DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30 March 2026 has been entered.
Response to Amendment
The specification (including the abstract and claims), and any amendments for applications, except as provided for in 37 CFR 1.821 through 1.825, must have text written plainly and legibly and presented in a form having sufficient clarity and contrast between the paper and the writing thereon to permit the direct reproduction of readily legible copies in any number by use of photographic, electrostatic, photo-offset, and microfilming processes and electronic capture by use of digital imaging and optical character recognition (OCR). See 37 CFR 1.52(a) and (b).
The application papers filed 30 March 2026 are objected to because the amendments to the claims, presumably due to the use of a color other than black to mark changes to the claims, is difficult to read and/or electronically reproduce by use of OCR.
Since Applicant's amendments can be discerned by the examiner, said amendments have been entered. However, the examiner respectfully requests use of black colored font for text on a white background in any future claim listing(s) submitted by Applicant, consistent with the recommendations by the Office (see MPEP 608.01(I), "In order to enhance readability of electronic submissions, the USPTO strongly recommends use of a black colored font for text on a white background"). With entry of said amendments, claims 1, 4 and 6 are currently amended (despite claim 6 having the identifier "Previously Presented"). Claim 9 was previously canceled, such that claims 1-8 and 10-16 are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 112(b) (or pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception(s) without significantly more.
Claims 1-5 recite the steps of calculating a volume flow from a medical image(s); and calculating a hemodynamic parameter, microvascular reserve from an invasive pressure measurement and the volume flow. These limitations are a process that, under BRI thereof, covers performance of the limitations in the mind. That is, nothing in the claim elements preclude the steps from practically being performed in the mind. For example, in the context of this claim, the limitations encompass the user manually and/or manually assessing the diameter of a vessel from an image or series of images; estimating, from a series of images, the time taken for a contrast medium to travel between a first point and a second point, multiplying values to determine volume, dividing by the estimated time to determine volume flow rate; and estimating microvascular resistance based on said volume flow and a pressure measurement. If claim limitations, under their BRI, covers performance of the limitation in the mind, then it falls within the "mental processes" grouping of abstract ideas. Alternatively/Additionally, each of the above-noted steps could reasonably be interpreted as falling within the mathematical concepts grouping of abstract ideas (e.g., claims 3 and 5; ¶ [0064] microvascular resistance may be calculated by dividing the pressure measurement by the volume flow, etc.). Accordingly, the claim recites at least one abstract idea.
The judicial exception is not integrated into a practical application. The claims recite the additional elements of a processor for performing the steps of the abstract idea; a medical imaging device for taking/acquiring the medical images; and an intravascular pressure measurement device for acquiring at least one pressure measurement in the artery. The processor of the computing system is recited at a high-level of generality (i.e., as a generic processor performing generic computer functions, such as performing calculations), such that this additional element amounts no more than mere instructions to apply the exception using a generic computer component. Additionally, measuring at least one pressure measurement, taking medical images, and feeding said images to the computing system (or processor thereof) is only utilized in the claim for the purpose of gathering the data necessary to perform the abstract idea. Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, claims 1-5 are directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of a computing system/processor that executes the abstract idea amounts to no more than mere instructions to apply the exception using a generic computer component. Additionally, with respect to the data gathering steps and/or elements, said steps/elements are highly generic, with Applicant acknowledging the steps of and/or elements for acquiring contrast images are well-understood, routine and/or conventional in the field (e.g., ¶¶ [0006]-[0007]). Mere instructions to apply an exception using a generic computer component; adding insignificant extra-solution activity to the judicial exception; and/or generally linking the use of a judicial exception to a particular technological environment or field of use cannot provide an inventive concept. See MPEP 2106.05(I). When considered in combination, the additional elements amount to no more than conventional pressure measurement and image data being analyzed using the computer system as a tool. Accordingly, the additional elements are not sufficient to ensure that the claims amount to significantly more than the abstract idea. Therefore, claims 1-5 are not patent eligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5,150,292 A (previously cited, Hoffman) in view of US 20170032097 A1 (previously cited, Itu).
Regarding claim 1, Hoffman discloses/suggests a method executable, at least in part, by a computing system comprising a processor in communication with a non-invasive medical imaging instrument (Fig. 23; col. 16, line 9 – col. 17, line 22, program(s) in hardware or software analyzing data from image acquisition device 200), the method comprising:
taking, with the non-invasive medical imaging instrument, at least two medical images of the artery during propagation of a radiation-absorbing contrast medium in the artery (Abstract, angiographic images; col. 1, lines32-35 sequence of two-dimensional images of the vascular system acquired by the projection of X-rays through blood vessels into which a bolus of a contrast material is being injected);
feeding the at least two medical images to the computing system (Fig. 23; col. 16, lines 16-21; etc.);
measuring, by the computing system, in the at least two medical images, a diameter D of the artery which varies along a length of the artery (col. 5, line 66 – col. 6, line 2, cross-sectional vessel size);
tracking a propagation of the radiation-absorbing contrast medium in the artery and measuring a time taken for a propagation along the length of the artery between a first point L1 to a second point L2 in the artery (col. 5, line 58 – col. 6, line 11, tracking movement/travel of the contrast bolus between image acquisitions);
calculating, by the processor, a volume flow from the at least two medical images, by determining a volume of the artery based on the diameter D of the artery which varies along the length of the artery between the first point L1 and the second point L2 (col. 5, line 58 – col. 6, line 11, estimating cross-sectional area from the vessel size and multiplying said area by the distance the contrast material traves during the time between the two image acquisitions).
Hoffman does not expressly disclose taking the at least two medical images of the artery during propagation of the radiation-absorbing contrast medium in the artery are executed by the computing system, or processor thereof. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hoffman with said step(s) being executing by the computing system in order to provide the inherent advantages of computerization and/or because it has been held that broadly providing an automatic or mechanical means to replace a manual activity which accomplishes the same result is not sufficient to distinguish over the prior art. See MPEP 2144.04(III).
Hoffman as modified does not disclose the computing system is in communication with an intravascular pressure measurement device, or the method comprises measuring, by said intra-vascular pressure measurement device, at least one pressure measurement in the artery. Additionally, while Hoffman discloses/suggests, e.g., evaluating the functional significance of vascular disease (col. 5, lines 42-46), Hoffman as modified does not disclose calculating, by the processor, a microvascular resistance based on at least one pressure measurement and the volume flow of the artery calculated based on the diameter D which varies along the length of the artery.
Itu discloses/suggests a computing system (e.g., Fig. 10) comprising a processor in communication with an intravascular pressure measurement device (Fig. 1, 106; ¶ [0029]) and with a non-invasive medical imaging instrument (Fig. 1, 102; ¶ [0204]), wherein the computing system is configured to perform a method comprising: calculating, by the processor, a volume flow based on medical image data (¶ [0040] determining flow rate Q); measuring, by the intravascular pressure measurement device, at least one pressure measurement in the artery (¶ [0040] invasive pressure measurements, or distal pressure (Pd) determined therefrom); and calculating, by the processor, a microvascular resistance based on the at least one pressure measurement and the volume flow (¶ [0040] computing microvascular resistance according to Equation (4)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hoffman with the computing device being in communication with an intravascular pressure measurement device, and the method comprising measuring, by the intravascular pressure measurement device, at least one pressure measurement in the artery and calculating, by the processor, a microvascular resistance based on the at least one pressure measurement and the calculated volume flow as taught and/or suggested by Itu in order to facilitate further/an enhanced evaluation of vascular disease, e.g., evaluating the function of the coronary microvasculature (Itu, ¶ [0039]).
Regarding claim 2, Hoffman as modified discloses/suggests calculating the volume flow further comprises dividing the volume of the artery by the time taken for the contrast agent to propagate along the length of the artery between the first point L1 and the second point L2 in the artery (col. 5, line 58 – col. 6, line 11, where volume (area x distance) is multiplied by the frame rate to determine the flow rate; Fig. 1; etc.).
Regarding claim 3, Hoffman as modified discloses/suggests the volume is calculated by the claimed equation (e.g., col. 5, line 58 – col. 6, line 11, cross-sectional area is calculated from vessel size assuming circular cross section (i.e., πd2/4), which is multiplied by distance (i.e., L2-L1); col. 8, lines 23-33, cumulative distance (and subsequently the cumulative vessel volume calculated by multiplying the distance by the vessel cross-sectional area) is obtained as a function of time; etc.).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman in view of Itu as applied to claim(s) 1 above, and further in view of "A Simplified Method for Densitometric Determination of Vessel Stenosis from Angiographic Images" (previously cited, Dougherty).
Regarding claims 4-5, Hoffman as modified discloses/suggests the limitations of claim 1, as discussed above, and further discloses/suggests measuring, in the at least two medical images defining a plane, the diameter D of the artery which is perpendicular to the plane of the at least two medical images comprises using densitometry on the radiation-absorbing contrast medium to measure D along the length of the artery (col. 7, line 54 – col. 8, line 4, vessel size is quantified along the length of the vessel; col. 3, lines 19-25, col. 11, lines 53-65, etc., vessel size is determined from densitometric methods). Hoffman as modified does not expressly disclose said densitometric methods apply Beer-Lambert's law on a measured intensity in a section of the artery, or determine a depth of the artery perpendicular to the plane of the at least two medical images according to the equation of claim 5.
Dougherty discloses a densitometric method applying Beer-Lambert's law on a measured intensity in a section of the artery, disclosing the claimed relationship between depth of an artery perpendicular to the plane of a least one medical image (Equation 1a or 1b, thickness d1 or d2), incident radiation intensity (I0), transmitted radiation intensity (I1 or I2), and a contrast agent absorbing coefficient (μ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hoffman with determining vessel size (e.g., arterial depth or diameter) by applying Beer-Lambert's law on a measured intensity in a section of the artery according to the equation of claim 5 as taught/suggested by Dougherty as a simple substitution of one known/suitable densitometric method for determining arterial diameter (i.e., vessel size) for another to yield no more than predictable results. See MPEP 2143(I)(B).
Response to Arguments
Applicant's arguments with respect to the prior art rejection(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's remaining arguments have been fully considered but they are not persuasive.
With respsect to eligibility under 35 U.S.C. 101, Applicant contends at least some claim features, particularly acquiring pressure measurements and taking medical images and providing this data to a computing system "cannot be performed by the human mind without the elements of the system recited in claim 1" (Remarks, pg. 7).
The examiner has made no contention that the above-noted features are capable of being practically performed in the mind. Rather, said steps are explicitly identified as additional elements of the claims. However, for at the reasons noted in the rejection of record above, said additional elements neither practically apply nor amount to significantly more than the judicial exception(s).
Applicant further contends, "It would not be possible to gather data without the combination of the elements that measure and take images. These cited steps provide a technological improvement, which allows to determine the microvascular resistance based on measured pressure and images. Applicant submits that the subject matter claimed in the amended claim 1 serves for a practical application and the steps of the recited method are used for such practical application of determining the microvascular resistance"
The examiner respectfully disagrees. Performing the recited judicial exception(s) requires acquiring at least one pressure measurement and medical images. Accordingly, the step and/or generic elements for generically gathering this required data amounts to no more than necessary data gathering, an activity that has been identified by the courts as insignificant extra-solution activity (see MPEP 2106.05(g), e.g., performing clinical tests on individuals to obtain input for an equation). Generically acquiring the data necessary to perform the abstract idea, i.e., adding insignificant extra-solution activity to the judicial exception, does not amount to a technological improvement or practical application.
Allowable Subject Matter
Claim(s) 6 and claims dependent thereon is/are allowed.
The prior art of record fails to disclose and/or suggest a system comprising a computing system in communication with an intravascular pressure measurement device and with a non-invasive medical imaging instrument, the computing system comprising a memory for storing instructions and data from both the intravascular pressure measurement device and the non-invasive medical imaging instrument, and a processor which executes the instructions to: receive at least two pressure measurements from the intravascular pressure measurement device in an artery; receive at least one aortic pressure from another pressure device; receive at least two medical images of the artery from the non-invasive medical imaging instrument, each one of the at least two pressure measurements having a corresponding synchronous medical image of the at least two medical images; calculate a flow from the at least two medical images; calculate parameters of the artery from at least two artery pressure drops and corresponding synchronous flow components; and based on the flow and the parameters of the artery, calculate a patient-specific hemodynamic parameter of microvascular resistance or coronary flow reserve (CFR).
With respect to eligibility under 35 U.S.C. 101, the data gathering steps recited in claim 6 are not merely generically receiving pressure measurements and medical images, but require a unique combination of data to be acquired, i.e., receiving intravascular pressure measurements from the intravascular pressure and receiving corresponding, synchronous medical images from the non-invasive medical imaging instrument, that is not well-understood, routine and/or conventional in the field. Applicant discloses this combination of particular data as claimed is significant as this specific data enables calculating the recited parameters of the artery from at least two artery pressure drops and corresponding synchronous flow components, and subsequently microvascular resistance and/or a coronary flow reserve over any portion of a heartbeat of interest (e.g., ¶ [0073]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791
