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 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 1,13,15, and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. When reviewing independent claim *, and based upon consideration of all of the relevant factors with respect to the claim as a whole, claim(s) * are held to claim an abstract idea without reciting elements that amount to significantly more than the abstract idea and is/are therefore rejected as ineligible subject matter under 35 U.S.C. 101. The Examiner will analyze Claim *, and similar rationale applies to independent Claim/s *. The rationale, under MPEP § 2106, for this finding is explained below:
The claimed invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception, as defined below. The following two step analysis is used to evaluate these criteria.
Step 1: Is the claim directed to one of the four patent-eligible subject matter categories: process, machine, manufacture, or composition of matter?
When examining the claim under 35 U.S.C. 101, the Examiner interprets that the claims is related to a computer device or a computer implemented method since the claim is directed to a device to quantifying the extent of functional coronary artery disease (CAD)
Step 2a, Prong 1: Does the claim wholly embrace a judicially recognized exception, which includes laws of nature, physical phenomena, and abstract ideas, or is it a particular practical application of a judicial exception?
The Examiner interprets that the judicial exception applies since Claim * limitation of collecting analyzing and classifying medical measurement data(FFR values) is/are directed to an abstract idea . The claim is related to mental process and methods for organizing human activity . If the claim recites a judicial exception (i.e., an abstract idea enumerated in MPEP § 2106.04(a), a law of nature, or a natural phenomenon), the claim requires further analysis in Prong Two.
Step 2a, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
The Examiner interprets that Claim recitation of “ processor, display and computer readable media” does not provide additional elements or combination of additional elements to a practical application since the claim/s is/ represent no more than generic computer elements performing routine functions : See, MPEP §2106.04(a), Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). OR Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself."). For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must "transform the nature of the claim" into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B. If there are no additional elements in the claim, then it cannot be eligible. In such a case, after making the appropriate rejection (see MPEP § 2106.07 for more information on formulating a rejection for lack of eligibility), it is a best practice for the examiner to recommend an amendment, if possible, that would resolve eligibility of the claim.
Step 2b: If a judicial exception into a practical application is not recited in the claim, the Examiner must interpret if the claim recites additional elements that amount to significantly more than the judicial exception.
The Examiner interprets that the Claims do not amount to significantly more since the Claim/s is/state
Furthermore, the generic computer components of the computer recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The claims simply implement conventional statistical technique (piece wise linearization, change point detection, logistic regression) on a generic computer
Claims 2-12,14-20 depending on the independent claim/s include all the limitation of the independent claim.
Thus, Claims 1-20 recite the same abstract idea and therefore are not drawn to the eligible subject matter as they are directed to the abstract idea without significantly more.
Therefore, the Examiner interprets that the claims are rejected under 35 U.S.C. 101.
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.
Claim 2,4,5,8,13,15 and 19 recite indefinite language “ optionally” introduce indefiniteness or ambiguity into the claim. The claim should clearly define the scope both with and without the optional elements. Appropriate correction is required.
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, 2,4,5,9,10,13,15,18,19, and 20 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. When the claim recites "and/or' a three separate embodiments is needed to teach the limitations. In the instance application each of the claims (1, 2,4,5,9,10,13,15,18,19, and 20) teaches “classify the coronary vessel in healthy segments, focal diseased segments and/or diffused diseased segments by carrying out a piece-wise linearization of said FFR data by applying an automated change-points detection algorithm.” ; “wherein the logistic regression is two-variables logistic regression based on the FFR drop, the segment length and/or the slope of the associated segment.”. The specification DOES NOT enclose a :
1st embodiment that teaches “classify the coronary vessel in healthy segments, focal diseased segments and diffused diseased segments by carrying out a piece-wise linearization of said FFR data by applying an automated change-points detection algorithm”
2nd embodiment that teaches” classify the coronary vessel in healthy segments, diffused diseased segments by carrying out a piece-wise linearization of said FFR data by applying an automated change-points detection algorithm”
3rd embodiment that teaches” classify the coronary vessel in healthy segments, focal diseased segments and diffused diseased segments by carrying out a piece-wise linearization of said FFR data by applying an automated change-points detection algorithm”.
.The specification DOES NOT enclose three separate embodiment .Note that The MPEP discusses the use of “optionally” in patent claims in MPEP 2173.05(h). While not explicitly stating a stance, the MPEP provides guidance on how such terms are interpreted:
“A claim which recites “at least one member” of a group is a proper claim and should be treated as a claim reciting in the alternative. A claim which uses the phrase “and/or” should be treated as an alternative expression and should be rejected using the second paragraph of 35 U.S.C. 112 and should be treated as a conjunctive (“and”) or alternative (“or”) expression in the alternative.” Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sonck et al ( US 2022/0175260) in view of Lee et al (Automated Algorithm using pre-intervention fractional flow reserve pullback curve to predict post intervention physiological results)
As to claim 1, Sonck et al teaches a computer device for quantifying the extent of functional coronary artery disease (CAD) comprising a processor configured to:
i) process a set of fractional flow reserve (FFR) values obtained at different positions of a coronary vessel between the ostium and the most distal part of the coronary vessel(acquiring a fractional flow reserve (FFR) pullback curve based on a multiple of FFR values obtained at different positions of the coronary vessel between the ostium and the most distal part of the coronary vessel, paragraph [0037])and
ii) classify the coronary vessel in healthy segments , focal diseased segments and/or diffused diseased segments (FIG. 3: Reclassification between anatomical and physiological assessment on the pattern of coronary artery disease. The left pie chart presents the classification of the pattern and CAD based on coronary angiography (n=85 vessels). The pie chart on the right shows de classification of the CAD patterns assessed using the motorized FFR pullback curve) . While Sonck meets a number of the limitations of the claimed invention, as pointed out more fully above, Sonck fails to specifically teach “by carrying out a piece-wise linearization of said FFR data by applying an automated change-points detection algorithm” .
Specifically, Lee et al. teaches our main interest is dFFR(s)/ds, where s is the lumen centerline curvilinear coordinate, and dFFR(s)/ds can measure the local change of FFR along the lumen centerline path (Supplemental Figure 1). Namely, the dFFR(s)/ds reflects the local change in FFR with a small variation of FFR location measurement. Lee clearly teaches the calculation of dFFR(t)/dt, raw data of the hyperemic Pd/Pa value acquired at every 10 ms from commercialized FFR console were used. The automated algorithm consists of 2 steps. First, the original FFR(t)-time curve is obtained from the raw data of the pre-PCI FFR pullback recording, and then the original signal is filtered and smoothed. Second, the dFFR(t)/d(t) curve and peak values are acquired from the FFR(t)-time curve. The entire process takes only a few minutes onsite ( section; theoretical background of automated algorithm for dFFR(t)/DT from FFR pullback; page 2673-2674 ) 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 change point detection point in Sonck in order to develop an automated algorithm using pre-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) pullback recordings to predict post-PCI physiological results in the pre-PCI phase. Therefore, the claimed invention would have been obvious to one of ordinary skill in the art at the time of the invention by applicant.
As to claim 2, Sonck et al teaches the computer device according to claim 1, wherein the computer device further comprises a display configured to display said healthy segments, focal diseased segments and/or diffused diseased segments, optionally on an image of the coronary artery, optionally wherein the displayed image of the coronary artery is a 2-dimensional image( displaying the results of the FOI to aid in a treatment decision for revascularization for at least one lesion present in the coronary vessel; paragraph [0119])
As to claim 3, Lee et al teaches the computer device according to claim 1 wherein the automated change-point detection algorithm is configured to detect one or more change points in the set of FFR values, such that said change points each correspond to a position along the coronary vessel where an attribute of the set of FFR values changes (The dFFR(t)/dt is an index of instantaneous FFR gradient per unit time, and the peak value of dFFR(t)/dt represents the amount of FFR changes across the target stenosis. Therefore, the dFFR(t)/dt value is a surrogate marker of maximally expected FFR gain after treating the stenosis by PCI, page 2679 right column), wherein:- said one or more change points are configured to divide the set of FFR values in two or more segments, in which each change point defines an endpoint between two segments; and - said two or more segments, each corresponding to a linearized subset of the set of FFR values obtained at different positions along the coronary vessel between a proximal point of the segment and a distal point of the segment(page 2673 section coronary physiological measurement) .
As to claim 4, Lee et al teaches the computer device according to claim 3, wherein:- said attribute is an average value and/or a slope; and/or - said two or more segments are characterized by the following quantities:- FFR drop, which is the difference between the FFR value at the distal point and the FFR value at the proximal point of the segment; and segment length, which is as the distance along the coronary vessel axis between the distal point of the segment and the proximal point of the segment; and optionally segment slope, which is the ratio between the FFR drop and the segment length (The automated algorithm calculates slopes of the tangent at each point of the pre-PCI FFR pullback curve and generates dFFR(t)/dt, which is a surrogate marker of maximally expected FFR gain after PCI of target stenosis. Peak values of the dFFR(t)/dt curve can discriminate major, minor FFR gradient, or signal noise ( page 2682).
As to claim 5,Sonck teaches a computer device according toclaim 1,wherein the computer device is further configured to classify the coronary vessel such that:- segments are classified as healthy segments or as diseased segments by means of a predetermined first classification threshold function based on the FFR drop, the segment length and/or the segment slope of the segments; and - optionally, diseased segments are classified as: - focal diseased segments or as diffuse diseased segments by means of a predetermined second classification threshold function based on the FFR drop, segment length and/or segment slope of the segments (the functional contribution of the epicardial lesion with respect to the total vessel FFR (Δlesion FFR/Δvessel FFR) and (2) the length (mm) of epicardial coronary segments with FFR drops with respect to the total vessel length. The combination of these two ratios, namely, lesion-related pressure drops (% FFRlesion) and the extent of functional disease resulted in the functional outcomes index (FOI), a metric that depicts the pattern of CAD (i.e. focality or diffuseness) based on coronary physiology, paragraph [0179-0181]) ; and optionally, segments as classified as healthy when said segments exhibit a positive FFR drop and when said segments are contiguous to a diseased segment and said segments are shorter than 30mm and optionally the computer device further comprises a logistic regression model configured to automatically discriminate each segment as a healthy segment, a focal diseased segment and/or a diffuse diseased segment, optionally a two-variables logistic regression based on the FFR drop, the segment length and/or the slope of the segment, optionally, wherein the logistic regression model is determined from visual adjudication of a derivation cohort, configured to discriminate between healthy and diseased segments, and further to discriminate between focal diseased segments and diffuse diseased segments (The FOI is a continuous metric, values approaching 1.0 represent focal physiological coronary artery disease and value close to 0 diffuse coronary artery disease. In cases with serial lesions, the physiological contribution of each lesion was added to calculate ΔFFRlesion. The calculation was performed using an automated and a proprietary algorithm based on the motorized FFR curve, paragraph [0180-0181])
As to claim 6, Lee et al teaches the computer device according to claim 1,wherein said automated change-points detection algorithm is configured to operate based on a penalized parametric global method (dFFR(t)/DT AS A NOVEL METRIC FOR PREDICTING POST-PCI PHYSIOLOGICAL RESULTS, page 2679 left column) .
As to claim 7, Sonck et al teaches the computer device according to claim 2,wherein the display is further configured to display the image of the coronary artery in a 2- dimensional image (the computer output configured to display an FOI value, such that the FOI value is an expression of at least one of the following functional patterns of coronary artery disease: a focal functional coronary artery disease; a diffuse functional coronary artery disease, paragraph [0061-0063]).
As to claim 8, Sonck et al teaches the computer device according toclaim 1,further configured to obtain the set of FFR values from:- a pull-back curve; or - a 3-dimensional quantitative coronary angiography; or - a CT scan; or - intravascular imaging (generating a fractional flow reserve (FFR) pullback curve based on a multiple of FFR values obtained between the ostium of the vessel and the most distal part of the vessel, paragraph [0088]) , optionally an optical coherence tomography (OCT) or an intravascular ultrasound (IVUS); or - the combination between coronary angiography and intravascular imaging; or - the combination of a CT scan and intravascular imaging; or - computational fluid dynamics simulations applied to a 3D model of the coronary vessel as reconstructed from medical imaging (optical coherence tomography (OCT), paragraph [0147-0148]), optionally wherein the medical imaging comprises: a 3- dimensional quantitative coronary angiography, a CT scan, an OCT or an IVUS(see table 1).
As to claim 9, Sonck et al teaches the computer device according to claim 1,wherein the computer device is further configured to predict the response to a percutaneous coronary intervention (PCI) by said quantifying of the extent of functional CAD, and/or wherein the computer device is further configured to quantify the extent of functional CAD as the sum of the lengths of the diseased segments (predict the response to a percutaneous coronary intervention ;the availability of a quantitative metric to characterize CAD patterns under hyperaemic conditions has enabled us to design a clinical trial to investigate the effectiveness of PCI versus optimal medical therapy stratified by the physiological pattern of CAD, paragraph [0171-0172]).
As to claim 10, Sonck et al teaches the computer device according to claim 1,wherein the computer device is further configured to select a mammal suffering from coronary artery disease (CAD) to be eligible for a percutaneous coronary intervention (PCI) by said quantifying of the extent of functional CAD, and selecting a mammal when the extent of functional disease in the coronary artery is smaller than the extent of anatomical disease in the coronary artery; and/or wherein the computer device is further configured to calculate a Functional Anatomical Mismatch (FAM) as the difference between the extent of anatomical CAD and the extent of functional, thereby identifying two lesion endotypes: (1) functional CAD circumscribed within the anatomical CAD when FAM>0, and (2) functional CAD extending beyond the anatomical CAD when FAM<0 ( The mean FFR.sub.lesion 61.7±25% whereas the mean percent vessel length with physiological disease was 59.8±21%. The % FFR.sub.lesion and length with physiological disease stratified by the physiological CAD pattern is shown in Table 2. The correlation between delta FFR pressure drop and percent diameter stenosis was weak (r=0.21, p=0.028; FIG. 4); page [0165-0166] and table 2) .
As to claim 11, Sonck et al teaches the computer device according to claim 1,wherein the computer is configured to operate offline ( paragraph [0160-0161]).
As to claim 12, Sonck et al teaches the computer device according claim 1,wherein the computer device is configured to perform said automatic classification(it is understood that any steps related to data acquisition, data processing, calculation of the FOI, instrument control, and/or other processing or control aspects of the present disclosure may be implemented by the computing device using corresponding instructions stored on or in a non-transitory computer readable medium accessible by the computing device, paragraph [0160]).
The limitation of claims 13-20 has been addressed above.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANCY BITAR whose telephone number is (571)270-1041. The examiner can normally be reached Mon-Friday from 8:00 am to 5:00 p.m..
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, Mrs. Jennifer Mahmoud can be reached at 571-272-2976. 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.
NANCY . BITAR
Examiner
Art Unit 2664
/NANCY BITAR/Primary Examiner, Art Unit 2664