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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1, 14, and 16 are objected to because of the following informalities:
in claim 1, line 21: “a label” should be “the label”;
in claim 1, line 27: “an” before “inclusion” should be deleted;
in claim 1, line 28: “a” should be inserted before “right superior”;
in claim 1, line 29: “a” should be inserted before “left inferior”;
in claim 14, line 2: “a right” should be “the right”;
in claim 14, line 3: “a left” should be “the left”;
in claim 16, line 18: “a label” should be “the label”;
in claim 16, line 24: “an” before “inclusion” should be deleted;
in claim 16, line 25: “a” should be inserted before “right superior”;
in claim 16, line 26: “a” should be inserted before “left inferior”;
in claim 29, line 2: “a” should be inserted before “right superior”; and
in claim 29, line 3: “a” should be inserted before “left inferior”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-3, 12-18, and 27-30 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.
Claim 1 recites “the query” in line 30 in which there is insufficient antecedent basis for this limitation in the claim. Also, it is not clear what relationship this query has with the recitations that have come before it. Clarification is required.
Claim 1 recites “associated statistical metrics” in lines 32-33, but it is not clear if this recitation is the same as, related to, or different from “cohort-wise statistical metrics” of claim 1, line 31. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear, they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and it should be clear how the computation of the cohort-wise statistical metrics relates to the provision of the graphical outputs with its associated statistical metrics.
Claims 2-3 and 12-15 are rejected by virtue of their dependence from claim 1.
Claim 12 recites “the query pulmonary vein anatomy” in line 4, but it is not clear if this recitation is the same as, related to, or different from “query pulmonary vein anatomy data” of claim 1, line 6. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear. Also, if they are different, there is insufficient antecedent basis for “the query pulmonary vein anatomy” in claim 12.
Claim 16 recites “the query” in line 26 in which there is insufficient antecedent basis for this limitation in the claim. Also, it is not clear what relationship this query has with the recitations that have come before it. Clarification is required.
Claim 16 recites “associated statistical metrics” in lines 29-30, but it is not clear if this recitation is the same as, related to, or different from “cohort-wise statistical metrics” of claim 16, line 28. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear, they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and it should be clear how the computation of the cohort-wise statistical metrics relates to the provision of the graphical outputs with its associated statistical metrics.
Claims 17-18 and 27-30 are rejected by virtue of their dependence from claim 16.
Claim 27 recites “the query pulmonary vein anatomy” in line 4, but it is not clear if this recitation is the same as, related to, or different from “query pulmonary vein anatomy data” of claim 16, line 3. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear. Also, if they are different, there is insufficient antecedent basis for “the query pulmonary vein anatomy” in claim 16.
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.
Claims 1, 3, 15-16, 18, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2024/0120095 (Naghavi)(previously cited), in view of U.S. Patent Application Publication No. 2024/0260892 (Haas)(previously cited), and further in view of the article “Identifying and understanding the role of pulmonary vein activity in atrial fibrillation” (Khan)(previously cited), and further in view of the article “Pulmonary vein diameter, cross-sectional area, and shape: CT analysis” (Kim)(previously cited), and further in view of U.S. Patent Application Publication No. 2024/0170129 (Neumann)(previously cited), and further in view of WO 98/47428 (Wilk)(previously cited), and further in view of U.S. Patent Application Publication No. 2015/0142821 (Rassen).
Naghavi teaches computerized systems (paragraphs 0002, 0020, 0024-0026, 0029-0032, 0068, 0070, 0075, and 0081 of Naghavi). Haas teaches that such systems include computers, processors, and memories (paragraphs 0008-0009, 0022-0024, and 0028 of Haas). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the computerized system of Naghavi with processors and memories since components of the computerized system are necessary and Haas teaches such components.
Naghavi teaches the detection of characteristics of dilated pulmonary veins of Naghavi in the X-ray images (paragraph 0029 of Naghavi). Khan teaches that dilation is most prevalent at the ostium of the pulmonary veins (page 388 of Khan). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the locations at the ostium of the pulmonary veins to determine dilation since dilation is most prevalent at the ostium of the pulmonary veins.
Kim teaches that cross-sectional area is a metric when considering the shape of pulmonary veins (abstract of Kim). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the cross-sectional area values at the ostium of the pulmonary veins to determine dilation since a metric is required and Kim teaches one such metric and/or it is a simple substitution of one known element for another to obtain predictable results.
Naghavi teaches the training of a model using reference data (paragraphs 0057, 0062, 0066, and 0098 of Naghavi). Haas teaches that large language models (LLMs) are used to analyze medical diagnosis, initial symptoms, and initial observations so as to provide data for assessment of outcomes using X-ray and medical images (paragraph 0198 of Haas) and that these LLMs use/create categories and tags (paragraph 0215 of Haas). Neumann teaches that LLMs include transformer architecture, which is a neural network architecture that uses self-attention and positional encoding (paragraph 0065 of Neumann). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to do the training of a model using the LLMs having transformer architecture that uses self-attention and positional encoding since it allows more accurate results to be manifested.
The combination teaches or suggests the generation of the cross-sectional area values of the ostium of the pulmonary veins for the determination of dilation and non-dilation and the use of LLM to provide assessment of medical images. Wilk teaches the use of line (contour) and texture analysis of images so as to determine the presence of different organic structures (pages 26 and 30 of Wilk). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to generate at least a label using the plurality of reference pulmonary vein anatomy data by: generating a plurality of anatomic parameters based on the query pulmonary vein anatomy data by parameterizing features of the query pulmonary vein anatomy data including at least texture and contour (generating texture and contours for the line and texture analysis of the images); and labeling the query pulmonary vein anatomy data with the parameterized features using the anatomic parameters in comparison to the plurality of reference pulmonary vein anatomy data (labeling the pulmonary vein anatomy using the line and texture analysis) since it identifies the pulmonary vein anatomy from the images so that the generation of the cross-sectional area values of the ostium of the pulmonary veins for the determination of dilation and non-dilation can take place. Further, Neumann teaches the neural network are used to classify recognition algorithms (paragraph 0022 of Neumann). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the neural network of Neumann to generate the texture and contour since it allows more accurate results to be manifested and/or a method of classification is required and Neumann teaches one such classification and/or it is a simple substitution of one known element for another to obtain predictable results.
Rassen teaches the defining of cohorts for analysis based on measures based on events in a time series of events such that additional measures for the cohort are computed, the analysis is performed, and a report is generated (paragraph 0007 of Rassen). The query builder module has a user interface through which a user enters data defining a query definition 112. The query builder module can interact with the user to build a query definition 112 and then apply the query definition to the database. The database 108 can provide data 114 about the cohort to the query builder module to allow the query builder module to communicate information to the user, such as through a display (paragraph 0019 of Rassen).
A graphical user interface can be provided through which criteria defining a cohort are specified. Each cohort has a name and description, and source databases from which data is accessed. A cohort may span multiple underlying real world data sources, with matching patients drawn from each of the underlying patient universes. One or more entry criteria, based on defined measures, determine when a patient enters the cohort. One or more exclusion criteria determine when a patient is excluded from the cohort, and can be specified by the user based on defined measures (paragraph 0062 of Rassen).
After the selection is completed, the user can indicate that a cohort is defined and various measures to be used for analysis are then generated for the cohort. That is, various properties of the longitudinal data for the patients in the cohort can be measured (paragraph 0064 of Rassen). Details of the analysis to be performed also are defined or selected by the user. The analysis can then be run so as to generate results (including a statistical analysis) and a report (claims 1-2 and paragraph 0065 of Rassen).
These reports include tabular and graphical results including 2x2 tables, multivariate adjusted tables, diagnostic figures, and plots summarizing all results (paragraph 0024 of Rassen).
It would have been obvious to generate, using a cohort visualizer, a plurality of graphical outputs representative of a cohort-wise analysis, as a function on the labeled query pulmonary vein anatomy data, wherein the cohort visualizer: applies an inclusion and exclusion criteria to the labeled query pulmonary vein anatomy data; computes cohort-wise statistical metrics; and provides the graphical outputs as images together with associated statistical metrics, as suggested by Rassen, so as to provide a better understanding of how a specific patient fits with the general population with respect to the AT condition.
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use thresholds on right superior pulmonary vein ostium area and left inferior pulmonary vein ostium area to assign the query pulmonary vein anatomy data to a cohort since Rassen teaches that the query builder can choose relevant measures for the cohort assignment and Kim teaches that cross-sectional area is a relevant measure when considering the abnormal shape of pulmonary veins (abstract of Kim).
With respect to claim 1, the combination teaches or suggests an automated apparatus that suggests atrial fibrillation cases, the apparatus comprising:
at least a processor (the processor for the computerized system); and
a memory communicatively connected to the at least the processor (the memory for the computerized system), wherein the memory contains instructions configuring the at least the processor to:
receive query pulmonary vein anatomy data (the reception of the 2-D chest X-ray images of Naghavi; paragraph 0029 of Naghavi),
receive a plurality of reference pulmonary vein anatomy data (receiving the cross-sectional area values of the ostium of the pulmonary veins for the determination of dilation and non-dilation);
train a machine learning model comprising
generate, using the machine learning model, at least a label using the plurality of reference pulmonary vein anatomy data by: generating a plurality of anatomic parameters based on the query pulmonary vein anatomy by parameterizing features of the query pulmonary vein anatomy including at least texture and contour using a neural network (the generation of the texture and contour (lines) of the images, suggested by Wilk, using the neural network suggested by Neumann); and labeling the query pulmonary vein anatomy data with the parameterized features using the anatomic parameters in comparison to the plurality of reference pulmonary vein anatomy data (the labeling of the pulmonary veins in the images for analysis);
detect at least an abnormal pulmonary vein anatomy within the received query pulmonary vein anatomy data based on the at least a label (detecting in the X-ray images dilated pulmonary veins of Naghavi; paragraph 0029 of Naghavi); and
suggest a case of atrial fibrillation as a function of the at least the detected abnormal pulmonary vein anatomy (detecting individuals at high risk of atrial fibrillation of Naghavi based on the detected dilated pulmonary veins; paragraph 0029 of Naghavi);
generate, using a cohort visualizer, a plurality of graphical outputs representative of a cohort-wise analysis, as a function on the labeled query pulmonary vein anatomy data, wherein the cohort visualizer: applies an inclusion and exclusion criteria to the labeled query pulmonary vein anatomy data using thresholds on right superior pulmonary vein ostium area and left inferior pulmonary vein ostium area to assign the query to a cohort; computes cohort-wise statistical metrics; and provides the graphical outputs as images together with associated statistical metrics (generating the tabular and graphical results including 2x2 tables, multivariate adjusted tables, diagnostic figures, and plots summarizing all results of the cohort-wise analysis of Rassen including the cohorts and various properties of the longitudinal data for the patients in the cohort including a statistical analysis; claims 1-2 and paragraphs 0024 and 0065 of Rassen).
With respect to claim 3, the combination teaches or suggests that the received query pulmonary vein anatomy data include a plurality of images (the 2-D chest X-ray images of Naghavi; paragraph 0029 of Naghavi).
With respect to claim 15, the combination teaches or suggests that a suggestion of suggesting the case of atrial fibrillation comprises a prediction of a future case of atrial fibrillation (“detecting individuals at high risk of future adverse health outcomes”; paragraph 0029 of Naghavi, also paragraphs 0030 and 0071 and FIGS. 8-10 of Naghavi).
With respect to claim 16, the combination teaches or suggests a method for automatic suggestion of atrial fibrillation cases, the method comprising:
receiving query pulmonary vein anatomy data (the reception of the 2-D chest X-ray images of Naghavi; paragraph 0029 of Naghavi),
receiving a plurality of reference pulmonary vein anatomy data (receiving the cross-sectional area values of the ostium of the pulmonary veins for the determination of dilation and non-dilation);
training a machine learning model comprising
generating, using the machine learning model, at least a label using the plurality of reference pulmonary vein anatomy data by: generating a plurality of anatomic parameters based on the query pulmonary vein anatomy data by parameterizing features of the query pulmonary vein anatomy data including at least texture and contour using a neural network (the generation of the texture and contour (lines) of the images, suggested by Wilk, using the neural network suggested by Neumann); and labeling the query pulmonary vein anatomy data with the parameterized features using the anatomic parameters in comparison to the plurality of reference pulmonary vein anatomy data (the labeling of the pulmonary veins in the images for analysis);
detecting at least an abnormal pulmonary vein anatomy within the received query pulmonary vein anatomy data based on the at least a label (detecting in the X-ray images dilated pulmonary veins of Naghavi; paragraph 0029 of Naghavi); and
suggesting a case of atrial fibrillation as a function of the at least the detected abnormal pulmonary vein anatomy (detecting individuals at high risk of atrial fibrillation of Naghavi based on the detected dilated pulmonary veins; paragraph 0029 of Naghavi);
generating, using a cohort visualizer, a plurality of graphical outputs representative of a cohort-wise analysis, as a function on the labeled query pulmonary vein anatomy data, wherein the cohort visualizer: applies an inclusion and exclusion criteria to the labeled query pulmonary vein anatomy data using thresholds on right superior pulmonary vein ostium area and left inferior pulmonary vein ostium area to assign the query to a cohort; computes cohort-wise statistical metrics; and provides the graphical outputs as images together with associated statistical metrics (generating the tabular and graphical results including 2x2 tables, multivariate adjusted tables, diagnostic figures, and plots summarizing all results of the cohort-wise analysis of Rassen including the cohorts and various properties of the longitudinal data for the patients in the cohort including a statistical analysis; claims 1-2 and paragraphs 0024 and 0065 of Rassen).
With respect to claim 18, the combination teaches or suggests that the received query pulmonary vein anatomy data include a plurality of images (the 2-D chest X-ray images of Naghavi; paragraph 0029 of Naghavi).
With respect to claim 30, the combination teaches or suggests that suggesting the case of atrial fibrillation comprises automatically predicting a future case of atrial fibrillation using the at least the detected abnormal pulmonary vein anatomy (“detecting individuals at high risk of future adverse health outcomes”; paragraph 0029 of Naghavi, also paragraphs 0030 and 0071 and FIGS. 8-10 of Naghavi).
Claims 2, 12, 17, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Naghavi, in view of Haas, and further in view of Khan, and further in view of Kim, and further in view of Neumann, and further in view of Wilk, and further in view of Rassen, and further in view of U.S. Patent Application Publication No. 2022/0392065 (Min)(previously cited).
With respect to claim 2, Min teaches that medical images may be stored in and accessed from a medical image database (paragraph 0193 of Min). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to store the medical images in a medical image database, as suggested by Min, since it centralizes raw images for the users. Thus, the combination teaches or suggests that receiving the query pulmonary vein anatomy data comprises retrieving the query pulmonary vein anatomy data from a database (the use of the medical image database of Min).
With respect to claim 12, the combination teaches the analysis of the 2-D chest X-ray images of Naghavi and the detection in the X-ray images of the characteristics of dilated pulmonary veins of Naghavi (paragraph 0029 of Naghavi). Min teaches that CT scans are a suitable substitute for the X-ray images (paragraphs 0191, 0204, 0220, 0361, 0453, 0480, 0494, 0538, 0610, 0641, 0723, 0740, 0755, 0854, 1094, 1198-1199, 1227, 1608, 1650, 1664, 1673, 1680, 1741, 1764, 1777, 1817, 1831, 1881, and 1900 of Min) and that such CT scans may be take into account ECG gating parameters (paragraphs 0303, 0451, 0486, 0494, 0851, 1094, and 1102 of Min). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use CT scans with ECG gating of Min in place of the X-ray images of Naghavi since it is simple substitution of one known element for another to obtain predictable results. Thus, the combination teaches or suggests that receiving the query pulmonary vein anatomy data comprises estimating the query pulmonary vein anatomy as a function of ECG data contained within the received query pulmonary vein anatomy data (detecting in the CT scans and ECG readings the pulmonary veins).
With respect to claim 17, Min teaches that medical images may be stored in and accessed from a medical image database (paragraph 0193 of Min). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to store the medical images in a medical image database, as suggested by Min, since it centralizes raw images for the users. Thus, the combination teaches or suggests that receiving the query pulmonary vein anatomy data comprises retrieving the query pulmonary vein anatomy data from a database (the use of the medical image database of Min).
With respect to claim 27, Naghavi teaches the analysis of the 2-D chest X-ray images of Naghavi and the detection in the X-ray images of the characteristics of dilated pulmonary veins of Naghavi (paragraph 0029 of Naghavi). Min teaches that CT scans are a suitable substitute for the X-ray images (paragraphs 0191, 0204, 0220, 0361, 0453, 0480, 0494, 0538, 0610, 0641, 0723, 0740, 0755, 0854, 1094, 1198-1199, 1227, 1608, 1650, 1664, 1673, 1680, 1741, 1764, 1777, 1817, 1831, 1881, and 1900 of Min) and that such CT scans may be take into account ECG gating parameters (paragraphs 0303, 0451, 0486, 0494, 0851, 1094, and 1102 of Min). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use CT scans with ECG gating of Min in place of the X-ray images of Naghavi since it is simple substitution of one known element for another to obtain predictable results. Thus, the combination teaches or suggests that receiving the query pulmonary vein anatomy data comprises estimating the query pulmonary vein anatomy as a function of ECG data contained within the received query pulmonary vein anatomy data (detecting in the CT scans and ECG readings the pulmonary veins).
Claims 13 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Naghavi, in view of Haas, and further in view of Khan, and further in view of Kim, and further in view of Neumann, and further in view of Wilk, and further in view of Rassen, and further in view of the article “Variations in the pulmonary venous ostium in the left atrium and its clinical importance” (Prasanna)(previously cited).
The combination teaches or suggests the detection in the X-ray images of characteristics of dilated pulmonary veins of Naghavi (paragraph 0029 of Naghavi). Naghavi teaches the detection of a plurality of pulmonary veins, but not how many. Prasanna teaches that variation in the number of pulmonary veins in a person can range from 3 to 5 (Results of Prasanna). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to detect in the X-ray images the characteristics of five dilated pulmonary veins since Naghavi teaches a plurality of pulmonary veins are examined and Prasanna gives a suitable number of such pulmonary veins. Alternatively, Prasanna suggests that the number of pulmonary veins may change depending upon the subject’s anatomy and desired accuracy. As such, the number of examined pulmonary veins is a results-effective variable that would have been optimized through routine experimentation based on the subject’s anatomy and desired accuracy. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the number of examined pulmonary veins, using the range suggested by Prasanna as a starting point, so as to obtain the desired accuracy and the subject’s anatomy. Thus, the combination teaches or suggest that “wherein detecting the at least the abnormal pulmonary vein anatomy includes detecting 5 pulmonary veins” of claim 13 (the number of pulmonary veins suggested by Prasanna) and “wherein detecting the at least the abnormal pulmonary vein anatomy includes detecting 5 pulmonary veins” of claim 28 (the number of pulmonary veins suggested by Prasanna).
Claims 14 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Naghavi, in view of Haas, and further in view of Khan, and further in view of Kim, and further in view of Neumann, and further in view of Wilk, and further in view of Rassen, and further in view of U.S. Patent Application Publication No. 2003/0204187 (Hintringer)(previously cited).
Hintringer teaches that values of the pulmonary veins can be variable relative to atrial fibrillation (paragraph 0030 of Hintringer). The choice of the values for variables when determining the likelihood of atrial fibrillation will depend upon desired accuracy and margin of safety. As such, the cross-sectional area values of the ostium of the pulmonary veins for the determination of dilation and non-dilation are results-effective variables that would have been optimized through routine experimentation based on the factors of desired accuracy and margin of safety. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the cross-sectional area values of the ostium of the pulmonary veins when determining dilation with respect to atrial fibrillation, based on the diameters suggested by Hintringer, so as to obtain the desired accuracy and margin of safety.
Thus, the features of “wherein detecting the at least the abnormal pulmonary vein anatomy includes detecting a right superior pulmonary vein ostium area greater than or equal to 300 square millimeters and a left inferior pulmonary vein ostium area greater than or equal to 300 square millimeters” of claim 14 and “wherein detecting the at least the abnormal pulmonary vein anatomy includes detecting a right superior pulmonary vein ostium area greater than or equal to 300 square millimeters and a left inferior pulmonary vein ostium area greater than or equal to 300 square millimeters” of claim 29 would have been obvious.
Response to Arguments
The Applicant’s arguments filed 2/9/2026 have been fully considered.
Claim objections
There are new grounds of claim objections that were necessitated by the claim amendments filed on 2/9/2026.
With respect to the issue that “a label” should be “the label” in claim 1, line 21, the Applicant did not address this objection by amendment or argument. The Examiner cannot find a reason to withdraw the objection.
With respect to the issue that “a label” should be “the label” in claim 16, line 18, the Applicant did not address this objection by amendment or argument. The Examiner cannot find a reason to withdraw the objection.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that were necessitated by the claim amendments filed on 2/9/2026.
Prior art rejections
There are new grounds of prior art rejections that were necessitated by the claim amendments filed on 2/9/2026.
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 MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791