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 .
This communication is in response to the Pre-Appeal Conference held on 03/23/2026. The prosecution has been reopened and claims 1, 3-11 and 13-15 remain pending in this application.
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, 3-11 and 13-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1, 3-10 are drawn to a system which is within the four statutory categories (i.e. machine). Claims 11, 13-15 are drawn to a method which is within the four statutory categories (i.e. process).
Step 2A, Prong 1:
Claims 1 and 11have been amended to recite:
“receive imaging data of a patient;
perform segmentation on the imaging data of the patient to generate renal arterial anatomy information of the patient, the renal arterial anatomy information including one or more of a length of a main renal artery or a number of main renal arteries;
determine a renal anatomical complexity score based on the renal arterial anatomy information;
determine a type of renal denervation therapy to apply to the patient based on the renal anatomical complexity score; and
control the communication circuitry to output an indication of the determined type of renal denervation therapy to apply to the patient”
The limitations of “receive imaging data of a patient;… determine a renal anatomical complexity score based on the renal arterial anatomy information; determine a type of renal denervation therapy to apply to the patient based on the renal anatomical complexity score;…” is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “processing circuitry configured to:” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “processing circuitry configured to” language, “determining” in the context of this claim encompasses the user manually (or using pen and paper) determining a renal anatomical complexity and determining a type of renal denervation therapy for the patient.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, claims recite an abstract idea.
The limitation of “perform segmentation on the imaging data of the patient to generate renal arterial anatomy information of the patient,…” corresponds to performing mathematical relationships, which falls within the “mathematical concepts” of the abstract ideas.
Dependent claims also correspond to mental processes, since they are directed to processes that can be performed in human mind (or human using pen and paper), such as, claim 3 recites “determine a main renal artery length anatomical complexity score based on a length of the main renal artery”, claim 4 recites “determine the main renal artery length anatomical complexity score by comparing the length of the main renal artery to a main renal artery length threshold,…”, claim 5 recites “determine a main renal artery count anatomical complexity score by comparing the number of main renal arteries to a main renal artery count threshold; and determine the renal anatomical complexity score based at least in part on the main renal artery count anatomical complexity score”, claim 6 recites “determine the renal anatomical complexity score based on the main renal artery length anatomical complexity score and the main renal artery count anatomical complexity score”, claim 7 recites “determine to apply one or more ablations only to a trunk of the main renal artery in response to the renal anatomical complexity score being less than or equal to a lower treatment threshold”, claim 8 recites “determine to apply one or more ablations to a trunk of the main renal artery and primary and secondary branches of the main renal artery in response to the renal anatomical complexity score being greater than or equal to an upper treatment threshold”, claim 9 recites “determine to apply one or more ablations to a trunk of the main renal artery and to a primary branch of the main renal artery in response to the renal anatomical complexity score being between a lower treatment threshold and an upper treatment threshold”, claim 13 recites “determining a main renal artery length anatomical complexity score based on a length of the main renal artery”, claim 14 recites “determining the main renal artery length anatomical complexity score by comparing the length of the main renal artery to a main renal artery length threshold, wherein the length of the main renal artery is a length from a main renal artery ostium of the main renal artery to a primary bifurcation point of the main renal artery”, and claim 15 recites “determining a main renal artery count anatomical complexity score by comparing the number of main renal arteries to a main renal artery count threshold; and determining the renal anatomical complexity score based on the main renal artery count anatomical complexity score”.
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Claims 3-10 and 13-15 are ultimately dependent from claims 1, 11 and include all the limitations of claims 1, 11. Therefore, claims 3-10 and 13-15 recite the same abstract idea. Claims 3-10 and 13-15 describe a further limitation regarding the basis for determining a type of renal denervation therapy. These are all just further describing the abstract idea recited in claims 1, 11, without adding significantly more.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements of “a memory”, “communication circuitry”, “processing circuitry coupled to the memory and the communication circuitry”, “perform segmentation on the imaging data of the patient to generate renal arterial anatomy information of the patient,…”, “an imaging device configured to collect data indicative of the renal arterial anatomy information of a patient, and wherein the computing device processing circuitry is configured to receive the renal arterial anatomy information from the imaging device”, and using processing circuitry to perform the steps of determining a complexity score, determining a type of renal denervation therapy, which are hardware and software elements, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment, and mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment do not provide practical application for an abstract idea (MPEP 2106.05(f) & (h)).
The processing circuitry recited in the claims are directed to a generic computing component, such as the current specification recites “processing circuitry (e.g., of a computing device)” in [0018]
Claims also recite other additional limitations beyond abstract idea, including functions such as receiving data from/to a database, outputting data are insignificant extra-solution activities (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processing circuitry to perform determining steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claims have been amended to recite “perform segmentation …, the renal arterial anatomy information including one or more of a length of a main renal artery or a number of main renal arteries” and performing segmentation on the imaging data to generate renal arterial anatomy information of the patient is a well-understood, routine and conventional activity, as evidenced by the newly applied prior art, Florent (US 2015/0297151 A1). In particular, Florent teaches “…the organ or device footprint is segmented in an initial image and a spline curve is fitted to the boundary of the segmentation…” in [0065] and “…vessel RA segmentation is executed in the corresponding angiogram and the propagation d derived therefrom is the one used in the fluoro IM (assuming little motion at the targeted location, which is the case for renal denervation). As mentioned some embodiments rely on the wire in case of back-track ablation. In both cases a segmentation of the relevant vessel RA (or parts thereof or of device DC or of associated devices such as the catheter guidewire is executed.” in [0066] and in fig. 4.
The claims are not patent eligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 3-6, 10-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Müller at el. (hereinafter Müller) (US 2021/0251504 A1) in view of Florent (US 2015/0297151 A1).
Claim 1 has been amended to recite a system comprising:
a memory (Müller; [0086]);
communication circuitry (Müller; [0041]); and
processing circuitry coupled to the memory and the communication circuitry (Müller; [0041], [0086]), the processing circuitry configured to:
receive imaging data of the patient (Müller discloses “In a fourth exemplary embodiment of the system, the measurement arrangement comprises an extracorporeal imaging apparatus 30 configured to provide the morphological information of the vessel and the plurality of measurements along the length of the vessel of the patient.” in [0083]);
perform segmentation on the imaging data of the patient to generate renal arterial anatomy information of the patient…(Muller discloses “In a fourth exemplary embodiment of the system, the measurement arrangement comprises an extracorporeal imaging apparatus 30 configured to provide the morphological information of the vessel and the plurality of measurements along the length of the vessel of the patient… If the extracorporeal imaging apparatus 30 is suitable for any of the CT angiography and MR angiography, then the control unit 31 may control dosing contrast medium for the respective imaging modality, provide segmentation of the imaged anatomy, and calculate propagation of a change of flow and/or vessel morphology, based on which PWV is determined by the processing apparatus 20.” in [0083]);
determine a renal anatomical complexity score based on the renal arterial anatomy information (Müller discloses “…a processor configured to: ascertain a plurality of spatially resolved pulse wave velocity values along the length of the vessel based on the plurality of measurements; ascertain an inferior limit value of the ascertained pulse wave velocity values for classification of the patient according to a predicted therapeutic benefit.…” in [0010];
determine a type of renal denervation therapy to apply to the patient based on the renal anatomical complexity score (Müller discloses “…the received plurality of measurements are related to a renal artery and the processor is configured to recommend the patient eligible for a renal denervation therapy based on the limit value compared to a predetermined threshold value..…” in [0016]; and
control the communication circuitry to output an indication of the determined type of renal denervation therapy to apply to the patient (Müller; [0016], [0041]).
Müller fails to expressly teach “(perform segmentation on the imaging data), the renal arterial anatomy information including one or more of a length of a main renal artery or a number of main renal arteries”. However, this feature is well known in the art, as evidenced by Florent.
In particular, Florent discloses “…the organ or device footprint is segmented in an initial image and a spline curve is fitted to the boundary of the segmentation…” in [0065] and “…vessel RA segmentation is executed in the corresponding angiogram and the propagation d derived therefrom is the one used in the fluoro IM (assuming little motion at the targeted location, which is the case for renal denervation). As mentioned some embodiments rely on the wire in case of back-track ablation. In both cases a segmentation of the relevant vessel RA (or parts thereof or of device DC or of associated devices such as the catheter guidewire is executed.” in [0066] and in fig. 4.
One of ordinary skill in the art would have recognized that applying the known technique of Florent would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the technique of Florent to the teachings of reference A would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such data processing features into similar systems. Further, applying segmentation through a spline curve and vessel RS segmentation to Muller would have been recognized by those of ordinary skill in the art as resulting in an improved system that would allow more detailed segmentation.
Claim 3 has been amended to recite the system of claim 1, wherein the processing circuitry is further configured to: determine a main renal artery length anatomical complexity score based on a length of the main renal artery (Müller; [0016]).
As per claim 4, Müller discloses the system of claim 3, wherein the processing circuitry is further configured to: determine the main renal artery length anatomical complexity score by comparing the length of the main renal artery to a main renal artery length threshold, wherein the length of the main renal artery is a length from a main renal artery ostium of the main renal artery to a primary bifurcation point of the main renal artery (Müller; [0014]-[0015]).
As per claim 5, Müller discloses the system of claim 2, wherein the processing circuitry is further configured to: determine a main renal artery count anatomical complexity score by comparing the number of main renal arteries to a main renal artery count threshold; and determine the renal anatomical complexity score based at least in part on the main renal artery count anatomical complexity score (Müller; [0014]-[0015]).
As per claim 6, Müller discloses the system of claim 5, wherein the processing circuitry is further configured to: determine the renal anatomical complexity score based on the main renal artery length anatomical complexity score and the main renal artery count anatomical complexity score (Müller; [0014]-[0015]).
As per claim 10, Müller discloses the system of claim 1, wherein a computing device comprises the memory and the processing circuitry, the system further comprising: an imaging device configured to collect data indicative of the renal arterial anatomy information of a patient, and wherein the computing device processing circuitry is configured to receive the renal arterial anatomy information from the imaging device (Müller; [0036]).
Claim 11 has been amended to recite a method comprising:
receiving, by the processing circuitry, imaging data of a patient (Müller discloses “In a fourth exemplary embodiment of the system, the measurement arrangement comprises an extracorporeal imaging apparatus 30 configured to provide the morphological information of the vessel and the plurality of measurements along the length of the vessel of the patient.” in [0083]);
performing, by the processing circuitry, segmentation on the imaging data of the patient to generate renal arterial anatomy information of the patient…(Muller discloses “In a fourth exemplary embodiment of the system, the measurement arrangement comprises an extracorporeal imaging apparatus 30 configured to provide the morphological information of the vessel and the plurality of measurements along the length of the vessel of the patient… If the extracorporeal imaging apparatus 30 is suitable for any of the CT angiography and MR angiography, then the control unit 31 may control dosing contrast medium for the respective imaging modality, provide segmentation of the imaged anatomy, and calculate propagation of a change of flow and/or vessel morphology, based on which PWV is determined by the processing apparatus 20.” in [0083]);
determining, by the processing circuitry, a renal anatomical complexity score based on the renal arterial anatomy information (Müller; [0010]);
determining, by the processing circuitry, a type of renal denervation therapy to apply to the patient based on the renal anatomical complexity score (Müller; [0016]); and
controlling, by the processing circuitry, communication circuitry to output an indication of the determined type of renal denervation therapy to apply to the patient (Müller; [0016], [0041]).
Müller fails to expressly teach “(perform segmentation on the imaging data), the renal arterial anatomy information including one or more of a length of a main renal artery or a number of main renal arteries”. However, this feature is well known in the art, as evidenced by Florent.
In particular, Florent discloses “…the organ or device footprint is segmented in an initial image and a spline curve is fitted to the boundary of the segmentation…” in [0065] and “…vessel RA segmentation is executed in the corresponding angiogram and the propagation d derived therefrom is the one used in the fluoro IM (assuming little motion at the targeted location, which is the case for renal denervation). As mentioned some embodiments rely on the wire in case of back-track ablation. In both cases a segmentation of the relevant vessel RA (or parts thereof or of device DC or of associated devices such as the catheter guidewire is executed.” in [0066] and in fig. 4.
One of ordinary skill in the art would have recognized that applying the known technique of Florent would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the technique of Florent to the teachings of reference A would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such data processing features into similar systems. Further, applying segmentation through a spline curve and vessel RS segmentation to Muller would have been recognized by those of ordinary skill in the art as resulting in an improved system that would allow more detailed segmentation.
Claim 13 has been amended to recite the method of claim 11, wherein the method further comprises: determining a main renal artery length anatomical complexity score based on a length of the main renal artery (Müller; [0016]).
As per claim 14, Müller discloses the method of claim 13, wherein the method further comprises: determining the main renal artery length anatomical complexity score by comparing the length of the main renal artery to a main renal artery length threshold, wherein the length of the main renal artery is a length from a main renal artery ostium of the main renal artery to a primary bifurcation point of the main renal artery (Müller; [0014]-[0015]).
As per claim 15, Müller discloses the method of claim 11, wherein the method further comprises: determining a main renal artery count anatomical complexity score by comparing the number of main renal arteries to a main renal artery count threshold; and determining the renal anatomical complexity score based on the main renal artery count anatomical complexity score (Müller; [0014]-[0015]).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Müller at el. (hereinafter Müller) (US 2021/0251504 A1), Florent (US 2015/0297151 A1) and further in view of Cezo (US 2023/0233095 A1).
Claim 7 has been amended to recite the system of claim 1, wherein to determine the type of renal denervation therapy to apply, the processing circuitry is further configured to: determine to apply one or more ablations only to a trunk of the main renal artery in response to the renal anatomical complexity score being less than or equal to a lower treatment threshold.
Claim 8 has been amended to recite the system of claim 1, wherein to determine the type of renal denervation therapy to apply, the processing circuitry is further configured to: determine to apply one or more ablations to a trunk of the main renal artery and primary and secondary branches of the main renal artery in response to the renal anatomical complexity score being greater than or equal to an upper treatment threshold.
Claim 9 has been amended to recite the system of claim 1, wherein to determine the type of renal denervation therapy to apply, the processing circuitry is further configured to: determine to apply one or more ablations to a trunk of the main renal artery and to a primary branch of the main renal artery in response to the renal anatomical complexity score being between a lower treatment threshold and an upper treatment threshold.
Müller fails to expressly teach “determine to apply one or more ablations only to a trunk of the main renal artery in response to the renal anatomical complexity score being less than or equal to a lower treatment threshold”/ “determine to apply one or more ablations to a trunk of the main renal artery and primary and secondary branches of the main renal artery in response to the renal anatomical complexity score being greater than or equal to an upper treatment threshold”/ “determine to apply one or more ablations to a trunk of the main renal artery and to a primary branch of the main renal artery in response to the renal anatomical complexity score being between a lower treatment threshold and an upper treatment threshold”. However, this feature is well known in the art, as evidenced by Cezo.
In particular, Cezo discloses “In some embodiments, another device or system, such as one separate from the system 100 may be used to stimulate the sympathetic nervous system of the patient. In some aspects, the nerves stimulated by various components of the system 100 may include nerves proximate to the renal blood vessel, or any other target vessel in which a nerve ablation procedure may be performed, or may be nerves that are a part of the nervous system but spaced from or remote from the renal blood vessel or other target vessel. In some aspects, the device used to ablate renal nerves (e.g., the endovascular device 1602) may be any suitable type of ablation device. For example, the ablation device may include an ultrasound-based ablation device or an alcohol-based ablation device.” in [0068].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include the aforementioned limitation as disclosed by Cezo with the motivation of “cut off the sympathetic tone associated with hypertensive patients” (Cezo; [0087]).
Response to Arguments
Applicant's arguments filed 09/08/2025 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed below in the order in which they appear.
Arguments about 35 USC 101 rejection:
Applicant argues that the newly added feature of “perform segmentation on the imaging data of the patient to generate renal arterial anatomy information of the patient, the renal arterial anatomy information including one or more of a length of a main renal artery or a number of main arteries” is not directed an abstract idea of a mental process.
In response, Examiner submits that this feature is not directed to an abstract idea of a mental process, however, segmentation on the imaging data is directed to an abstract idea of a mathematical concept (see the updated rejection above). The feature of “perform segmentation on the imaging data of the patient to generate renal arterial anatomy information of the patient,…” corresponds to mere instructions to apply/implement/automate an abstract idea in a particular technological environment. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Also, performing segmentation on the imaging data to generate renal arterial anatomy information of the patient is a well-understood, routine and conventional activity, as evidenced by the newly applied prior art, Florent, as indicated in the rejection above.
The limitations of receiving data from/to a database and outputting data are insignificant extra-solution activities (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea.
Therefore, after considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Applicant argues that claim 1 covers a particular solution to a problem or a particular way to achieve a desired outcome. Applicant argues that claim 1 is directed to a particular solution of determining a type of renal denervation therapy, improving existing renal therapy technology by a new and improved way of determining a type of renal denervation therapy and providing the technical improvement to cardiac monitoring technology.
In response, Examiner submits that the current specification describes determining the treatment in [0018]-[0019] and these paragraphs recite “In some examples of the present technique, processing circuitry (e.g., of a computing device) may determine a targeted ablation strategy based on the complexity of the renal arterial anatomy. Processing circuitry may select a type of RDN ablation treatment based on complexity scores of the renal arterial anatomy of one or more kidneys. The complexity score may use any rating system, such as, but not limited, to a numerical rating system.” and “As described in more detail, the “complexity” of the renal arterial anatomy may include information such as whether a length of a main renal artery is less than a lower threshold, greater than upper threshold, or between the lower and upper threshold. In some examples, a main renal artery may be a blood vessel that feeds the largest volume of blood from the aorta to a respective kidney.”. There is no indication neither in the current claims nor in the current specification of any improvement to the technology. The processing circuitry determines treatment based on the complexity scores, which correspond to mere instructions to apply an exception using a generic computer component.
Therefore, the arguments are not persuasive, and claims are rejected under 35 USC 101 as being directed to non-statutory subject matter.
Arguments about 35 USC 103 rejection:
Applicant’s arguments, see Remarks, filed 09/08/2025, with respect to the rejection(s) of claim(s) 1, 3-11, 13-15 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Florent (US 2015/0297151 A1).
Claims have been amended to recite the limitation of canceled claim 2 (the renal arterial anatomy information including one or more of a length of a main renal artery or a number of main renal arteries), however, claims 1 and 11 have been amended to recite “performing, by the processing circuitry, segmentation on the imaging data of the patient to generate renal arterial anatomy information of the patient, the renal arterial anatomy information including one or more of a length of a main renal artery or a number of main renal arteries”. Therefore, the amendments necessitated the new ground(s) of rejection presented in this Office action.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/DILEK B COBANOGLU/ Primary Examiner, Art Unit 3687
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