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 amendments filed 6/19/2026 merit new grounds for rejection in view of Popovic et al. (Pub. No.: US 2016/0051817 A1).
Popovic teaches it is known to use such a modification as set forth in [0128]-[0130] to provide different currents of generated pulses to address impedance variations (e.g. see [0074]) in transcutaneous stimulation ([0071]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the amplitude and impedance in a spinal stimulation application (e.g. see [0181] and [0201]) as taught by Popovic in the system/method of Sharma, since said modification would provide the predictable results of different currents of generated pulses to address impedance variations in transcutaneous stimulation.
The Applicant’s arguments with respect to the Sit reference, previously cited, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On p. 10 of the Remarks dated 6/19/2026, Applicant argues that there is no reason or motivation to specify 3-10mA and 100-700Ohms, starting with Sharma’s broad ranges.
The examiner disagrees, in the new grounds for rejection, Popovic teaches the overlapping ranges of 0 to 5 mA and 5 to 15 mA would provide the predictable results of different currents of generated pulses to address impedance variations (e.g. see [0074]). Impedance variations occur within the context of transcutaneous stimulation, and PHOSITA would have been motivated to modify stimulation parameters for efficacy in any one or more of the stimulations provided by Sharma.
Applicant's arguments with respect to claim 21 filed 6/19/2026 have been fully considered but they are not persuasive.
Applicant 1st argues on pages 11-12: “Karim Does Not Teach Delivering an Electrical Impulse Transcutaneously Through Skin Over or Near a Spinal Fusion Site”.
Karim states “[0033] In certain embodiments, the fractured bone is one or more vertebrae. The bone fracture can be the result of a spinal fusion or can be the result of a compression fracture. The bone stimulator can be attached to the stabilization device along the contours of the orthosis to permit circumferential and uniform bone stimulation. Accordingly, the propensity to fuse a fracture is enhanced. Such stabilization devices include halos, cervical collars, thoracic orthosis, lumbosacral orthosis, thoracolumbar orthosis and peripheral extremity orthosis. In one embodiment, the one or more vertebrae include vertebrae in the cervical, lumbar or thoracic region. In one embodiment, the one or more vertebrae include vertebrae in the lumbar or thoracic region (see FIG. 3). In one embodiment, the one or more vertebrae include vertebrae in the cervical region (see FIG. 4).”
The examiner is interpreting stimulation applied to a fractured vertebra, which may be resulting from a spinal fusion as stimulation applied to a spinal fusion site. Further, stimulation applied from an orthosis is not implanted stimulation but rather stimulation applied through the skin, therefore transcutaneous. Additionally, [0039], [0040], and [0044] also disclose spinal fusion applications of the device/method that apply stimulation to the vertebrae at the spinal fusion site.
Applicant 2nd argues on page 13: “A person of ordinary skill in the art would not look to Karim - an orthotic limb fracture device - to supply the missing limitation of transcutaneous spinal stimulation in Sharma. The anatomical constraints, device form factors, and clinical contexts of limb fracture treatment and spinal fusion treatment are entirely different. Karim's device is designed to wrap around a limb and provide circumferential stimulation while simultaneously immobilizing the fracture site. This structural approach is inapplicable to the spine. The Examiner has not articulated why a skilled artisan would look to a limb orthotic device to solve the problem of delivering transcutaneous electrical stimulation at a spinal fusion site. Furthermore, even assuming arguendo that Karim's background statement could supply some general awareness of spinal stimulation, it would not supply the specific limitation of transcutaneous delivery now recited in the claim. The only delivery modalities Karim specifically describes for bone fusion sites are invasive and semi-invasive (see [0006]), and Karim's own non-invasive solution is limited to a circumferential orthotic for limbs. There is no path from Karim's disclosure to transcutaneous electrical stimulation through skin at a spinal fusion site”.
The examiner is not persuaded. [0033], [0039], [0040], and [0044] all disclose spinal fusion applications of the device/method that apply stimulation to the vertebrae, not limbs. As noted above, stimulation applied from an orthosis is not implanted stimulation but rather stimulation applied through the skin, therefore transcutaneous.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, there is no support in the specification or originally filed claims for the limitation “at an impedance between 100 Ohms to 700 Ohms” for an amplitude range of 3mA to 10mA. See [0102] and [0117] of the applicant’s printed publication for ranges that are supported. The examiner’s review of the originally filed disclosure suggests that the impedance range for a current of 3mA or greater is limited to 450 Ohms-750 Ohms.
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.
Claim(s) 1, 8-11, 13-14, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (Pub. No.: US 2018/0140835 A1); in view of Popovic et al. (Pub. No.: US 2016/0051817 A1); hereinafter referred to as “Popovic”.
Regarding claim 1, Sharma discloses a stimulation system, the system comprising: a stimulation device (e.g. see figure 1 element 100, [0048]) comprising: a signal generator (e.g. see [0038], [0089]), an electrode (e.g. see [0038]) coupled to the signal generator and configured to contact a skin over or near a spine of a user (e.g. see [0038]. Note: This is a functional use limitation the prior art is capable of and/or configured to perform), wherein the electrode is configured to deliver an electrical impulse generated by the signal generator to the skin of the user (e.g. see [0038]), and a sensor (e.g. see figure 2 elements 230-238, [0056]) configured to obtain a physiological parameter of the user; and a software application (e.g. see [0107]-[0113], “software application”) configured for downloading onto a remote device, the software application configured to: a) receive user status information from the user (e.g. see [0103]-[0107], “patient feedback”) and the physiological parameter from the sensor (e.g. see [0103]-[0107], “physiological data”), and b) generate a report based on the user status information and the physiological parameter (e.g. see [0103]-[0107], “report”).
Sharma discloses a pulse amplitude in the range of 0 mA to 500 mA (e.g. see [0089]) but is silent as to the electrical impulse has an amplitude of 3 mA to 10 mA at an impedance between 100 Ohms to 700 Ohms. Popovic teaches it is known to use such a modification as set forth in [0128]-[0130] to provide different currents of generated pulses to address impedance variations (e.g. see [0074]) in transcutaneous stimulation ([0071]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the amplitude and impedance in a spinal stimulation application (e.g. see [0181] and [0201]) as taught by Popovic in the system/method of Sharma, since said modification would provide the predictable results of different currents of generated pulses to address impedance variations in transcutaneous stimulation.
According to MPEP 2144.05, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. The instant specification does not disclose any criticality associated with the claimed amplitude range (see [0102] and [0117] of the applicant’s printed publication). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to use an amplitude of about 3 mA to about 10 mA in the system/method of Sharma, since Popovic teaches the overlapping ranges of 0 to 5 mA and 5 to 15 mA would provide the predictable results of different currents of generated pulses to address impedance variations (e.g. see [0074]).
Regarding claim 8, Sharma discloses the software application is configured to compare the user status information with the physiological parameter over a period of time (e.g. see [0070]-[0073]. Note: [0072] discloses “it is possible that subjective and objective evaluation results may not converge, the patient feedback coupled with statistics may precede physiological measurements”).
Regarding claim 9, Sharma discloses the period of time is at least 24 hours (e.g. see [0003], “more than one or two months”).
Regarding claim 10, Sharma discloses the software application is configured to prompt the user to enter the user status information before, during, or after the electrical impulse is delivered to the user (e.g. see figure 4 element 410 and 440, [0069]-[0070]).
Regarding claim 11, Sharma discloses the software application is configured to prompt the user periodically during or after the electrical impulse is delivered to the user (e.g. see figure 4 element 440, [0069]-[0070]).
Regarding claim 13, Sharma discloses the physiological parameter is obtained at least partially during delivery of the electrical impulse to the skin of the user (e.g. see figure 4 element 440, [0069]-[0070], [0038]).
Regarding claim 14, Sharma discloses the physiological parameter comprises a heart rate (e.g. see [0114]), a blood pressure (e.g. see [0114]), a blood oxygen level (e.g. see figure 2 element 234, [0056]), a blood flow (e.g. see figure 2 element 232, [0056]), or a body temperature (e.g. see figure 2 element 230, [0056]).
Regarding claim 16, Sharma discloses the software application is configured to compare the user status information with the physiological parameter from the sensor (e.g. see [0070]-[0073]. Note: [0072] discloses “it is possible that subjective and objective evaluation results may not converge, the patient feedback coupled with statistics may precede physiological measurements”).
Regarding claim 17, Sharma discloses the software application is configured to generate an additional report on the electrical impulse, or a usage level of the device, or a combination thereof (e.g. see [0103]-[0107]).
Regarding claim 18, Sharma discloses the software application is configured to display the report on the remote device (e.g. see figure 1 elements 112/122, [0113], [0120], [0140]).
Regarding claim 19, Sharma discloses the remote device comprises a mobile device (e.g. see [0101]).
Regarding claim 20, Sharma discloses the electrical impulse is delivered non-invasively (e.g. see [0038]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma and Popovic as applied to claim 1 above, and further in view of Brighton (Pub. No.: US 2008/0215116 A1).
Regarding claim 3, Sharma and Popovic disclose the claimed invention but is silent as to the electrical impulse has a frequency of about 50 kHz to about 70 kHz. Brighton teaches it is known to use such a modification as set forth in figure 3, [0018] to provide maximal therapeutic response in patients with osteoporosis, osteopenia, osteonecrosis, fresh fractures, fractures at risk, delayed unions, nonunion fractures, bone defects, as an adjunct in spinal fusion (e.g. see [0012], [0013], [0018]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use an electrical pulse in the 60 kHz range as taught by Brighton in the system/method of Sharma and Popovic, since said modification would provide the predictable results of maximal therapeutic response in patients with osteoporosis, osteopenia, osteonecrosis, fresh fractures, fractures at risk, delayed unions, nonunion fractures, bone defects, as an adjunct in spinal fusion.
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma and Popovic as applied to claim 1 above, and further in view of Karim (Pub. No.: US 2012/0316482 A1).
Regarding claims 4-5, Sharma and Popovic disclose the claimed invention but is silent as to the user previously underwent a surgical intervention and the surgical intervention comprises a spinal fusion. Karim teaches it is known to use such a modification as set forth in [0031], [0033], [0039], [0040], and [0044] to provide healing or re-calcification to greater degree with the present device (e.g. see [0027]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a bone healing stimulator after spinal fusion surgery as taught by Karim in the system/method of Sharma and Popovic, since said modification would provide the predictable results of healing or re-calcification to greater degree with the present device.
Regarding claim 6, Sharma discloses the electrical impulse is configured to enhance bone healing in the user (e.g. see [0029]-[0030]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma and Popovic in view of Karim as applied to claims 1 and 4 above, and further in view of Yoo et al. (Pub. No. US 2019/0001135 A1); hereinafter referred to as “Yoo”.
Regarding claim 7, Sharma, Popovic, and Karim disclose the user status information comprises a level of pain (e.g. see [0050]) but is silent as to the user status information comprises a mood, a medication use, an activity level, or an amount of sleep. Yoo teaches it is known for the user status information to comprise a level of pain (e.g. see [0135]), a mood (e.g. see [0135]), a medication use (e.g. see [0134]), or an amount of sleep (e.g. see [0135]) to adjust the therapy regimen based upon the user responses to survey questions (e.g. see [0136]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the survey questions as taught by Yoo in the system/method of Sharma, Popovic, and Karim, since said modification would provide the predictable results of adjusting the therapy regimen based upon the user responses to survey questions.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma and Popovic as applied to claim 1 and 10 above, and further in view of Reynolds et al. (Pub. No. US 2017/0277852 A1); hereinafter referred to as “Reynolds”.
Regarding claim 12, Sharma and Popovic disclose the software application is configured to prompt the user (e.g. see figure 4 elements 410 and 440, [0069]-[0070]) but is silent as the software application is configured to prompt the user on an hourly basis. Reynolds teaches it is known to use such a modification as set forth in [0043] to collect sufficient and timely health data to develop a treatment plan (e.g. see [0043]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use prompting on an hourly basis as taught by Reynolds in the system/method of Sharma and Popovic, since said modification would provide the predictable results of collecting sufficient and timely health data to develop a treatment plan.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma and Popovic as applied to claim 1 above, and further in view of Yoo et al. (Pub. No. US 2019/0001135 A1); hereinafter referred to as “Yoo”.
Regarding claim 15, Sharma and Popovic disclose the invention but is silent as to the sensor comprises a motion sensor. Yoo teaches it is known to use such a modification as set forth in [0116]-[0117] to provide advantages such as adjusting therapy in response to user activity (e.g. see [0116]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a motion sensor as taught by Yoo in the system/method of Sharma and Popovic, since said modification would provide the predictable results of advantages such as adjusting therapy in response to user activity.
Claim(s) 21 and 25-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Karim.
Regarding claim 21, Sharma discloses the invention (see the rejection for claim 1 above) and discloses a method for enhancing bone healing in a user (e.g. see [0029]-[0030]) but is silent as to delivering an electrical impulse from an electrode through a skin over or near a spinal fusion site of the user. Karim teaches it is known to use such a modification as set forth in [0031], [0033], [0039], [0040], and [0044] to provide healing or re-calcification to greater degree with the present device (e.g. see [0027]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a bone healing stimulator as taught by Karim in the system/method of Sharma, since said modification would provide the predictable results of healing or re-calcification to greater degree with the present device.
Regarding claim 25, Sharma discloses comparing the user status information with the physiological parameter over a period of time of at least 24 hours (e.g. see [0003], “more than one or two months”).
Regarding claim 26, Sharma discloses prompting the user to enter the user status information before, during, or after the electrical impulse is delivered to the user (e.g. see figure 4 element 440, [0069]-[0070]).
Regarding claim 27, Sharma discloses prompting the user periodically during or after the electrical impulse is delivered to the user (e.g. see figure 4 element 440, [0069]-[0070]).
Regarding claim 28, Sharma discloses prompting the user on an hourly basis (e.g. see figure 4 element 440, [0069]-[0070]).
Regarding claim 29, Sharma discloses generating an additional report on the electrical impulse, or a usage level of the device, or a combination thereof (e.g. see [0103]-[0107]).
Regarding claim 30, Sharma discloses displaying the report on a remote device (e.g. see figure 1 elements 112/122, [0113], [0120], [0140]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma and Karim as applied to claim 21 above, and further in view of Popovic.
Regarding claim 22, Sharma and Karim disclose a pulse amplitude in the range of 0 mA to 500 mA (e.g. see [0089] of Sharma) but is silent as to the electrical impulse has an amplitude of about 3 mA to about 10 mA. Popovic teaches it is known to use such a modification as set forth in [0128]-[0130] to provide different currents of generated pulses to address impedance variations (e.g. see [0074]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the amplitude in a spinal stimulation application (e.g. see [0181] and [0201]) as taught by Popovic in the system/method of Sharma, since said modification would provide the predictable results of different currents of generated pulses to address impedance variations.
According to MPEP 2144.05, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. The instant specification does not disclose any criticality associated with the claimed amplitude range. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to use an amplitude of about 3 mA to about 10 mA in the system/method of Sharma and Karim, since Popovic teaches the overlapping ranges of 0 to 5 mA and 5 to 15 mA would provide the predictable results of different currents of generated pulses to address impedance variations (e.g. see [0074]).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma and Karim as applied to claim 21 above, and further in view of Brighton.
Regarding claim 23, Sharma and Karim disclose the claimed invention but is silent as to the electrical impulse has a frequency of about 50 kHz to about 70 kHz. Brighton teaches it is known to use such a modification as set forth in figure 3, [0018] to provide maximal therapeutic response in patients with osteoporosis, osteopenia, osteonecrosis, fresh fractures, fractures at risk, delayed unions, nonunion fractures, bone defects, as an adjunct in spinal fusion (e.g. see [0012], [0013], [0018]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use an electrical pulse in the 60 kHz range as taught by Brighton in the system/method of Sharma and Karim, since said modification would provide the predictable results of maximal therapeutic response in patients with osteoporosis, osteopenia, osteonecrosis, fresh fractures, fractures at risk, delayed unions, nonunion fractures, bone defects, as an adjunct in spinal fusion.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma and Karim as applied to claim 21 above, and further in view of Yoo.
Regarding claim 24, Sharma and Karim disclose the user status information comprises a level of pain (e.g. see [0050]) but is silent as to the user status information comprises a mood, a medication use, an activity level, or an amount of sleep. Yoo teaches it is known for the user status information to comprise a level of pain (e.g. see [0135]), a mood (e.g. see [0135]), a medication use (e.g. see [0134]), or an amount of sleep (e.g. see [0135]) to adjust the therapy regimen based upon the user responses to survey questions (e.g. see [0136]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the survey questions as taught by Yoo in the system/method of Sharma and Karim, since said modification would provide the predictable results of adjusting the therapy regimen based upon the user responses to survey questions.
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.
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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