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
This office action is responsive to the amendment filed on 04/28/2026. As directed by the amendment: claim 1 have been amended, claims 15 and 22-24 have been cancelled and claims 6-9 and 21 remain withdrawn. Thus, claims 1-14 and 16-21 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 04/28/2026, with respect to the rejection(s) of claim(s) 1-5, 10-12, and 16 under 35 U.S.C. 102(a)(1) as being by anticipated by Meade et al (US 20100152751 A1), herein referenced to as “Meade” have been fully considered and are persuasive.
The applicant amended claim 1 to additionally claim “a first portion rotatably coupled to the first drive member at a location offset a first distance from the first drive member axis along a radial dimension perpendicular to the first drive member axis, and a second portion between the first portion and the distal end portion, the second portion rotatably coupled to the second drive member at a location offset a second distance from the second drive member axis along a radial dimension perpendicular to the second rive member axis, wherein the first distance and the second distance are not equal to each other”.
The examiner agrees that the interpretation of Meade relied upon does not teach this, as the first and second distances are not along a radial dimension perpendicular to the drive member axes, but rather, parallel and along the drive member axes, see annotated Fig. 35 below.
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Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a variant interpretation of Meade.
Applicant's arguments, see pages 7-10, filed 04/28/2026, with respect to the rejection of claims 13-14 and 17-20 under 35 U.S.C. 103 as being unpatentable over Meade have been fully considered but they are not persuasive.
The applicant argues that it would not be obvious to one of ordinary skill in the art to modify Meade with a variant embodiment of mead to teach “the distal end portion of the needle drive link traverses an arcuate-shaped path”.
The applicant argues that the entirety of the suture head assembly 156 and the its proximal drive mechanisms would need to be reconstructed to teach the aforementioned claimed limitation. And that such reconstruction cannot be considered a simple substitution.
In response to applicant's argument that it would require reconstruction of the embodiment of Meade shown in Figs. 24-38 to incorporate the variant embodiment of Meade shown in Figs. 39A-43, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The applicant additionally argues that it is not clear what portions of Figs. 24-38 is proposing to modify and what portions of the variant embodiment of Meade is proposing to incorporate. In this case, the structure that is being modified is from an arcuate-shaped path that does not deviate into one that deviates in shape, and more specifically, the structural elements that allow for such a function is the anti-rotate spring in combination with a secondary disengagement track 335 (see Figs. 40-42, [0142] and [0145]). The applicant claims that it requires the entirety of the structure of the distal head and its proximal drive structures to allow for such a function, but the examiner respectfully disagrees as shown in ([0142] and [0145]).
The applicant further argues that one of ordinary skill in the art would not be motivated to modify the embodiment of Meade (Figs. 24-38) with Meade (Figs. 39A-43) because the embodiment of Meade (Figs. 24-38) already have an anti-rotation feature in the form of the notch 234 on the needle and anti-rotate spring. However, as shown in Meade, this functionally is different as (Figs. 24-38) discusses it as preventing “needle backing-up” which is not the same as shown in Figs. 39A-43, as this allows the needle to return via a separate disengagement track 335 (see [0147] and [0149]) and allows for cyclical suturing (see [0149]). Furthermore, in this alternate embodiment, this would prevent the needle from traveling back through the same puncture site from its initial rotation.
As such the USC 103 rejection will be maintained.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim #
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Suggested change
1
10
“a needle”
“the needle”
Appropriate correction is required.
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.
Claim(s) 1-5 and 10-12 is/are rejected under 35 U.S.C. 102(a)(1) as being by anticipated by Meade et al (US 20100152751 A1), herein referenced to as “Meade”.
Claim 1
Meade discloses: A needle driver device 150 (see Figs. 24-38, [0119]), comprising: a needle track 192 (see Figs. 26 and 28, [0125]) defining a curved path the curved path of 192 (see Figs. 26 and 28, [0125]); and a drive system 170 (see Figs. 26-27B and 34-38, [0125]) configured to operably engage with and drive a needle 220 (see Figs. 24-38, [0125]) along the needle track 192, the drive system 170 comprising a first drive member 180 (see Figs. 36-36, [0125], is a drive member as it assists in transferring force to the needle 220), a second drive member 176 (see Figs. 26-27B and 34-35, [0125]), and a needle driver link 184 + 186 + 202 (see Figs. 36-37, [0125] and [0133]), wherein the first drive member 180 is rotatable about a first drive member axis the axis that runs through the center of 180 (see Figs. 36-37, [0132]) , wherein the second drive member 176 is rotatable about a second drive member axis the axis that runs through the center of 176 spaced apart from the first drive member axis the axis that runs through the center of 180, and wherein the needle driver link 184 + 186 + 202 comprises: a distal end portion 198 (see Figs. 26-27B, 29, and 33, [0130]) removably engageable (see [0125], the shoulder screw can be removed to disengage the needle from the pawl 198) with a needle 220 (see Figs. 26-27B, 29, and 33, [0121]) that is positionable in the needle track 192, the distal end portion 98 being movable along an arcuate- shaped path the larger outside slot for the pawl 198 (see Fig. 28, [0127], larger outside slot) proximate the needle track 192, a first portion (see annotated Fig. 36 below) rotatably coupled to the first drive member 180 at a location offset a first distance (see annotated Fig. 36 below) from the first drive member axis (see annotated Fig. 36 below) along a radial dimension perpendicular to the first drive member axis (see annotated Fig. 36 below, the first portion is along a radial dimension perpendicular to the first drive member axis), and a second portion (see annotated Fig. 36 below) between the first portion (see annotated Fig. 37 below) and the distal end portion 198, the second portion (see annotated Fig. 37 below) rotatably coupled to the second drive member 176 at a location offset a second distance (see annotated Fig. 37 below) from the second drive member axis (see annotated Fig. 37 below) along a radial dimension perpendicular to the second drive member axis (see annotated Fig. 36 below, the second portion is along a radial dimension perpendicular to the second drive member axis), wherein the first distance (see annotated Fig. 37 below) and the second distance (see annotated Fig. 37 below) are not equal to each other (see annotated Fig. 37 below, the distance of 180 is less than the distance of 176).
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Claim 2
Meade discloses: The needle driver device of claim 1, see 102 rejection above. Meade further discloses: wherein the first drive member axis the axis that runs through the center of 180 (see annotated Fig. 37 below claim 1) and the second drive member axis the axis that runs through the center of 174 (see annotated Fig. 37 below claim 1) are parallel to each other and are perpendicular to and intersect a longitudinal axis a longitudinal axis of 150 which is perpendicular to the parallel axis of the first and second drive member axes of the needle driver device 150.
Claim 3
Meade discloses: The needle driver device of claim 1, see 102 rejection above. Meade further discloses: further comprising an actuation member 175 (see Fig. 34, [0132]) operably coupled to one or both of the first drive member 174 and the second drive member 172 to transmit force (see [0132]-[0133], synchronized rotation, as 180 rotates, so does 174 and 172) to rotate the one or both of the first drive member 180 and the second drive member 172.
Claim 4
Meade discloses: The needle driver device of claim 3, see 102 rejection above. Meade further discloses: wherein the actuation member 175 comprises a cable (see [0132], wires, a wire is a cable).
Claim 5
Meade discloses: The needle driver device of claim 1, see 102 rejection above. Meade further discloses: wherein the first drive member 180 and the second drive member 174 are operatively coupled to one another (see Figs. 34-35, [0132], connected via 175 and 202) such that the first drive member 180 and the second drive member 174 rotate in a same rotational direction (see [0132]-[0133], synchronized rotation, as 180 rotates, so does 174) throughout a range of motion of the first drive member 180 and the second drive member 174.
Claim 10
Meade discloses: The needle driver device of claim 1, see 102 rejection above. Meade further discloses: wherein one or both of: the first portion (see annotated Fig. 37 below claim 1) of the needle driver link 202 + 184 + 186 is rotatably coupled to the first drive member 180 at a location (see annotated Fig. 37 below claim 1) movable along a longitudinal axis (see [0126], 202 can sweep back and forth in arc spanning about 190 degrees or more, which is along the longitudinal axis, distally and proximally, when 180 rotates, further the portion that is by 180 moves longitudinally forwards and backwards as 174 also rotates) of the needle driver link 202; and the second portion (see annotated Fig. 37 below claim 1) of the needle driver link 202 is rotatably coupled to the second drive member 174 at a location (see annotated Fig. 37below claim 1) movable along the longitudinal axis (see [0126], 202 can sweep back and forth in arc spanning about 190 degrees or more, which is along the longitudinal axis, distally and proximally, when 174 rotates) of the needle driver link 202.
Claim 11
Meade discloses: The needle driver device of claim 1, see 102 rejection above. Meade further discloses: wherein the needle track 192 is arc- shaped (see Figs. 28-31, [0127], 192 is arc-shaped, [0121], circular arc).
Claim 12
Meade discloses: The needle driver device of claim 11, see 102 rejection above. Meade further discloses: wherein the needle track 192 is shaped as a circular arc (see Figs. 28-31, [0127], 192 is a circular arc).
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.
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) 13-14 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meade.
Claim 13
Meade discloses: The needle driver device of claim 12, see 102 rejection above. Meade does not explicitly disclose: wherein the path along which distal end portion of the needle driver link is movable is a non-circular arc path.
However, a variant embodiment (Figs. 39A-43) of Meade teaches in the same field of invention a needle driver device 356 (see Figs. 39A-43) with a needle driver link 302 (see Figs. 39A-43) with a distal end portion 308 (see Figs. 39A-43), a needle 220 (see Figs. 39A-43) with a circular arc needle track 332 (see Figs. 39A-43). The variant embodiment of Meade (Figs. 39A-43) further teaches: wherein the path 334 + 335 (see Figs. 40-43, [0142]) along which distal end portion 308 of the needle driver link 302 is movable is a non-circular arc path (see Figs. 40-43, [0143], it is a non-circular path, as 308 moves distally in a circular arc, and then disengages from the needle moves away from 334 into 335, and rotates back, which is a non-circular arc path as it does not come back on the same path).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Meade to incorporate the teachings of a variant embodiment (Figs. 39A-43) of Meade and teach a needle driver wherein the path along which distal end portion of the needle driver link is movable is a non-circular arc path. Motivation for such can be found in Meade as this assists in preventing an anti-rotate motion, or reverse motion of the needle during surgery (see [0147] and [0149]).
Claim 14
Meade teaches: The needle driver device of claim 13, see 103 rejection above. Meade further discloses: further comprising a curved needle 220 (see Fig. 26, 220 is a curved needle) movable along the needle track 192 (see Figs 26-37).
Claim 17
Meade discloses: A needle driver device 150 (see Figs. 24-38, [0119]) comprising: a curved needle track 192 (see Figs. 26 and 28, [0125]) defining a curved path the curved path of 192 (see Figs. 26 and 28, [0125]); a rotary drive member 174 + 172 (see Figs. 26-27B and 34-35, [0125]); and a needle driver link 202 (see Figs. 26-27B and 34-35, [0125]) comprising: a distal end portion 198 (see Figs. 26-27B, 29, and 33, [0130]) removably engageable (see [0125], the shoulder screw can be removed to disengage the needle from the pawl 198) with a curved needle 220 (see Figs. 26-38, [0121]) configured to be received in the curved needle track 192, a first portion (see annotated Fig. 34 and 35 below) coupled to the rotary drive member 174; and a longitudinal axis the longitudinal axis of 202 (see Figs. 34-35) extending between the distal end portion 198 and the first portion (see annotated Fig. 34 and 35 below), wherein the needle driver link 202 moves in response to rotation of the rotary drive member 174 + 172 to drive the curved needle 220 along the curved needle track 192 (see [0126]) and wherein, in response to rotation of the rotary drive member 174 + 172, the distal end portion 198 of the needle drive link 202 traverses an arcuate-shaped path (see [0126]).
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Meade does not explicitly teach: that deviates in shape from the curved path defined by the curved needle track.
However, a variant embodiment (Figs. 39A-43) of Meade teaches in the same field of invention a needle driver device 356 (see Figs. 39A-43) with a needle driver link 302 (see Figs. 39A-43) with a distal end portion 308 (see Figs. 39A-43) with an arcuate-shaped path 334 + 335 (see Figs. 39A-43), a needle 220 (see Figs. 39A-43) with a circular arc needle track 332 (see Figs. 39A-43) with a circular path circular path of 332. The variant embodiment of Meade (Figs. 39A-43) further teaches: wherein the arcuate-shaped path 334 + 335 (see Figs. 39A-43, [0143]) deviates in shape (see Figs. 40-43, [0143], it is a non-circular path, as 308 moves distally in a circular arc, and then disengages from the needle moves away from 334 into 335, and rotates back, which is a non-circular arc path as it does not come back on the same path) from the curved path the curved path of 332 defined by the curved needle track 332.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Meade to incorporate the teachings of a variant embodiment (Figs. 39A-43) of Meade and teach a needle driver with an arcuate-shaped path for the distal end portion of the needle drive link that deviates in shape from the curved path defined by the curved needle track. Motivation for such can be found in Meade as this assists in preventing an anti-rotate motion, or reverse motion of the needle during surgery (see [0147] and [0149]).
Claim 18
Meade teaches: The needle driver device of claim 17, see 103 rejection above. Meade further teaches: wherein the rotary drive member 174 + 172 is a first rotary drive member 174 (see Figs. 26-27B and 34-35, [0125]), and wherein the needle driver link 202 comprises a second portion (see annotated Fig. 34 and 35 below claim 17) rotatably coupled to a second rotary drive member 172 (see Figs. 26-27B and 34-35, [0125]).
Claim 19
Meade teaches: The needle driver device of claim 18, see 103 rejection above. Meade further teaches: wherein the first rotary drive member 174 and the second rotary drive member 172 are coupled (see Figs. 34-35, [0132], coupled via 175 and 202) to rotate in a same direction (see [0132], synchronized rotation).
Claim 20
Meade teaches: The needle driver device of claim 19, see 103 rejection above. Meade further teaches: wherein the first rotary drive member 174 and the second rotary drive member 172 are rotationally coupled by an actuation member 175 (see Fig. 34, [0132]) actuatable to rotate the first rotary drive member 174 and the second rotary drive member 172 (see [0132], synchronized rotation).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meade in view of Khanicheh et al (US 20210322004 A1), herein referenced to as “Khanicheh”.
Claim 16
Meade discloses: The needle driver device of claim 1, see 102 rejection above. Meade does not explicitly disclose: wherein the needle driver link comprises a tapered shape tapering from a first width at the first portion to a second width smaller than the first width at the distal end portion.
However, Khanicheh in a similar field of invention teaches a needle driver device 100 (see Figs. 1-6) with a needle driver link 130 + 130A (see Figs. 1-6) with a first portion 117 (see Fig. 3) rotatably coupled (130 is moved via rotation of 113) coupled to a first drive member 113 (see Fig. 3) and a distal end portion 130 attached to 120 (see Fig. 6). Khanicheh further teaches: wherein the needle driver link 130a + 130 comprises a tapered shape (see Figs. 1-6, 130A + 130 is a wider shape, that tapers down to 130 at 120, where 130A no longer covers 130, [0131]) tapering from a first width the width of 130 + 130A (see Fig. 3, [0131]) at the first portion 170 to a second width the width of just 130 which is smaller than the width of 130A + 130 (see Figs. 3 and 6) smaller than the first width at the distal end portion 130 attached to 120 (see Fig. 6).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the needle driver link of Meade to incorporate the teachings of Khanicheh and teach a needle driver device with the needle driver link comprises a tapered shape tapering from a first width at the first portion to a second width smaller than the first width at the distal end portion. Motivation for such can be found in Khanicheh as the sheath and cable together improves endoscopic flexibility and manipulation with precise actuation of the needle and assists in protecting the integrity of control covering the cable that controls motion (see [0131] and [0134]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Harris et al (US 20110082472 A1) teaches a fastener deployer with two driver members connected to a driver link, with two different radial distances (Fig. 68)
Mumaw et al (US 20160367239 A1) teaches a needle driver device with driver link with two driver members 94 + pin within 85 (see Figs. 5A) with different radial distances
Levy (US 6475135 B1) teaches a needle driver with two driver members with different radial distances from the driver link (see Fig. 7)
Meade (US 20180242967 A1) teaches a needle driver similar to that of Meade (US 20100152751 A1)
Martin et al (US 9125645 B1) teaches a needle driver with a driver link and two driver members (see Fig. 9)
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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