DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 18-19 are objected to because of the following informalities: claims 18-19 are identical. 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.
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 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9259275, claims 1-16 of 10206748, claims 1-13 of 10835331, claims 1-22 11304768, and claims 1-11 of 12114941. 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 § 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.
Claims 4-6 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.
Regarding claims 4-6, it is unclear what the relationship between the control cables and tension members are with relation to each other. Are the control cables the same thing as tension members? Further clarification is needed.
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 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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 2-4, 6, 13-17, 21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Madhani (US 5792135).
Regarding claim 2, Madhani discloses a surgical tool comprising: an elongate shaft having a proximal end and a distal end, wherein a longitudinal axis extends through the proximal end and the distal end (eg. Col. 3, Ln. 65- Col. 4, Ln. 16, Fig. 3, tubular support 24, Col. 5 Ln. 40-55); an end effector movably coupled to the distal end of the elongate shaft for selective rotation of the end effector relative to the elongate shaft around a first axis and a second axis, wherein the first axis is transverse to the longitudinal axis, wherein the second axis is transverse to each of the longitudinal axis and the first axis (eg. Col. 8, Ln. 8-17); four tension members extending along the elongate shaft, wherein each of the four tension members is coupled to the end effector (eg. Col. 8, Ln. 26-Col. 11, Ln. 10); and an actuation assembly disposed at the proximal end of the elongate shaft, wherein the actuation assembly is operable to actuate the four tension members to selectively rotate the end effector relative to the elongate shaft around the first axis and the second axis and rotate the elongate shaft relative to the actuation assembly (eg. multiple embodiments, Col. 8, Ln. 26-Col. 11, Ln. 10).
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 embodiments of Madhani to have the cables twisting about in different directions to provide the predictable result of having more degrees of freedom and expanding articulation (eg. Col. 4, Ln. 15-50).
Regarding claim 3, Madhani discloses an intermediate member pivotally coupled with the elongate shaft to rotate relative to the elongate shaft around the first axis, wherein the end effector is pivotally coupled with the intermediate member to rotate relative to the intermediate member around the second axis (eg. Col. 5, Ln. 40-55).
Regarding claim 4, Madhani discloses a pair of control cables drivingly coupled with a cable articulated member of the end effector (eg. Col. 7, Ln. 45-63).
Regarding claim 6, Madhani discloses the cable articulated member of the end effector is configured for grasping tissue (eg. Col, 7 Ln. 63 – Col. 8, Ln. 7, graspers).
Regarding claim 13, Madhani discloses the intermediate member has an exterior width along one of the first axis and the second axis;the intermediate member has an exterior length along the other of the first axis and the second axis; and the exterior width is less than the exterior length so that the intermediate member has an elongate shape (eg. Col, 7 Ln. 63 – Col. 8, Ln. 7, it would have been obvious to have changed the size/shape of the part to achieve the desired shape of the same functional grasping tool, see MPEP 2144.04).
Regarding claim 14, Madhani discloses the actuation assembly is configured to be mounted to a surgical robot (eg. Col. 2, Ln. 24-44, Col. 4, Ln. 40-50).
Regarding claim 15, Madhani discloses the actuation assembly comprises an end effector articulation mechanism drivingly coupled with the four tension members; the end effector articulation mechanism comprises a first capstan and a second capstan; the first capstan is drivingly coupled with a first diagonally opposed pair of the four tension members; and the second capstan is drivingly coupled with a second diagonally opposed pair of the four tension members (eg. Col. 8, Ln. 26-Col. 11, Ln. 10, one of ordinary skill to have implemented a known mechanism of antagonistic-pair drive arrangement to coordinate pitch/yaw with fewer drive elements).
Regarding claim 16, Madhani discloses the four tension members are intertwisted for one or more ranges of orientations of the elongate shaft relative to the actuation assembly. (eg. Col. 8, Ln. 26-Col. 11, Ln. 10, can be twisted as an obvious consequence of the shaft being rolled about the support axis).
Regarding claim 17, Madhani discloses the end effector articulation mechanism is back-drivable to accommodate reorientation of the end effector relative to the elongate shaft induced by forces applied to the end effector via contact with tissue (eg. Abstract, Col. 4, Ln. 42-50, Col. 5, Ln. 20-40, Col 5, Ln. 55 – Col. 6, Ln. 2).
Regarding claim 21, Madhani discloses each of the four tension members is under tension for all orientations of the end effector relative to the elongate shaft (eg. Col. 8, Ln. 26-Col. 11, Ln. 10).
Claim 5, 18-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Madhani (US 5792135) in view of Cooper (US 6817974 B2).
Regarding claim 5, Madhani discloses the invention of claim 4, but does not disclose the intermediate member comprises internal passages configured to constrain cross-sectional positions of the pair of control cables relative to the longitudinal axis.
Cooper teaches a medical instrument with a tendon actuated multi-disk wrist joint that has a tendon/cable passing through apertures in each adjacent vertebrae (eg. Col. 7, Ln. 49 – Col. 8, Ln. 5, Col. 12, Ln. 59 – Col. 13, Ln. 21).
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 Madhani with the vertebrae setup as taught by Cooper to provide the predictable result of allowing the cable tension to remain constant during articulation.
Regarding claims 18-19, the combined invention of Madhani and Cooper discloses the invention of claim first axis and the second axis are non- intersecting (eg. Col. 5, Ln. 20-42, Col. 11, Ln. 60 – Col. 12, Ln. 5).
Regarding claim 20, the combined invention of Madhani and Cooper discloses the first axis and the second axis are separated by 2 mm or less (Eg. Col. 12, Ln. 59 – Col. 13, Ln. 21, one of ordinary skill would have been able to resize the parts as desired, see MPEP 2144.04).
Claim 7-8, 10-11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Madhani (US 5792135) in view of Shelton (US 7766219 B2).
Regarding claim 7, Madhani discloses the invention of claim 3, but does not disclose a first drive shaft assembly that extends past the intermediate member on a first side of the intermediate member, wherein the actuation assembly is operable to selectively rotate the first drive shaft assembly relative to the elongate shaft to actuate a first shaft driven mechanism of the end effector.
Shelton teaches a cable tensioning surgical device that uses a main drive shaft 48 and shaft 50 that allows the secondary shaft 50 to rotate and allows end effectors to travel longitudinally along channel 22 (eg. Fig. 4-5, Col 7, Ln. 20-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Madhani with the drive shaft as taught by Shelton to provide the predictable result of adding a high-force shaft driven end effector function.
Regarding claim 8, the combined invention of Madhani and Shelton discloses the first shaft driven mechanism of the end effector is configured for stapling and cutting tissue (. Fig. 4-5, Col 7, Ln. 20-65).
Regarding claim 10, the combined invention of Madhani and Shelton discloses a second drive shaft assembly that extends past the intermediate member on a second side of the intermediate member, wherein the actuation assembly is operable to selectively rotate the second drive shaft assembly relative to the elongate shaft to actuate a second shaft driven mechanism of the end effector,and wherein the second side of the intermediate member is opposite to the first side of the intermediate member (It would have been obvious to one of ordinary skill as a mere duplication of parts for the same function, See MPEP 2144.04).
Regarding claim 11, the combined invention of Madhani and Shelton discloses the second shaft driven mechanism of the end effector is configured for clamping tissue (eg. Madhani, eg. Col, 7 Ln. 63 – Col. 8, Ln. 7, graspers).
Claims 9, 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Madhani (US 5792135) in view of Shelton (US 7766219 B2), further in view of Kirson (US 6203438 B1).
Regarding claim 9, the combined invention of Madhani and Shelton discloses the invention of claim 7, but does not disclose the first drive shaft assembly comprises a first drive shaft, a first coupling member, and a first driven shaft for all orientations of the end effector relative to the elongate shaft; and the first driven shaft is coupled with the first drive shaft via the first coupling member so that the first driven shaft rotates at the same rate of rotation as the first drive shaft for all orientations of the end effector relative to the elongate shaft.
Kirson teaches a coupling shaft that translates rotational motion from one shaft 12 to second shaft 14 while keeping angular velocities of the shafts equal at all times (eg. Col. 3, Ln. 60-67).
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 Madhani and Shelton with the constant-velocity coupling as taught by Kirson by substituting Shelton’s bevel transmission to provide the predictable result of yielding smooth, equal-rate torque transfer through the angled wrist for all orientations.
Regarding claim 12, the combined invention of Madhani, Shelton, and Kirson discloses the second drive shaft assembly comprises a second drive shaft, a second coupling member, and a second driven shaft for all orientations of the end effector relative to the elongate shaft; and the second driven shaft is coupled with the second drive shaft via the second coupling member so that the second driven shaft rotates at the same rate of rotation as the second drive shaft for all orientations of the end effector relative to the elongate shaft (eg. Kirson, Col. 3, Ln. 60-67).
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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