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 1-8, 10-18 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a mental process of determining possible pathways, determining transition costs, identifying a path of possible pathways and selecting programming parameters based on the identified path. This judicial exception is not integrated into a practical application because a processor and memory and neurostimulation programming circuity are generically recited computer elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Moreover, the above-identified abstract idea is not integrated into a practical application because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., processor, memory, and neurostimulation programming circuitry as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93. Per Applicant’s specification, the computer system comprising the at least one processor, at least one memory and neurostimulation programming circuitry may be a personal computer (PC), a tablet PC, a hybrid tablet, a personal digital assistant (PDA), a mobile telephone, an implantable pulse generator (IPG), an external remote control (RC), a User's Programmer (CP), or any machine capable of executing instructions. In addition Figure 15 illustrates the additional elements as parts of a generic computer system. Accordingly, in light of Applicant’s specification, the claimed term at least one processor, at least one memory and neurostimulation programming circuitry is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the at least one processor, at least one memory and neurostimulation programming circuitry. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
Dependent claims 2-8, 10, 12-18, and 20 further recite the abstract idea and does not integrate them into a practical application or amount to significantly more than the abstract idea itself.
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.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Claims 1-20 are 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. Claims 1 and 11 require “determining transition costs between the pain experience states involved in each of the possible pathways, wherein respective states of the pain experience states are associated with different pain management characteristics based on therapy with the neurostimulation device”. However, the claims and the specification do not provide any insight into how these functions are being performed by the processor. MPEP 2161.01(I) discloses original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. In addition MPEP 2161.01(I) disclose when examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. The examiner notes the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention.
Dependent claims inherit the same deficiencies.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 1 and 11 require “determining transition costs between the pain experience states involved in each of the possible pathways, wherein respective states of the pain experience states are associated with different pain management characteristics based on therapy with the neurostimulation device”. MPEP 2181(II)(B) discloses for a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite under 35 U.S.C. 112(b). See Net MoneyIN, Inc. V. Verisign. Inc., 545 F.3d 1359, 1367, 88 USPQ2d 1751, 1757 (Fed. Cir. 2008). See also In re Aoyama, 656 F.3d 1293, 1297, 99 USPQ2d 1936, 1939 (Fed. Cir. 2011). Upon review of the written disclosure does not disclose any specific structure or programming, such as an algorithm, that would particularly define how the "determining”, function is achieved by the processor.
As per MPEP 2173.05(g), notwithstanding the permissible instances of including functional recitations within claim language, the use of functional recitations may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). Such is the case here. Where a claim merely recites a function or result to be achieved by a computing device, without any specific structure or programming ascribed to the computing device to perform this function, the boundaries of the claim scope may be unclear. See Halliburton Energy Servs., Inc. V. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008) noting that the Supreme Court explained that a vice of functional claiming occurs "when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty") (quoting General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 371 (1938)). Therefore, the scope of the claim is unclear due to a lack of sufficient precision to permit one endeavoring to practice the invention to adequately determine the metes and bounds thereof. Dependent claims inherit the same deficiencies.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-11, and 13-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grill et al (US Publication 2017/0182322).
Referring to Claim 1, Grill et al teaches a method, performed by a computing device to determine programming of an implantable electrical neurostimulation device for treating a chronic pain condition of a human patient, the method comprising: determining possible pathways to traverse pain experience states of the chronic pain condition, wherein the possible pathways provide respective paths among the pain experience states from a starting state to one or more intermediate states to a goal state (e.g. Figure 1 and Paragraph [0116] discloses combinations of multiple, distinct frequencies); determining transition costs between the pain experience states involved in each of the possible pathways, wherein respective states of the pain experience states are associated with different pain management characteristics based on therapy with the neurostimulation device (e.g. Figure 1 and Paragraphs [0024], [0099], and [0116]); identifying a path of the possible pathways to reach the goal state, based on the transition costs and characteristics of the human patient (e.g. Figure 1 and Paragraph [0116]); selecting programming parameters for use in the neurostimulation device of the human patient to cause a neurostimulation therapy, based on the identified path to achieve the goal state (e.g. Figure 1 and Paragraph [0116]).
Referring to Claim 3, Grill et al teaches the method of claim 1, wherein determining the possible pathways includes identifying the pain experience states and relative rankings of the pain experience states, and wherein the relative rankings are customized to the human patient (e.g. Figure 1, Element 108 ranks the best patterns for survival which are used to determine offspring/pathways (elements 112 and 114)).
Referring to Claim 4, Grill et al teaches the method of claim 3, wherein the relative rankings are customized to the human patient based on a measurement of: one or more preference associated with the human patient, or a resilience of the human patient (e.g. Paragraphs [0025], [0084]-[0085], and [0100]).
Referring to Claim 5, Grill et al teaches the method of claim 1, wherein identifying the path to reach the goal state for the human patient includes use of a path traversal strategy provided from one of: a shortest path independent of the transition costs from the starting state to the goal state; a path with a lowest total cost of the transition costs to traverse from the starting state to the goal state; a path with a lowest initial cost of the transition costs to traverse from the starting state to a first of the one or more intermediate states; or a path with a lowest individual transition costs to traverse from the starting state to the one or more intermediate states to the goal state (e.g. Paragraphs [0116] and [0121] and Figure 9).
Referring to Claim 6, Grill et al teaches the method of claim 5, wherein the path traversal strategy is selected for the human patient based on one or more preference associated with the human patient or resilience associated with the human patient (e.g. Paragraphs [0116]-[0117] and [0120]).
Referring to Claim 7, Grill et al teaches the method of claim 1, wherein the pain experience states are associated with defined attributes based on one or more of: medication management, pain level, emotional state, or mobility; wherein the goal state is associated with an attribute that provides an improvement of one or more of: a sleep state, a mobility state, a medication state, an emotional state, or a pain level measurement (e.g. Paragraph [0083] discloses optimization of pain suppression and Paragraphs [0084]-[0085]).
Referring to Claim 8, Grill et al teaches the method of claim 1, wherein selecting the programming parameters for use in the neurostimulation device of the human patient includes a selection or recommendation of one or more program that includes the programming parameters (e.g. Paragraphs [0114] and [0116]); wherein each of the respective states used in the possible pathways is associated with a separate program used for the neurostimulation device that includes respective combinations of the programming parameters (e.g. Paragraphs [0114] and [0116]).
Referring to Claim 9, Grill et al teaches the method of claim 1, further comprising outputting the programming parameters to the neurostimulation device of the human patient, and wherein deployment of the programming parameters within one or more neurostimulation program causes a change in operation of the implantable electrical neurostimulation device ((e.g. Paragraphs [0006]-[0007], [0027] and [0085]).
Referring to Claim 10, Grill et al teaches the method of claim 1, wherein the implantable electrical neurostimulation device is further configured to treat the chronic pain condition by delivering at least one of: an electrical spinal cord stimulation, an electrical brain stimulation, or an electrical peripheral nerve stimulation, in the human patient (e.g. Paragraph [0002]); wherein the programming parameters cause a change in programming for the implantable electrical neurostimulation device for one or more of: pulse patterns, pulse shapes, a spatial location of pulses, waveform shapes, or a spatial location of waveform shapes, for modulated energy provided with a plurality of leads of the implantable electrical neurostimulation device (e.g. Paragraphs [0006] and [0116]).
Referring to Claim 11, Grill et al teaches a device to determine programming of an implantable electrical neurostimulation device for treating a chronic pain condition of a human patient, the device comprising: at least one processor and at least one memory (e.g. Paragraph [0113] discloses the SCS device includes a processor and memory); pain experience state evaluation circuitry, operable with the at least one processor and the at least one memory, configured to: determine possible pathways to traverse pain experience states of the chronic pain condition, wherein the possible pathways provide respective paths among the pain experience states from a starting state to one or more intermediate states to a goal state (e.g. Figure 1 and Paragraph [0116]); determine transition costs between the pain experience states involved in each of the possible pathways, wherein respective states of the pain experience states are associated with different pain management characteristics based on therapy with the neurostimulation device (e.g. Figure 1 and Paragraphs [0024], [0099], and [0116]); identify a path of the possible pathways to reach the goal state, based on the transition costs and characteristics of the human patient (e.g. Figure 1 and Paragraph [0116]); neurostimulation programming circuitry, in operation with the at least one processor and the at least one memory, configured to: select programming parameters for use in the neurostimulation device of the human patient to cause a neurostimulation therapy, based on the identified path to achieve the goal state (e.g. Figure 1 and Paragraph [0116]).
Referring to Claim 13, Grill et al teaches the device of claim 11, wherein to determine the possible pathways includes to identify the pain experience states and relative rankings of the pain experience states, and wherein the relative rankings are customized to the human patient (e.g. Figure 1, Element 108 ranks the best patterns for survival which are used to determine offspring/pathways (elements 112 and 114)).
Referring to Claim 14, Grill et al teaches the device of claim 13, wherein the relative rankings are customized to the human patient based on a measurement of: one or more preference associated with the human patient, or a resilience of the human patient (e.g. Paragraphs [0025], [0084]-[0085], and [0100]).
Referring to Claim 15, Grill et al teaches the device of claim 11, wherein to identify the path to reach the goal state for the human patient includes use of a path traversal strategy provided from one of: a shortest path independent of the transition costs from the starting state to the goal state; a path with a lowest total cost of the transition costs to traverse from the starting state to the goal state; a path with a lowest initial cost of the transition costs to traverse from the starting state to a first of the one or more intermediate states; or a path with a lowest individual transition costs to traverse from the starting state to the one or more intermediate states to the goal state (e.g. Paragraphs [0007], [0116] and [0121] and Figure 9).
Referring to Claim 16, Grill et al teaches the device of claim 15, wherein the path traversal strategy is selected for the human patient based on one or more preference associated with the human patient or resilience associated with the human patient ((e.g. Paragraphs [0116]-[0117] and [0120]).
Referring to Claim 17, Grill et al teaches the device of claim 11, wherein the pain experience states are associated with defined attributes based on one or more of: medication management, pain level, emotional state, or mobility; wherein the goal state is associated with an attribute that provides an improvement of one or more of: a sleep state, a mobility state, a medication state, an emotional state, or a pain level measurement (e.g. Paragraph [0083] discloses optimization of pain suppression and Paragraphs [0084]-[0085]).
Referring to Claim 18, Grill et al teaches the device of claim 11, wherein to select the programming parameters for use in the neurostimulation device of the human patient includes a selection or recommendation of one or more program that includes the programming parameters (e.g. Paragraphs [0114] and [0116]); wherein each of the respective states used in the possible pathways is associated with a separate program used for the neurostimulation device that includes respective combinations of the programming parameters (e.g. Paragraphs [0114] and [0116]).
Referring to Claim 19, Grill et al teaches the device of claim 11, wherein the neurostimulation programming circuitry is further configured to output the programming parameters to the neurostimulation device of the human patient, and wherein deployment of the programming parameters within one or more neurostimulation program causes a change in operation of the implantable electrical neurostimulation device (e.g. Paragraphs [0006]-[0007], [0027] and [0085]).
Referring to Claim 20, Grill et al teaches the device of claim 11, wherein the implantable electrical neurostimulation device is further configured to treat the chronic pain condition by delivering at least one of: an electrical spinal cord stimulation, an electrical brain stimulation, or an electrical peripheral nerve stimulation, in the human patient (e.g. Paragraph [0002]); wherein the programming parameters cause a change in programming for the implantable electrical neurostimulation device for one or more of: pulse patterns, pulse shapes, a spatial location of pulses, waveform shapes, or a spatial location of waveform shapes, for modulated energy provided with a plurality of leads of the implantable electrical neurostimulation device (e.g. Paragraphs [0006] and [0116]).
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.
Claim(s) 2 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grill et al (US Publication 2017/0182322) in view of McDonald (US Publication 2020/0282218).
Referring to Claims 2 and 12, Grill et al teaches the claimed invention, wherein the transition costs are determined based on a frequency of transitions associated with the patients (e.g. Paragraph [0100]). However, Grill et al does not explicitly disclose wherein the pain experience states are determined based on pain experience data collected from a population of patients. McDonald teaches that it is known to use the pain experience states are determined based on pain experience data collected from a population of patients as set forth in Paragraph [0062] to provide improved distinguishing of typical pain making evaluations more consistent and reducing anomalies. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Grill et al, with the pain experience states are determined based on pain experience data collected from a population of patients as taught by McDonald, since such a modification would provide the predictable results of distinguishing of typical pain making evaluations more consistent and reducing anomalies.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Grill et al (US Publication 2010/0152807) discloses the voltage output of several candidate temporal patterns of stimulation can be evaluated and the cost calculated.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights