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 .
Response to Arguments
Applicant’s amendments filed 3/5/2026 merit additional citations in view of the prior art of record to Coates and therefore may be considered new grounds for rejection. Applicant's arguments filed 3/5/2026 directed to Coates have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. § 102, on pp. 8-9 of the Remarks, Applicant firstly states that Coates does not perform any evaluation of the geometric renal arterial information.
This is not found persuasive. Coates performs an evaluation (broadly recited) insofar that Coates reproduces the imaging data in a computer model of the patient anatomy. Therefore, evaluation occurs to translate the imaging data to a computer model. The computer model is then used to determine the volume of influence from denervation therapy, guide, orient, and position a denervation therapy delivery device, and control the treatment parameters such as energy level.
On p. 9 of the Remarks, Applicant states that Coates is not shown to specifically disclose or suggest determining one or more of a location of renal denervation therapy or a modality of renal denervation therapy to apply to the patient by evaluating geometric renal arterial anatomy information.
This is not found persuasive. As noted above, the evaluation of the geometric renal arterial anatomy information comprises creating a computer model of the patient anatomy and using the computer model to specifically control the location of the volume of influence and the energy level treatment parameters. These are considered to meet the requirements of the claim by the examiner.
With respect to the rejections under 35 U.S.C. § 101, on pp. 11-12 of the Remarks, Applicant alleges that the claims are not directed to any abstract ideas as they are directed to only a specific practical application that provides a technical improvement to the field of renal denervation therapy selection.
This is not found persuasive as the alleged improvement is apparently provided by only the features identified as comprising the abstract idea.
Applicant further states that the combination of features as claimed is unconventional and provides a specific technical benefit that is not well-understood, routine, or conventional.
This is not found persuasive as the conventionality consideration is directed to the combination of additional elements, not the abstract idea alone.
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 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
This analysis in view of 35 U.S.C. § 101 is based on MPEP § 2106, please see
this section of the MPEP for additional information.
First, the broadest reasonable interpretation of the claim as a whole is
established:
Claims 1, 9, and 14 claim a computing device, system, and method comprising a memory, processing circuitry, and (in claim 9) a positive recitation of an imaging device, which determine either a location or modality of renal denervation therapy based on anatomy information received by the processing circuitry, and outputting an indication of either the location or modality, in order for it to be later applied to the patient.
Claims 2-4, 10-12, and 15-17 include additional specificity to location determination and output, modality determination and output, and selection of modality.
Claims 5-6, 13, and 18-21 add specific therapies the determined modality must be chosen from, and a number of alternative anatomical parameters that are received by the processing circuitry.
Claims 7-8 add a machine learning model and training data set.
Step 1 of the analysis is the question: “Is the claim to a process, machine,
manufacture, or composition of matter?” and the answer is determined to be yes, as the
claims as a whole are directed to a manufacture and a method.
For Step 2, the preliminary question is whether the eligibility of the claim is self-
evident. The answer is determined to be no, as the claim is not immediately self-evident
as statutory.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
A claim is directed to a judicial exception when a law of nature, a natural
phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim.
While the terms “set forth” and “describe” are thus both equated with “recite”, their
different language is intended to indicate that there are different ways in which an
exception can be recited in a claim. For instance, the claims in Diehr set forth a
mathematical equation in the repetitively calculating step, the claims in Mayo set forth
laws of nature in the wherein clause, meaning that the claims in those cases contained
discrete claim language that was identifiable as a judicial exception. The claims in Alice
Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
Claim 1/9, and 14 recites the following limitations:
determine one or more of a location of renal denervation therapy or a modality of renal denervation therapy to apply to the patient based on the renal arterial anatomy information
The above identified elements comprise an explicit claim recitation of an abstract idea. Therefore, rather than merely involve a judicial exception, the claims are directed to the identified judicial exception.
This claim language is identified as an abstract idea, because in MPEP §
2106.04(a)(2) III B. this language is similar to concepts relating to organizing or
analyzing information in a way that can be performed mentally or are analogous to
human mental work. For example, Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d
1138, 120 USPQ2d 1473 (Fed. Cir. 2016). In Synopsys, the patentee claimed methods
of logic circuit design, comprising converting a functional description of a level sensitive
latch into a hardware component description of the latch. 839 F.3d at 1140; 120 USPQ2d at 1475. Although the patentee argued that the claims were intended to be
used in conjunction with computer-based design tools, the claims did not include any
limitations requiring computer implementation of the methods and thus do not involve
the use of a computer in any way. 839 F.3d at 1145; 120 USPQ2d at 1478-79. The
court therefore concluded that the claims “read on an individual performing the claimed
steps mentally or with pencil and paper,” and were directed to a mental process of
“translating a functional description of a logic circuit into a hardware component
description of the logic circuit.” 839 F.3d at 1149-50; 120 USPQ2d at 1482-83.
In the instant case, the identified abstract idea is similar to Synopsys because the
language reads on an individual receiving renal arterial anatomy information, and determining a location or modality for therapy for a patient mentally or with a pencil and paper. They do not require any particular computer technology and therefore are directed to a mental process of evaluating imaging data determining an appropriate treatment plan.
Yes. The claim is directed to an abstract idea.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
First, the additional elements are identified.
In claim 1 and 9: memory, processing circuitry, receiving renal arterial anatomy information, outputting an indication; In claim 14: receiving renal arterial anatomy, outputting an indication
Claims 2-4, 7-8, 10-12, 15-17: receiving and outputting
Claim 9: imaging device
The imaging device is recited broadly as any imaging device without reference to a particular arrangement or configuration. The imaging sensors are only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed, as no additional data collection or active imaging is claimed. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity.
The processing circuitry, memory, output, and receiving of data appear to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter. Output or display is considered to be insignificant extra-solution activity as to outputting certain aspects of the abstract idea.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
The imaging device is recited broadly as any imaging device without reference to a particular arrangement or configuration. The imaging sensors are only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed, as no additional data collection or active imaging is claimed. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity.
The processing circuitry, memory, output, and receiving of data appear to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter. Output or display is considered to be insignificant extra-solution activity as to outputting certain aspects of the abstract idea.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6 and 9-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coates et al. (U.S. Patent Application Publication No. 2019/0223955) hereinafter referred to as Coates.
Regarding claim 1, Coates teaches a computing device (¶[0101], ¶[0115] computer model, therefore computing device) comprising:
a memory; and processing circuitry coupled to the memory (¶[0102] memory, processor coupled to the memory), the processing circuitry being configured to:
receive geometric renal arterial anatomy information of a patient (¶[0101] takes into consideration patient-specific tissue characteristics and anatomy, including ¶[0245] vessel diameter, length, intima-media thickness, coefficient of friction, tortuousity, distensibility, stiffness, modulus of elasticity, etc. of renal artery as the vessel of interest, e.g. ¶[0246]) based on imaging data (¶[0107] patient-specific image of the region generated using imaging modality, ¶[0115]);
determine one or more of a location of renal denervation therapy (¶[0111] guided) or a modality of renal denervation therapy (¶[0112] amount of energy) to apply to the patient by evaluating the geometric renal arterial anatomy information (¶¶[0112-0114] parameters of therapy dependent on types of tissue in individual patient-specific anatomy, ¶[0115] digital reconstruction and computer modeling of patient anatomy is used to choose location of the therapy, and based on obtained geometric information from imaging); and
output an indication of one or more of the determined location to apply renal denervation therapy to the patient or the determined modality of renal denervation therapy to apply to the patient (¶¶[0117-0118] therapy plan, Figs. 8-9 GUI includes display of locations and therapy parameters, Fig. 4).
Regarding claim 2, Coates teaches the computing device of claim 1.
Coates further teaches wherein the processing circuitry is further configured to:
determine the location of renal denervation therapy to apply to the patient based on the geometric renal arterial anatomy information (¶[0111], and ¶[0115] digital reconstruction and computer modeling of patient anatomy is used to choose location of the therapy, and based on obtained geometric information from imaging); and output the indication of the determined location to apply the renal denervation therapy to the patient (¶¶[0117-0118] therapy plan, Figs. 8-9 GUI includes display of locations and therapy parameters, Fig. 4).
Regarding claim 3, Coates teaches the computing device of claim 1.
Coates further teaches wherein the processing circuitry is further configured to:
receive an indication of the determined modality of renal denervation therapy to apply to the patient (¶[0100]);
determine the location of renal denervation therapy based on the geometric renal arterial anatomy information and the determined modality of renal denervation therapy (¶[0106] select a volume of influence that extends to the tissue of interest); and
output the indication of the determined location to apply the renal denervation therapy to the patient (¶¶[0117-0118] therapy plan, Figs. 8-9 GUI includes display of locations and therapy parameters, Fig. 4).
Regarding claim 4, Coates teaches the computing device of claim 1.
Coates further teaches wherein the processing circuitry is further configured to:
determine the modality of renal denervation therapy to apply to the patient based on the geometric renal arterial anatomy information (¶¶[0112-0114] parameters of therapy dependent on types of tissue in individual patient-specific anatomy); and
output the indication of the determined modality of renal denervation therapy to apply to the patient (¶¶[0117-0118] therapy plan, Figs. 8-9 GUI includes display of locations and therapy parameters, Fig. 4).
Regarding claim 5, Coates teaches the computing device of claim 1.
Coates further teaches wherein the modality of renal denervation therapy includes one or more of radiofrequency (¶[0118], ¶[0121]), cryoablation (¶[0121]), ultrasound (¶[0121]), microwave (¶[0121]), radiation (¶[0121]), and chemical (¶[0121]).
Regarding claim 6, Coates teaches the computing device of claim 1.
Coates further teaches wherein the geometric renal arterial anatomy information includes one or more of a length of aorta to hilum, number of branches, location of branches, length of aorta to primary bifurcation point, maximum diameter of main renal artery, minimum diameter of the main renal artery, mean diameter of the main renal artery, diameter of branches, length of branches, length of proximal segment of the main renal artery, length of middle segment of the main renal artery, or length of distal segment of the main renal artery (¶[0245] vessel diameter, length, intima-media thickness, coefficient of friction, tortuousity, distensibility, stiffness, modulus of elasticity, etc. of renal artery as the vessel of interest, e.g. ¶[0246]).
Regarding claim 9, Coates teaches a system comprising:
an imaging device configured to collect the imaging data indicative of the geometric renal arterial anatomy information of a patient (¶[0137]); and
the computing device of claim 1 (see rejection of claim 1, above), wherein the computing device is communicatively coupled to the imaging device (¶[0107]).
Regarding claims 10-13/14-19, the claims are directed to a system/method comprising substantially the same subject matter as claims 2-5/1-6, and are rejected under substantially the same sections of Coates.
Regarding claim 20, Coates teaches the computing device of claim 1.
Coates teaches wherein evaluating the geometric renal arterial anatomy information comprises evaluating a length of a space from an aorta to a renal hilum to select a distal portion of the space as the location to apply the renal denervation therapy (¶[0246] selecting within 5mm from inner wall of the renal artery).
Regarding claim 21, Coates teaches the computing device of claim 1.
Coates further teaches wherein evaluating the geometric renal arterial anatomy information comprises determining the location based on a convergence of one or more renal nerves toward a main renal artery to minimize a depth of ablation (¶[0246] selecting within 5mm from inner wall of the renal artery).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coates as applied to claims 1 and 3 above, and further in view of Amit et al. (U.S. Patent Application Publication No. 2021/0085387) hereinafter referred to as Amit.
Regarding claims 7-8, Coates teaches the computing device of claim 1/3.
Coates further teaches wherein to determine the one or more of a location of renal denervation therapy (¶[0111]) or a modality of renal denervation therapy to apply to the patient based on the geometric renal arterial anatomy information (¶¶[0112-0114] parameters of therapy dependent on types of tissue in individual patient-specific anatomy),
the processing circuitry is configured to generate an output indicating one or more of the determined location to apply renal denervation therapy to the patient or the determined modality of renal denervation therapy to apply to the patient (¶¶[0117-0118] therapy plan, Figs. 8-9 GUI includes display of locations and therapy parameters, Fig. 4) using a plurality of examples of renal arterial anatomy information labeled with a respective one or more of a plurality of locations to apply renal denervation therapy or a plurality of modalities of renal denervation therapy to apply to the patient (¶[0109], ¶[0170], ¶¶[0185-0186]).
Coates does not teach the processing circuitry configured to apply the geometric renal arterial anatomy information to a machine learning model, the machine learning model trained to generate an output indicating one or more of the determined location to apply renal denervation therapy to the patient or the determined modality of renal denervation therapy to apply to the patient using a training set comprising a plurality of examples of renal arterial anatomy information labeled with a respective one or more of a plurality of locations to apply renal denervation therapy or a plurality of modalities of renal denervation therapy to apply to the patient.
Attention is drawn to the Amit reference, which teaches a processing circuitry configured to apply geometric arterial anatomy information (¶[0102], ¶[0124] imaging data) to a machine learning model (¶¶[0130-0133] one or two machine learning models trained and used), the machine learning model trained to generate an output indicating one or more of a determined location to apply therapy to the patient (¶[0078]) or a determined modality of therapy to apply to the patient (¶[0084]) using a training set (¶¶[0036-0037]), comprising a plurality of examples of arterial anatomy information labeled with a respective one or more of a plurality of locations to apply therapy or a plurality of modalities of therapy to apply to the patient (¶¶[0108-0121], ¶[0123], ¶¶[0136-0139]). Further, while this embodiment of Amit is directed primarily to cardiac ablation, Amit contemplates the application of the techniques therein to renal denervation (¶[0143]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the renal denervation system of Coates to include a machine learning algorithm, as taught by Amit, because Amit teaches a benefit to machine learning algorithm inferences, including simple assessment of the quality of ablative treatment, leading to increased accuracy and improvement in ablation procedure outcomes (Amit ¶[0043]).
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 AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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