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 .
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11793392 B2 and claims 1-21 of U.S. Patent No. 12193637 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims read on the application claims.
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.
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, 5, 10-11, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauerfeind (US 5337733) in view of Nakao (US 5217001), further in view of Dubrul (US 5431676).
Regarding claims 1, 10, and 20, Bauerfeind discloses a system (eg. Fig.1-2 endoscope with pressure system) comprising: an elongate rigidizing device configured to transition between a flexible configuration and a rigid configuration by the application of pressure (eg. Col. 2, Ln. 21-44, Col. 5, Ln. 35 – Col. 6, Ln. 20); but does not disclose a working channel sleeve extending over the elongate rigidizing device, the working channel sleeve comprising one or more expandable external working channels, the expandable external working channels formed by one or more filaments, wherein the working channel sleeve is configured so that the one or more external working channels expands when a tool is passed therethrough, wherein the one or more filaments are knitted, braided or woven to form pores having a pore size that may vary as the one or more expandable external working channels is expanded or collapsed.
Nakao teaches an endoscope system that uses a disposable sheath assembly for an insertion member with a thin-walled elongate tubular sheath made of a strong flexible material that can expand (eg. Fig. 9-10, Col. 8, Ln. 39 – Col. 9, Ln. 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Bauerfeind with the outer sheath with expandable channels as taught by Nakao to provide the predictable result of adding instrument-delivery capacity to an elongate insertion member without enlarging the device’s profile during insertion.
Dubrul teaches an endoscopic device with a tubular braid comprising non-elastic filaments creating a mesh that is radially expandable from a small diameter configuration to a large diameter configuration where the tubular braid is anchored by axial shortening of a braid upon radial expansion that changes the dimension of the filaments (eg. Abstract, Col. 3, Ln. 55 – Col. 4, Ln. 60, Col. 6, Ln. 40-65, Fig. 10, braid 20).
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 Bauerfeind and Nakao to have Nakao’s outer sleeve be made of the tubular braid as taught by Dubrul as a simple substitution for having the predictable result of being able to radially expand/collapse as needed.
Regarding claims 2 and 11, the combined invention of Bauerfeind, Nakao, and Dubrul discloses the one or more expandable external working channels is coupled to a proximal end region and to a distal end region of the elongate rigidizing device (eg. Nakao, Abstract, Col. 5, Ln. 30 – Col. 6, Ln. 53).
Regarding claim 5, the combined invention of Bauerfeind, Nakao, and Dubrul discloses the expandable external working channels comprise a mix of elastic and non-elastic filaments (eg. Dubrul, Abstract, Col. 3, Ln. 5-25, Col. 3, Ln. 55 – Col. 4, Ln. 10, Col. 6, Ln. 40-65, Col. 7, Ln. 9-27, can have elastic/deformable layers with the braid layer).
Claim(s) 3-4 and 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauerfeind (US 5337733) in view of Nakao (US 5217001), further in view of Dubrul (US 5431676), further in view of Silverstein (US 5025778).
Regarding claims 3 and 12, the combined invention of Bauerfeind, Nakao, and Dubrul discloses the invention of claim 1, but does not disclose comprising at least one guide configured to be removably inserted into the one or more expandable external working channels, the at least one guide including a lumen configured to expand the one or more expandable external working channels to enable passage of the tool therethrough.
Silverstein teaches a rigid rod and lining that can be inserted into the tubing through an endoscope channel (eg. Col. 6, Ln. 30 – Col. 7, Ln. 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Bauerfeind, Nakao, and Dubrul with the guide rod as taught by Silverstein to provide the predictable result of providing structural support for the channel and instruments during passage.
Regarding claim 4, the combined invention of Bauerfeind, Nakao, Dubrul, and Silverstein discloses at least one guide includes an atraumatic distal end (eg. Silverstein Col. 6, Ln. 30 – Col. 7, Ln. 25, tapered).
Regarding claim 13, the combined invention of Bauerfeind, Nakao, Dubrul, and Silverstein discloses the at least one guide comprises a protrusion configured to enable rotational alignment of the at least one guide relative to the elongate rigidizing device (eg. Dubrul, Col. 10, Ln. 20-35, the cone is used as an alignment mechanism and would have been obvious to one of ordinary skill to make a simple substitution for such this well-known mechanism for the same function of alignment).
Regarding claim 14, the combined invention of Bauerfeind, Nakao, Dubrul, and Silverstein discloses the expandable external working channels comprise a mix of elastic and non-elastic filaments (eg. Dubrul, Abstract, Col. 3, Ln. 5-25, Col. 3, Ln. 55 – Col. 4, Ln. 10, Col. 6, Ln. 40-65, Col. 7, Ln. 9-27, can have elastic/deformable layers with the braid layer).
Regarding claim 15, the combined invention of Bauerfeind, Nakao, Dubrul, and Silverstein discloses the expandable external working channels comprise a mix of elastic and non-elastic filaments (eg. Bauerfeind, Col. 5, Ln. 35-46, Dubrul, Col. 7, Ln. 9-26).
Regarding claim 16, the combined invention of Bauerfeind, Nakao, Dubrul, and Silverstein discloses the outer member comprises a polyurethane or silicone material (eg, Dubrul, Col. 6, Ln. 40-65).
Claim(s) 6 and 9s/are rejected under 35 U.S.C. 103 as being unpatentable over Bauerfeind (US 5337733) in view of Nakao (US 5217001), further in view of Dubrul (US 5431676), further in view of Chouinard (US 7438712 B2).
Regarding claims 6, and 9, the combined invention of Bauerfeind, Nakao, and Dubrul discloses the invention of claim 1, but does not disclose the one or more expandable external working channels comprises a fluoropolymer material (eg. Dubrul, Col. 6, Ln. 40 – Col. 7, Ln. 8, various rubbers etc. but not specifically fluoropolymers.
Chouinard teaches an endoluminal tube device with a layer that uses PTFE (eg. Col. 5, Ln. 8-65).
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 Bauerfeind, Nakao, and Dubrul to have the layers made of PTFE as a well-known material in the art for constructing sheaths for delivery systems (eg. Chouinard, Col. 5, Ln. 8-65).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauerfeind (US 5337733) in view of Nakao (US 5217001), further in view of Dubrul (US 5431676), further in view of Belson (US 2006/0235458 A1)
Regarding claim 7, the combined invention of Bauerfeind, Nakao, and Dubrul discloses the invention of claim 1, but does not disclose the one or more expandable external working channels comprises a hydrophilic coating.
Belson teaches hydrophilic gel coating to an endoscopic working channel (eg. Para. 60, 153, 156).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Bauerfeind, Nakao, and Dubrul with the hydrophilic coating as taught by Belson to provide the predictable result of helping instruments and the channel to be inserted without binding, catching, or distorting the channel (eg. Belson, Para. 60).
Regarding claim 8, the combined invention of Bauerfeind, Nakao, Dubrul, and Belson discloses one or more expandable external working channels comprises a proximal entry marker thereon configured to indicate a distal exit position (eg. Belson, Para. 54 and 122).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauerfeind (US 5337733) in view of Nakao (US 5217001), further in view of Dubrul (US 5431676), further in view of Silverstein (US 5025778), further in view of Chouinard (US 7438712 B2).
Regarding claim 17, the combined invention of Bauerfeind, Nakao, and Dubrul, and Silverstein discloses the invention of claim 10 but does not disclose the outer member comprises a fluoropolymer material.
Silverstein teaches a rigid rod and lining that can be inserted into the tubing through an endoscope channel (eg. Col. 6, Ln. 30 – Col. 7, Ln. 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Bauerfeind, Nakao, and Dubrul with the guide rod as taught by Silverstein to provide the predictable result of providing structural support for the channel and instruments during passage.
Chouinard teaches an endoluminal tube device with a layer that uses PTFE (eg. Col. 5, Ln. 8-65).
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 Bauerfeind, Nakao, Dubrul, and Silverstein to have the layers made of PTFE as a well-known material in the art for constructing sheaths for delivery systems (eg. Chouinard, Col. 5, Ln. 8-65).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauerfeind (US 5337733) in view of Nakao (US 5217001), further in view of Dubrul (US 5431676), further in view of Silverstein (US 5025778), further in view of Belson (US 2006/0235458 A1)
Regarding claim 18, the combined invention of Bauerfeind, Nakao, Dubrul, and Silverstein discloses the invention of claim 10, but does not disclose the one or more expandable external working channels comprises a hydrophilic coating.
Silverstein teaches a rigid rod and lining that can be inserted into the tubing through an endoscope channel (eg. Col. 6, Ln. 30 – Col. 7, Ln. 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Bauerfeind, Nakao, and Dubrul with the guide rod as taught by Silverstein to provide the predictable result of providing structural support for the channel and instruments during passage.
Belson teaches hydrophilic gel coating to an endoscopic working channel (eg. Para. 60, 153, 156).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Bauerfeind, Nakao, and Dubrul with the hydrophilic coating as taught by Belson to provide the predictable result of helping instruments and the channel to be inserted without binding, catching, or distorting the channel (eg. Belson, Para. 60).
Regarding claim 19, the combined invention of Bauerfeind, Nakao, Dubrul, Silverstein, andBelson discloses one or more expandable external working channels comprises a proximal entry marker thereon configured to indicate a distal exit position (eg. Belson, Para. 54 and 122).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/Examiner, Art Unit 3796
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