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 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. - US 12239318 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they are substantially co-extensive in scope, at least in regard to the novel subject matter, and differ merely in equivalent terminology used as to function. Both claim a surgical tool having an elongate shaft/rod with a wrist at end having an effector with first and second jaws attached to the wrist end of the shaft/rod, a knife coupled to the shaft/rod having a - releasable connection (current claim 1 & patented claims 1 and 4) where in the releasable connection includes a crimp (current claims 2 and 12 & patented claims 6 and 18) a disc mount (current claims 7-8 & patented claims 19-20) and knife drive spacer (current claims 3-6 & patented claims 5 and 17). Generally, all of the dependent claims of the patent set forth the equivalent subject matter of the dependent claims of the current application. Therefore, it would have been obvious to one skilled in the art to substitute the terminology recited in the current claims with the equivalent components of the patented claims, since to do so provides nothing new or unexpected.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0083], recites “the drive inputs that are actuatable to manipulate joint cables 1310 associated with the wrist 206 may need to be rotated to allow the joint cables 1310 to pay out as the shaft internal structure 1304 moves distally B” which is not clear what “pay out” is. 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.
Claim 13 is 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.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being unclear what “pay out” and the what structural members/structural connections are involved with the “pay out.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Swayze. et al. (US 20190105052 A1).
Regarding claims 1, Swayze. et al. discloses a surgical tool (200), comprising: a drive housing (210); an elongate shaft (230) extending from the drive housing; a wrist (300) coupled to a distal end of the elongate shaft; an end effector (240) coupled to a distal end of the wrist including opposing upper and lower jaws (243/242 & 290/296); and
a knife assembly (245) including a knife arranged at the end effector and a drive member (drive shaft 232/drive nut 270) extending from the knife to the drive housing through the wrist and the elongate shaft (figs. 7-18),
the drive member (drive shaft 232/270) including a distal section (286) connected to a proximal section (236) by a releasable connection (250- inside socket 237 with hexagonal slot/recess 236 and 250 is spline connection and is releasable to disconnect 232 with 280 [0068-0090], figs. 7-18. Moreover, drive members 232 and 250, 260, 270, 280 are all connected via a releasable connection).
Regarding claims 10, Swayze. et al. discloses surgical tool (200), comprising: a drive housing (210); an elongate shaft (230) extending from the drive housing; a shaft internal structure (232 and/or 270 [0073], figs. 8-18) disposed in the elongate shaft (230) and moveable relative to the elongate shaft between a first and a second position (control ring 216 moves 232 proximal/distal and drive nut 270 translates relative to cartridge housing 300/shaft 230 to move staple driver 243 via 280 [0074-0076], figs. 7-10),
the shaft internal structure including a slot (inside socket 237 with hexagonal slot/recess 236, figs. 17-18);
a wrist (300) coupled to a distal end of the shaft internal structure (232 and/or 270 [0073], figs. 8-18); an end effector (240) coupled to a distal end of the wrist including opposing upper and lower jaws (243/242 & 290/296); a knife assembly including a knife (245) arranged at the end effector and a drive member (243/276/232) extending from the knife to the drive housing (210) through the wrist and shaft internal structure, the drive member including a distal section connected to a proximal section by a releasable connection (250 – drive shaft 232 connects with 250 that connects with 280 via splines, also 232 has end 233 that couples with the motor – both 233/250 are releasable connections), wherein the releasable connection (250) is accessible through the slot (inside socket 237 with hexagonal slot/recess 236, figs. 17-18) when the shaft internal structure is in the second position to release the connection between the proximal and distal sections (250 is spline connection and is releasable to disconnect 232 with 280, [0068-0090], figs. 7-18. Moreover, drive members 232 and 250, 260, 270, 280 are all connected via a releasable connection).
Regarding claims 11, Swayze. et al. discloses an adapter (260 and/or proximal portion of 300 with resilient arms 304 couples with socket 237, figs. 17-18) interposing the wrist and the shaft internal structure (232 and/or 270), wherein the wrist is coupled to the distal end of the shaft internal structure by the adapter ([0073-0084], figs. 7-18).
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsuruta et al. (US 5389098 A).
Regarding claim 1, Tsuruta et al. discloses an surgical tool (figs. 1-11 and 90-109), comprising: a drive housing (1); an elongate shaft (2) extending from the drive housing; a wrist (8) coupled to a distal end of the elongate shaft (figs. 2-7); an end effector (5) coupled to a distal end of the wrist including opposing upper and lower jaws (4/3); and a knife assembly including a knife (29/302) arranged at the end effector figs. 1-11 and 90-109) and a drive member (306/314- wires 303, 304, and 305 joined to form connector 306/307 or 518/519) extending from the knife (302) to the drive housing through the wrist and the elongate shaft,
the drive member (306/314) including a distal section (514/306) connected to a proximal section (“a pin (not shown) protruding from the distal end of the insertion section” and/or 590/516 inside insertion section 2) by a releasable connection (307 and cylindrical split-spring 5160 crimping/elastically couples, col. 32, line 23-67- col. 36, line 25, figs. 90-109).
Claim Rejections - 35 USC § 102/103
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.
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 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by LEE et al. (US 20250195070 A1) or, in the alternative, under 35 U.S.C. 103 as obvious over LEE et al. (US 20250195070 A1) in view of Tsuruta et al. (US 5389098 A).
Regarding claim 1, LEE et al. discloses an surgical tool (2000), comprising: a drive housing (200); an elongate shaft (401) extending from the drive housing; a wrist (tool hub 2106 and a pitch hub 2107) coupled to a distal end of the elongate shaft; an end effector (2100) coupled to a distal end of the wrist including opposing upper and lower jaws (2102& 2101/500 [0259-0260, 0294]); and a knife assembly (540/542, figs. 28-32) including a knife arranged at the end effector ([0264, 0304, 0357-0369, 0467, 0483-0558], figs. 28-32 and 56-59) and a drive member (302/307-310 with first staple pulleys 2181/2191 and staple link assembly 2170 [0465-0467, 0481-0484, 0547], figs. 45-46) extending from the knife to the drive housing through the wrist and the elongate shaft,
the drive member (retraction wire 302 and/or staple wires 307-310) including a distal section (at 2100 around pulley 2121, a pulley 2122, a pulley 2123, figs. 4-10 [0296]) connected to a proximal section (at manipulation part 200/power transmission part 300 [0270-0300], figs. 1-10) by a releasable connection (retraction wire 302 and/or staple wires 307-310 can re “released”/unwound and removed if desired absent any particular structure or function of how the connection is “releasable”).
In the alternative, if it can be argued that LEE et al. fails to disclose having a releasable connection; wherein the drive member including a distal section connected to a proximal section by a releasable connection-
Tsuruta et al. teaches a similar stapler (fig. 1) having an operation section 1, an insertion section 2, and a stapling member 5 with cartridge 3 and an anvil 4 and pushers 300/cutter 302 (figs. 1 and 90-109) having cable drive members (321, 303, 304, 305 and/or 518/519) including a distal section (insertion section 2 with pin fig. 90-91 and 590 figs. 105-109) connected to a proximal section (306, 518 respectively) by a releasable connection (307 and/or 518/516 crimping/elastically couples, col. 32, line 23-67- col. 36, line 25, figs. 90-109).
Given the teachings of LEE et al. to have a cable driven effector with the cable passing through a wrist coupling assembly, it 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 to modify the drive member including a distal section connected to a proximal section by a releasable connection to easier connection of an effector to an operation section/handle section, quick release of cables/wires when reloading a cartridge, replacing parts, and/or for articulating purposes as taught by Tsuruta et al.
Allowable Subject Matter
Claims 15-20 would be allowable if a proper Terminal Disclaimer is filed for U.S. Patent No. - US 12239318 B2
Claims 2-9 and 12-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if a proper and if a Terminal Disclaimer is filed for U.S. Patent No. - US 12239318 B2
Claim 13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims and if a proper and if a Terminal Disclaimer is filed for U.S. Patent No. - US 12239318 B2
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Reasons for Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance: the prior art of record fails to teach or render obvious a surgical tool comprising all the structural and functional limitations and further comprising, amongst other limitations/features, an apparatus method for replacing a drive member or portions of the surgical tool (high-wear components) of a surgical tool comprising a drive housing, a shaft, an end effector having jaws, a wrist at an end of the shaft connecting to the end effector, a knife assembly having at least one drive member extending from the knife to the housing, uncoupling the end effector and knife from the wrist, removing the knife assembly from the end effector, replacing the drive member, knife, or portions of the surgical tool (high-wear components) of the tool, and reassembling the knife to the tool and the end effector to the wrist. The closest prior art Swayze. et al. (U.S. Patent Application Publication US 20190105052 A1) discloses a surgical tool 200, a housing, an end effector 240/290, a blade 245, jaws (243/242 & 290/296) actuated on the end effector by actuator rods 232 and 250, 260, 270, 280 (See Figs. 7-18), and a wrist 300, but lacks the specifically recited removal steps for installing replacement parts. See the attached PTO-892 for other related art.
While various features of the claimed subject matter are found individually in the prior art, a skilled artisan would have to include knowledge gleaned only from the applicant's disclosure to combine or modify the teachings of the prior art to produce the claimed subject matter, and thus obviousness would not be proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). There is no teaching, suggestion, or motivation found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to combine or modify the teachings of the prior art to produce the claimed invention, and thus obviousness would not be proper. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Additional prior art considered pertinent: see form 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT LONG whose telephone number is (571)270-3864. The examiner can normally be reached M-F, 9am-5pm, 8-9pm (EST).
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/ROBERT F LONG/Primary Examiner, Art Unit 3731