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 .
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 29 September 2025 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, claim(s) 1-6, 8, 10-12 and 16 is/are currently amended; and claim(s) 9 has/have been canceled. Accordingly, claim(s) 1-8 and 10-16 is/are pending.
Priority
In view of Applicant's amendments to the claims, the disclosure of the prior-filed application, Application No. 16/963,131, provides adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for claim 1 of the present application. Accordingly, claims 1-5 are entitled to the benefit of the prior '131 application.
Terminal Disclaimer
The terminal disclaimer filed on 29 September 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of USPN 11,369,277 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Objections and/or Rejections Withdrawn
Objections the claims, rejections under 35 U.S.C. 101, rejections under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph), rejections under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) and/or nonstatutory double patenting rejections not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims, Applicant's submitted remarks and/or the above-noted terminal disclaimer(s).
With respect to eligibility under 35 U.S.C. 101, Applicant's arguments with respect to claim 6 (and claims dependent thereon) are persuasive, and the rejections in view thereof withdrawn. Specifically, Applicant contends (Remarks, pg. 10) the specific combination of an intravascular pressure measurements and (non-invasive) medical images and receiving pressure drop data along with synchronous medical images is not well-understood, routine and/or conventional in the field. Further, Applicant discloses this data gathering arrangement is significant as it enables calculating parameters of the artery, and subsequently microvascular resistance and/or a coronary flow reserve over any portion of a heartbeat of interest (e.g., ¶ [0073]).
Claim Interpretation
As noted in the prior Office action (mailed 04 June 2025), claims 1, 6 and claims dependent thereon has/have been interpreted to invoke 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph).
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 pre-AIA 35 U.S.C. 112, 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(s) 1, 4, 6 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 1, claim 6 and claims dependent thereon, as noted above, the limitation "a medical imaging instrument" has been interpreted to invoke 35 U.S.C. 112(f). However, Applicant does not sufficiently and/or clearly disclose the corresponding structure for the above-noted limitation, such that the pending claims are indefinite. See MPEP 2181(II)(A).
Regarding claim 4 and claims dependent thereon, "as a function of x" in the limitation "using densitometry on the radiation-absorbing contrast medium to measure D as a function of x by applying Beer-Lambert's law on a measured intensity in a section of the artery" is indefinite in view of Applicant's amendment to claim 1, as it is unclear to what "x" refers.
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, such as microvascular reserve or coronary flow reserve therefrom. These limitations are a process that, under its broadest reasonable interpretation (BRI), covers performance of the limitation 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, it encompasses 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 a hemodynamic parameter, e.g., CFR, based on said volume flow. 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. 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 medical images; and a requirement that the processor is in communication with an intravascular pressure measurement device. 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, 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. The intravascular pressure measurement device of the computing device is not recited as being utilized for any purpose other than tangentially being a part of the "system" by which the abstract idea is performed. Accordingly, the limitation appears to do no more than generally link the use of the judicial exception to a particular technological environment, i.e., a computing system in communication with an intravascular pressure sensor. 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., ¶ [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 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), US 2014/0121513 A1 (previously cited, Tolkowsky) and US 2012/0072190 A1 (Sharma).
Regarding claim 1, Hoffman teaches/suggests a method executable, at least in part, by a computing system comprising a processor in communication with a 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 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 introducing a radiation-absorbing contrast medium in the artery and taking, with the medical imaging instrument, at least one medical image 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 steps 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. Tolkowsky discloses a computing device similarly configured for measuring flow from angiographic images (e.g., ¶ [0035]), wherein said computing device is further in communication with an intravascular pressure measurement device (¶ [0467]). 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 as taught/suggested by Tolkowsky in order to facilitate validating determinations made from image analysis (e.g., Tolkowsky, ¶ [0362]).
Hoffman as modified does not disclose the method further comprises calculating, by the processor, a microvascular resistance or a coronary flow reserve (CFR) based on the volume flow of the artery calculated based on the diameter D which varies along the length of the artery.
Sharma discloses a computer-implemented method comprising calculating a coronary flow reserve based on volume flow of a coronary calculated based on the diameter D which varies along the length of the artery (e.g., ¶¶ [0028]-[0034]).
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 calculating, by the processor, a coronary flow reserve (CFR) based on the volume flow of the artery calculated based on the diameter D which varies along the length of the artery as taught and/or suggested by Sharma (e.g., by receiving and analyzing image data during rest and during hyperemia in order to facilitate providing a flow reserve parameter for functional assessment of coronary artery stenosis (Sharma, ¶ [0026]).
Regarding claim 2, Hoffman as modified teaches/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 teaches/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 Tolkowsky and Sharma 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 teaches/suggests the limitations of claim 1, as discussed above, 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 as a function of artery length (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 respect to rejections under 35 U.S.C. 112(b), Applicant contends, "A person skilled in the art would understand that such medical images are taken/captured by a non-invasive imaging instrument," citing paragraph [0053] of the application as filed (Remarks, pg. 8).
The examiner respectfully disagrees. The BRI of a "medical imaging instrument" encompasses both non-invasive and invasive devices, such as the imaging systems described by Applicant, e.g., in ¶ [0007], as well as imaging (e.g., IVUS) guidewires. Applicant broadly discloses the disclosed invention "relates to a method for determining hemodynamic parameters using an intravascular pressure measurement device combined with medical imaging" (¶ [0002]). There is nothing inherently non-invasive about the terms "medical imaging instrument" and/or "medical imaging." However, the examiner acknowledges that Applicant further refers to using both invasive and non-invasive methods in combination (e.g., ¶¶ [0053]-[0054]). In view of the above, it is unclear if Applicant is attempting to act as his/her own lexicographer to narrow the scope of "medical imaging instrument" to be limited to non-invasive imaging instruments, or if the BRI of the term noted above is to be used. The examiner notes this issue could be obviated by amending the claims to clarify the imaging instrument is non-invasive, e.g., "with a non-invasive medical imaging instrument," which one of ordinary skill in the art would understand to have a sufficiently definite meaning as a name for a broad class of known structures/instruments (e.g., those described by Applicant in ¶ [0007]).
With respsect to eligibility under 35 U.S.C. 101 of claims 1-5, Applicant appears to contend the steps of claim 1 cannot be practically performed in the mind because the Applicant discloses "the computing system is required to advantageously compute the hemodynamic parameter in a timely manner, since the values often need to be computed in real time during intervention for rapid and critical decision-making" (Remarks, pg. 10).
The examiner respectfully disagrees. There is no requirement in the claims that values are computed in real time, during an intervention, or output for any kind of decision-making. Further, improving speed or efficiency inherent with applying an abstract idea on a computer does not integrate a judicial exception into a practical application or provide an inventive concept. See MPEP 2106.05(f).
Applicant further submits, "[The] specific combination of the processor, the intravascular pressure measurement device, the medical imaging instrument are not routinely used and well understood in the art and/or conventional activities. The steps performed by the specific combination of the processor, the intravascular pressure measurement device, the medical imaging instrument should not be viewed as an insignificant extra-solution data gathering step" (Remarks, pg. 10).
There is no "unique combination of steps performed with the intravascular pressure measurement device and the medical imaging instrument simultaneously," as Applicant alleges (pg. 10), because no steps are recited as being performed by the intravascular pressure measurement device in the rejected claims. Rather, as noted in the rejections of record, the presence of the intravascular pressure measurement device in the claim appears tangential to the recited steps.
Applicant contends claims 1-5 amount to a practical application, citing various paragraphs of the specification that indicate patient-specific measurements are provided to the clinicians in a catheterization laboratory (cath lab) in a rapid and timely manner for rapid and critical decision-making (Remarks, pgs. 11-14).
The examiner respectfully disagrees. Even assuming, inter alia, that the these are practical applications of the recited abstract idea, as noted above, there is no requirement that patient-specific values are computed in real time, in a catheterization laboratory, during an intervention, output for any kind of decision-making, etc. Accordingly, none of the alleged practical applications are recited in the claims.
For at least the reasons discussed above, the rejection of claims 1-5 under 35 U.S.C. 101 has been maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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