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 .
Election/Restrictions
Applicant's election with traverse of Species II (figs. 22 - 25) in the reply filed on 10/29/2025 is acknowledged.
However, upon further consideration, the election of species requirement has been withdrawn. Claims 1 - 18 are fully examined herein.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 3 - 5, 10 - 11, and 16 - 17 are objected to because of the following informalities:
Claim 3 is objected to because the language describing the processor’s functionalities is generally narrative. Examiner suggests amending the claim to replace the language reciting that “the processor reacquires”, “regenerates”, and “outputs” with language reciting that the processor is “configured to” perform the claimed steps, in order to clearly define structural features of the claimed system.
Claims 4, 10, and 16 are objected to because a conjunction is missing after the term “ultrasonic sensor” in line 7.
Claims 5, 11, and 17 are objected to because a word such as “captured” appears to be missing before the term “by the ultrasonic sensor” at the end of the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 - 5, 10 - 11, and 16 - 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 4, 10, and 16 are indefinite for the following reasons:
It is unclear what is meant by “the angiographic image includes a first angiographic image” in line 2. It is unclear how an image may ‘include’ itself. For the purposes of examination, the limitation will be interpreted as intending that the angiographic image will be referred to as a “first angiographic image” within the claim.
There is insufficient antecedent basis for “the first mark position within the target blood vessel” in line 12. The first mark position has not been set forth as being “within the target blood vessel”. It is unclear if this is required or not.
There is insufficient antecedent basis for “the medical device different from the ultrasonic sensor arranged at the second mark position within the target blood vessel” in line 13. The medical device has not been set forth as being “different from the ultrasonic sensor”. In addition, the ultrasonic sensor has not been set forth as being “at the second mark position within the target blood vessel”. It is unclear if these features are required or not.
Claims 5, 11, and 17 are indefinite by virtue of dependency.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3 - 7, 9 - 13, and 15 - 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 21 of copending Application No. 19/062879 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to surgery assistance systems and methods, as recited in instant claims 1, 7, and 13, involving:
acquiring three dimensional position information of a true lumen existing in a target blood vessel (reference claim 7, 18);
acquiring an angiographic image of the target blood vessel from a flat panel detector (FPD) disposed at a first imaging position (reference claim 7, 18),
generating a true lumen image representing the true lumen at a position and in a posture corresponding to the angiographic image by using position information of the first imaging position and the three dimensional position information of the true lumen (reference claim 7, 18);
generating a composite image by compositing the angiographic image and the true lumen image (reference claim 7, 18); and
outputting the composite image to a display (reference claim 7, 18).
In particular:
Claims 1, 7, and 13 are suggested by reference claim 7 and/or 18.
Claims 3, 9, and 15 are suggested by reference claim 8 and/or 19.
Claims 4 - 5, 10 - 11, and 16 - 17 are suggested by reference claim 8 and/or 19.
Claims 6, 12, and 18 are suggested by reference claim 8 and/or 19.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 8, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and/or 18 of copending Application No. 19/062879 in view of Iguchi (JP 2022-055170, of record).
Regarding claims 2, 8, and 14, the reference claims recite the claimed invention substantially as noted above.
However, the reference claims do not explicitly recite that the three dimensional position information of the true lumen includes information of a width of the true lumen, and the true lumen image is generated having the width.
Iguchi discloses intravascular ultrasound imaging. Iguchi teaches three dimensional position information of a true lumen includes information of a width of the true lumen, and a true lumen image is generated having the width (“superimposes … three dimensional image of a blood vessel … on an angiographic image …”, [0014]; “… true lumen … three-dimensional image…”, [0068]).
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 invention of reference claim 7 and/or 18 to have the three dimensional position information of the true lumen include information of a width of the true lumen, and to have the true lumen image be generated having the width, as taught by Iguchi, in order to accurately portray the lumen in the composite image
This is a provisional nonstatutory double patenting 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.
Claims 1 - 5, 7 - 11, and 13 - 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iguchi (JP 2022-055170, of record).
Regarding claims 1, 7, and 13, Iguchi shows a surgery assistance device (“superimposing … image of a blood vessel on an angiographic image and allowing an operator to easily intuitively grasp a state of the blood vessel”, [0007]) and method of use thereof. The device comprises a processor that is configured to implement the method by executing a computer program stored on a non-transitory computer readable medium (“…executing the computer program … control unit 31 executes a process of acquiring an IVUS image … mapping … angiography image … superimposed and displayed”, [0031]). The method comprises:
acquiring three dimensional position information (“coordinate transformation matrix … IVUS coordinate system … world coordinate system”, [0054]; [0059]) of a true lumen existing in a target blood vessel (“… vessel wall … true lumen … superimposed … easily recognize … blood vessel wall … true lumen … in the angiographic image”, [0068]);
acquiring an angiographic image of the target blood vessel from a flat panel detector (FPD) (x-ray sensor, [0020]) disposed at a first imaging position (“acquires the angiographic image and the imaging direction …”, [0064]),
generating a true lumen image representing the true lumen at a position and in a posture corresponding to the angiographic image by using position information of the first imaging position and the three dimensional position information of the true lumen (“… true lumen … three-dimensional image…”, [0068]);
generating a composite image by compositing the angiographic image and the true lumen image (“superimposes … three dimensional image of a blood vessel … on an angiographic image …”, [0014]; [0068]); and
outputting the composite image to a display (“superimposes and displays a three dimensional image of a blood vessel … on an angiographic image, and enables an operator to an operator to easily and intuitively grasp the state of the blood vessel”, [0014]; “superimposed display … the operator can easily recognize the positions of the blood vessel wall V, the true lumen A, the false lumen B, and the catheter 1 in the angiographic image”, [0068]).
Regarding claims 2, 8, and 14, Iguchi discloses the claimed invention substantially as noted above. Further, in the invention of Iguchi, the three dimensional position information of the true lumen includes information of a width of the true lumen, as each pixel of the true lumen is classified ([0046]), therefore providing “information of a width of the true lumen”. The method further includes generating the true lumen image representing the true lumen having the width, as the width of the true lumen image is represented in the superimposed display ([0014], [0068], inter alia).
Regarding claims 3, 9, and 15, Iguchi discloses the claimed invention substantially as noted above. Iguchi further shows in response to the FPD being moved to a second imaging position different from the first imaging position and imaging is performed by the FPD at the second imaging position, the method includes reacquiring an angiographic image captured at the second imaging position, and regenerating a true lumen image representing the true lumen at a position and in a posture corresponding to the reacquired angiographic image by using position information of the second imaging position and three dimensional position information of the true lumen, and wherein method includes regenerating a composite image by compositing the reacquired angiographic image and the regenerated true lumen image, and outputs the regenerated composite image (coordinate conversion, [0049] - [0055]; “repeatedly … acquire the angiography image and the imaging direction … in time series, obtain the coordinate conversion image corresponding to the imaging direction … each time, and superimpose and display …”, [0069]).
Regarding claims 4, 10, and 16, Iguchi discloses the claimed invention substantially as noted above. Iguchi further shows the angiographic image includes a first angiographic image (implicit), the method further includes:
acquiring a second angiographic image captured by the FPD arranged at a second position different from the first imaging position (“repeatedly … acquire the angiography image and the imaging direction … in time series, obtain the coordinate conversion image corresponding to the imaging direction … each time, and superimpose and display …”, [0069]); and
acquiring an ultrasonic image of an inside of the target blood vessel captured by an ultrasonic sensor (“IVUS image is an image obtained by emitting an ultrasonic wave and detecting a reflected wave while rotating the ultrasonic probe 10”, [0036]),
the ultrasonic image is an image captured in a state where the ultrasonic sensor is arranged at a first mark position (implicit, the position of the sensor is interpreted as a “first mark position”, lacking any further limiting features of such a position),
the ultrasonic image includes the target blood vessel and a medical device (“IVUS image is a cross-sectional image of the vessel … guidewire…” [0035]; “included in the IVUS image … blood vessel wall … catheter … guidewire …”, [0039]) arranged at a second mark position within the target blood vessel (implicit, the position of the medical device is interpreted as a “second mark position”, lacking any further limiting features of such a position),
the first angiographic image includes the ultrasonic sensor (“angiographic image including images of the blood vessels, the catheter … guidewire …”, [0021]) arranged at a first mark position within the target blood vessel (implicit, the position of the sensor within the target blood vessel is interpreted as a “first mark position”, lacking any further limiting features of such a position),
the medical device different from the ultrasonic sensor (implicit, the medical device is necessary “different from the ultrasonic sensor” in at least some manner) arranged at the second mark position within the target blood vessel,
the second angiographic image includes the ultrasonic sensor arranged at the first mark position within the target blood vessel (see [0069]), and
the method further includes acquiring the three dimensional position information of the true lumen by using position information of the first imaging position, the first angiographic image, position information of the second imaging position, the second angiographic image, and the ultrasonic image (coordinate conversion, [0049] - [0055]; “repeatedly … acquire the angiography image and the imaging direction … in time series, obtain the coordinate conversion image corresponding to the imaging direction … each time, and superimpose and display …”, [0069]).
Regarding claims 5, 11, and 17, Iguchi discloses the claimed invention substantially as noted above. Iguchi further shows generating position information of the ultrasonic sensor by using images of the ultrasonic sensor included in the first angiographic image and the second angiographic image (“first to third markers 11a,11b,11c … determine a positional relationship between an IVUS image …
angiographic image … including images of the … markers …”, [0017] and fig. 2. Note that markers 11a and 11b delineate the position of ultrasonic sensor 10a and represent the sensor’s position within the angiographic image),
acquiring position information (“coordinate transformation matrix … IVUS coordinate system … world coordinate system”, [0054]; [0059]) of the true lumen from the ultrasonic image (“… vessel wall … true lumen … superimposed … easily recognize … blood vessel wall … true lumen … in the angiographic image”, [0068])
associating a positional relation between the first angiographic image and the ultrasonic image by using images of the medical device included in the first angiographic image and the ultrasonic image (“angiographic image including … catheter … guidewire …”, [0021]; “IVUS image … guidewire…” [0035]; “included in the IVUS image … catheter … guidewire …”, [0039]), and
acquiring the three dimensional position information of the true lumen by using the position information of the ultrasonic sensor and the position information of the true lumen in the ultrasonic image by the ultrasonic sensor (coordinate conversion, [0049] - [0055]; “repeatedly … acquire the angiography image and the imaging direction … in time series, obtain the coordinate conversion image corresponding to the imaging direction … each time, and superimpose and display …”, [0069]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Iguchi in view of Zhang (US 2021/0244371).
Regarding claims 6, 12, and 18, Iguchi discloses the claimed invention substantially as noted above. Iguchi further shows the angiographic image includes a first angiographic image (implicit), the method further includes acquiring a second angiographic image captured by the FPD arranged at a second imaging position different from the first imaging position (“repeatedly … acquire the angiography image and the imaging direction … in time series, obtain the coordinate conversion image corresponding to the imaging direction … each time, and superimpose and display …”, [0069]),
the first and second angiographic images include a medical device (“angiographic image including images of the blood vessels, the catheter … guidewire …”, [0021]) arranged at a first mark position within the target blood vessel (implicit, the position of the medical device within the target blood vessel is interpreted as a “first mark position”, lacking any further limiting features of such a position), and
acquiring the three dimensional position information of the true lumen by using an image of the medical device and an image of the true lumen (coordinate conversion, [0049] - [0055]; “repeatedly … acquire the angiography image and the imaging direction … in time series, obtain the coordinate conversion image corresponding to the imaging direction … each time, and superimpose and display …”, [0069]).
Iguchi fails to show that the angiographic images include the true lumen.
Zhang discloses surgical navigation techniques. Zhang teaches angiographic images that include a true lumen (“angiography indicated that the guide wire reached the true lumen of the distal segment, whereby the operation was successfully completed”, [0171]).
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 invention of Iguchi to have the angiographic images include the true lumen, as taught by Zhang, in order to facilitate visualizing the operation, as suggested by Zhang ([0171]).
Conclusion
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798