DETAILED ACTION
This office action is in response to the communication received on 11/12/2025 concerning application no. 17/790,579 filed on 07/01/2022.
Claims 1-2, 11, 13, and 15-17 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/05/2025 has been entered.
Claims 1-2, 11, 13, and 15-17 are pending.
Response to Arguments
Applicant's arguments filed 11/12/2025 have been fully considered but they are not persuasive.
Regarding the 103 rejection, Applicant argues that the combination of Kunio and Hoffman does not address the assessment for each of the number of intravascular images that are specified. Applicant argues that Kunio only evaluates individual frames. Applicant argues Hoffman only compares mean values and across the segments and not individually.
Examiner disagrees. 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). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the use of a mean value and the assessment of individualized images) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant’s arguments appear to contradict each other as in the case of Kunio, Applicant alleges that the use of individual image assessment is unsatisfactory, but in the case of Hoffman, Applicant argues that the reference is insufficient as it does not address individual image assessment. Regardless, as noted above, the individualization of the image analysis is not present in the claim. In the case of Kunio, Paragraph 0098 teaches that the frames are assessed outside the stent region and is not in an overlapped region. Fig. 9 shows an interactive process that considers all frames. Paragraph 0052 teaches that the stenting status can be evaluated and assigned for each image frame. With Hoffman, Fig. 1 shows the segments that are analyzed for the assessment of the stent status. The segments include regions in and out of the stent along the longitude of the vessel. Fig. 3 shows the assessment of the lumen throughout the segments. The regions outside the stent in the distal and proximal areas beyond the stent are shown to be greater than the lumen with the stenting. The assessment is done with respect CSA. Furthermore, Applicant’s argument that Hoffman is a mean value is unpersuasive as the plot still clearly shows each image’s CSA with respect to the stented region and shows it to be greater than the stented lumen. MPEP 716.01(c) establishes “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).” Applicant is reminded that Buccheri is a motivational reference.
Examiner maintains the rejection.
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 1-2, 11, 13, and 15-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite for the following reasons:
Recites “wherein the stent extends partially along the length of the blood vessel”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the positioning to the stenting is in the vessel such that is partially along the length. Stents are commonly understood in the art to be placed in their entirety in the vasculature to address issues of plaque narrowing vasculature.1
Applicant is encouraged to provide consistent and clear language.
Recites “a specified number of second intravascular images representative of the outside of the stent”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art in what manner that the second intravascular images are specified. One interpretation is that they are the images located outside the stent. Another interpretation is that they are user determined. Another interpretation is that the specifying of the images is according to an algorithmic approach.
Applicant is encouraged to provide consistent and clear language.
Recites “detect under-dilation at the edge of the stent by determining that the second measurement of the outside of the stent exceeds the first measurement of the edge of the stent for each of the specified number of second intravascular images”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art in what manner the assessment of a measure of an area without the stent would provide a dispositive indication that the stent is under-dilated. That is, given that the stent is not within the region, the stent’s status would not be provided by regions outside the region.
Applicant is encouraged to provide consistent and clear language.
Claim 2 is indefinite for the following reasons:
The term “smoothed representation” is a relative term which renders the claim indefinite. The term “smoothed” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It would be unclear to one with ordinary skill in the art what degree of sampling and graphing constitutes as “smoothed”. It would be further unclear what “smoothed” is referring to in the graphical representation as it is an indication of the state of the data.
Claim 11 is indefinite for the following reasons:
Recites “wherein the processor circuit is configured to detect the under-dilation by determining that the second measurement of the outside of the stent exceeds the first measurement of the edge of the stent by more than a threshold amount”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art in what manner the assessment of a measure of an area without the stent would provide a dispositive indication that the stent is under-dilated. That is, given that the stent is not within the region, the stent’s status would not be provided by regions outside the region.
Applicant is encouraged to provide consistent and clear language.
Claim 13 is indefinite for the following reasons:
Recites “the second graphical representation”. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 is indefinite for the following reasons:
Recites “the stent extends partially along the length of the blood vessel”. This claim element is indefinite. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the positioning to the stenting is in the vessel such that is partially along the length. Stents are commonly understood in the art to be placed in their entirety in the vasculature to address issues of plaque narrowing vasculature.2
Applicant is encouraged to provide consistent and clear language.
Recites “a specified number of second intravascular images representative of the outside of the stent”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art in what manner that the second intravascular images are specified. One interpretation is that they are the images located outside the stent. Another interpretation is that they are user determined. Another interpretation is that the specifying of the images is according to an algorithmic approach.
Applicant is encouraged to provide consistent and clear language.
Recites “detecting under-dilation at the edge of the stent by determining that the second measurement of the outside of the stent exceeds the first measurement of the edge of the stent for each of the specified number of second intravascular images”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art in what manner the assessment of a measure of an area without the stent would provide a dispositive indication that the stent is under-dilated. That is, given that the stent is not within the region, the stent’s status would not be provided by regions outside the region.
Applicant is encouraged to provide consistent and clear language.
Claim 16 is indefinite for the following reasons:
Recites “the first graphical representation”. There is insufficient antecedent basis for this limitation in the claim.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 11, 13, and 15-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite an intravascular imaging system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “identify, from among the plurality of intravascular images, a first intravascular image representative of an edge of the stent; determine, using the first intravascular image, a first measurement of the edge of the stent; identify, from among the plurality of intravascular images, a specified number of second intravascular images representative of the outside of the stent; determine a second measurement of the outside of the stent for each of the specified number of second intravascular images; detect under-dilation at the edge of the stent by determining that the second measurement of the outside of the stent exceeds the first measurement of the edge of the stent for each of the specified number of second intravascular images; and wherein the first measurement of the edge of the stent and the second measurement of the outside of the stent each comprise an area measurement or a diameter measurement”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to identification of the measurement of the edge of the stent and parts outside the stent that is then used to detect under dilation at the edge of the stent and the measurements are area or diameter measurements. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “an intravascular imaging catheter comprising at least one of an intravascular ultrasound (IVUS) catheter or an optical coherence tomography (OCT) catheter; and a processor circuit configured for communication with the intravascular imaging catheter, wherein the processor circuit configured to: control the intravascular imaging catheter to obtain a plurality of intravascular images while the intravascular imaging catheter is positioned inside a blood vessel with an expansion of a stent providing a treatment for a blockage in the blood vessel, wherein the plurality of intravascular images is obtained along a length of the blood vessel, wherein the stent extends partially along the length of the blood vessel such that: a first portion of the length of blood vessel includes the stent, and a second portion of the length of the blood vessel includes an outside of the stent, provide, to a display in communication with the processor circuit, an output associated with a change in the expansion of the stent to correct the under-dilation”. Acquisition of the images of the stent and outside the stent via an imaging catheter is a data gathering step that is a form of a pre-solution insignificant activity. Display of the output associated with a change in expansion is a display step that merely amounts to a post-solution insignificant activity. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 1 is ineligible.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite an intravascular imaging system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “determine a measurement in each image of the plurality of intravascular images, thereby resulting in a plurality of measurements along the length of the blood vessel, wherein the plurality of measurements comprises the first measurement of the edge of the stent and the second measurement of the outside of the stent for each of the specified number of second intravascular images; and generate a first graphical representation of the plurality of measurements, wherein the output comprises: the first graphical representation; and a second graphical representation indicating the under-dilation along the first graphical representation”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to determining the measurements and using that as the basis to generate a graphical representation. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor circuit is configured to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 17 is ineligible.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite an intravascular imaging system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein the first graphical representation comprises a smoothed representation of the plurality of measurements”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the generation of a smooth graphical representation. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 2 is ineligible.
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “detect the under-dilation by determining that the second measurement of the outside of the stent exceeds the first measurement of the edge of the stent by more than a threshold amount”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the detection of under dilation by thresholding the measurements. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor circuit is configured to detect”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 11 is ineligible.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “to co-register the plurality of intravascular images to a plurality of locations along the length of the blood vessel in the extravascular image”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to co-registration of intravascular images with respect to an extravascular image. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processor circuit is configured to receive an extravascular image of the blood vessel and…, wherein the output comprises the extravascular image, and wherein the second graphical representation comprises an indication of the under-dilation along the length of the vessel in the extravascular image”. The reception of the extravascular images is a data gathering step that is a form of a pre-solution insignificant activity. Output of the representation is a display step that merely amounts to a post-solution insignificant activity. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 13 is ineligible.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite an intravascular imaging method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “identify, from among the plurality of intravascular images, a first intravascular image representative of an edge of the stent; determining, using the first intravascular image, a first measurement of the edge of the stent; identifying, from among the plurality of intravascular images, a specified number of second intravascular images representative of the outside of the stent; determining a second measurement of the outside of the stent for each of the specified number of second intravascular images; detecting under-dilation at the edge of the stent by determining that the second measurement of the outside of the stent exceeds the first measurement of the edge of the stent for each of the specified number of second intravascular images; and wherein the first measurement of the edge of the stent and the second measurement of the outside of the stent each comprise an area measurement or a diameter measurement”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to identification of the measurement of the edge of the stent and parts outside the stent that is then used to detect under dilation at the edge of the stent and the measurements are area or diameter measurements. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “controlling, with a processor circuit, an intravascular imaging catheter to obtain a plurality of intravascular images while the intravascular imaging catheter is positioned inside a blood vessel with an expansion of a stent providing a treatment for a blockage in the blood vessel, wherein the plurality of intravascular images is obtained along a length of the blood vessel, wherein the stent extends partially along the length of the blood vessel such that: a first portion of the length of blood vessel includes the stent; and a second portion of the length of the blood vessel includes an outside of the stent, providing, to a display in communication with the processor circuit, an output associated with a change in the expansion of the stent to correct the under-dilation”. Acquisition of the images of the stent and outside the stent via an imaging catheter is a data gathering step that is a form of a pre-solution insignificant activity. Display of the output associated with a change in expansion is a display step that merely amounts to a post-solution insignificant activity. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 15 is ineligible.
Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein the first graphical representation comprises a curve of the plurality of measurements”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to generation of a graphical curve. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 16 is ineligible.
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 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.
Claims 1-2, 13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kunio et al. (PGPUB No. US 2019/0099080) in view of Hoffman et al. ("Patterns and Mechanisms of In-Stent Restenosis", 1996) as supported by Buccheri et al. ("Understanding and managing in-stent restenosis: a review of clinical data, from pathogenesis to treatment", 2016).
Regarding claim 1, Kunio teaches an intravascular imaging system, comprising:
an intravascular imaging catheter comprising at least one of an intravascular ultrasound (IVUS) catheter or an optical coherence tomography (OCT) catheter (Paragraph 0045 teaches that the intravascular image system can be an intravascular ultrasound (IVUS) system, optical coherence tomography (OCT) system or multi-modality OCT (MM-OCT) system); and
a processor circuit configured for communication with the intravascular imaging catheter (Paragraph 0045 teaches the operation of a processor), wherein the processor circuit configured to:
control the intravascular imaging catheter to obtain a plurality of intravascular images while the intravascular imaging catheter is positioned inside a blood vessel with an expansion of a stent providing a treatment for a blockage in the blood vessel, wherein the plurality of intravascular images is obtained along a length of the blood vessel, wherein the stent extends partially along the length of the blood vessel such that (Paragraph 0045 teaches that the processor receives imaging signals from the optical system and performs steps of image processing and control of information to be displayed. Abstract teaches that the stenting is performed and imaged for evaluation. Paragraph 0101 teaches the display on a GUI for the longitudinal view of the intravascular image. Fig. 26 shows the longitudinal length of the vessel with and without the stent):
a first portion of the length of blood vessel includes the stent, and a second portion of the length of the blood vessel includes an outside of the stent (Paragraph 0101 teaches the display on a GUI for the longitudinal view of the intravascular image. Fig. 26 shows the longitudinal length of the vessel with and without the stent),
identify, from among the plurality of intravascular images, a first intravascular image representative of an edge of the stent (Paragraph 0065 teaches that the images with the stent struts are assessed);
determine, using the first intravascular image, a first measurement of the edge of the stent (Paragraph 0052 teaches that the stenting status for each of the images is assessed and classifying according to Table 1 which shows the consideration of malapposition. Paragraph 0053 teaches if the stent is malposed and not well-expanded, the stent might be undersized or improperly expanded);
identify, from among the plurality of intravascular images, a specified number of second intravascular images representative of the outside of the stent (Paragraph 0052 teaches that the stenting status for each of the images is assessed and classifying according to Table 1 which shows the consideration of malapposition. Paragraph 0053 teaches if the stent is malposed and not well-expanded, the stent might be undersized or improperly expanded. Paragraph 0098 teaches that the frames are assessed outside the stent region and is not in an overlapped region. Fig. 9 shows an interactive process that considers all frames. Paragraph 0052 teaches that the stenting status can be evaluated and assigned for each image frame);
determine a second measurement of the outside of the stent for each of the specified number of second intravascular images (Paragraph 0052 teaches that the stenting status for each of the images is assessed and classifying according to Table 1 which shows the consideration of malapposition. Paragraph 0053 teaches if the stent is malposed and not well-expanded, the stent might be undersized or improperly expanded. Paragraph 0098 teaches that the frames are assessed outside the stent region and is not in an overlapped region. Fig. 9 shows an interactive process that considers all frames. Paragraph 0052 teaches that the stenting status can be evaluated and assigned for each image frame);
detect under-dilation at the edge of the stent by determining that the second measurement of the outside of the stent exceeds the first measurement of the edge of the stent for each of the specified number of second intravascular images (Paragraph 0008 teaches that the stent malapposition can be determined at multiple locations throughout the range of the stent. Paragraph 0050 teaches where the distance to the lumen is greater than the distance to the stent strut, there is malapposition. This is done based on the assessment of the area. Paragraph 0052 teaches that the stenting status for each of the images is assessed and classifying according to Table 1 which shows the consideration of malapposition. Paragraph 0053 teaches if the stent is malposed and not well-expanded, the stent might be undersized or improperly expanded. See Figs. 4, 12, and 19. Paragraph 0098 teaches that the frames are assessed outside the stent region and is not in an overlapped region. Fig. 9 shows an interactive process that considers all frames. Paragraph 0052 teaches that the stenting status can be evaluated and assigned for each image frame); and
provide, to a display in communication with the processor circuit, an output associated with a change in the expansion of the stent to correct the under-dilation (Paragraph 0054 teaches that the stent expansion information is detected and displayed. See Fig. 26),
wherein the first measurement of the edge of the stent and the second measurement of the outside of the stent each comprise an area measurement or a diameter measurement (Paragraphs 0069-0071 teaches the consideration of the lumen area and the stent areas. Paragraph 0089 teaches the determination and indication of the lumen diameter).
However, Kunio is silent regarding an intravascular imaging system, comparison of the edge of the stent for each of the specified number of second intravascular images with images outside the stent for purposes of assessment of under-dilation.
In an analogous imaging field of endeavor, regarding the IVUS imaging of blood vessels, Hoffman teaches an intravascular imaging system, detect under-dilation at the edge of the stent by determining that the second measurement of the outside of the stent exceeds the first measurement of the edge of the stent for each of the specified number of second intravascular images (Fig. 1 shows the segments that are analyzed for the assessment of the stent status. The segments include regions in and out of the stent along the longitude of the vessel. Fig. 3 shows the assessment of the lumen throughout the segments. The regions outside the stent in the distal and proximal areas beyond the stent are shown to be greater than the lumen with the stenting. The assessment is done with respect CSA).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Kunio with Hoffman’s teaching of the consideration of lumen measurements outside the stent for the assessment of stenting effectiveness. Given that it is well-known that under-dilation causes restenosis, as evidenced by Table 2 of Buccheri, it would be obvious to one with ordinary skill in the art that the formation of restenosis is indicative of stenting being under expanded and thereby resulting in inadequate treatment. Furthermore, Kunio already teaches the assessment of under-expansion of the stenting with respect to the lumen diameters and consideration for each image frame. Given this, it would be clear to one with ordinary skill in the art that the under-expansion can be considered according to regions outside the stenting area as discussed by Hoffman as it teaches the assessment of the areas outside the stenting area in both the proximal and distal directions. This modified apparatus would allow a user to assess failures of treatment strategies and thereby prevent restenosis (Conclusion of Hoffman). Furthermore, the modification would allow for the combining an endovascular prosthesis (to withstand remodeling forces) and a pharmacological agent (to inhibit cellular proliferation) (Conclusion of Hoffman). Additionally, the modification ensures the improvement of stenting outcomes as the stenting expansion information can be displayed (Paragraph 0043 of Kunio).
Regarding claim 17, modified Kunio teaches the intravascular imaging system in claim 1, as discussed above.
Kunio further teaches an intravascular imaging system, wherein the processor circuit is configured to:
determine a measurement in each image of the plurality of intravascular images, thereby resulting in a plurality of measurements along the length of the blood vessel, wherein the plurality of measurements comprises the first measurement of the edge of the stent and the second measurement of the outside of the stent for each of the specified number of second intravascular images (Paragraph 0008 teaches that the stent malapposition can be determined at multiple locations throughout the range of the stent. Paragraph 0050 teaches where the distance to the lumen is greater than the distance to the stent strut, there is malapposition. This is done based on the assessment of the area. Paragraph 0052 teaches that the stenting status for each of the images is assessed and classifying according to Table 1 which shows the consideration of malapposition. Paragraph 0053 teaches if the stent is malposed and not well-expanded, the stent might be undersized or improperly expanded. See Figs. 4, 12, and 19. Paragraph 0098 teaches that the frames are assessed outside the stent region and is not in an overlapped region. Fig. 9 shows an interactive process that considers all frames. Paragraph 0052 teaches that the stenting status can be evaluated and assigned for each image frame); and
generate a first graphical representation of the plurality of measurements, wherein the output comprises:
the first graphical representation (Paragraph 0101 teaches that the GUI can show the stent edge. Fig. 26 shows the lumen and the stent boundaries shown together and with respect to one another. Paragraph 0054 teaches that the stent expansion information is detected and displayed. See Fig. 26); and
a second graphical representation indicating the under-dilation along the first graphical representation (See Fig. 26).
However, Kunio is silent regarding an intravascular imaging system, comparison of the edge of the stent for each of the specified number of second intravascular images with images outside the stent for purposes of assessment of under-dilation.
In an analogous imaging field of endeavor, regarding the IVUS imaging of blood vessels, Hoffman teaches an intravascular imaging system, wherein the plurality of measurements comprises the first measurement of the edge of the stent and the second measurement of the outside of the stent for each of the specified number of second intravascular images (Fig. 1 shows the segments that are analyzed for the assessment of the stent status. The segments include regions in and out of the stent along the longitude of the vessel. Fig. 3 shows the assessment of the lumen throughout the segments. The regions outside the stent in the distal and proximal areas beyond the stent are shown to be greater than the lumen with the stenting. The assessment is done with respect CSA).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Kunio with Hoffman’s teaching of the consideration of lumen measurements outside the stent for the assessment of stenting effectiveness. Given that it is well-known that under-dilation causes restenosis, as evidenced by Table 2 of Buccheri, it would be obvious to one with ordinary skill in the art that the formation of restenosis is indicative of stenting being under expanded and thereby resulting in inadequate treatment. Furthermore, Kunio already teaches the assessment of under-expansion of the stenting with respect to the lumen diameters and consideration for each image frame. Given this, it would be clear to one with ordinary skill in the art that the under-expansion can be considered according to regions outside the stenting area as discussed by Hoffman as it teaches the assessment of the areas outside the stenting area in both the proximal and distal directions. This modified apparatus would allow a user to assess failures of treatment strategies and thereby prevent restenosis (Conclusion of Hoffman). Furthermore, the modification would allow for the combining an endovascular prosthesis (to withstand remodeling forces) and a pharmacological agent (to inhibit cellular proliferation) (Conclusion of Hoffman). Additionally, the modification ensures the improvement of stenting outcomes as the stenting expansion information can be displayed (Paragraph 0043 of Kunio).
Regarding claim 2, modified Kunio teaches the intravascular imaging system in claim 17, as discussed above.
Kunio further teaches an intravascular imaging system, wherein the first graphical representation comprises a smoothed representation of the plurality of measurements (Paragraph 0101 teaches that the GUI can show the stent edge. Fig. 26 shows the lumen and the stent boundaries shown together and with respect to one another. Paragraph 0054 teaches that the stent expansion information is detected and displayed. See Fig. 26).
Regarding claim 13, modified Kunio teaches the intravascular imaging system in claim 1, as discussed above.
Kunio further teaches an intravascular imaging system, wherein the processor circuit is configured to receive an extravascular image of the blood vessel and to co-register the plurality of intravascular images to a plurality of locations along the length of the blood vessel in the extravascular image (Paragraph 0101 teaches that the angiographic image can be co-registered with the intravascular image. See Fig. 26),
wherein the output comprises the extravascular image (Fig. 26 shows the angiographic image), and
wherein the second graphical representation comprises an indication of the under-dilation along the length of the vessel in the extravascular image (Paragraph 0101 teaches that the angiographic image indicates the selected and modified location. Fig. 26 shows the variation in the lumen width).
Regarding claim 15, Kunio teaches an intravascular imaging method, comprising:
controlling, with a processor circuit, an intravascular imaging catheter to obtain a plurality of intravascular images while the intravascular imaging catheter is positioned inside a blood vessel with an expansion of a stent providing a treatment for a blockage in the blood vessel, wherein the plurality of intravascular images is obtained along a length of the blood vessel, wherein the stent extends partially along the length of the blood vessel such that (Paragraph 0045 teaches that the intravascular image system can be an intravascular ultrasound (IVUS) system, optical coherence tomography (OCT) system or multi-modality OCT (MM-OCT) system. Paragraph 0045 teaches that the processor receives imaging signals from the optical system and performs steps of image processing and control of information to be displayed. Abstract teaches that the stenting is performed and imaged for evaluation. Paragraph 0101 teaches the display on a GUI for the longitudinal view of the intravascular image. Fig. 26 shows the longitudinal length of the vessel with and without the stent):
a first portion of the length of blood vessel includes the stent; and a second portion of the length of the blood vessel includes an outside of the stent (Paragraph 0101 teaches the display on a GUI for the longitudinal view of the intravascular image. Fig. 26 shows the longitudinal length of the vessel with and without the stent),
identify, from among the plurality of intravascular images, a first intravascular image representative of an edge of the stent (Paragraph 0065 teaches that the images with the stent struts are assessed);
determining, using the first intravascular image, a first measurement of the edge of the stent (Paragraph 0052 teaches that the stenting status for each of the images is assessed and classifying according to Table 1 which shows the consideration of malapposition. Paragraph 0053 teaches if the stent is malposed and not well-expanded, the stent might be undersized or improperly expanded);
identifying, from among the plurality of intravascular images, a specified number of second intravascular images representative of the outside of the stent (Paragraph 0052 teaches that the stenting status for each of the images is assessed and classifying according to Table 1 which shows the consideration of malapposition. Paragraph 0053 teaches if the stent is malposed and not well-expanded, the stent might be undersized or improperly expanded. Paragraph 0098 teaches that the frames are assessed outside the stent region and is not in an overlapped region. Fig. 9 shows an interactive process that considers all frames. Paragraph 0052 teaches that the stenting status can be evaluated and assigned for each image frame);
determining a second measurement of the outside of the stent for each of the specified number of second intravascular images (Paragraph 0052 teaches that the stenting status for each of the images is assessed and classifying according to Table 1 which shows the consideration of malapposition. Paragraph 0053 teaches if the stent is malposed and not well-expanded, the stent might be undersized or improperly expanded. Paragraph 0098 teaches that the frames are assessed outside the stent region and is not in an overlapped region. Fig. 9 shows an interactive process that considers all frames. Paragraph 0052 teaches that the stenting status can be evaluated and assigned for each image frame);
detecting under-dilation at the edge of the stent by determining that the second measurement of the outside of the stent exceeds the first measurement of the edge of the stent for each of the specified number of second intravascular images (Paragraph 0008 teaches that the stent malapposition can be determined at multiple locations throughout the range of the stent. Paragraph 0050 teaches where the distance to the lumen is greater than the distance to the stent strut, there is malapposition. This is done based on the assessment of the area. Paragraph 0052 teaches that the stenting status for each of the images is assessed and classifying according to Table 1 which shows the consideration of malapposition. Paragraph 0053 teaches if the stent is malposed and not well-expanded, the stent might be undersized or improperly expanded. See Figs. 4, 12, and 19. Paragraph 0098 teaches that the frames are assessed outside the stent region and is not in an overlapped region. Fig. 9 shows an interactive process that considers all frames. Paragraph 0052 teaches that the stenting status can be evaluated and assigned for each image frame); and
providing, to a display in communication with the processor circuit, an output associated with a change in the expansion of the stent to correct the under-dilation (Paragraph 0054 teaches that the stent expansion information is detected and displayed. See Fig. 26),
wherein the first measurement of the edge of the stent and the second measurement of the outside of the stent each comprise an area measurement or a diameter measurement (Paragraphs 0069-0071 teaches the consideration of the lumen area and the stent areas. Paragraph 0089 teaches the determination and indication of the lumen diameter).
However, Kunio is silent regarding a method, comparison of the edge of the stent for each of the specified number of second intravascular images with images outside the stent for purposes of assessment of under-dilation.
In an analogous imaging field of endeavor, regarding IVUS imaging of blood vessels, Hoffman teaches a method, detecting under-dilation at the edge of the stent by determining that the second measurement of the outside of the stent exceeds the first measurement of the edge of the stent for each of the specified number of second intravascular images.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Kunio with Hoffman’s teaching of the consideration of lumen measurements outside the stent for the assessment of stenting effectiveness. Given that it is well-known that under-dilation causes restenosis, as evidenced by Table 2 of Buccheri, it would be obvious to one with ordinary skill in the art that the formation of restenosis is indicative of stenting being under expanded and thereby resulting in inadequate treatment. Furthermore, Kunio already teaches the assessment of under-expansion of the stenting with respect to the lumen diameters and consideration for each image frame. Given this, it would be clear to one with ordinary skill in the art that the under-expansion can be considered according to regions outside the stenting area as discussed by Hoffman as it teaches the assessment of the areas outside the stenting area in both the proximal and distal directions. This modified method would allow a user to assess failures of treatment strategies and thereby prevent restenosis (Conclusion of Hoffman). Furthermore, the modification would allow for the combining an endovascular prosthesis (to withstand remodeling forces) and a pharmacological agent (to inhibit cellular proliferation) (Conclusion of Hoffman). Additionally, the modification ensures the improvement of stenting outcomes as the stenting expansion information can be displayed (Paragraph 0043 of Kunio).
Regarding claim 16, modified Kunio teaches the intravascular imaging system in claim 17, as discussed above.
However, Kunio is silent regarding an intravascular imaging system, wherein the first graphical representation comprises a curve of the plurality of measurements.
In an analogous imaging field of endeavor, regarding IVUS imaging of blood vessels, Hoffman teaches an intravascular imaging system, wherein the first graphical representation comprises a curve of the plurality of measurements (Fig. 1 shows the segments that are analyzed for the assessment of the stent status. The segments include regions in and out of the stent along the longitude of the vessel. Fig. 3 shows the assessment of the lumen throughout the segments. The regions outside the stent in the distal and proximal areas beyond the stent are shown to be greater than the lumen with the stenting).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Kunio with Hoffman’s teaching of the consideration of lumen measurements outside the stent for the assessment of stenting effectiveness. Given that it is well-known that under-dilation causes restenosis, as evidenced by Table 2 of Buccheri, it would be obvious to one with ordinary skill in the art that the formation of restenosis is indicative of stenting being under expanded and thereby resulting in inadequate treatment. Furthermore, Kunio already teaches the assessment of under-expansion of the stenting with respect to the lumen diameters. Given this, it would be clear to one with ordinary skill in the art that the under-expansion can be considered according to regions outside the stenting area as discussed by Hoffman as it teaches the assessment of the areas outside the stenting area in both the proximal and distal directions. This modified apparatus would allow a user to assess failures of treatment strategies and thereby prevent restenosis (Conclusion of Hoffman). Furthermore, the modification would allow for the combining an endovascular prosthesis (to withstand remodeling forces) and a pharmacological agent (to inhibit cellular proliferation) (Conclusion of Hoffman). Additionally, the modification ensures the improvement of stenting outcomes as the stenting expansion information can be displayed (Paragraph 0043 of Kunio).
Claims 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kunio et al. (PGPUB No. US 2019/0099080) in view of Hoffman et al. ("Patterns and Mechanisms of In-Stent Restenosis", 1996) further in view of Gopinath et al. (PGPUB No. US 2017/0024532).
Regarding claim 11, modified Kunio teaches the system in claim 1, as discussed above.
However, Kunio is silent regarding a system, wherein the processor circuit is configured to detect the under-dilation by determining that the second measurement of the outside of the stent exceeds the first measurement of the edge of the stent by more than a threshold amount.
In an analogous imaging field of endeavor, regarding IVUS imaging of blood vessels, Hoffman teaches a system, detect the under-dilation by determining that the second measurement of the outside of the stent exceeds the first measurement of the edge of the stent (Fig. 1 shows the segments that are analyzed for the assessment of the stent status. The segments include regions in and out of the stent along the longitude of the vessel. Fig. 3 shows the assessment of the lumen throughout the segments. The regions outside the stent in the distal and proximal areas beyond the stent are shown to be greater than the lumen with the stenting).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Kunio with Hoffman’s teaching of the consideration of lumen measurements outside the stent for the assessment of stenting effectiveness. Given that it is well-known that under-dilation causes restenosis, as evidenced by Table 2 of Buccheri, it would be obvious to one with ordinary skill in the art that the formation of restenosis is indicative of stenting being under expanded and thereby resulting in inadequate treatment. Furthermore, Kunio already teaches the assessment of under-expansion of the stenting with respect to the lumen diameters and consideration for each image frame. Given this, it would be clear to one with ordinary skill in the art that the under-expansion can be considered according to regions outside the stenting area as discussed by Hoffman as it teaches the assessment of the areas outside the stenting area in both the proximal and distal directions. This modified apparatus would allow a user to assess failures of treatment strategies and thereby prevent restenosis (Conclusion of Hoffman). Furthermore, the modification would allow for the combining an endovascular prosthesis (to withstand remodeling forces) and a pharmacological agent (to inhibit cellular proliferation) (Conclusion of Hoffman). Additionally, the modification ensures the improvement of stenting outcomes as the stenting expansion information can be displayed (Paragraph 0043 of Kunio).
However, the combination of Kunio and Hoffman is silent regarding a system, wherein the processor circuit is configured to detect the under-dilation by determining that the second measurement of the outside of the stent exceeds the first measurement of the edge of the stent by more than a threshold amount.
In an analogous imaging field of endeavor, regarding observation of blood vessels and relevant disorders via ultrasound imaging, Gopinath teaches a system, wherein the processor circuit is configured to detect the under-dilation by determining that the second measurement of the outside of the stent exceeds the first measurement of the edge of the stent by more than a threshold amount (Paragraph 0128 teaches that the apposition thresholds can be set. The apposition distance is defined between the stent strut and the lumen contour. See Fig. 15B. Paragraph 0015 teaches that the stent is positioned within the blood vessel. Paragraphs 0120-22 teaches the stents are color coded based on the apposition with respect to the thresholding. See Fig. 14A which shows under-dilation with respect to the anatomy).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Kunio and Hoffman with Gopinath’s teaching of thresholding to determine the condition of under-dilation for stenting procedures. This modified apparatus would allow the user to monitor and observe the stent position and possible issues (Paragraph 0061 of Gopinath). Furthermore, the modification will alert the user that further intervention may be required to fully expand (Paragraph 0122 of Gopinath).
Regarding claim 16, modified Kunio teaches the intravascular imaging system in claim 17, as discussed above.
However, Kunio is silent regarding an intravascular imaging system, wherein the first graphical representation comprises a curve of the plurality of measurements.
In an analogous imaging field of endeavor, regarding IVUS imaging of blood vessels, Hoffman teaches an intravascular imaging system, wherein the first graphical representation comprises a curve of the plurality of measurements (Fig. 1 shows the segments that are analyzed for the assessment of the stent status. The segments include regions in and out of the stent along the longitude of the vessel. Fig. 3 shows the assessment of the lumen throughout the segments. The regions outside the stent in the distal and proximal areas beyond the stent are shown to be greater than the lumen with the stenting).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Kunio with Hoffman’s teaching of the consideration of lumen measurements outside the stent for the assessment of stenting effectiveness. Given that it is well-known that under-dilation causes restenosis, as evidenced by Table 2 of Buccheri, it would be obvious to one with ordinary skill in the art that the formation of restenosis is indicative of stenting being under expanded and thereby resulting in inadequate treatment. Furthermore, Kunio already teaches the assessment of under-expansion of the stenting with respect to the lumen diameters. Given this, it would be clear to one with ordinary skill in the art that the under-expansion can be considered according to regions outside the stenting area as discussed by Hoffman as it teaches the assessment of the areas outside the stenting area in both the proximal and distal directions. This modified apparatus would allow a user to assess failures of treatment strategies and thereby prevent restenosis (Conclusion of Hoffman). Furthermore, the modification would allow for the combining an endovascular prosthesis (to withstand remodeling forces) and a pharmacological agent (to inhibit cellular proliferation) (Conclusion of Hoffman). Additionally, the modification ensures the improvement of stenting outcomes as the stenting expansion information can be displayed (Paragraph 0043 of Kunio).
Alternatively, in an analogous imaging field of endeavor, regarding observation of blood vessels and relevant disorders via ultrasound imaging, Gopinath teaches a system, wherein the first graphical representation comprises a curve of the plurality of measurements (Paragraph 0105 teaches that the vessel features can be toggled. Fig. 9 shows the lumen view where the diameter can be assessed according to the x and y axes and the variation of the lumen size is displayed).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Kunio and Hoffman with Gopinath’s teaching of a curve of the anatomical measurements. This modified apparatus would allow the user to monitor and observe the stent position and possible issues (Paragraph 0061 of Gopinath). Furthermore, the modification will alert the user that further intervention may be required to fully expand (Paragraph 0122 of Gopinath).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wang et al. (PGPUB No. US 2016/0213253): Teaches the consideration of areas outside the stenting area for malapposition.
Gopinath et al. (PGPUB No. US 20170103520): Teaches the consideration of areas outside the stenting area for malapposition.
Ambwani et al. (PGPUB No. US 20160335766): Teaches the consideration of areas outside the stenting area for malapposition.
Chao et al. (US Patent No. 12,232,907): Teaches the consideration of areas outside the stenting area for malapposition.
Begin et al. (US Patent No. 10,568,586): Teaches the consideration of areas outside the stenting area for malapposition.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADIL PARTAP S VIRK whose telephone number is (571)272-8569. The examiner can normally be reached Mon-Fri 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
1 Link: https://www.nhlbi.nih.gov/health/stents
2 Link: https://www.nhlbi.nih.gov/health/stents
Prosecution Insights