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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12 February 2026 has been entered.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18/146,991 (the instant application), filed on 27 December 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12 February 2026 was received and the information disclosure statement has been considered by the examiner.
Response to Arguments
Claims 1-2, 5-6, 13, and 16 have been amended. Claim 17 was withdrawn previously. Claims 1-7, 13-16, and 21-28 are pending in this action.
Applicant' s arguments, see pg. 10, filed 12 February 2026, with respect to the rejection of claims 14, 15, 27, and 28 under 35 U.S.C. 112(b) have been fully considered and are not persuasive. The applicant argues that the amendments to claim 13 cause the rejections of claims 14, 15, 27, and 28 to be moot. The examiner disagrees. While the applicant amended claim 13 to avoid the language defining the first image as being captured after the injection of a drug and the second image as being captured before the injection of a drug, which does provide some clarity, claims 14 and 15 are still unclear because they claim the first image and the second image respectively are each captured at two time points, before and after enhancement, i.e. before and after infusion of a drug. In the Final Rejection filed 16 December 2025, pg. 4 para. last, the examiner presented the question “How may an image be both before an infusion of a drug and after an infusion of a drug?” That question has not been resolved by the amendments to claim 13. In the Final Rejection filed 16 December 2025, the examiner interpreted the first image in claim 14 as a first image sequence, pg. 4 para. last, and interpreted the second image in claim 15 as a second image sequence, pg. 5 para. 1. These interpretations were to explain how the images may be from before and after an infusion of a drug. The claims require some statement of there being plural first images and plural second images such that at least one first image and one second image were captured before an infusion of a drug and at least one first image and one second image were captured after an infusion of a drug. Therefore, claims 14, 15, 27, and 28 remain rejected under 35 U.S.C. 112(b).
Applicant’s arguments, see pg. 10-14, filed 12 February 2026, with respect to the rejections of claims 1-3, 5-7, 13, 14, 16, and 21 under 35 U.S.C. 103 have been fully considered and are persuasive. Specifically, the applicant argues that Gong et al. (CN 112085730 A as recited in the IDS received 04/22/2025; hereafter, Gong) in view of Jia et al. (CN 112634196 A as recited in the IDS received 08/14/2023; hereafter, Jia) does not disclose “the enhancement level of the target tissue indicates an instability of the plaque” as amended into claims 1 and 13. The examiner agrees that Gong in view of Jia does not expressly disclose that language Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Buckler et al. (US 20130202173 A1; hereafter, Buckler).
Buckler discloses:
the enhancement level of the target tissue ([0069] and Fig. 4 and Fig. 5D, the intensity of a region is tracked over time after the infusion of the contrast agent. As the intensity is tracked over time, as seen in Fig. 5D, it is understood to indicate the enhancement of the tissue. Further, the intensity is consolidated into coefficients for a polynomial which may be understood to indicate an enhancement level. When considered in combination with Gong in view of Jia, a person of ordinary skill in the art would be able to substitute the enhancement level of Buckler with the enhancement level of Gong in view of Jia as both consider the intensity of a region before and after infusion of a contrast agent in the identification of plaques) indicates an instability of the plaque ([0079]-[0080] and Fig. 4, the features are classified as stable plaque or vulnerable plaque with further classification as an acute vulnerable plaque and an intermediate vulnerable plaque. As opposed to stable plaque, vulnerable plaque is understood as unstable and classifying the plaque based on the features is understood as determining the instability based on the enhancement level)
The complete rejection, including motivations to combine, is below in the section “Claim Rejections - 35 USC § 103”. Therefore, claims 1-3, 5-7, 13, 14, 16, and 21 are rejected under 35 U.S.C. 103.
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 14-15 and 27-28 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.
Regarding claim 14, the first image is stated to occur both before and after enhancement. In light of the specification, " enhancement" of claim 14 is understood as an infusion or injection of the drug, see [0107]. It is unclear how the first image may have an intensity before and after enhancement as that would require the image being acquired at two separate time points. How may an image be both before an infusion of a drug and after an infusion of a drug? For the purpose of examination the examiner interprets the “first image” as a first image sequence wherein at least one image of the sequence is acquired before the subject is injected with the drug and at least one image of the sequence is acquired after the subject is injected with the drug. Claim 15 is dependent on claim 14 and is rejected for failing to correct the ambiguity of claim 14.
Regarding claim 15, the second image is stated to occur both before and after enhancement. In light of the specification, " enhancement" of claim 15 is understood as an infusion or injection of the drug, see [0107]. It is unclear how the second image may have an intensity before and after enhancement as that would require the image being acquired at two separate time points. How may an image be both before an infusion of a drug and after an infusion of a drug? For the purpose of examination the examiner interprets the “second image” as a second image sequence wherein at least one image of the sequence is acquired before the subject is injected with the drug and at least one image of the sequence is acquired after the subject is injected with the drug. Claims 27-28 are dependent on claim 15 and are rejected for failing to correct the ambiguity of claim 15.
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.
Claims 1-3, 5-7, 13-14, 16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gong et al. (CN 112085730 A as recited in the IDS received 04/22/2025; hereafter, Gong) in view of Jia et al. (CN 112634196 A as recited in the IDS received 08/14/2023; hereafter, Jia) in further view of Buckler et al. (US 20130202173 A1; hereafter, Buckler).
Regarding claim 1, Gong discloses:
A system for image analysis, comprising: at least one storage device (pg. 16 para. 1, the electronic device includes a memory) including a set of instructions (pg. 16 para. 2, the memory may store programs such as instructions);
and at least one processor configured to communicate with the at least one storage device (pg. 16 para. 1, the electronic device includes a processor. The processor is in communication with the memory by a bus connection), wherein when executing the set of instructions, the at least one processor is configured to direct the system to perform operations including: obtaining a plurality of image sequences (pg. 5 para. 2, medical images are acquired. Pg. 5 para. 4, the medical images may be scanning sequences at different contrasts. This is understood as a plurality of image sequences), at least one of the plurality of image sequences being acquired using a black blood imaging sequence (pg. 5 para. 6, the scan sequence may be T1 weighted imaging, which is understood as a black blood imaging sequence. A person of ordinary skill in the art would understand that a T1 weighted MRI image shows fatty tissue as bright and watery tissue, such as blood, as dark. This is in contrast to a T2 weighted MRI image in which watery tissue, such as blood, appears bright);
determining a plurality of aligned image sequences by aligning (pg. 5 para. 8, the medical images are registered or aligned),
determining a target region including a region of a target tissue based on the plurality of aligned image sequences (pg. 5 para. 10, target regions in the medical images, after aligning, are determined. Any tissue withing a target region may be understood as a target tissue);
and determining one or more target parameters based on the target region (pg. 7 para. 4, a comparison result is made based on the target region. The comparison result is understood as a target parameter),
wherein the one or more target parameters include an enhancement level of a target tissue (pg. 7 para. 5, the comparison result is based on signal values from the target region and the reference region of interest. As they are compared, the comparison result is understood as representing a difference in contrast between the regions which is understood as an enhancement level), the enhancement level of the target tissue is determined based on a first enhancement degree (pg. 7 para. 5, the signal value of the "region of interest", i.e. the region of target tissue, with contrast is compared. As this value indicates the contrast it is understood as an enhancement degree) of a region of the target tissue (pg. 7 para. 5, the value is from the "region of interest" which is understood as the region of target tissue) and a second enhancement degree (pg. 7 para. 5, the signal value of the "reference region", i.e. the reference ROI, with contrast is compared. As this value indicates the contrast it is understood as an enhancement degree) of a reference region of interest (ROI) (pg. 7 para. 5, the value is from the "reference region" which is understood as the reference ROI),
Gong in the present embodiment does not disclose expressly that the reference image sequence is acquired using a bright blood imaging sequence and that the reference ROI is determined based on the reference image sequence.
In another embodiment, Gong discloses:
wherein the reference image sequence is acquired using a bright blood imaging sequence (pg. 13 para. 7, the image sequence may be a bright blood image sequence. pg. 14 para. 1, the reference area is determined based on these images, and the lumen extraction performed on them. Therefore, the bright blood images may be understood as a reference sequence);
and the reference ROI is determined based on the reference image sequence (pg. 14 para. 1, the reference area is determined based on the bright blood images of pg. 13 para. 7).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to combine the bright blood reference image sequence of the another embodiment of Gong with the invention of the first embodiment of Gong.
The motivation for doing so would have been that "extraction of the center line of the blood vessel may be performed by first determining whether or not the blood vessel includes a bright blood sequence image, and if so, automatically segmenting the blood vessel to extract the center line. If the bright blood sequence image does not exist, the user needs to manually perform dotting on the blood vessel image and then generate a blood vessel central line" (Gong, pg. 13 para. 7). The extraction of a center line results in a more precise identification of the lumen or wall area (see Gong, pg. 13 para. 11) which is used in identifying the region of interest (see Gong, pg. 13 para. last through pg. 14 para. 1).
Gong does not disclose expressly that the image sequence relates to a blood vessel, that the plurality of image sequences include an image acquired before injection of a drug and an image acquired after an inject of the drug, that the aligning is based on a reference sequence of images, and that a target region is a plaque.
Jia discloses:
relating to a blood vessel of a subject (pg. 5 col. 1 para. 9, step s1 involves acquiring medical images of at least one blood vessel),
the at least one of the plurality of image sequences including an image acquired before the subject is injected with a drug (pg. 21 col. 1 para. 4, the value SpreBBMR is the intensity in the black blood image, which is before enhancement by contrast. The black blood image in this operation is 3D model) and an image acquired after the subject is injected with the drug (pg. 21 col. 1 para. 4, the value SpostBBMR is the intensity in the contrast enhanced black blood image, which is after enhancement by contrast. The black blood image in this operation is 3D model);
aligning, based on a reference image sequence the plurality of image sequences (pg. 6 col. 1 para. 1, register a groups, i.e. sequence, of images based on a reference image group);
wherein the target tissue includes a plaque (pg. 21 col. 1 para. 3, the blood vessel wall is made obvious and plaque appears or is made visible in the region)
Gong and Jia are combinable because they are from the same field of endeavor of analyzing plaque in blood vessels (Gong, pg. 13 para. 2; Jia, pg. 2 col. 1 para. 4).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to combine the images being of blood vessels, the images including images before and after injection of a drug, and aligning the images as taught by Jia with the invention of Gong.
The motivation for doing so would have been that “images can be unified under the same coordinate system through the image registration, so that doctors can conveniently understand the blood vessel images corresponding to the black blood sequences and the bright blood sequences, comprehensive information required by diagnosis can be simply, conveniently and quickly obtained, and accurate and reliable reference information is provided for subsequent medical diagnosis, operation plan making, radiotherapy plan and the like” (Jia, pg. 14 para. 6).
Therefore, it would have been obvious to combine Jia with Gong.
Gong in view of Jia does not disclose expressly that an enhancement level indicates the instability of the plaque.
Buckler discloses:
the enhancement level of the target tissue ([0069] and Fig. 4 and Fig. 5D, the intensity of a region is tracked over time after the infusion of the contrast agent. As the intensity is tracked over time, as seen in Fig. 5D, it is understood to indicate the enhancement of the tissue. Further, the intensity is consolidated into coefficients for a polynomial which may be understood to indicate an enhancement level. When considered in combination with Gong in view of Jia, a person of ordinary skill in the art would be able to substitute the enhancement level of Buckler with the enhancement level of Gong in view of Jia as both consider the intensity of a region before and after infusion of a contrast agent in the identification of plaques) indicates an instability of the plaque ([0079]-[0080] and Fig. 4, the features are classified as stable plaque or vulnerable plaque with further classification as an acute vulnerable plaque and an intermediate vulnerable plaque. As opposed to stable plaque, vulnerable plaque is understood as unstable and classifying the plaque based on the features is understood as determining the instability based on the enhancement level),
Buckler is combinable with Gong in view of Jia because it is in the same field of endeavor of analyzing plaque in blood vessels (Buckler, [0056]).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to combine the indication of instability of Buckler with the invention of Gong in view of Jia.
The suggestion for doing so would have been that Gong states that there is a need for quantitative analysis of "plaque stability" due to the subjectivity of analysis "according to naked eyes" (Gong, pg. 2 para. last and pg. 3 para. 1). Further, Jia discloses a detection of "vulnerable plaque" though it is not expressly apparent if the vulnerable or unstable nature of the plaque is determined based on an enhancement level (Jia, pg. 21 para. 3). Finally, Buckler provides a motivation for using the method of Buckler in that "Due to the clinical nature of plaques, and their dependency on quantifiable changes in intensity values over time, a computer-aided diagnosis (CAD) system that could detect the plaque type would assist clinicians in therapeutic decision-making, monitoring therapy response, and increase our understanding of vulnerable and stable carotid atherosclerotic plaques" (Buckler, [0058]).
Therefore, it would have been obvious to combine Buckler with Gong in view of Jia to obtain the invention as specified in claim 1.
Regarding claim 2, Gong in view of Jia in further view of Buckler discloses the subject matter of claim 1.
Gong further discloses:
The system of claim 1, wherein determining the one or more target parameters based on the target region includes: determining, based on the region of the target tissue, the first enhancement degree (pg. 7 para. 5, the signal value of the "region of interest", i.e. the region of target tissue, with contrast is compared. As this value indicates the contrast it is understood as an enhancement degree) of the region of the target tissue (pg. 7 para. 5, the value is from the "region of interest" which is understood as the region of target tissue);
determining, based on the reference ROI, the second enhancement degree (pg. 7 para. 5, the signal value of the "reference region", i.e. the reference ROI, with contrast is compared. As this value indicates the contrast it is understood as an enhancement degree) of the reference ROI (pg. 7 para. 5, the value is from the "reference region" which is understood as the reference ROI);
and determining the enhancement level of the target tissue (pg. 7 para. 5, a comparison result is determined. As the comparison is between values indicating contrast it is understood to indicate an enhancement level) based on the first enhancement degree and the second enhancement degree (pg. 7 para. 5, the comparison result, i.e. enhancement level, is based on the signal value of the region of interest, i.e. the first enhancement degree as taught above, and the signal value of the region of interest, i.e. the second enhancement degree as taught above).
Regarding claim 3, Gong in view of Jia in further view of Buckler discloses the subject matter of claim 2.
Gong does not disclose expressly that the first enhancement degree includes determining a first intensity before enhancement, a second intensity after enhancement and determining the first enhancement degree based on the first and second intensity.
Jia discloses:
wherein determining, based on the region of the target tissue, the first enhancement degree of the region of the target tissue includes: determining a first intensity of the region of the target tissue (pg. 17 col. 1 para. 6, in step 4 the 3D model is created of the blood vessel which is understood as a region of target tissue) before enhancement (pg. 21 col. 1 para. 4, the value SpreBBMR is the intensity in the black blood image, which is before enhancement by contrast. The black blood image in this operation is 3D model);
determining a second intensity of the region of the target tissue after enhancement (pg. 21 col. 1 para. 4, the value SpostBBMR is the intensity in the contrast enhanced black blood image, which is after enhancement by contrast. The black blood image in this operation is 3D model);
and determining, based on the first intensity and the second intensity, the first enhancement degree of the region of the target tissue (pg. 21 col. 1 para 4, the enhancement index, CE, is based on the first intensity and the second intensity, i.e. the intensity values before and after contrast enhancement).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention to combine determining the first enhancement degree by the intensity of a region before and after enhancement as taught by Jia with the invention of Gong.
The motivation for doing so would have been “so that a doctor can conveniently obtain more detailed blood vessel information,” (Jia, pg. 21 col. 1 para. 5).
Therefore, it would have been obvious to combine Jia with Gong to obtain the invention as specified in claim 3.
Regarding claim 5, Gong in view of Jia in further view of Buckler discloses the subject matter of claim 1.
Gong does not disclose expressly that the target tissue includes a vascular wall and a plaque and determining the vascular wall and the plaque from the sequence of images.
Jia discloses:
wherein the target tissue includes a vascular wall (pg. 21 col. 1 para. 3, the blood vessel wall is made obvious), and the target tissue is determined by: determining the vascular wall by identifying the vascular wall (pg. 21 col. 1 para. 3, the vascular wall is made "obvious" which is understood as identifying the vascular wall) from the plurality of aligned image sequences (the vascular wall identified on pg. 21 col. 1 para. 3 is in step s72 and is dependent on step s2, pg. 6 col. 1 para. 1, wherein the image groups, understood as sequences, are registered or aligned) and determining the plaque by identifying the plaque from the vascular wall (pg. 21 col. 1 para. 3, the plaque "appears" in the region is understood as identifying the plaque from the vascular wall).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention to combine the images of vascular wall and plaque of Jia with the invention of Gong.
The motivation for doing so would have been because it is "helpful for identifying responsible artery plaque and the like" (Jia, pg. 21 col. 1 para. 5).
Regarding claim 6, Gong in view of Jia in further view of Buckler discloses the subject matter of claim 1.
Gong does not disclose expressly that the region of interest is determined by inputting the plurality of image sequences into a segmentation model.
Jia discloses:
wherein the reference ROI is determined by: inputting the plurality of aligned image sequences (pg. 6 col. 1 para. 1, the image groups, understood as sequences, are registered or aligned in step s2) into a segmentation model (pg. 18 col. 1 para. 2 a threshold based on the blood information is calculated. Pg. 18 col. 1 para. 4, generate a 3D model using the calculated threshold by a moving cube method. As the generation of the 3D model is based on a threshold of the blood it is understood as segmentation. As it is segmenting the blood vessel in order to make a 3D representation of the tissue it is understood as a model).
It would have been obvious to a person having ordinary skill in the art to use the segmentation as taught by Jia with the invention of Gong.
The motivation for doing so would have been that “Compared with other surface drawing algorithms, the method for moving the cube has the advantage of good grid generation quality” (Jia, pg. 18 col. 1 para. 6).
Therefore, it would have been obvious to combine Jia with Gong to obtain the invention as specified in claim 6.
Regarding claim 7, Gong in view Jia discloses the subject matter of claim 6.
Gong further discloses:
wherein determining the enhancement level of the target tissue based on the first enhancement degree and the second enhancement degree includes: determining the enhancement level by dividing the first enhancement degree by the second enhancement degree (pg. 9 para. 1, the comparison result, i.e. the enhancement level, is determined as a ratio of the signal value of the region of interest, i.e. the first enhancement degree, to the signal value of the reference region, i.e. the second enhancement level. As a ratio it is understood that the first is divided by the second, i.e. the first enhancement degree by the second enhancement degree).
Regarding claim 13, Gong discloses:
A system for image analysis, comprising: at least one storage device (pg. 16 para. 1, the electronic device includes a memory) including a set of instructions (pg. 16 para. 2, the memory may store programs such as instructions);
and at least one processor configured to communicate with the at least one storage device (pg. 16 para. 1, the electronic device includes a processor. The processor is in communication with the memory by a bus connection) wherein when executing the set of instructions, the at least one processor is configured to direct the system to perform operations including: obtaining an image to be processed (pg. 5 para. 2, medical images are acquired) determining a first image of a region of a target tissue (pg. 5 para. 10, the system determines "interested areas" which are understood as a region of target tissue, see pg. 5 para. 11) and a second image of a reference region of interest (ROI) (pg. 5 para. 10, the system determines "reference areas" which are understood as a reference region of interest), wherein the first image and the second image are acquired using a black blood imaging sequence (pg. 5 para. 6, the scan sequence may be T1 weighted imaging, which is understood as a black blood imaging sequence. A person of ordinary skill in the art would understand that a T1 weighted MRI image shows fatty tissue as bright and watery tissue, such as blood, as dark. This is in contrast to a T2 weighted MRI image in which watery tissue, such as blood, appears bright)
determining a first enhancement degree (pg. 7 para. 5, the signal value of the "region of interest", i.e. the region of target tissue, with contrast is compared. As this value indicates the contrast it is understood as an enhancement degree) of the first image (pg. 7 para. 5, the value is from the "region of interest" which is understood as the region of target tissue. The examiner is interpreting the image containing the region of interest as the first image) and a second enhancement degree (pg. 7 para. 5, the signal value of the "reference region", i.e. the reference ROI, with contrast is compared. As this value indicates the contrast it is understood as an enhancement degree) of the second image (pg. 7 para. 5, the value is from the "reference region" which is understood as the reference ROI. The examiner is interpreting the reference image containing the reference region as the second image);
and determining an enhancement level of the target tissue (pg. 7 para. 5, a comparison result is determined. As the comparison is between value indicating contrast it is understood to indicate an enhancement level) based on the first enhancement degree and the second enhancement degree (pg. 7 para. 5, the comparison result, i.e. enhancement level, is based on the signal value of the region of interest, i.e. the first enhancement degree as taught above, and the signal value of the region of interest, i.e. the second enhancement degree as taught above).
Gong does not disclose expressly that the image is a vascular image, performing an identification operation of the vascular image, and that the target tissue includes a plaque.
Jia discloses:
obtaining a vascular image (pg. 5 col. 1 para. 9, step s1 involves acquiring medical images of at least one blood vessel);
performing an identification operation on the vascular image (pg. 21 col. 1 para. 3, the blood vessel wall is made obvious which is understood as an identification);
and the target tissue includes a plaque (pg. 21 col. 1 para. 3, the blood vessel wall is made obvious and plaque appears or is made visible in the region)
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention to modify the image of Gong into a vascular image as taught by Jia and to acquire an image before and after injection of a drug.
The motivation for doing so would have been that it is “helpful for identifying responsible artery plaque and the like" (Jia, pg. 21 col. 1 para. 5).
Therefore, it would have been obvious to combine Jia with Gong.
Gong in view of Jia does not disclose expressly that an enhancement level indicates the instability of the plaque.
Buckler discloses:
wherein the enhancement level of the target tissue ([0069] and Fig. 4 and Fig. 5D, the intensity of a region is tracked over time after the infusion of the contrast agent. As the intensity is tracked over time, as seen in Fig. 5D, it is understood to indicate the enhancement of the tissue. Further, the intensity is consolidated into coefficients for a polynomial which may be understood to indicate an enhancement level. When considered in combination with Gong in view of Jia, a person of ordinary skill in the art would be able to substitute the enhancement level of Buckler with the enhancement level of Gong in view of Jia as both consider the intensity of a region before and after infusion of a contrast agent in the identification of plaques) indicates an instability of the plaque ([0079]-[0080] and Fig. 4, the features are classified as stable plaque or vulnerable plaque with further classification as an acute vulnerable plaque and an intermediate vulnerable plaque. As opposed to stable plaque, vulnerable plaque is understood as unstable and classifying the plaque based on the features is understood as determining the instability based on the enhancement level),
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to combine the indication of instability of Buckler with the invention of Gong in view of Jia.
The suggestion for doing so would have been that Gong states that there is a need for quantitative analysis of "plaque stability" due to the subjectivity of analysis "according to naked eyes" (Gong, pg. 2 para. last and pg. 3 para. 1). Further, Jia discloses a detection of "vulnerable plaque" though it is not expressly apparent if the vulnerable or unstable nature of the plaque is determined based on an enhancement level (Jia, pg. 21 para. 3). Finally, Buckler provides a motivation for using the method of Buckler in that "Due to the clinical nature of plaques, and their dependency on quantifiable changes in intensity values over time, a computer-aided diagnosis (CAD) system that could detect the plaque type would assist clinicians in therapeutic decision-making, monitoring therapy response, and increase our understanding of vulnerable and stable carotid atherosclerotic plaques" (Buckler, [0058]).
Therefore, it would have been obvious to combine Buckler with Gong in view of Jia to obtain the invention as specified in claim 13.
Regarding claim 14, Gong in view of Jia in further view of Buckler discloses the subject matter of claim 13.
Gong does not disclose expressly that determining the first enhancement includes determining a first intensity and a second intensity and determining the first enhancement based on the first intensity and the second intensity.
Jia discloses:
wherein determining the first enhancement degree of the first image includes: determining a first intensity of the first image of the region of the target tissue (pg. 17 col. 1 para. 6, in step 4 the 3D model is created of the blood vessel which is understood as a region of target tissue) before enhancement (pg. 21 col. 1 para. 4, the value SpreBBMR is the intensity in the black blood image, which is before enhancement by contrast. The black blood image in this operation is the 3D model);
determining a second intensity of the first image of the region of the target tissue after enhancement (pg. 21 col. 1 para. 4, the value SpostBBMR is the intensity in the contrast enhanced black blood image, which is after enhancement by contrast. The black blood image in this operation is the 3D model);
and determining, based on the first intensity and the second intensity, the first enhancement degree of the first image (pg. 21 col. 1 para 4, the enhancement index, CE, is based on the first intensity and the second intensity, i.e. the intensity values before and after contrast enhancement).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention to combine determining the first enhancement degree by the intensity of a region before and after enhancement as taught by Jia with the invention of Gong.
The motivation for doing so would have been “so that a doctor can conveniently obtain more detailed blood vessel information,” (Jia, pg. 21 col. 1 para. 5).
Therefore, it would have been obvious to combine Jia with Gong to obtain the invention as specified in claim 14.
Regarding claim 16, Gong in view of Jia in further view of Buckler discloses the subject matter of claim 13. Gong does not disclose expressly that the target tissue includes a vascular wall and plaque and identifying the vascular wall and plaque.
Jia discloses:
wherein the target tissue includes a vascular wall (pg. 21 col. 1 para. 3, the blood vessel wall in the 3D model is made obvious. The 3D model is understood as the target region), and the target tissue is determined by: determining the vascular wall by identifying the vascular wall from the vascular image to be processed (pg. 21 col. 1 para. 3, the vascular wall is made "obvious" which is understood as identifying the vascular wall) and determining the plaque by identifying the plaque from the vascular wall (pg. 21 col. 1 para. 3, the plaque "appears" in the region is understood as identifying the plaque from the vascular wall).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention to combine the images of vascular wall and plaque of Jia with the invention of Gong.
The motivation for doing so would have been because it is "helpful for identifying responsible artery plaque and the like" (Jia, pg. 21 col. 1 para. 5).
Therefore, it would have been obvious to combine Jia with Gong to obtain the invention as specified in claim 16.
Regarding claim 21, Gong in view of Jia in further view of Buckler discloses the subject matter of claim 6. Gong does not disclose expressly a three-dimensional segmentation model and that the output is capable of being adjusted.
Jia discloses:
wherein the segmentation model is a three-dimensional (3D) segmentation network model (pg. 18 col. 1 para. 4, the segmentation is a 3D segmentation and is therefore understood as a 3D segmentation model), and an output of the 3D segmentation network model (pg. 18 col. 1 para. 4, the 3D model is output) is capable of being adjusted according to actual needs of a user (pg. 19 col. 1 para. 1, the 3D model of the blood may be expanded to cover the blood vessel wall. This can be understood as adjusting the segmentation output for the needs of the user as the user needs to consider the vessel wall).
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention to modify the invention of Gong with the 3D segmentation of Jia.
The motivation for doing so would have been "to obtain a three-dimensional model of the blood vessel closer to the real blood vessel condition" (Jia, pg. 19 col. 1 para. 2).
Therefore, it would have been obvious to combine Jia with Gong to obtain the invention as specified in claim 21.
Allowable Subject Matter
Claims 4 and 22-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 15 and 27-28 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 4 and 15, the closest prior art, Gong et al. (CN 112085730 A as recited in the IDS received 04/22/2025; hereafter, Gong), discloses determining an enhancement level based on an enhancement degree of a reference region of interest (ROI). Gong does not disclose or reasonably suggest that the enhancement degree of the reference region of interest is determined based on an intensity of the region before enhancement and an intensity of the region after enhancement. Jia et al. (CN 112634196 A as recited in the IDS received 08/14/2023; hereafter, Jia) discloses determining a first enhancement degree based on the intensity of a target region before enhancement and the intensity after enhancement. However, when considered in combination with Gong, it is not reasonable for Jia to disclose both the enhancement degree of the target tissue region (see claim 3 and claim 14) and the enhancement degree of the reference ROI (claims 4 and 15).
Therefore, claims 4 and 15 are considered to contain allowable subject matter because the prior art does not teach, suggest, or provide motivation to combine multiple prior art references before the effective filing date of this application to teach the entirety of claims 4 and 15 in a non-obvious manner.
Claim 4 in its entirety is found non-obvious over the prior art, including the following limitations:
wherein determining, based on the refence ROI, the second enhancement degree of the reference ROI includes:
determining a third intensity of the reference ROI before enhancement;
determining a fourth intensity of the reference ROI after enhancement;
and determining, based on the third intensity and the fourth intensity, the second enhancement degree of the reference ROI.
Claim 15 in its entirety is found non-obvious over the prior art, including the following limitations:
wherein determining the second enhancement degree of the second image includes:
determining a third intensity of the second image of the reference ROI before enhancement;
determining a fourth intensity of the second image of the reference ROI after enhancement;
and determining, based on the third intensity and the fourth intensity, the second enhancement degree of the second image.
Claims 25-26 depend on claim 4 and claims 27-28 depend on claim 15 and are therefore likewise considered to contain allowable subject matter.
Regarding claim 22, the closest prior art, Molloi (US 10898150 B2), discloses determining a confidence level of an enhancement level. Molloi does not disclose expressly the confidence level being based on a value of the enhancement level deviating from a preset range and when the confidence level deviating from a preset range exceeds a threshold adjusting the enhancement level of the target tissue.
Therefore, claim 22 is considered to contain allowable subject matter because the prior art does not teach, suggest, or provide motivation to combine multiple prior art references before the effective filing date of this application to teach the entirety of claim 22 in a non-obvious manner.
Claim 22 in its entirety is found non-obvious over the prior art, including the following limitations:
the determining the one or more target parameters based on the target region further includes: determining the confidence level of the enhancement level based on a value of the enhancement level deviating from a preset range;
in response to determining that the value of the enhancement level deviating from the preset range exceeds a threshold, adjusting the enhancement level of the target tissue.
Claims 23 and 24 depend on claim 22 and are therefore likewise considered to contain allowable subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Peter et al., US 20230355105 A1, discloses a system which detects vulnerable atherosclerotic plaques based on intensity of the received signal.
Stocker et al., US 20210298611 A1, discloses a system which detects unstable plaque based on a change in contrast before and after infusion of a contrast agent.
Hamilton et al., US 20100137711 A1, discloses a system which detects whether plaque is stable or vulnerable based on a comparison of pixel intensity of the plaque.
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/JOSHUA B. CROCKETT/Examiner, Art Unit 2661
/JOHN VILLECCO/Supervisory Patent Examiner, Art Unit 2661