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Claims 6, 8-9, 16, and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species/embodiment, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/26/25.
Applicant's election with traverse of the election of species in the reply filed on 8/26/25 is acknowledged. The traversal is on the ground(s) that there is no serious search and/or examination burden as the search for the two groups overlap in A61B5. This is not found persuasive because A61B5 has over a million documents, and while the searches may “overlap”, the searches diverge due to the different claimed limitations of the embodiments/species. For example, while the data comprises electrodes and catheter for embodiment 1, a search for embodiment 2 of a histogram and EP map would require a different search and text search using terms such as “histogram” and “map” that aren’t required for embodiment 1. In addition, the applicant has not stated on the record that the species/embodiments are patentably distinct.
The requirement was deemed proper and was previously made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7, 10-15, 17 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The subject matter which was not described is the exact way the determination engine examines the acquired medical procedure information using a machine learning tool to then output a catheter structure including at least a catheter type, catheter size and shape, and electrode placement for one or more procedures based on the data and the catheter structure criteria, in combination with the other steps or elements in the claim(s).
The applicant/disclosure/inventors had a general idea of performing this activity, but they did not possess the specific details of how this action/idea is carried out when they filed the application.
The disclosure/inventors present a general idea of gathering information about the medical procedure, submitting it to a machine learning processor (e.g. AI, deep learning, etc.) to discover data and catheter structure criterial including size, shape, and electrode placement, and then allow the device to output a catheter structure including type, size, shape, and electrode placement, but go no further into the specifics of examining the medical procedure information using the machine learning tool, and/or outputting of the catheter structure. The specification does not disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. The disclosure/inventors do not describe exactly what weights and biases are used and/or exactly what parameters are used in the machine learning to discover the catheter structure criteria to include size, shape, and electrode placement. In addition, how these weight, biases, and/or parameters then interact in the layers to choose and output a desired catheter structure such as type, size, shape, and electrode placement. Without this knowledge the claims fail to comply with the written description requirement.
The disclosure has minimal discussion of how to determine the output, and the system and method describe general hardware and software (e.g. paras. 33, 81, etc. in the specification), amounting to a general “black box” designed to perform the functions of the claims. As set forth in MPEP 2161.01, claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed.
It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court’s grant of summary judgment of invalidity for lack of adequate written description where there were genuine issues of material fact regarding "whether the specification show[ed] possession by the inventor of how accessing disparate databases is achieved").
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 1-5, 7, 10-15, 17 and 20 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, lines 9 and 10, “a catheter structure including at least a catheter type, catheter size and shape, and electrode placement” is vague as similar language is used in lines 6 and 7. It is unclear if the elements used in lines 9 and 10 are the same elements from lines 6 and 7. If they are the same, then lines 9 and 10 should use “the catheter structure criteria at least including the catheter size, the catheter shape, and the electrode placement”. If they are different, then a modifier such as “suggested”, “optimal”, or “recommended” should be used with the elements in lines 9 and 10.
Claim 11 also uses this language and is therefore vague.
In claim 3, “acquired using …” is vague and in the passive voice. It is unclear if this is a positive method step recitation and whether this needs to be found in the prior art or not. It is suggested to use active voice, such as “acquiring the plurality of electrophysiological maps using at least…”.
Similarly, in claim 5, “acquired by…” is vague and in the passive voice.
In claim 11, line 7, “using a machine learning tool” is vague and inferentially including the machine learning tool. No element has been set forth to provide/produce the tool and it is unclear if it is being positively recited/claimed or functionally recited. It is suggested to first state an element that provides the tool before it is used.
In claim 13, “acquired using….” is vague and sounds more like a method than a structural limitation of the system. It is unclear what structure is being recited and what element is doing the acquiring. It is also unclear if the different catheters are being positively recited or not.
Similarly, claim 15 has this problem.
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 1-5, 7, 10-15, 17 and 20 are 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 receiving medical data, examining the medical data to discover data and catheter structure criteria of size, shape, and placement, and outputting data of a catheter structure based on the examination. 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. determination engine, machine learning tool, memory, processor, etc.) do not add a meaningful limitation to the abstract idea because it amounts to simply implementing the abstract idea on a computer. 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, store, and/or retrieve information in memory and these 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 receiving medical data, examining the medical data to discover data and catheter structure criteria of size, shape, and placement, and outputting data of a catheter structure based on the examination, 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. determination engine, machine learning tool, processor, memory, 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. 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 11 having a memory and processor, and corresponding method claim 1) is a system having a memory and processor, wherein the processor is programmed with executable instructions to perform the calculations/mental process/critical thinking. The claims do not impose any limits on how the medical procedure information is received by the processor, and thus this step covers any and all possible ways in which this can be done, for instance by typing the information into the system, or by the system obtaining the information from another device. 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 memory and processor are recited so generically (no details whatsoever are provided other than that they are a memory and processor) that they 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. 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 memory. No element has been set forth to sense the medical procedure information/signal, and the only additional element is the memory, where the processor performs the necessary software tasks so that the result of the abstract mental process is just data/optimized catheter structure. The memory limitation represents extra-solution activity because it is a mere nominal or tangential addition to the claim. 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 receiving medical data, examining the medical data to discover data and catheter structure criteria of size, shape, and placement, and outputting data of a catheter structure based on the examination.), 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.
Response to Arguments
Applicant's arguments filed 12/22/25 have been fully considered but they are not persuasive.
The argument that the disclosure describes how the system acquires maps, biometric signals, and catheter design data from procedures and then examines and aggregates that data to provide the output of catheter structure and therefore the rejection of the claims under 112a should be withdrawn is not persuasive. While the applicant/disclosure may have had a general idea of how to perform these functions using general purpose computers and AI algorithms, they did not describe the functions with sufficient detail so that one of ordinary skill in the art would understand how the inventors intended the functions to be performed or that the inventors possessed the claimed subject matter at the time of filing.
The argument that the claims are “directed to a method for using past medical procedure data to optimize the catheter type, size and shape, and electrode placement for a subsequent medical procedure” and therefore the examiner has failed to establish a prima facie case of patent ineligibility under Prone One of Step 2A is not persuasive and does not explain why the examiner has failed to establish a prima facie case. The abstract idea/judicial exception along cannot provide the improvement, but additional elements that practically integrate the abstract idea into a complete system must be present in the claim(s), and/or so that the claim as a whole amounts to significantly more than the abstract idea/judicial exception. The use of a general purpose processor, software, and memory to aggregate data does not practically integrate the abstract idea into a complete system or method.
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 George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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, 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 3/26/26
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