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 .
Election/Restrictions
Claims 3-8 and 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species/embodiment, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/13/25.
The requirement is still deemed proper and was previously made FINAL.
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, 9-13, 15, and 22-26 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, “wherein assessing the envelope” is vague as there are two different assessed envelopes in claim 1. It is unclear if this is directed to both or a single one.
Similarly, claim 15 has this problem.
In claims 9-11, “the comparison is indicative of…” is vague and the claims are not setting forth any structural or method step limitation, but only setting forth a definition. It is unclear what the claims are trying to limit. In addition, “the ECG component for a DeEP” is vague and unclear which component is being discussed.
Similarly, claims 22-24 have these problems.
In claim 12, “the sequence of regular pacing stimuli at sinus-rate intervals” lacks antecedent basis. Claim 1 has it faster than sinus interval. In line 2, “includes a normal sinus-rhythm of a heart” is vague and it is unclear how this is determined as no element has been set forth to determine or sense the rhythm.
Similarly, claim 25 has these problems.
In claim 13, the claim is vague for having the extrastimuli “include a premature ventricular contraction”. PVCs are what happens in the heart and it is unclear how a pacing stimulus is a premature ventricular contraction. Is this supposed to mean that the stimuli cause PVCs?
Similarly, claim 26 has this problem. In addition, the claim is vague as the claim sounds like it is claiming a part of the body. Apparatus claims cannot claim the body or a connection to it.
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 1-2, 9-15, and 22-26 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 data for an envelope of body surface ECG signals and for pacing signals, assessing the ECG at two different times to compare the two, and outputting an indication of the comparison. 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 computer elements (e.g. interface, processor) do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer (Note that claim 1 and dependents are not connected to any physical element). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered separately and in combination do not add significantly more to the exception. The additional elements only receive and process information 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 data for an envelope of body surface ECG signals and for pacing signals, assessing the ECG at two different times to compare the two, and outputting an indication of the comparison, 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. interface, 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 14 having an interface and processor, and corresponding method claim 1, which does not claim any physical element) is a system having an interface and 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 ECG or pacing information is received by the processor except through a port/interface, 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 interface and processor are recited so generically (no details whatsoever are provided other than that they are a memory and 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 interface and the memory. No element has been set forth to sense the ECG and pacing signals, and the only additional element is the interface, where the processor performs the necessary software tasks so that the result of the abstract mental process is just data/an output of the comparison indicating DeEP. The interface limitation represents extra-solution activity because it is a mere nominal or tangential addition to the claim. 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 data for an envelope of body surface ECG signals and for pacing signals, assessing the ECG at two different times to compare the two, and outputting an indication of the comparison, 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 § 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.
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.
Claims 1, 9-14, and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Nanthakumar et al (2016/0128785) in view of Bullinga (2005/0004608). As to the newly amended claim limitations of receiving signals indicative of pacing and receiving signals of an envelope of a body surface ECG, it is noted that these signals are just relative data and that no pulse generator/electrode has been set forth to apply the pacing, and that no body surface electrodes are being positively recited or used. Claim 14 only positively recites two elements--a processor, and an interface to receive data/signals. Similarly, method claim 1 does not positively recite applying the stimulation or sensing with body surface electrodes. Therefore, to meet the claimed limitations, the prior art must either have those specific intended use recitations/elements or be capable of performing/meeting the intended use recitations/elements presented in the claims.
Nanthakumar discloses a processor and interface (e.g. figures 1 and 2, paras. 48-82, etc.) that receive data indicative of pacing signals at regular intervals above sinus rhythm (e.g. para. 93, etc.) and with extrastimuli (e.g. para. 93, etc.), where the system and method can use different electrode catheters, such as a multi-electrode catheter, a single catheter, or a non-invasive surface mapping tool to sense the ECG and provide cardiac sensed data indicative of an envelope (the system and method is catheter agnostic—it acts on the data presented, whether it is from an internal electrode array or body surface electrode array and therefore does have, or does meet and perform, the intended use recitations of receiving data/signals to act on the signals; e.g. paras. 99, 130, 139, etc.) to assess an envelope of one ECG signal after the regular pacing to the envelope of another ECG signal after the extrastimuli (e.g. para. 141, etc.) to compare the two by determining a difference (e.g. para. 141, etc.) to output the comparison/difference (e.g. paras. 59, 99, etc.). As to claims 9-11 and 22-24, it is unclear what is being further recited in the claims, but the output does provide indications of the DeEP which may be used to indicate different patient conditions. For claims 13 and 26, the heart may have a PVC that affects the ECG and may be recorded by the system and method.
Nanthakumar does not disclose assessing the ECG to determine stability during the pacing. Bullinga disclose assessing the ECG during pacing to check the stability of the ECG to determine if the pacing is effective and/or not causing an arrhythmia or other heart complications (e.g. paras. 161-163, 79, 83, 99, etc.). It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Nanthakumar, with assessing the ECG during pacing to check the stability of the ECG, as taught by Bullinga, since it would provide the predictable results of determining if the pacing is effective and/or not causing an arrhythmia or other heart complications.
Claims 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nanthakumar et al (2016/0128785) in view of Bullinga (i.e. “modified Nanthakumar”). Modified Nanthakumar discloses assessing the ECG, but not assessing the duration of the QRS. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by modified Nanthakumar, with the assessment of the QRS duration, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of allowing the physician to detect heart conduction disturbances caused by as an enlarged left ventricle, VT, and/or bundle branch block.
Response to Arguments
Applicant's arguments filed 12/15/25 have been fully considered but they are not persuasive. The amended independent claims addressed the 112b rejections, however the dependent claims did not address most of the 112b rejections and therefore the rejections have not been withdrawn. The argument regarding the 103 rejection and that Nanthakumar uses an invasive approach is not persuasive as addressed above in the 103 rejection. Nanthakumar does meet, and is capable of meeting, the functional use recitations presented in the claims. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The argument that a human mind cannot process or receive a first pacing signal and a plurality of cardiac signals is not persuasive. These claimed limitations are only directed to receiving “data”/ signals as the claims contain no elements or steps to apply the pacing to the heart or using body surface electrodes to sense the cardiac potentials. In addition, heart doctors for decades have received in their mind heart data and pacing data by looking at ECG displays, paper graphs, and/or receiving data verbally to make diagnoses. Note that no time limit has been set forth in the claims on how long the processing takes. In addition, as the examiner previously noted and the courts have held, “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”. Similarly, the argument that “outputting the comparison” provides both a tangible output and could not be performed in the human mind is not persuasive as the output can be provided with a physical aid, verbally, or determining the result of the comparison in the mind. In addition, the use of a display or output port as an output does not provide post solution activity that practically integrates the mental concept into a complete system or method and is a well-understood, routing, conventional activity recited at a high level of generality. Note that claim 1 does not recite any physical element connected to the method steps or for performing any of the method steps. While claim 14 does claim an interface and processor, as the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) ("The fact that a computer ‘necessarily exist[s] in the physical, rather than purely conceptual, realm,’ is beside the point"). The claims in Alice Corp. v. CLS Bank International did not meaningfully limit the abstract idea of mitigating settlement risk. 573 U.S. 208, 110 USPQ2d 1976 (2014). In particular, the Court concluded that the additional elements such as the data processing system and communications controllers recited in the system claims did not meaningfully limit the abstract idea because they merely linked the use of the abstract idea to a particular technological environment (i.e., "implementation via computers") or were well-understood, routine, conventional activity recited at a high level of generality. 573 U.S. at 225-26, 110 USPQ2d at 1984-85.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/ Primary Examiner, Art Unit 3792 12/27/25
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