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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/30/2026 has been entered. Accordingly, claims 1, 4-10, 12-14, and 15 remain pending, claims 1, 5, 7, 10, 12, 14, and 15 have been amended, and claims 16-17 have been canceled.
Response to Arguments
Rejections under 35 USC 112
In light of applicant’s amendments filed 03/30/2026, the previous rejections under 112(a)and 112(b) have been rendered moot and have been withdrawn.
However, applicant’s claim amendments have introduced new clarity issues to the claims. See the rejections below.
Rejections under 35 USC 103
Applicant's arguments filed 03/30/2026 has have been fully considered but they are not persuasive.
It is noted that the header on page 10 of applicant’s response is “Claim Rejections - 35 U.S.C. § 102”, however, it is noted that the rejections of the claims were made under 35 USC 103. Applicant appears to acknowledge this, by presenting arguments directed to how “obviousness” is defined under 103 and cited the MPEP.
Applicant then argues in the fourth paragraph of page 6 through the fourth paragraph 8
“ It appears that the Office is analogizing the ‘indicator 882’ of Jenkins and Brown to the claimed ‘indicator of the minimum lumen area.’ Applicant disagrees that these are analogous and argues that the indicator 882 is more analogous to the claimed scrubber. For example, regarding the indicator 882, Jenkins teaches that the ‘image 810 may include an indicator 882. The graphical user interface 800 additionally includes the IVUS image 840 displayed adjacent to the x-ray image 810. The indicator 882 may identify to the user of the system 100 the location along the guidewire 890 or pathway 830 at which the IVUS image 840 was obtained.’ Thus, the indicator 882 is analogous to the scrubber or the location of the scrubber. For example, incorporating the teachings of Jenkins into the device of Cohen would result in indicator 882 disposed on an angiogram and linked to the scrubber 726 such that these two icons move in tandem. However, nothing within the disclosure of Jenkins teaches that the indicator 720 for the minimum lumen area of Cohen is moveable by the scrubber as claimed. At best is teaches that the scrubber itself of Cohen (e.g., scrubber 726) can be moved by another scrubber disposed on a pathway (e.g., pathway 830) over an angiogram. This is not at all what is claimed…”.
As a preliminary matter, applicant is reminded that “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). (See MPEP 2145(X)(D)(1)).
Applicant’s remarks above characterize the field of endeavor more narrowly than is appropriate. As noted in In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009), “This court cannot, in the face of KSR, cling to formalistic rules for obviousness, customize its legal tests in specific scientific fields in a way that deem entire classes of prior art teachings irrelevant, or discount significant abilities of artisans of ordinary skill in an advanced area of art”.
In response to applicant's argument that the indicator of secondary reference Jenkins is nonanalogous art, it has been held that a prior art reference must either be in the field of applicant' s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, indicator 882 of secondary reference Jenkins is the scrubber, indicator 862 which corresponds to indicator 872 for the MKA via overlap of indicator 876 corresponds to the MLA. See [0083], [0107]-[0116], [0120], [0149], [0165], FIG. 8, of secondary reference Jenkins.
It is noted that the arguments presented are unsupported by objective evidence. Applicant is reminded that arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Objections
Claim 8 is objected to because of the following informalities: the limitation “wherein the processor is configured to identify a second minimum lumen area…” in lines 1-2 should be amended in kind with the presently presented amendments to recite “wherein the processor is configured to identify a position of a second minimum lumen area…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10 and 14 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 10 recites the limitations "the catheter" and "the imaging device" in lines 3, 6-7. There are insufficient antecedent bases for these limitations in the claim. The claim does not prior recite a catheter nor an imaging device. It is unclear if the catheter recited in line 3 as being coupled to the processor is the same as the imaging catheter recited earlier in the claim in line 2. Similarly, it is unclear if the imaging device in lines 6-7 are meant to refer to the imaging catheter recited earlier in the claim in line 2.
All dependent claims are also rejected by the nature of their dependency.
Claim 14 has been amended to recite “wherein a position of the processor is configured to identify a second minimum lumen area along…” in lines 1-3, which renders the claim indefinite because it is unclear how the geographical placement or the physical location of the processing device is functionally capable to identify the second minimum lumen area. It appears, although it is unclear, that applicant meant to amend the claim to instead recite “wherein the processor is configured to identify a position of a second minimum lumen area along…”. If applicant meant to amend the claim to recite the latter, applicant should amend claim 14 to reflect the correction.
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.
Claim(s) 1, 4-10, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. (US20200029932, hereafter “Cohen”), in view of Jenkins et al. (US20240245465, hereafter “Jenkins”)ꝉ.
ꝉSupported by the disclosure of Brown et al. (US20240245390, hereafter “Brown”).
Regarding claims 1 and 10, Cohen discloses intravascular imaging systems (FIG. 1), comprising:
a catheter (see 102 in FIG. 1), the catheter configured to be inserted into a blood vessel of a patient ([0031], [0034] catheter 102 is configured for insertion into a vessel);
a processor coupled to a catheter (see 106 in FIG. 1),
the processor configured to process imaging data received from the imaging catheter ([0039] processor 106 receives echo signals where the ultrasound image is reconstructed and then displayed on the monitor), the imaging data generated while the imaging device is within the blood vessel ([0008], abstract the two or more images of the body lumen to their corresponding locations within the body lumen that is acquired from the catheter inside the lumen of the blood vessel);
wherein the processor is configured to generate a longitudinal section view of the blood vessel from the imaging data ([0053] see FIG. 6 having imaging data corresponding to a straight you down the lumen otherwise discussed as being a longitudinal view);
wherein the processor is configured to identify a minimum lumen area position along the longitudinal section view of the blood vessel ([0056] automatic measurements shown in FIG. 6 include a minimum lumen area), a distal reference point (see 830 in FIG. 7), and a proximal reference point (see 832 in FIG. 7);
a display unit coupled to the processor (see monitor 108 in FIG. 1), the display unit being configured to show a display ([0039] image data reconstructed by the processor is displayed on the display); and
wherein a position of the indicator of the minimum lumen area is movable along the longitudinal section view of the blood vessel by a user ([0061], FIG. 9, the MLA may be manually moved by the user to be displayed along any position on the lumen).
And with specific regard to claim 1, Cohen discloses the catheter including an imaging device (see 102 in FIG. 1); and
the display including the longitudinal section view of the blood vessel (see longitudinal view displayed in FIGS. 6-9), a scrubber icon disposed in a location along the longitudinal section view of the blood vessel ([0061], FIG. 9, the indicator 726 represents a scrubber is movable by a user to view different views along the along the longitudinal section view of the blood vessel/lumen), and a transverse cross-sectional image corresponding to the location ([0061] see the transverse cross-sectional image view 709 corresponding to the location), and an indicator of the minimum lumen area position (see 614 in FIG. 7; 720 in FIG. 9).
And with specific regard to claim 10, Cohen discloses an imaging catheter (see 102 in FIG. 1);
wherein the processor is configured to identify a minimum lumen area position along the longitudinal section view of the blood vessel ([0056] automatic measurements shown in FIG. 6 include a minimum lumen area), a distal reference point (see 830 in FIG. 7) disposed distal of the minimum lumen area position, and a proximal reference point (see 832 in FIG. 7) disposed proximal of the minimum lumen area position ([0057] see as outlined in FIG. 7); and
wherein the display includes an indicator of the minimum lumen area position (see 614 in FIG. 7), an indicator of the distal reference point (see 830 in FIG. 7), and an indicator of the proximal reference point along the longitudinal section view of the blood vessel (see 832 in FIG. 7).
While Cohen discloses the scrubber icon being displayed on the longitudinal section view as cited above, Cohen is silent on the position of the minimum lumen area being movable along the longitudinal section view of the blood vessel by a user as being via the scrubber icon.
However, in the same field of endeavor, Jenkins teaches wherein a position of the minimum lumen area is movable along the longitudinal section view of the blood vessel by a user via the scrubber icon ([0083], [0107]-[0116], [0120], [0149], [0165], FIG. 8, data acquired is intravascular data, i.e., IVUS images, then the user may input any commands to the system 100 via a mouse, a mouse click, cursor, pointer, joystick, physical button, pressure of depressing a physical button, a control pad, finger or touch of the finger on a screen, with a stylus or touch of a stylus on a screen, or by any other means, including but not limited to, the user may select and drag the indicator or annotations that mark IVUS images to move the location of the indicator, which each IVUS image may display a region along the imaged vessel with greatest constriction, a minimum lumen area and/or maximal venous compression, a minimum lumen diameter, bookmark 872 may be placed within the x-ray image 810 corresponding to the bookmark 876, indicator 862 then moves to the location of the bookmark 876 on the ILD 850, the bookmarks are adjusted in real time by the user, where indicator 862 displayed on the ILD 850 may be of any suitable appearance or positioned at any suitable location inclusive of the MLA and indicator 882 is to a different location in response to the touch input provided by the user so that the indicator 882 is moved to the different location, in response, the indicator 862 is then moved to the corresponding location along the ILD 850 and the IVUS image acquired at the new location may be displayed inclusive of a new MLA; please note: indicators 882 and 862 may each be referred to as a scrubber, marker, marking, pointer, or by any other suitable term; the indicator/scrubber 882 in FIG. 8 corresponding to the position of the MLA 872 and scrubber 862, the indicator 865 is moved to a different location, the indicator 882 may be moved to the corresponding location, see FIGS. 8-10 in Brown which correspond to FIGS. 8-10, which correspond to FIG. 8 of Jenkins as FIGS. 8-10 show reference numerals for the slider 862 in higher resolution).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the intravascular systems disclosed by Cohen with the position of the minimum lumen area being movable along the longitudinal section view of the blood vessel by a user as being via the scrubber icon for as taught by Jenkins in order to provide the physician with the location of the treatment device relative to other previously marked locations, such as areas of occlusions or lesions, or surrounding structures in addition to providing the physician with the ability to quickly view IVUS images of any location along the vessel being treated, including IVUS images of the current location of the treatment device ([0005] of Jenkins).
And specifically, with regard to claims 4-5 and 12, Cohen, substantially discloses all the limitations of the claimed invention, specifically Cohen discloses wherein the display includes an indicator of the distal reference point and a position of the indicator of the distal reference point is movable along the longitudinal section view of the blood vessel by a user ([0061], FIG. 9, the distal reference point may be manually moved by the user to be displayed along any position on the lumen).
And specifically, with regard to claims 6-7 and 13, Cohen, substantially discloses all the limitations of the claimed invention, specifically Cohen discloses wherein the display includes an indicator of the proximal reference point and a position of the indicator of the proximal reference point is movable along the longitudinal section view of the blood vessel by a user ([0061], FIG. 9, the proximal reference point may be manually moved by the user to be displayed along any position on the lumen).
Regarding claim 8, Cohen, substantially discloses all the limitations of the claimed invention, specifically Cohen discloses wherein the processor is configured to identify a second minimum lumen area along the longitudinal section view of the blood vessel ([0057] after the processor generates data to identify the plaque burden which has been automatically measured by the processor, the marker for the MLA is placed at the location where the plaque burden is the highest and the lumen is the smallest).
Regarding claims 9 and 15, Cohen, substantially discloses all the limitations of the claimed invention, specifically Cohen discloses wherein the processor is configured to identify a secondary reference point along the longitudinal section view of the blood vessel ([0052], FIG. 5 the imaging data may show other reference data [secondary reference] areas [point(s)] along the lumen).
Regarding claim 14, Cohen, substantially discloses all the limitations of the claimed invention, specifically Cohen discloses wherein a position of the processor is configured to identify a second minimum lumen area along the longitudinal section view of the blood vessel ([0057] after the processor generates data to identify the plaque burden which has been automatically measured by the processor, the marker for the MLA is placed at the location where the plaque burden is the highest and the lumen is the smallest).
Claim(s) 22-23 is rejected under 35 U.S.C. 103 as being unpatentable over Cohen, in view of Jenkins, as applied to claims 1 and 10 above, further in view of Liu et al. (US20150157295, hereafter “Liu”).
Regarding claim 22 and 23, Cohen, in view of Jenkins, substantially discloses all the limitations of the claimed invention, specifically Cohen discloses wherein the processor is configured to:
receiving a long hold action on the scrubber icon ([0061], [0077], a user moves the scrubber icon 726 to view different views along the lumen which is shown in transverse view 709, the user moves the scrubber icon/indicator 726 by sliding an indicator along a longitudinal image of the lumen; therefore, under the broadest reasonable interpretation, the term sliding is interpreted to read on the limitation of a “long press action”, since the scrubber has to be selected/pressed for an extended action in order to functionally slide the scrubber icon along the longitudinal section view);
displaying a text box comprising options corresponding to the minimum lumen area, the distal reference point, and the proximal reference point ([0061], FIG.9, text box 853 displays data corresponding to the entire lumen or a portion of the lumen, such as MLA, average diameter, minimum area, maximum area, and other data; therefore, under the broadest reasonable interpretation, the other data is interpreted to read on being also inclusive of the distal reference point and the proximal reference point);
receiving, via the text box, a selection of the minimum lumen area ([0061], [0071], [0075]-[0077], FIGS. 9, 14, the guided workflow may be provided as a series of prompts, instructions, and visualizations that are displayed on a display device, such as but not limited to in prompt/step 1414 for displaying the imaging data on a display device including two to more views of the lumen showing different areas along the vessel, such as a MLA, MSA, and proximal and distal reference points. This step includes on the display device are a plurality of views including but not limited to the transverse view 704 which shows a distal end of an area of interest, the transverse view 706 shows a proximal end of the area of interest, the transverse view 708 shows an MLA of the lumen, and the transverse view 709 is manually moved by a user to display any position along the lumen, therefore, the cited disclosure of “any position along the lumen” is interpreted under the broadest reasonable interpretation to be inclusive of the distal end, the proximal end, and the MLA of the lumen); and
adjusting, responsive to the selection, the position of the minimum lumen area ([0069], [0077] the operator selects various views for comparison, for example by sliding an indicator along a longitudinal image of the lumen and the operator may be able to select any of the indicators on the longitudinal views and drag the indicators to view imaging data on neighboring frames; therefore, under the broadest reasonable interpretation, the cited disclosure by selecting any one of the indicators and dragging the indicators to a neighboring frame, reads on the limitation of the adjusting of the position of the MLA, distal and proximal reference points, which, brim may correspond to the location of the scrubber icon); and specifically, Jenkins discloses receiving a long press action via the scrubber icon ([0110] the user selects and drag the indicator/scrubber icon 862 to different locations along the ILD 850, the user may use a mouse to click on a location, or via a mouse, a mouse click, cursor, pointer, joystick, physical button, pressure of depressing a physical button, a control pad, finger or touch of the finger on a screen, with a stylus or touch of a stylus on a screen, or by any other means, the user may move the indicator 862 to different locations along the ILD 850); but does not explicitly disclose the text box as being a popup.
However, in solving the same problem, Liu discloses in response to a long press action, a popup graphic being displayed on the display of an ultrasound device ([0022] the user may make a long push by push button, in response, on the display, the display pops up a menu with operating buttons, each of the buttons related to at least one function).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by Cohen with the display and receipt of input being via a popup graphic as taught by Liu in order for the user easily operating the ultrasound system or processing the image ([0021] of Liu).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SHAFQAT whose telephone number is (571)272-4054. The examiner can normally be reached Monday-Friday 9:30AM-5:30PM MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.S./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
Prosecution Insights