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 .
Amendment
This action is in response to the Amendment filed on 4/1/2026.
Claims 193-212 are pending.
Response to Arguments
Applicant's arguments with respect to claims 193-212 have been fully considered but are not persuasive.
Claim Rejections - 35 U.S.C. § 103 - Klostermann in view of Denker.
Amended Independent claim 193 recites:
A medical system for a patient, comprising:
1.an external device comprising an external antenna, wherein the external device is configured to transmit power and a periodic signal to an implantable device; and
2. the implantable device, wherein the implantable device is configured to receive the power and the periodic signal from the external device, and comprises an implantable antenna and at least one functional element configured to one or both of neuromodulate tissue of the patient or record patient information, and
3. wherein the system is configured to enter a “warning state” when one or both of: the implantable device does not reply to the periodic signal or the implantable device does not receive the periodic signal, the “warning state comprising an alarm” for the patient to adjust a position of the external antenna relative to the implantable antenna to improve a coupling therebetween.
Applicant argues that Klostermann and Denker, alone or in combination, fail to teach or suggest a system configured to enter a warning state when one or both of the implantable device does not reply to the periodic signal or the implantable device does not receive the periodic signal, where the warning state comprises an alarm for the patient to adjust a position of the external antenna relative to the implantable antenna.
Applicant’s argument that Denkler’s alarm is different from the Applicant's claimed warning state in both its nature and its purpose and that a skilled artisan would not have been motivated to modify Klostermann's system to include a warning state directed to positional adjustment of the external antenna relative to the implantable antenna is not also persuasive.
While the claim has been amended to define the “warning state” as comprising an alarm, the claim as recited just requires an alarm. The language “for the patient to adjust a position of the external antenna relative to the implantable antenna to improve coupling therebetween” is intended use since the actions after the alarm is outputted are actions that are intended to be performed once the alarm signal is output from the system. The claim does not recite any testing of the alignment of the external antenna with respect to the internal antenna. The claim as recited just requires that when a condition is met a warning state that comprises an alarm is reached, the condition being that the implantable device does not reply to or receive the periodic signal.
Klostermann teaches sending a periodic signal and but does teach providing an alarm when the signal is not received by the implantable device. Denker teaches providing an alarm via a speaker (e.g. 118 Fig.3) or a visual indication (e.g. [0043]: Data specifying operational conditions of the implanted medical device 15 also can be transmitted via the second wireless signal 68. For example, if the implanted medical device 15 fails to receive the first wireless signal 53 for a predefined period of time. The control circuit 55 generates alarm data which it transmitted via the second wireless signal 68 to alert a data receiver outside the patient of a malfunction of the cardiac pacing system 10. When the extracorporeal power supply 14 receives the second wireless signal 68, the data receiver 116 extracts data which then is transferred to the control circuit 106. Upon interpreting the data as indicating an alarm condition, control circuit 106 activates an alarm, such as by producing an audio signal via a speaker 118 or activate light emitters to produce a visual indication of the alarm.) Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Klostermann with the external device being capable of charging the IMD and with the system entering a warning state that comprises an alarm when the internal device does not receive a signal for a predefined time as taught by Denker in order to provide the predictable results of having a more efficient system with external devices that can be used to transmit power as well as data as and when required and providing safety and adequate warning to the user for intervention when required.
Double Patenting
Applicant states that they will consider filing a terminal disclaimer after receiving an indication that the claims are allowable. Therefore, the double patenting rejection has been maintained.
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.
Claims 193, 194,197,198 and 207-212 are rejected under 35 U.S.C. 103 as being unpatentable over Klostermann et al (U.S. Patent Application Publication Number: US 2007/0049991 A1, hereinafter Klostermann”- PREVIOUSLY CITED) in view of Denker et al (U.S. Patent Application Publication Number: US 2007/0156204 A1, hereinafter “Denker” - PREVIOUSLY CITED).
Regarding claim 193 and 194, Klostermann teaches a medical system for a patient, comprising:
an external device (i.e. external component such as a hand-held programmer HHP 202 or clinician programmer CP 204 e.g. [0028], [0030]) configured to transmit a periodic signal (e.g. [0009]: broadcast wake up procedure) to an implantable device (e.g. IPG 100, i.e. the external component sends a periodic broadcast wake- up signal as seen by the code transmitted by the external component in Fig. 6); and
an implantable device (e.g. IPG 100) comprising an antenna 250 (e.g. [0030]) configured to receive the power and the periodic signal from the external device, wherein the implantable device comprises at least one functional element configured to one or both of neuromodulate tissue of the patient (e.g. [0024], [0026]: spinal cord stimulation, etc.) and record patient information.
Klosterman also teaches a separate charger for charging the implantable device IPG 100 (e.g. [0028], [0032]), and also receiving information about the battery status so that the external programmer can calculate the estimated time to recharge (e.g. [0040]).
Klostermann does not specifically teach that the external component devices such as the hand-held programmer HHP 202 or clinician programmer CP 204 are configured to provide power to the implantable device. Klostermann also does not specifically teach that wherein the system is configured to enter a warning state that comprises an alarm when one or both of:
the implantable device does not reply to the periodic signal and
the implantable device does not receive the periodic signal.
In a similar field of endeavor, Denker teaches a system comprising an implantable device comprising an antenna (e.g. 15 Fig. 3, [0023]) and an external device (e.g. 14 Fig.5, [0023]) comprising an antenna. They further teach providing power and data (i.e. first wireless signal 53 provides power and data) from the external device to the internal device (e.g. [0012], [0015], [0023],[0028]). They further teach that the system is configured to enter a warning state that comprises an alarm when the implantable device does not receive the signal (e.g. [0043]: if the implanted medical device 15 fails to receive the first wireless signal 53 for a predefined period of time. The control circuit 55 generates alarm data which it transmitted via the second wireless signal 68 to alert a data receiver outside the patient of a malfunction of the cardiac pacing system 10. When the extracorporeal power supply 14 receives the second wireless signal 68, the data receiver 116 extracts data which then is transferred to the control circuit 106. Upon interpreting the data as indicating an alarm condition, control circuit 106 activates an alarm, such as by producing an audio signal via a speaker 118 or activate light emitters to produce a visual indication of the alarm. An alarm indication also can be sent via the serial data interface 104 to an external device, such as personal computer 100. In other situations, a wireless communication apparatus, such as a cellular telephone, may be integrated into the extracorporeal power supply 14 to transmit an alarm signal to a central monitoring facility). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Klostermann with the external device being capable of charging the IMD and with the system entering a warning state when the internal device does not receive a signal for a predefined time as taught by Denker in order to provide the predictable results of having a more efficient system with external devices that can be used to transmit power as well as data as and when required and providing safety and adequate warning to the user for intervention when required. (Note: As discussed above, the limitation “for the patient to adjust a position of the external antenna relative to the implantable antenna is intended use since the actions after the alarm is outputted are actions that are intended to be performed once the alarm signal is output from the system. The claim does not recite any testing of the alignment of the external antenna with respect to the internal antenna. The claim as recited just requires that when a condition is met a warning state that comprises an alarm is reached, the condition being that the implantable device does not reply to or receive the periodic signal).
Page 2 of 64823-1328-8702Appl. No. 16/266,822 Attorney Docket No. 47476-704.302Regarding claim 197, Klostermann in view of Denker teaches the claimed invention as discussed above, and Klostermann further teaches that the implantable device is further configured to maintain a timing of neuromodulation of the tissue of the patient based on the periodic signal (e.g. [0028] Fig. 6 shows that once the periodic wake up signal from the external device is recognized, the IPG receives the control data that comprises parameters setting such as pulse width, amplitude and rate and therefore they teach that IPG is further configured to maintain a timing of neuromodulation of the tissue of the patient based on the periodic signal).
Regarding claim 198, Klostermann in view of Denker teaches the claimed invention as discussed above and since they teach that the system enters a warning state when the signal is not received within a predetermined period of time they teach that the system is configured to maintain operation of a power and data link between the external device and the implantable device within a predetermined quality range based on the periodic signal.
Amdt. dated November 8, 2021Regarding claim 207, Klostermann in view of Denker teaches the claimed invention as discussed above, and Klostermann further teaches that the system is further configured to provide treatment for a medical condition comprising one or more of: medically refractory angina, a movement disorder, pain, chronic critical limb ischemia, complex regional pain syndrome, a condition treated using deep brain stimulation (e.g. [0024]), medically refractory epilepsy, failed back surgery syndrome, fecal constipation, fecal incontinence, urinary incontinence (e.g. [0024]), a urologic disorder, a gastric disorder, GERD, chronic indigestion, gastroparesis, obesity, diabetes, medically refractory headaches, migraine treatment, neuropathy, neuropathic pain, peripheral neuropathy, pelvic floor dysfunction, Parkinson's disease, and spasticity.
Regarding claim 208, Klostermann in view of Denker teaches the claimed invention as discussed above, and Klostermann further teaches that the at least one functional element is configured to neuromodulate the tissue of the patient by delivering stimulation to the tissue of the patient, the stimulation comprising one or more of spinal cord stimulation (e.g. [0001], [0024],[0026]), vagus nerve stimulation, gastric stimulation, sacral nerve stimulation, auditory brainstem stimulation, occipital nerve stimulation, and peripheral nerve stimulation.
Regarding claim 209, Klostermann in view of Denker teaches the claimed invention as discussed above and Klostermann further teaches that the at least one functional element is configured to neuromodulate the tissue (e.g. [0004], [0024],[0026], [0033],[0034])of the patient via one or more of nerve activation, inhibition of nerve activity, and inhibition of propagation of neural signaling.
Regarding claim 210 and 211, Klostermann in view of Denker teaches the claimed invention as discussed above and Klostermann further teaches that the periodic signal comprises a control signal (e.g. [0009],[0049] Fig. 6: the external device broadcasts a wake up signal periodically) configured to control a state of the implantable device and wherein the state of the implantable device comprises an active state (i.e. power-on state) and an inactive state (i.e. powered off state).
Regarding claim 212, Klostermann in view of Denker teaches the claimed invention as discussed above, and Klostermann further teaches that the periodic signal comprises a control signal that is further configured to control a duty cycle of the implantable device (e.g. [0028] Fig. 6 shows that once the periodic wake up signal from the external device is recognized, the IPG receives the control data that comprises parameters setting such as pulse width, amplitude and rate and therefore they teach that the control signal is configured to control a duty cycle of the IPG).
Claims 195, 201 and 202 are rejected under 35 U.S.C. 103 as being unpatentable over Klostermann et al (U.S. Patent Application Publication Number: US 2007/0049991 A1, hereinafter Klostermann” - PREVIOUSLY CITED) in view of Denker et al (U.S. Patent Application Publication Number: US 2007/0156204 A1, hereinafter “Denker” - PREVIOUSLY CITED) and further in view of Yakolev (U.S. Patent Application Publication Number: US 2013/0215979 A1, hereinafter “Yakolev” - PREVIOUSLY CITED).
Regarding claims 195, Klostermann in view of Denker teaches the claimed invention as discussed above, and Klostermann further teaches that the device comprises an implantable antenna (e.g. 170 Fig.3). Klostermann does not specifically teach that the data is transmitted to the external antenna by varying a load coupled to the implantable antenna and wherein the medical apparatus is configured to provide asynchronous transfer of data and wherein the external device is further configured to transmit the data to the implantable device using an ASK modulated signal that comprises pulse width and that the data is encoded in the pulse width.
In a similar field of endeavor, Yakolev teaches a method and apparatus for efficient communication with implantable medical devices and also teach that it is well known to use an asynchronous modulation scheme such as amplitude shift keying (ASK) to transfer data (e.g. Abstract) to communicate with implantable medical devices and also teaches the use of a variable load connected to the at least one implantable antenna, wherein data is transmitted by varying the load (e.g. Fig. 9, [0042]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the system of Klostermann in view of apparatus of Denker to have a variable load and transmit by varying the load and to provide asynchronous transfer of data between the external system and the implantable medical device as taught by Yakovlev in order to provide the predictable results of having a more efficient way of communication.
Claims 203-206 are rejected under 35 U.S.C. 103 as being unpatentable over Klostermann et al (U.S. Patent Application Publication Number: US 2007/0049991 A1, hereinafter Klostermann” - PREVIOUSLY CITED) in view of Denker et al (U.S. Patent Application Publication Number: US 2007/0156204 A1, hereinafter “Denker” - PREVIOUSLY CITED) and Yakolev (U.S. Patent Application Publication Number: US 2013/0215979 A1, hereinafter “Yakolev” - PREVIOUSLY CITED) and further in view of Aghassian (U.S. Patent Application Publication Number: US 2010/0137948 A1, hereinafter “Aghassian” - PREVIOUSLY CITED).
Regarding claim 201 and 202, Klostermann in view of Denker and Yakolev teaches the claimed invention as discussed above, however Klostermann does not specifically teach that the transmission of the data is reconfigurable and comprises an adjustable parameter comprising one or more of data rate, pulse width, and modulation depth. Aghassian teaches calculating the depth at which an implantable medical device is implanted (e.g. Fig. 7, [0013]) and adjusting therapy based on the depth at which the device is implanted and therefore they teach that the reconfigurable transmission of the data comprises one or more of data rate, modulation depth and pulse width. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Klostermann in view of Denker and Yakolev with determining depth of the implantable medical device and adjusting the transmission as taught by Aghassian in order to provide the predictable results of ensuring a more accurate transmission between the devices.
Claims 203, 205 and 206 are rejected under 35 U.S.C. 103 as being unpatentable over Klostermann et al (U.S. Patent Application Publication Number: US 2007/0049991 A1, hereinafter Klostermann” - PREVIOUSLY CITED) in view of in view of Denker et al (U.S. Patent Application Publication Number: US 2007/0156204 A1, hereinafter “Denker” - PREVIOUSLY CITED) and further in view of Hill et al (U.S. Patent Application Publication Number: US 2007/0213773 A1, hereinafter “Hill” - PREVIOUSLY CITED).
Regarding claims 203, 205, 206, Klostermann in view of Denker teaches the claimed invention as discussed above, and while Klostermann teaches that the apparatus is an SCS system (e.g. [0024]), they do not specifically teach that the implantable device if further configured to adjust the stimulation parameters in real-time based on closed-loop feedback wherein the stimulation parameters are patient parameters and the external device adjusts the stimulation waveform.
Hill teaches a closed loop neuromodulation system with an implantable neural stimulator and one or more sensors to provide real-time closed loop feedback control and wherein a treatment parameter is adjusted based on sensed change in patient parameter (e.g. [0031] claims 1-19). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the system of Klostermann in view of Aghassian to closed loop feedback to adapt the performance of the apparatus in real time as taught by Hill in order to provide the predictable results of providing a more effective stimulation therapy.
Claim 204 is rejected under 35 U.S.C. 103 as being unpatentable over Klostermann et al (U.S. Patent Application Publication Number: US 2007/0049991 A1, hereinafter Klostermann” - PREVIOUSLY CITED) in view of in view of Denker et al (U.S. Patent Application Publication Number: US 2007/0156204 A1, hereinafter “Denker”) and Hill et al (U.S. Patent Application Publication Number: US 2007/0213773 A1, hereinafter “Hill” - PREVIOUSLY CITED) and further in view of Aghassian (U.S. Patent Application Publication Number: US 2010/0137948 A1, hereinafter “Aghassian” - PREVIOUSLY CITED).
Regarding claim 204,Resp. to Office Action of October 7, 2021 Klostermann in view of Denker and Hill teaches the claimed invention as discussed above, but does not specifically teach adjusting the stimulation based on performance of the implantable device. Aghassian further teaches that the depth at which the implantable medical device is implanted is calculated and the stimulation is adjusted based on depth of the implantable device (e.g. Fig. 7, [0013]) and therefore they teach at the treatment parameter is adjusted based on performance of the implantable device. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Klostermman in view of Denker and Hill and adjust the stimulation based on the performance of the implanted device as taught by Aghassian in order to provide the predictable results of providing a more effective and customized therapy to the patient.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 193-212 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-22 of U.S. Patent No. US 11633151. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader and overlaps the subject matter of US Patent Number US 11633151 since both claims comprise an external and an implantable device comprising an external and an implantable antenna configured to transmit and receive a power and a periodic signal and wherein the implantable device comprises at least one functional element configured to one or both of neuromodulate tissue of the patient and record patient information, wherein the system is configured to enter a warning state that comprises an alarm when one or both of: the implantable device does not reply to the periodic signal and the implantable device does not receive the periodic signal. Further the dependent claims of the current application recite limitations which are similar to or are broader and overlap subject matter of US Patent Number US 11633151. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Keenan et al (U.S. Patent Application Publication Number: US 2011/0313493 A1, hereinafter “Keenan”) teaches an external device comprising an antenna and an implantable medical device (IMD) comprising an antenna (e.g. [0024) and teaches that the implantable device and performing proximity testing comprising a plurality of proximity test signals and for each of the plurality of proximity test signals, the processor determines whether a response has been received from the external device within a certain time after sending the corresponding proximity signal to determine position of the external antenna with respect to the IMD antenna and providing a warning signal (e.g. [0025]: "alarm proximity tests have failed-press green button to continue").
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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