and also as evidenced by Rajguru, as discussed above (In re claim 13, as rejected under 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 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 promoting healing of the injured target nerve”,
see in re claim 13 above.
Conclusion
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.
Contact
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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