DETAILED ACTION
This office action is in response to the communication received on December 8, 2025 concerning application No. 18/667,989 filed on May 17, 2024.
Claims 1-2, 4-13, and 15-20 are currently pending.
Claims 8-10 and 17-19 are withdrawn.
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
Applicant's arguments filed 12/08/2025 regarding the drawing objections have been fully considered. The amendments to the drawings and specification have been entered and overcome the drawing objections previously set forth.
Applicant's arguments filed 12/08/2025 regarding the double patenting have been fully considered. The amendments to the claims have been entered and overcome the double patenting rejection previously set forth.
Applicant's arguments filed 12/08/2025 regarding the 35 USC 101 rejection have been fully considered. The amendments to the claims have been entered and overcome the 35 USC 101 rejection of claims 7 and 11 previously set forth.
Applicant's arguments filed 12/08/2025 regarding the prior art rejection have been fully considered but they are not persuasive. In response to the applicant’s arguments that the prior art fails to teach “determine a second offset for the first plurality of frames based at least in part on the second plurality of frames; apply the second offset to ones of the first plurality of frames to generate a second series of IVUS images”, examiner respectfully disagrees. As set forth in the previous office action Sakaguchi is relied upon for teaching the determining and application of a second offset. Pg. 12, para. 5-8 of Sakaguchi disclose identifying a distance and central angle between the different IVUS images and then applying the determined distance and central angle to align the IVUS images, thereby generating a second series of adjusted IVUS images. Therefore Sakaguchi teaches the argued limitation recited above.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/502,859, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically provisional Application No. 62/502,859 does not specifically disclose the limitations of claims 1, 7, and 12 regarding the determining of a second offset of the first plurality of frames based at least in part on the second plurality of frames and applying the second offset to ones of the first plurality of frames to generate a second offset series of IVUS frames. Therefore the priority date for the claims is May 16, 2024.
Response to Amendment
Examiner notes that the amendments of claim 12 do not include proper markings to show the changes to the claims. Specifically, amended claim 12 does not include strike-throughs to show deleted matter that is no longer being presented in the claims when compared to the claims as originally filed on 05/17/2024.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4-7, 11-13, 15-16, and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1, 7, and 12 recite “apply the first offset to one of the first plurality of frames to generate a first offset series of IVUS images…apply the second offset to ones of the first plurality of frames to generate a second offset series of IVUS frames; generate a graphical user interface (GUI), the GUI comprising indication of the first and second offset series of IVUS images” which is not recited in the specification in such a way to convey the inventor has possession of the limitation at the time the application was filed. [0033] of the present applications specification discloses “the offset serios of IVUS images is generated by applying the offset distance and the offset angle to the first plurality of frames”, but nowhere in the specification could it found where it specifically discloses generating a first offset series and a second offset series and further generating a GUI that includes both indications of the first offset series and second offset series. For at least these reasons the limitations recited above are considered new matter.
Claims dependent upon the rejected claims above, but not directly addressed, are also rejected because they inherit the indefiniteness of the claim(s) they respectively depend upon.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2, 4-7, 11-13, 15-16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable by Li et al. (US 20240346670, hereinafter Li) in view of Sakaguchi (WO2023189308A1).
Regarding claim 1, Li teaches an apparatus (system 100 in fig. 1) for an intravascular imaging system ([0015] discloses the system is used for an intravascular imaging device), comprising:
a display ([0043] display 118);
a processor coupled to the display ([0043] the electronic circuitry of computing device 112 in fig. 1); and
a memory device coupled to the processor (fig. 1 shows a memory 114 coupled with the computing device), the memory device comprising instructions executable by the processor ([0023] discloses instructions 115 stored in the memory an 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 ([0063] discloses receiving a first set of intravascular data including intravascular images (plurality of frames) at step 630);
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 ([0065] discloses receiving a second set of intravascular data which includes intravascular images (plurality of frames) at step 650);
determine a first offset for the first plurality of frames based at least in part on the second plurality of frames ([0068] discloses determining a difference (offset) between the position of the first plurality of frames and the second plurality of frames. Also see [0041]);
apply the first offset to ones of the first plurality of frames to generate a first offset series of IVUS images ([0068] discloses aligning the first frames and the second frames using the difference (offset) thereby generating an offset series of IVUS images);
generate a graphical user interface (GUI) ([0044] GUI of display 118 in fig. 1), the GUI comprising indications of the first offset series of IVUS images and the second series of IVUS images (fig. 1 and fig. 5 show the GUI comprising indications of the offset series and the second series. [[0068] further discloses the offset images are being displayed in order for the first and second series of images to be aligned on the display); and display the GUI on the display (fig. 1 shows the GUI being displayed).
Li does not specifically teach determine a second offset for the first plurality of frames based at least in part on the second plurality of frames; apply the second offset to ones of the first plurality of frames different than the first offset to generate a second offset series of IVUS frames; and generate a graphical user interface comprising indications of the second offset series of IVUS images.
However,
Sakaguchi in a similar field of endeavor teaches determining a second offset for the first plurality of frames based at least in part on a plurality of frames (pg. 12, para. 5-7 disclose first identifying a distance and central angle (second offset) between the calcification in each of the images); applying the second offset to ones of the first plurality of frames different than the first offset to generate a second offset series of IVUS frames (pg. 12, para. 7 disclsoes using the distance and angle to rotate the IVUS images thereby creating a second offset series of IVUS frames); and generating a graphical user interface comprising indications of the second offset series of IVUS images (pg. 12, para. 8 discloses displaying (generating a graphical user interface) of the adjusted images).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intravascular imaging system disclosed by Li to determine a second offset for the first plurality of frames based at least in part on the second plurality of frames; apply the second offset to ones of the first plurality of frames different than the first offset to generate a second offset series of IVUS frames; and generate a graphical user interface comprising indications of the second offset series of IVUS images in order to more accurately align the first and second plurality of image frames by increasing the number of data points used for aligning the images, thereby increasing the accuracy of the system.
Regarding claim 7, Li teaches at least one non-transitory computer readable medium, comprising a plurality of instructions ([0024]-[0025] discloses the instructions 115 are machine code that are executed by the processor) that in response to being executed by a processor of an intravascular ultrasound (IVUS) imaging system cause the processor 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 ([0063] discloses receiving a first set of intravascular data including intravascular images (plurality of frames) at step 630);
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 ([0065] discloses receiving a second set of intravascular data which includes intravascular images (plurality of frames) at step 650);
determine a first offset for the first plurality of frames based at least in part on the second plurality of frames ([0068] discloses determining a difference (offset) between the position of the first plurality of frames and the second plurality of frames. Also see [0041]);
apply the first offset to ones of the first plurality of frames to generate a first offset series of IVUS images ([0068] discloses aligning the first frames and the second frames using the difference (offset) thereby generating an offset series of IVUS images);
generate a graphical user interface (GUI) ([0044] GUI of display 118 in fig. 1), the GUI comprising indications of the first offset series of IVUS images and the second series of IVUS images (fig. 1 and fig. 5 show the GUI comprising indications of the offset series and the second series. [[0068] further discloses the offset images are being displayed in order for the first and second series of images to be aligned on the display); and display the GUI on the display (fig. 1 shows the GUI being displayed).
Li does not specifically teach determine a second offset for the first plurality of frames based at least in part on the second plurality of frames; apply the second offset to ones of the first plurality of frames different than the first offset to generate a second offset series of IVUS frames; and generate a graphical user interface comprising indications of the second offset series of IVUS images.
However,
Sakaguchi in a similar field of endeavor teaches determining a second offset for the first plurality of frames based at least in part on a plurality of frames (pg. 12, para. 5-7 disclose first identifying a distance and central angle (second offset) between the calcification in each of the images); applying the second offset to ones of the first plurality of frames different than the first offset to generate a second offset series of IVUS frames (pg. 12, para. 7 disclsoes using the distance and angle to rotate the IVUS images thereby creating a second offset series of IVUS frames); and generating a graphical user interface comprising indications of the second offset series of IVUS images (pg. 12, para. 8 discloses displaying (generating a graphical user interface) of the adjusted images).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor disclosed by Li to determine a second offset for the first plurality of frames based at least in part on the second plurality of frames; apply the second offset to ones of the first plurality of frames different than the first offset to generate a second offset series of IVUS frames; and generate a graphical user interface comprising indications of the second offset series of IVUS images in order to more accurately align the first and second plurality of image frames by increasing the number of data points used for aligning the images, thereby increasing the accuracy of the system.
Regarding claim 12, Li teaches a method ([0060] the method shown in fig. 6) for a computing device, comprising:
receiving, by a processor, 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 ([0063] discloses receiving a first set of intravascular data including intravascular images (plurality of frames) at step 630);
receiving, by the processor, 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 ([0065] discloses receiving a second set of intravascular data which includes intravascular images (plurality of frames) at step 650);
determining, by the processor, a first offset for the first plurality of frames based at least in part on the second plurality of frames ([0068] discloses determining a difference (offset) between the position of the first plurality of frames and the second plurality of frames. Also see [0041]);
applying, by the processor, the first offset to ones of the first plurality of frames to generate an offset series of IVUS images ([0068] discloses aligning the first frames and the second frames using the difference (offset) thereby generating an offset series of IVUS images);
generating, by the processor, a graphical user interface (GUI) ([0044] GUI of display 118 in fig. 1), the GUI comprising indications of the offset series of IVUS images and the second series of IVUS images (fig. 1 and fig. 5 show the GUI comprising indications of the offset series and the second series. [[0068] further discloses the offset images are being displayed in order for the first and second series of images to be aligned on the display); and display the GUI on the display (fig. 1 shows the GUI being displayed).
Li does not specifically teach determine a second offset for the first plurality of frames based at least in part on the second plurality of frames; apply the second offset to ones of the first plurality of frames different than the first offset to generate a second offset series of IVUS frames; and generate a graphical user interface comprising indications of the second offset series of IVUS images.
However,
Sakaguchi in a similar field of endeavor teaches determining a second offset for the first plurality of frames based at least in part on a plurality of frames (pg. 12, para. 5-7 disclose first identifying a distance and central angle (second offset) between the calcification in each of the images); applying the second offset to ones of the first plurality of frames different than the first offset to generate a second offset series of IVUS frames (pg. 12, para. 7 disclsoes using the distance and angle to rotate the IVUS images thereby creating a second offset series of IVUS frames); and generating a graphical user interface comprising indications of the second offset series of IVUS images (pg. 12, para. 8 discloses displaying (generating a graphical user interface) of the adjusted images).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor disclosed by Li to determine a second offset for the first plurality of frames based at least in part on the second plurality of frames; apply the second offset to ones of the first plurality of frames different than the first offset to generate a second offset series of IVUS frames; and generate a graphical user interface comprising indications of the second offset series of IVUS images in order to more accurately align the first and second plurality of image frames by increasing the number of data points used for aligning the images, thereby increasing the accuracy of the system.
Regarding claims 2 and 13, Li in view of Sakaguchi teaches the apparatus of claim 1 and method of claim 12, as set forth above. Li further teaches the instructions further cause the intravascular imaging system to:
identify a frame of the first plurality of frames comprising a vessel fiducial ([0050] discloses identifying a proximal point (vessel fiducial) using a wire mask image frame of the image frame of the first pullback);
identify a frame of the second plurality of frames comprising the vessel fiducial ([0055] discloses identifying a proximal point (vessel fiducial) using a wire mask image frame of the image frame of the second pullback); and
determine the 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 ([0068] discloses determining a difference (offset) between the position of the first proximal point and the second proximal point and aligning the frames using the difference (offset)).
Regarding claims 4 and 15, Li in view of Sakaguchi teaches the apparatus of claim 1 and method of claim 12, as set forth above. Li further teaches the first offset comprises an offset distance or an offset angle ([0065]-[0068] discloses the offset is a distance). Sakaguchi further teaches the second offset comprises an offset distance and an offset angle (pg. 12, para. 5-7 disclose the offset is a distance and an angle).
Regarding claims 5 and 16, Li in view of Sakaguchi teaches the apparatus of claim 2 and method of claim 13, as set forth above. Li further teaches the instructions further cause the intravascular imaging system to: execute a machine learning (ML) model to infer the frame of the first plurality of frames comprising the vessel fiducial; and execute the ML model to infer the frame of the second plurality of frames comprising the vessel fiducial ([0048] discloses the wire mask module uses machine learning techniques to identify the location of the proximal point. Therefore the machine learning infers the frame of the plurality of frames comprising the proximal point (vessel fiducial)).
Regarding claim 6, Li in view of Sakaguchi teaches the apparatus of claim 5, as set forth above. Li further teaches the 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 ([0050] and [0055] discloses identifying a proximal point (vessel fiducial) of the catheter. Therefore the vessel fiducial is a guide catheter position).
Regarding claims 11 and 20, Li in view of Sakaguchi teaches the non-transitory computer-readable medium of claim 7 and the method of claim 12, as set forth above. Li further teaches the offset for the first plurality of frames is a distance offset, an angle offset, or a distance and an angle offset ([0068] discloses determining a difference (offset) in the distance between the position of the first plurality of frames and the second plurality of frames. Therefore the offset is a distance offset).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW BEGEMAN whose telephone number is (571)272-4744. The examiner can normally be reached Monday-Thursday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at 5712701790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW W BEGEMAN/Examiner, Art Unit 3798
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