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Claims 4, 16, and 31 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species A2 and B4, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 12, 2025.
Claims 1-3, 5-15, and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Groups I and III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on November 12, 2025.
The traversal is on the ground(s) that the amendments to the claims have negated the reasons for the restriction and there is no serious burden to the examiner to examine all of the claims. Both of these arguments are not found persuasive.
Examiner notes the claims, as amended, have diverse subject matter. As disclosed more fully in the 101 and 102 rejections below, claim 17 does not require applying a first intervention as required by method claim 1, but merely requires acquiring the electrophysiological data with the perturbations already performed. Examiner also notes that a search burden still exists between the three groups. As stated above, the device of Group 2 does not require the application of the first intervention, and thus falls into a different class/subclass of search than groups 2 and 3.
The requirement is still deemed proper and is therefore made FINAL.
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 17, 28, 29 and 32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea of a non-transitory memory configured to store specific data and one or more processor adapted to access the memory and execute the instructions programmed to perform a method on that data without significantly more.
Step 1:
Claims 17-30 and 32 recite a system, and thus falls into a statutory category.
Step 2A, Prong 1
Claim 17 recites the following abstract ideas:
a non-transitory memory configured to store data and machine-readable instructions, the data including electrophysiological data representing cardiac electrophysiological signals for a plurality of locations across a cardiac surface over time;
one or more processors adapted to access the memory and execute the instructions programmed to perform a method comprising:
generating an electroanatomic map for the cardiac surface based on the electrophysiological data acquired over time that includes a first time interval and at least one other time interval, one of the first or other time intervals occurring during or after application of a first intervention to temporarily perturb electrical properties of a region of interest on or within a patient's heart; and
determining changes in the map or in information derived from the map between the first time interval and the other time interval.
All of these limitations, at the broadest reasonable interpretation, cover a method of organizing human activity and mental process except for the recitation of “a non-transitory memory” and “one or more processors”. See MPEP 2106.04(a)(2)II and III.
All of these steps, other than reciting that a circuitry and display is performing these tasks, can be performed by a human. For example, a human can take a rudimentary spreadsheet of hand written data points, measured at two cardiac locations, for 2 different time periods and determine if a change has occurred between the first and second time period.
Examiner notes that the claim does not require any limitations for collecting or generating the electrophysiological data, but merely only requires that the data be stored in the non-transitory memory.
As such, the claims are directed towards an abstract idea.
Step 2A, Prong 2
The claims do not include additional elements that integrate the abstract idea into a practical application. The following elements do not add meaningful limitation to the abstract idea.
The “non-transitory memory” and “one or more processors” are recited at a high level of generality, i.e. as generic circuitry, performing a generic computer function of processing and displaying data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additionally limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The limitation " controlling a second intervention to permanently alter the electrical properties of the region of interest based on the determined changes.” does not integrate the judicial exception into a practical application. A “second intervention” is a generic treatment.
Therefore, this is not an example of applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. Instead, this "performing/treating" step is an example of generally linking the use of a judicial exception to a particular field of use, which is an example of a limitation that the courts have found to not integrate a judicial exception into a practical application [MPEP 2106.04(d)(I) and 2106.05(h)].
Step 2B
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer components and a “performing/treating” step that is not found to integrate a judicial excpetion into a practical application. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification does not provide any indication that the computer processor is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer-implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, the generic computer functions merely are being used to implement an abstract idea is well-understood, routine, conventional activity.
For these reasons, there is no inventive concept in the claim and thus it is ineligible.
Dependent claims 18-19, 23-27 further includes an interventional device, but the device is not connected to any of the limitations of the claim 17, and thus the interventional device does not does not integrate the judicial exception into a practical application.
Dependent claim 28 further limits the abstract idea of generating a map.
Dependent claim 29 further limits the abstract idea of generating a map and providing a generic performing/treating step.
Dependent claim 32 further limits the abstract idea.
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 17-30 and 32 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.
Claim 17, lines 6-11 recite the phrase “generating an electroanatomic map for the cardiac surface based on the electrophysiological data acquired over time that includes a first time interval and at least one other time interval, one of the first or other time intervals occurring during or after application of a first intervention to temporarily perturb electrical properties of a region of interest on or within a patient's heart.” This phrase is unclear, as it is not known if the claim is attempting to positively recite a processor that performs the first intervention, or if the electrophysiological data contained in the non-transitory medium of lines 2-4 already contains that data including the first and other time interval.
Claim 18, lines 1-3 recite the phrase “an interventional device configured to deliver an energy and/or a bioactive agent to induce or inhibit conduction of electrical signals for the region of interest.” It is unclear if this energy or bioactive agent is related to the first intervention, the second intervention, or is a completely separate intervention not previously claimed.
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 17-27, 30, and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pappone (US 2007/0060829).
Regarding claim 17, Pappone discloses the claimed system including:
a non-transitory memory configured to store data and machine-readable instructions, the data including electrophysiological data representing cardiac electrophysiological signals for a plurality of locations across a cardiac surface over time (e.g. storage used for later comparison as disclosed in [0017]);
one or more processors adapted to access the memory and execute the instructions programmed to perform a method comprising:
generating an electroanatomic map for the cardiac surface based on the electrophysiological data acquired over time that includes a first time interval and at least one other time interval, one of the first or other time intervals occurring during or after application of a first intervention to temporarily perturb electrical properties of a region of interest on or within a patient's heart (e.g. pace-mapping of source locations prior to the arrythmia as disclosed in [0024] and measurement of ECG during the arrythmia as disclosed in [0024])
determining changes in the map or in information derived from the map between the first time interval and the other time interval (e.g. determination of the closest matching pace-map is the source of the arrythmia, as disclosed in [0024]; and
controlling a second intervention to permanently alter the electrical properties of the region of interest based on the determined changes (e.g. ablating the arrythmia as disclosed in [0025]).
Regarding claim 18, as best the claim can be understood, Pappone discloses comprising an interventional device configured to deliver an energy and/or a bioactive agent to induce or inhibit conduction of electrical signals for the region of interest (e.g. catheter that can both apply electrical stimulation and ablation of the desired location as disclosed in [0025].
Regarding claim 19, as best the claim can be understood, Pappone additionally discloses wherein the interventional device is configured to set a level of the energy and/or a potency of the bioactive agent based on control instructions provided by the one or more processors (e.g. correct ablation will necessarily require control by the ablation device).
Regarding claim 20, as best the claim can be understood, Pappone additionally discloses wherein the interventional device is configured to apply the first intervention directly or indirectly to the region of interest (e.g. electrical stimulation of arrythmia at step 24 at all of the regions and determining the region of interest using the data collected).
Regarding claim 21, as best the claim can be understood, Pappone additionally discloses wherein the interventional device is configured to deliver a non-lethal level of energy to alter temporarily electrical properties of cardiac tissue in the region of interest for at least one cardiac cycle during the first time interval based on a first control instruction provided by the one or more processors (e.g. electrical stimulation of arrythmia at step 24 at all of the regions and determining the region of interest using the data collected).
Regarding claim 22, as best the claim can be understood, Pappone additionally discloses, wherein the one or more processors are further programmed to provide a second control instruction based on the map or information derived from the map indicating a desired change in a rhythm condition responsive to the first intervention, and the interventional device is configured to set a level of applied energy and/or a cytotoxic potency of the bioactive agent delivered by the interventional device during the second intervention based on the second control instruction (e.g. ablation therapy that is applied in [0025]).
Regarding claim 23, as best the claim can be understood, Pappone additionally discloses a second interventional device configured to apply the energy or the bioactive agent to permanently alter the electrical properties of the region of interest (e.g. a separate ablation device can also be used as disclosed in [0025]).
Regarding claim 24, as best the claim can be understood, Pappone additionally discloses, wherein the interventional device is configured to apply one of electrical stimulation, cryomapping or reversible electroporation (e.g. electrical stimulation as disclosed in Figure 1).
Regarding claim 25, as best the claim can be understood, Pappone additionally discloses, wherein the one or more processors are further programmed to generate guidance based on the determined changes indicating whether a desired effect is achieved responsive to the first intervention (e.g. determination if the location of the catheter is in the correct location at 36).
Regarding claim 26, as best the claim can be understood, Pappone additionally discloses, wherein the one or more processors are further programmed to set a parameter to control the interventional device for the application of the second intervention based on the determined changes representing a positive therapeutic effect being achieved responsive to the first intervention (e.g. when the correct ablation location is found, then positive therapeutic effect will be achieved).
Regarding claim 27, as best the claim can be understood, Pappone additionally discloses, wherein the one or more processors are further programmed to display a recommendation to identify a next target region of interest for another application of the first intervention based on the determined changes representing a negative or lack of desired therapeutic effect being achieved responsive to the first intervention (e.g. collection of all data to determine the best location for the ablation to occur).
Regarding claim 30, Pappone additionally discloses, further comprising an arrangement of body surface electrodes adapted to measure the cardiac electrophysiological signals non- invasively from an outer surface of a patient's body, the one or more processors further programmed to reconstruct electrophysiological signals on locations distributed across a surface of interest within the patient's body to provide the map based on the measured cardiac electrophysiological signals and geometry data, in which the surface of interest includes at least the region of interest (e.g. ECG data collected as shown in Figure 2).
Regarding claim 32, Pappone additionally discloses, wherein the other time interval occurs before the first time interval (e.g. as disclosed in Figure 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792