DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on March 30, 2026 were received and fully considered. Claim 1 was amended. Please see corresponding rejection headings and response to arguments section below for more detail.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on March 30, 2026 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-9, 13-17, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (US PG Pub. No. 2014/0207008 A1), Kawasaki et al. (US PG Pub. No. 2009/0016483 A1) (hereinafter “Kawasaki”), and Rold et al. (US PG Pub. No. 2006/0241469 A1) (hereinafter “Rold”).
Davies and Kawasaki were applied in the previous office action.
With respect to claim 1, Davies teaches a system, comprising: processor configured for communication with an intravascular pressure-sensing guidewire and a display device (processor 172 is connected to pressure sensor 175 as depicted in Fig. 1; par.0041 “the computing device 172 includes a processor”; par.0043-44 “pressure sensor… communication with interface 176 via connection 177… facilitate communication between the one or more sensors… and the computing device 172”), wherein the processor is configured to: receive pressure measurements obtained by the intravascular pressure-sensing guidewire while the intravascular pressure-sensing guidewire is positioned within a blood vessel of a patient (par.0036 “monitor pressure within the vessel 100”; par.0037-38, 0043-44), wherein the blood vessel comprises a blockage (par.0029 “vessel 100 includes a stenosis 108… representative of any blockage or other structural arrangement that results in a restriction to the flow of fluid through the lumen 106 of the vessel 100”); output, to the display device, a screen display for a user to plan a treatment for the blockage (par.0008 “visually depicting the vessel on a display based on the obtained pressure measurements; and modifying the visual depiction of the vessel to simulate one or more treatment options”), wherein the screen display comprises: an
However, Davies does not teach output, in response to the first user input, an updated screen display, wherein the screen display comprises: an x-ray image of the blood vessel… wherein the x-ray image and the first treatment option field are displayed simultaneously in the screen display… wherein the updated screen display comprises a first change in the x-ray image to include a graphical representation of the first treatment option, wherein the graphical representation of the first treatment option is overlaid on the blood vessel in the x-ray image such that the graphical representation of the first treatment option visually depicts a length and a position of the first treatment option in the x-ray image, wherein the first treatment option field and the graphical representation of the first treatment option are displayed simultaneously in the updated screen display; and receive, via interaction with the graphical representation of the first treatment option in the x-ray image, supplementary user input that modifies at least one characteristic of the first treatment option, wherein the at least one characteristic comprises at least one of the length or the position of the first treatment option in the x-ray image, wherein, after the supplementary user input is received, the graphical representation of the first treatment option is updated in the x-ray image to reflect changes to the at least one of the length or the position of the first treatment option.
Kawasaki teaches output, in response to the first user input, an updated screen display, wherein the screen display comprises: an x-ray image of the blood vessel… wherein the x-ray image and the first treatment option field are displayed simultaneously in the screen display… wherein the updated screen display comprises a first change in the x-ray image to include a graphical representation of the first treatment option, wherein the graphical representation of the first treatment option is overlaid on the blood vessel in the x-ray image such that the graphical representation of the first treatment option visually depicts a length and a position of the first treatment option in the x-ray image, wherein the first treatment option field and the graphical representation of the first treatment option are displayed simultaneously in the updated screen display (par.0047-48 “X-ray imaging apparatus… prior to a Percutaneous Coronary Intervention (PCI) treatment…imaged based on three-dimensional volume data”; par.0049-50 “display pattern is changed in accordance with whether the plaque is present in front of or in the back of the three-dimensional blood-vessel core line with respect to a projection direction, based on the information about the positions of the three-dimensional blood-vessel core line and the plaque created before the treatment…created image of plaque-area information in a superimposed manner over an X-ray image of a blood vessel under operation of the treatment after performing position-matching…main feature configured to display during a PCI treatment an image of plaque area information of which display pattern (color, in this case) is changed in accordance with whether the plaque is present in front of or in the back of a blood-vessel core line, in a superimposed manner over an X-ray image of a blood vessel under operation of the treatment”).
Rold teaches receive, via interaction with the graphical representation of the first treatment option in the image, supplementary user input that modifies at least one characteristic of the first treatment option, wherein the at least one characteristic comprises at least one of the length or the position of the first treatment option in the image, wherein, after the supplementary user input is received, the graphical representation of the first treatment option is updated in the image to reflect changes to the at least one of the length or the position of the first treatment option (par.0020-22 “user interface 100 include control elements that allow a user to control the display of the longitudinal image 105… control elements may be buttons, keys, sliders, scrollbars, virtual keys on a touch screen, or other user actuatable devices… provide a graphical tool that allows a clinician to apply a graphical representation of a stent 160 over the longitudinal image 105 being analyzed. The clinician may be able to graphically adjust the size of the stent 160 to a desired size. One approach may be to drag a mouse pointer over a corner of the stent to adjust the size… may be desirable to provide a graphical palette 165, or a predefined library, of one or more pre-defined stents with their sizes and other characteristics in the user interface 100… the clinician may simply click on or otherwise select the desired stent within the palette 165 and drag the desired stent to a desired position on the longitudinal image 105 to determine if the selected stent is appropriate… Providing a clinician a graphical tool to simulate the length and position of a stent within the image 105 facilitates in the selection of the proper stent size and position prior to placing the actual stent, which are costly and permanent implants, within the area of interest”).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Davies’ screen display to incorporate the use of x-ray imaging, a widely known imaging technique, in the manner recited for assisting a treatment that is performed by inserting a linear structure, such as a guide wire, into a blood vessel, as evidence by Kawasaki (par.0003). Additionally, PHOSITA would have had predictable success when the invention was filed to modify Davies and Kawasaki to receive supplementary user input that modifies the graphical display, in the manner recited, in order to facilitate in the selection of the proper stent size and position prior to placing the actual stent, which are costly and permanent implants, within the area of interest, as evidence by Rold (par.0022). While Rold does not teach an x-ray image, Kawasaki provides motivation for PHOSITA to utilize an x-ray image for purposing of selecting proper treatment thereafter. For purposes of compact prosecution, Examiner cites additional references that further set forth the known nature of utilizing x-rays for treatment, stent planning, etc. See prior art of record section at the end of the current office for additional example teaching(s).
With respect to claim 2, Davies teaches and/or suggests the treatment planning related pressure value comprises at least one of a desired pressure value or a minimum pressure value (par.0061 “expected outcome can be selected by a user… adjusts the pressure differential values to meet the threshold”, which equates to a desired pressure value).
With respect to claim 3, Davies teaches and/or suggests the screen display comprises a treatment planning related pressure field, wherein the processor is further configured to receive, via the treatment planning related pressure field, a further user input comprising the treatment planning related pressure value, and wherein, after the further user input is received, the treatment planning related pressure value is displayed in the treatment planning related pressure field (par.0068+; see also Figs. 5-15).
With respect to claim 4, Davies teaches and/or suggests determine whether the first selected treatment option satisfies the treatment planning related pressure value, the processor is configured to determine, based on the pressure measurements, a first corrected pressure value expected to result from the first selected treatment option, and wherein the updated screen display further comprises the first corrected pressure value (par.0061, 68+; see also Figs. 5-15).
With respect to claim 5, Davies teaches and/or suggests wherein, to determine whether the second selected treatment option satisfies the treatment planning related pressure value, the processor is configured to determine, based on the pressure measurements, a second corrected pressure value expected to result from the second treatment option, and wherein the updated screen display further comprises the second corrected pressure value (par.0061, 68+; see also Figs. 5-15).
With respect to claim 6, Davies teaches and/or suggests the updated screen display further comprises the treatment planning related pressure value (par.0068+; see also Figs. 5-15).
With respect to claim 7, Davies teaches and/or suggests the updated screen display simultaneously provides an evaluation of the first selected treatment option and the second selected treatment option based on a visual comparison of the first corrected pressure value, the second corrected pressure value, and the treatment planning related pressure value (par.0068+; see also Figs. 5-15).
With respect to claim 8, Davies teaches and/or suggests the first selected treatment option and the second selected treatment option comprise a same treatment type with different parameter values (par.0068+; see also Figs. 5-15).
With respect to claim 9, Davies teaches and/or suggests the same treatment type comprises stenting, wherein the different parameter values correspond to at least one of stent length, stent diameter, or stent material (par.0061, 68; see also Figs. 5-15).
With respect to claim 13, Davies teaches and/or suggest the first treatment option and the second treatment option comprise different treatment types (par.0061,68; see also Figs. 5-15).
With respect to claim 14, Davies teaches and/or suggests the processor is further configured to determine, based on the pressure measurements, whether the first treatment option satisfies a treatment planning related pressure value (par.0068+; see also Figs. 5-15).
With respect to claim 15, Davies teaches wherein the processor is configured to receive, via the second treatment option field, a second user input from the user to plan the treatment, wherein the second user input comprises a selection of the second treatment option, wherein the updated screen display further comprises a second change in the
However, Davies does not teach receiving x-ray images, wherein the graphical representation of the second treatment option is overlaid on the blood vessel in the
Kawasaki teaches receiving x-ray images, wherein the graphical representation of the second treatment option is overlaid on the blood vessel in the X-ray imaging apparatus… prior to a Percutaneous Coronary Intervention (PCI) treatment…imaged based on three-dimensional volume data”; par.0049-50 “display pattern is changed in accordance with whether the plaque is present in front of or in the back of the three-dimensional blood-vessel core line with respect to a projection direction, based on the information about the positions of the three-dimensional blood-vessel core line and the plaque created before the treatment…created image of plaque-area information in a superimposed manner over an X-ray image of a blood vessel under operation of the treatment after performing position-matching…main feature configured to display during a PCI treatment an image of plaque area information of which display pattern (color, in this case) is changed in accordance with whether the plaque is present in front of or in the back of a blood-vessel core line, in a superimposed manner over an X-ray image of a blood vessel under operation of the treatment”).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Davies’ screen display to incorporate the use of x-ray imaging, a widely known imaging technique, in the manner recited for assisting a treatment that is performed by inserting a linear structure, such as a guide wire, into a blood vessel, as evidence by Kawasaki (par.0003).
With respect to claim 16, Davies teaches and/or suggests the processor is further configured to determine, based on the pressure measurements, whether the second treatment option satisfies the treatment planning related pressure value (par.0068+; see also Figs. 5-15).
With respect to claim 17, Davies teaches and/or suggests the screen display comprises a second treatment option field associated with a second treatment option, wherein, in the screen display, the second treatment option field is displayed simultaneously as the
However, Davies does not teach receiving x-ray images.
Kawasaki teaches receiving x-ray images (par.0047-48 “X-ray imaging apparatus… prior to a Percutaneous Coronary Intervention (PCI) treatment…imaged based on three-dimensional volume data”; par.0049-50 “display pattern is changed in accordance with whether the plaque is present in front of or in the back of the three-dimensional blood-vessel core line with respect to a projection direction, based on the information about the positions of the three-dimensional blood-vessel core line and the plaque created before the treatment…created image of plaque-area information in a superimposed manner over an X-ray image of a blood vessel under operation of the treatment after performing position-matching…main feature configured to display during a PCI treatment an image of plaque area information of which display pattern (color, in this case) is changed in accordance with whether the plaque is present in front of or in the back of a blood-vessel core line, in a superimposed manner over an X-ray image of a blood vessel under operation of the treatment”).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Davies’ screen display to incorporate the use of x-ray imaging, a widely known imaging technique, in the manner recited for assisting a treatment that is performed by inserting a linear structure, such as a guide wire, into a blood vessel, as evidence by Kawasaki (par.0003).
With respect to claim 21, Davies does not explicitly teach wherein the first treatment option field comprises a name of the first treatment option and an area to receive the first user input selecting the first treatment option, wherein, before the first user input is received, the area to receive the first user input is in an unselected state comprising a first visual appearance in the screen display, wherein, after the first user input is received, the area to receive the first user input is in a selected state comprising a different, second visual appearance in the updated screen display.
However, Davies also discloses the following:
[0059] While the visual representations 180, 200, 210, and 220 of FIGS. 5, 6, 7, and 8 have been described separately. It is understood that a system may display any combination of these visual representations in series, simultaneously, and/or combinations thereof. In some instances, a system provides the user the ability to select which individual visual representation and/or combination of visual representations will be displayed.
[0068] Based on information about stenosis 258, stenosis 268, and/or vessel 250 derived from visual representation 300, one or more treatment options (e.g., angioplasty, stent(s), pharmaceutical(s), etc.) can be simulated for the vessel 250. In that regard, the techniques discussed above with respect to FIG. 9 for simulating and/or evaluating treatment options for a vessel having a single lesion or stenosis can likewise be applied to vessels having multiple lesions or stenosis, as with vessel 250. FIGS. 13-15 illustrate three different treatment options for vessel 250 in accordance with embodiments of the present disclosure.
Although Davies does not explicitly teach a name of a first treatment option in an unselected state on the screen, this is implied as Davies explicitly discloses various treatment names (par.68 “angioplasty, stent(s), pharmaceuticals(s)”) can be selected for visual representation. Moreover, in the modified Davies display (that shows simultaneous visual representation and treatment options), all the treatments (disclosed in par.69) are understood to initially not be selected (before the user input is received). Additionally, Examiner argues that modifying Davies to include various unselected/selected treatment options in drop-down menu, dialogue option/button, etc. corresponding to the treatment options on the screen for the user to select would only require routine skill in the art. For purposes of compact prosecution, Examiner also cites additional reference(s) that set forth the concept of allowing a user to select treatment options (via user input) that is also displayed proximate and simultaneously with physiological information, effects, etc. See prior art cited, but not relied upon, at the end of the current office action for example teaching(s).
With respect to claims 22, Davies teaches wherein the first corrected pressure value is specific to a location of the blood vessel, wherein, in the updated screen display, the first corrected pressure value is displayed proximate to the graphical representation of the first treatment option at the location in the
However, Davies does not teach graphical representation of the first treatment option at the location in the x-ray image.
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Davies’ screen display with x-ray imaging, a widely known imaging technique, in the manner recited in for assisting a treatment that is performed by inserting a linear structure, such as a guide wire, into a blood vessel, as evidence by Kawasaki (par.0003).
With respect to claim 23, Davies teaches wherein the updated screen display further comprises an original pressure value based on the pressure measurements, wherein the original pressure value is specific to the location, wherein, in the updated screen display, the original pressure value is displayed proximate to the blood vessel at the location in
However, Davies does not teach the original pressure value is displayed proximate to the blood vessel at the location in the x-ray image.
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Davies’ screen display with x-ray imaging, a widely known imaging technique, in the manner recited in for assisting a treatment that is performed by inserting a linear structure, such as a guide wire, into a blood vessel, as evidence by Kawasaki (par.0003).
With respect to claim 24, Davies teaches wherein at least one of a numerical value of the first corrected pressure value or a numerical value of the original pressure value is displayed in the updated screen display (par.0061 “the simulated plot of the treatment options adjusts the pressure differential values”; see also par.0069-71).
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent No. 7650179
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered, but they are moot in view of the current combination of references. Please see prior art section above for more detail, updated citations (new secondary reference, Rold), and updated obviousness rationale.
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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