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 .
Formal Matters
Applicant’s Response and amendments filed 23 December 2025 is acknowledged. Claims2, 3, 10, and 15 are cancelled. Claims 1, 11, 16, and 19 are currently amended. New claims 21-24 are added. Claims 1, 4-9, 11-14, and 16-24 are pending and under examination.
Response to Arguments
Applicant’s claims have been substantially amended and subject matter from prior claims has been incorporated into the independent claims. Applicant argues the references do not teach each and every element of the claims as amended. Applicant argues that obviousness rejections cannot be sustained by mere conclusory statements and that some rational underpinning must support the legal conclusion of obviousness. Applicant’s arguments have been fully considered. However, new grounds of rejection are required in light of Applicant’s amendments to the claims. Applicant’s argument as to claim 9 is recognized. Accordingly this Office Action is non-final.
Claim Rejections Withdrawn
The rejection of claim 11 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn in light of Applicant’s amendments.
The rejection of claims 1, 2, 4, 5, 10, 12 under 35 U.S.C. 102(a)(1) as being anticipated by Martin et al., US 20120289975 (15 November 2012) is withdrawn in light of Applicant’s amendments. However, new rejections are set forth below.
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 (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 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, 4-9, 11-14, and 21-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kessler, US 20050125013 (9 June 2005).
Regarding claim 1, Kessler teaches an apparatus (forceps 10), comprising:
(a) a first jaw member (FIGs 1, 3; ¶59) including:
(i) a first clamp arm (12),
(ii) a first needle clamp pad (20) projecting from the first clamp arm (12), and
(iii) a first suture clamp pad (16) projecting from the first clamp arm (12); and
(b) a second jaw member (FIGs 1, 3; ¶59) including:
(i) a second clamp arm (14),
(ii) a second needle clamp pad (22) projecting from the second clamp arm (14), and
(iii) a second suture clamp pad (18) projecting from the second clamp arm (14),
the first and second jaw members being pivotable relative to each other between (FIGs 1, 3, 4, 12; ¶21):
(i) an open state (FIGs 1, 3, 12) in which the first suture clamp pad (16) and the first needle clamp pad (20) are respectively spaced apart from the second suture clamp pad (18) and the second needle clamp pad (22) such that the first suture clamp pad (16) in a first uncompressed state projects further from the first clamp arm than the first needle clamp pad (20) (FIG 3; ¶73),
(ii) a first closed state in which the first (16) and second (18) suture clamp pads are engaged with each other while the first (20) and second (22) needle clamp pads are spaced apart from each other for securely gripping a suture (72) with the first (16) and second (18) suture clamp pads (FIGs 3, 8; ¶¶61, 65), and
(iii) a second closed state in which the first suture clamp pad (16) is deformably compressed against the second suture clamp pad (18) and toward the first clamp arm such that the first and second needle clamp pads are engaged to cooperate with each other for securely gripping a needle (70) with the first (20) and second (22) needle clamp pads (FIG 4; ¶62).
Regarding claim 4, Kessler teaches the apparatus of claim 1, as set forth above, wherein the first and second needle clamp pads are rigid (¶17).
Regarding claim 5, Kessler teaches the apparatus of claim 4, as set forth above, wherein the first and second needle clamp pads comprise metal (¶17).
Regarding claim 6, Kessler teaches the apparatus of claim 1, as set forth above, wherein the first (16) and second (18) suture clamp pads are flexible (¶73).
Regarding claim 7, Kessler teaches the apparatus of claim 6, as set forth above, wherein the first (16) and second (18) suture clamp pads comprise at least one elastomer (¶73).
Regarding claim 8, Kessler teaches the apparatus of claim 1, as set forth above, wherein the first (16) and second (18) suture clamp pads are overmolded onto the first (20) and second (22) needle clamp pads, respectively (FIG 7; ¶74).
Regarding claim 9, Kessler teaches the apparatus of claim 1, as set forth above, wherein the first (16) and second (18) suture clamp pads are proud (FIG 3) relative to the first (20) and second (22) needle clamp pads, respectively, when the first and second jaw members are in each of the open state and the first closed state (FIGs 3, 8; ¶65).
Regarding claim 11, Kessler teaches the apparatus of claim 1, as set forth above, wherein the first (16) and second (18) suture clamp pads are at least partially surrounded by respective portions of the first (20) and second (22) needle clamp pads, respectively (FIG 7; ¶74).
Regarding claim 12, Kessler teaches the apparatus of claim 1, as set forth above, wherein the first (20) and second (22) needle clamp pads include first (52) and second (56) recesses, respectively (FIGs 5-6; ¶¶63,64), wherein the first (16) and second (18) suture clamp pads are securely retained within the first and second recesses, respectively (FIGs 7-8; ¶65). See also, annotated FIGs 7, 8 below.
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Regarding claim 13, Kessler teaches the apparatus of claim 1, as set forth above, wherein the first (20) and second (22) needle clamp pads each include a plurality of rigid teeth (FIGs 1, 5, 6; ¶59).
Regarding claim 14, Kessler teaches the apparatus of claim 1, as set forth above, wherein the first (16) and second (18) suture clamp pads each include a plurality of flexible protrusions (FIGs 1, 5, 6; ¶73).
Regarding claim 21, Kessler teaches the apparatus of claim 11, as set forth above, wherein the first (16) and second (18) suture clamp pads are respectively surrounded by the first (20) and second (22) needle clamp pads (FIG 7; ¶74).
Regarding claim 22, Kessler teaches the apparatus of claim 1, as set forth above, wherein first and second jaw members (FIGs 1, 3; ¶59) are configured to pivot (¶21) relative to each other from the open state, through first closed state, and to the second closed state (FIGs 3, 4) such that the first and second jaw member pass through first closed state when first and second jaw members pivot from the open state to the second closed state (FIGs 3, 4, 8; ¶¶58, 59, 61, 62, 65).
Regarding claim 23, Kessler teaches the apparatus of claim 1, as set forth above, wherein, in the open state (FIG 3), the first suture clamp pad (16) and the first needle clamp pad (20) are respectively spaced apart from the second suture clamp pad (18) and the second needle clamp pad (22) such that the second suture clamp pad (18) in a second uncompressed state projects further from the second clamp arm than the second needle clamp pad (22) (FIG 3; ¶73).
Regarding claim 24, Kessler teaches the apparatus of claim 23, as set forth above, wherein, in the second closed state, the second suture clamp pad is deformably compressed against the first suture clamp pad and toward the second clamp arm (FIG 4, ¶73).
Claims 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taylor, EP 1389446 A2 (18 February 2004).
Regarding independent claim 16, Taylor teaches an apparatus (FIG 14, grasper 10a), comprising:
(a) a shaft extending along a longitudinal axis to a distal end (barrel 21a); and
(b) an end effector (jaw assembly 32a) operatively coupled to the distal end of the shaft (FIG 14), the end effector including a pair of jaw members (34a, 36a), the pair of jaw members being pivotable (¶22) relative to each other (FIGs 16, 17) for gripping at least one surgical object (¶5),
at least one jaw member of the pair of jaw members (34a, 36a) including:
(i) a first clamp arm (36a),
(ii) a first clamp pad projecting from the first clamp arm (FIG 15, low-profile pad, 45a), and
(iii) a second clamp pad projecting from the first clamp arm (FIG 15, high-profile pad 47a) and configured to transition between an undeformed state and a deformed state (¶¶23-25), the second clamp pad (47a) of the at least one jaw member (36a) extending laterally inwardly relative to the respective first clamp pad at least when in the undeformed state (¶25), wherein the second clamp pad (47a) in the undeformed state projects further from the first clamp arm (36a) than the first clamp pad (45a), and wherein the second clamp pad in the deformed state projects from the first clamp arm such that the second clamp pad is flush with the first clamp pad (¶¶24,25).
Regarding claim 17, Taylor teaches apparatus of claim 16, as set forth above, wherein the first clamp pad (45a) of the at least one jaw member is rigid (¶23).
Regarding claim 18, Kessler teaches the apparatus of claim 16, as set forth above, further comprising a wrist (FIG 15), wherein the end effector is operatively coupled to the distal end of the shaft via the wrist (FIG 15).
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.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Martin et al., US 20120289975 (15 November 2012) in view of Diamond et al., US 20210298856 (30 September 2021) (previously cited of record).
Regarding independent claim 19, Martin teaches a system (laparoscopic suturing system, ¶¶3, 5), comprising:
(a) an end effector (FIGs 9, 10A-B; needle driver 400; ¶67), including a pair of opposing clamp pads (FIG 10A) and configured to transition between a suture-gripping mode in which the end effector is configured to apply a soft grip to a suture such that the pair of opposing clamp pads cooperatively engage to grasp the suture (¶71, “grasping and/or holding onto material such as a suture”), and a needle-gripping mode in which the end effector is configured to apply a hard grip to a needle such that the pair of opposing clamp pads cooperatively engage to grasp the needle (¶75, picking up needle 490); and
(b) a controller (control portion 470; ¶¶73, 74) configured to transition the end effector between the suture-gripping mode and the needle-gripping mode (FIG 10A; ¶75 control cable 498).
Martin does not teach wherein the controller is configured to provide at least one of audible feedback or haptic feedback to indicate transitioning of the end effector from the suture-gripping mode to the needle-gripping mode.
Diamond teaches a multi-link grasper as an input device for controlling a robotic surgical tool (Abstract; ¶141; FIGs 21A-B, 22, 23, 24A-D). Diamond teaches that the springs of the grasper can provide slight haptic feedback when the link reaches a certain degree of closure to indicate to the user when the grasper is closed and that further motion to close the grasper will result in an increase of clamping force of the surgical instrument (¶¶149, 166; FIG 24D, secondary spring 280).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Martin and Diamond, given that the prior art included each element claimed, although not necessarily in a single reference. Martin and diamond teach in the same field of endeavor, apparatus comprising laparoscopic and robotic surgical instruments comprising end effectors.
Although, Martin discloses the claimed base needle driver comprising an end effector comprising jaws with suture and needle grip pads and cable-linked controller, does not disclose that the controller is configured to provide at least one of audible feedback or haptic feedback to indicate transitioning of the end effector from the suture-gripping mode to the needle-gripping mode.
Diamond specifically addresses surgical graspers designed to provide haptic feedback to the user. Diamond discloses a multi-link grasper as an input device for controlling a robotic surgical tool (¶141). Diamond teaches that the springs of the grasper can provide haptic feedback when the link reaches a certain degree of closure to indicate to the user when the grasper is closed and that further motion to close the grasper will result in an increase of clamping force of the surgical instrument (¶¶149, 166, secondary spring 280).
Because Martin includes a shaft-linked cable connected controller, a person of ordinary skill in the art, seeking more refined surgical control of the end effector including haptic feedback using Martin’s end effector architecture would reasonably consult Diamond’s haptic feedback system. Diamond’s haptic feedback system can be incorporated alongside Martin’s end effector (within the same surgical system) using known assembly methods without redesigning Martin’s end effector. Because the references address the same engineering problem (controlling laparoscopic end effectors) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a grasping controller with haptic feedback to control a control-ready end effector), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 20, Martin modified by Diamond teaches claim 19, as set forth above.
Martin does not teach wherein the controller includes at least one detent configured to generate the at least one of audible feedback or haptic feedback during transitioning of the end effector between the suture-gripping mode and the needle-gripping mode.
Diamond teaches that each of a plurality of links on the haptic controller can be biased or spring-loaded in an open position. “In some configurations, there are at least two springs (not shown) for each link with a first spring providing the majority of the force to bias the link in an open position. A second spring can provide a slight haptic feedback when the link reaches a certain degree of closure to indicates to the user when the grasper is closed and that further motion to close the grasper will result in an increase of clamping force of the surgical instrument” (¶149).
It is old and well known in the mechanical arts that springs are useful as detents because they are designed to provide resistance and hold a component or mechanism in a specific position. Detent springs are commonly used in mechanical and haptic feedback systems to generate a tactile feedback or “click” sensation when actions are performed.
Diamond expressly teaches that the springs of the grasper can provide slight haptic feedback when the link reaches a certain degree of closure to indicate to the user when the grasper is closed and that further motion to close the grasper will result in an increase of clamping force of the surgical instrument (¶149 (springs not shown); ¶166, secondary spring 280). Accordingly, Diamond provides an express motivation and a suggestion to use springs as haptic-based detents.
Conclusion
No Claim is allowed. This Office Action is NON-FINAL.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Carter, US 5,899,911 (4 May 1999) teaches needle-point suture passer to retract and reinforce ligaments.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771