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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). Figs. 10 is a functional block diagram that merely show blank boxes/blocks for reference numbers 201-293 which do not show the features of the invention as recited in the claims. In other words, raw reference numbers and otherwise blank boxes are simply not sufficient to show the claimed device features directed to structure. Therefore, the processing pipeline applying analysis algorithm(s) to respective multiple two-D images of claim 1 must be shown or the features canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-10 and 14-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Each of the claims fall within one statutory category (process) thus passing Step 1.
Under Step 2A, Prong One, the claims recite abstract mathematical concepts identified in bold or abstract mental processes ad identified in italics as follows:
A computer-implemented {high-level generic computer} method, comprising:
obtaining multiple two-dimensional images of an angiographic X-ray examination of a coronary system, for each one of the multiple two-dimensional images {mere data gathering, insignificant extra-solution activity},
in a respective processing pipeline, applying one or more analysis algorithms to the respective one of the multiple two-dimensional images to obtain a respective first-order estimate of a hemodynamic property of the coronary system {high-level generic computer}, and
determining at least one second-order estimate of the hemodynamic property from a consolidation of the first-order estimates of the hemodynamic property obtained for each one of the multiple two-dimensional images
Each of the elements identified in bold are mathematical calculations that fall within the mathematical concepts grouping of abstract ideas because the BRI of these claim elements encompasses and is otherwise consistent with mathematical concepts. See for example [0010], [0015]-[0016], Tables 1 and 2, [0059], [0064]-[0082], wherein the first-order estimates and analysis algorithms correspond to mathematical calculations such as artery lumen segmentation, contrast detection and including outputting numerical “intermediate processing results” such as average diameter and wherein second-order estimates include mathematical calculations such as determining averages and statistical distributions of the first order estimates. Likewise, claims 2-10 and 14-18 are directed to mathematical algorithms (claims 2, 3, 5, 6, 7, 8, 9, 10, and 18) and mere field of use/context (claims 4, 14-17).
As to the groupings of abstract ideas and the procedural and legal basis of this rejection generally see Section I of the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
Under Step 2A, Prong Two, additional elements that extend beyond the judicial exception are identified above in normal font (not bold) and may be summarized as mere data gathering or otherwise insignificant extra-solution activity, a high-level generic computer, and mere field of use/context as further identified above.
Under Step 2B, the additional elements do not amount to significantly more because each of the additional elements are recited at a high level of generality and amounts to no more than mere instructions to apply the exception using a generic computer. In this regard, it is suggested that switching to an apparatus claim format instead of method claims and closely patterning and detailing the parallel processing architecture of Figure 10 may be a more productive than the current high level generic computer currently recited.
Furthermore, there is no extra-solution activity recited in the claims. Indeed, no output is explicitly claimed. Instead, the claims “determine at least one second-order estimate” by [doing math] such that the claimed inventive result is merely the numerical result of the equations for performing the first and second order estimates.
Nor do the claims recite any function whatsoever following the calculation of a second order estimate which contrasts sharply with the Anomaly Detection Example 47 (from the 2024 Guidance Update on Patent Subject Matter Eligibility, Including On Artificial Intelligence) in which the claim elements of detection, dropping, and blocking integrated the abstract idea of anomaly detection into a practical application.
In contrast, the pending claims seek to preempt all applications of the abstract concept and fail to integrate the judicial exception into a practical application. Therefore, claims 1-10 and 14-18 are non-statutory.
Response to Arguments
Applicant's arguments filed 05 January 2026 have been fully considered but they are not persuasive.
In regards to the 112(a) rejection, Applicant’s incorrectly asserts that the BRI of “a respective first-order estimate” is singular and refers to one estimate. This assertion conveniently ignores later claim language requiring plural first-order estimates; namely the “consolidation of first-order estimates” language of claim 1. Clearly, “first-order estimates” employs the plural form and by itself reveals the flaw in Applicant’s logic.
Furthermore, a “consolidation” requires combining multiple things into one thing which, in this case, is a consolidation of multiple “first-order estimates” into a “second-order estimate”. As such, Applicant’s assertion that a “first-order estimates” are singular and refer to one estimate is grammatically incorrect.
In the instant application, the terms at issue include “first-order estimates of a hemodynamic property” and “second-order estimates of the hemodynamic property”. Applicant has acted as their own lexicographer for both of terms/phrases. Indeed, the isolated word “hemodynamic” has a plain an ordinary meaning but the terms at issue are coined or unique phrases proffered by Applicant.
In other words, there is no plain and ordinary means of first and second “order” “estimates” of a hemodynamic “property” and the definition thereof is solely, and poorly, informed by the instant specification. See also MPEP 2111.01(I) in which the presumption that a term is given its ordinary and customary meaning may be rebutted by the applicant by clearly setting forth a different definition of the term in the specification. In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1028 (Fed. Cir. 1997). Such is the case here made more strongly by the absence of any plain and ordinary meaning of “first-order estimates of a hemodynamic property” and “second-order estimates of the hemodynamic property”.
Furthermore. Applicant has indeed provided an explicit lexicographic definitions of “first-order estimates of a hemodynamic property” and “second-order estimates of the hemodynamic property” in, for example, [0009]-[0010], [0064], [0075], [0082] and tables 1-2 of the published version of the instant application. Therefore, the broadest reasonable interpretation consistent with the specification with respect to the lexicographically defined term “first-order estimates” includes, per [0009]-[0010] of instant specification the following long list:
automatic view classification,
vesselness/contrast detection,
branch labeling,
stenosis detection,
stenosis grading,
coronary tree tracing/reconstruction,
artery lumen segmentation, and/or
fractional flow reserve (FFR) computation.
Given the presence of at least eight different categories of first-order estimates, the number of possible combinations encompassed by the BRI of the lexicographically defined term “first-order estimates” includes a very large number of permutations; indeed the number is properly calculated as N! wherein N=8 such that there are 8! = 40,320 total combinations of “first-order estimates” and their permutations. Applicant’s argument that the number is 8 (equal to the number of categories) flies in the face of the definition provided to this term in [0009]-[0010] and standard math on calculating the number of permutations from a set of N distinct items.
Moreover, it is unclear if elements 2) and/or 6) comprise one or two “first-order estimates” because it is unclear if vessleness and contrast detection are two distinct first-order estimates; likewise, it is unclear if coronary tree tracing and reconstruction are two distinct first-order estimates. If these are distinct first order elements then the total number of combinations of “first-order estimates” and their permutations is 10! = 3,628,800.
The instant specification also purports to determine a wide range of “second-order estimates” from these at least 40,320 combinations of first-order estimates wherein the second-order estimates include:
consolidation,
removing outliers,
determining averages or mean,
analyze a statistical distribution of the first-order estimates to determine second-order estimates,
weighted combination of first order estimates in which weights are set based on one or more similarity measures between intermediate processing results or first-order estimates including soft and hard filters;
fit a statistical model and select/compute the most probably value as the second-order estimate;
RANSAC to identify outliers; and/or
Min, Max, percentile-based, standard deviation.
Still further, given the presence of at least eight different categories of second-order estimates, the number of possible combinations encompassed by the “and/”or” expression is 8! = 40,320 total combinations of “second-order estimates” and their permutations.
While a mathematical proof is not necessary to show exactly how many permutations of first and second order estimates are encompassed by claim 1, clearly the number of permutations is quite large particularly when one considers the combined permutations of both the first and second order estimates.
In sum, claim 1 amounts to unlimited functional claiming given the myriad different types and permutations of first and second-order estimates which have not been described in detail sufficient to demonstrate possession of claims having such sweeping and unlimited functional scope. See MPEP 2173.05(g)
Furthermore and as is the case here:
Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197 (Fed. Cir. 1983); Ariad, 598 F.3d at 1340, 94 USPQ2d at 1167.
MPEP 2173.05(g)
Applicant argues that the conclusion of unlimited functional claiming is misplaced because “MPEP 2163.02 states that disclosure of a representative species or a disclosed genus-level concept is sufficient when the invention resides in the overall framework” and that the primary focus of the invention is the two-stage architecture with first order estimation followed by consolidation into a second order estimate.
In response, MPEP 2163.02 does not support the proposition argued by Applicant because it does not refer to representative species or genus-level concepts in any manner.
Applicant further argues that the “Examiner’s reliance on In re Hyatt is misplaced because Hyatt addressed claims that attempt to cover all methods of achieving a result without disclosing any operative embodiments. In contrast, the present specification discloses numerous operative embodiments…”.
In response, the instant specification does not disclose even a single operative embodiment. Instead, the specification uses laundry lists for both the first and second order estimates without providing a single end-to-end example of a specific analysis algorithm for a first order estimate generating specific intermediate results which are consolidated by a specific consolidation algorithm.
Should Applicant wish to continue prosecution of this application it is strongly suggested that Applicant identify, by specific citations to the instant specification, an end-to-end operative embodiment that employs identified algorithms for both the first and second order estimates and further including identifying a specific example of an intermediate processing result generated by an identified algorithm for the first order estimate that produces such intermediate processing results.
See also the expanded rejections under 35 USC 112(b) regarding the unclear, inconsistent and confusingly overlapping definitions provided for the first order estimate, intermediate processing results, and second order estimates which also significantly compound the inadequate disclosure issues.
The disclosure and original claim 3 also refer to “intermediate processing results” that may be used/required for a later stage of processing to determine the second order estimate. Another laundry list of intermediate processing results is merely mentioned in [0075] in which “intermediate processing results can be selected from a group including: a length of a main branch of vessels the coronary system; an average diameter of a selected one of a vessel of the coronary system; a maximum diameter of the main branch of the coronary system; a maximum diameter of a stenosis at the main branch of the coronary system; an integral computed along the main branch of the coronary system; a number of detected stenosis; a position of a proximal clipping point; a position of a distal clipping point; a position of a catheter tip; a position of centerline trace of the main branch of the coronary system; a number of bifurcations of the coronary system; positions of the bifurcations; a number of branches of the coronary system; a position of the branches of the coronary system; a number of detected stenoses; a position of the detected stenosis; and/or a consistency between heat maps.”
The relationships of these myriad intermediate processing results to the various different first or second order estimates is not explained in the instant specification. Instead, the disclosure not provide detail sufficient to demonstrate possession of claims having myriad functionalities that may involve “intermediate processing results”.
Furthermore, [0011] blurs the distinction between intermediate processing results and first-order estimates by including elements 1) and 2) in both categories. [0013] further confuses the issue by including 6) and 7) in both categories, for example. It would appear that a substantial rewrite of the specification is in order.
In summary, the items detailed above are not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to the prior art rejection, Applicant admits that “M’hiri discloses segmentation …of vessel diameter at each frame of a temporal sequence”. In response, The BRI of “first-order estimate” includes vessel segmentation {see [0009]-[0010] table 1, [0059] in which artery lumen segmentation is specifically listed as a “first-order estimate of the hemodynamic property”.
Applicant also argues that “M’hiri expressly characterizes diameter measurement as a geometric quantity and repeatedly distinguishes its work from direct hemodynamic modeling on pg. 9 but fails to provide any cross reference or citation to support such contentions in contrast to the office actions in this case which back up the arguments with citations and evidence.
Moreover, Applicant’s arguments point out an indefiniteness issue regarding the term “first-order estimate” as somehow not including the very type of analysis (vessel segmentation) disclosed in the instant specification as being included within this term.
Applicant also argues that M’hiri does not disclose the claimed processing architecture. In response, it is noted that claim 1 only requires a single “processing pipeline” because only one analysis algorithm is required. In other words, since one analysis algorithm is an option for the applying step, there need only be one “respective processing pipeline”. Applicant argues that “for each one of the multiple two-dimensional images: in a respective processing pipeline” requires a logical association between each image and its own pipeline instance. But the claim does not specify any such logical association between each image and its own pipeline instance. Moreover, “for each one” refers to the input images only one of which is provided to the one analysis algorithm as recited in claim 1.
In further response, a single “processing pipeline” encompasses a standard CPU running a single thread which is essentially a basic processing element met by any generic computer or CPU such as that used by M’hiri’s automatic method of vessel segmentation in Segmentation and Tracking of Artery section pgs. 1868-1869.
In regards to the 112(b) rejection Applicant argues that claim 10 that the unclear terms and verbiage would be reasonably clear to a person of ordinary skill in medical image analysis after reading the instant specification. In response, 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). The 112(b) rejection of clam 10 is predicated upon missing context within the claim language itself which cannot properly be rebutted by importing limitations into the claims which are clearly not recited in the pending claims.
Lastly, the rejection of claim 18 under 112(b) has been withdrawn in view of the substantive amendment to that claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 and 14-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “applying one or more analysis algorithms to the respective one of the multiple two-dimensional images to obtain a respective first-order estimate of a hemodynamic property of the coronary system” and “determining at least one second-order estimate of the hemodynamic property from a consolidation of the first-order estimates of the hemodynamic property obtained for each one of the multiple two-dimensional images”.
First of all, the specification does not adequately disclose the “analysis algorithms”. Instead of disclosing what such analysis algorithms may comprise the specification solely focuses on the output (the so-called “first-order estimates”). For example, [0010] merely states that the analysis algorithms may be analytical algorithms or trained using machine learning techniques. But this disclosure merely identifies two broad categories (analytical and machine learning) not specific algorithms capable of generating the “first-order estimates”. [0014] merely states that “Each one of the one or more analysis algorithms can thus employ a single frame metric that operates based on individual ones of the multiple 2-D images and/or respective intermediate processing results derived therefrom” but without providing any specifics on the algorithms themselves of the methodology they employ. Table 1 also fails to elucidate one of ordinary skill by merely including a general reference to “a framework for calculating a FFR value” absent any details.
Fig. 2 includes an obtain first order-estimate step 3015 but the corresponding disclosure in [0047] again fails to identify any particular analysis algorithm whatsoever.
In summary, the analysis algorithms used to obtain the first order estimates are not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Furthermore, the terms at issue include “first-order estimates of a hemodynamic property” and “second-order estimates of the hemodynamic property”. Applicant has acted as their own lexicographer for both of terms/phrases. Indeed, the isolated word “hemodynamic” has a plain an ordinary meaning but the terms at issue are coined or unique phrases proffered by Applicant.
In other words, there is no plain and ordinary means of first and second “order” “estimates” of a hemodynamic “property” and the definition thereof is solely, and poorly, informed by the instant specification. See also MPEP 2111.01(I) in which the presumption that a term is given its ordinary and customary meaning may be rebutted by the applicant by clearly setting forth a different definition of the term in the specification. In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1028 (Fed. Cir. 1997). Such is the case here made more strongly by the absence of any plain and ordinary meaning of “first-order estimates of a hemodynamic property” and “second-order estimates of the hemodynamic property”.
Furthermore. Applicant has indeed provided an explicit lexicographic definitions of “first-order estimates of a hemodynamic property” and “second-order estimates of the hemodynamic property” in, for example, [0009]-[0010], [0064], [0075], [0082] and tables 1-2. Therefore, the broadest reasonable interpretation consistent with the specification with respect to the lexicographically defined term “first-order estimates” includes, per [0009]-[0010] of instant specification the following long list:
automatic view classification,
vesselness/contrast detection,
branch labeling,
stenosis detection,
stenosis grading,
coronary tree tracing/reconstruction,
artery lumen segmentation, and/or
fractional flow reserve (FFR) computation.
Given the presence of at least eight different categories of first-order estimates, the number of possible combinations encompassed by the BRI of the lexicographically defined term “first-order estimates” includes a very large number of permutations; indeed the number is properly calculated as N! wherein N=8 such that there are 8! = 40,320 total combinations of “first-order estimates” and their permutations. Applicant’s argument that the number is 8 (equal to the number of categories) flies in the face of the definition provided to this term in [0009]-[0010] and standard math on calculating the number of permutations from a set of N distinct items.
Moreover, it is unclear if elements 2) and/or 6) comprise one or two “first-order estimates” because it is unclear if vessleness and contrast detection are two distinct first-order estimates; likewise, it is unclear if coronary tree tracing and reconstruction are two distinct first-order estimates. If these are distinct first order elements then the total number of combinations of “first-order estimates” and their permutations is 10! = 3,628,800.
The instant specification also purports to determine a wide range of “second-order estimates” from these at least 40,320 combinations of first-order estimates wherein the second-order estimates include:
consolidation,
removing outliers,
determining averages or mean,
analyze a statistical distribution of the first-order estimates to determine second-order estimates,
weighted combination of first order estimates in which weights are set based on one or more similarity measures between intermediate processing results or first-order estimates including soft and hard filters;
fit a statistical model and select/compute the most probably value as the second-order estimate;
RANSAC to identify outliers; and/or
Min, Max, percentile-based, standard deviation.
Still further, given the presence of at least eight different categories of second-order estimates, the number of possible combinations encompassed by the “and/”or” expression is 8! = 40,320 total combinations of “second-order estimates” and their permutations.
While a mathematical proof is not necessary to show exactly how many permutations of first and second order estimates are encompassed by claim 1, clearly the number of permutations is extremely large particularly when one considers the combined permutations of both the first and second order estimates.
In sum, claim 1 amounts to unlimited functional claiming given the myriad different types and permutations of first and second-order estimates which have not been described in detail sufficient to demonstrate possession of claims having such sweeping and unlimited functional scope.
Furthermore and as is the case here:
Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197 (Fed. Cir. 1983); Ariad, 598 F.3d at 1340, 94 USPQ2d at 1167.
MPEP 2173.05(g)
Applicant argues that the conclusion of unlimited functional claiming is misplaced because “MPEP 2163.02 states that disclosure of a representative species or a disclosed genus-level concept is sufficient when the invention resides in the overall framework” and that the primary focus of the invention is the two-stage architecture with first order estimation followed by consolidation into a second order estimate.
In response, MPEP 2163.02 does not support the proposition argued by Applicant because it does not refer to representative species or genus-level concepts in any manner.
Applicant further argues that the “Examiner’s reliance on In re Hyatt is misplaced because Hyatt addressed claims that attempt to cover all methods of achieving a result without disclosing any operative embodiments. In contrast, the present specification discloses numerous operative embodiments…”.
In response, the instant specification does not disclose even a single operative embodiment. Instead, the specification uses laundry lists for both the first and second order estimates without providing a single end-to-end example of a specific analysis algorithm for a first order estimate generating specific intermediate results which are consolidated by a specific consolidation algorithm.
See also the expanded rejections under 35 USC 112(b) regarding the unclear, inconsistent and confusingly overlapping definitions provided for the first order estimate, intermediate processing results, and second order estimates which also compound the inadequate disclosure issues.
The disclosure and original claim 3 also refer to “intermediate processing results” that may be used/required for a later stage of processing to determine the second order estimate. Another laundry list of intermediate processing results is merely mentioned in [0075] in which “intermediate processing results can be selected from a group including: a length of a main branch of vessels the coronary system; an average diameter of a selected one of a vessel of the coronary system; a maximum diameter of the main branch of the coronary system; a maximum diameter of a stenosis at the main branch of the coronary system; an integral computed along the main branch of the coronary system; a number of detected stenosis; a position of a proximal clipping point; a position of a distal clipping point; a position of a catheter tip; a position of centerline trace of the main branch of the coronary system; a number of bifurcations of the coronary system; positions of the bifurcations; a number of branches of the coronary system; a position of the branches of the coronary system; a number of detected stenoses; a position of the detected stenosis; and/or a consistency between heat maps.”
The relationships of these myriad intermediate processing results to the various different first or second order estimates is not explained in the instant specification. Instead, the disclosure not provide detail sufficient to demonstrate possession of claims having myriad functionalities that may involve “intermediate processing results”.
Furthermore, [0011] blurs the distinction between intermediate processing results and first-order estimates by including elements 1) and 2) in both categories. [0013] further confuses the issue by including 6) and 7) in both categories, for example.
In summary, the items detailed above are not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The 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 1-10 and 14-18 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.
The scope of first order estimates, second order estimates and intermediate processing results are unclear because the specification fails to provide a consistent definition for these terms and instead defines these supposedly separate terms in an overlapping manner.
For example, it is unclear if elements 2) and/or 6) (see above) comprise one or two “first-order estimates” because it is unclear if vessleness and contrast detection are two distinct first-order estimates; likewise, it is unclear if coronary tree tracing and reconstruction are two distinct first-order estimates.
Furthermore, intermediate processing result is defined as including background/foreground segmentation and vesselness as per [0077] but [0010] states that the (unidentified) analysis algorithms can determine vesselness/contrast detection. As such, the distinction between first order estimates and intermediate processing results is unclear which carries through to the claimed intermediate processing result of claims 2 and 5 and first order estimates of claims 1, 6, 14, and 16.
Claim 10 recites “wherein the at least one similarity measure comprises a position-based similarity measure, wherein the position-based similarity measure is determined in accordance with deformation fields between at least one of views or timestamps associated with respective pairs of the images”. The recited use of the “deformation fields” is unclear and thus indefinite due in part to the lack of detailed context for the ”views” and “timestamps”.
Claims 1, 3-6, 8, 9, and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by M’hiri {M’hiri, Faten, et al. "Automatic evaluation of vessel diameter variation from 2D X-ray angiography." International Journal of Computer Assisted Radiology and Surgery 12.11 (2017): 1867-1876).
Claim 1
In regards to claim 1, M’hiri discloses a computer-implemented method {references are repeatedly made to “automatic methods” processing data-rich, complex 2D X-ray sequences such that that method is considered to be “computer implemented”}, comprising:
obtaining multiple two-dimensional images of an angiographic X-ray examination of a coronary system, for each one of the multiple two-dimensional images
{see abstract discussing monoplane 2D X-ray sequences for coronary arteries and Fig. 1, pg. 1869 Imaging Data}:
in a respective processing pipeline, applying one or more analysis algorithms to the respective one of the multiple two-dimensional images to obtain a respective first-order estimate of a hemodynamic property of the coronary system
{initially, it is noted that this claim only requires a single “processing pipeline” because only one analysis algorithm is required. In other words, since one analysis algorithm is an option for the applying step, there need only be one “respective processing pipeline”. Applicant argues that “for each one of the multiple two-dimensional images: in a respective processing pipeline” requires a logical association between each image and its own pipeline instance. But the claim does not specify any such logical association between each image and its own pipeline instance. Moreover, “for each one” refers to the input images only one of which is provided to the one analysis algorithm as recited in claim 1.
It is further noted that a single “processing pipeline” encompasses a standard CPU running a single thread which is essentially a basic processing element met by any generic computer or CPU such as that used by M’hiri’s automatic method of vessel segmentation in Segmentation and Tracking of Artery section pgs. 1868-1869.
The automatic method of evaluating variation of vessel diameter from 2D X-ray angiographic image sequences as per pg. 1869, Measuring a Vessel’s Diameter, Fig. 4 includes vessel (artery lumen) segmentation which corresponds to the instant disclosure’s analysis algorithm that obtains a first order estimate (vessel segmentation) as per [0010] of the instant specification}, and
determining at least one second-order estimate of the hemodynamic property from a consolidation of the first-order estimates of the hemodynamic property obtained for each one of the multiple two-dimensional images
{the segmented vessels (first order estimates) from a temporal image sequence (thus, plural first order estimates) are consolidated by determining a mean vessel diameter over the whole image sequence by temporally averaging the diameters determined from the segmentation (first order estimate) for each image in the sequence and thus determines a second order estimate (means vessel diameter) from a consolidation (temporal averaging) of the first order estimates. Pg. 1868, 1869, 1870, Tables 1 and 2}.
Claim 3
In regards to claim 3, M’hiri discloses wherein said consolidating is based on one or more comparative metrics that compare one or more data structures of the processing pipelines associated the multiple two-dimensional images
{the BRI (Broadest Reasonable Interpretation) of “comparative metric” includes a statistical analysis performed based on the results of first order estimates such as a median or mean value as per [0041], [0064]-[0070] of the instant specification as published. M’hiri consolidates the vessel diameters based on such a mean value “comparative metric” Pg. 1868, 1869, 1870, Tables 1 and 2. See also the identification of local deformations and distensibilities within the vessel, pg. 1868-9, that compares the local vessel diameter with the mean diameters of the relevant vessel segment.}.
Claim 4
In regards to claim 4, M’hiri discloses wherein the one or more data structures comprise the multiple two-dimensional images {see abstract discussing monoplane 2D X-ray sequences for coronary arteries and Fig. 1}.
Claim 5
In regards to claim 5, M’hiri discloses wherein the one or more data structures comprise at least one intermediate processing result of the one or more analysis algorithms
{see tracking an artery segment to assess vessel diameter changes over time to detect blood vessel anomalies, pg. 1869-70 in which the vessel diameter is an intermediate result that is tracked/compared over time to produce a consolidated second-order estimate. See also Materials and Methods including Segmentation and Tracking of a Section of Artery as different times (t), (t-1), etc. and Results in which diameter changes are tracked during systole and diastole cycles}.
Claim 6
In regards to claim 6, M’hiri discloses wherein the one or more data structures comprise the first-order estimates of the hemodynamic property
{the BRI (Broadest Reasonable Interpretation) of “comparative metric” includes a statistical analysis performed based on the results of first order estimates (data structures) such as a median or mean value as per [0041], [0064]-[0070] of the instant specification as published. M’hiri consolidates the vessel diameters based on such a mean value “comparative metric” Pg. 1868, 1869, 1870, Tables 1 and 2. See also the identification of local deformations and distensibilities within the vessel, pg. 1868-9, that compares the local vessel diameter with the mean diameters of the relevant vessel segment.}.
Claim 8
In regards to claim 8, M’hiri discloses wherein the one or more comparative metrics comprise a statistical analysis of a distribution of the first-order estimates of the hemodynamic property
{ the BRI (Broadest Reasonable Interpretation) of “comparative metric” includes a statistical analysis performed based on the results of first order estimates (data structures) such as a median or mean value as per [0041], [0064]-[0070] of the instant specification as published. Moreover, a mean value is a statistical analysis of a distribution that calculates the mean value of the distribution. M’hiri consolidates the vessel diameters based on such a mean value “comparative metric” Pg. 1868, 1869, 1870, Tables 1 and 2}. See also the identification of local deformations within the vessel, pg. 1869, that compares the local vessel diameter with the mean diameters of the relevant vessel segment.}.
Claim 9
In regards to claim 9, M’hiri discloses wherein the one or more comparative metrics comprise at least one similarity measure between at least one of pairs of the first-order estimates of the hemodynamic properties or pairs of intermediate processing results of the one or more analysis algorithms.
{See also the identification of local deformations and distensibilities within the vessel which involve similarity measures between pairs of first order estimates (vessel diameters at various different locations), pg. 1868-9}.
Claim 14 and 16
In regards to claims 14 and 16, M’hiri discloses wherein the one or more analysis algorithms are single frame metrics that operate based on individual ones of the multiple two-dimensional images {M’hiri’s automatic method of evaluating vessel diameter variation from 2D X-ray angiographic image sequences as per pg. 1869, Measuring a Vessel’s Diameter, Fig. 4 operates on individual ones of plural 2D images}.
Claim 15 and 17
In regards to claims 15 and 17, M’hiri discloses
wherein the multiple two-dimensional images are associated with multiple views of the coronary system {see abstract discussing monoplane 2D X-ray sequences for coronary arteries and Fig. 1, pg. 1869 Imaging Data wherein multiple view of the coronary arteries are taken at different times (time-sequence of images).
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 2 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over M’hiri and This (US 20240407656 A1).
Claim 2
In regards to claim 2, M’hiri is not relied upon to disclose wherein an intermediate processing result of the one or more analysis algorithms comprises a length of a vessel of the coronary system, wherein the length of the vessel is compensated with respect to a perspective foreshortening associated with a respective view of the respective two-dimensional image.
This is an analogous reference from the same field of analyzing angiographic x-ray images of a coronary system including vessel segmentation and calculating first and second order estimates. See abstract, [0001]-[0022] and cites below.
This also teaches wherein an intermediate processing result of the one or more analysis algorithms comprises a length of a vessel of the coronary system, wherein the length of the vessel is compensated with respect to a perspective foreshortening associated with a respective view of the respective two-dimensional image.
{See Figs. 15, 16, [0162]-[0166] including equation 13 that compensates the vessel segment length for foreshortening}.
It 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 to have modified M’hiri which already discloses various intermediate processing results such that wherein an intermediate processing result of the one or more analysis algorithms comprises a length of a vessel of the coronary system, wherein the length of the vessel is compensated with respect to a perspective foreshortening associated with a respective view of the respective two-dimensional image as taught by This because doing so increases the accuracy of vessel segment length as motivated by This in [0166], because there is a reasonable expectation of success and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Claim 18
In regards to claim 18, M’hiri discloses wherein said consolidating is based on one or more comparative metrics that compare one or more data structures of the processing pipelines associated the multiple two-dimensional images.
{M’hiri consolidates the vessel diameters based on such a mean value “comparative metric” Pg. 1868, 1869, 1870, Tables 1 and 2. See also the identification of local deformations and distensibilities within the vessel, pg. 1868-9, that compares the local vessel diameter with the mean diameters of the relevant vessel segment. See also the 112(b) rejection above}.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over M’hiri and Schwemmer, C., et al. "CoroEval: a multi-platform, multi-modality tool for the evaluation of 3D coronary vessel reconstructions." Physics in medicine & biology 59.17 (2014): 5163.
Claim 7
In regards to claim 8, M’hiri discloses wherein the one or more comparative metrics comprise a statistical analysis of a distribution of the of the first-order estimates of the hemodynamic property, wherein the at least one second-order estimate of the hemodynamic property is determined based on
Schwemmer is an analogous reference from the same field of analyzing angiographic x-ray images of a coronary system including vessel segmentation and determining vessel sharpness and diameter (first order estimates). See abstract and Introduction.
Schwemmer also teaches wherein the one or more comparative metrics comprise a statistical analysis of a distribution of the of the first-order estimates of the hemodynamic property, wherein the at least one second-order estimate of the hemodynamic property is determined based on a most probable value of the distribution {see section 2.2 Segmentation, 3.1.4 Vessel diameter, and 3.2 discussing most probable vessel center calculation (second order estimate) using a statistical distribution of the first-order estimates}.
It 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 to have modified M’hiri which already discloses wherein the one or more comparative metrics comprise a statistical analysis of a distribution of the of the first-order estimates of the hemodynamic property, such that wherein the at least one second-order estimate of the hemodynamic property is determined based on a most probable value of the distribution as taught by Scwemmer because doing so increases the accuracy of centerline extraction and vessel segmentation as motivated by Schwemmer, because there is a reasonable expectation of success and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Frangi A, Niessen W, Vincken K, Viergever M (1998) Multiscale vessel enhancement filtering. In: Medical image computing and computer-assisted intervention MICCAI98, p 130.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael R Cammarata whose telephone number is (571)272-0113. The examiner can normally be reached M-Th 7am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella can be reached at 571-272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL ROBERT CAMMARATA/ Primary Examiner, Art Unit 2667