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 § 112
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.
Claims 2-19 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.
In claim 2, line 2, “one electrode of the plurality of electrodes” is vague as claim 1, line 11, uses “one or more electrodes” to deliver the therapy. It is unclear if the “one” electrode in claim 2 is the same as the one electrode in claim 1 (if it is, then “the one” should be used in claim 2). In addition, it is unclear if claim 2 should use “the one or more electrodes” since that term is used in claim 1 to deliver the therapy. In line 4 and 6, “acquiring…” is vague as it is unclear if the impedances and decay curve are being “calculated” or if all that is needed to be done is to sense the voltage decay curve and impedance. If it is the latter, then all electrodes necessarily perform this function as the electrode receives those electrical signals. It is suggested to replace “acquiring” with “calculating”. In claim 5, line 2, “based on a voltage decay curved…delivers the treatment” is vague, inferentially included, and makes the claim incomplete for omitting an element to perform these functions. If the “determining” is “based on” the voltage decay curve where each electrodes delivers the treatment, then it is suggested to first state an element to deliver treatment from each electrode and also calculate a second voltage decay curve from the sensed voltages.
Similarly, claim 15 has this problem.
In claims 6, 7, 9, and 16-19, “electrical activity delivering the treatment” is vague as it is unclear what this phrase means. Does it mean “electrical activity during delivery of the treatment”? Does it mean “electrical activity of the treatment during delivery of the treatment”? Is it measuring the electrical activity of the body? Or just the voltage of the treatment itself that is leaving the electrodes? Or does it mean something else? These claims could not be further examined in view of the prior art as it is unclear what is being claimed.
In claim 11, line 2, “in response to determining…delivers a treatment to a patient” is vague, inferentially included, and makes the claim incomplete for not setting forth an element to perform this function. If the device is configured to receiving potentials “in response” to “determining…delivers a treatment”, then some other element must perform the “determining” for the device to be “in response to” it. The last two lines of the claim are vague for attempting to limit the plurality of electrodes. The electrodes have not been positively recited/claimed, but have only been set forth as an intended/functional use. If the electrodes are meant to be positively recited, it is suggested to first state the system comprises the electrodes. If the electrodes are meant to be functionally recited, then the claim should put the last two lines in terms of a positively recited element, such as “wherein the device is configured to use the plurality of electrodes while being positioned in the brain…”.
In claim 12, line 2, “one electrode of the plurality of electrodes” is vague as claim 11, line 3, uses “one or more electrodes” to deliver the therapy. It is unclear if the “one” electrode in claim 12 is the same as the one electrode in claim 11 (if it is, then “the one” should be used in claim 2). In addition, it is unclear if claim 12 should use “the one or more electrodes” since that term is used in claim 11 to deliver the therapy.
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 11-15 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) the mental concept of receiving potential data to calculate a difference value between the potentials to determine a voltage. This judicial exception is not integrated into a practical application because the combination of additional elements fails to integrate the judicial exception into a practical application. The generically recited elements/computer elements (e.g. multiple “a device” elements/processor) do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more to the exception. The additional limitations on receive or calculate data and these are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP 2106.05.
The claims are directed to an abstract idea and/or the end result of the system/method, the essence of the whole, is a patent-ineligible concept. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they amount to a general computer performing a calculation. The claims are directed to an abstract idea, i.e. implementing the idea of receiving potential data to calculate a difference value between the potentials to determine a voltage, such as may be done by a mental process, critical thinking, and/or paper and pencil, or done by a mathematical equation, with additional generic computer elements, or additional structure (e.g. multiple “a device” elements/processor, etc.) recited at a high level of generality that perform generic functions routinely used in the art, and do not add a meaningful limitation to the abstract idea because they would be routine in any computer implementation or in the relevant art. Thus, the recited generic computer components perform no more than their basic computer functions. These additional elements are well‐understood, routine and conventional limitations (see cited document(s)) that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. See the recent decisions by the U.S. Supreme Court, including Alice Corp., Myriad, and Mayo. In addition, the current claims are similar to other recent court decisions dealing with analyzing, comparing, and/or displaying data, such as Electric Power Group, Digitech, Grams, and Classen.
Based on the plain meaning of the words in the claim, the broadest reasonable interpretation of the claims (e.g. claim 11 having multiple “a device” elements/processor) is a system having a processor, wherein the processor is programmed with executable instructions to perform the calculations/mental process/critical thinking. The claims do not impose any limits on how the potential information is received by the processor, and thus this step covers any and all possible ways in which this can be done, for instance by typing the information into the system, or by the system obtaining the information from another device. The claim also does not impose any limits on how the computations are accomplished, and thus it can be performed in any way known to those of ordinary skill in the art.
The calculations are simple enough to be practically performed in the human mind or through critical thinking. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Nor does the recitation of a processor in the claim negate the mental nature of this limitation because the claim here merely uses the processor as a tool to perform the otherwise mental process.
The multiple “a device” elements/processor are recited so generically (no details whatsoever are provided other than that they are multiple “a device” elements/processor) that they represent no more than mere instructions to apply the judicial exception on a computer. These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer. It should be noted that because the courts have made it clear that mere physicality or tangibility of an additional element or elements is not a relevant consideration in the eligibility analysis, the physical nature of these computer components does not affect this analysis. See MPEP 2106.05(I) for more information on this point, including explanations from judicial decisions including Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224-26 (2014).
Although the processor or claim limitations may fall under several exceptions (e.g., a mathematical concept-type abstract idea or a mental process-type abstract idea), there are no bright lines between the types of exceptions. See, e.g., MPEP 2106.04(I). Thus, it is sufficient for the examiner to identify that the limitations align with at least one judicial exception, and to conduct further analysis based on that identification.
The limitations of the claims are carried out by the multiple “a device” elements/processor. No element has been set forth to sense the potential signals, and the only additional element is multiple “a device” elements/processor that performs the necessary software tasks so that the result of the abstract mental process is just data/a voltage value. See MPEP 2106.05(g), discussing limitations that the Federal Circuit has considered to be insignificant extra-solution activity. Even when viewed in combination, the additional elements in this claim do no more than automate the mental processes (e.g., the mental computation of receiving potential data to calculate a difference value between the potentials to determine a voltage, etc.), using the computer components as a tool. While this type of automation may improve the life of a practitioner/physician (by minimizing or eliminating the need for mentally computing metrics), there is no change to the computers and other technology that are recited in the claim as automating the abstract ideas, and thus this claim cannot improve computer functionality or other technology. See, e.g., Trading Technologies Int’l v. IBG, Inc., 921 F.3d 1084, 1093 (Fed. Cir. 2019) (using a computer to provide a trader with more information to facilitate market trades improved the business process of market trading, but not the computer) and the cases discussed in MPEP 2106.05(a)(I), particularly FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095 (Fed. Cir. 2016) (accelerating a process of analyzing audit log data is not an improvement when the increased speed comes solely from the capabilities of a general-purpose computer) and Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055 (Fed. Cir. 2017) (using a generic computer to automate a process of applying to finance a purchase is not an improvement to the computer’s functionality). Accordingly, the claim as a whole does not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 2, 4, 11, 12, 14, and 20 are rejected under 35 U.S.C. 102a1 as being anticipated by Tsampazis et al. (2011/0087085). Tsampazis meets the claimed limitations as follows:
--a plurality of electrodes (e.g. figures 1, 2, Ea, Eb, etc., E1, E2, etc.) that are capable of being positioned within the brain (e.g. the electrodes are implantable electrodes and therefore are capable of meeting the intended use of being capable of being positioned within the brain)
--a treatment delivery circuit to delivery treatment to one or more electrodes (e.g. figures 4-5, stimulation circuitry S to deliver pulses, etc.)
--sensing circuitry coupled to the electrodes to sense electrical activity (e.g. figure 4, measurement circuitry MC, etc.)
--a controller (e.g. para. 15, claim 14, internal controller; figure 4, Controller C and/or speech processor SP, etc.) to control delivery of treatment to one or more electrodes and sense potentials through electrodes from the lead wire/extensions (e.g. figures 1, 4, etc.), and calculating a difference value between potentials of two electrodes among the plurality to obtain a voltage between the two electrodes (e.g. abstract, paras. 16-17, 28-35, etc.)
For claims 2/12 and 4/14, Tsampazis also senses the voltage decay/stimulation residual from the electrodes used to deliver the treatment (e.g. paras. 16-17, etc.) and also measures the impedance between electrodes (e.g. paras. 18, 30-35, etc.), where the results are used to determine the electrode combination for setting the T and C levels for delivering the treatment (e.g. paras. 49-50, 64, etc.).
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.
Claims 1, 11, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-20 of copending Application No. 18/690923 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application’s claims are narrower and meet the limitations of this application’s claims. In addition, to include a pulse generator and lead wires/extensions in the copending application’s claims would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed since it would provide the predictable results of allowing the electrodes to be easily placed in different areas of the body while providing an effective stimulation therapy.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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/George R Evanisko/Primary Examiner, Art Unit 3792 5/14/26
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