The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
DETAILED ACTION
Claim Objections
Claim 10 is objected to because of the following informalities: typographical error “An medical” in Line 1. Appropriate correction is required.
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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Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 17/476,040. Although the claims at issue are not identical, they are not patentably distinct from each other because the medical insertion device of Application No. 17/476,040 reads on the medical insertion device of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 of this title, 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 1, 2, 4-7, 9, 10, 12-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fujita et al. (U.S. Publication 2015/0216391, hereinafter “Fujita”) and in further views of Gat et al. (U.S. Publication 2016/0135668, hereinafter “Gat”) and Higgins et al. (U.S. Publication 2007/0013710, hereinafter “Higgins”).
As to Claim 1, Fujita discloses a medical insertion device assembly (1) in [0046] and Fig. 1A comprising:
a medical insertion device (3) in [0046] comprising:
a control handle (33) in [0047] configured to control one or more functions of the medical insertion device;
an insertion tube (31) in [0047] having a length extending distally from said control handle; and
at least one imaging assembly (32) in [0046] and Fig. 1A at a tip section of the insertion tube configured to generate image data of a plurality of areas in a field of view of the at least one imaging assembly, and to transmit the image data to a processor (44, 45) in [0051] and Fig. 3A;
a display screen (7) in [0057]; and
a control unit (5) in [0067] and Fig. 5 and “computer” in [0013] and [0112] coupled to the control handle and comprising the processor;
wherein the display screen is configured to display the image data in a first portion (61) in [0069] and Fig. 1C of the display screen and display a medical insertion device image map (62, 63) in [0093] in [0069] and Fig. 1C captured in a second portion of the display screen.
However Fujita does not specifically disclose a speed notification. Gat teaches in the analogous field of endoscopy wherein a control unit is adapted to generate a notification “alert” in [0093] and [0097] and Fig. 10 when the speed at which the insertion tube is moving through the patient’s body exceeds a threshold speed value. It would have been obvious to one of ordinary skill in the art at the time of invention to provide the control unit of Fujita to capably generate the notification as taught by Gat in order to notify the user when there is a discrepancy between calculated velocity and desired/expected velocity (Gat, [0093]) while fulfilling the same function of device navigation.
In order to expedite prosecution, Higgins teaches in the analogous field of endoscopy wherein images and corresponding depth maps can be pre-rendered in [0032]. It would have been obvious to one of ordinary skill in the art that the device of Fujita would display the endoscopic image map at a second point in time prior to generation of image data as taught by Higgins in order to fulfill the same function of providing visual information to the user with predictable results in accordance with the image data being in synch with a current speed under normal operation.
As to Claim 2, Fujita discloses the medical insertion device assembly of claim 1, wherein the insertion tube includes a plurality of markings “optical pattern” in [0053] and Figs. 3A and 3B, and the medical insertion device assembly further comprises:
a detector (4) in [0046] and Fig. 1 configured to detect said plurality of markings during insertion of the insertion tube into a subject, and to transmit data “displacement amount information” in [0051] representative of said plurality of markings to the processor.
As to Claim 4, Fujita discloses the medical insertion device assembly of claim 2, wherein the detector is adapted to surround a portion of the length of the insertion tube and remain outside of the control handle as shown in Fig. 1.
As to Claim 5, Fujita discloses the medical insertion device assembly of claim 2, wherein the detector is configured to detect rotation of the insertion tube about a central longitudinal axis of the insertion tube as described in [0051].
As to Claim 6, Fujita discloses the medical insertion device assembly of claim 2, wherein the processor is adapted to use the data representative of the plurality of markings to calculate location information related to a location of the insertion tube as described in [0051], wherein the image data includes a plurality of image frames, and wherein the processor is adapted to stamp “time” in [0053] each image frame with the location information.
As to Claim 7, Fujita discloses the medical insertion device assembly of claim 5, wherein the image data includes a first image frame and a second image frame; wherein the processor is adapted to store a rotation angle associated with each of the first image frame and the second image frame as described in [0051]; wherein the first image frame has a rotation angle different from the rotation angle of the second image frame during normal operation and movement; and wherein the processor is configured to align the first image frame and the second image frame to a common rotation angle as described in [0051].
As to Claim 9, Fujita discloses the medical insertion device assembly of claim 8, wherein the control unit is adapted to generate a notification in the form of (i) a signal to a vibrator in the control handle, (ii) a signal to an audio speaker, or (iii) a signal to the display screen to visually present an icon, image, color, or other picture when the speed at which the insertion tube is moving through the patient's body exceeds a threshold speed value as shown in Fig. 1B.
As to Claim 10, Fujita discloses a medical insertion device assembly (1) in [0046] and Fig. 1A comprising:
an medical insertion device (3) in [0046] comprising:
a control handle (33) in [0047] configured to control one or more functions of the medical insertion device;
an insertion tube (31) in [0047] having a length extending distally from said control handle and including a plurality of markings “optical pattern” in [0053] and Figs. 3A and 3B; and
at least one imaging assembly (32) in [0046] and Fig. 1A at a tip section of the insertion tube configured to generate image data of a plurality of areas in a field of view of the at least one imaging assembly, and to transmit the image data to a processor (44, 45) in [0051] and Fig. 3A;
a display screen (7) in [0057];
a detector (4) in [0046] and Fig. 1 configured to detect the plurality of markings during insertion of the insertion tube into a subject, and to transmit data “displacement amount information” in [0051] representative of the plurality of markings to the processor; and
a control unit (5) in [0067] and Fig. 5 and “computer” in [0013] and [0112] coupled to said control handle and comprising the processor;
wherein the processor is adapted to determine a speed at which the insertion tube is moving through the subject using the data representative of the plurality of markings; and
wherein the display screen is configured to display the speed at which the insertion tube is moving through the subject in a portion of the display screen.
However Fujita does not specifically disclose a speed notification. Gat teaches in the analogous field of endoscopy wherein a control unit is adapted to generate a notification “alert” in [0093] and [0097] and Fig. 10 when the speed at which the insertion tube is moving through the patient’s body exceeds a threshold speed value. It would have been obvious to one of ordinary skill in the art at the time of invention to provide the control unit of Fujita to capably generate the notification as taught by Gat in order to notify the user when there is a discrepancy between calculated velocity and desired/expected velocity (Gat, [0093]) while fulfilling the same function of device navigation.
In order to expedite prosecution, Higgins teaches in the analogous field of endoscopy wherein images and corresponding depth maps can be pre-rendered in [0032]. It would have been obvious to one of ordinary skill in the art that the device of Fujita would display the endoscopic image map at a second point in time prior to generation of image data as taught by Higgins in order to fulfill the same function of providing visual information to the user with predictable results in accordance with the image data being in synch with a current speed under normal operation.
As to Claim 12, Fujita discloses the medical insertion device assembly of claim 10, wherein the imaging assembly includes a plurality of imaging assemblies as shown in Figs. 15-18.
As to Claim 13, Fujita discloses the medical insertion device assembly of claim 10, wherein the detector is adapted to surround a portion of the length of the insertion tube and remain outside of the control handle as shown in Fig. 1.
As to Claim 14, Fujita discloses the medical insertion device assembly of claim 10, wherein the detector is configured to detect rotation of the insertion tube about a central longitudinal axis of the insertion tube as described in [0051].
As to Claim 15, Fujita discloses the medical insertion device assembly of claim 10, wherein the processor is adapted to use the data representative of the plurality of markings to calculate location information related to the location of the medical insertion device as described in [0051].
As to Claim 16, Fujita discloses the medical insertion device assembly of claim 10, wherein the image data includes a plurality of image frames, wherein the processor is adapted to map the plurality of image frames in a real time image map; and wherein the display screen is configured to display the real time image map in a first portion of the display screen and display a medical insertion device image map (62, 63) in [0093] in [0069] and Fig. 1C captured prior to generation of the image data in a second portion of the display screen (the image map being acquired during normal operation alongside operation of the device at a current speed at any given point in time).
As to Claim 18, Fujita discloses a method comprising:
inserting a medical insertion device into a patient, an medical insertion device comprising
a control handle configured to control one or more functions of the medical insertion device;
an insertion tube having a length extending distally from said control handle; and
at least one imaging assembly at a tip section of the insertion tube configured to generate image data of a plurality of areas in a field of view of the at least one imaging assembly,and to transmit the image data to a processor;
processing, at a control unit coupled to the control handle, image data of a plurality of areas in a field of view of the at least one imaging assembly;
displaying, on a display screen, a medical insertion device map (62, 63) in [0093] in [0069] and Fig. 1C in synch with a current speed at which the insertion tube moves within a subject (the image map being acquired during normal operation alongside operation of the device at a current speed at any given point in time).
As to Claim 19, Fujita discloses the method of claim 18, wherein the insertion tube includes a plurality of markings, and the method further comprises:
detecting, via a detector device (4) in [0046] and Fig. 1, at least one of the plurality of markings during insertion of the insertion tube into a subject, and
transmitting data representative of the plurality of markings to the control unit, wherein the control unit is adapted to determine the current speed of the medical insertion device using the data representative of the plurality of markings.6
As to Claim 20, Fujita discloses the method of claim 18, wherein the at least one imaging assembly includes a plurality of imaging assemblies as shown in Figs. 15-18.
Claims 3, 11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Fujita, Gat, and Higgins in further view of Hart et al. (U.S. Publication 2011/0290005, hereinafter “Hart”).
As to Claims 3, 11, and 17, Fujita discloses the endoscope assembly of claim 25, however does not specifically dicslose merging image data into three-dimensional image image data. Hart teaches in the related field of medical imaging that forming composite three-dimensional images from multiple images are known in the art in [0054]. It would have been obvious to one of ordinary skill in the art at the time of invention to provide the main control unit of Fujita to be adapted to merge a plurality of image frames of the image data, based on the transmitted data representative of the plurality of markings, to generate three-dimensional image data of the areas viewed by the at least one imaging assembly as taught by Hart, as such a modification would be an improvement of visualization for the user to facilitate navigation of the device.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Fujita, Gat, and Higgins and in further view of Urakawa et al. (U.S. Publication 2009/0177034, hereinafter “Urakawa”), and Okawa (U.S. Publication 2007/0276184).
As to Claim 8, Fujita discloses the medical insertion device assembly of claim 3, wherein the processor is adapted to determine a speed “insertion amount” in [0051] over a given amount of time during normal operation at which the insertion tube is moving through a patient's body using the data representative of said plurality of markings; and wherein the display screen is configured to display the speed at which the insertion tube is moving through the patient's body in a third portion of the display screen.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM B CHOU whose telephone number is (571) 270-3367. The examiner can normally be reached on M-F 9 am - 6 pm.
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/WILLIAM CHOU/
Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
Prosecution Insights