DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a continuation of US Application no. 18/982,251, now US Patent no. 12/226,172, filed 19 October 2022, which is a continuation of US Application no. 17/148,054, now US Patent no. 11,633,238, filed 13 January 2021, which is a continuation of US Application no. 16/426,091, now US Patent no. 10,918,446, filed 30 May 2019, which is a continuation of US Application no. 15/860,921, now US Patent no. 10,470,826, filed 3 January 2018, which is a continuation of US Applications no. 15/254,207, now US Patent no. 9,888,972, filed 1 September 2016, which is a continuation of US Application no. 14/686,408, now US Patent no. 9,445,862, filed 14 April 2015, which is a continuation of US Application no. 13/792,670, now US Patent no. 9,011,423, filed 11 March 2013, which claims the benefit of priority from US Provisional Application nos. 61/723,311, 61/670,881, and 91/649,734 respectively filed 6 November 2012, 12 July 2012, and 21 May 2012.
Response to Amendment
The preliminary amendment filed 8 January 2025 has been acknowledged. Claims 2-27 are pending, wherein claims 2-27 are new.
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 2–27 are rejected under 35 U.S.C. § 101 because the claimed inventions are directed to a judicial exception (i.e., an abstract idea) with significantly more.
Step 1
The claims are directed to a system (medical system claims 2-25), a method (claim 26) and a non-transitory computer-readable medium (claim 27).
Step 2A, Prong One
Claim 2 recites a medical system comprising:
a data processing device system
an input-output device system, and
a memory device system storing a program that configures the data processing device system to:
(1) cause display of a graphical representation of at least a portion of a bodily cavity;
(2) receive an input indicating a region graphically depicted in the graphical representation;
(3) identify, in response to the input, a group of transducers from a plurality of transducers in relation to the indicated region; and
(4) alter a display of electrogram signals to provide an arrangement of electrogram signals derived from electrophysiological activity detected by the identified group of transducers.
Claim 2 recites the abstract idea of evaluating information to identify information associated with a selected region and organizing the identified information for presentation, which constitutes a mental process involving observation, evaluation, and judgment. In particular, the claim receives an indication of a selected region, identifies a group of transducers in relation to the selected region, and organizes for display electrogram signals associated with the identified transducers. These limitations encompass the type of evaluation that may be performed by observing a selected anatomical region, determining which transducers correspond to that region, and identifying the electrogram information associated with those transducers.
The recitation that the transducers are configured to detect electrophysiological activity does not itself constitute the identified abstract idea. Rather, the electrophysiological activity detected by the transducers supplies the information upon which the claimed evaluation and organization are performed.
Step 2A, Prong Two
The additional elements do not integrate the judicial exception into a practical application. The data processing device system, memory device system, and input-output device system provide the computer environment in which the information is received, evaluated, organized, and displayed. The graphical representation of the bodily cavity provides the information from which the region is selected, while the plurality of transducers provides the electrophysiological information that is ultimately selected and presented.
Although claim 2 requires the displayed arrangement of electrogram signals to be derived from electrophysiological activity detected by the particular group of transducers identified in relation to the selected region of the bodily cavity, this relationship does not integrate the judicial exception into a practical application. The identification of the transducers is used to determine the electrogram information to be presented, and the claimed response to the identification is an alteration of the display resulting in an arrangement of the corresponding electrogram signals. Thus, while the displayed electrogram signals correspond to electrophysiological activity detected by particular physical transducers associated with the selected bodily region, the claim ultimately applies the identification to the selection, organization, and presentation of information. The claim does not require the identification to alter operation of the transducers, modify acquisition of the electrophysiological activity, control the transducer-based device, or cause treatment or another physical medical operation. Accordingly, considered as a whole, the additional elements do not apply the judicial exception in a manner that provides a claimed improvement to the functioning of the transducer-based device or another medical technology.
Step 2B
The additional elements, considered individually and in combination, do not amount to significantly more than the judicial exception. The data processing device system, memory device system, and input-output device system perform their ordinary functions of processing, storing, receiving, and displaying information. Likewise, the transducers perform their ordinary function of detecting electrophysiological activity. The claim does not recite a particular improvement in the construction or operation of these components, nor does it recite a particular technological technique by which the relationship between the selected region and the group of transducers is determined.
Considered as an ordered combination, the additional elements merely obtain electrophysiological information, implement the claimed evaluation of that information using a data processing system, and display the resulting selected and organized electrogram information. The additional elements therefore do not transform the nature of the claim into a patent-eligible application of the judicial exception.
Accordingly, claim 2 is directed to a judicial exception without significantly more and is therefore ineligible under 35 U.S.C. § 101.
Claims 3-24 are considered to further limit the manner in which the transducers are identified relative to the selected region, the type of transducer data considered in making the identification, the anatomical relationship between the transducers and the selected region, and/or the manner in which the resulting electrogram signals are displayed. These additional limitations further specify the information evaluated, the criteria used in evaluating or selecting that information, or the manner in which the resulting information is organized and presented, but do not require the result of the evaluation to control the transducer-based device or otherwise effect a physical medical operation. Accordingly, these limitations do not integrate the judicial exception into a practical application and do not provide significantly more than the judicial exception.
In particular, claims 3–8 and 17–20 further specify spatial or anatomical relationships used in identifying the transducers; claims 9–16 further specify transducer-acquired information, including electrical characteristics, impedance information, flow characteristics, and information distinguishing tissue from blood; and claims 21–24 further specify the manner in which electrogram information is arranged or displayed. These limitations further refine the information gathering, evaluation, selection, and presentation underlying claim 2 and do not alter the eligibility analysis.
Claim 25 further recites that each transducer of the plurality of transducers is selectively activatable to provide ablative energy. However, claim 25 does not require that any transducer actually be activated to provide ablative energy in response to the selected region, identified group of transducers, or displayed electrogram signals. Thus, the recitation merely describes an additional capability of the transducers and does not require application of the abstract evaluation to perform an ablation or otherwise effect a treatment. Claim 25 therefore does not integrate the judicial exception into a practical application or provide significantly more.
Method claim 26 and computer-readable-medium claim 27 recite substantially the same information-processing sequence as claim 2, namely displaying a graphical representation of a bodily cavity, receiving an input identifying a region, identifying a group of transducers in relation to the region, and altering a display to provide an arrangement of electrogram signals derived from electrophysiological activity detected by the identified group. Accordingly, for substantially the same reasons discussed above with respect to claim 2, claims 26 and 27 recite the abstract idea of evaluating information to identify information associated with a selected region and organizing the identified information for presentation, without integrating the judicial exception into a practical application or providing additional elements amounting to significantly more.
Therefore, claims 2–27 are ineligible under 35 U.S.C. § 101.
Allowable Subject Matter
Claims 2-27 would be allowable should Applicant’s response either comply with or specifically traverse the rejection set forth under 35 USC 101.
The following is an examiner’s statement of reasons for allowance: the prior art fails to teach the step of receiving input indicating a region in the body cavity and then identifying which physical transducers are related to that anatomical region.
MacAdam et al. (US Publication no. 2012/0035488) is considered relevant prior art and provides a system comprising the data processing system, the input-output device, memory, and display for displaying a rendering of a body surface and associated electrophysiological channels. However, MacAdam et al. fail to teach the step of receiving input identifying a graphically depicted anatomical region and, responsive to that input, identifying a group of physical transducers based on their relationship with the selected anatomical region.
Additionally, co-pending US Patent nos. 12,133,745 and 12,383,208 have been considered for non-statutory double patenting. The references describe similar features as the present invention, and describe a step that causes in response to receiving an input about a plurality transducers altering a display electrogram signals, the altering resulting in the display of first arrangement of electrogram signals derived from the electrophysiological activity detected by the group of transducers. However, neither recite the step of receiving input indicating the region of the bodily cavity. Thus, the references are considered patentably distinct.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 31 August 2026
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