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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 31-56 are rejected under 35 U.S.C. 101 because of the following analysis:
1 – statutory category: Claims 31-56 recite a series of steps and therefore, falls under the statutory category of being a process. See MPEP 2106.03.
2A – Prong 1: The independent claims 31, 44 and 54 recite a judicial exception by reciting the limitations of “programming a signal generator”. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper. That is, other than reciting “programming a signal generator to,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “programming a signal generator to” language, “delivering” in the context of this claim encompasses the user manually delivering, via at least one implanted signal delivery element, an electrical therapy signal. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. Therefore, an abstract idea is involved.
2A – Prong 2: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The independent claims 31, 44 and 54 recite the additional limitations of “spinal cord stimulation”, etc. The mentioned limitations are recited at a high level of generality and are considered to be data gathering/processing which are mere extra-solution activity. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
2B: The emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Claims 32-43, 45-53, 55-56 depend on claims 31, 44 and 54. The mentioned dependent claims recite the same abstract idea as the independent claims. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the dependent claim recites the limitations of different positions and parameters of the stimulation that are recited at a high level of generality and are mere extra-solution activity, and recited as performing generic computer functions. i.e., data processing. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)).
The additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Thus, claims 31-56 are directed to an abstract idea and are therefore rejected.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims is/are rejected under 35 U.S.C. 103 as being unpatentable over Chitre et al., (US 20100274326; hereinafter Chitre) in view of Kelm et al., (US 20140081358; hereinafter Kelm).
Regarding claim 31. (New) Chitre discloses a method of treating a patient having sensation loss (para 0090), via spinal cord stimulation (para 0090, fig. 1), the method comprising:, programming a signal generator to deliver a non-paresthesia producing electrical signal (para 0027 “use the external programmer 105 to vary the modulation parameters provided to the signal delivery element 110”) having a frequency in a frequency range of 1.2 kHz to 100 kHz (para 0035, 0046, 0048, 0078 “the frequency of the signal (or at least a portion of the signal) can be from about 1.5 kHz to about 100 kHz”) to the patient's spinal cord via at least one implanted signal delivery element (abstract, para 0005, 0022, etc.), but fails to disclose wherein the non-paresthesia producing electrical signal at least partially restores the sensation that was lost, and wherein the sensation was lost in association with diabetic neuropathy.
Chitre does not explicitly disclose at least partially in response to the patient having the sensation loss [performing the steps above] and wherein the non-paresthesia producing electrical signal at least partially restores the sensation that was lost, and wherein the sensation was lost in association with diabetic neuropathy.
However, Kelm teaches a method of treating a patient's sensory impairment, e.g., associated with peripheral neuropathy. The sensory impairment associated with neuropathic disease may be pain or lack/loss of sensation (para 0093, 0112). The lost sensation may include loss of response to a pin prick, pressure, heat, cold and/or electrical test pulse (para 0041, 0051). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chitre such that the method is for treating a patient specifically having sensation loss associated with a neuropathic disease, the method comprising performing the steps above at least partially in response to the patient having the sensation loss in order to at least partially restore the lost sensation, wherein the lost sensation includes loss of response to a pin prick, pressure, heat, cold and/or electrical test pulse, as taught by Kelm, because applying the known method of treatment for neuropathic disease disclosed by Chitre in response to the specific sensation loss associated with a neuropathic disease as taught by Kelm would produce the same expected results. MPEP 2143.I.C.
Regarding claim 32. (New) Chitre as modified by Kelm renders obvious the method of claim 31 wherein the signal generator is implantable (Chitre para 0022), the at least one implanted signal delivery element is positioned in the patient's thoracic vertebral region between T8 and T12 (Chitre, para 0090 “vertebral levels T9, T10, T11, and/or T12”), and the non-paresthesia producing electrical signal has (a) a pulse width in a pulse width range of 10 microseconds to 333 microseconds (Chitre para 0076 “The pulse width (e.g., for just the cathodic phase of the pulses) can vary from about 10 microseconds to about 333 microseconds”), and (b) an amplitude in an amplitude range of 0.5 milliamps to 10 milliamps (Chitre para 0022, 0046, 0048, 0076).
Regarding claim 33. (New) The method of claim 31 wherein the frequency range is from 3 kHz to 20 kHz (Chitre para 0022, 0046, 0048, 0076; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 34. (New) The method of claim 31 wherein the non-paresthesia producing electrical signal has a pulse width in a pulse width range of 10 microseconds to 333 microseconds (Chitre para 0076 “The pulse width (e.g., for just the cathodic phase of the pulses) can vary from about 10 microseconds to about 333 microseconds”; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 35. (New) The method of claim 31 wherein the non-paresthesia producing electrical signal has a pulse width in a pulse width range of 25 microseconds to 35 microseconds (para 0035 “The width of the applied pulses was about 30-35 microseconds”, 0076; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 36. (New) The method of claim 31 wherein the non-paresthesia producing electrical signal has an amplitude in an amplitude range of 0.5 milliamps to 10 milliamps (Chitre para 0022, 0046, 0048, 0076).
Regarding claim 37. (New) The method of claim 31 wherein the at least one implanted signal delivery element is positioned in the patient's thoracic vertebral region Chitre, para 0090).
Regarding claim 38. (New) The method of claim 37 wherein the at least one implanted signal delivery element is positioned in the patient's thoracic vertebral region between T8 and T12, inclusive (Chitre, para 0090 “vertebral levels T9, T10, T11, and/or T12”).
Regarding claim 39. (New) The method of claim 31 wherein the at least one implanted signal delivery element is positioned in the patient's epidural space (Chitre, para 0092).
Regarding claim 40. (New) The method of claim 31 wherein the sensation loss is in the patient's f or leg, and wherein the non-paresthesia producing electrical signal at least partially restores the sensation that was lost in the patient's foot or leg (see rejection of claim 31).
Regarding claim 41. (New) The method of claim 31 wherein the non-paresthesia producing electrical signal at least partially alleviates extremity pain associated with the diabetic neuropathy in addition to restoring the sensation (see rejection of claim 31; Kelm para 0007-0008, 0052, 0112-0113, etc.).
Regarding claim 42. (New) The method of claim 31 wherein the non-paresthesia producing electrical signal at least partially eliminates sensations of tingling, pins-and-needles, and/or electric shock associated with the diabetic neuropathy, in addition to at least partially restoring the sensation (see rejection of claim 31; Kelm para 0007-0008, 0052, 0112-0113).
Regarding claim 43. (New) The method of claim 31 wherein the sensation lost in association with the diabetic neuropathy includes sensation loss caused by diabetes (see rejection of claim 31; Kelm para 0007-0008, 0052, 0112-0113).
Regarding claim 44. (New) Chitre discloses method of treating a patient having a loss of sensation (para 0090), via spinal cord stimulation (para 0090, fig. 1), the method comprising: programming a signal generator to deliver (para 0027 “use the external programmer 105 to vary the modulation parameters provided to the signal delivery element 110”), via at least one implanted signal delivery element (abstract, para 0005, 0022, etc.), a non-paresthesia producing electrical signal having a frequency in a frequency range of 1.2 kHz to 100 kHz to the patient's spinal cord (para 0035, 0046, 0048, 0078 “the frequency of the signal (or at least a portion of the signal) can be from about 1.5 kHz to about 100 kHz”) but fails to disclose loss of sensation associated with diabetic neuropathy, and at least partially in response to the patient having the sensation loss associated with diabetic neuropathy to at least partially restore the sensation that was lost in association with diabetic neuropathy.
However, Kelm teaches a method of treating a patient's sensory impairment, e.g., associated with peripheral neuropathy. The sensory impairment associated with neuropathic disease may be pain or lack/loss of sensation (para 0093, 0112). The lost sensation may include loss of response to a pin prick, pressure, heat, cold and/or electrical test pulse (para 0041, 0051). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chitre such that the method is for treating a patient specifically having sensation loss associated with a neuropathic disease, the method comprising performing the steps above at least partially in response to the patient having the sensation loss in order to at least partially restore the lost sensation, wherein the lost sensation includes loss of response to a pin prick, pressure, heat, cold and/or electrical test pulse, as taught by Kelm, because applying the known method of treatment for neuropathic disease disclosed by Chitre in response to the specific sensation loss associated with a neuropathic disease as taught by Kelm would produce the same expected results. MPEP 2143.I.C.
Regarding claim 45. (New) Chitre as modified by Kelm renders obvious the method of claim 44 wherein the signal generator is implantable, the at least one implanted signal delivery element is positioned in the patient's thoracic vertebral region between T8 and T12 (Chitre, para 0090 “vertebral levels T9, T10, T11, and/or T12”), and the non-paresthesia producing electrical signal has (a) a pulse width in a pulse width range of 10 microseconds to 333 microseconds (Chitre para 0076 “The pulse width (e.g., for just the cathodic phase of the pulses) can vary from about 10 microseconds to about 333 microseconds”), and (b) an amplitude in an amplitude range of 0.5 milliamps to 10 milliamps (Chitre para 0022, 0046, 0048, 0076).
Regarding claim 46. (New) Chitre as modified by Kelm renders obvious the method of claim 44 wherein the frequency range is from 2 kHz to 50 kHz (Chitre para 0022, 0046, 0048, 0076; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 47. (New) Chitre as modified by Kelm renders obvious the method of claim 44 wherein the non-paresthesia producing electrical signal has (a) a pulse width in a pulse width range of 10 microseconds to 333 microseconds (Chitre para 0076 “The pulse width (e.g., for just the cathodic phase of the pulses) can vary from about 10 microseconds to about 333 microseconds”), and (b) an amplitude in an amplitude range of 0.5 milliamps to 10 milliamps (Chitre para 0022, 0046, 0048, 0076).
Regarding claim 48. (New) Chitre as modified by Kelm renders obvious the method of claim 44 wherein the non-paresthesia producing electrical signal has (a) a pulse width in a pulse width range of 25 microseconds to 35 microseconds (para 0035 “The width of the applied pulses was about 30-35 microseconds”, 0076; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)), and (b) an amplitude in an amplitude range of 0.5 milliamps to 10 milliamps (Chitre para 0022, 0046, 0048, 0076).
Regarding claim 49. (New) Chitre as modified by Kelm renders obvious the method of claim 44 wherein the at least one implanted signal delivery element is positioned in the patient's thoracic vertebral region between T8 and T12 (Chitre, para 0090 “vertebral levels T9, T10, T11, and/or T12”), inclusive.
Regarding claim 50. (New) Chitre as modified by Kelm renders obvious the method of claim 44 wherein the non-paresthesia producing electrical signal at least partially eliminates sensations of tingling, pins-and-needles, and/or electric shock associated with the diabetic neuropathy, in addition to at least partially restoring the sensation (see rejection of claim 44; Kelm para 0007-0008, 0052, 0112-0113).
Regarding claim 51. (New) Chitre as modified by Kelm renders obvious the method of claim 44 wherein the sensation loss is in the patient's foot or leg, and wherein the non-paresthesia producing electrical signal at least partially restores the sensation that was lost in the patient's foot or leg (see rejection of claim 44).
Regarding claim 52. (New) Chitre as modified by Kelm renders obvious the method of claim 44 wherein the non-paresthesia producing electrical signal at least partially alleviates extremity pain associated with the diabetic neuropathy in addition to restoring the sensation (see rejection of claim 44).
Regarding claim 53. (New) Chitre as modified by Kelm renders obvious the method of claim 44 wherein the sensation lost in association with the diabetic neuropathy includes sensation loss caused by diabetes (see rejection of claim 44; Kelm para 0007-0008, 0052, 0112-0113).
Regarding claim 54. (New) Chitre discloses a method of treating a patient having sensation loss (para 0090), via spinal cord stimulation (para 0090, fig. 1), the method comprising: directing an electrical signal (para 0027 “use the external programmer 105 to vary the modulation parameters provided to the signal delivery element 110”) having a frequency in a frequency range of 1.2 kHz to 100 kHz (para 0035, 0046, 0048, 0078 “the frequency of the signal (or at least a portion of the signal) can be from about 1.5 kHz to about 100 kHz”) to the patient's spinal cord region via an implanted signal delivery element (abstract, para 0005, 0022, etc.), but fails to disclose sensation loss associated with diabetic neuropathy; wherein the electrical signal at least partially restores the sensation that was lost in association with diabetic neuropathy without causing paresthesia in the patient.
However, Kelm teaches a method of treating a patient's sensory impairment, e.g., associated with peripheral neuropathy. The sensory impairment associated with neuropathic disease may be pain or lack/loss of sensation (para 0093, 0112). The lost sensation may include loss of response to a pin prick, pressure, heat, cold and/or electrical test pulse (para 0041, 0051). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chitre such that the method is for treating a patient specifically having sensation loss associated with a neuropathic disease, the method comprising performing the steps above at least partially in response to the patient having the sensation loss in order to at least partially restore the lost sensation, wherein the lost sensation includes loss of response to a pin prick, pressure, heat, cold and/or electrical test pulse, as taught by Kelm, because applying the known method of treatment for neuropathic disease disclosed by Chitre in response to the specific sensation loss associated with a neuropathic disease as taught by Kelm would produce the same expected results. MPEP 2143.I.C.
Regarding claim 55. (New) Chitre as modified by Kelm renders obvious the method of claim 54 wherein the electrical signal has (a) a pulse width in a pulse width range of 10 microseconds to 333 microseconds (Chitre para 0076 “The pulse width (e.g., for just the cathodic phase of the pulses) can vary from about 10 microseconds to about 333 microseconds”), and (b) an amplitude in an amplitude range of 0.5 milliamps to 10 milliamps (Chitre para 0022, 0046, 0048, 0076).
Regarding claim 56. (New) Chitre as modified by Kelm renders obvious the method of claim 54 wherein the electrical signal at least partially alleviates sensations of tingling, pins-and-needles, and/or electric shock associated with the diabetic neuropathy, in addition to restoring the sensation (see rejection of claim 54; Kelm para 0007-0008, 0052, 0112-0113).
Double Patenting
Claims 31, 44, 54 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 11, 13, 17, 19, 23, 25, 28-29, 30 of U.S. Patent No. 11,986,657 Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 31, 44, 54 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 11, 13, 17, 19, 21, 23, 26 of U.S. Patent No. 12,343,537 Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 31, 44, 54 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-10, 22-24 of U.S. Patent No. 12,133,981 Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 31-57 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-9, 13-18, 23-24 of U.S. Patent No. 12,226,634 Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 31- 57 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-28 of copending Application No. 17/672,447 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31- 57 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-28 of copending Application No. 18/131,791 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31, 44, 54 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 15 and 29 of copending Application No. 18/916,512 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31, 44, 54 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 15-17of copending Application No. 19/239,029 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31, 44, 54 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-10, 13, 17, 19 of copending Application No. 19/238,870 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31, 44, 54 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 24, 27-29, 32, 35-36 of copending Application No. 19/238,870 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31, 44, 54 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 29, 34, 37, 4146, 51 of copending Application No. 17011908 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31, 44, 54 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 29, 31-33, 38, 40, 44, 45-46, 50 of copending Application No. 18338285 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
It is noted that due to the large number of applications/patents, double patenting issues will be reassessed when the claims are in condition of allowance.
Conclusion
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