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 .
Response to Arguments
Regarding claim objections
Examiner notes that the previously set forth claim objections are withdrawn in view of the amendments to the claims, however, new claim objection is necessitated by amendment.
Regarding 35 U.S.C. 112
Examiner notes that the previously set forth 112(b) rejections are withdrawn in view of the amendments to the claims.
Regarding 35 U.S.C. 101
Examiner notes that the 101 rejections of claims 19-20 are withdrawn in view of the amendments to the claims.
Applicant's arguments filed 10/03/2025 with respect to 101 have been fully considered but they are not persuasive. For example, applicant argues “that claims 1-12 and 14-20 are not directed to a judicial exception” and specifically arguing that “applicant disagrees that a physician can look at intravascular ultrasound (IVU) data and identify a mapping that would angularly align the frames in one run of IVUS data with frames in another run of IVUS data as claimed” and “a human, even with the aid of pen and paper, cannot practically review multiple IVUS runs and identify a mapping that includes mapping between the two runs that would align the runs angularly as claimed” (REMARKS pg. 8). Examiner respectfully disagrees, in that first the claims are broad and do not necessarily require two different runs. In other words, the claims merely require acquiring a first and second series of IVUS images which may be performed in the same run. Nonetheless, examiner notes applicant’s arguments are merely conclusory without providing evidence as to why a person having ordinary skill in the art with pen and paper or in the mind could not reasonably determine a mapping including an angular offset. Examiner notes that a person could reasonably identify a mapping including an angular offset by evaluating the images themselves (where the claim recites a plurality of images thus only requires two images thus a person could observe two images from each series to determine a mapping including an angular offset) or could determination the mapping in the way the probe/transducer is manipulated during the acquisition, the claim does not recite the manner in which the angular offset is determined which would preclude a person having ordinary skill in the art from determining such a mapping. Therefore, examiner notes that determination of an angular offset between the first plurality of images and the second plurality of images could reasonably be performed by a human as previously set forth and applicant’s arguments are not found persuasive.
Applicant further argues “Independent claims 1, 14, and 19 integrate the alleged judicial exceptions into a practical application of a system to that presents a GUI where multiple IVUS runs are aligned” and points to paragraph [0053] of the originally filed specification. In response to applicant's argument and further argues “this provides an improvement to intravascular ultrasound imaging technology in that a GUI can be presented where multiple runs are viewed in alignment” and that the generating of the GUI is “not merely ‘insignificnat post-solution activity’ but is instead the entire focus of the claimed activity, which is to present aligned IVUS runs to a physician to enable the physician ‘ to observe a more direct understanding of their treatment of the vessel, for example, by observing the difference in lesion properties with a side-by-side comparison” (REMARKS pg. 9-11). It is noted that the features upon which applicant relies (i.e., a GUI where multiple IVUS runs are aligned) 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). In this case, it is noted that the claim merely recites “generating… a graphical user interface (GUI), the GUI comprising indications of the first series of IVUS images and the second series of IVUS images based on the mapping between the first plurality of frames and the second plurality of frames”. Such generating of a GUI comprising indications of the images does not require multiple IVUS runs to be aligned and does not require the GUI to include the images at all but rather indications of the images and based on the mapping does not require any aligning of images. Furthermore, it is noted that aligning/correlating indications/images based on the offsets as recited in dependent claims 4-5 amongst others is broadly recited and merely requires the images to be physically aligned without specifically reciting the nature of alignment/correlation and how it is based on the angular/longitudinal offsets. For at least the reasons listed above, applicant’s arguments are not found persuasive.
Regarding Double Patenting
Applicant's arguments filed 10/03/2025 have been fully considered but they are not persuasive. For example, applicant argues “the rejection is premature and applicant respectfully request that it be held in abeyance until at least one of the rejected claims is allowed by the Office” (REMARKS pg. 7). Examiner respectfully notes that such a request is not considered a complete response to a provisional nonstatutory double patenting rejection (See MPEP 804.I.1). Specifically a complete response is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 and is required even when the nonstatutory double patenting rejection is provisional. Such a filing should not be held in abeyance (See MPEP 804.I.1).
The provisional non-statutory double patenting rejection is maintained/updated in view of the amendments to the claims as no terminal disclaimer has been provided and no arguments are specifically made against the rejection which may be considered for withdrawal of the rejection.
Regarding prior art
Applicant’s arguments with respect to claims 1-12 and 14-20 have been considered but are moot in view of the new grounds of rejection necessitated by amendment. Specifically, examiner notes that the claims are now relied upon with respect to Sakaguchi alone and applicant’s arguments that the additionally cited reference fails to cure the deficiencies of the primary reference are found unpersuasive as Sakaguchi teaches all of the elements of claims 1, 14, and 19 (see below rejection for further detail).
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites the limitation “the one of the first plurality of frames and the one of the second plurality of frames”, however, the limitation should read –[[the]] one of the first plurality of frames and [[the]] one of the second plurality of frames—as these elements are not previously set forth in claim 1.
Appropriate correction is required.
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 1-12 and 14-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea without significantly more.
In a test for patent subject matter eligibility, the claims pass Step 1 (see 2019 Revised Patent Subject Matter Eligibility), as they are related to a process, machine, manufacture, or composition of matter.
When assessed under Step2A, Prong I, Independent claims 1, 14, and 19 are found to recite a judicial exception (i.e. abstract idea). In this instance, claims 1, 14, and 19 recite the limitations “determine/determining a mapping between the first plurality of frames and the second plurality of frames, wherein the mapping includes an angular offset”. The cited limitations, under their broadest reasonable interpretation, encompass a mental process (i.e. abstract idea) of determining a mapping including an angular offset which can be performed in the mind or by a human using a pen and a paper (e.g. observation, evaluation, judgment, opinion). In other words, a person could reasonably evaluate a set of images and associated data thereof and determine a mapping including an angular offset between the two such as a distance/orientation between features or other types of mapping. Examiner notes that with the exception of generic computer-implemented steps (e.g. processor recited in claims 14 and 19), there is nothing in the claims that preclude the limitation from being performed by a human, mentally or with pen and paper, thus the cited limitation(s) recites a judicial exception (MPEP 2106.04(a)) and the claim must be reviewed under Step 2A, Prong II to determine patent eligibility.
Step 2A, Prong II determines whether any claim recites an additional element that integrates the judicial exception into a practical application. Independent claims recites the following additional element(s):
Receive/receiving a first series of intravascular ultrasound (IVUS) images of a vessel of a patient, the first series of IVUS images comprising a first plurality of frames;
Receive/receiving a second series of intravascular ultrasound (IVUS) images of the vessel of the patient, the second series of IVUS images comprising a second plurality of frames;
Generate a graphical user interface (GUI), the GUI comprising indications of the first series of IVUS images and the second series of IVUS images based on the mapping between the first plurality of frames and the second plurality of frames.
A memory
A processor
The additional elements in the cited independent claims are not found to integrate the judicial exception into a practical application. In this case, a memory and a processor are merely generic components of an IVUS system, receiving a first and second series of intravascular ultrasound images is considered merely insignificant extra-solution activity of data gathering in the field of intravascular ultrasound and generating a graphical user interface (GUI) comprising indications of the first series of IVUS images and the second series of IVUS images is considered merely insignificant extra-solution activity of displaying data (e.g. the first and second series of IVUS images or indications thereof) where based on the mapping is broadly recited and merely requires the GUI to include the indications after a determination of the mapping. These elements are seen as adding insignificant extra-solution activity to the judicial exception. They do no more than link the judicial exception to a particular technological environment or field of use. Therefore, under step 2A Prong II the Judicial exception is not integrated into a practical application by additional elements of independent claims 1, 14, and 19 and the claims must be reviewed under Step 2B to determine patent eligibility.
Step 2B determines where a claim amounts to significantly more.
The additional element(s) listed above do not amount to significantly more than the judicial exception. In this instance, as noted above, the additional elements amount to merely insignificant extra-solution activity. Additionally there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. Therefore, under Step 2B in a test for patent subject matter eligibility, the judicial exception of the independent claim(s) do not amount to significantly more and the independent claim(s) remain patent ineligible.
Dependent claims 2-12, 15-18, and 20 further limit the abstract idea of independent claims 1, 14, and 19. When analyzed as a whole, these claims are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed towards an abstract idea and do not sufficiently integrate the subject matter into a practical application or recite elements which constitute significantly more than the abstract ideas identified. The dependent claims are directed toward additional elements which encompass abstract ideas
In this instance, dependent claims recite the following limitations:
Identify/ing a one of the first plurality of frames comprising a particular vessel fiducial (claims 2, 15, and 20)
Identify/ing a one of the second plurality of frames comprising the particular fiducial (claims 2, 15, and 20)
Wherein the mapping further comprises a longitudinal offset (claims 3 and 16)
Determining the mapping between the first plurality of frames and the second plurality of frames… to infer the mapping based on the first series of IVUS images and the second series of IVUS images (claim 12)
To infer the one of the first plurality of frames (claims 7 and 17)
To infer the one of the second plurality of frames (claims 7 and 17)
The cited limitation(s), under their broadest reasonable interpretation, encompass mental processes (i.e. abstract idea) which can be performed in the mind or by a human using a pen and a paper (e.g. observation, evaluation, judgment, opinion). In other words, a human could reasonably identify/infer a one of the first or second plurality of frames comprising a particular vessel fiducial through evaluation/observation, determine an offset through evaluation, determine/infer the mapping. Examiner notes that with the exception of generic computer-implemented steps (e.g. processor), there is nothing in the claims that preclude the limitation from being performed by a human, mentally or with pen and paper, thus the claimed limitation is considered to be directed towards a judicial exception (MPEP 2106.04(a)).
Under Step 2A, Prong II for dependent claims 4-6, 7-12, 15-18, and 20, present additional elements which only further narrow the judicial exceptions (e.g. claims 4 and 16 which recites indications of the first series of IVUS images and the second series of IVUS images aligned based on the angular offset and longitudinal offset which amounts to merely insignificant extra-solution activity of images in an aligned manner, claims 5, 6, and 16 which recite that the indications comprise an on-axis view/a longitudinal view of the first series of IVUS images and the second series of IVUS images and wherein the on-axis views/longitudinal views are correlated with each other based on the offset which amounts to merely providing images which are correlated where correlation, claims 7 and 17 which recite execute/executing a machine learning (ML) model which is recited at such a highly generic level that it merely amounts to applying a judicial exception with a generic computer, claims 8, 15 and 16 which further narrow a particular vessel fiducial, claims 9 and 18 which further narrow the nature in which the IVUS images are received, claims 10 and 11 which further narrow the timing at which the first and second series are captured, claim 12 which recites executing a machine learning (ML) model which is recited with at such a highly generic level that it amounts to merely applying a judicial exception with a generic computer), and provide no additional element which are found to integrate the judicial exception into a practical application.
These dependent claims include no additional claims that are sufficient to amount to significantly more than the judicial exception. Additionally, there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. As discussed above with respect to integration of the abstract idea into a practical application, the additional claims do not provide any additional elements that would amount to significantly more than the judicial exception. Under Step 2B, these claims are not patent eligible.
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 1-12, and 14-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WIPO Sakaguchi (WO 2023189308 A1), hereinafter, Sakaguchi. Examiner notes that text citations to Sakaguchi are with reference to the translated copy provided herein.
Regarding claims 1, 14, and 19,
Sakaguchi discloses an apparatus for an intravascular imaging system (at least fig. 1 (100) and corresponding disclosure in at least pg. 2 second to last paragraph describing fig. 1), comprising:
a processor (at least fig. 1 and 5 (3) and corresponding disclosure in at least pg. 5 second paragraph describing fig. 5);
and a memory device (at least fig. 5 (32, 36, and/or 30) and corresponding disclosure in at least pg. 5 third-fourth paragraphs) coupled to the processor (3), the memory device (32) comprising instructions (pg. 5 fourth full paragraph describing computer program) executable by the processor, which instructions when executed by the processor cause the intravascular imaging system to:
receive a first series of intravascular ultrasound (IVUS) images of a vessel of a patient, the first series of IVUS images comprising a first plurality of frames (at least fig. 7 (S111) and corresponding disclosure in at least pg. 7 last paragraph);
receive a second series of intravascular ultrasound (IVUS) images of the vessel of the patient, the second series of IVUS images comprising a second plurality of frames (at least fig. 7 (S113) and corresponding disclosure in at least ;
determine a mapping between the first plurality of frames and the second plurality of frames, wherein the mapping includes an angular offset (pg. 14 second paragraph which discloses For example, the processing unit 31 calculates the difference between the central angle of the calcified site image included in the representative frame image before processing and the central angle of the calcified site image included in the corresponding representative frame image after treatment. Then, the processing unit 31 similarly calculates the difference in center angle for the other representative frame images, calculates the correction amount of the rotation angle so that the sum of the differences is the minimum, and processes the IVUS image by the calculated correction amount);
and generate a graphical user interface (GUI), the GUI comprising indications of the first series of IVUS images and the second series of IVUS images based on the mapping between the first plurality of frames and the second plurality of frames (pg. 2 second to last paragraph which discloses he display device 4 and the input device 5 may be integrally stacked to form a touch panel. Furthermore, the input device 5 and the image processing device 3may be configured as one unit the processing unit 31 associates the pre-treatment and post-treatment IVUS images P1 so that the longitudinal positions of the plurality of calcified sites match (step S422). For example, when a calcified site image is included in a plurality of consecutive IVUS images P1, the processing unit 31recognizes the plurality of IVUS images P1 as one group, and selects an IVUS image P1 at the center in the longitudinal direction of the blood vessel. Specify as a representative frame image. The processing unit 31 treats as a pair the representative frame image before treatment and the representative frame image after treatment whose distance is closest in the longitudinal direction, and calculates the distance between the representative frame images. When there are multiple sets of representative frame images, the processing unit 31 calculates the distance between each representative frame image, finely adjusts the longitudinal position of the IVUS image P1 so that the sum of the distances is the minimum, and takes appropriate action. The previous IVUS image P1 and the post-treatment IVUS image P1 are associated. Next, the processing unit 31 corrects the rotation angle of the IVUS image P1 so that the center angles of the calcified site images in the IVUS image P1 match. See also fig. 10 and disclosure in at least pg. 6 third full paragraph)
Regarding claims 2, 8, 15 and 20,
Sakaguchi further discloses the instructions when executed by the processor further cause the intravascular imaging system to determine the mapping between the first plurality of frames and the second plurality of frames by identifying a one of the first plurality of frames comprising a particular vessel fiducial (pg. 13 sixth full paragraph which discloses the processing unit 31 executes image recognition processing of the IVUS image P1 by inputting the plurality of IVUS images P1 acquired before and after the treatment to the IVUS image recognition learning model 61, and detects calcification. The part image is recognized (step S421) and the processing unit 31 identifies a frame image of the IVUS image P1 including the calcified site image. See also fig. 15 depicting the pre-treatment IVUS images arranged in the longitudinal direction with the hatched part showing images comprising calcified sites as disclosed in pg. 13 seventh full paragraph);
Identifying a one of the second plurality of frames comprising the particular vessel fiducial (pg. 13 sixth full paragraph which discloses the processing unit 31 executes image recognition processing of the IVUS image P1 by inputting the plurality of IVUS images P1 acquired before and after the treatment to the IVUS image recognition learning model 61, and detects calcification. The part image is recognized (step S421) and the processing unit 31 identifies a frame image of the IVUS image P1 including the calcified site image. See also fig. 15 depicting the post-treatment IVUS images arranged in the longitudinal direction with the hatched part showing images comprising calcified sites as disclosed in pg. 13 seventh full paragraph),
wherein the particular vessel fiducial is a calcium morphology (pg. 13 sixth full paragraph which discloses plurality of IVUS images P1 acquired before and after the treatment to the IVUS image recognition learning model 61, and detects calcification)
Regarding claim 3,
Sakaguchi further discloses wherein the mapping further comprises a longitudinal offset, wherein the angular offset and the longitudinal offset are between the one of the first plurality of frames and the one of the second plurality of frames (pg. 14 first full paragraph which discloses The processing unit 31 treats as a pair the representative frame image before treatment and the representative frame image after treatment whose distance is closest in the longitudinal direction, and calculates the distance between the representative frame images. When there are multiple sets of representative frame images, the processing unit 31 calculates the distance between each representative frame image, finely adjusts the longitudinal position of the IVUS image P1 so that the sum of the distances is the minimum, and takes appropriate action and pg. 14 second full paragraph which discloses for example, the processing unit 31 calculates the difference between the central angle of the calcified site image included in the representative frame image before processing and the central angle of the calcified site image included in the corresponding representative frame image after treatment. Then, the processing unit 31 similarly calculates the difference in center angle for the other representative frame images, calculates the correction amount of the rotation angle so that the sum of the differences is the minimum, and processes the IVUS image by the calculated correction amount. By rotating P1, the orientation of the IVUS image P1 is corrected. In the example shown in FIG. 15, by subtracting the circumferential angle of the IVUS image P1 after).
Regarding claim 4,
Sakaguchi further discloses wherein the indications of the first series of IVUS images and the second series of IVUS images are aligned based on the angular offset and the longitudinal offset (pg. 14 first-third paragraph disclosing associating and aligning the indications based on both the angular offset (i.e. difference in orientation/angle) and the longitudinal offset).
Regarding claim 5,
Sakaguchi further discloses wherein the indications of the first series of IVUS images and the second IVUS images comprise an on-axis view of the first series of IVUS images and the second series of IVUS images and wherein the on-axis views are correlated with each other based on the angular offset and the longitudinal offset (pg. 14 fourth full paragraph which discloses as described above, according to the image processing device 3 and the like according to the fourth embodiment, compared to the first embodiment, the longitudinal position of the blood vessel can be aligned more accurately and the IVUS images P1 before and after the treatment can be displayed in association with each other where the IVUS images P1 before and after may be cross-sectional or on-axis views as depicted in fig. 10 and/or fig. 15).
Regarding claim 6,
Sakaguchi further discloses wherein the indications comprise a longitudinal view of the first series of IVUS images and the second series of IVUS images longitudinal views are correlated with each other based on the angular offset and the longitudinal offset (pg. 14 first-fourth full paragraph which discloses as described above, according to the image processing device 3 and the like according to the fourth embodiment, compared to the first embodiment, the longitudinal position of the blood vessel can be aligned more accurately and the IVUS images P1 before and after the treatment can be displayed in association with each other where the IVUS images P1 before and after may be longitudinal views as depicted in fig. 10 and/or 15),
Regarding claims 7 and 17,
Sakaguchi further discloses comprising:
Executing a machine Learning (ML) model (pg. 6 fifth full paragraph which discloses IVUS image recognition learning model 61 is, for example, a convolutional neural network) to infer the one of the first plurality of frames comprising the particular vessel fiducial based on the first series of IVUS images (pg. 13 sixth full paragraph which discloses the processing unit 31 executes image recognition processing of the IVUS image P1 by inputting the plurality of IVUS images P1 acquired before and after the treatment to the IVUS image recognition learning model 61, and detects calcification. The part image is recognized (step S421) and the processing unit 31 identifies a frame image of the IVUS image P1 including the calcified site image. See also fig. 15 depicting the pre-treatment IVUS images arranged in the longitudinal direction with the hatched part showing images comprising calcified sites as disclosed in pg. 13 seventh full paragraph); and
Executing the ML model (pg. 6 fifth full paragraph which discloses IVUS image recognition learning model 61 is, for example, a convolutional neural network) to infer the one of the second plurality of frames comprising the particular vessel fiducial based on the second series of IVUS images (pg. 13 sixth full paragraph which discloses the processing unit 31 executes image recognition processing of the IVUS image P1 by inputting the plurality of IVUS images P1 acquired before and after the treatment to the IVUS image recognition learning model 61, and detects calcification. The part image is recognized (step S421) and the processing unit 31 identifies a frame image of the IVUS image P1 including the calcified site image. See also fig. 15 depicting the post-treatment IVUS images arranged in the longitudinal direction with the hatched part showing images comprising calcified sites as disclosed in pg. 13 seventh full paragraph)
Regarding claim 9,
Sakaguchi further discloses receiving the second series of IVUs images from an intravascular imaging device (at least fig. 1 (101) and corresponding disclosure in at least pg. 2 second to last paragraph) (pg. 5 second to last full paragraph which discloses The ultrasound line data generation unit 33 acquires the reflected wave signal of the ultrasound output from the ultrasound transmitting/receiving unit 12a of the intravascular examination apparatus 101 and pg. 8 fourth paragraph which discloses the processing unit 31 uses the ultrasound line data generation unit 33 to acquire a plurality of post-treatment IVUS images P1 (step S114). The processing unit 31 that executes the process in stepS114 functions as an acquisition unit that acquires a plurality of IVUS images P1 of the blood vessel while moving the sensor unit 12 along the running direction of the blood vessel. Then, the processing unit 31 stores the plurality of IVUS images P1 acquired after the treatment on the blood vessel in the storage unit 32 in association with the ID, imaging date and time, blood vessel name, lesion name, and treatment-related information (step S115)); and
receiving the first series of IVUS images from a memory storage device (pg. 17 eighth full paragraph which discloses a plurality of tomographic images acquired before the treatment and to be displayed in association with a plurality of tomographic images acquired after the treatment are read from the storage unit (i.e. memory storage device))
Regarding claim 10,
Sakaguchi further discloses wherein the first series of IVUS images acre captured during a pre-percutaneous coronary intervention (PCI) procedure (pg 6 third full paragraph which discloses thereby processing a plurality of IVUS images acquired before a predetermined treatment such as stent placement in a blood vessel and pg. 2 first paragraph which discloses As a minimally invasive treatment for ischemic heart disease such as angina pectoris or myocardialinfarction, endovascular treatment typified by percutaneous coronary intervention (PCI) is performed. IntraVascular Ultra Sound (
IVUS) and near-infrared optical coherence tomography (OFDI) are used for preoperative
diagnosis in endovascular treatment or to confirm postoperative results. Examiner notes that the stent placement is a percutaneous coronary intervention procedure).
Regarding claim 11,
Sakaguchi further discloses wherein the second series of IVUS images are captured during a post-PCI procedure (pg. 6 fourth full paragraph which discloses a process of aligning P1 and a plurality of IVUS images P1 acquired after the treatment in the longitudinal direction and displaying them is executed (see FIG. 10)).
Regarding claim 12,
Sakaguchi further discloses determining the mapping between the first plurality of frames and the second plurality of frames comprising executing a machine learning (ML) model (pg. 6 fifth full paragraph which discloses IVUS image recognition learning model 61 is, for example, a convolutional neural network) to infer the mapping based on the first series of IVUS images and the second series of IVUS images (pg. 13 sixth full paragraph which discloses the processing unit 31 executes image recognition processing of the IVUS image P1 by inputting the plurality of IVUS images P1 acquired before and after the treatment to the IVUS image recognition learning model 61, and detects calcification. The part image is recognized (step S421) and the processing unit 31 identifies a frame image of the IVUS image P1 including the calcified site image. Examiner notes that “to infer the mapping…” is directed to intended use, where it is noted that such execution of the machine learning model is capable of being used to infer the mapping based on the first series of IVUS images and the second series of IVUS images).
Regarding claims 16,
Sakaguchi further discloses wherein the angular offset is between the one of the first plurality of frames and the one of the second plurality of frames (pg. 14 first full paragraph which discloses The processing unit 31 treats as a pair the representative frame image before treatment and the representative frame image after treatment whose distance is closest in the longitudinal direction, and calculates the distance between the representative frame images. When there are multiple sets of representative frame images, the processing unit 31) and
Wherein the indications of the first series of IVUS images comprises indications of the first series of IVUS images and the second series of IVUS images are aligned based on the angular offset (pg. 14 second paragraph which discloses By rotating P1, the orientation of the IVUS image P1 is corrected. In the example shown in FIG. 15, by subtracting the circumferential angle of the IVUS image P1 after the treatment by 30 degrees, in other words, by rotating it clockwise by 30 degrees, the difference between the IVUS image P1 before the treatment and the IVUS image P1 after the treatment is you can align the orientation and fourth full paragraph which discloses as described above, according to the image processing device 3 and the like according to the fourth embodiment, compared to the first embodiment, the longitudinal position of the blood vessel can be aligned more accurately and the IVUS images P1 before and after the treatment can be displayed in association with each other),
Wherein the indications comprise an on-axis view of the first series of IVUS images and the second series of IVUS images and wherein the on-axis views are correlated with each other based on the offset (pg. 14 fourth full paragraph which discloses as described above, according to the image processing device 3 and the like according to the fourth embodiment, compared to the first embodiment, the longitudinal position of the blood vessel can be aligned more accurately and the IVUS images P1 before and after the treatment can be displayed in association with each other where the IVUS images P1 before and after may be cross-sectional or on-axis views as depicted in fig. 10), and
Wherein the indications comprise a longitudinal view of the first series of IVUS images and the second series of IVUS images longitudinal views are correlated with each other based on the offset (pg. 14 fourth full paragraph which discloses as described above, according to the image processing device 3 and the like according to the fourth embodiment, compared to the first embodiment, the longitudinal position of the blood vessel can be aligned more accurately and the IVUS images P1 before and after the treatment can be displayed in association with each other where the IVUS images P1 before and after may be longitudinal views as depicted in fig. 10 and/or 15).
Regarding claim 18,
Sakaguchi further discloses comprising an intravascular imaging device (at least fig. 1 (101) and corresponding disclosure in at least (at least fig. 1 (101) and corresponding disclosure in at least pg. 2 second to last paragraph), wherein at least one of the first series of IVUS images or the second series of IVUS images are received from the intravascular imaging device (pg. 5 second to last full paragraph which discloses The ultrasound line data generation unit 33 acquires the reflected wave signal of the ultrasound output from the ultrasound transmitting/receiving unit 12a of the intravascular examination apparatus 101 and pg. 8 fourth paragraph which discloses the processing unit 31 uses the ultrasound line data generation unit 33 to acquire a plurality of post-treatment IVUS images P1 (step S114). The processing unit 31 that executes the process in stepS114 functions as an acquisition unit that acquires a plurality of IVUS images P1 of the blood vessel while moving the sensor unit 12 along the running direction of the blood vessel. Then, the processing unit 31 stores the plurality of IVUS images P1 acquired after the treatment on the blood vessel in the storage unit 32 in association with the ID, imaging date and time, blood vessel name, lesion name, and treatment-related information (step S115))
Double Patenting
Claim 1-12 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 5, 7, 12-13, and 16 of copending Application No. 18667989 (reference application) in view of Sakaguchi.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claims 1, 14, and 19,
Reference claims 1, 7, and 12 recite
An apparatus for an intravascular imaging system (reference claim 1 line 1), comprising:
A processor (reference claim 1 line 3); and
A memory device coupled to the processor, the memory device comprising instructions executable by the processor, which instruction when executed by the processor cause the intravascular imaging system to (reference claim 1 lines 4-6):
Receive a first series of intravascular ultrasound (IVUS) images of a vessel of a patient, the first series of IVUS images comprising a first plurality of frames (reference claim 1 lines 7-8);
Receive a second series of intravascular ultrasound (IVUS) images of a vessel of a patient, the first series of IVUS images comprising a first plurality of frames (reference claim 1 lines 9-10)
Determine a mapping between the first plurality of frames and the second plurality of frames, wherein the mapping comprises an offset (reference claim 1 “Determine an offset for the first plurality of frames based at least in part on the second plurality of frames” where such an offset is considered a mapping between the first plurality of frames and the second plurality of frames in its broadest reasonable interpretation)
Generate a graphical user interface (GUI) (reference claim 1), the GUI comprising indications of the first series of IVUS images and the second series of IVUS images (reference claim 1) based on the mapping between the first plurality of frames and the second plurality of frames (See reference claim 1 which recites “indications of the offset series of IVUS images and the second series of IVUS images” understood to be indications of the first series (which is offset based on the mapping) and the second series of IVUS images))
Reference claims 1, 7, and 12 fail to explicitly recite wherein the offset is an angular offset.
Sakaguchi, in a similar field of endeavor involving IVUS imaging teaches determining a mapping between the first plurality of frames and the second plurality of frames, wherein the mapping includes an angular offset (pg. 14 second paragraph which discloses For example, the processing unit 31 calculates the difference between the central angle of the calcified site image included in the representative frame image before processing and the central angle of the calcified site image included in the corresponding representative frame image after treatment. Then, the processing unit 31 similarly calculates the difference in center angle for the other representative frame images, calculates the correction amount of the rotation angle so that the sum of the differences is the minimum, and processes the IVUS image by the calculated correction amount).
It would have been obvious to a person having ordinary skill in the art before the effective filing date/at the time of the invention to have modified reference claims 1, 7, and 12 to include an angular offset as taught by Sakaguchi in order to accurately align the IVUS images in all manners thereby enhancing the comparison between IVUS series.
Where the modified apparatus of reference claim 1 in view of Sakaguchi would perform the method of instant claim 14 and would comprise the machine readable storage medium of instant claim 19. See also corresponding method steps in reference claim 12, and corresponding machine readable storage device in reference claim 7.
Regarding instant claim 2,
Reference claims 2 and 13 recite the elements of instant claim 2.
Regarding instant claim 3,
Reference claims 1, 7, and 12, as modified, teach the elements of instant claim 1 as previously stated.
Sakaguchi, as applied to instant claim 1 above, further teaches wherein the angular offset is between the one of the first plurality of frames and the one of the second plurality of frames.
Reference claims 1 and 7, as currently modified, fails to explicitly teach wherein the mapping further comprises a longitudinal offset and wherein the longitudinal offset are between the one of the first plurality of frames and the one of the second plurality of frames.
Nonetheless, Sakaguchi further teaches wherein the mapping further comprises a longitudinal offset and wherein the angular offset and the longitudinal offset are between the one of the first plurality of frames and the one of the second plurality of frame (pg. 14 first full paragraph which discloses The processing unit 31 treats as a pair the representative frame image before treatment and the representative frame image after treatment whose distance is closest in the longitudinal direction, and calculates the distance between the representative frame images. When there are multiple sets of representative frame images, the processing unit 31 calculates the distance between each representative frame image, finely adjusts the longitudinal position of the IVUS image P1 so that the sum of the distances is the minimum, and takes appropriate action and pg. 14 second full paragraph which discloses for example, the processing unit 31 calculates the difference between the central angle of the calcified site image included in the representative frame image before processing and the central angle of the calcified site image included in the corresponding representative frame image after treatment. Then, the processing unit 31 similarly calculates the difference in center angle for the other representative frame images, calculates the correction amount of the rotation angle so that the sum of the differences is the minimum, and processes the IVUS image by the calculated correction amount. By rotating P1, the orientation of the IVUS image P1 is corrected. In the example shown in FIG. 15, by subtracting the circumferential angle of the IVUS image P1 after).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Reference claims 1, 7, and 12, as currently modified, to include a longitudinal offset in order to accurately align the IVUS images in all manners thereby enhancing the comparison between IVUS series.
Regarding instant claim 4,
Reference claims 2 and 13 recite that the offset results in an alignment between the frame of the first plurality of frames comprising the vessel fiducial with the frame of the second plurality of frames comprising the vessel fiducial. Examiner notes that in the modified system/method that the alignment is based on the angular offset and longitudinal offset.
Regarding claim 5,
Reference claims 2 and 13 anticipate instant claim 4 as previously stated. Reference claims 2 and 13 fail to explicitly recite “wherein the indications of the first series of IVUS images and second series of images comprise an on-axis view of the first series of IVUS images and the second series of IVUS images and wherein the on-axis views are correlated with each other based on the angular offset”
Nonetheless, Sakaguchi further teaches wherein indications comprises an on-axis view of the first series of IVUS images and the second series of IVUS images and wherein the on-axis views are correlated with each other based on the angular offset (pg. 14 fourth full paragraph which discloses as described above, according to the image processing device 3 and the like according to the fourth embodiment, compared to the first embodiment, the longitudinal position of the blood vessel can be aligned more accurately and the IVUS images P1 before and after the treatment can be displayed in association with each other where the IVUS images P1 before and after may be cross-sectional or on-axis views as depicted in fig. 10)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Reference claims 2 and 13 to include an on-axis view of the first series of IVUS images and the second series of IVUS images correlated with each other based on the offset as taught by Sakaguchi in order to provide a cross-sectional or longitudinal view of the vessel which are correlated with one another accordingly. Such a modification amounts to merely a simple substitution of one known image display type for another yielding predictable results with respect to image association.
Regarding instant claim 6,
Reference claims 2 and 13, as modified, teach the elements of instant claim 4 as previously stated. Reference claims 2 and 13, as currently modified, fail to explicitly recite “wherein the indications of the first series of IVUS images and the second series of IVUS images comprise a longitudinal view of the first series of IVUS images and the second series of IVUS images and wherein the on-axis views are correlated with each other based on the angular offset and the longitudinal offset”.
Nonetheless, Sakaguchi further teaches wherein the indications comprises a longitudinal view of the first series of IVUS images and the second series of IVUS images, wherein the longitudinal views are correlated with each other based on the angular offset and the longitudinal offset (pg. 14 first-fourth full paragraph which discloses as described above, according to the image processing device 3 and the like according to the fourth embodiment, compared to the first embodiment, the longitudinal position of the blood vessel can be aligned more accurately and the IVUS images P1 before and after the treatment can be displayed in association with each other where the IVUS images P1 before and after may be longitudinal views as depicted in fig. 10 and/or 15).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Reference claims 2 and 13 to include a longitudinal view of the first series of IVUS images and the second series of IVUS images correlated with each other based on the offset as taught by Sakaguchi in order to provide longitudinal views of the vessel obtained by IVUS which are correlated with one another accordingly. Such a modification amounts to merely a simple substitution of one known image display type for another yielding predictable results with respect to image association.
Regarding instant claims 7 and 17,
Reference claims 5 and 16 recite the elements of instant claims 7 and 17.
Regarding instant claim 8,
Reference claims 2 and 13, as modified, teach instant claim 2 as previously stated. Reference claims 2 and 13, as currently modified, fail to explicitly recite wherein the particular vessel fiducial is one of a lumen geometry, a vessel geometry, a side branch location, a calcium morphology, a plaque distribution, or a guide catheter position.
Nonetheless, Sakaguchi further teaches wherein the particular vessel fiducial is a calcium morphology (pg. 13 sixth full paragraph which discloses plurality of IVUS images P1 acquired before and after the treatment to the IVUS image recognition learning model 61, and detects calcification)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Reference claims 2 and 13, as currently modified, to include a particular vessel fiducial as taught by Sakaguchi in order to align the vessels in a longitudinal direction with respect to a calcification. Such a modification amounts to merely a simple substitution of one known vessel fiducial for another yielding predictable results with respect to vessel alignment rendering the claim obvious (MPEP 2143).
Regarding instant claim 9,
Reference claims 1, 7, and 12, as modified, teach instant claim 1 as previously stated. Reference claims 1, 7, and 12, as currently modified, fail to explicitly teach comprising receiving the second series of IVUS images from an intravascular imaging device; and receiving the first series of IVUS images from a memory storage device.
Nonetheless, Sakaguchi further teaches receiving a second series of IVUS images from an intravascular imaging device (at least fig. 1 (100) and corresponding disclosure in at least pg. 2 second to last paragraph) and receiving a first series of IVUS images from a memory storage device (pg. 17 eighth full paragraph which discloses a plurality of tomographic images acquired before the treatment and to be displayed in association with a plurality of tomographic images acquired after the treatment are read from the storage unit (i.e. memory storage device)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Reference claims 1, 7, and 12, as currently modified, to include receiving the first and second series as taught by Sakaguchi in order to provide IVUS images acquired at different times (i.e. before and after treatment) for comparison accordingly.
Regarding instant claims 10 and 11,
Reference claims 1, 7, and 12, as modified, teach instant claim 1 as previously stated. Reference claims 1, 7, and 12, as currently modified, fail to explicitly recite wherein the first series of IVUS images are captured during a pre-percutaneous coronary intervention procedure (PCI) procedure and wherein the second series of IVUS images are captured during a peri-PCI or post-PCI procedure.
Nonetheless, Sakaguchi further teaches wherein the first series of IVUS images are captured during a pre-percutaneous coronary intervention (PCI) procecure (pg. 2 which discloses endovascular treatment typefied by percutaneous coronary intervention and pg. 10 fifth full paragraph which discloses IVUS images acquired before and after treatment of the blood vessel) and wherein the second series of IVUS images are captured during a post-PCI procedure (pg. 2 which discloses endovascular treatment typefied by percutaneous coronary intervention and pg. 10 fifth full paragraph which discloses IVUS images acquired before and after treatment of the blood vessel).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified reference claims 1, 7, and 12, as currently modified, to include capturing the first and second series before and after a PCI procedure as taught by Sakaguchi in order to align images acquired at different times with respect to treatment accordingly. Such a modification would allow for images obtained pre-treatment and post-treatment to be compared for visualizing the effectiveness of the treatment accordingly.
Regarding instant claim 12,
Reference claims 5 and 16 recite executing a machine learning (ML) model. Examiner notes that to infer the mapping based on the first series of IVUS images and the second series of IVUS images is directed toward an intended use where claims 5 and 16 recite executing a machine learning (ML) model to infer a frame of the first series and a frame of the second series which are used to determine an offset, thus executing the machine learning (ML) model as recited in claims 5 and 16 is capable of being done to infer the mapping (i.e. the offset).
Regarding instant claims 15 and 20,
Reference claims 1, 7, and 12, as modified, teach instant claim 14 as previously stated. Reference claims 2 and 13 recite identify a one of the first plurality of frames comprising a particular vessel fiducial and identify a one of the second plurality of frames comprising the particular vessel fiducial, however, fail to explicitly recite wherein the particular vessel fiducial is one of a lumen geometry, a vessel geometry, a side branch location, a calcium morphology, a plaque distribution, or a guide catheter position.
Nonetheless, Sakaguchi further teaches wherein a particular vessel fiducial used for identifying a one of a first plurality of IVUS frames and a one of a second plurality of IVUS frames is a calcium morphology (pg. 13 sixth full paragraph which discloses plurality of IVUS images P1 acquired before and after the treatment to the IVUS image recognition learning model 61, and detects calcification)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Reference claims 2 and 13, as currently modified, to include a particular vessel fiducial as taught by Sakaguchi in order to align the vessels in a longitudinal direction with respect to a calcification. Such a modification amounts to merely a simple substitution of one known vessel fiducial for another yielding predictable results with respect to vessel alignment rendering the claim obvious (MPEP 2143).
Regarding claim 16,
Reference claims 2 and 13, as modified, further teach wherein the angular offset is between the one of the first plurality of frames and the one of the second plurality of frames (Reference claims 2 and 13 “determining an offset for the first plurality of frames that when applied aligns the frame of the first plurality of frames comprising the vessel fiducial with the frame of the second plurality of frames comprising the vessel fiducial”)
Wherein the indications of the first series of IVUS images and the second series of IVUS images aligned based on the angular offset (Reference claims 2 and 13 recite that the offset results in an alignment between the frame of the first plurality of frames comprising the vessel fiducial with the frame of the second plurality of frames comprising the vessel fiducial, therefore the indications on the GUI as recited in reference claim 1 are understood to be aligned based on the angular offset in the modified system/method).
Regarding claim 18,
Reference claims 1, 7, and 12, as modified, teach the elements of instant claim 1, 14, and 19 as previously stated. Reference claims 1, 7, and 12 fail to explicitly recite further comprising an intravascular imaging device, wherein at least one of the first series of IVUS images or the second series of IVUS images are received from the intravascular imaging device.
Nonetheless, Sakaguchi further teaches an intravascular imaging device (at least fig. 1 (101) and corresponding disclosure in at least pg. 2), wherein at least one of the first series of IVUS images or the second series of IVUS images are received from the intravascular imaging device (pg. 5 third to last paragraph which discloses ultrasound transmitting/receiving unit 12a of the intravascular examination apparatus 101 as reflected wave data, and generates ultrasound line data based on the acquired reflected wave data)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Reference claims 1, 7, and 12, as currently modified, to include an intravascular imaging device and receiving the images therefrom in order to provide a device for providing the IVUS images accordingly.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BROOKE LYN KLEIN/Examiner, Art Unit 3797
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