DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 4, 2026 has been entered.
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Claims 3-5 & 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 13, 2025.
Applicant's election with traverse of species I, i.e. claims 2, 6-16 & 19-20 in the reply filed on August 13, 2025 is acknowledged.
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 1-2, 6-16 & 19-20, specifically independent claim 1 and claim 14, are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea without significantly more. Please see the below ‘2 Prong Test’ analysis:
Step 1:
Claim 1 is directed to a method, which is a statutory category of invention.
Claim 14 is directed a system, which is a statutory category of invention.
Step 2A, Prong 1:
Claim 1 recites the steps of:
“…providing a plurality of values…mapped data point of an electro-anatomical map…”
“…displaying…a simplex…”
“…displaying, via an interface, a visual depiction of a defined range on the simplex…”
“…acquiring, in real-time, the data point for inclusion in the electro-anatomical mapping…”
“…outputting to a display the electro-anatomical mapping…”
Claim 14 recites a processor configured to:
“…configure a catheter for mapping a data point in an electro-anatomical mapping…”
“…determine a plurality of values…mapped data point of an electro-anatomical map…”
“…display…a simplex…”
“…displaying, via an interface, a visual depiction of a defined range on the simplex…”
“…acquiring, in real-time, the data point for inclusion in the electro-anatomical mapping…”
“…display, via the interface, the electro-anatomical mapping…”
These limitations, under their broadest reasonable interpretation, fall within the mental processes grouping of abstract ideas. It would be practical, but for the recitation “processor configured to” and “via an interface” to perform the steps in a human’s mind, or with pen and paper, to receive and/or train the method and/or system.
Under the broadest interpretation, claims 1 & 14 recite a series of steps that are practically performable in the human mind. A human could determine a plurality of values in a quality profile of mapped data points, and acquiring, in real-time, the data point for inclusion in the electro-anatomical mapping. Therefore, it would be practical to perform the steps in a human’s mind, or with a pen and paper, to utilize the claimed signals.
Claims 1 & 14, recite method steps comprising mental processes (i.e. determining, acquiring). Thus, since claims 1 and 1 recite limitations that fall within the mental processes of abstract ideas, the claims are directed to an abstract idea.
Step 2A, Prong 2:
Claims 1 & 1 4 recite additional elements that integrate the judicial exception into a practical application. Claims 1 & 14 recites the following additional elements:
…a catheter for mapping, which is directed to data gathering, see MPEP 2106.05(g).
A processor configured to…which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
…an interface, which is directed to data output, see MPEP 2106.05(g).
…a display, which is directed to data output, see MPEP 2106.05(g).
The above additional elements do not integrate the abstract idea into a practical application because they are insignificant extra-solution activity and do not further integrate the abstract idea into a practical application.
*Note: None of the additional elements recited in claims 1 & 14 applies or uses the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. The claims are silent to providing any treatment at all to a patient.
Step 2B:
When considered individually and in combination, the claims do not recite additional elements that are sufficient to amount to significantly more than the judicial exception, as discussed above with respect to Step 2A, prong 2. Therefore, the claims fail to recite significantly more than the abstract idea.
The examiner notes that dependent claims 6-12, 16 & 19 do not provide additional elements and/or claim limitations that would read over the above analysis and are also directed towards an abstract idea without significantly any more.
Response to Arguments
Note: The examiner notes that there is no pending prior art rejection of the present claims. The 35 U.S.C 101 rejections are still pending.
Applicant's arguments filed May 4, 2026 have been fully considered but they are not persuasive. The applicant argues the following point(s) in which the examiner provides a reason(s) as to why the arguments are not persuasive:
The applicant argues that the claims are not directed to an abstract idea under Step 2A, Prong One because the claims allegedly recite a system and method for using a catheter for electro-anatomical mapping that improves mapping efficiency and quality. Applicant further argues that the claims cannot practically be performed in the human mind and are integrated into a practical application because the claims recite medical device equipment, interfaces, displays and real-time acquisition of mapping data.
The above arguments are not persuasive.
With respect to Step 2A, Prong One, the claims recite concepts that fall within the mental processes grouping of abstract ideas, including evaluation, analysis, comparison, judgement and determination of information. Specifically, the claims recite limitations directed to:
determining a plurality of values in a quality profile,
evaluating whether values fall within a defined range,
assessing acceptable values associated with mapped data points,
analyzing mapping quality information, and
presenting results associated with such analysis.
Such limitations constitute observations, evaluations, judgements and comparisons that can practically be performed in the human mind or with pen and paper and therefore fall within the mental processes category of abstract ideas identified in the 2019 Revised Patent Subject Matter Eligibility Guidance and MPEP §2106.04(a)(2)(III),
Applicant’s arguments improperly focus on whether every claimed limitation individually can literally be performed in the human mind. However, the rejection does not assert that every recited element, taken individually, is mentally performed. Rather, the claims, as a whole, recite abstract evaluative and analytical concepts implemented using generic technological components.
The additional recitations relating to:
configuring a catheter,
displaying information via an interface,
displaying a simplex,
displaying a visual depiction of a range,
displaying electro-anatomical mapping data, and
outputting mapping information,
do not remove the claims from the mental process grouping because such limitations merely gather, display or present information associated with the abstract analysis.
Furthermore, merely limiting the abstract idea to a particular technological environment, including a medical or electro-anatomical mapping environment, does not render the claims non-abstract. The recited catheter, interface, display and mapping environment merely provide a field of use in which the abstract idea is implemented. See MPEP §2106.04(d)(I).
The applicant additionally argues that the claims improve organ mapping efficiency and mapping quality. However, the applicant has not identified, and the claims do not recite a specific technological improvement to the functioning of a computer, display device, catheter, processor or other technological component itself.
Instead, the claims merely use generic medical and computing components as tools to collect, analyze, evaluate and display information. The alleged improvement is directed to the content of information and the analysis of information rather than an improvement to the underlying technology itself.
For example, the claims do not recite:
a specific improvement to catheter operation,
a specific improvement to electro-anatomical signal acquisition hardware,
a specific improvement to graphical rendering technology,
a specific improvement to processor functionality, or
a particular technological mechanism that improves computer performance.
Rather, the claims merely recite analyzing mapping quality information and presenting the results of such analysis. Collecting information, analyzing information and displaying the results of the analysis constitute abstract ideas.
Applicant further argues that the claims recite “real-time” acquisition and inclusion of mapping data. However, merely performing an abstract idea in real-time does not integrate the judicial exception into a practical application absent a specific technological improvement. The claims do not recite a particular improvement in real-time processing technology, computer functionality or medical device operation, but instead merely perform the abstract analysis in a particular operational context.
The applicant also argues that the recited simplex visualization supports eligibility. However, merely displaying or visualizing analyzed data does not integrate the abstract idea into a practical application where the claims do not improve display technology itself or otherwise improve computer functionality. The recited visualization merely presents the results of the abstract analysis.
Accordingly, the additional elements do not impose a meaningful limit on the judicial exception and do not integrate the exception into a practical application under Step 2A, Prong Two.
With respect to Step 2B, the claims likewise fail to recite significantly more than the judicial exception itself. The additional elements, including the catheter, interface, display, processor and electro-anatomical mapping environment are recited at a high level of generality and merely perform well-understood, routine and conventional functions including data gathering, analysis, evaluation, display and output of information.
Therefore, when considered individually and as an ordered combination, the claims do not amount to significantly more than the recited abstract idea itself. Accordingly, the rejection under 35 U.S.C §101 is maintained.
Conclusion
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.
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/NICOLE F JOHNSON/ Primary Examiner, Art Unit 3796
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