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 .
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 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.
Response to Amendment
Acknowledgement is made to the amendment received 12/22/2025.
Acknowledgement is made to the amendment of claims 1, 3, 8, 10-11, 13, 18, and 20.
Claims 1-20 are pending. A complete action on the merits appears below.
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 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis in accordance with MPEP 2106.04 of said claim set follows.
Analysis of claims 1-20:
Step 1 per MPEP 2106.03
Regarding claim 1, the claim recites a method. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
Regarding claim 11, the claim recites a system. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1 per MPEP 2106.04(a)
Claim 1 contains the following limitation:
“receiving at least one of locations of multiple ablation sites and coordinates of one or more anatomical regions over a surface of a heart; categorizing the multiple ablation sites and the one or more anatomical regions according to predefined categories wherein the predefined categories comprise specific anatomical regions of the heart and types of ablation sources; graphically encoding the multiple ablation sites and the anatomical regions on an anatomical map according to their respective categories by assigning distinct graphical attributes to each of the multiple ablation sites and each of the anatomical regions belonging to different predefined categories; and displaying the graphically encoded anatomical map to a user.”
These limitations describe mental processes which are discussed as being concepts performed in the human mind (including performing an observation, evaluation, judgement, opinion, etc. as is discussed in MPEP 2106.04(a)(2)(III)). Accordingly, claim 1 recites an abstract idea as these limitations describe a mental process as a person having ordinary skill in the art is capable of understanding data relevant to ablations procedures and their planning/review and making a mental assessment thereafter (or using pen and paper).
Claim 11 contains the following limitation:
“an interface configured to receive at least one of locations of multiple ablation sites and coordinates of one or more anatomical regions over a surface of a heart; and a processor, which is configured to: categorize the multiple ablation sites and the one or more anatomical regions according to predefined categories, wherein the predefined categories comprise specific anatomical regions of the heart and types of ablation sources; graphically encode the multiple ablation sites and the anatomical regions on an anatomical map according to their respective categories by assigning distinct graphical attributes to each of the multiple ablation sites and each of the anatomical regions belonging to different predefined categories; and display the graphically encoded anatomical map to a user”
These limitations describe mental processes which are discussed as being concepts performed in the human mind (including performing an observation, evaluation, judgement, opinion, etc. as is discussed in MPEP 2106.04(a)(2)(III)). Accordingly, claim 11 recites an abstract idea as these limitations describe a mental process as a person having ordinary skill in the art is capable of understanding data relevant to ablations procedures and their planning/review and making a mental assessment thereafter (or using pen and paper).
Dependent claims 2-10 and 12-20 also fail to add to the abstract independent claims as they merely further limit the abstract idea or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely identical or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea is not integrated into a practical application under MPEP 2106.04(d) because the additional elements, either alone or in combination generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h). More specifically, the additional element of: an interface, a processor, and a display are generally recited computer elements which do not improve the functioning of a computer or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., an interface, a processor, and a display). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f).
Accordingly, independent claims 1 and 11 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
Claims 1-20 do not include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05.
These claims require the additional elements of: an interface, a processor, and a display.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract ideas to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Furthermore, these additional limitations amount to well-known conventional techniques for obtaining data (e.g. receiving at least one of locations of multiple ablation sites and coordinates of one or more anatomical regions over a surface of a heart) and generically recited step of outputting (e.g. displaying the graphically encoded anatomical map to a use), which does not add significantly more to the judicial exception. Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity (e.g. receiving the location and displaying the map) according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, claims 1-20 are not patent eligible under 35 U.S.C. 101.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 7, 9-15, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Tal (US 20130296845 A1) in view of Sanchez (US 20030028183 A1).
Regarding claim 11, Bar-Tal teaches a system (Fig. 1; mapping and ablation system 20), comprising:
an interface (Fig. 1; console 34) configured to receive at least one of locations of multiple ablation sites and coordinates of one or more anatomical regions over a surface of a heart ([0003] teaches the CARTO system as tracking the position and operating parameters of the distal end of the catheter and displaying this information on a 3D anatomical map of the heart [0032]- [0033]); and
a processor (Fig. 1; processor 40), which is configured to:
categorize the multiple ablation sites ([0035] discusses the processor as automatically placing a mark on a map of a display to indicate a site where ablation parameters have been met indicating the adequacy of ablation at the treatment site in the heart, where the processor may vary the appearance of the marks in response to the parameters at each site) and the one or more anatomical regions according to predefined categories ([0037] discusses the map as being a 3D representation of the heart, having different regions which are represented separately by color, as broadly as is currently claimed, specifically, as different anatomical regions of the heart will have different local electrical activity), wherein the predefined categories comprise specific anatomical regions of the heart ([0037]);
graphically encode the multiple ablation sites ([0038] teaches that the processor places marks on the map to indicate sites that have been ablated and that the marks may be colored differently to indicate different ranges of measured parameters) and the anatomical regions on an anatomical map according to their respective categories by assigning distinct graphical attributes to each of the multiple ablation sites and each of the anatomical regions belonging to different predefined categories ([0023] discusses the heart as being separated into separate zones based on the position within the heart, [0035], [0037]); and
display the graphically encoded anatomical map to a user ([0034]).
However, Bar-Tal fails to teach one of the predefined categories as further comprising a type of ablation source.
Bar-Tal does however teach the system which distinguishes between sites that have been adequately ablated and those which have not been adequately ablated as determining this ablation adequacy based on selected parameters such as the time or temperature of the ablation ([0021], [0028]).
Sanchez teaches a system which measures parameters so as to determine if an ablation treatment has been clinically efficacious (Abstract).
Sanchez further teaches a variety of known parameters as being used to determine the efficacy of the treatment, such as the amount of time, the ablation temperature, and the type of ablation therapy ([0016]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the as parameter such as ablation time or temperature which is used to distinguish, and subsequently mark on a map, sites which have been and sites which have not been adequately ablated as is taught by Bar-Tal with the use of an ablation parameter such as type of ablation therapy to determine the efficacy of an ablation treatment, as is taught by Sanchez, as the parameters of the amount of time of ablation, the ablation temperature, and the type of ablation therapy all are used to perform the function of determining the efficacy of an ablation treatment, as is taught by Sanchez, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Regarding claim 12, Bar-Tal teaches the system according to claim 11, wherein the processor is configured to receive locations of multiple ablation sites by receiving at least one of planned and formed ablation sites ([0006]).
Regarding claim 13, Bar-Tal teaches the system according to claim 11, wherein the predefined categories further comprise at least one of one or more types of ablation catheter ([0007], [0021]- [0022], [0024]).
Regarding claim 14, Bar-Tal teaches the system according to claim 11, wherein the processor is configured to graphically encode by at least one of coloring and texturing ([0051]).
Regarding claim 15, Bar-Tal teaches the system according to claim 11, wherein the processor is configured to graphically encode sites by tagging sites ([0003]).
Regarding claim 17, Bar-Tal teaches the system according to claim 11, wherein the processor is configured to graphically encode by using an automated algorithm ([0006]- [0009]).
Regarding claim 19, Bar-Tal teaches the system according to claim 11, wherein the anatomical map is an EA map ([0034], [0037]).
Regarding claim 20, Bar-Tal teaches the system according to claim 11, the processor is further configured to provide statistics of ablation results within at least one of the graphically encoded anatomical regions ([0041], [0051] teach providing an indication that a specific location has been ablated).
Regarding claims 1-5, 7, and 9-10, the method steps provided are the same as described as the steps the system is configured to perform and therefore taught by in the same way as seen in claims 11-15, 17, and 19-20.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Tal (US 20130296845 A1) and Sanchez (US 20030028183 A1) in view of Panescu (US 5916163 A).
Regarding claim 16, Bar-Tal as modified teaches the system according to claim 11, wherein the processor is configured to graphically encode by using an interface ([0033]).
However, Bar-Tal as modified fails to teach the interface as being a graphical user interface (GUI).
Panescu teaches a system for interpreting data collected by a multiple electrode catheter and displaying an image of the catheter (Abstract).
Panescu further teaches the interface as being a graphical user interface (Abstract).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the use of a known interface, such as a graphical user interface, as is taught by Panescu, into the interface of Bar-Tal as modified to produce the predictable result of displaying an image of interpreted data of a multiple electrode catheter.
Regarding claim 6, the method steps provided are the same as described as the steps the system is configured to perform and therefore taught by in the same way as seen in claim 16.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Tal (US 20130296845 A1) and Sanchez (US 20030028183 A1) in view of Zoabi (US 20180161097 A1).
Regarding claim 18, Bar-Tal as modified teaches the system according to claim 11.
However, Bar-Tal as modified fails to teach the system wherein the processor is configured to graphically encode by changing visibility of at least one of the encoded sites and regions between opaque, semi-transparent and fully transparent.
Zoabi teaches visualizing ablation by displaying a three-dimensional display that visually represents a region for ablation and the impact the ablation has on the region (Abstract).
Zoabi further teaches displaying an impact of an ablation based on markings, wherein the indication displayed by the markings may be transparent or not transparent sections so as to indicate the state of the tissue ([0036], [0045]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of indicating a difference based on markings which are either transparent or not transparent, as is taught by Zoabi, into the system which denotes indications through the using of displayed markings, as is taught by Bar-Tal as modified, so as to produce the predictable result of indicating a difference in marking denotation, as is taught by Zoabi.
Regarding claim 8, the method steps provided are the same as described as the steps the system is configured to perform and therefore taught by in the same way as seen in claim 18.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, Applicant’s arguments of the limitations that art not taught by the Bar-Tal reference are moot in view of the new rejections under Bar-Tal and Sanchez.
In response to Applicant’s arguments that the invention cannot be practically performed in the human mind because a human mind cannot categorize hundreds of individual ablation tags in real time on a complex 3D electro anatomical map, it is noted that the features upon which applicant relies (i.e., categorizing hundreds of individual ablation tags in real time) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, in response to Applicant’s arguments that the human mind cannot perform these functions due to the large volume of data, it is noted that the features upon which applicant relies (i.e., specific quantities of data) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant’s arguments that the human mind cannot apply visual encoding are currently unpersuasive as this visual encoding is a type of displaying data which is currently rejected as a type of extra-solution activity, see paragraphs 22-23 provided above.
Applicant’s argument that the claim language overcomes the currently provided 101 rejection at Step 2A, Prong 2 is currently unpersuasive as these cited argued improvements, as provided in the above rejection as being based on the MPEP 2106.04(d) citation, are not specifically provided as being relevant to a particular technology as these limitations are able to be performed by any generic computer, as broadly as is currently claimed.
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 extension fee 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 date of this final action.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794