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 .
Response to Amendment
In response to the amendment filed on 7/3/2025, no claims have been cancelled, no claims have been newly added Claims 1-20 are pending.
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, 8, 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12390214 (hereinafter Pat ‘214) in view of US20160367243A1 Martin et al. (hereinafter Martin).
Regarding instant claim 1, claim 1 of Pat ‘214 discloses a computer-assisted device comprising:
an end effector having a drive mechanism configured to be coupled to a curved needle and configured to rotationally actuate the curved needle along an arcuate path (col. 26 line 45-48); and
a control unit coupled to the drive mechanism (col. 26 line 50);
wherein the control unit is configured to:
receive an operator input signal (col. 26 line 51-52);
based on a mapping of a plurality of different values of the operator input signal to a plurality of different values of a rotational arc amount of the curved needle, determine an arc of rotation for the curved needle along the arcuate path corresponding to the operator input signal (col. 26 line 53-57); and
cause the drive mechanism to rotationally actuate the curved needle through the arc of rotation along the arcuate path (col. 26 line 58-60).
Pat ‘214 fails to disclose the end effector having a gap configured to receive a material and the drive mechanism to rotationally actuate the curved needle into the gap.
However, Martin teaches a computer-assisted device for suturing tissue (abstract, paragraph 100) comprising an end effector (30, Fig. 1) having a drive mechanism (combination of needle driver 86, rotary input 94 and link 85, Fig. 4-5a) configured to be coupled to a curved needle (70) and configured to rotationally actuate the curved needle along an arcuate path (paragraph 71), the end effector having a gap (as seen in Fig. 3a-5c, a gap is seen between arms 93a and 93b) configured to receive a material (paragraph 70-71, 74, 84), a control unit (290, Fig. 15a) coupled to the drive mechanism (paragraph 96-97) and configured to cause the drive mechanism to rotationally actuate the curved needle through the arc of rotation along the arcuate path and into the gap (paragraph 96-97).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pat ‘214 with the teachings of Martin in order to provide a gap wherein tissue can be received in between and sutured as disclosed by Martin (paragraph 70-71, 74, 84, 96-97).
Regarding instant claim 8, the combination of Pat ‘214 and Martin teaches the limitations of instant claim 1, and claim 7 of Pat ‘214 further discloses this.
Regarding instant claim 13, the combination of Pat ‘214 and Martin teaches the limitations of instant claim 1, and claim 1 and claim 11 of Pat ‘214 further discloses this.
Regarding instant claim 14, the combination of Pat ‘214 and Martin teaches the limitations of instant claim 13, and claim 12 of Pat ‘214 further discloses this.
Regarding instant claim 15, the combination of Pat ‘214 and Martin teaches the limitations of instant claim 13, and claim 13 of Pat ‘214 further discloses this.
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 4-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US20160367243A1 Martin et al. (hereinafter Martin).
Regarding claim 1, Martin discloses a computer-assisted device (paragraph 100) comprising:
an end effector (30, Fig. 1) having a drive mechanism (combination of needle driver 86, rotary input 94 and link 85, Fig. 4-5a) configured to be coupled to a curved needle (70) and configured to rotationally actuate the curved needle along an arcuate path (paragraph 71), the end effector having a gap (as seen in Fig. 3a-5c, a gap is seen between arms 93a and 93b) configured to receive a material (paragraph 70-71, 74, 84); and
a control unit (290, Fig. 15a) coupled to the drive mechanism (paragraph 96-97);
wherein the control unit is configured to:
receive an operator input signal (paragraph 97, “Operator inputs (280, 282, 284) are positioned just like inputs (12, 14, 16) and provide an outward appearance that is similar to that of inputs (12, 14, 16). Operator input (280) includes a manually actuated trigger (e.g., similar to first input (12), etc.)…It should also be understood that operator input (280) and switch feature (292) are just merely illustrative examples of features that may be used to actuate needle applier cartridge (30) via motor (202)”);
based on a mapping of a plurality of different values of the operator input signal to a plurality of different values of a rotational arc amount of the curved needle, determine an arc of rotation for the curved needle along the arcuate path corresponding to the operator input signal (paragraph 74: “when first input (12) is depressed, closing the trigger, needle driver (86) will be actuated through its drive stroke where it orbits along an angular range of motion at least about 180 degrees counterclockwise”; therefore, closure of the trigger is mapped to a 180 degree rotation); and
cause the drive mechanism to rotationally actuate the curved needle through the arc of rotation along the arcuate path and into the gap (paragraph 96-97).
Regarding claim 2, Martin discloses the limitations of claim 1, and further discloses wherein the operator input signal is received from a rotary input device (paragraph 60, 62, an input device as a rotary knob; paragraph 100, it is apparent to those of ordinary skill in the art that operator inputs 280, 282, 284, can take on any suitable form and can be located on a console or computer).
Regarding claim 4, Martin discloses the limitations of claim 2, and further discloses wherein operator input signal corresponds to rotation of the rotary input device in a clockwise direction (paragraph 60, 62, 72, rotary input device can be rotated clockwise or counterclockwise to impart a clockwise or counterclockwise rotation of the needle 70).
Regarding claim 5, Martin discloses the limitations of claim 1, and further discloses wherein the operator input signal is received from a gripping controller (paragraph 60, 62, handle 10 and trigger 12 of Fig. 1 allows an operator to provide gripping control; paragraph 97, “Operator inputs (280, 282, 284) are positioned just like inputs (12, 14, 16) and provide an outward appearance that is similar to that of inputs (12, 14, 16). Operator input (280) includes a manually actuated trigger (e.g., similar to first input (12), etc.)”; paragraph 100, it is apparent to those of ordinary skill in the art that operator inputs 280, 282, 284, can take on any suitable form and can be located on a console or computer).
Regarding claim 6, Martin discloses the limitations of claim 5, and further discloses wherein the mapping maps values corresponding to movement of the gripping controller from open to closed to values corresponding to 180 degrees or 360 degrees of rotation for the curved needle (paragraph 74: “when first input (12) is depressed, closing the trigger, needle driver (86) will be actuated through its drive stroke where it orbits along an angular range of motion at least about 180 degrees counterclockwise”; therefore, closure of the trigger is mapped to a 180 degree rotation).
Regarding claim 7, Martin discloses the limitations of claim 5, and further discloses wherein operator input signal indicates that the gripping controller has moved from at least partially open to at least partially closed (paragraph 62, trigger 12/280 is squeezed to selectively actuate and rotate the needle 70 through the arcuate path, therefore there is a point between when the trigger 12/280 is not squeezed and a point when the trigger 12/280 is fully squeezed where it is partially squeezed to indicate at least partially open to at least partially closed).
Regarding claim 8, Martin discloses the limitations of claim 1, and further discloses wherein the arcuate path comprises a circular path and the drive mechanism is configured to rotationally actuate the curved needle about an axis that includes a center point of the circular path (paragraph 61, 71-72, 129, abstract, needle 70 is driven by the drive mechanism in a circular path about a rotation axis).
Regarding claim 9, Martin discloses the limitations of claim 1, and further discloses wherein:
the operator input signal indicates movement of an input device in a first direction (paragraph 74, 97, when first input (12) is depressed, closing the trigger, needle driver (86) will be actuated through its drive stroke where it orbits along an angular range of motion at least about 180 degrees counterclockwise);
the rotation of the curved needle along the arcuate path is in a first rotational direction (paragraph 72: “As shown in FIG. 5C, continued counterclockwise rotation of the rotary input (94) will continue to translate needle driver (86) and thereby drive needle (70) clockwise until it reaches the other end of its stroke in carrier track (88). In this example, the drive stroke rotates the needle (70) in its circular path along an angular range of about 180 degrees.”); and
the control unit is further configured to:
receive a second operator input signal indicating movement of the input device in a second direction (paragraph 74-75, 97, When first input (12) is released and the spring return opens the trigger, needle driver (86) reciprocates through its return stroke where it orbits along an angular range of motion about 180 degrees clockwise back to the return position shown in FIG. 5A);
determine a second arc of rotation for the curved needle in a second rotational direction based on the second operator input signal (paragraph 74-75); and
cause the drive mechanism to rotationally actuate the curved needle through the second arc of rotation in the second rotational direction (paragraph 74-75).
Regarding claim 10, Martin discloses the limitations of claim 9, and further discloses wherein rotationally actuating the curved needle through the second arc of rotation in the second rotational direction causes the curved needle to be withdrawn from the gap (paragraph 75).
Regarding claim 11, Martin discloses the limitations of claim 9, and further discloses wherein rotationally actuating the curved needle through the second arc of rotation in the second rotational direction causes the curved needle to return toward a home position (paragraph 75).
Regarding claim 12, Martin discloses the limitations of claim 9, and further discloses wherein the second direction is opposite the first direction (paragraph 74-75).
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, 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Martin.
Regarding claim 3, Martin discloses the limitations of claim 2. Martin discloses wherein a curved needle is driven along 360 degree rotation using a first input (Fig. 5a-5c, paragraph 76). Martin is silent on wherein the mapping of the 360 degree rotation of the curved needle is mapped to one revolution of the rotary input device.
Martin discloses that the first input is a trigger, a second input as a rotary knob and a third input as a rotary knob, and that the type, configuration and operation of the inputs can vary (paragraph 62). Furthermore, Martin discloses that it is apparent to those of ordinary skill in the art that operator inputs 280, 282, 284, can take on any suitable form (paragraph 100). Therefore, it is within the capability of one with ordinary skill in the art prior to the effective filing date of the invention to have applied a simple substitution of one known operator input for another to obtain the predictable result of mapping a 360 degree rotation of the curved needle to one revolution of a rotary knob, in order to provide a complete and secure suture attachment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/ Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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