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 .
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 12/09/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. (U.S. Pat. No. 11,666,232 hereinafter Li ‘232. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant invention would be an obvious modification of the reference patent.
Regarding claim 1, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) teaches:
A system for evaluating a vessel of a patient (abstract, figure 4, system 150), the system comprising:
a display (Li ‘232, claim 1);
a memory comprising instructions; and a processor coupled to the memory and to the display, the processor configured to execute the instructions (Li ‘232, claim 1), which when executed cause the processor to:
receive, from a first pressure measurement device, first data indicative of a plurality of pressures measured along a longitudinal section of a vessel of a patient (Li ‘232, claim 1),
receive, from a second pressure measurement device, second data indicative of a pressure at a proximal end of the longitudinal section of the vessel (Li ‘232, claim 1),
derive a pressure ratio curve from the first data and the second data (Li ‘232, claim 1),
identify a window on the pressure ratio curve where a slope of the pressure ratio curve is above a threshold value (Li ‘232, claim 1),
identify a starting point and an ending point of a stepped change in the pressure ratio curve based on the window (Li ‘232, claim 1), and
cause the display to display the pressure ratio curve and a label indicating the starting point and the ending point (Li ‘232, claim 1).
Regarding claim 2, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the instructions when executed by the processor further cause the processor to derive the pressure ratio curve as the ratio of the first data over the second data (Li ‘232, claims 1-13).
Regarding claim 3, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the label comprises a visual indication of the pressure ratio at the starting point (Li ‘232, claims 1-13).
Regarding claim 4, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the label comprises a visual indication of the pressure ratio at the ending point (Li ‘232, claims 1-13).
Regarding claim 5, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the label comprises a visual indication of the change in the pressure ratio between the starting point and the ending point (Li ‘232, claims 1-13).
Regarding claim 6, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the pressure ratio curve and the label are depicted in a user interface on the display, wherein the user interface allows a user to indicate a location on an image of the vessel, and in response, the instructions when executed by the processor further cause the processor to output to the display an indicator showing a position on the pressure ratio curve that corresponds to the location on the image of the vessel (Li ‘232, claims 1-13).
Regarding claim 7, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the image of the vessel shows the position of the first pressure measurement device (Li ‘232, claims 1-13).
Regarding claim 8, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
A computer-implemented method for a vessel imaging system (Li ‘232, claim 1), comprising:
receiving, at a processor of the vessel imaging system from a first pressure measurement device, first data indicative of a plurality of pressures measured along a longitudinal section of a vessel of a patient (Li ‘232, claim 1),
receiving, at the processor from a second pressure measurement device, second data indicative of a pressure at a proximal end of the longitudinal section of the vessel (Li ‘232, claim 1),
deriving, by the processor, a pressure ratio curve from the first data and the second data (Li ‘232, claim 1),
identifying, by the processor, a window on the pressure ratio curve where a slope of the pressure ratio curve is above a threshold value (Li ‘232, claim 1),
identifying, by the processor, a starting point and an ending point of a stepped change in the pressure ratio curve based on the window (Li ‘232, claim 1), and
causing, by the processor, a display of the vessel imaging system to display the pressure ratio curve and a label indicating the starting point and the ending point (Li ‘232, claim 1).
Regarding claim 9, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the instructions when executed by the processor further cause the processor to derive the pressure ratio curve as the ratio of the first data over the second data (Li ‘232, claims 1-13).
Regarding claim 10, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the label comprises a visual indication of the pressure ratio at the starting point, a visual indication of the pressure ratio at the ending point, and/or a visual indication of the change in the pressure ratio between the starting point and the ending point (Li ‘232, claims 1-13).
Regarding claim 11, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the pressure ratio curve and the label are depicted in a user interface on the display, wherein the user interface allows a user to indicate a location on an image of the vessel, and wherein the method further comprises outputting to the display an indicator showing a position on the pressure ratio curve that corresponds to the location on the image of the vessel (Li ‘232, claims 1-13).
Regarding claim 12, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the image of the vessel shows the position of the first pressure measurement device (Li ‘232, claims 1-13).
Regarding claim 13, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
further comprising selectively outputting the image of the vessel to the display upon a command by a user made through the user interface (Li ‘232, claims 1-13).
Regarding claim 14, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
One or more computer-readable medium comprising instructions, which when executed by a processor of a vessel imaging system cause the vessel imaging system (Li ‘232, claim 1) to:
receive, from a first pressure measurement device, first data indicative of a plurality of pressures measured along a longitudinal section of a vessel of a patient (Li ‘232, claim 1),
receive, from a second pressure measurement device, second data indicative of a pressure at a proximal end of the longitudinal section of the vessel (Li ‘232, claim 1),
derive a pressure ratio curve from the first data and the second data (Li ‘232, claim 1),
identify a window on the pressure ratio curve where a slope of the pressure ratio curve is above a threshold value (Li ‘232, claim 1),
identify a starting point and an ending point of a stepped change in the pressure ratio curve based on the window (Li ‘232, claim 1), and
cause a display of the vessel imaging system to display the pressure ratio curve and a label indicating the starting point and the ending point (Li ‘232, claim 1).
Regarding claim 15, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the instructions when executed by the processor further cause the vessel imaging system to derive the pressure ratio curve as the ratio of the first data over the second data (Li ‘232, claims 1-13).
Regarding claim 16, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the label comprises a visual indication of the pressure ratio at the starting point (Li ‘232, claims 1-13).
Regarding claim 17, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the label comprises a visual indication of the pressure ratio at the ending point (Li ‘232, claims 1-13).
Regarding claim 18, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the label comprises a visual indication of the change in the pressure ratio between the starting point and the ending point (Li ‘232, claims 1-13).
Regarding claim 19, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the pressure ratio curve and the label are depicted in a user interface on the display, wherein the user interface allows a user to indicate a location on an image of the vessel, and in response, the instructions when executed by the processor further cause the processor to output to the display an indicator showing a position on the pressure ratio curve that corresponds to the location on the image of the vessel (Li ‘232, claims 1-13).
Regarding claim 20, reference patent Li ‘232 (U.S. Pat. No. 11,666,232) further teaches:
wherein the image of the vessel shows the position of the first pressure measurement device (Li ‘232, claims 1-13).
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 14-20 are rejected under 35 U.S.C. 101 because the claim does not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to a product that does not have a physical or tangible form.
Regarding claim 14, the claimed product is a computer-readable medium that encompasses a broadest reasonable interpretation that includes the ineligible subject matter of transitory signals. The limitation of “One or more computer-readable medium comprising instructions, which when executed by a processor of a vessel imaging system cause the vessel imaging system to” is considered to encompass transitory signals, which while physical and real, does not possess concrete structure that would qualify as a device or part under the definition of a machine. While the claim includes the structure of “a processor”, claims directed to both eligible and ineligible subject matter are rejected under 35 U.S.C. 101. Thus, the product claim directed to a has no physical or tangible form, and does not fall within any statutory category. Examiner suggests positive recitation of structure of a “non-transitory” form of computer readable storage medium to overcome the current rejection. See also MPEP 2106.03 (I). For these reasons, the claim is rejected under 35 U.S.C. 101.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Merritt et al. (U.S. Pub. No. 20160157787) hereinafter Merritt, in view of Davies et al. (WO2016/005944) hereinafter Davies (see attached WO publication for citations).
Regarding claim 1, primary reference Merritt teaches:
A system for evaluating a vessel of a patient (abstract, figure 4, system 150; [0077]; system 150 implements a method of evaluating a vessel system of a patient to identify and classify a lesion; see figure 11, method 1000), the system comprising:
a display (figure 9; see also figure 4, display device 180 as well as [0042], the computing device is communicatively coupled to a display device; [0064]-[0072]);
a memory comprising instructions ([0039], memory); and
a processor coupled to the memory and to the display, the processor configured to execute the instructions (figure 4, computing device 172; [0039]-[0040]), which when executed cause the processor to:
receive, from a first pressure measurement device, first data indicative of a plurality of pressures measured along a longitudinal section of a vessel of a patient ([0078], i.e. pressure based diagnostic measurements from a second instrument; see also figure 4, instrument 152 and [0038], “the housing 156 contains at least a pressure sensor configured to monitor a pressure within a lumen in which the instrument 152 is positioned” as a guidewire this occurs during pullback along the longitudinal section of the vessel; [0046], “control instruments 152 and 175 to acquire pressure data during a procedure; and [0080]; figure 11),
receive, from a second pressure measurement device, second data indicative of a pressure at a proximal end of the longitudinal section of the vessel ([0078], i.e. pressure based diagnostic measurements from a first instrument; [0034]-[0035], instruments 130 and 132 configured to monitor pressure of the vessel proximal of the stenosis which forms a proximal end; [0036]; figure 11),
derive a pressure ratio curve from the first data and the second data (figure 9 and [0067], i.e. pressure ratio over time),
identify a window on the pressure ratio curve where a slope of the pressure ratio curve is above a threshold value (figure 9, region of interest 630, a region of interest is identified by the system and is centered around a sharp pressure change in the vessel, which forms a slope of a pressure ratio curve being above a threshold value (sharp change); [0072]);,
Primary reference Merritt fails to teach:
identify a starting point and an ending point of a stepped change in the pressure ratio curve based on the window
cause the display to display the pressure ratio curve and a label indicating the starting point and the ending point
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
identify a starting point and an ending point of a stepped change in the pressure ratio curve based on the window (page 22, line 25 through page 23 line 13, the pressure ratio value shown in figure 10 with graph 310 is determined with specifically on page 23, lines 7-23 the larger bars of pressure ratio values over the distance is the identification of the pressure ratio over a threshold value and thus a starting point and ending point of the pressure ratio curve), and
cause the display to display the pressure ratio curve and a label indicating the starting point and the ending point (page 22, line 11 through page 23 line 13, the pressure ratio value shown in figure 10 with graph 310 is determined with specifically on page 23, lines 7-23 the larger bars of pressure ratio values over the distance is the identification of the pressure ratio over a threshold value and thus a starting point and ending point of the pressure ratio curve. The annotated regions 322, 324, 326, and 328 correspond to notable changes in the pressure ratio values in figure 10, and correspond with lesions or stenosis. These regions label the starting and ending points of the notable changes in pressure ratio values ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt to incorporate the position determination of the starting and ending point as taught by Davies because it enables the determination of the relative position of the at least one measured stenosis in a vessel and enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 2, the combined references of Merritt and Davies teaches all of the limitations of claim 1. Primary reference Merritt further fails to teach:
wherein the instructions when executed by the processor further cause the processor to derive the pressure ratio curve as the ratio of the first data over the second data
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the instructions when executed by the processor further cause the processor to derive the pressure ratio curve as the ratio of the first data over the second data (page 22, line 11 through page 23 line 13, ratio of the pressure measurements form the first data over the second data as the first instrument to the second instrument ratio; figures 10-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the ratio measurement of the instruments as taught by Davies because changes in pressure ratio values over time provide indications of a lesion or stenosis in a vessel. This enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 3, the combined references of Merritt and Davies teaches all of the limitations of claim 1. Primary reference Merritt further fails to teach:
wherein the label comprises a visual indication of the pressure ratio at the starting point
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the label comprises a visual indication of the pressure ratio at the starting point (page 22, line 29 through page 23 line 13, the pressure ratio value shown in figure 10 with graph 310 is determined with specifically on page 23, lines 7-23 the larger bars of pressure ratio values over the distance is the identification of the pressure ratio over a threshold value and thus a starting point and ending point of the pressure ratio curve. The annotated regions 322, 324, 326, and 328 correspond to notable changes in the pressure ratio values in figure 10, and correspond with lesions or stenosis. These regions label the starting and ending points of the notable changes in pressure ratio values for display and include plot values; see also page 22, lines 11-22 for display of visual representations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the visual indication of the starting point as taught by Davies because it enables the determination of the relative position of the at least one measured stenosis in a vessel and enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 4, the combined references of Merritt and Davies teaches all of the limitations of claim 3. Primary reference Merritt further fails to teach:
wherein the label comprises a visual indication of the pressure ratio at the ending point
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the label comprises a visual indication of the pressure ratio at the ending point (page 22, line 29 through page 23 line 13, the pressure ratio value shown in figure 10 with graph 310 is determined with specifically on page 23, lines 7-23 the larger bars of pressure ratio values over the distance is the identification of the pressure ratio over a threshold value and thus a starting point and ending point of the pressure ratio curve. The annotated regions 322, 324, 326, and 328 correspond to notable changes in the pressure ratio values in figure 10, and correspond with lesions or stenosis. These regions label the starting and ending points of the notable changes in pressure ratio values for display and include plot values; see also page 22, lines 11-22 for display of visual representations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the visual indication of the ending point as taught by Davies because it enables the determination of the relative position of the at least one measured stenosis in a vessel and enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 5, the combined references of Merritt and Davies teaches all of the limitations of claim 4. Primary reference Merritt further fails to teach:
wherein the label comprises a visual indication of the change in the pressure ratio between the starting point and the ending point
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the label comprises a visual indication of the change in the pressure ratio between the starting point and the ending point (page 22, line 29 through page 23 line 13, the pressure ratio value shown in figure 10 with graph 310 is determined with specifically on page 23, lines 7-23 the larger bars of pressure ratio values over the distance is the identification of the pressure ratio over a threshold value and thus a starting point and ending point of the pressure ratio curve. The annotated regions 322, 324, 326, and 328 correspond to notable changes in the pressure ratio values in figure 10, and correspond with lesions or stenosis. These regions label the starting and ending points of the notable changes in pressure ratio values for display and include plot values which indicate the change in ratio between the starting and ending points; see also page 22, lines 11-22 for display of visual representations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the visual indication of the change between starting and ending point as taught by Davies because it enables the determination of the relative position of the at least one measured stenosis in a vessel and enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 6, the combined references of Merritt and Davies teaches all of the limitations of claim 1. Primary reference Merritt further fails to teach:
wherein the pressure ratio curve and the label are depicted in a user interface on the display, wherein the user interface allows a user to indicate a location on an image of the vessel, and in response, the instructions when executed by the processor further cause the processor to output to the display an indicator showing a position on the pressure ratio curve that corresponds to the location on the image of the vessel
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the pressure ratio curve and the label are depicted in a user interface on the display, wherein the user interface allows a user to indicate a location on an image of the vessel, and in response, the instructions when executed by the processor further cause the processor to output to the display an indicator showing a position on the pressure ratio curve that corresponds to the location on the image of the vessel (page 22, lines 11-15, user selects visual representations which includes visual representations of measurements and images; page 22, line 16 through page 26, line 26; figures 9-13; page 25, line 26-33, user selection and annotation of the image that indicates selection on the displayed pressure ratio curve).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the visual indication of the user input position as taught by Davies because it enables the annotation of additional information observed by a user on the output image, providing increased treatment data as an output and improved diagnostic accuracy (Davies, page 25, line 26-33).
Regarding claim 7, the combined references of Merritt and Davies teaches all of the limitations of claim 6. Primary reference Merritt further fails to teach:
wherein the image of the vessel shows the position of the first pressure measurement device
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the image of the vessel shows the position of the first pressure measurement device (page 4, lines 11-19, position of one or more treatment devices; figure 10, the instrument maintained in a proximal position is located at the left portion of the plot 312, and therefore the correspond figure 11-13, the proximal portion of the tracked measurement zone is the position of the first pressure measurement device that is stationary; see pages 22-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the visual indication of the location of the pressure measurement device proximally as taught by Davies because it enables the determination of the relative position of the at least one measured stenosis in a vessel relative to the start of pushing of the second measurement device or ending of the pullback of the second measurement device and enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 8, primary reference Merritt teaches:
A computer-implemented method for a vessel imaging system (abstract, figure 4, system 150; [0077]; system 150 implements a method of evaluating a vessel system of a patient to identify and classify a lesion; see figure 11, method 1000), comprising:
receiving, at a processor of the vessel imaging system from a first pressure measurement device, first data indicative of a plurality of pressures measured along a longitudinal section of a vessel of a patient ([0078], i.e. pressure based diagnostic measurements from a second instrument; see also figure 4, instrument 152 and [0038], “the housing 156 contains at least a pressure sensor configured to monitor a pressure within a lumen in which the instrument 152 is positioned” as a guidewire this occurs during pullback along the longitudinal section of the vessel; [0046], “control instruments 152 and 175 to acquire pressure data during a procedure; and [0080]; figure 11),
receiving, at the processor from a second pressure measurement device, second data indicative of a pressure at a proximal end of the longitudinal section of the vessel ([0078], i.e. pressure based diagnostic measurements from a first instrument; [0034]-[0035], instruments 130 and 132 configured to monitor pressure of the vessel proximal of the stenosis which forms a proximal end; [0036]; figure 11),
deriving, by the processor, a pressure ratio curve from the first data and the second data (figure 9 and [0067], i.e. pressure ratio over time),
identifying, by the processor, a window on the pressure ratio curve where a slope of the pressure ratio curve is above a threshold value (figure 9, region of interest 630, a region of interest is identified by the system and is centered around a sharp pressure change in the vessel, which forms a slope of a pressure ratio curve being above a threshold value (sharp change); [0072]);,
Primary reference Merritt fails to teach:
identifying, by the processor, a starting point and an ending point of a stepped change in the pressure ratio curve based on the window, and
causing, by the processor, a display of the vessel imaging system to display the pressure ratio curve and a label indicating the starting point and the ending point
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
identifying, by the processor, a starting point and an ending point of a stepped change in the pressure ratio curve based on the window (page 22, line 25 through page 23 line 13, the pressure ratio value shown in figure 10 with graph 310 is determined with specifically on page 23, lines 7-23 the larger bars of pressure ratio values over the distance is the identification of the pressure ratio over a threshold value and thus a starting point and ending point of the pressure ratio curve), and
causing, by the processor, a display of the vessel imaging system to display the pressure ratio curve and a label indicating the starting point and the ending point (page 22, line 11 through page 23 line 13, the pressure ratio value shown in figure 10 with graph 310 is determined with specifically on page 23, lines 7-23 the larger bars of pressure ratio values over the distance is the identification of the pressure ratio over a threshold value and thus a starting point and ending point of the pressure ratio curve. The annotated regions 322, 324, 326, and 328 correspond to notable changes in the pressure ratio values in figure 10, and correspond with lesions or stenosis. These regions label the starting and ending points of the notable changes in pressure ratio values ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt to incorporate the position determination of the starting and ending point as taught by Davies because it enables the determination of the relative position of the at least one measured stenosis in a vessel and enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 9, the combined references of Merritt and Davies teaches all of the limitations of claim 8. Primary reference Merritt further fails to teach:
wherein the instructions when executed by the processor further cause the processor to derive the pressure ratio curve as the ratio of the first data over the second data
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the instructions when executed by the processor further cause the processor to derive the pressure ratio curve as the ratio of the first data over the second data (page 22, line 11 through page 23 line 13, ratio of the pressure measurements form the first data over the second data as the first instrument to the second instrument ratio; figures 10-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the ratio measurement of the instruments as taught by Davies because changes in pressure ratio values over time provide indications of a lesion or stenosis in a vessel. This enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 10, the combined references of Merritt and Davies teaches all of the limitations of claim 8. Primary reference Merritt further fails to teach:
wherein the label comprises a visual indication of the pressure ratio at the starting point, a visual indication of the pressure ratio at the ending point, and/or a visual indication of the change in the pressure ratio between the starting point and the ending point
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the label comprises a visual indication of the pressure ratio at the starting point, a visual indication of the pressure ratio at the ending point, and/or a visual indication of the change in the pressure ratio between the starting point and the ending point (page 22, line 29 through page 23 line 13, the pressure ratio value shown in figure 10 with graph 310 is determined with specifically on page 23, lines 7-23 the larger bars of pressure ratio values over the distance is the identification of the pressure ratio over a threshold value and thus a starting point and ending point of the pressure ratio curve. The annotated regions 322, 324, 326, and 328 correspond to notable changes in the pressure ratio values in figure 10, and correspond with lesions or stenosis. These regions label the starting and ending points of the notable changes in pressure ratio values for display and include plot values; see also page 22, lines 11-22 for display of visual representations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the visual indication of the starting point, ending point and change in pressure ratio as taught by Davies because it enables the determination of the relative position of the at least one measured stenosis in a vessel and enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 11, the combined references of Merritt and Davies teaches all of the limitations of claim 8. Primary reference Merritt further fails to teach:
wherein the pressure ratio curve and the label are depicted in a user interface on the display, wherein the user interface allows a user to indicate a location on an image of the vessel, and wherein the method further comprises outputting to the display an indicator showing a position on the pressure ratio curve that corresponds to the location on the image of the vessel
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the pressure ratio curve and the label are depicted in a user interface on the display, wherein the user interface allows a user to indicate a location on an image of the vessel, and wherein the method further comprises outputting to the display an indicator showing a position on the pressure ratio curve that corresponds to the location on the image of the vessel (page 22, lines 11-15, user selects visual representations which includes visual representations of measurements and images; page 22, line 16 through page 26, line 26; figures 9-13; page 25, line 26-33, user selection and annotation of the image that indicates selection on the displayed pressure ratio curve).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the visual indication of the user input position as taught by Davies because it enables the annotation of additional information observed by a user on the output image, providing increased treatment data as an output and improved diagnostic accuracy (Davies, page 25, line 26-33).
Regarding claim 12, the combined references of Merritt and Davies teaches all of the limitations of claim 11. Primary reference Merritt further fails to teach:
wherein the image of the vessel shows the position of the first pressure measurement device
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the image of the vessel shows the position of the first pressure measurement device (page 4, lines 11-19, position of one or more treatment devices; figure 10, the instrument maintained in a proximal position is located at the left portion of the plot 312, and therefore the correspond figure 11-13, the proximal portion of the tracked measurement zone is the position of the first pressure measurement device that is stationary; see pages 22-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the visual indication of the location of the pressure measurement device proximally as taught by Davies because it enables the determination of the relative position of the at least one measured stenosis in a vessel relative to the start of pushing of the second measurement device or ending of the pullback of the second measurement device and enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 13, the combined references of Merritt and Davies teaches all of the limitations of claim 11. Primary reference Merritt further fails to teach:
further comprising selectively outputting the image of the vessel to the display upon a command by a user made through the user interface
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
further comprising selectively outputting the image of the vessel to the display upon a command by a user made through the user interface (page 22, lines 11-15, user selects visual representations which includes visual representations of measurements and images see page 22, lines 1-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the selective visual indication of the image based upon user input as taught by Davies because it enables the selection of particular information observed by a user as the output image, providing increased treatment data as an output and improved diagnostic accuracy (Davies, page 25, line 26-33).
Regarding claim 14, primary reference Merritt teaches:
One or more computer-readable medium comprising instructions, which when executed by a processor of a vessel imaging system cause the vessel imaging system (abstract, figure 4, system 150; [0077]; system 150 implements a method of evaluating a vessel system of a patient to identify and classify a lesion; see figure 11, method 1000) to:
receive, from a first pressure measurement device, first data indicative of a plurality of pressures measured along a longitudinal section of a vessel of a patient ([0078], i.e. pressure based diagnostic measurements from a second instrument; see also figure 4, instrument 152 and [0038], “the housing 156 contains at least a pressure sensor configured to monitor a pressure within a lumen in which the instrument 152 is positioned” as a guidewire this occurs during pullback along the longitudinal section of the vessel; [0046], “control instruments 152 and 175 to acquire pressure data during a procedure; and [0080]; figure 11),
receive, from a second pressure measurement device, second data indicative of a pressure at a proximal end of the longitudinal section of the vessel ([0078], i.e. pressure based diagnostic measurements from a first instrument; [0034]-[0035], instruments 130 and 132 configured to monitor pressure of the vessel proximal of the stenosis which forms a proximal end; [0036]; figure 11),
derive a pressure ratio curve from the first data and the second data (figure 9 and [0067], i.e. pressure ratio over time),
identify a window on the pressure ratio curve where a slope of the pressure ratio curve is above a threshold value (figure 9, region of interest 630, a region of interest is identified by the system and is centered around a sharp pressure change in the vessel, which forms a slope of a pressure ratio curve being above a threshold value (sharp change); [0072]);,
Primary reference Merritt fails to teach:
identify a starting point and an ending point of a stepped change in the pressure ratio curve based on the window, and
cause a display of the vessel imaging system to display the pressure ratio curve and a label indicating the starting point and the ending point
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
identify a starting point and an ending point of a stepped change in the pressure ratio curve based on the window (page 22, line 25 through page 23 line 13, the pressure ratio value shown in figure 10 with graph 310 is determined with specifically on page 23, lines 7-23 the larger bars of pressure ratio values over the distance is the identification of the pressure ratio over a threshold value and thus a starting point and ending point of the pressure ratio curve), and
cause a display of the vessel imaging system to display the pressure ratio curve and a label indicating the starting point and the ending point (page 22, line 11 through page 23 line 13, the pressure ratio value shown in figure 10 with graph 310 is determined with specifically on page 23, lines 7-23 the larger bars of pressure ratio values over the distance is the identification of the pressure ratio over a threshold value and thus a starting point and ending point of the pressure ratio curve. The annotated regions 322, 324, 326, and 328 correspond to notable changes in the pressure ratio values in figure 10, and correspond with lesions or stenosis. These regions label the starting and ending points of the notable changes in pressure ratio values ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt to incorporate the position determination of the starting and ending point as taught by Davies because it enables the determination of the relative position of the at least one measured stenosis in a vessel and enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 15, the combined references of Merritt and Davies teaches all of the limitations of claim 14. Primary reference Merritt further fails to teach:
wherein the instructions when executed by the processor further cause the vessel imaging system to derive the pressure ratio curve as the ratio of the first data over the second data
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the instructions when executed by the processor further cause the vessel imaging system to derive the pressure ratio curve as the ratio of the first data over the second data (page 22, line 11 through page 23 line 13, ratio of the pressure measurements form the first data over the second data as the first instrument to the second instrument ratio; figures 10-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the ratio measurement of the instruments as taught by Davies because changes in pressure ratio values over time provide indications of a lesion or stenosis in a vessel. This enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 16, the combined references of Merritt and Davies teaches all of the limitations of claim 14. Primary reference Merritt further fails to teach:
wherein the label comprises a visual indication of the pressure ratio at the starting point
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the label comprises a visual indication of the pressure ratio at the starting point (page 22, line 29 through page 23 line 13, the pressure ratio value shown in figure 10 with graph 310 is determined with specifically on page 23, lines 7-23 the larger bars of pressure ratio values over the distance is the identification of the pressure ratio over a threshold value and thus a starting point and ending point of the pressure ratio curve. The annotated regions 322, 324, 326, and 328 correspond to notable changes in the pressure ratio values in figure 10, and correspond with lesions or stenosis. These regions label the starting and ending points of the notable changes in pressure ratio values for display and include plot values; see also page 22, lines 11-22 for display of visual representations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the visual indication of the starting point as taught by Davies because it enables the determination of the relative position of the at least one measured stenosis in a vessel and enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 17, the combined references of Merritt and Davies teaches all of the limitations of claim 16. Primary reference Merritt further fails to teach:
wherein the label comprises a visual indication of the pressure ratio at the ending point
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the label comprises a visual indication of the pressure ratio at the ending point (page 22, line 29 through page 23 line 13, the pressure ratio value shown in figure 10 with graph 310 is determined with specifically on page 23, lines 7-23 the larger bars of pressure ratio values over the distance is the identification of the pressure ratio over a threshold value and thus a starting point and ending point of the pressure ratio curve. The annotated regions 322, 324, 326, and 328 correspond to notable changes in the pressure ratio values in figure 10, and correspond with lesions or stenosis. These regions label the starting and ending points of the notable changes in pressure ratio values for display and include plot values; see also page 22, lines 11-22 for display of visual representations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the visual indication of the ending point as taught by Davies because it enables the determination of the relative position of the at least one measured stenosis in a vessel and enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 18, the combined references of Merritt and Davies teaches all of the limitations of claim 17. Primary reference Merritt further fails to teach:
wherein the label comprises a visual indication of the change in the pressure ratio between the starting point and the ending point
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the label comprises a visual indication of the change in the pressure ratio between the starting point and the ending point (page 22, line 29 through page 23 line 13, the pressure ratio value shown in figure 10 with graph 310 is determined with specifically on page 23, lines 7-23 the larger bars of pressure ratio values over the distance is the identification of the pressure ratio over a threshold value and thus a starting point and ending point of the pressure ratio curve. The annotated regions 322, 324, 326, and 328 correspond to notable changes in the pressure ratio values in figure 10, and correspond with lesions or stenosis. These regions label the starting and ending points of the notable changes in pressure ratio values for display and include plot values which indicate the change in ratio between the starting and ending points; see also page 22, lines 11-22 for display of visual representations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the visual indication of the change between starting and ending point as taught by Davies because it enables the determination of the relative position of the at least one measured stenosis in a vessel and enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Regarding claim 19, the combined references of Merritt and Davies teaches all of the limitations of claim 14. Primary reference Merritt further fails to teach:
wherein the pressure ratio curve and the label are depicted in a user interface on the display, wherein the user interface allows a user to indicate a location on an image of the vessel, and in response, the instructions when executed by the processor further cause the processor to output to the display an indicator showing a position on the pressure ratio curve that corresponds to the location on the image of the vessel
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the pressure ratio curve and the label are depicted in a user interface on the display, wherein the user interface allows a user to indicate a location on an image of the vessel, and in response, the instructions when executed by the processor further cause the processor to output to the display an indicator showing a position on the pressure ratio curve that corresponds to the location on the image of the vessel (page 22, lines 11-15, user selects visual representations which includes visual representations of measurements and images; page 22, line 16 through page 26, line 26; figures 9-13; page 25, line 26-33, user selection and annotation of the image that indicates selection on the displayed pressure ratio curve).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the visual indication of the user input position as taught by Davies because it enables the annotation of additional information observed by a user on the output image, providing increased treatment data as an output and improved diagnostic accuracy (Davies, page 25, line 26-33).
Regarding claim 20, the combined references of Merritt and Davies teaches all of the limitations of claim 19. Primary reference Merritt further fails to teach:
wherein the image of the vessel shows the position of the first pressure measurement device
However, the analogous art of Davies of a device and method of assessing the severity of a blockage in a vessel such as stenosis (abstract) teaches:
wherein the image of the vessel shows the position of the first pressure measurement device (page 4, lines 11-19, position of one or more treatment devices; figure 10, the instrument maintained in a proximal position is located at the left portion of the plot 312, and therefore the correspond figure 11-13, the proximal portion of the tracked measurement zone is the position of the first pressure measurement device that is stationary; see pages 22-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure measurement and imaging system of Merritt and Davies to incorporate the visual indication of the location of the pressure measurement device proximally as taught by Davies because it enables the determination of the relative position of the at least one measured stenosis in a vessel relative to the start of pushing of the second measurement device or ending of the pullback of the second measurement device and enables increased treatment and diagnostic accuracy (Davies, page 22, line 29 through page 23, line 13).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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/SEAN A FRITH/Primary Examiner, Art Unit 3798