Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 1-20 are objected to because of the following informalities: Claims 1 and 14 have two “(e)” limitations (the empty spaces and the nozzles). The Examiner assumes the second limitation should be “(f)”, and dependent claims should be amended accordingly. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 8-12, 14-15, and 18-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kennedy, II et al. (US 2013/0172674) in view of Ouyang et al. (US 2012/0289858).
Regarding Claim 1, Kennedy discloses:
An endoscopic device comprising:
(a) an insertion tube (104);
(b) a distal tip at the distal end of the insertion tube (distal end of 104);
(c) an imaging device (116) located in the distal tip, the imaging device comprising an objective lens (118);
(d) a plurality of longitudinal elements comprised of tubes, wires, and cables that pass through the interior of the insertion tube (see Fig. 6 showing the various tubes, Paragraph 0074 mentioning cables (not shown), and other components);
(e) empty spaces (108) between the plurality of longitudinal elements, wherein the empty spaces are configured to be utilized as a channel that enables liquid or gas to flow through the insertion tube to the distal tip (flushing voids 108 are used for fluid to be directed out the distal end; see Paragraph 0078).
Kennedy does not explicitly disclose (e) one or more nozzles at the distal tip for spraying said liquid or gas over the objective lens of the imaging device for cleaning said lens. Ouyang teaches using distal ports 620/622 for allowing fluid to exit the tip to clear debris from the tip (see Paragraph 0121). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kennedy’s device to include Ouyang’s ports. Such a modification helps clear debris from the tip to improve visualization.
Regarding Claim 2, Kennedy does not explicitly disclose (f) a handle section comprising one or more fluid sealed compartments. Ouyang teaches having a handle with seals to isolate the handle from patient matter during the procedure (see Paragraph 0152). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kennedy’s device to include Ouyang’s handle with seals. Such a modification isolates the handle portion from the rest of the device to prevent unwanted contamination.
Regarding Claim 3, Kennedy does not explicitly disclose wherein the handle section further comprises an inlet port for introducing the liquid or gas into at least one of said fluid sealed compartments in the handle section. However, something is needed for fluid to enter the flushing voids 108. Ouyang teaches using a port (114) on the handle for delivering fluid. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kennedy’s device to include Ouyang’s port. Such a modification provides a way for fluid to enter the device.
Regarding Claim 8, Kennedy as modified further discloses wherein the imaging device activated by power delivered thereto and transmitting images captured therewith via said one or more of the plurality of longitudinal elements comprising one or more cables, wires, or optical fibers (see Paragraph 0065 discussing the camera cables).
Regarding Claim 9, Kennedy as modified further discloses wherein the imaging device is a video camera (camera train holder 114 holds the camera 116, which is an image sensor).
Regarding Claim 10, Kennedy as modified further discloses illumination devices located in the distal tip (106), the illumination devices activated by said one or more of the plurality of longitudinal elements (fibers 106 are included as longitudinal elements).
Regarding Claim 11, Kennedy as modified further discloses wherein the liquid or gas sprayed through one or more nozzles clean the illumination devices (as described in Ouyang Paragraph 0121, the nozzles clear debris from the distal face including the illumination fibers).
Regarding Claim 12, Kennedy does not explicitly disclose wherein the distal tip comprises a pattern of alternating grooves and lands on its outer surface and a cap configured to fit over said lands. However, Ouyang shows such a configuration with a cap 600 fitting over said lands (see Figs. 8B-8E). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kennedy’s device to include Ouyang’s grooves, lands, and cap. Such a modification provides an alternative means of closing the distal end so that fluid can flow through the empty spaces as desired in both Kennedy and Ouyang.
Regarding Claim 14, Kennedy discloses:
A method of cleaning an imaging device of an endoscopic device, wherein the endoscope device comprises:
(a) an insertion tube (104);
(b) a distal tip at the distal end of the insertion tube (distal end of 104);
(c) an imaging device (116) located in the distal tip comprising an objective lens (118);
(d) a plurality of longitudinal elements comprised of tubes, wires, and cables that pass through the interior of the insertion tube (see Fig. 6 showing the various tubes, Paragraph 0074 mentioning cables (not shown), and other components);
(e) empty spaces (108) between the plurality of longitudinal elements (flushing voids 108 are used for fluid to be directed out the distal end; see Paragraph 0078);
utilizing the empty spaces between the plurality of longitudinal elements as a liquid or gas channel which enables liquid or gas to flow through the insertion tube to the distal tip (flushing voids 108 are used for fluid to be directed out the distal end; see Paragraph 0078).
Kennedy does not explicitly disclose (e) one or more nozzles at the distal tip; and utilizing the one or more nozzles for spraying said liquid or gas over the objective lens of the imaging device thereby cleaning the lens. Ouyang teaches using distal ports 620/622 for allowing fluid to exit the tip to clear debris from the tip (see Paragraph 0121). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kennedy’s device to include Ouyang’s ports. Such a modification helps clear debris from the tip to improve visualization.
Regarding Claim 15, Kennedy does not explicitly disclose wherein the endoscopic device further comprises: (f) a handle section comprising one or more fluid sealed compartments comprising an inlet port for introducing the liquid or gas into at least one of said fluid sealed compartments in the handle section, and wherein the method further comprises introducing liquid or gas through the inlet port, the empty spaces between the plurality of longitudinal elements and one or more nozzles.
Ouyang teaches having a handle with seals to isolate the handle from patient matter during the procedure (see Paragraph 0152) and a port (114) on the handle for delivering fluid. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kennedy’s device to include Ouyang’s handle with seals and a port. Such a modification isolates the handle portion from the rest of the device to prevent unwanted contamination while allowing fluid to be delivered to the distal end.
Regarding Claim 18, Kennedy as modified further discloses activating the imaging device by delivering power thereto and transmitting images captured therewith via said one or more of the plurality of longitudinal elements comprising one or more cables, wires, or optical fibers (see Paragraph 0065 discussing the camera cables).
Regarding Claim 19, Kennedy as modified further discloses illumination devices located in the distal tip, the illumination devices (106) activated by said one or more of the plurality of longitudinal elements (fibers 106 are included as longitudinal elements), and wherein the method further comprises utilizing the one or more nozzles for spraying said liquid or gas over the illumination devices thereby cleaning the illumination devices (as described in Ouyang Paragraph 0121, the nozzles clear debris from the distal face including the illumination fibers).
Claim 4 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kennedy, II et al. (US 2013/0172674) and Ouyang et al. (US 2012/0289858), as applied to claims 1 and 2 above, and further in view of Konstorum et al. (US 6,749,560).
Kennedy and Ouyang disclose the invention substantially as claimed as stated above, but they do not explicitly disclose (g) an articulation section located at the distal end of the insertion tube proximally to the distal tip, the articulation section activated by at least some of said plurality of longitudinal elements comprising articulation cables or wires. Distal articulating sections and associated control wires are common in the art. Konstorum teaches one such example with deflection section 16 and wires 24a/24b for articulating the distal tip. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kennedy and Ouyang’s device to include a deflection section with control wires. Such a modification provides a means for changing the orientation of the tip as is known in the art.
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 1-12 and 13-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-9, 12, 14, and 18-19 of U.S. Patent No. 12,232,692 in view of Kennedy, II et al. (US 2013/0172674) and Ouyang et al. (US 2012/0289858).
The patent claims the device handle with sealed compartments and articulation cables in claim 1 and the device and methods more generally in claims 5 and 14. The patent also claims the imaging and illumination devices and the cover (see claims 3 and 8 for example). The scopes of the claims are not identical, but to the extent they are different, Kennedy and Ouyang render those differences obvious as discussed in more detail above. No additional features in the present claim represent a patentable distinction over the prior art and the patent.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,492,662 in view of Kennedy, II et al. (US 2013/0172674) and Ouyang et al. (US 2012/0289858).
The patent claims the device with a cap and a corresponding method. The scopes of the claims are not identical, but to the extent they are different, Kennedy and Ouyang render those differences obvious as discussed in more detail above. The additional features are standard in the art and as taught to be beneficial by Kennedy and Ouyang, these features help reduce the cross-section of the device while providing fluid to the distal end. No additional features in the present claims represent a patentable distinction over the prior art and the patent.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,266,300 in view of Kennedy, II et al. (US 2013/0172674) and Ouyang et al. (US 2012/0289858).
The patent claims the device with a cap and a corresponding method. The scopes of the claims are not identical, but to the extent they are different, Kennedy and Ouyang render those differences obvious as discussed in more detail above. The additional features are standard in the art and as taught to be beneficial by Kennedy and Ouyang, these features help reduce the cross-section of the device while providing fluid to the distal end. No additional features in the present claims represent a patentable distinction over the prior art and the patent.
Conclusion
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795
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