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 . Claims 1-19 are pending examination below.
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.
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Claim 1, 8, and 14 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 12, and 18 respectively of copending Application No. 18/196,508 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the language in reference application uses the same language recited in claim 1, 12 and 18 respectively.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 –
Claims 1-2, 8-9, 13-15 are rejected under 35 U.S.C. 102(a)(1)/ 102(a)(2) as being anticipated by US 2023/011855 A1 (hereinafter "Owens").
Regarding claim 1, Owens discloses a stent delivery system (Fig. 1, stent delivery system, 100, para 0038), comprising:
a stent delivery device (Fig. 1, stent deployment device, 200, para 0039)
configured to carry a stent to a stenosis (Fig. 6B, stenosis, 415, para 0057)
and indwell the stent (stent, 215, para 0041);
an observation device (Fig. 1, imaging device, 160, para 0049)
configured to observe the stenosis (Fig. 6B, stenosis, 415, para 0057);
and one or more processors comprising hardware (Fig. 1, processors, 110, para 0038),
the one or more processors being configured to:
acquire an observation image (Fig. 1, images, 145, para 0048)
from the observation device (Fig. 1, imaging device, 160, para 0049),
and determine, based on the observation image,
at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100),
which is a position within the stenosis where the stent delivery device is recommended to be inserted.
Regarding claim 2, Owen further discloses wherein the one or more processors (Fig. 1, processors, 110, para 0038)
being configured to determine the at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100)
from a three-dimensional model (Fig. 1, OSS processing module, 125, in combination with OSS sensing module, 120, para 0038-0039, discloses the OSS processor generation of a three dimensional model both before and after stent deployment)
created based on a plurality of observation images (Fig. 1, images, 145, para 0048),
each observed from a different angle (Fig. 1, images, 145, in combination with OSS sensing module, 125, para 0048 and para 0114).
Regarding claim 8, Owens further discloses a stent delivery method (Fig. 7-9, methods, 700-900, para 0097-0098)
for inserting a stent delivery device (Fig. 1, stent deployment device, 200, para 0039)
to a stenosis position (Fig. 6B, stenosis, 415, para 0057),
the method comprising: obtaining an observation image (Fig. 1, images, 145, para 0048, see also Fig. 7, step, 702, para 0079)
from an observation device (Fig. 1, imaging device, 165, para 0048)
used to observe a stenosis (Fig. 6B, stenosis, 415, para 0057, see also, Fig. 7, step, 704, para 0080);
determining at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100, see also Fig. 7, step, 710, para 0084),
which is a position in a stenosis where the stent delivery device is recommended to be inserted,
based on the observation image (Fig. 1, images, 145, para 0048).
Regarding claim 9, Owens further discloses the stent delivery method (Fig. 7-9, methods, 700-900, para 0097-0098) according to claim 8,
wherein the determining comprises determining the at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100))
from a three-dimensional model (Fig. 1, OSS processing module, 125, in combination with OSS sensing module, 120, para 0038-0039, see also Fig. 7, step, 710, para 0084)
created based on a plurality of observation images (Fig. 1, images, 145, para 0048),
each observed from a different angle (Fig. 1, images, 145, in combination with OSS sensing module, 125, para 0048 and para 0114).
Regarding claim 13, Owens further discloses the stent delivery method (Fig. 7-9, methods, 700-900, para 0097-0098) according to claim 8,
further comprising driving the stent delivery device (Fig. 1, stent deployment device, 200, para 0039)
to move the stent delivery device so that the stent delivery device passes through the at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100, see also, Fig. 9, step, 902, para 0098).
Regarding claim 14, Owens further discloses a control device (Fig. 1, interface, 155, in combination with display, 150, para 0051, para 0051)
for a stent delivery system (Fig. 1, stent delivery system, 100, para 0038),
the stent delivery system including a stent delivery device (Fig. 1, stent delivery device, 200, para 0048)
that carries and indwells a stent (Fig. 1, stent, 215, para 0041)
to a stenosis (Fig. 6B, stent, 215, in combination with stenosis, 415, para 0061),
an observation device (Fig. 1, imaging device, 160, para 0049) used to observe the stenosis,
and one or more processors (Fig. 1, processors, 110, para 0038) comprising hardware,
wherein the one or more processors being configured to determine at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100)),
which is a position within the stenosis where the stent delivery system is recommended to be inserted,
based on the observation image (Fig. 1, images, 145, para 0048) acquired from the observation device.
Regarding claim 15, Owens discloses the control device (Fig. 1, interface, 155, in combination with display, 150, para 0051) according to claim 14,
wherein the one or more processors (Fig. 1, processors, 110, para 0038)
being configured to determine the at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100))
from a three-dimensional model (Fig. 1, OSS processing module, 125, in combination with OSS sensing module, 120, para 0038-0039, discloses the OSS processor controls generation of a three dimensional model both before and after stent deployment)
created based on a plurality of observation images (Fig. 1, images, 145, para 0048),
each observed from a different angle (Fig. 1, images, 145, in combination with OSS sensing module, 125, para 0048 and para 0114).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3-7, 10-12, 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/011855 A1 (hereinafter "Owens") in view of US 12,408,827 B2 (hereinafter “Chelala”).
Regarding claim 3, Owens discloses the stent delivery system (Fig. 1, stent delivery system, 100, para 0038), according to claim 1 further comprising:
one or more processors (Fig. 1, processors, 110, para 0038) configured to control position based on the observation image (Fig. 1, images, 145, para 0048)
and adjust a position of the stent delivery device (Fig. 1, stent delivery device, 200, para 0048) so that the stent delivery device passes through the at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100)).
However, Owens does not explicitly disclose the stent delivery system is comprised of an endoscope having an formed with a channel through which the stent delivery device is inserted; and a driving actuator configured to drive the endoscope, wherein the one or more processors are configured to: control the driving actuator based on the observation image to drive the endoscope, and adjust a position of the stent delivery device so that the stent delivery system passes through the at least one insertion position.
Chelala discloses a medical device for establish access to body passageways further comprising:
an endoscope (Fig. 3A, endoscopic accessory tool, 100, col. 6 lines 21-25, presence of an endoscopic accessory tool would therefore include an endoscope)
having an insertion portion (Fig. 3A, 110, elongate member, col. 6 lines 54-65)
formed with a channel (Fig. 4, elongate tubular body, col. 6 line 66 – col. 7 line 4) through which the delivery device is inserted;
and a driving actuator (Fig. 3A, actuator, 149, col. 7 lines 5-13) configured to drive the endoscope,
with processors (col. 6, lines 14-20) are configured to:
control the driving actuator (Fig. 3A, actuator, 149, col. 7 lines 5-13) based on the observation image to drive the endoscope (Fig. 3A, endoscopic accessory tool, 100, col. 6 lines 21-25), and adjust the delivery device.
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the stent delivery system of Owen to include an endoscope controlled by a driving actuator to provide the medical professional with enhanced control to steer towards a targeted area (Chelala, col. 8 lines 13-17).
Regarding claim 4, Owens further discloses that the stent delivery system (Fig. 1, stent delivery system, 100, para 0038) according to claim 3,
However, Owens does not explicitly disclose wherein the driving actuator comprises: a bending driving actuator configured to bend the insertion portion; an elevator driving actuator configured to drive an elevator provided in the channel of the insertion portion; a forward/backward driving actuator configured to move the insertion portion back and forth; and a roll rotation driving actuator configured to rotate the insertion portion in a roll, wherein the driving actuator adjusts the position of the stent delivery device by driving at least one of the bending driving actuator, the elevator driving actuator, the forward/backward driving actuator, and the roll rotation driving actuator.
Chelala further discloses wherein the driving actuator (Fig. 3A, actuator, 149, col. 7 lines 5-13) comprises:
a bending driving actuator (Fig. 3D, actuator, 149, col. 7 lines 29-34, prior art teaches actuator allowing motion in the -y and +y direction)
configured to bend the insertion portion (Fig. 8A-8B, elongate member, 110, in combination with guidewire, 122, col. 10, lines 57-62);
an elevator driving actuator (Fig. 3A, elevator, 140, col. 6 lines 44-51 in combination with actuator, 149, col. 7 lines 5-13, see also col. 7 lines 34-40 teach that any combination of the embodiments and actuator configurations can be used to allow for motion in the x, y, and z directions)
configured to drive an elevator provided in the channel (Fig. 4, elongate tubular body, col. 6 line 66 – col. 7 line 4) of the insertion portion;
a forward/backward driving actuator (Fig. 3B, actuator, 149, col. 7 lines 19-24, prior art teaches actuator allowing motion in the -x and +x direction) configured to move the insertion portion back and forth;
and a roll rotation driving actuator (Fig. 3C, actuator, 149, col. 7 lines 15-25, prior art teaches actuator allowing motion in the -z and +z direction) configured to rotate the insertion portion in a roll,
wherein the driving actuator adjusts the position of the stent delivery device by driving at least one of the bending driving actuator (Fig. 3D, actuator, 149, col. 7 lines 29-34, prior art teaches actuator allowing motion in the -y and +y direction),
the elevator driving actuator (Fig. 3A, elevator, 140, col. 6 lines 44-51 in combination with actuator, 149, col. 7 lines 5-13),
the forward/backward driving actuator (Fig. 3B, actuator, 149, col. 7 lines 19-24, , prior art teaches actuator allowing motion in the -x and +x direction),
and the roll rotation driving actuator (Fig. 3C, actuator, 149, col. 7 lines 15-25, prior art teaches actuator allowing motion in the -z and +z direction).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the stent delivery system of Owen with the various disclosed actuators of Chelala since doing so merely involves combining prior art elements according to known methods to yield predictable results (see MPEP 2143).
Regarding claim 5, Owens further discloses the stent delivery system (Fig. 1, stent delivery system, 100, para 0038) according to claim 3,
wherein the one or more processors (Fig. 1, processors, 110, para 0038)
are configured to adjust the position of the stent delivery device,
based on the observation image (Fig. 1, images, 145, para 0048),
such that a first direction (see below, annotated Fig. 2, first direction, D1, para 0086)
in which a distal end of the stent delivery device (see below, annotated Fig. 2, distal end, DE, para)
faces substantially coincides with a second direction (see below, annotated Fig. 2, second direction, D1, para 0086)
from the distal end of the stent delivery device toward the at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100)).
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Regarding claim 6, Owens further discloses the stent delivery system (Fig. 1, stent delivery system, 100, para 0038) according to claim 5,
wherein the one or more processors (Fig. 1, processors, 110, para 0038)
being configured to calculate the first direction (see above, annotated Fig. 2, first direction, D1, para 0086)
and the second direction (see above, annotated Fig. 2, second direction, D1, para 0086)
from a three-dimensional model (Fig. 1, OSS processing module, 125, para 0038-0039, discloses the generation of a three dimensional model both before and after stent deployment)
created based on a plurality of observation images (Fig. 1, images, 145, para 0048),
each observed from a different angle (Fig. 1, images, 145, in combination with OSS sensing module, 125, para 0048 and para 0114).
Regarding claim 7, Owens further discloses the stent delivery system (Fig. 1, stent delivery system, 100, para 0038)
configured to drive the stent delivery device (Fig. 1, stent deployment device, 200, para 0039),
wherein the one or more processors (Fig. 1, processors, 110, para 0038) to drive the stent delivery device,
so that the stent delivery device passes the at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100).
However, Owens does not explicitly disclose the stent delivery system further comprises that the processor control a driving actuator and move the stent delivery device.
Chelala further discloses a driving actuator (Fig. 3A, actuator, 149, col. 7 lines 5-13) to drive the medical device (Fig. 1, medical device, 200, col. 4 lines 54-56)
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the stent delivery system of Owen with the various driving actuator of Chelala to provide automatically controlled proximal and distal movement of the stent delivery device (Owens, para 0077).
Regarding claim 10, Owens further discloses the stent delivery method (Fig. 7-9, methods, 700-900, para 0097-0098) according to claim 8, further comprising:
adjusting the position of the stent delivery device (Fig. 1, stent deployment device, 200, para 0039, position of the stent delivery device is adjusted in combination with the processors, 110, and the workstation, 105, para 0038)
formed in the insertion portion (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100))
so that the stent delivery device (Fig. 1, stent deployment device, 200, para 0039)
passes through the at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100))
based on the observation image (Fig. 1, images, 145, para 0048).
However, Owens does not explicitly disclose the stent delivery device is inserted through a channel formed in the insertion portion of an electrically driven endoscope.
Chelala further discloses an endoscopic accessory tool
inserted through a channel (Fig. 4, elongate tubular body, col. 6 line 66 – col. 7 line 4)
formed in the insertion portion (Fig. 8A-8B, elongate member, 110, in combination with guidewire, 122, col. 10, lines 57-62)
of an electrically driven endoscope (Fig. 3A, endoscopic accessory tool, 100, col. 6 lines 21-25, presence of an endoscopic accessory tool would therefore include an endoscope).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the stent delivery method of Owen with the electrically driven endoscope of Chelala to automatically adjust the movement of the stent delivery device based to determine proper positioning of the stent strut relative to the lumen wall (Owens, para 0089).
Regarding claim 11, Owens further discloses the stent delivery method (Fig. 7-9, methods, 700-900, para 0097-0098) according to claim 10,
wherein, the adjusting comprises adjusting the position of the stent delivery device (Fig. 1, stent deployment device, 200, para 0039, see also Fig. 8, step, 802, position is adjusted with respect to sensed data),
based on the observation image (Fig. 1, images, 145, para 0048),
so that a first direction (see below, annotated Fig. 2, first direction, D1, para 0086) in which a distal end of the stent delivery device (Fig. 1, stent deployment device, 200, para 0039) faces substantially coincides with a second direction (see below, annotated Fig. 2, second direction, D2, para 0086) from the distal end of the stent delivery device
toward the at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100, see also, Fig. 9, step, 902, para 0098).
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Regarding claim 12, Owens further discloses the stent delivery method (Fig. 7-9, methods, 700-900, para 0097-0098) according to claim 11,
wherein the adjusting comprises calculating the first direction (see above, annotated Fig. 2, first direction, D1, para 0086)
and the second direction (see above, annotated Fig. 2, second direction, D2, para 0086)
from a three-dimensional model (Fig. 1, OSS processing module, 125, in combination with OSS sensing module, 120, para 0038-0039, see also Fig. 7, step, 710, para 0084)
created based on a plurality of observation images (Fig. 1, images, 145, para 0048),
each observed from a different angle (Fig. 1, images, 145, in combination with OSS sensing module, 125, para 0048 and para 0114).
Regarding claim 16, Owens discloses the control device (Fig. 1, interface, 155, para 0051) according to claim 14,
through which the stent delivery device (Fig. 1, stent deployment device, 200, para 0039) is inserted,
and one or more processors (Fig. 1, processors, 110, para 0038)
being configured to be controlled based on the observation image (Fig. 1, images, 145, para 0048)
to adjust the position of the stent delivery device so that the stent delivery device passes through the at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100).
However, Owens does not explicitly disclose the control device wherein an endoscope is comprised of an insertion portion formed with a channel including a driving actuator for driving the electric endoscope.
Chelala further discloses wherein an endoscope (Fig. 3A, endoscopic accessory tool, 100, col. 6 lines 21-25, presence of an endoscopic accessory tool would therefore include an endoscope)
comprising an insertion portion formed with a channel (Fig. 4, elongate tubular body, col. 6 line 66 – col. 7 line 4)
and a driving actuator (Fig. 3A, actuator, 149, col. 7 lines 5-13) for driving the electric endoscope,
with an electrically driven endoscope (Fig. 3A, endoscopic accessory tool, 100, col. 6 lines 21-25, presence of an endoscopic accessory tool would therefore include an endoscope).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the control device of Owen with the electrically driven endoscope of Chelala to automatically adjust the movement of the stent delivery device based to determine proper positioning of the stent strut relative to the lumen wall (Owens, para 0089).
Regarding claim 17, Owens discloses the control device (Fig. 1, interface, 155, para 0051) according to claim 16,
wherein the one or more processors (Fig. 1, processors, 110, para 0038) being configured to adjust the position of the stent delivery device,
based on the observation image (Fig. 1, images, 145, para 0048),
such that a first direction (see below, annotated Fig. 2, first direction, D1, para 0086) in which the distal end of the stent delivery device
faces substantially coincides with a second direction (see below, annotated Fig. 2, second direction, D2, para 0086) from the distal end of the stent delivery device (Fig. 1, stent deployment device, 200, para 0039)
toward the at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100).
Regarding claim 18, Owens further discloses the control device (Fig. 1, interface, 155, para 0051) according to claim 17,
wherein the one or more processors (Fig. 1, processors, 110, para 0038)
are configured to calculate the first direction (see below, annotated Fig. 2, first direction, D1, para 0086)
and the second direction (see below, annotated Fig. 2, second direction, D2, para 0086)
from a three-dimensional model (Fig. 1, OSS processing module, 125, in combination with OSS sensing module, 120, para 0038-0039, discloses the OSS processor generation of a three dimensional model both before and after stent deployment)
created based on a plurality of observation images (Fig. 1, images, 145, para 0048),
each observed from a different angle (Fig. 1, images, 145, in combination with OSS sensing module, 125, para 0048 and para 0114).
Regarding claim 19, Owens further discloses the control device (Fig. 1, interface, 155, in combination with display, 150, para 0051) according to claim 14,
wherein the one or more processors (Fig. 1, processors, 110, para 0038, processors are disclosed to cause the system to follow the methods steps 700-900, para 0078)
that drives the stent delivery device (Fig. 1, stent deployment device, 200, para 0039),
and move the stent delivery device so that the stent delivery device passes the at least one insertion position (Fig. 6A, stenosed region, 415 in combination with height, 440, para 0100).
However, Owens does not explicitly disclose the control device has one or more processors are configured to control driving actuator that drive the stent delivery device.
Chelala further discloses a driving actuator (Fig. 3A, actuator, 149, col. 7 lines 5-13, wherein the actuator is configured to transmit mechanical motion)
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the control device of Owen with the driving actuator of Chelala since doing so merely involves combining prior art elements according to known methods to yield predictable results (see MPEP 2143).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2021/0161361 A1 (Flanagan) discloses the use of a medical system using an imaging device to facilitate endoscopic procedures, targeting the treatment position using a sensor and a light source (Abs).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JICHELE MONIQUE SANDERS whose telephone number is (571)272-2240. The examiner can normally be reached M-Thu 6:30-5:15.
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/JICHELE MONIQUE SANDERS/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774