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
Applicant’s election without traverse of species I, i.e. claims 2-5, 12 & 15, in the reply filed on September 16, 2025 is acknowledged.
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 1-20, specifically independent claims 1 & 11 are directed to an abstract idea without significantly more. Please see the below analysis providing the details as to why the invention is directed towards non-statutory subject matter.
Step 1:
Claim 1 is directed to a system, which is a product, i.e. a statutory category of invention.
Claim 11 is directed to a method, a statutory category of invention.
Step 2A, Prong 1:
Claims 1 & 11, as amended, recites steps including:
selecting contiguous subgroup of electrodes,
computing a representative cycle length by identifying a dominant spectral peak,
applying a consistency test based on a predefined threshold, and
identifying a region based on the processed signals.
These limitations, under their broadest interpretation, describe analyzing electro-physiological signal data using mathematical relationships and evaluative criteria to identify patterns and make a determination, which falls within the category of mathematical concepts and mental processes (i.e. data analysis, evaluation and classification). It would be practical, to perform the steps in a human’s mind, or with a pen and paper. Accordingly, the claims recite an abstract idea.
Step 2A, Prong 2:
The claims as a whole fails to integrate the abstract idea into a practical application. Claims 1 & 11 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application.
“…a catheter with a plurality of electrodes…” which is directed to data gathering, see MPEP 2106.05(f).
“…a processor configured to…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…a display configured to render an EA map…” which is directed to data output, see MPEP 2106.05(g).
These additional elements are considered individually and in combination.
The catheter and electrodes are used to collect physiological data, and the display is used to present the results of the analysis. The processor performs the recited data processing steps.
However, the claims do not recite:
Any improvement to the structure or function of the catheter or the electrodes.
Any improvement to signal acquisition techniques, or
Any specific technological improvement in how electro-anatomical maps are generated beyond the abstract data analysis itself.
The additional elements merely collect data, execute data and display the results, which amounts to insignificant extra-solution activity.
Furthermore, the claimed data processing steps are recited at a high level of generality (e.g. “select,” “compute,” “apply,” etc.) without specifying a particular algorithmic implementation or technological mechanism that improves signal processing. As such, the claim is result-oriented and does not impose meaningful limits on the abstract idea.
Step 2B:
The claims as a whole fails to recite an inventive concept. The additional elements, when considered individually and in combination, do not recite significantly more than the abstract idea for the reasons as set forth above in Step 2A, Prong 2. Upon re-evaluating the limitation that was previously identified as insignificant extra-solution activity in Step 2A, Prong 2, the following evidence to show that the limitation is well-understood, routine and conventional:
real-time discrete data obtained from a medical device/data previously collected from a medical device (i.e. body surface/unipolar electrodes) Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93; Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
producing at said computer processor a human-readable output (i.e. processor) of the analysis of the gathered data, this is also WURC, as evidenced by Electric Power Group, LLC v. Alstom S.A., 830F.3d 1350, 119 USPQ2d 1739 (Fed.Cir. 2016), which discusses “conventional computer, network, and display technology” and states that “nothing in the patent contains any suggestion that the displays needed for that purpose are anything but readily available. We have repeatedly held that such invocations of computers and networks that are not even arguably inventive are “insufficient to pass the test of an inventive concept in the application” of an abstract idea”.” Similarly, there is nothing in Applicant’s specification that indicates that the device that is “producing at said computer processor a human-readable output indicating” the findings of the analysis is anything but readily available.
Therefore, the claims fail to recite significantly more than the abstract idea and claims 9-28 are rejected under 35 U.S.C 101.
The limitations of the dependent claims 2-5, 10-12, 15 & 20-21 further defines steps of calculating power spectra for the EP signals, calculate local Cycle Length values for the EP signals, etc. which further limit claim limitations already indicated above as being directed to an abstract idea. Therefore, the above claims are directed to patient-ineligible subject matter.
Claim Rejections - 35 USC § 103
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(s) 1-5, 10-12, 15 & 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laughner et al. (US 2015/0342488) in view of Krishna et al. (US 2015/0227702) and one having ordinary skill in the art.
Laughner et al. discloses:
1.
A system (10) configured for rendering and electro-anatomical (BA) map of signals from tissue inside a chamber of a patient’s heart, (e.g., [0091], [0095]; Fig 1)
the system comprising: a catheter (14) configured to be inserted into the cardiac chamber, the catheter having a distal end carrying a plurality of electrodes (24), the electrodes being configured to collect electro-physiological (EP) signals from cardiac tissue (e.g., [0091], [0095]; Fig 2)
a processor (32) configured to receive electro-physiological (EP) signals from the plurality of electrodes located in the chamber; select a contiguous sub-group of the plurality of electrodes, the sub-group including physically contiguous electrodes on the distal end assembly of the catheter (e.g., [0094]-[0095]; Fig 1)
Note: Laughner et al. teaches that the electrodes are arranged on a distal structure and detect electrical wave propagation across adjacent electrodes [0094], which correspond to localized regions of cardiac tissue. Accordingly, it would have been obvious to one having ordinary skill in the art to select a contiguous sub-group of the plurality of electrodes, as is instantly claimed, including physically continuous electrodes on the distal end assembly, in order to analyze localized electrical activity with improved spatial resolution, since selecting adjacent electrodes in a spatial array is a known and predictable technique for isolating localized signal sources.
compute, for each electrode in the contiguous sub-group, a representative cycle length
(e.g., [0034], [0042]-[0043]).
Note: Laughner teaches processing the EP signals to determine activation timing and/or frequency characteristics of the cardiac signals which corresponds to cycle-related characteristics of the signals.
and when the consistency test is successful, identify a region in the chamber for which the EP signals have been acquired by the contiguous sub-group (e.g., [0095], [0099]).
Note: Laughner et al. teaches that the mapping-processed electrode signals to anatomical regions for diagnostic purpose, which it would have been obvious to one having ordinary skill to identify the region corresponding to the contiguous subgroup of electrodes that satisfy the consistency condition.
and a display configured to render an electro-anatomical (BA) map of the chamber and to indicate the region on the rendered EA map.
E.G. via the disclosed display (e.g., [0043], [0099]; Fig 1).
Laughner et al. discloses the claimed invention having a system including a mapping catheter via electrodes that are arranged on a distal structure wherein said electrodes are used to detect wave propagation across adjacent electrodes, i.e. contiguous sub-group of electrodes, to obtain cycle-related characteristics of cardiac signals except wherein Laughner et al. explicitly teaches computing, for each electrode in a contiguous sub-group, a representative cycle length by calculating a power spectrum and identifying a dominant spectral peak for that electrode and apply a consistency test to the EP signals acquired by said group by determining whether the cycle lengths are within a predefined tolerance threshold.
Krishna et al. teaches that it is known to compute a power spectrum for signals acquired from individual channels, including performing FFT-based power spectrum analysis and displaying or analyzing FFT power spectra for one or more selected channels (e.g., [0104]-[0108]). Krishna et al. further teaches that such spectral analysis may be performed on multiple channels independently, thereby enabling characterizations of signal frequency content on a per-channel basis. In addition, Krishna et al. teaches comparing signal characteristics across channels, including coherence analysis between signals and identifying values that fall within specified range relative to a threshold (e.g., [0110]-[0116]). Such threshold-based comparison of signal characteristics across multiple channels teaches or suggests determining whether signals satisfy a similarity condition within a defined tolerance.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Laughner et al. with computing a power spectrum for signals acquired from individual channels, including performing FFT-based power spectrum analysis, as taught by Krishna et al., since such a modification would provide the predictable results pertaining to precisely characterizing the frequency content of signals from each electrode.
It also would have been obvious to modify the invention of Laughner et al. with applying such threshold-based comparison techniques as taught by Krishna et al. since such a modification would provide the predictable results pertaining to determining whether signals from a contiguous group of electrodes exhibit consistent behavior, thereby improving robustness and reducing the effect of noise.
2.
The system according to claim 1, wherein the processor is configured to calculate power spectra for the EP signals acquired by the electrodes in the sub-group (e.g., Krishna, [0104]-[0108]), and to apply the consistency test to the power spectra (e.g., Krishna, [0110]-[01116]).
3.
The system according to claim 2, wherein, when the consistency test is successful, the processor is configured to compare a representative frequency value of the sub-group to a sinus frequency value of the heart and provide indication if the representative frequency value is smaller than the sinus frequency by a minimum amount (e.g., Laughner; [0112]-[0116]).
Note: It would have been obvious to compare the representative frequency value of the subgroup to a reference frequency (i.e. sinus frequency) as a further diagnostic refinement, since comparing measured signal frequencies to reference physiological values is a well-known technique in signal analysis.
4.
The system according to claim 2, wherein, when the consistency test is unsuccessful, the processor is further configured to select a smaller contiguous sub-group of the electrodes of the catheter and apply a consistency test to the EP signals acquired by the electrodes in the smaller sub-group (e.g., Laughner; [0115]-[0116]).
It would have been obvious to one having ordinary skill in the art to select a smaller contiguous subgroup of electrodes and reapply the consistency test when the initial subgroup does not satisfy the consistency conditions, in order to provide the predictable results pertaining to improve localization accuracy, as iterative refinement of a region of interest, i.e. optimization technique I signal processing and spatial analysis, particularly in the presence of noisy physiological signals.
5.
The system according to claim 2, wherein the processor is configured to apply the consistency test by estimating a width of a peak of a representative power spectrum peak for the sub-group (e.g., Krishna, [0104]-[0108]).
Note: The analysis of spectral data inherently includes evaluating characteristics of spectral peaks including their distribution and spread across frequencies. It would have been obvious to one having ordinary skill in the art to estimate a width of a representative spectral peak as part of analyzing the spectral content of signals, since such peak characteristics are routinely used to assess signal consistency and stability in signal processing.
10.
The system according to claim 1, wherein EP signals are one of unipolar and bipolar electrograms (e.g., Laughner, [0094], [0095]).
Note: EP signals are conventionally recorded as unipolar or bipolar electrograms, which are standard signal acquisition configurations in cardiac electrophysiology. Therefore, the limitation is inherent in the system taught by Laughner.
Note: It is inherent in cardiac mapping systems that both unipolar and bipolar EP signals are used directly associated with near and far-field signal components, as disclosed [0095].
11.
Laughner et al. teaches a method for rendering and electro-anatomical (EA) map of signals from tissue inside a chamber of a patient’s heart, the method including a catheter having a distal end with a plurality of electrode, acquiring multiple respective electrophysiological (EP) signals from tissue inside a heart, and mapping the electrical activity to anatomical regions (e.g., [0094]-[0095], [0099]-[0101])
As discussed above with respect to claim 1, it would have been obvious to one of ordinary skill in the art to select a contiguous subgroup of electrodes, computer a representative cycle length for each electrode using spectral analysis as taught by Krishna et al. (e.g., [0104]-[0108]), and apply a threshold-based consistency test across electrodes (e.g., [0110]-[0116]) in order to identify a region of interest. Accordingly, the method of claim 11 is rendered obvious by the combination of Laughner et al. and Krishna et al
12.
The method according to claim 11, and comprising calculating power spectra for the EP signals acquired by the electrodes in the sub-group (e.g., Krishna, [0104]-[0108]), and to apply the consistency test to the power spectra (e.g., Krishna, [0110]-[01116]).
15.
The method according to claim 12, wherein applying the consistency test comprises estimating a width of a peak of a representative power spectrum peak for the sub-group.
(e.g., Krishna, [0104]-[0108]).
Note: The analysis of spectral data inherently includes evaluating characteristics of spectral peaks including their distribution and spread across frequencies. It would have been obvious to one having ordinary skill in the art to estimate a width of a representative spectral peak as part of analyzing the spectral content of signals, since such peak characteristics are routinely used to assess signal consistency and stability in signal processing.
20.
The method according to claim 11, wherein EP signals are one of unipolar and bipolar electrograms (e.g., Laughner, [0094], [0095]).
Note: EP signals are conventionally recorded as unipolar or bipolar electrograms, which are standard signal acquisition configurations in cardiac electrophysiology. Therefore, the limitation is inherent in the system taught by Laughner.
Note: It is inherent in cardiac mapping systems that both unipolar and bipolar EP signals are used directly associated with near and far-field signal components, as disclosed [0095].
21.
The system of claim 2, wherein calculating the power spectra for each electrode comprises applying a Fast Fourier Transform (FFT) to the EP signals acquired by that electrode and identifying a dominant spectral peak from the resulting power spectrum
Krishna teaches applying a FFT to signals acquired form individual channels to generate power spectra and identify frequency characteristics of those signals ([0104]-[0108]). It would have been obvious to one having ordinary skill in the art to apply FFT-based spectral analysis to each electrode signal and identify a dominant spectral peak, as this represents a standard technique for extracting frequency information from physiological signals.
Response to Arguments
Applicant's arguments filed January 26, 2026 have been fully considered but they are not persuasive. The applicant argues the following points in which the examiner provide a reason(s) as to why the arguments are not persuasive:
In regards to the claim rejections under 35 U.S.C. §101, the applicant argues that claims 1 and 11 are not directed to a disembodied abstract idea, rather targeted to controlling and processing signals from a real-world electrode array and producing specific visualization used during a physical medical procedure, i.e. the combination of catheter hardware, per-electrode spectral computation/extraction contiguous spatial selection and threshold-gating transforms raw detected signals into actionable mapped regions, which is rooted in physical device and concrete signal transformation.
Based on the broadest reasonable interpretation of the claims, the applicant’s arguments are not persuasive. While the claims recite a catheter and electrodes for acquiring electro-physiological signals, the recited limitations beyond data acquisition are directed to processing the acquired signals, including selecting a subgroup of data, performing spectral analysis, determining representative values, comparing those values to a threshold and identifying a result based on the comparison.
Such operation constitutes data analysis and evaluation of information, which fall within the category of abstract ideas, including mathematical concepts and mental processes. The recited catheter and electrodes merely serve as data-gathering mechanisms and do not integrate the abstract idea into a practical application. See MPEP 2106.05(g).
The amended claims recite limitations that supply an inventive concept because they are specific algorithms operations tied to physical hardware and they improve the operation of the mapping apparatus.
Based on the broadest reasonable interpretation of the claims, the applicant’s arguments are not persuasive. Although the applicant asserts that the claims improve identification of regions associated with cardiac activity, the claimed improvement is achieved through the application of mathematical and analytical techniques (e.g., spectral analysis, peak identification, and threshold comparison) to data, rather than through any improvement to the underlying technology or hardware.
The claims do not recite any improvement to the catheter, electrodes, or signal acquisition mechanisms, nor do they change how the data is collected. Instead, the claims merely apply mathematical analysis to existing data to derive a result.
Accordingly, the claims do not reflect an improvement to the functioning of a computer or to another technology or technical field, but rather recite the use of conventional techniques to analyze.
The claim rejections under 35 U.S.C. §101 are maintained. Please see the above action for further detail.
In regards to the Laughner et al. reference, the applicant argues that the disclosed frequency/activation mapping does not teach forming such a spatially-contiguous subgroup on a catheter array and applying a threshold based, histogram and peak-width style consistency test applied across per-electrode representative cycle lengths for mapping.
Laughner et al. teaches a plurality of electrodes arranged on a distal structure within the cardiac chamber, wherein electrical activity is detected across spatially distributed electrodes and wave propagation occurs across neighboring electrodes (e.g., [0094], [0101]). Such an arrangement inherently defines spatial relationships between electrodes corresponding to localized regions of tissue.
While Laughner et al. may not explicitly use the term ‘contiguous subgroup,’ it would have been obvious to one having ordinary skill in the art to select a subset of physically adjacent electrodes in order to analyze localized electrical activity, since selecting neighboring electrodes in a spatial array is a well-known and predictable technique for isolating localized signal sources and improving spatial resolution. Accordingly, the claimed ‘contiguous subgroup’ does not distinguish over the combination of references.
The examiner also notes that while Laughner et al. teaches acquiring and processing signals from a plurality of electrodes, the modifying reference, Krishna et al., explicitly teaches computing spectral characteristics for signals acquired from individual channels, including performing FFT-based power spectrum analysis for each channel independently ([0104]-[0108]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to apply the per-channel spectral analysis techniques of Krishna et al. to the electrode signals of Laughner et al. in order to more precisely characterize the frequency content of each signal source. Applying known signal processing techniques to each electrode in an electrode array system is predictable use of prior art elements according to their established functions.
Accordingly, the combination of Laughner et al. and Krishna et al. teaches or renders obvious the claimed per-electrode spectral analysis.
Further, in regards to the argument pertaining to the cited art not teaching the application of a threshold-based consistency test across the electrodes, the examiner disagrees and further points out that Krishna et al. teaches comparing signal characteristics across multiple channels, including performing coherence analysis and identifying values that fall within a defined range relative to a threshold, with threshold-based highlighting and grouping of signals (e.g., [0110]-[0116]).
Such threshold-based comparison inherently involves determining whether signal characteristics satisfy a similarity condition within a predefined threshold. Applying such threshold-based comparison techniques to the electrodes signals of Laughner et al. in order to identify consistent signal patterns across electrodes would have been obvious to a person of ordinary skill in the art.
Accordingly, the claimed ‘consistency test’ does not distinguish over the combination of references.
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 NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
Prosecution Insights