DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This action is in response to the remarks filed on 11/25/2025.
The amendments filed on 11/25/2025 have been entered. Accordingly claims 1, 3-6, 9-11, 13-16, and 19-22 are pending. Claims 1-10 and 17-18 have been withdrawn from further consideration. Claims 1, 3-5, 9-11, 13-14, and 19 have been amended, claims 2, 7-8, 12, and 17-18 have been canceled, and claims 21-22 have been newly added.
Some of the claim rejections under 35 USC 112 have been withdrawn in light of the amendments and the applicant’s remarks and some are maintained as further detailed below.
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 1, 13-16, 19-20 and 22 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 pre-AIA the applicant regards as the invention.
Claim 11 recites the limitation of “determining a maximum diameter of the first segment” which again is not clear segment of what. It is presumed that the claim rather meant “determining a maximum diameter of the first segment of the blood vessel” which should also be added after the each “segment” recitation.
Claim 11 further recites “calculating a calculated maximum diameter of the second segment according to a power law including the determined maximum diameter of the first segment” which is not clear when or where the maximum diameter was “calculated” as the claim does not recite any calculation step prior to this “calculating a calculated maximum diameter” step. In other words there is not antecedent basis for this “calculating a calculated maximum diameter” step.
Therefore, the claims rendered indefinite.
The depending claims are also rejected due to their dependency
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, 13-16, 19-20 and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim 11 recites the mental process of “determining”, “dividing”, “calculating” as abstract ideas.
The limitation of “dividing”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting by “a processor,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “by a processor” language, “dividing” in the context of this claim encompasses the user manually dividing each vessel into segments or using a pen and paper to draw and divide. Similarly, the limitations of “determining”, and “calculating”, as drafted, is a process that, under their broadest reasonable interpretation, cover performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “by a processor” language, in the context of this claim encompasses the user thinking or using a pen and paper to determine the diameter. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using a processor to perform the limitation of “determining”, “dividing”, “calculating”, “defining”, “selecting”, “using” and “displaying”. The processor in these steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer functions such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 using a processor to perform “determining”, “dividing”, “calculating”, “defining”, “selecting”, “using” and “displaying” steps amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claim is not patent eligible.
The depending claims also recite similar abstract ideas (e.g., determining, correlating, etc.) without 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.
Therefore, the claims are not patent eligible.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 11, 13-16, 19-20 and 22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schmitt et al (US 20110071404, March 24, 2011, applicant submitted prior art), (hereinafter “Schmitt”) in view of Kassab et al (US20110282586, 2011-11-17, cited in the IDS), (hereinafter “Kassab”).
Regarding claim 11 (as the claims best understood in light of the 35 USC 112 rejections above), Schmitt teaches an apparatus for sizing a stent for placement in a blood vessel (“new methods for optimization of stent sizing and positioning based on measurements derived from intravascular images” [0013]; “the parameters of vessel size and blood flow resistance are calculated, the present invention also provides methods for optimizing stent choice and placement automatically or semi-automatically via interactive commands” [0113]) comprising:
a processor having imaging data for the blood vessel, the processor executing a program comprising instructions to perform the following steps (“automated computer-based method of evaluating a region of a lumen” [0015]; “the method includes comprises the steps of generating a mask of the OCT lumen image using a computer” [0017]):
dividing a representation of the blood vessel into a plurality of segments including at least a first segment and a second segment (“collecting a set of data regarding a vessel segment of length” [0015]; “automatically locating a lumen boundary at a position in a vessel of interest ….measuring the diameter of the vessel” [0059]; “identify stenotic and normal vessel segments,…the software shows the cross-sectional areas calculated automatically for all frames in a sequence as a graph superimposed on the longitudinal (L)-mode image [FIG. 3]” [0060]; also see figs. 21-22 for segmentation of the vessel and the associated pars. as well as figs. 23 and 25),
determining a maximum diameter of the first segment (“collecting a set of data regarding a vessel segment of length” [0015]; “Dmax is set equal to the maximum diameter of the vessel measured within the imaged segment” [0116]; “the system first creates arrays of area and diameter for each cross-section along the unstented vessel” [0119]; “automatically locating a lumen boundary at a position in a vessel of interest ….measuring the diameter of the vessel” [0059]; “identify stenotic and normal vessel segments,…the software shows the cross-sectional areas calculated automatically for all frames in a sequence as a graph superimposed on the longitudinal (L)-mode image (FIG. 3)” [0060]);
determining a measured diameter of the second segment (“Fig. 1… lumen boundary at a position in a vessel of interest (using an OCT image or the underlying data) and from that measuring the diameter of the vessel [as seen in fig. 1 measured diameter of the segments of the vessel]) … these measurements to allow the clinician to simulate the placement of a stent and determine the effect of the placement” [0059]);
calculating a calculated maximum diameter of the second segment according to a power law including the determined maximum diameter of the first segment (“Murray's [power] law states that the cube of the radius of a parent vessel equals the sum of the cubes of the radii of the daughters. Table 2 shows the area increase calculated by Murray's law when the branches are symmetric” [0094]; “The radius of the vessels is calculated, assuming they are circular. These radii are all multiplied by a single scale factor. The scale factor is determined by Murray's [power] law” [0096]);
defining a maximum diameter of the second segment as a larger of the calculated maximum diameter or the measured diameter (“identify stenotic and normal vessel segments, … the cross-sectional areas [from the radius/diameter] calculated automatically for all frames in a sequence as a graph superimposed on the longitudinal (L)-mode image (FIG. 3). The lines 10, 10′ indicate the position of the user-selected proximal and distal reference frames… the mean diameter values profile in a separate panel above the L-mode display (FIG. 3). FIG. 4 shows an alternative display in which the mean cross-sectional diameters and an “Alert Frame” feedback are shown in a separate panel above the OCT L-mode. The alert frame, labeled AF indicates a frame where the system believes human intervention is required to verify the values shown.” [0060]);
iteratively determining a maximum diameter of the remaining segments in the plurality of segments (“proceeds iteratively to find the longitudinal position of the stent, xopt, and diameter of the stent, Dopt, that minimizes VRR while maintaining a malapposition distance, ε, less than a maximum allowable distance, εmax, and a stent diameter less than Dmax. Typically εmax is fixed at a small value between 0 and a value deemed clinically insignificant (e.g., 0.1 mm) and Dmax is set equal to the maximum diameter of the vessel measured within the imaged segment plus one stent diameter increment (typically 0.25 mm). To accelerate the iteration, the sets of available stent diameters {Dmin≦D≦Dmax}” []);
determining, based on the maximum diameters of the first segment and a segment of the plurality of segments distal to the first segment, a landing zone for placement of a stent (“FIG. 22 outlines the steps of an embodiment of a fully automatic optimization procedure in which the diameter, length, and longitudinal position are optimized simultaneously” [0118]; “the system first creates arrays of area and diameter for each cross-section along the unstented vessel. Next, the system creates a lookup table that has the available ranges of stent diameter, length and position. Then, progressing through each entry in the lookup table, the system calculates the VRR and maximum malapposition value. The maximum malapposition value equals the distance between the maximum unstented diameter in the segment and the diameter of the stent… The table entry in which the stent length is a minimum defines the optimal stent parameters.” [0119]); and
providing for output an indication of the landing zone (“FIGS. 25 and 26 depict the output results of the specific embodiments of the invention. FIGS. 25 a and 25 b show the pre- and (predicted) post-stented mean-diameter lumen profiles resulting from the fixed-stent-length optimization procedure for two different stent lengths” [0126]).
As seen above. Schmitt clearly teaches broad claimed invention. Yet, if one argues in a narrow interpretation that Schmitt does not teach (the office does not concede, and merely to provide a compact prosecution), Kassab reference is brought in to show the teaching of using the selected maximum diameter to find a maximum diameter of a next segment.
However, in the same field of endeavor, Kassab teaches systems and methods to determine optimal diameters of vessel segments. Identifying a diameter of a first segment, a second segment of the vessel, and determining a diameter of a third segment of the vessel based upon the diameter of the first segment and the diameter of the second segment (abst). A processor is [in an automated manner] operable to determine a diameter of a third segment of a bifurcated vessel based upon a diameter of a first segment of the bifurcated vessel and a diameter of a second segment of the bifurcated vessel based upon an exponential relationship of or about 7/3 for each diameter. Receiving data indicative of the diameter of a first segment of the bifurcated vessel and the diameter of a second segment of the bifurcated vessel from a system and determined diameter of the third segment of the bifurcated vessel. In yet another embodiment, the processor is operable to determine the diameter of the third segment of the bifurcated vessel by executing a program stored on the storage medium, the program comprising program steps indicative of the exponential relationship of or about 7/3 for each diameter [0017] (also see [0012]-[0016]). Several concepts are defined to formulate resistance scaling (power) laws [0075]. Structure-function scaling laws obtained from resistance scaling law. A mathematical model (the ¾-power scaling law) was derived in a symmetric vasculature to characterize the allometric scaling laws [0100]. Scaling law of the disclosure of the present application is further validated through diameter-length, volume-length, flow-diameter, and volume-diameter scaling relations [0104]. The resistance scaling laws (Equations #9, #12, and #13) are derived based on the relation of diameter ratio (DR=Di/Di-1) [0098]. Also see the calculations of the maximum diameter (Dmax) in eq. 2 [0057], eq. 9 [0085], eq. 11 [0092], eq. 12-13 [0093]-[0095], eq. 14 [0107], eq. 23 [0127], eq. 27 [0129].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and device of Schmitt with calculating a maximum diameter of a other segments based upon the defined maximum diameter of the first segment and according to a power law; and using the calculated maximum diameter of the second segment to find a maximum diameter of another segment as taught by Kassab because it would help to determine the optimal diameter of a segment of a vessel to ensure optimal flow through based on the diameters of the other two segments of the vessel (see [0011] of Kassab).
Regarding the claim 13, Schmitt teaches the power law is: Dε(i+1)= Dε(i) + Dbε (i) wherein Db is a diameter one of the plurality of segments or a blood vessel branch D(i) is a diameter of a segment of the plurality of segments distal to the segment with the diameter Db, D(i+1) is a diameter of a segment of the plurality of segments proximal to the segment with the diameter Db, and F is an exponent (“Murray's law states that the cube of the radius of a parent vessel equals the sum of the cubes of the radii of the daughters” [0094]).
Further Kassab also teaches FIG. 18 shows a relationship between Dm/(Dl+Ds) and diameter ratio (Ds/Dl) determined by the HK, Finet, Muray and area-preservation models, according to an embodiment of the present disclosure [0040]. FIG. 19 shows a table demonstrating a relationship between Dm/(Dl+Ds) in Y and T bifurcations determined by the HK, Murray, and area-preservation models [0041]. Also see figs. 16-24 and the associated pars.
Regarding the claim 14, Schmitt teaches ε has a value between 2.0 and 3.0 (“Murray's law states that the cube of the radius of a parent vessel equals the sum of the cubes of the radii of the daughters” [0094]).
Further Kassab also teaches wherein the processor is operable to determine a diameter of a third segment of a bifurcated vessel based upon a diameter of a first segment of the bifurcated vessel and a diameter of a second segment of the bifurcated vessel based upon an exponential relationship of or about 7/3 for each diameter.
Regarding the claim 15, Schmitt teaches normalcy of the tissue is determined by a method selected from the group of automated tissue characterization, user identification and morphology (“the method is applied to the region that contains a stenotic lesion. In another embodiment, the method further comprises the step of displaying at least one numerical or graphical measure of stent length used to treat the stenotic lesion. In yet another embodiment, the step of determining the vascular resistance ratio is performed using a lumped resistor model” [0016]; “To help the user identify stenotic and normal vessel segments, in one embodiment the software shows the cross-sectional areas calculated automatically for all frames in a sequence as a graph superimposed on the longitudinal (L)-mode image” [0060]; “a stenosed branch of a coronary artery under hyperemic conditions” [0078]).
Further Kassab also teaches aforementioned Equations are useful to diagnose DCAD. For such a diagnosis, the applications of Equations #1-#3 may provide the “signatures” of normal vascular trees and impart a rationale for diagnosis of disease processes [0066].
Regarding the claim 16, Schmitt teaches the method of automated tissue characterization includes cross-correlating an optical coherence tomography signal between adjacent regions of the vessel (“To help the user identify stenotic and normal vessel segments, in one embodiment the software shows the cross-sectional areas calculated automatically for all frames in a sequence as a graph superimposed on the longitudinal (L)-mode image” [0060]).
Regarding the claim 19, Schmitt teaches the method of automated tissue characterization uses one of frame based intensity profiles or intima-media (IM) to outer adventitia (OA) ratios (“an intensity profile using the cleared mask; identifying the guide wire shadow region in the intensity profile; detecting a guide wire offset within the shadow region; collecting the midpoint of detected guide wires on all frame” [0019]).
Regarding the claim 20, Schmitt teaches processor configured to determine a stent contact location in the vessel by determining an amount of disease present in the vessel (“the length of the stenosis, defined as the region between the wall angle inflection points on either side of the stenosis” [0090]; “select the length of a stent required to cover a stenotic lesion” [0112] also see [0113]-[0123]).
Further Kassab also teaches this website or application can be downloaded to a mobile phone or other portable device, for example, for a quick and easy rule to determine the reference diameter of a bifurcation for the sizing of balloons or stents [0153].
Claim 22 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schmitt in view of Kassab and further in view of Rollins et al (US 20120075638).
Regarding claim 22, the above combination teaches all the limitations of the claims except for perform filtering images of the vessel segments with a Gabor filter.
However, in the same field of endeavor, Rollins teaches system and related methods for automatic or semi-automatic segmentation and quantification of blood vessel structure and physiology, including segmentation and quantification of lumen (abst). Characterization of fibrous and lipid plaques may be performed based on vessel wall segmentation results. Via Gabor filtered images [0093].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with vessel segments with a Gabor filter as taught by Rollins because it provides valuable information, for example, for optimal placement of coronary stents. Further, detection and quantification of structures such as stents can help evaluate risks of the malaposition and uncovered struts associated with thrombosis ([0003] of Rollins).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive at least for the reasons noted below;
Regarding the rejection of claims under 35 USC 101, the applicant argues the following;
Applicant respectfully submits that claim 11, as amended, recites patent eligible subject matter for at least the following reasons, each explained in more detail below.
A. The claims are integrated into a practical application as an improvement to the technical field; and
B. The claims are integrated into a practical application as a prophylaxis for a disease of medical condition.
A. The Claims are Integrated into a Practical Application as an Improvement to the technical field.
…
Applicant respectfully submits that the claims reflect the disclosed improvement in the technology and, therefore, the claims as a whole integrate the exception into a practical application.
…
Applicant respectfully submits that the claims integrate the exception into a practical application by "effect[ing] a particular treatment or prophylaxis for a disease or medical condition."
…
Accordingly, the claims as a whole integrate the exception into a practical application.
Contrary to the applicant’s assertion, claims still recite abstract idea as "dividing" and "determining" and "calculating" which is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. Other than the recitation of generic computer components (“processor”) nothing in the claim element precludes the step from practically being performed in the mind.
Further, the applicant also argues that claims as a whole integrate the exception into a practical application, yet all generic limitations with their generic component that is used for mere data gathering which are examples of activities that courts have found to be insignificant extra-solution activity. These components are widely practiced and commonly known with no specificity which courts have found to be insignificant extra-solution activity.
Therefore, under its broadest reasonable interpretation, claims cover performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Judicial exception is not integrated into a practical application since the claim only recites additional element generic computer components (“processor”).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The claims are not patent eligible.
Regarding the rejection of claim, the applicant argues the following;
Applicant respectfully submits that these claim features are patentable over the applied combination of references.
…
The Action relies on Schmitt in combination with Kassab for the claimed power law. (Action pp.10-11.) The Action cites to [0104] in Kassab, which states that "[a] novel scaling law of the disclosure of the present application is further validated through diameter-length, volume-length, flow-diameter, and volume-diameter scaling relations." (Kassab [0104].) The Action then concludes that it would be obvious to modify "the method and device of Schmitt with calculating a maximum diameter of a other segments based upon the defined maximum diameter of the first segment and according to a power law; and using the calculated maximum diameter of the second segment to find a maximum diameter of another segment as taught by Kassab because it would help to determine the optimal diameter of a segment of a vessel to ensure optimal flow through based on the diameters of the other two segments of the vessel (see [0011] of Kassab)."…
However, initially it is noted that Schmitt specifically teaches the (assumed due to the indefiniteness) limitation “calculating a calculated maximum diameter of the second segment according to a power law including the determined maximum diameter of the first segment” (“Murray's [power] law states that the cube of the radius of a parent vessel equals the sum of the cubes of the radii of the daughters. Table 2 shows the area increase calculated by Murray's law when the branches are symmetric” [0094]; “The radius of the vessels is calculated, assuming they are circular. These radii are all multiplied by a single scale factor. The scale factor is determined by Murray's [power] law” [0096]);
As seen above, Schmitt teaches “Murray” law which states that the cube of the radius of a parent vessel (Rp) must equal the sum of the cubes of the radii of its daughter branches (Rd). Claim 14 and the specification noted that the power of the equation is 3 (hence cube) which correlates with the Murray law. This is explained despite the claim merely requires a generic “power law” NOTHING in specific.
Contrary to the applicant’s assertion, the cited prior art specifically teaches the claimed limitations.
Further, Kassab also teaches the generic “power law” by stating the diameter of a first segment of the bifurcated vessel and the diameter of a second segment of the bifurcated vessel from a system and determined diameter of the third segment of the bifurcated vessel [0017]. Scaling law of the disclosure of the present application is further validated through diameter-length, volume-length, flow-diameter, and volume-diameter scaling relations [0104].
As can be clearly and factually seen above, the cited prior art teaches the argued points.
Therefore, the rejections are 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797