DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The preliminary Amendment filed 13 March 2024 has been entered and considered. Claims 13-14 have been amended. Claims 1-14 are all the claims pending in the application.
Priority
This application claims benefit of foreign priority under 35 U.S.C. 119(a)-(d) of Application No. CN202111073928.9, filed in China on 09/14/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/13/2024 was considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Claim 12 recites the limitations “intravascular image obtaining module”, “extravascular image obtaining module”, “registration module”, and “fractional flow reserve determining module”. These limitations have been interpreted under 112(f) as a means plus function because of the combination of the non-structural, generic placeholder “intravascular image obtaining module”, “extravascular image obtaining module”, “registration module”, and “fractional flow reserve determining module”, as well as their respective functional languages “configured to obtain an intravascular image…”, “configured to obtain an extravascular image…”, “configured to perform registration…”, and “configured to determine a target fractional flow reserve…” and is being interpreted collectively as “memory 910 can be used to store a software program and a module, and the processor 920 executes various functional applications and data processing by running and executing the software program and the module stored in the memory 910 and calling the data stored in the memory 910” that corresponds to the structure found in the disclosure (p. 23, par. 3 and Fig. 9).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 14 is rejected under 35 U.S.C. 112(b) because the claimed invention is not clearly a device nor a method. In Ex Parte Miyazaki, the BPAI held “that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite.” Ex Parte Miyazaki, 89 USPQ2d 1207, 11-12 (Bd. Pat. App. & Int. 2008).
Claim Rejections - 35 USC § 101
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. In particular, Claim 14 is directed to a computer-readable storage medium. The United States Patent and Trademark Office (USPTO) is obliged to give claims their broadest reasonable interpretation consistent with the specification during proceedings before the USPTO. See In re Zletz, 893F.2d 319 (Fed. Cir. 1989) (during patent examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of Claim 14 drawn to a computer readable medium covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter). Applicants are advised to amend Claim 14 to recite “A non-transitory computer-readable storage medium…” in order to overcome the rejection.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-9, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xiang et al. (C.N. Patent Pub No. 111134651 A, hereafter referred as Xiang).
Regarding Claim 1:
Xiang teaches an FFR determination method based on multi-modal medical image (Xiang: Par. [0049]; method for calculating blood reserve fraction based on intra-cavity image), comprising: obtaining an intravascular image comprising a blood vessel segment of interest; obtaining an extravascular image comprising a blood vessel segment to be detected, wherein the blood vessel segment to be detected at least partially coincides with the blood vessel segment of interest (Xiang: Par. [0055-0057]; step S1, the intra-cavity image data is obtained by introducing a high-frequency micro-ultrasonic probe into the coronary blood vessel cavity of interest by using a catheter using a catheter to detect; the coronary angiography image data is obtained by digital silhouette angiography (ICA) technology; the image data in the cavity is obtained by arranging the multiple blood vessel images obtained in the coronary blood vessel of the IVUS/OCT device in sequence; wherein the image data in the cavity is the IVUS/OCT device for detecting the pathological changes in the coronary artery); performing registration on the intravascular image and the extravascular image to obtain a registration result (Xiang: Par. [0061]; mapping the vascular segmentation image to the three-dimensional catheter path according to the catheter central position of each segmented blood vessel image; constructing to obtain coronary artery blood vessel model of three-dimensional form); and determining a target fractional flow reserve based on multi-modal medical image by using the registration result on the basis of the intravascular image and the extravascular image (Xiang: Par. [0052-0053]; step S2, calculating blood flow equation according to the three-dimensional blood vessel model and fluid dynamics method, to obtain blood dynamic parameter distribution of coronary artery of three-dimensional blood vessel model expression area; step S3, according to the blood dynamic parameter obtained in step S2, calculating to obtain the blood flow reserve fraction).
In regards to Claim 3, Xiang further teaches the method according to claim 1, wherein the determining a target fractional flow reserve based on multi-modal medical image by using the registration result on the basis of the intravascular image and the extravascular image comprises: determining a first retracement curve corresponding to a fractional flow reserve of the blood vessel segment of interest based on the intravascular image; determining a second retracement curve corresponding to a fractional flow reserve of the blood vessel segment to be detected based on the extravascular image (Xiang: Par. [0097-0098] and Figs. 10-11; the hemodynamics parameter may include patient height, weight, heart rate, systolic and diastolic blood pressure, hematocin, blood viscosity, blood density, blood flow and the like; hemodynamics parameter further comprises physiological medical test result (cardiac cycle, blood pressure, blood, hemoglobin, platelets, electrocardiogram, gene, family history and so on), image data/segmentation data/reconstruction geometric data (cardiac size, coronary artery branch and topological structure; narrow position, narrow length, narrow section, calcified plaque, etc.); Fig. 10 is a schematic diagram of the mapping of the three-dimensional catheter path and the blood vessel ultrasonic image and Fig. 11 is a schematic diagram of the distribution of FFR numerical values); and determining a target fractional flow reserve based on multi-modal medical image by using the registration result on the basis of the first retracement curve and the second retracement curve (Xiang: Par. [0052-0053]; step S2, calculating blood flow equation according to the three-dimensional blood vessel model and fluid dynamics method, to obtain blood dynamic parameter distribution of coronary artery of three-dimensional blood vessel model expression area; step S3, according to the blood dynamic parameter obtained in step S2, calculating to obtain the blood flow reserve fraction).
In regards to Claim 4, Xiang further teaches the method according to claim 3, wherein the determining a first retracement curve corresponding to a fractional flow reserve of the blood vessel segment of interest based on the intravascular image comprises: obtaining a blood flow velocity of the blood vessel segment to be detected; and determining a first retracement curve corresponding to a fractional flow reserve of the blood vessel segment of interest based on the intravascular image and the blood flow velocity (Xiang: Par. [0097-0098] and Figs. 10-11; the hemodynamics parameter may include patient height, weight, heart rate, systolic and diastolic blood pressure, hematocin, blood viscosity, blood density, blood flow and the like; hemodynamics parameter further comprises physiological medical test result (cardiac cycle, blood pressure, blood, hemoglobin, platelets, electrocardiogram, gene, family history and so on), image data/segmentation data/reconstruction geometric data (cardiac size, coronary artery branch and topological structure; narrow position, narrow length, narrow section, calcified plaque, etc.); Fig. 10 is a schematic diagram of the mapping of the three-dimensional catheter path and the blood vessel ultrasonic image and Fig. 11 is a schematic diagram of the distribution of FFR numerical values).
In regards to Claim 5, Xiang further teaches the method according to claim 3, wherein the determining a first retracement curve corresponding to a fractional flow reserve of the blood vessel segment of interest based on the intravascular image comprises: obtaining a first branch blood vessel information of the blood vessel segment of interest, wherein the first branch blood vessel information comprises branch opening information obtained based on the intravascular image, and branch information obtained based on the extravascular image; and determining a first retracement curve corresponding to a fractional flow reserve of the blood vessel segment of interest based on the intravascular image and the first branch blood vessel information (Xiang: Par. [0097-0098] and Figs. 10-11; the hemodynamics parameter may include patient height, weight, heart rate, systolic and diastolic blood pressure, hematocin, blood viscosity, blood density, blood flow and the like; hemodynamics parameter further comprises physiological medical test result (cardiac cycle, blood pressure, blood, hemoglobin, platelets, electrocardiogram, gene, family history and so on), image data/segmentation data/reconstruction geometric data (cardiac size, coronary artery branch and topological structure; narrow position, narrow length, narrow section, calcified plaque, etc.); Fig. 10 is a schematic diagram of the mapping of the three-dimensional catheter path and the blood vessel ultrasonic image and Fig. 11 is a schematic diagram of the distribution of FFR numerical values).
In regards to Claim 6, Xiang further teaches the method according to claim 3, wherein the determining a second retracement curve corresponding to a fractional flow reserve of the blood vessel segment to be detected based on the extravascular image comprises: obtaining a blood flow velocity of the blood vessel segment to be detected; and determining a second retracement curve corresponding to a fractional flow reserve of the blood vessel segment to be detected based on the extravascular image and the blood flow velocity (Xiang: Par. [0097-0098] and Figs. 10-11; the hemodynamics parameter may include patient height, weight, heart rate, systolic and diastolic blood pressure, hematocin, blood viscosity, blood density, blood flow and the like; hemodynamics parameter further comprises physiological medical test result (cardiac cycle, blood pressure, blood, hemoglobin, platelets, electrocardiogram, gene, family history and so on), image data/segmentation data/reconstruction geometric data (cardiac size, coronary artery branch and topological structure; narrow position, narrow length, narrow section, calcified plaque, etc.); Fig. 10 is a schematic diagram of the mapping of the three-dimensional catheter path and the blood vessel ultrasonic image and Fig. 11 is a schematic diagram of the distribution of FFR numerical values).
In regards to Claim 7, Xiang further teaches the method according to claim 3, wherein the determining a second retracement curve corresponding to a fractional flow reserve of the blood vessel segment to be detected based on the extravascular image comprises: obtaining a second branch blood vessel information of the blood vessel segment to be detected, wherein the second branch blood vessel information comprises branch opening information obtained based on the intravascular image, and branch information obtained based on the extravascular image; and determining a second retracement curve corresponding to a fractional flow reserve of the blood vessel segment to be detected based on the extravascular image and the second branch blood vessel information (Xiang: Par. [0097-0098] and Figs. 10-11; the hemodynamics parameter may include patient height, weight, heart rate, systolic and diastolic blood pressure, hematocin, blood viscosity, blood density, blood flow and the like; hemodynamics parameter further comprises physiological medical test result (cardiac cycle, blood pressure, blood, hemoglobin, platelets, electrocardiogram, gene, family history and so on), image data/segmentation data/reconstruction geometric data (cardiac size, coronary artery branch and topological structure; narrow position, narrow length, narrow section, calcified plaque, etc.); Fig. 10 is a schematic diagram of the mapping of the three-dimensional catheter path and the blood vessel ultrasonic image and Fig. 11 is a schematic diagram of the distribution of FFR numerical values).
In regards to Claim 13, Xiang further teaches an electronic device, wherein the electronic device comprises a processor and a memory, at least one instruction or at least one program is stored in the memory, and the at least one instruction or the at least one program is loaded and executed by the processor to implement the FFR determination method based on multi-modal medical image according to claim 1 (Xiang: Par. [0007]; method for calculating blood flow reserve fraction based on intra-cavity image, device, computer device and storage medium).
In regards to Claim 14, Xiang further teaches a computer-readable storage medium, wherein at least one instruction or at least one program is stored in the computer-readable storage medium, and the at least one instruction or at least one program is loaded and executed by a processor to implement the FFR determination method based on multi-modal medical image according to claim 1 (Xiang: Par. [0007]; method for calculating blood flow reserve fraction based on intra-cavity image, device, computer device and storage medium).
Regarding Claim 12:
Xiang further teaches an FFR determination apparatus based on multi-modal medical image (Xiang: Par. [0007]; method for calculating blood flow reserve fraction based on intra-cavity image, device, computer device and storage medium), comprising: an intravascular image obtaining module, configured to obtain an intravascular image comprising a blood vessel segment of interest; an extravascular image obtaining module, configured to obtain an extravascular image comprising a blood vessel segment to be detected, wherein the blood vessel segment to be detected at least partially coincides with the blood vessel segment of interest (Xiang: Par. [0055-0057]; step S1, the intra-cavity image data is obtained by introducing a high-frequency micro-ultrasonic probe into the coronary blood vessel cavity of interest by using a catheter using a catheter to detect; the coronary angiography image data is obtained by digital silhouette angiography (ICA) technology; the image data in the cavity is obtained by arranging the multiple blood vessel images obtained in the coronary blood vessel of the IVUS/OCT device in sequence; wherein the image data in the cavity is the IVUS/OCT device for detecting the pathological changes in the coronary artery); a registration module, configured to perform registration on the intravascular image and the extravascular image to obtain a registration result (Xiang: Par. [0061]; mapping the vascular segmentation image to the three-dimensional catheter path according to the catheter central position of each segmented blood vessel image; constructing to obtain coronary artery blood vessel model of three-dimensional form); and a fractional flow reserve determining module, configured to determine a target fractional flow reserve based on multi-modal medical image by using the registration result on the basis of the intravascular image and the extravascular image (Xiang: Par. [0052-0053]; step S2, calculating blood flow equation according to the three-dimensional blood vessel model and fluid dynamics method, to obtain blood dynamic parameter distribution of coronary artery of three-dimensional blood vessel model expression area; step S3, according to the blood dynamic parameter obtained in step S2, calculating to obtain the blood flow reserve fraction).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Xiang et al. (C.N. Patent Pub No. 111134651 A, hereafter referred as Xiang) in view of Yu et al. (U.S. Patent App. Pub No. 2019/0110776 A1, hereafter referred as Yu).
In regards to Claim 2, Xiang fails to further teach the method according to claim 1, wherein the performing registration on the intravascular image and the extravascular image to obtain a registration result comprises: obtaining a first feature information of the blood vessel segment of interest in the intravascular image, wherein the first feature information comprises internal lumen information of the blood vessel segment of interest; obtaining a second feature information of the blood vessel segment to be detected in the extravascular image, wherein the second feature information comprises external lumen information of the blood vessel segment to be detected; and performing registration based on the first feature information and the second feature information to obtain a registration result.
Yu, like Xiang, is directed to intravascular interventional imaging medical devices. Yu in combination with Xiang does teach wherein the performing registration on the intravascular image and the extravascular image to obtain a registration result comprises: obtaining a first feature information of the blood vessel segment of interest in the intravascular image, wherein the first feature information comprises internal lumen information of the blood vessel segment of interest (Yu: Par. [0035] and Fig. 1; in FIG. 1, the lumen volume V is calculated from the morphological parameters measured using intravascular imaging based on the high precision registration model); obtaining a second feature information of the blood vessel segment to be detected in the extravascular image, wherein the second feature information comprises external lumen information of the blood vessel segment to be detected (Yu: Par. [0007]; measure lumen morphology and vascular resistance, in particular related to a method to compute FFR indirectly using OCT images); and performing registration based on the first feature information and the second feature information to obtain a registration result (Xiang: Par. [0061]; mapping the vascular segmentation image to the three-dimensional catheter path according to the catheter central position of each segmented blood vessel image; constructing to obtain coronary artery blood vessel model of three-dimensional form).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xiang to utilize the lumen information, as taught by Yu, to arrive at the claimed invention discussed above. Such a modification is the result of combining prior art elements according to known methods to yield predictable results. As taught by Yu, the proposed modification would address the problems of high complexity, high cost and low precision associated with the current methods for measuring coronary artery parameters (Yu: Par. [0010]).
In regards to Claim 10, Xiang as modified by Yu further teaches the method according to claim 1, wherein the determining a target fractional flow reserve based on multi-modal medical image by using the registration result on the basis of the intravascular image and the extravascular image comprises: obtaining a first feature information of the blood vessel segment of interest in the intravascular image, wherein the first feature information comprises internal lumen information of the blood vessel segment of interest (Yu: Par. [0035] and Fig. 1; in FIG. 1, the lumen volume V is calculated from the morphological parameters measured using intravascular imaging based on the high precision registration model); obtaining a second feature information of the blood vessel segment to be detected in the extravascular image, wherein the second feature information comprises external lumen information of the blood vessel segment to be detected (Yu: Par. [0007]; measure lumen morphology and vascular resistance, in particular related to a method to compute FFR indirectly using OCT images); and calculating the target fractional flow reserve based on multi-modal medical image by using the registration result on the basis of the first feature information and the second feature information (Xiang: Par. [0052-0053]; step S2, calculating blood flow equation according to the three-dimensional blood vessel model and fluid dynamics method, to obtain blood dynamic parameter distribution of coronary artery of three-dimensional blood vessel model expression area; step S3, according to the blood dynamic parameter obtained in step S2, calculating to obtain the blood flow reserve fraction).
In regards to Claim 11, Xiang as modified by Yu further teaches the method according to claim 1, wherein the determining a target fractional flow reserve based on multi-modal medical image by using the registration result on the basis of the intravascular image and the extravascular image comprises: performing image fusion on the intravascular image and the extravascular image by using the registration result to obtain a fused image; obtaining fusion feature information of the blood vessel segment to be detected in the fused image (Xiang: Par. [0061]; mapping the vascular segmentation image to the three-dimensional catheter path according to the catheter central position of each segmented blood vessel image; constructing to obtain coronary artery blood vessel model of three-dimensional form), wherein the fusion feature information comprises fusion lumen information (Yu: Par. [0035] and Fig. 1; in FIG. 1, the lumen volume V is calculated from the morphological parameters measured using intravascular imaging based on the high precision registration model; Par. [0007]; measure lumen morphology and vascular resistance, in particular related to a method to compute FFR indirectly using OCT images); and calculating the target fractional flow reserve based on multi-modal medical image on the basis of the fusion feature information (Xiang: Par. [0052-0053]; step S2, calculating blood flow equation according to the three-dimensional blood vessel model and fluid dynamics method, to obtain blood dynamic parameter distribution of coronary artery of three-dimensional blood vessel model expression area; step S3, according to the blood dynamic parameter obtained in step S2, calculating to obtain the blood flow reserve fraction).
Allowable Subject Matter
Claims 8-9 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.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 8 recites, wherein the determining a target fractional flow reserve based on multi-modal medical image by using the registration result on the basis of the first retracement curve and the second retracement curve comprises: determining a first fractional flow reserve sequence based on the first retracement curve, wherein the first fractional flow reserve sequence is corresponding to a first blood vessel position sequence of the blood vessel segment of interest in the intravascular image; determining a second fractional flow reserve sequence based on the second retracement curve, wherein the second fractional flow reserve sequence is corresponding to a second blood vessel position sequence of the blood vessel segment to be detected in the extravascular image, and the second blood vessel position sequence at least partially coincides with the first blood vessel position sequence; fusing the first fractional flow reserve sequence and the second fractional flow reserve sequence by using the registration result to obtain a target fractional flow reserve sequence; and determining a target fractional flow reserve based on multi-modal medical image on the basis of the target fractional flow reserve sequence. The cited art of record does not teach or suggest such a combination of features.
Claim 9 is allowed by virtue of its dependency on Claim 8.
Because the cited art of record, alone or in combination, does not teach or suggest each and every feature of dependent Claims 8-9, these claims would be allowable.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Edic et al. (U.S. Patent App. Pub No. 2013/0226003 A1) teaches approaches for assessing hemodynamic characteristics for an organ of interest.
Schmitt et al. (U.S. Patent App. Pub No. 2013/0072805 A1) teaches automatically locating in an image of a blood vessel the lumen boundary at a position in the vessel and from that measuring the diameter of the vessel.
Conclusion
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/RENAE A BITOR/Examiner, Art Unit 2663
/GREGORY A MORSE/Supervisory Patent Examiner, Art Unit 2698
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