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/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1, 3-7 9-12, 14-25, 27-28, 30-31, and 33, drawn to a defibrillator having a tiered therapy delivery.
Group II, claims 54-55, drawn to a defibrillator to optimize therapy delivery.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a sensor and a therapy control sub-system, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Pei (2019/0168003). The shared technical feature of the sensor and therapy control sub-system lack novelty and/or inventive step in view of Pei (as discussed below in the art rejection).
During a telephone conversation with Daidre Burgess on 1/30/26 a provisional election was made without traverse to prosecute the invention of group I, claims 1, 3-7 9-12, 14-25, 27-28, 30-31, and 33. Affirmation of this election must be made by applicant in replying to this Office action. Claims 54-55 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 3, 17, 19-20, and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected embodiment/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/25.
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 1, 4-7, 9-12, 14-16, 18, 21, 23-25, 27-28, 30-31, and 33 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 1, line 10, “with a period of time” and line 18, “a first period of time” are vague as it is unclear if they are the same period of time or are meant to be different. If they are the same then line 18 should use “the period of time”. Note that claim 4 uses “the period of time”.
In claim 1, in the next to last paragraph, line 3, the first use of “or” is vague as it is unclear if the claim is setting forth that both of the no energy delivery and first energy therapy are needed for the “when” clauses, or if just one or the other of the energy therapy is needed. Similarly in line 3 the second occurrence of “or” for the first or second energy therapy. It is suggested to use something similar to
“wherein when the probability is above a first threshold after a first period of time, the therapy control subsystem is configured to transmit instructions to effect the defibrillation therapy of no energy,
and when the probability is at or below the first threshold after the first period of time, the therapy control subsystem is configured to transmit instructions to effect and select the defibrillation therapy between the first energy therapy and the second energy therapy…”.
In claim 4, “wherein the heart rhythm disorder is…” is vague as claim 1 only sets forth this element in the preamble. Claim 1 defines an “arrhythmia” as being detected. It is suggested to use in claim 4, “wherein the arrhythmia detected is…”.
In claim 5, the claim depends from a canceled claim and therefore is vague and could not be examined in view of prior art or the 101 rejection. Similarly, claims 6-7 and 10-12 depend from claim 5 and a canceled claim.
In claim 16, “wherein the signals are analyzed…” is vague and makes the claim incomplete for omitting a structure to perform this function. It is unclear what element in the system is doing this function or if some other structure is performing this function and transmitting it to the system. It is unclear what the claim is trying to limit.
In claim 18, line 1, “is measured using parameters obtained from recurrence networks…joint recurrence plots” and “synchronization measures derived from…” are vague and sound more like method steps than a structural limitation. It is unclear what structure is performing these functions, what structure is being positively recited/claimed or whether these limitations are meant to be intended/functional use.
In claim 21, “comprises circuitry within an implantable device, wherein the implantable device is configured to deliver defibrillation therapy” is vague as it is unclear how a housing for the circuitry delivers defibrillation therapy. It is suggested to state that the circuity is configured to deliver the defibrillation therapy.
In claim 25, “the effector” lacks antecedent basis. It is suggested to depend the claim off of claim 24.
In claims 30 and 33, the claims depend off of claims that use “or”, and therefore if the single implantable device is chosen in the dependent claims, then claims 30 and 33 are unclear as to what is being limited. It is suggested to first state that the two separate devices are used before they are further limited.
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, 4, 9, 14-16, 18, 21, 23-25, 27-28, 30-31, and 33are 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 detecting an arrhythmia, calculating a probability if the arrhythmia will terminate, and transmitting instructions to time and deliver or not deliver therapy. 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. therapy control sub-system, etc.) do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Also, the additional element of the sensor (or in the dependent claims of the implantable device, lead, electrodes, etc.) does not add a meaningful limitation as it is merely a nominal or token extra solution component of the claims, is only meant to gather data for the abstract idea or house the components, and does not practically integrate the mental abstract into a complete system. 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 process or receive data and 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 detecting an arrhythmia, calculating a probability if the arrhythmia will terminate, and transmitting instructions to time and deliver or not deliver therapy, 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. therapy control sub-system and sensor, and dependent claims use of an implantable device, 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. Also, the additional element of the sensor (or in the dependent claims of the implantable device, lead, electrodes, etc.) does not add a meaningful limitation as it is merely a nominal or token extra solution component of the claims, is only meant to gather data for the abstract idea or house the components, and does not practically integrate the mental abstract into a complete system. 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 1 having a sensor and therapy control subsystem (i.e. processor)) is a system having a processor, wherein the processor is programmed with executable instructions to perform the calculations/mental process/critical thinking. The sensor is set forth to just “collect data” for the calculations being performed in the mental concept/abstract idea. 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 therapy control sub-system/processor is recited so generically (no details whatsoever are provided other than that it is a processor) that it 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. Also, the additional element of the sensor (or in the dependent claims of the implantable device, leads, electrodes, etc.) does not add a meaningful limitation as it is merely a nominal or token extra solution component of the claims, is only meant to gather data for the abstract idea or house the components, and does not practically integrate the mental abstract into a complete system. 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 processor and the sensor, where the processor performs the necessary software tasks so that the result of the abstract mental process is just data/outputting of instructions. Also, the additional element of the sensor (or in the dependent claims of the implantable device, leads, electrodes, etc.) does not add a meaningful limitation as it is merely a nominal or token extra solution component of the claims, is only meant to gather data for the abstract idea or house the components, and does not practically integrate the mental abstract into a complete system. 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 detecting an arrhythmia, calculating a probability if the arrhythmia will terminate, and transmitting instructions to time and deliver or not deliver therapy, 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.
It is suggested to actively claim in claim 1 a component that generates and delivers the defibrillation therapy to overcome the 101 rejection.
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, 14, 21, 23-25, 27, 28, 30-31, and 33 are rejected under 35 U.S.C. 102a1 as being anticipated by Pei (2019/0168003).
Pei discloses the claimed invention as follows:
--a sensor to collect intracardiac data (e.g. figure 1, electrodes and leads, figure 1B, sense amplifier 144, etc.)
--a therapy control sub-system to receive sensor cardiac data (e.g. figure 1b, microcontroller and memory, 120 and 162, etc.)
--where the subsystem detects dynamics and determine a probability of the arrhythmia self-terminating in a period of time (e.g. paras. 80-85, etc.)
--where the subsystem transmits instructions and has circuitry that uses no-therapy, a first energy therapy, or second energy therapy (e.g. figure 1B, figure 5, no delivery of therapy when self-terminating; para. 87, etc., delivery of ATP or high voltage shock for first and second energy therapy—Note that the claim uses “or” language and at the minimum only requires one or the other of the three)
--where the first energy therapy is configured to optimize a delivery time of the defibrillation therapy (e.g. para. 30, figure 5, etc.).
-- For claims 21, 23-25, 27, 28, 30-31 and 33, Pei discloses the use of circuitry to deliver the therapy, the sensor to transmit information to effect therapy, where the circuitry is located in an implantable device having leads and at least two electrodes as the sensor and to deliver the therapy (e.g. figures 1 and 1b, paras. 31-59, etc.). Note for claims 30 and 33, if the single device is chosen in claims 28 and 31, that the two separate devices are not needed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Pei. Pei discloses the claimed invention and monitoring VF and VT (e.g. paras. 80, 11, etc.) where the probability is about 90% (e.g. para. 81, etc.) and that observation period until shock is programmed and/or based on similar arrhythmias (e.g. para. 88, etc.), but does not specifically disclose 1-10 seconds. This provides a clear suggestion that the time can be modified to change the amount of time to determine when to shock, such as 1-10 seconds. The determination of the most appropriate time to shock, such as 1-10 seconds, by routine experimentation would, therefore, be prima facie obvious to one having ordinary skill in the medical art. In addition, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and that it is known to quickly determine when a VF is still occurring as the probability of successful resuscitation decreases by 7–10% for every minute without a shock, as the heart's quivering muscle degrades from a shockable rhythm to a non-shockable, fatal standstill (asystole) within minutes.
Claims 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Pei. Pei discloses the claimed invention and providing therapy at optimum times and sensing and analyzing signals in real time but does not disclose the therapy delivery time is at periods of tissue synchronization, and using real-time recurrence quantitative analysis to analyze the cardiac signals. 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 Pei, with the therapy delivery time is at periods of tissue synchronization, and using real-time recurrence quantitative analysis to analyze the cardiac signals, as is well known and common knowledge in the art (mpep 2144I, 2144.03) since it would provide the predictable results of providing the shock at known times to revert the arrhythmia and not cause further fibrillation, and allows the system to analyze to analyze, quantify, and visualize complex, nonlinear, and non-stationary time-series data, particularly when patterns repeat or evolve over time to identify system transitions and detect dynamics in data that traditional linear methods might miss.
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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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 2/7/26