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 .
Priority
The instant application claims benefit to Application No. 16/257982 filed on 01/25/2019 based on continuation and divisional. Domestic benefit is acknowledged. Thus, the effective filing date of Claims 1-20 is 01/25/2019.
Information Disclosure Statement
The information disclosure statements (“IDS”) filed on 09/12/2023 and 09/26/2025 was reviewed and the listed references were noted.
Drawings
The 19 page drawings have been considered and placed on record in the file.
Status of Claims
Claims 1-20 are currently pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 19 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 19 recites the limitation " the wall" towards the end of the third line and. There is insufficient antecedent basis for this limitation in the claim. Claim 20 is rejected under this section of the rules due to its dependency from claim 19.
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 1-15 and 17-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Consider independent Claim 1 is directed to determining a scaling between an image and real distance of a calibration device and determining a property of one or more prosthetic heart valve leaflet based on the scaling factor.
Step 1:
With regard to Step 1, the instant claim is directed to a method, i.e., among the statutory categories of invention.
Step 2A – Prong 1:
With regard to Step 2A – Prong 1, the limitation “determining a scaling between an image distance and a real distance based on one or more images of a calibration device”, as recited, is a method that, under its broadest reasonable interpretation, is mathematically capable of being performed via pen and paper. Furthermore, the limitation “determining a property, based on the scaling, of one or more leaflets of a prosthetic valve shown in one or more images”, as recited, is a method that, under its broadest reasonable interpretation, covers performance of the limitation in the mind/observation of a person inspecting an image of a prosthetic heart valve. That is nothing in the claim steps preclude the limitations from practically being performed mathematically on paper to determine scaling between image and real distance, and/or in the mind or through observation/judgement of a person inspecting an image for the openness of a prosthetic heart valve to determine certain flow properties. If a claim limitation, under its broadest reasonably interpretation covers performance of the limitation in the mind then it falls within the "Mental processes" grouping of the abstract idea, which include concepts performed in the human mind, including an observation, evaluation, judgement, opinion. Accordingly, the claim recites an abstract idea
Step 2A – Prong 2:
The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in Claim 1 to apply, rely on, or use the judicial exception. In the instant case, no other additional elements in Claim 1 apply, rely on, or use the judicial exception.
Step 2B:
Because Claim 1 fail under Step 2A, the claim is further evaluated under Step 2B. Claim 1 herein does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Accordingly, Claim 1 is not patent eligible.
Further, with regard to dependent Claims 2-15 and 17-18 viewed individually, these additional elements are under their broadest reasonable interpretation, cover performance of the limitation in the mind and do not provide limitations that integrate the abstract idea into a practical application and/or are considered as significantly more that the identified abstract idea. Accordingly, Claims 1-15 and 17-18 are rejected under 35 U.S.C. 101. Claims 16 and 19-20 are not rejected under this section of rules, as they include limitations that are either integrate the identified abstract idea into a practical application or considered to be significantly more than the identified abstract idea.
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.
Claims 1, 4-5, 10-12, 14-15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Iyengar ( “Dynamic in vitro quantification of bioprosthetic heart valve leaflet motion using structured light projection.” (2001) ) in view of Gao ( "Bioprosthetic heart valve leaflet deformation monitored by double-pulse stereo photogrammetry." (2002) ).
Consider Claim 1, Iyengar and Gao disclose “A method comprising: determining a scaling between an image distance and a real distance” ( Iyengar; Section Appendix; “Values of the constants can be determined via calibration using a set of six or more noncoplanar points whose object space coordinates are known a priori and using the above equations. Once the constants are determined the same expressions can be used to transfer the camera coordinates of any object in the two views back to its coordinates in the object space.” (emphasis added) ) “based on one or more images” ( Iyengar; Section Image Acquisition and 3D Point Cloud Reconstruction; “An IC-ASYNC (Imaging Technology Inc., USA) frame grabber that has the capability to simultaneously acquire images from up to four monochrome cameras was used” ) “( Iyengar; Section Measurement accuracy; “A matrix of markers of known distances was created with a 1200 dpi laser printer (21 mm accuracy) and was attached to the surface of the phantoms.” ) and determining a property, based on the scaling, of one or more leaflets of a prosthetic valve shown in one or more images.” ( Iyengar; Section Introduction; “In the present work we present a novel optical-based valve imaging system to quantify leaflet motion and shape for the study of heart valve dynamics” ).
Iyengar does not explicitly teach “of a calibration device having a plurality of walls extending outward from each other”. However, in analogous field, Gao teaches a prosthetic heart valve marked with a grid of indicator with known distance between each marker ( Gao; Figure 3) (See image below) ). Examiner notes the prosthetic valve depicted in Figure 3, below, is interpreted to have a plurality of walls extending outward from each other.
Accordingly, before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to combine Iyengar with the teachings of Gao to substitute the calibration structure disclosed in Iyengar with the marked prosthetic valve of Gao to calculate the scaling between the known real distance of the indicators and the perceived distance between each marker in captured images of the marked prosthetic valve using the same calibration method. One of ordinary skill in the art would be motivated to combine Iyengar and Gao to use a prosthetic heart valves as the calibration structure to calculate a more accurate scaling factor. Accordingly, the combination of Iyengar and Gao, disclose the invention of Claim 1.
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Consider Claim 4, the combination of Iyengar and Gao discloses “The method of claim 1, wherein each of the plurality of walls in the one or more images of the calibration device (Iyengar; Section Image Acquisition and 3D Point Cloud Reconstruction; “frame grabber that has the capability to simultaneously acquire images from up to four monochrome cameras was used.” ) extend in a contact plane of the one or more leaflets.” ( Iyengar; Section Image Acquisition and 3D Point Cloud Reconstruction; “The DLT was calibrated (see the Appendix) using a cube machined out of aluminum to a tolerance of 5 mm. The calibration was performed in situ in the same volume as the leaflets were imaged to minimize calibration errors.” ). Examiner notes the sides of the cube, with the exception of the top and bottom sides of the cube, are parallel to the plane of contact between the leaflets.
Consider Claim 5, the combination of Iyengar and Gao discloses “The method of claim 1, wherein the calibration device includes a central portion and each of the plurality of walls extend radially outward from the central portion to a respective end portion.” ( Gao; Figure 3) (See image above) ). The proposed combination as well as the motivation for combining the Iyengar and Gao references presented in the rejection of claim 1, apply to claim 5 and are incorporated herein by reference. Thus, the method recited in claim 5 is met by Iyengar and Gao.
Consider Claim 10, the combination of Iyengar and Gao discloses “The method of claim 1, wherein the scaling includes a pixel to length ratio.”. (Gao; Section Image System Calibration; “The in situ calibration was performed by fitting the observed coordinates to the calculated coordinates of the grid target. The calculated coordinates (jk ,ik) of it were the pixel coordinates calculated from the known grid coordinates (xk ,yk ,zk) of the same marker, referred to as the object coordinate”). Examiner notes the equations disclosed in Gao to convert the pixel position coordinate to real position coordinates of the prosthetic heart valve is interpreted as the transform of a pixel to length ratio. The proposed combination as well as the motivation for combining the Iyengar and Gao references presented in the rejection of claim 1, apply to claim 10 and are incorporated herein by reference. Thus, the method recited in claim 10 is met by Iyengar and Gao.
Consider Claim 11, the combination of Iyengar and Gao discloses “The method of claim 1, further comprising measuring an image distance between portions of the one or more leaflets of the prosthetic valve and determining a real distance between the portions of the one or more leaflets of the prosthetic valve based on the scaling.” ( Iyengar; Section Appendix; “Once the constants are determined the same expressions can be used to transfer the camera coordinates of any object in the two views back to its coordinates in the object space.” ). Examiner notes the camera coordinates are interpreted as the image distance and the object space coordinates are interpreted as the real distance.
Consider Claim 12, the combination of Iyengar and Gao discloses “The method of claim 1, wherein one or more cameras provide the one or more images” ( Iyengar; Section Image Acquisition and 3D Point Cloud Reconstruction; “frame grabber that has the capability to simultaneously acquire images from up to four monochrome cameras was used.” ) “of the calibration device.” ( Iyengar; Section Image Acquisition and 3D Point Cloud Reconstruction; “The calibration was performed in situ in the same volume as the leaflets were imaged to minimize calibration errors.” ).
Consider Claim 14, the combination of Iyengar and Gao discloses “The method of claim 1, wherein the one or more images of the prosthetic valve are taken with the prosthetic valve positioned within a test chamber of a testing apparatus.” ( Iyengar; Figure 2(a) (See Image below) ).
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Consider Claim 15, the combination of Iyengar and Gao discloses “The method of claim 14, wherein the testing apparatus is configured to provide pulsatile flow through the prosthetic valve.” ( Iyengar; Section Method; “A pulsatile flow loop capable of reproducing physiological aortic pressure wave forms was developed for the present study (Fig. 1).” ).
Consider Claim 17, the combination of Iyengar and Gao discloses “The method of claim 14, wherein the one or more images of the calibration device are taken with the calibration device positioned within the test chamber of the testing apparatus.” ( Iyengar; Section Image Acquisition and 3D Point Cloud Reconstruction; “The calibration was performed in situ in the same volume as the leaflets were imaged to minimize calibration errors.” )
Consider Claim 18, the combination of Iyengar and Gao discloses “The method of claim 1, wherein the prosthetic valve is a prosthetic heart valve.” ( Iyengar; Section Abstract; “To demonstrate our approach, we utilized a bovine pericardial bioprosthetic heart valve” ).
Consider Claim 19, the combination of Iyengar and Gao discloses “The method of claim 1, wherein: the plurality of walls each extend radially outward from a central portion of the plurality of walls to a respective end portion of the wall,” ( Gao; Figure 3) (See image above) ) “each of the plurality of walls extending axially to a respective top surface of the wall,” ( Gao; Figure 3) (See image above) ). Examiner notes the top surface of the wall limitation stated in Claim 19 is interpreted as the edge of a leaflet. Examiner further notes that Figure 3 in Gao depicts a prosthetic valve with marking that appear from the top most edge of the leaflet to the root, and the entire marked valve area is interpreted as a calibration wall extending to a top surface. “and the calibration device includes a plurality of indicators on at least one of the plurality of walls, the plurality of indicators being spaced from each other at the defined real distance.” ( Iyengar; Section Measurement accuracy; “A matrix of markers of known distances was created with a 1200 dpi laser printer (21 mm accuracy) and was attached to the surface of the phantoms.” ). The proposed combination as well as the motivation for combining the Iyengar and Gao references presented in the rejection of claim 1, apply to claim 19 and are incorporated herein by reference. Thus, the method recited in claim 19 is met by Iyengar and Gao.
Consider Claim 20, the combination of Iyengar and Gao discloses “The method of claim 19, wherein the plurality of indicators comprise a pattern on the at least one of the plurality of walls.” ( Iyengar; Section Measurement Accuracy; “A matrix of markers of known distances was created with a 1200 dpi laser printer (21 mm accuracy) and was attached to the surface of the phantoms.” ). Examiner notes the matrix of markers is interpreted as a grid and pattern.
Claims 2 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Iyengar ( “Dynamic in vitro quantification of bioprosthetic heart valve leaflet motion using structured light projection.” (2001) ) in view of Gao ( "Bioprosthetic heart valve leaflet deformation monitored by double-pulse stereo photogrammetry." (2002) ) and in further view of Susin ( “Integrated strategy for in vitro characterization of a bileaflet mechanical aortic valve” (2017) ).
Consider Claim 2, the combination of Iyengar and Gao does not explicitly disclose “The method of claim 1, wherein the property is a quantitative measure of a coaptation of the one or more leaflets.”.
However, in an analogous field, Susin teaches ( Susin; Section Pressure and EOA measurement; “To this aim we examined the variability of both the mean…transvalvular pressure drop…and the EOA…” ). Examiner notes that Susin calculates a quantitative measure for the effective orifice area (EOA) and EOA is interpreted to be characterized by the coaptation of the leaflets to define the opening of the prosthetic heart valve.
Accordingly, before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to combine Iyengar and Gao with the teachings of Susin to further calculate a quantitative property of the leaflet dynamics of a prosthetic heart valve. One of ordinary skill in the art would be motivated to combine Iyengar, Gao, and Susin to analyze a wider range of hemodynamic parameters to further the understanding of heart valve flow and its effects on blood cell damage and leaflet degenerations (Susin; Section Background). Accordingly, the combination of Iyengar, Gao, and Susin discloses the invention of Claim 2.
Consider Claim 16, the combination of Iyengar, Gao and Susin discloses “The method of claim 14, further comprising operating the testing apparatus to determine a leakage of the prosthetic valve or to determine an effective orifice area of the prosthetic valve.” ( Susin; Section Pressure and EOA measurement; “To this aim we examined the variability of both the mean…transvalvular pressure drop…and the EOA…” ). The proposed combination as well as the motivation for combining the Iyengar, Gao and Susin references presented in the rejection of claim 2, apply to claim 16 and are incorporated herein by reference. Thus, the method recited in claim 16 is met by Iyengar, Gao and Susin.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Iyengar ( “Dynamic in vitro quantification of bioprosthetic heart valve leaflet motion using structured light projection.” (2001) ) in view of Gao ( "Bioprosthetic heart valve leaflet deformation monitored by double-pulse stereo photogrammetry." (2002) ) and in further view of Susin ( “Integrated strategy for in vitro characterization of a bileaflet mechanical aortic valve” (2017) ) and in further view of Condurache ( “Video-based measuring of quality parameters for tricuspid xenograft heart valve implants” (2009) )
Consider Claim 3, the combination of Iyengar, Gao, and Susin does not explicitly discloses “The method of claim 2, wherein the quantitative measure is a real distance of a mismatch of the one or more leaflets.”.
However, in analogous field, Condurache teaches a video based system for measuring parameters of heart valve implants and calculates the area of the valve’s orifice. Condurache discloses the segmentation of the EOA from images captured by the camera by first calculating the centerlines between each leaflet and determining the distance from the edge of each leaflet to the center line ( Condurache; Fig. 5 (See image below) ).
Accordingly, before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to combine Iyengar, Gao and Susin with the teachings of Condurache to more accurately measure the EOA of a prosthetic heart valve by measuring the distance between leaflets. One of ordinary skill in the art would be motivated to combine Iyengar, Gao, Susin, and Condurache to measure the mismatch distance between leaflets to verify and ensure the performance of a prosthetic heart valve because ( Condurache; Section Introduction; “implants do not by far reach the reliability of native valves, mainly because they do not have the autorepair abilities of native tissue.” ). Accordingly, the combination of Iyengar, Gao, Susin, and Condurache discloses the invention of Claim 3.
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Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Iyengar ( “Dynamic in vitro quantification of bioprosthetic heart valve leaflet motion using structured light projection.” (2001) ) in view of Gao ( "Bioprosthetic heart valve leaflet deformation monitored by double-pulse stereo photogrammetry." (2002) ) and in further view of Marassi ( "Cardiac valve prosthesis flow performances measured by 2D and 3D-stereo particle image velocimetry." (2004) ).
Consider Claim 6, the combination of Iyengar and Gao does not explicitly disclose “The method of claim 5, wherein the scaling is a first scaling determined between an image distance and a real distance based on an image distance between one or more portions of the calibration device at the central portion; and the method further comprises determining a second scaling between an image distance and a real distance based on an image distance between one or more portions of one of the plurality of walls at the end portion of the respective wall.”.
However, in an analogous field, Marassi teaches (Marassi; Figure12; Section 2.4.3; “The target was moved to two positions about the Z=0 location (Z=-1.00 mm, Z=+1.00 mm) and imaged at each position. Fig. 12 shows a typical view of calibration target used in 3D-stereo PIV obtained from one camera, and related calibration image used to find the calibration coefficients…” ). Examiner notes the two positions (Z = 0 and Z = +/- 1.00) are interpreted as a center position and an end position on the calibration target and the calculated coefficient for each respective position are not the same.
Accordingly, before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to combine Iyengar and Gao with the teachings of Marassi to determine different calibration coefficient at different positions on the calibration target. One of ordinary skill in the art would be motivated to combine Iyengar and Gao and Marassi to derive more accurate real distances from the captured images due to the variation of optical distortion based on the depth or position of a structure in a fluid. Accordingly, the combination of Iyengar, Gao and Marassi discloses the invention of Claim 6.
Consider Claim 7, the combination of Iyengar, Gao and Marassi discloses “The method of claim 6, wherein the one or more portions of the calibration device at the central portion include one or more indicators positioned on one or more of the plurality of walls, and the one or more portions of the plurality of walls at the end portion of the respective wall include one or more indicators positioned on the respective wall.” (Marassi; Section 2.4.3; “A special calibration dot-target of 50×50 mm with one zero marker (diameter 0.675) and four axis markers (diameters equal to 0.325) was designed and produced; dot spacing was fixed to 1.25 mm and main marker diameter was 0.5 mm.” ). The proposed combination as well as the motivation for combining the Iyengar, Gao and Marassi references presented in the rejection of claim 6, apply to claim 7 and are incorporated herein by reference. Thus, the method recited in claim 7 is met by Iyengar, Gao and Marassi.
Consider Claim 8, the combination of Iyengar, Gao and Marassi discloses “The method of claim 7, wherein a real distance is known between the one or more indicators of the central portion of the calibration device, and a real distance is known between the one or more indicators of the end portion of the respective wall.” (Marassi; Section 2.4.3; “A special calibration dot-target of 50×50 mm with one zero marker (diameter 0.675) and four axis markers (diameters equal to 0.325) was designed and produced; dot spacing was fixed to 1.25 mm and main marker diameter was 0.5 mm.” ). Examiner notes the known distance between each marker remains consistent across the entire calibration target and is interpreted to apply to both indicators of the central and end portions for the target. The proposed combination as well as the motivation for combining the Iyengar, Gao and Marassi references presented in the rejection of claim 6, apply to claim 8 and are incorporated herein by reference. Thus, the method recited in claim 8 is met by Iyengar, Gao and Marassi.
Consider Claim 9, the combination of Iyengar, Gao and Marassi discloses “The method of claim 6, wherein the first scaling is different than the second scaling.” (Marassi; Figure12; Section 2.4.3; “The target was moved to two positions about the Z=0 location (Z=-1.00 mm, Z=+1.00 mm) and imaged at each position. Fig. 12 shows a typical view of calibration target used in 3D-stereo PIV obtained from one camera, and related calibration image used to find the calibration coefficients…” ). Examiner notes the two positions (Z = 0 and Z = +/- 1.00) are interpreted as the center position and end position on the calibration target and the calculated coefficient for each respective position are not the same. The proposed combination as well as the motivation for combining the Iyengar, Gao and Marassi references presented in the rejection of claim 6, apply to claim 9 and are incorporated herein by reference. Thus, the method recited in claim 9 is met by Iyengar, Gao and Marassi.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Iyengar ( “Dynamic in vitro quantification of bioprosthetic heart valve leaflet motion using structured light projection.” (2001) ) in view of Gao ( "Bioprosthetic heart valve leaflet deformation monitored by double-pulse stereo photogrammetry." (2002) ) and in further view of Abbasi ( "High resolution three-dimensional strain mapping of bioprosthetic heart valves using digital image correlation." (2018) ).
Consider Claim 13, the combination of Iyengar and Gao discloses “The method of claim 12, wherein the one or more cameras include a side camera” ( Iyengar; Section Leaflet Visualization Technique; “…two boroscopes (Hawkeye, Gradient Lens Co., USA! were mounted proximally [Fig. 2~b]). The boroscopes measured 4.2 mm in diameter and had a field of view of ~40°.” (emphasis added) ) “( Iyengar; Figure 2 (See image above) )
The combination of Iyengar and Gao does not explicitly teach an axial camera or axial view of the calibration device; however, in an analogous field, Abbasi teaches ( Abbasi; Section Materials and methods; “The system consists of two high-speed cameras…. Both cameras were placed at the measuring distance of 575 mm from the valve housing. For each one of the bioprostheses, DIC measurement was conducted both from top and side views in separate experiments.” (emphasis added) ).
Accordingly, before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to combine Iyengar and Gao with the teachings of Abbasi to capture multiple different views of the prosthetic heart valve during testing. One of ordinary skill in the art would be motivated to combine Iyengar and Gao and Abbasi to analyze the leaflet and valve dynamics with a wider image range to capture the entirety of the valve’s movements. Accordingly, the combination of Iyengar, Gao and Abbasi discloses the invention of Claim 13.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Annie Pham whose telephone number is (571)272-1673. The examiner can be normally be reached Mon-Fri 9:00a – 5:00p.
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/ANNIE H PHAM/Examiner, Art Unit 2662
/Siamak Harandi/Primary Examiner, Art Unit 2662