DETAILED ACTION
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 .
Response to Arguments
Applicant’s arguments, filed 20 November 2025, with respect to the rejection(s) under U.S.C. 102(a)(1) of claims 1, 4-5, 7-8, 10-11, 14-15, 18-19, 21-22, and 24 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Koo (US Publication No. 20170017771 A1).
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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, 4-5, 7-8, 10-11, 14-15, 18-19, 21-22, 24, and 28-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Specifically, Claim 1 raises new matter by introducing the limitation “identifying a proximal point of the lesion and a distal point of the lesion on respective sides of the maximal point of the lesion using a gradient of the mean lumen area as a function of straightened length of the vessel, and determining the first candidate stent location from the proximal point of the lesion and the distal point of the lesion”. Specifically, the specification makes no mention of a “gradient” or how a gradient might be used to determine the maximal point of the lesion. With no mention of or direct linkage to such a gradient, it is difficult to tell what specific structure is using it or in what manner. We do not know what type of gradient is being discussed, but in the field of image analysis gradients commonly refer to space of vectors showing the direction and steepest rate of increase. And specifically in the world of coronary artery lumen structures such gradients might point to either a pressure or a radius gradient (as described in cited art Koo paragraph 0028). However, there is no structure, equation or graph pointed to in the specification which describes this gradient and no previous mention of any gradient was made prior to this amendment. Therefore, the amendment to Claim 1 introduces new matter and should be rejected per MPEP 608.04.
Claims 1, 4-5, 7-8, 10-11, 14, and 28 are rejected for being dependent to Claim 1.
Claim 15 is rejected for containing similar limitations to those described above in Claim 1.
Claims 18-19, 21-22, 24, and 29 are rejected for being dependent to Claim 15.
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 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because “A computer readable carrier medium carrying processor executable instructions which when executed on a processor cause the processor to carry out a method according to claim 1” under the broadest reasonable interpretation in light of the specification includes non-statutory subject matter such as a signal per se.
An Examiner is obliged to give claims their broadest reasonable interpretation consistent with the specification during examination. The broadest reasonable interpretation of a claim drawn to a computer program product (also called a computer readable medium, machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal, per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter.
In the Specification, while there is mention of a “computer readable carrier medium carrying processor executable instructions” (See paragraph 0022), but there is no strict definition made of a “computer readable carrier medium carrying processor executable instructions”. In other parts of the Specification, there is mention of a program storage 120: “The program storage 120 may be referred to in some contexts as computer readable storage media and/or non-transitory computer readable media”, but the language is not limiting to specifically only non-transitory computer readable media (or medium). There are also concerns the “carrier” limitation in claim 14 points more strictly towards transitory signals (such as a carrier wave or carrier signal). Therefore, since the specification does not strictly limit the claim to only non-transitory mediums, the claim should be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter.
However, the Examiner respectfully submits a claim drawn to such a computer program product or computer readable storage medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation “non-transitory” to the claim. Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. For additional information, please see the Patents’ Official Gazette notice published February 23, 2010 (1351 OG 212).
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.
Claims 1, 4-5, 7-8, 10, 14-15, 18-19, 21-22, 24, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Gopinath (US Publication No. 20180085170 A1) in view of Koo (US Publication No. 20170017771 A1).
Regarding Claim 1, Gopinath discloses A method of simulating a stent (Reference “stent planning method”, see Specification paragraph 0040. Also note the virtual stent being a simulation of a stent in Figure 7 and Specification paragraph 0047) in a coronary artery lumen structure (Reference “coronary artery” and “lumen”, see Specification paragraph 0027 where the lumen diameters are taken of a coronary artery), the method comprising: reconstructing a three-dimensional coronary artery tree from segmented coronary lumen contours (Reference “three-dimensional”, see Specification paragraph 0054, where a three-dimensional view is made of the blood vessels and includes lumen contours and artery branch is interpreted as the coronary artery tree); identifying a first candidate stent location for a first candidate stent structure (Reference “virtual/hypothetical stent candidate”, see Figure 4B and Specification paragraph showing locations for candidate stent structure) by:
determining a mean lumen area as a function of straightened length of a vessel (Reference “mean” and “lumen areas”, see Specification paragraph 0081 where the above candidate landing zones are identified by mean lumen diameters or lumen areas. Note in Specification paragraph 0040 the data used to extract these areas comes from a pullback of the vessel and therefore is a function of the straightened length of the vessel);
identifying a proximal point of a lesion and a distal point of the lesion (Reference “stenosis” and “proximal” and “distal”, see Specification paragraph 0047 where proximal and distal points of the stenosis are described as having a bottleneck and this stenosis is an indicator of a lesion. Also note Reference “distal and proximal”, see Specification paragraph 0075 describing the distal and proximal landing points. These landing points are further described in paragraph 0077 in relation to the stenosis or lesion area)
determining the first candidate stent location from the proximal point of the lesion and the distal point of the lesion (Reference “proximal and distal landing zone locations”, see Specification paragraph 0075 describing these specifically as landing zone locations which would be to land the stent in this zone and is therefore use to determine stent location);
replacing a first part of the three-dimensional coronary artery tree corresponding to the first candidate stent location with the first candidate stent structure (Reference “virtual stent”, see Specification paragraph 0054 where a virtual stent is placed in the vessel. Also see Specification paragraph 0082 where the images taken to determine these virtual stents are coronary arteries); and simulating pressure distribution through the three-dimensional coronary artery tree (Reference “pressure” and “parameters”, see Specification paragraph 0044 where many pressure parameters are generated which are used to determine stent placement scores) to determine a non-invasive fractional flow reserve through the first candidate stent structure (Examiner’s Note: Applicant Background gives measurement sources to create a “non-invasive fractional flow reserve measurement” as seen in the second paragraph of the background “We have adopted a system to assess non-invasive FFR, named as FFRB, by combining both computed tomography coronary angiography (CTCA) and reduced-order computational fluid dynamics (CFD) techniques. Based on the platform, we propose to model virtual stenting for assessing the functional status of the coronary lesions” Returning to Gopinath, Specification paragraph 0045 describes similar measurement being taken “This imagining data [sic] and lumen areas and diameters facilitates a volume-based analysis. Further, by using angiography and other parallel sources of data and coupling them, fluid dynamics, and the frames of imaging data vascular system parameters such as VFR [virtual fractional flow reserve] can be used to obtain correlation similar to or better than FFR. These parameters can be used with virtual stents, landing zones, clustering-based methods and others methods as described herein to perform stenting planning and other diagnostic and analytic methods”. Also note “flow” and “virtual”, see Specification paragraph 0042 where the flow reserve is calculated to estimate change in flow for a virtual stent which is noted being virtual and thus is non-invasive. This flow reserve is coupled to the stent placement score which is further explained in Specification paragraph 0044). However, Gopinath fails to disclose identifying a maximal point of a lesion from a minimum in the mean lumen area, identifying a proximal point of the lesion and a distal point of the lesion on respective sides of the maximal point of the lesion using a gradient of the mean lumen area as a function of straightened length of the vessel.
Instead, Koo discloses identifying a maximal point of a lesion from a minimum in the mean lumen area (See Figure 2B showing the section of a vessel with an obstruction, which as defined in paragraph 0036 may be caused by lesion. Further, see paragraph 0053 where a radius gradient is used on this obstructed vessel to find lesion point to minimum lumen area), identifying a proximal point of the lesion and a distal point of the lesion on respective sides of the maximal point of the lesion using a gradient of the mean lumen area (Examiner’s Note: Please see rejection under U.S.C. 112(a) regarding the “using a gradient of the mean lumen area” as potential new matter. Reference “starting” and “end points”, see paragraph 0053 describing the radius gradient as the radius change from starting or ending point) as a function of straightened length of the vessel (Reference “radius gradient”, see paragraph 0033 and 0034 where the radius gradient is computes over a vessel of length l and is therefore a function of straightened length of the vessel). Motivations for using this radius gradient is also taught by Koo (See Specification paragraph 0029) where these radius gradients can be used to understand plaque ruptures and (See Specification paragraph 0046) be utilized to warn patients or doctors of a risk score due. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to modify Gopinath in view of Koo.
Regarding Claim 4, Gopinath discloses A method according to claim 3, wherein identifying the proximal point of the lesion and the distal point of the lesion using the gradient of the mean lumen area as a function of straightened length of the vessel comprises determining a curvature of the mean lumen area (Examiner’s Note: Please see rejection under U.S.C. 112(a) regarding the “using a gradient of the mean lumen area” as potential new matter and the rejection under U.S.C. 103 of Claim 1 above. Reference “contour”, see Specification paragraph 0047, as cited above in Claim 1 with regard to distal and proximal areas noting the cross sectional areas relative to the contour) as a function of straightened length of the vessel and identifying the proximal point of the lesion and the distal point of the lesion as maxima in the absolute values of the curvature (Reference “curve” and “local maxima”, see Specification paragraph 0086 where local maxima of the curve and blood vessel data is taken. Noting these maxima are used to find the same landing zone sites described above in Claim 1 containing the distal and proximal points)
Regarding Claim 5, Gopinath discloses A method according to claim 3, but fails to disclose wherein identifying the proximal point of the lesion and the distal point of the lesion using the gradient of the mean lumen area as a function of straightened length of the vessel comprises determining a change of slope of the mean lumen area as a function of straightened length of the vessel and identifying the proximal point of the lesion and the distal point of the lesion as maxima of the change of slope.
Instead Koo discloses wherein identifying the proximal point of the lesion and the distal point of the lesion using the gradient of the mean lumen area as a function of straightened length of the vessel comprises determining a change of slope of the mean lumen area (Examiner’s Note: Please see rejection under U.S.C. 112(a) regarding the “using a gradient of the mean lumen area” as potential new matter and the rejection under U.S.C. 103 of Claim 1 above. Reference “cross-sectional area”, see Specification paragraph 0053 where the lumen characteristics include the cross sectional area. Also note the linear fitting of the lumen areas used) as a function of straightened length of the vessel and identifying the proximal point of the lesion and the distal point of the lesion as maxima of the change of slope (Reference “distal” and “proximal” and “radius gradient”, see Specification paragraph 0053 Specifically note the definition of the radius gradient which is a measure of change of diameter over the lesion length. Specifically note the distal and proximal points are found in regard to the lesions to find the length where this cross sectional area was determined). Motivations for using this radius gradient is also taught by Koo (See Specification paragraph 0029) where these radius gradients can be used to understand plaque ruptures and (See Specification paragraph 0046) be utilized to warn patients or doctors of a risk score due. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to modify Gopinath in view of Koo.
Regarding Claim 7, Gopinath discloses A method according to claim 1, further comprising determining a diameter for the first candidate stent structure from a mean lumen diameter at the proximal point of the lesion and the distal point of the lesion (Reference “mean” and “lumen diameter”, see Specification paragraph 0081 where the mean lumen diameter is used to identify local maxima and also the candidate landing zones).
Regarding Claim 8, Gopinath discloses A method according to claim 3, further comprising determining a length for the first candidate stent structure from a location the proximal point of the lesion and a location of the distal point of the lesion (Reference “proximal and distal locations”, see Specification paragraph 0056 where the proximal and distal points are sent to the user. The selection of the landing zones in relation to the stenosis, bottleneck, or lesion is shown in Figures 3A and 3B).
Regarding Claim 10, Gopinath discloses A method according to claim1, further comprising segmenting a coronary artery lumen structure from a set of computed tomography coronary angiography images to obtain the segmented coronary lumen contours (Reference “angiography” and “tomography”, see Specification paragraph 0084 where the blood vessel data used is extracted from angiography and tomography data).
Regarding Claim 14, Gopinath discloses A computer readable carrier medium carrying processor executable instructions which when executed on a processor cause the processor to carry out a method according to claim 1 (First, please see rejection of claim 1 where it is shown Gopinath discloses the method of Claim 1. Also see Specification paragraph 0053 describing a processor with memory and instructions to perform this method).
Claim 15 is rejected for containing similar limitations to the rejected Claims 1 and 14, please see above while noting a medical image processing system embodiment is specifically disclosed by Gopinath (Reference “optic”, “processor”, and “system”, See Specification paragraph 0053).
Claim 18 is rejected for containing similar limitations to rejected Claim 4, please see above.
Claim 19 is rejected for containing similar limitations to rejected Claim 5, please see above.
Claim 21 is rejected for containing similar limitations to rejected Claim 7, please see above.
Claim 22 is rejected for containing similar limitations to rejected Claim 8, please see above.
Claim 24 is rejected for containing similar limitations to rejected Claim 10, please see above.
Regarding Claim 28, Gopinath discloses A method according to claim 1, further comprising: identifying a second candidate location for a second candidate stent structure (Note “virtual stents” and “stent pair” in Specification paragraph 0041 where a stent pair is evaluated with the SES sent score metric); replacing a second part of the three-dimensional coronary artery tree corresponding to the second candidate stent location with the second candidate stent structure (Note “stent pair” and “each stent in the artery” in Specification paragraph 0041 where the stent score or SES is assigned to a pair of stents and these are evaluated “relative to criteria or score that is reflexive of how the selection and placement of the stent(s) affects a given vascular system parameter”); simulating pressure distribution through the three-dimensional coronary artery tree (Note “cardiovascular or vascular system parameters” in Specification paragraph 0044 where a pressure value and fractional flow reserve values are used for generating the stent score or SES used in stent planning, as described in Specification paragraph 0041) to determine a non-invasive fractional flow reserve through the second candidate stent structure (Examiner’s Note: Applicant Background gives measurement sources to create a “non-invasive fractional flow reserve measurement” as seen in the second paragraph of the background “We have adopted a system to assess non-invasive FFR, named as FFRB, by combining both computed tomography coronary angiography (CTCA) and reduced-order computational fluid dynamics (CFD) techniques. Based on the platform, we propose to model virtual stenting for assessing the functional status of the coronary lesions” Returning to Gopinath, Specification paragraph 0045 describes similar measurement being taken “This imagining data [sic] and lumen areas and diameters facilitates a volume-based analysis. Further, by using angiography and other parallel sources of data and coupling them, fluid dynamics, and the frames of imaging data vascular system parameters such as VFR [virtual fractional flow reserve] can be used to obtain correlation similar to or better than FFR. These parameters can be used with virtual stents, landing zones, clustering-based methods and others methods as described herein to perform stenting planning and other diagnostic and analytic methods”. Specifically noting the multiple language in mentioning the virtual stents and their landing zones. See rejection of Claim 1 for more details regarding the flow reserve in the first stent candidate); and displaying an indication of the first candidate stern structure, an indication of the second candidate stent structure (Note “Stents” in Specification paragraph 0055 where the stents at optimal locations are displayed along with their size. Also note the paragraph indicates the placement of these virtual stents can be done atomically), an indication of the non-invasive fractional flow reserve through the first candidate stent structure, and an indication of the non-invasive fractional flow reserve through the second candidate stent structure (Note “SES” and “VFR” in Specification paragraph 0092 where the stent score described above is obtained by determining the virtual flow reserve value, see examiner’s note above, after placement of the stent in the blood vessel. This is compared to the baseline of before placement to determine change in the virtual flow reserve from the placement of the stent. Also note paragraph 0100 where the highest scoring stent locations are displayed)).
Claim 29 is rejected for containing similar limitations to rejected Claim 28, please see above.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gopinath (US Publication No. 20180085170 A1) in view of Koo (US Publication No. 20170017771 A1) further in view of Funabashi (JP Publication No. 2001095795 A).
Regarding Claim 11, Gopinath discloses A method according to claim 10, but fails to disclose A method according to claim 10, wherein segmenting the coronary artery lumen structure from a set of computed tomography coronary angiography images to obtain the segmented coronary lumen contours comprises: designating points at aortic sinus as starting points of coronary artery trees; determining vessel centerlines for arteries of the coronary artery trees; using the vessel centerlines to create a stretched multiplanar reformatted volume for segments of the coronary artery trees; extracting longitudinal cross sections from the stretched multiplanar reformatted volume; detecting lumen borders in the extracted longitudinal cross sections; and detecting lumen border contours in slices of the multiplanar reformatted volume using the detected lumen borders.
Instead, Funabashi discloses wherein segmenting the coronary artery lumen structure from a set of computed tomography coronary angiography images to obtain the segmented coronary lumen contours comprises: designating points at aortic sinus as starting points of coronary artery trees (Reference “starting point”, see Specification paragraph 0017 where the three dimensional image of a descending aorta is described and the starting and end points are selected); determining vessel centerlines for arteries of the coronary artery trees (Reference “CT value” and “center”, see Specification paragraph 0017 where CT values which designate the centers of the artery are measured); using the vessel centerlines to create a stretched multiplanar reformatted volume for segments of the coronary artery trees (Reference “cross sectional plane”, see Specification paragraph 0017 where these values are used to create a cross sectional plane view and also the above three dimensional image described above); extracting longitudinal cross sections from the stretched multiplanar reformatted volume; detecting lumen borders in the extracted longitudinal cross sections (Reference “threshold”, see Figure 9 and Specification paragraph 0017 where thresholds of the coronary artery are set to extract the vessel area and these thresholds are applied to cross sections which as shown in Figure 7 for example is longitudinal) ; and detecting lumen border contours in slices of the multiplanar reformatted volume using the detected lumen borders (Reference “contour”, see Specification paragraph 0006 where the contour of the lumen of the blood vessel is extracted). Motivation for this modification is given in improving the accuracy of the lumen contour of the blood vessel (Reference “contour” and “accuracy”, see Specification paragraph 0006). Therefore, it would have been obvious to one of ordinary skill in the art before the time of filing to modify Gopinath in view of Koo to improve the accuracy of blood vessel contour detection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER JOHN RODGERS whose telephone number is (703)756-1993. The examiner can normally be reached 5:30AM to 2:30PM ET.
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/ALEXANDER JOHN RODGERS/Examiner, Art Unit 2661
/JOHN VILLECCO/Supervisory Patent Examiner, Art Unit 2661
/JOHN VILLECCO/Supervisory Patent Examiner, Art Unit 2661