DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 12, has been entered.
The Examiner acknowledges the amendments to claims 1, 9-11, 13, and 15-16; the cancellation of claims 2-8, 12, and 14; and the addition of new claims 17-19. Claims 1, 9-11, 13 and 15-19 are currently pending.
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 9, 11, 13 and 15-16 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 9 recites “providing the treatment suggestion to the interventional cardiologist based on a likelihood of a presence of focal or diffuse coronary artery disease, wherein when the value of the FOI is higher than 0.7, this indicates a function pattern of a focal coronary artery disease”. It is unclear whether this limitation of claim 9 is further limiting the providing step of claim 1 to say that a FOI of at least 0.7 is indicative of a likelihood of a presence of focal coronary artery disease, and further it is unclear how the likelihood of a presence of diffuse coronary artery disease is determined. The Examiner suggests claim 9 should be drafted to further limit the providing step of claim 1 to say that a FOI of at least 0.7 is indicative of the likelihood of a presence of focal coronary artery disease and/or claim 9 should be drafted to further define how the likelihood of a presence of diffuse coronary artery disease is determined. For examination purposes, it will be interpreted that a FOI of at least 0.7 is indicative of the likelihood of a presence of focal coronary artery disease in a patient, wherein an interventional cardiologist suggests to treat the patient with percutaneous coronary intervention with stent implantation based on the likelihood of a presence of focal coronary artery disease.
Claim 11 recites “the distal part of the coronary vessel” at lines 34 and 38-39 (including lines that have been struck through). There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it will be interpreted that FFR values at a distal part of a coronary vessel of a patient and the total vessel length between the ostium and a distal part of the coronary vessel of a patient are used in the calculation of the functional outcome index for the patient to assess coronary artery functional disease.
Claim 13 recites “wherein the computer device comprises a computer output configured to display the value of the FOI, such that the value of the FOI is an expression of at least one of the following functional patterns of coronary artery disease: a focal coronary artery disease; and a diffuse coronary artery disease”. As claim 11 recites only how a presence of a focal lesion in the coronary vessel is determined based upon the value of the FOI, it is unclear how the functional pattern of a diffuse coronary artery disease is determined in claim 13. The Examiner respectfully requests clarification.
Dependent claims are similarly rejected as their base claim.
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 11, 13 and 15-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 11 follows.
Regarding claim 11, the claim recites a system comprising a computer device that is configured to perform a series of steps or acts, including identifying a presence of a focal lesion in the coronary vessel when the value of the FOI is higher than 0.7. Thus, the claim is directed to a system/process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of identifying a presence of a focal lesion in the coronary vessel when the value of the FOI is higher than 0.7 sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Therefore, the claim does not provide an improvement to the technological field, the system does not effect a particular treatment or effect a particular change, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of generating fractional flow reserve (FFR) using at least one of a catheter and a pressure wire comprising at least one pressure sensor, a catheter and a pressure wire coupled to a motorized device with a fixed pullback speed, a catheter and a pressure wire comprising multiple built-in pressure sensors, and a device configured to provide FFR values derived from angiography or CT angiography, generating an FFR curve by mapping FFR values along the length of the coronary vessel, and calculating a value of a functional outcome index (FOI) based on a formula. The generating and calculating steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and data processing. The generating and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Allowable Subject Matter
Claims 1, 10 and 17-19 are allowed.
Claims 9, 13 and 15-16 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101 or 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a list of pertinent prior art to applicant’s invention:
US Patent Application Publication 2021/0085397, see par 0048-0049, fig. 3, disclosing using a functional diagnostic index, such as FFR, to non-invasively determine/diagnose diffuse coronary artery disease.
US Patent Application Publication 2021/0064936, see par 0025, disclosing machine learning models used for predicting functional measures of coronary artery disease at different measurement locations, wherein the functional measures include FFR values.
US Patent Application Publication 2017/0265831, see par 0024-0026, disclosing machine learning algorithms used to identify focal and diffuse disease in stenoses of coronary arteries.
US Patent Application Publication 2014/0114618, see claims 3, 5-7, 11, 13-15, 17-20, disclosing a method for identifying diffuse coronary artery disease in coronary arteries based upon blood flow properties such as FFR, wherein the values of FFR can be predetermined values.
Regarding claim 1, none of the prior art teaches or suggests, either alone or in combination, calculating a value of a functional outcome index (FOI) based on formula:
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in combination with the other claimed steps.
Regarding claim 11, none of the prior art teaches or suggests, either alone or in combination, a computer device configured to calculate a value of a functional outcome index (FOI) based on formula:
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in combination with the other claimed elements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Destiny J Cruickshank whose telephone number is (571)270-0187. The examiner can normally be reached M-F, 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./Examiner, Art Unit 3791
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