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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/09/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 07/09/2026. As directed by the amendment: claims 16, 19, 25, 41, 49-50, 57 have been amended, claims 54-56 have been cancelled, claim 58 has been added, and claims 6-7 and 53 remain withdrawn. Thus, claims 1-53 and 57-58 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 11, filed 07/09/2026, with respect to claim objections have been fully considered and are persuasive. The applicant’s amendments to the claims overcome the minor informalities within the claims. The claim objections have been withdrawn.
Applicant’s arguments, see page 11, filed 07/09/2026, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The applicant’s amendments to the claims overcome the issues of clarity within the claims. The 112(b) rejections have been withdrawn.
Applicant’s arguments, see pages 16-18, filed 07/09/2026, with respect to the rejection(s) of claim(s) 25 under 35 U.S.C. 103 as being unpatentable over Shelton et al (US 20060282098 A1), herein referenced to as “Shelton” have been fully considered and are persuasive.
The applicant has amended claim 25 to further recite “a cable comprising a flattened portion with a pawl coupled thereto”.
The examiner agrees that Shelton does not explicitly teach “a cable comprising a flattened portion with a pawl coupled thereto”.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Shelton in view of Meade et al (US 20180242967 A1).
Applicant's arguments, see pages 11-16, and 18-20, filed 07/09/2026 have been fully considered but they are not persuasive.
Claim(s) 57 was rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton et al (US 20060282098 A1), herein referenced to as “Shelton”.
The applicant traverses the rejection on the basis of the following arguments:
Shelton’s cable and alleged pawl are not rigidly coupled
Shelton does not disclose a cable and pawl that rotate together about a shared axis
Argument 1 (Shelton’s cable and alleged pawl are not rigidly coupled)
The applicant argues that the cable 42 and the pawl 38 are not rigidly attached. Specifically, they state 42 is rigidly attached to 40, a pin. They argue that because the pin slides within the slot 64 of the coming member 60, that due to this sliding interaction that 42 is not rigidly attached to 38. The examiner respectfully disagrees.
The basis of an intermediate element (40) that moves in some form (via sliding) does not indicate that the cable 42 and the pawl 38 are incapable of being rigidly coupled. This is supported in the patent application publication [0148] and [0150]. The pertinent excerpts are provided and bolded for emphasis below:
[0148] Per FIG. 8 the exemplary shuttle 123 further comprises a cable attachment 127 to connect to the cable 130. As shown, the cable attachment 127 comprises a cavity that receives and secures a portion of the cable 130. Alternatively, in some embodiments, the cable attachment 127 comprises a clamp, a hole, a screw, a bolt, a nut, a clip, a pin, or any combination thereof. In some embodiments, the cable attachment 127 comprises a terminal cable attachment, wherein the cable terminates at the cable attachment 127. In some embodiments, the cable attachment 127 comprises a non-terminal cable attachment, wherein the cable passes through and couples to the cable attachment 127. In some embodiments, the shuttle 123 comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more cable attachments 127. As seen, the exemplary shuttle 123 is rigidly connected to the cable 130 at the cable attachment 127 such that a tensile force on the cable 130 causes the shuttle 123 to translate in the direction of the tensile force.
[0150] In some embodiments, the pawl 124 is biased towards engagement with the notch 122A of the arcuate needle 122. In some embodiments, the pawl 124 is biased towards the first direction 1000. In some embodiments, the pawl 124 comprises a pivot 127 to rotate about the shuttle 123. In some embodiments, the pivot 127 comprises a pin extrusion element of the pawl 124. In some embodiments, the pivot 127 comprises a pin that is rigidly attached to the pawl 124, and which rotates about a hole in the shuttle 123. In some embodiments, the pivot 127 comprises a pin that is rigidly attached to shuttle 123, and which rotates about a hole in the pawl 124. Alternatively, in some embodiments, the pivot 127 comprises a divot, a slot, a screw, or any combination thereof within the pawl 124, the shuttle 123, or both.
This indicates that applicant’s own invention which is asserted to include the cable 130 is rigidly coupled to the pawl 124 includes an intermediate element 127, which in [0150] is further described to rotate about a hole in the pawl 124. In fact, one of ordinary skill in the art would note that limitation for what is considered to be “rigidly coupled” is described in [0148] in the provided definition of “such that a tensile force on the cable causes the shuttle to translate in the direction of the tensile force”.
Shelton’s cable and pawl are connected in this very method in [0092] of Shelton as the drive cable 42 is pushed distally, 38 is moved in the counter-clockwise/distal direction per the direction of the tensile force.
Argument 2 (Shelton does not disclose a cable and pawl that rotate together about a shared axis)
The applicant asserts that drive cable 42 does not rotate about a shared axis with the pawl, as it describes 42 as being extended and retracted, and this is a linear push-pull actuation system and not a rotating about a shared axis.
The examiner respectfully disagrees.
The cable 42 is rigidly coupled to the pin 42, as the applicant noted in argument 1 above. Therefore, tracking the movement of 40 as shown in Figures 3-8, it is clearly shown that the distal end of 42 attached to 40 rotates with the pawl 38 through a rotational axis through 44. As such, the cable 42 and the pawl 38 rotate together about a shared axis.
As such the rejection will be maintained.
Claim(s) 1, 3-4, 8-16, 18-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Ainslie (US 1822330 A), herein referenced to as “Ainslie”.
The applicant traverses the rejection on the basis of the following arguments:
Shelton does not disclose a unitary cable pawl, and Ainslie does not cure the deficiency because Ainslie does not disclose a pawl
There is no motivation to combine Shelton with Ainslie
The proposed combination would not yield the claimed structure
Argument 1 (Shelton does not disclose a unitary cable pawl, and Ainslie does not cure the deficiency because Ainslie does not disclose a pawl)
The applicant argues that the element of 10 is not unitary cable pawl as the cable segment attached to a groove 12a is no cable-carried pawl as there is no ratcheting engagement and no structure that engages a needle during cable translation in one rotational direction.
The examiner respectfully disagrees.
Applicant’s assertion that 10 is not a unitary cable pawl because there is no ratcheting engagement would indicate that their own disclosure of a unitary cable pawl is not a unitary cable pawl either.
Applicant’s unitary cable pawl and its variations are shown in Figs. 30A-30C and described in [0190] of applicant’s patent application publication. As clearly shown, there is no ratcheting engagement or structure for ratcheting engagement on the structure of this “single cable pawl”. In fact, the element 2124A, is disclosed as engaging with a the notch of a needle, which is not a ratcheting engagement as there is no plurality of teeth for ratcheting to occur. As such, applicant’s assertion that a unitary cable pawl requires a ratcheting engagement is contradictory to their own disclosure.
Ainslie’s unitary cable pawl reads on the limitation of “a unitary cable pawl” as it one unit, a cable, with a distal end/finger that engages with the notch of a needle.
Argument 2 (There is no motivation to combine Shelton with Ainslie)
The applicant argues that there is not motivation to combine Shelton with Ainslie, as the space saving describe arise from eliminating the swinging curved arm of the earlier embodiment so that the distal arm may be annular in form, and is unrelated to whether a pawl is formed unitary with a cable.
The examiner respectfully disagrees. One of ordinary skill in the art would understand, that turning a pawl and cable structure to a smaller unitary cable pawl, wherein the distal tip of the cable acts as a pawl would result in a smaller shape profile in comparison to a two separate elements, which relates to Ainslie comparison to its earlier embodiments which is similar to the construction of Shelton with its separate cable and pawl.
Argument 3 (The proposed combination would not yield the claimed structure)
In response to applicant's argument that if Shelton’s separate camming drive is retaining that the combination still lacks a unitary cable pawl and if Shelton’s drive is replaced with Ainslie’s cable-to-needle-butt connector, 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).
As such the rejection will be maintained.
Claim(s) 26-41, 43-45, and 50-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view Meade (US 20180242967 A1), herein referenced to as “Meade”.
The applicant traverses the rejection on the basis of the following arguments:
Shelton’s anti-backup lever is not part of a removable arcuate needle guide cover
The Office Action’s reliance on different Shelton structures does not supply the claimed arrangement
Meade does not cure the missing cover-carried backstop
The proposed combination provides no reason to place the backstop on the removable cover
Shelton does not disclose the claimed “at most about 270 degrees” backstop
Arguments 1-4
The applicant argues that the combination of Shelton and Meade does not teach the anti-backup lever is part of a removable arcuate needle cover, because they argue that the combination does not specifically teach wherein the arcuate needle guide cover comprises a backstop. The examiner respectfully disagrees. One of ordinary skill in the art would ascertain that if the arcuate needle guide cover modified to have a backstop within Shelton is further to be modified to be removable, that the backstop would remain on the removable cover that is modified to be removable.
Arguments 5
The applicant argues that Shelton does not teach “the backstop and needle engage to prevent the arcuate needle from rotating within the arcuate needle guide by at most about 270 degrees in the second rotational direction”. The examiner respectfully disagrees.
If the backstop of Shelton prevents the rotation in the second rotational direction, then it will not rotate 270 degrees or less in the second rotational direction, which is what is required by the claim. “prevent the arcuate needle from rotating within the arcuate needle guide by at most about 270 degrees” in broadest reasonable interpretation means, that it will not rotate more than 270 degrees in the second rotational direction, if it does not rotate in the second rotational direction, it will not rotate more than 270 degrees in the second rotational direction. There is no requirement in the claim for the needle to rotate in the second rotational direction as the applicant appears to interpret the limitation.
As such the rejection will be maintained.
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) 57-58 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton et al (US 20060282098 A1), herein referenced to as “Shelton”.
Claim 57
Shelton discloses: An endoscopic suturing system 10 (see Figs. 1-2, [0067]) comprising: an endoscope fastener 17 (see [0072], 17 is a clamp which fastens to the endoscope 18), wherein the endoscope fastener 17 is configured to couple to an endoscope 18 (see Figs. 1-2, [0072]); an arcuate needle guide 26 (see Figs. 3-4,[0068]); an arcuate needle guide cover 20 functions as a needle guide cover for needle 28 (see Figs. 1-10, [0068]) coupled to the arcuate needle guide 26; an arcuate needle 28 (see Figs. 1-10, [0068]) comprising a notch 56 (see Figs. 1-10, [0088]) and a suture attachment 12 (see Fig. 1, [0087]), wherein the arcuate needle 28 has a center axis the axis that 28 rotates about in the space 44 (see Figs. 1-10), and wherein the arcuate needle 28 is disposed within the arcuate needle guide 26 (see Figs. 3-4); and a cable 42 (see Figs. 3-10, [0070]) and a pawl 38 (see Figs. 3-10, [0070], the cable 42 is connected to 40 which is connected to 38, 38 is a pawl as it frictionally engages the needle 28 with teeth), wherein the cable 42 and pawl 38 are rigidly coupled (see [0089], 42 is rigidly coupled to 40 which is coupled to 38, hence 42 is rigidly coupled to 38) and rotate together about a shared axis (see Figs. 3-10, 42 and 38 rotate together about a shared axis within 44), wherein the notch 56 and the pawl 38 engage (see [0089]-[0093], the engagement member 58 is moved into and out of engagement with the needle as the radial position of 60 is altered) when the pawl translates in a first rotational direction (clockwise/proximal) about the center axis center axis that goes through 14 about which the needle 12 rotates, wherein the notch and the pawl disengage when the pawl translates in a second direction (distal/counter-clockwise) opposite the first rotational direction (clockwise/proximal).
Claim 58
Shelton discloses: the endoscopic suturing system of claim 57, see 102 rejection above. Shelton further discloses: wherein the arcuate needle guide 26 defines a gap 44 (see Figs. 1-4, [0071]) configured to receive tissue (see [0071], tissue is positioned during suturing), and rotation of the arcuate needle through the gap is configured to compress the tissue between the arcuate needle and the arcuate needle guide during suturing.
The language, " rotation of the arcuate needle through the gap is configured to compress the tissue between the arcuate needle and the arcuate needle guide during suturing," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Shelton meets the structural limitations of the claim, and is capable of the needle which is directed through the gap with a suture attached to the needle to compress the tissue between the needle and the needle guide during suturing, such that the sutured tissue is evenly compressed (see [0176]), as the force of the needle pinches and tensions the tissue, pulling it into the gap.
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
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) 25-41, 43-45, and 50-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view Meade (US 20180242967 A1), herein referenced to as “Meade”.
Claim 25
Shelton discloses: An endoscopic suturing system 10 (see Figs. 1-2, [0067]) comprising:(a) a distal assembly the assembly comprising 14 + 17 (see Figs. 1-2, [0067]) comprising:(i) an arcuate needle guide 26 (see Figs. 3-10) and an endoscope fastener 17 (see [0072], 17 is a clamp which fastens to the endoscope 18), wherein the endoscope fastener 17 configured to attach to an endoscope 18 (see Figs. 1-2, [0072]); (ii) an arcuate needle 28 (see Figs. 1-10, [0068]) comprising a notch 56 (see Figs. 1-10) and a suture attachment 12 (see Fig. 1, [0087]), wherein the arcuate needle 28 has a center axis center axis that goes through 14 about which the needle 12 rotates (see Figs. 1-10), and wherein the arcuate needle 28 is disposed within the arcuate needle guide 26 (see Figs. 3-4); and (b) a cable 42 (see Figs. 3-10, [0070]) having a pawl 38 (see Figs. 3-10, [0070], the cable 42 is connected to 40 which is connected to 38, 38 is a pawl as it frictionally engages the needle 28 with teeth); wherein the notch 56 and the pawl 38 engage (see [0089]-[0093], the engagement member 58 is moved into and out of engagement with the needle as the radial position of 60 is altered) when the pawl translates in a first rotational direction (clockwise/proximal) about the center axis center axis that goes through 14 about which the needle 12 rotates, wherein the notch and the pawl disengage when the pawl translates in a second direction (distal/counter-clockwise) opposite the first rotational direction (clockwise/proximal).
Shelton (Figs. 1-10 and 47-51) does not explicitly disclose: the cable comprising a flattened portion and wherein the pawl is coupled to the flattened portion of the cable; (iii) a backstop; and wherein the backstop and the needle engage to prevent the arcuate needle from rotating within the arcuate needle guide by at most about 270 degrees in the second rotational direction.
However, a variant embodiment (Fig. 18) of Shelton teaches an endoscopic suturing system 510 with an arcuate needle 628 (see Fig. 18) and an arcuate needle guide the needle guide 628 is within (see Fig. 18), a first rotational direction (counter-clockwise or proximal), and a second rotational direction (clockwise or distal). Shelton further teaches: (iii) a backstop 672 (see Fig. 18, [0102]-[0103]); and wherein the backstop 672 and the needle 628 engage to prevent the arcuate needle 628 from rotating within the arcuate needle guide the needle guide 628 is within (see Fig. 18) by at most about 270 degrees in the second rotational direction the clockwise direction (see [0103], specifically the direction opposite to the needle’s actuation movement is stopped by the anti-backup device, meaning it stops rotation of at least more than 0 degrees, hence the needle doesn’t rotate more than 270 degrees in the second rotational direction).
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 Shelton to incorporate the teachings of a variant embodiment (Fig. 18) of Shelton and have an endoscopic suturing device with a backstop; and wherein the backstop and the needle engage to prevent the arcuate needle from rotating within the arcuate needle guide by at most about 270 degrees in the second rotational direction. Motivation for such can be found in Shelton as this creates frictional impendent to movement of the needle and prevents the needle from backing up unintentionally (see [0101]-[0103]).
Shelton does not explicitly teach: the cable comprising a flattened portion and wherein the pawl is coupled to the flattened portion of the cable.
However, Meade in a similar field of invention teaches an endoscopic suturing device (see Figs. 40-42A) with a cable 302 (see Figs. 40-42), a pawl 308 (see Figs. 40-42), with the pawl 308 engaged with the notch 232B (see Fig. 42A) of a needle 220 (see Fig. 42A). Meade further teaches: the cable 302 comprising a flattened portion 302A (see Figs. 41-42A, [0152]) and wherein the pawl 308 is coupled to the flattened portion 302A (see Figs. 41-42A) of the cable 302.
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 Shelton to incorporate the teachings of Meade and teach an endoscopic suturing system with the cable comprising a flattened portion and wherein the pawl is coupled to the flattened portion of the cable. Motivation for such can be found in Meade as when the cable is formed as a tendon, as a flat band, it has the advantage of limiting the flexibility of the tendon to one lateral dimension that opposes lateral flexion, thus assuring that the tendon only moves in one dimension (see [0148]).
Claim 26
Shelton discloses: An endoscopic suturing system 10 (see Figs. 1-2, [0067]) comprising:(a) a distal assembly the assembly comprising 14 + 17 (see Figs. 1-2, [0067]) comprising: (i) an arcuate needle guide 26 (see Figs. 3-10) and an endoscope fastener 17 (see [0072], 17 is a clamp which fastens to the endoscope 18), wherein the endoscope fastener 17 is configured to attach to an endoscope 18 (see Figs. 1-2, [0072]); (ii) an arcuate needle 28 (see Figs. 1-10, [0068]) comprising a notch 56 (see Figs. 1-10, [0088]) and a suture attachment 12 (see Fig. 1, [0087]), wherein the arcuate needle 28 has a center axis center axis that goes through 14 about which the needle 12 rotates (see Figs. 1-10), and wherein the arcuate needle 28 is disposed within the arcuate needle guide 26 (see Figs. 3-4); and (iii) an arcuate needle guide cover 20 functions as a needle guide cover for needle 28 (see Figs. 1-10); and (b) a cable 42 (see Figs. 3-10, [0070]) having a pawl 38 (see Figs. 3-10, [0070], the cable 42 is connected to 40 which is connected to 38, 38 is a pawl as it frictionally engages the needle 28 with teeth); wherein the notch 56 and the pawl 38 engage (see [0089]-[0093], the engagement member 58 is moved into and out of engagement with the needle as the radial position of 60 is altered) when the pawl translates in a first rotational direction (clockwise/proximal) about the center axis center axis that goes through 14 about which the needle 12 rotates, wherein the notch and the pawl disengage when the pawl translates in a second direction (distal/counter-clockwise) opposite the first rotational direction (clockwise/proximal).
Shelton (Figs. 1-10 and 47-51) does not explicitly disclose: wherein the arcuated needle guide cover removably attaches to the arcuate needle guide and wherein the arcuate needle guide cover comprises a backstop; and wherein the backstop and the needle engage to prevent the arcuate needle from rotating within the arcuate needle guide by at most about 270 degrees in the second rotational direction.
However, a variant embodiment (Fig. 18) of Shelton teaches an endoscopic suturing system 510 with an arcuate needle 628 (see Fig. 18) and an arcuate needle guide the needle guide 628 is within (see Fig. 18), an arcuate needle guide cover 614 (see Fig. 18), a first rotational direction (counter-clockwise or proximal), and a second rotational direction (clockwise or distal). Shelton further teaches: wherein the arcuate needle guide cover 614 comprises a backstop 672 (see Fig. 18, [0102]-[0103]); and wherein the backstop 672 and the needle 628 engage to prevent the arcuate needle 628 from rotating within the arcuate needle guide the needle guide 628 is within (see Fig. 18) by at most about 270 degrees in the second rotational direction the clockwise direction (see [0103], specifically the direction opposite to the needle’s actuation movement is stopped by the anti-backup device, meaning it stops rotation of at least more than 0 degrees, hence the needle doesn’t rotate more than 270 degrees in the second rotational direction).
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 Shelton to incorporate the teachings of a variant embodiment (Fig. 18) of Shelton and have an endoscopic suturing device with a backstop; and wherein the backstop and the needle engage to prevent the arcuate needle from rotating within the arcuate needle guide by at most about 270 degrees in the second rotational direction. Motivation for such can be found in Shelton as this creates frictional impendent to movement of the needle and prevents the needle from backing up unintentionally (see [0101]-[0103]).
Sheldon does not explicitly teach: wherein the arcuated needle guide cover removably attaches to the arcuate needle guide.
However, Meade in a similar field of invention teaches a suturing system 50 (see Fig. 1) with a distal assembly 56 comprising an arcuate needle guide 92 (see Fig. 3A), an arcuated needle guide cover 110 (see Fig. 3A). Meade further teaches: wherein the arcuated needle guide cover 110 (see Fig. 3A) removably attaches (see [0096], [0098], and [0109] 110 can be removed via 108 and away from 88 to remove the disposable cartridge 88) to the arcuate needle guide 92.
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 Shelton to incorporate the teachings of Meade and have an endoscopic suturing system with wherein the arcuated needle guide cover removably attaches to the first housing. Motivation for such can be found in Meade as this allows for a disposable needle cartridge that can be replaced when needed and be manufactured to be low-cost (see [0098] and [0169]).
Claim 27
The combination of Shelton and Meade teaches: the system of claim 26, see 103 rejection above. Shelton further discloses: wherein the pawl 38 comprises a spring (will not be examined due to being an optional claim limitation), a flexure (will not be examined due to being an optional claim limitation), a dual spring gate (will not be examined due to being an optional claim limitation), a cushion (will not be examined due to being an optional claim limitation), a piston (will not be examined due to being an optional claim limitation), a rod 40 (see Figs. 1-4, [0070], a pin is a rod), a pin 40 (see Figs. 1-4, [0070], a pin is a rod), a tooth 62 (see Figs. 1-4, 62 are teeth that engage grooves), or any combination thereof.
Claim 28
The combination of Shelton and Meade teaches: the system of claim 26, see 103 rejection above. Shelton further discloses: wherein the pawl 38 is engagement biased (see Figs. 1-10, [0089], described as a friction camming member, and engages via friction and biased towards engagement).
Claim 29
The combination of Shelton and Meade teaches: the system of claim 26, see 103 rejection above. Shelton further discloses: wherein the notch 56 is ramped in a direction (see Figs. 1-4, the notches 56 are ramped in the direction opposite the first direction being the proximal/counter-clockwise rotational direction) opposite the first direction proximal/counter-clockwise rotational direction.
Claim 30
The combination of Shelton and Meade teaches: the system of claim 26, see 103 rejection above. Shelton does not explicitly disclose: wherein the notch is located on an inner surface of the arcuate needle.
However, Meade in a similar field of invention teaches a suturing system 50 (see Fig. 1) with an arcuate needle 120 (see Figs. 15 and 18) with a notch 132 (see Figs. 15 and 18). Meade further teaches: wherein the notch 132 is located on an inner surface inner surface of 120 (see Figs. 15 and 18, [0111]) of the arcuate needle 120.
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 Shelton to incorporate the teachings of Meade and teach a suturing system with wherein the notch is located on an inner surface of the arcuate needle. Motivation for such can be found in Meade as notches from an opposite side of which the pawl functions can be used for anti-rotation and/or backstop mechanisms (see [0111]).
Claim 33
The combination of Shelton and Meade teaches: the system of claim 26, see 103 rejection above. Shelton further discloses: wherein the arcuate needle 28 comprises two or more notches 56 (see Figs. 1-4, there are a plurality of notches, 2 and more).
Claim 34
The combination of Shelton and Meade teaches: the system of claim 26, see 103 rejection above. Shelton further discloses: wherein the endoscope fastener 17 comprises a press-fit fastener (the alternatives to “a clamp” will not be examined here due to being optional claim limitations), a clamp (see Figs. 1-2, [0072], clamp), an adhesive, a tape, a strap, a set screw, a hook and loop fastener, a magnet, or any combination thereof.
Claim 35
The combination of Shelton and Meade teaches: the system of claim 26, see 103 rejection above. Shelton does not explicitly disclose: wherein the endoscope has a distal outer diameter of about 5 mm to about 156 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Shelton to have the endoscope has a distal outer diameter of about 5 mm to about 156 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Shelton would not operate differently with the endoscope has a distal outer diameter of about 5 mm to about 156 mm. Further, applicant places no criticality on the range claimed, see ([0007]-[0008]) of the applicant’s patent application publication, which lists several ranges as acceptable alternatives, such as 5 mm to about 16 mm, which excludes diameters from about 17 mm to about 156, hence the range of 5 mm to about 156 mm is not critical.
Claim 36
The combination of Shelton and Meade teaches: the system of claim 26, see 103 rejection above. Shelton further discloses: further comprising a cable sheath (see [0070] and Figs. 47-52, a sheath covers the drive cable, 42/2542) surrounding at least a portion of the cable 42.
Claim 37
The combination of Shelton and Meade teaches: the system of claim 36, see 103 rejection above. Shelton further discloses: further comprising a cable fastener 2184 + 2186 (see Fig. 40, [0137]) that removably couples (see Fig. 40, 2184 is attached to 2170, which is removably coupled to the endoscope as in Fig. 1) at least a portion of the cable the drive cable within 2182 (see Fig. 40 as with Figs. 1-10) to the endoscope 2174.
Claim 38
The combination of Shelton and Meade teaches: the system of claim 36, see 103 rejection above. Shelton further discloses: wherein the cable fastener 2184 + 2186 comprises a press-fit fastener (the alternatives to “a set screw” will not be examined here due to being optional claim limitations), a tie, a string, a band, a hook and loop fastener, a tape, a strap, a magnet, a cinch, a press fit, a set screw (see [0137], screw threads), an adhesive, or any combination thereof.
Claim 39
The combination of Shelton and Meade teaches: the system of claim 26, see 103 rejection above. Shelton further discloses: wherein an angle between a center axis (see annotated Fig. 2 below) of the arcuate needle guide 26 plane (see annotated Fig. 2 below) and a distal axis of the endoscope 16 (see Fig. 2, [0067]) is about 5 degrees to about 85 degrees.
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Claim 40
The combination of Shelton and Meade teaches: the system of claim 39, see 103 rejection above. Shelton does not explicitly disclose: wherein the angle between the center axis of the arcuate needle guide and a proximal axis of the endoscope is adjustable within about 5 degrees to about 85 degrees.
However, Shelton in a variant embodiment (see Figs. 41-42) teaches an endoscopic suturing system 2210 (see Figs. 41-42) with an endoscope 2272 (see Figs. 41-42) and an arcuate needle guide 2214 (see Figs. 41-42). Shelton (Figs. 41-42) further teaches: wherein the angle the angle between 2272 and 2214 between the center axis of the arcuate needle guide and a proximal axis of the endoscope is adjustable within about 5 degrees to about 85 degrees (see [0142], 2282a is flexible, allowing 2214 to deflect off axis from the endoscope, hence the angle is adjustable).
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 Shelton to incorporate the teachings of a variant embodiment of Shelton (Figs. 41-42) and teach an endoscopic suturing system with the angle between the center axis of the arcuate needle guide and a proximal axis of the endoscope is adjustable within about 5 degrees to about 85 degrees. Motivation for such can be found in Shelton as this allows improving visualization of the suturing apparatus while still allowing it to deflect against the endoscope during insertion and extraction, reducing its overall profile during these activities (see [0142]).
Claim 41
The combination of Shelton and Meade teaches: the system of claim 26, see 103 rejection above. Meade further teaches: wherein at least one of the endoscope fastener, arcuate needle guide, arcuate needle guide cover 110, the arcuate needle, and an actuator (the alternatives to “arcuate needle guide cover” will not be examined here due to being optional claim limitations) are composed of plastic (see [0097], plastic material), metal (the alternatives to “plastic” will not be examined here due to being optional claim limitations), fiberglass, carbon fiber, wood, or any combination thereof.
Claim 43
The combination of Shelton and Meade teaches: the system of claim 26, see 103 rejection above. Shelton further discloses: wherein the arcuate needle 28 further comprises a suture attachment fastener (see [0087], the blunt end fastens to the suture 12, hence it is a suture attachment fastener).
Claim 44
The combination of Shelton and Meade teaches: the system of claim 26, see 103 rejection above. Shelton further discloses: further comprising a proximal assembly 2570 (see Figs. 47-48, [0147]) comprising: (i) a second housing 2580 (see Figs. 47-51, [0149]) ; and(ii) an actuator 2574 (see Figs. 47-51, [0149]) connected to the second housing 2580; wherein the second housing 2580 removably couples to the endoscope (see [0148], quick handle disconnect).
Claim 45
The combination of Shelton and Meade teaches: the system of claim 26, see 103 rejection above. Shelton further teaches: wherein the backstop 672 comprises a flexure (the alternatives to “clasp” will not be examined here due to being optional claim limitations), a snap, a magnet, a clasp (see [0102], 672 is a lever that clasps onto the needle, preventing movement in clockwise rotation, meets the definition according to the online Merriam-Webster dictionary as “a device (such as a hook) for holding objects or parts together”), or any combination thereof.
Claim 50
The combination of Shelton and Meade teaches: the endoscopic suturing system of claim 26, see 103 rejection above. Meade further teaches: an endoscopic suturing platform (see Fig. 3A) comprising: a needle replacement mount 108 (see Fig. 3A, [0098]) removably coupled to the arcuate needle 120 and the endoscope fastener (will not be examined due to being an optional claim limitation), arcuate needle guide 88 (see Fig. 3A, [0098]), or arcuate needle guide cover 110 (see Fig. 3A, [0098]).
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 Shelton to incorporate the teachings of Meade and teach an endoscopic suturing platform with needle replacement mount removably coupled to the arcuate needle and the arcuate needle guide, or arcuate needle guide cover. Motivation for such can be found in Meade as this allows for a disposable needle cartridge that can be replaced when needed and be manufactured to be low-cost (see [0098] and [0169]).
Claim 51
The combination of Shelton and Meade teaches: The platform of claim 50, see 103 rejection above. Meade further teaches: wherein the needle replacement mount 108 removably couples to the arcuate needle 120 by a screw (see [0098], shoulder screw), a nut (the alternatives to “screw” will not be examined here due to being optional claim limitations), a tongue, a groove, a clip, a knob, a cam, or any combination thereof.
Claim 52
The combination of Shelton and Meade teaches: The platform of claim 50, see 103 rejection above. Meade further teaches: wherein the needle replacement mount 108 removably couples to the endoscopic fastener (will not be examined here due to being an optional claim limitation), arcuate needle guide 88, or arcuate needle guide cover 110 by a screw (see [0098], shoulder screw), a nut (the alternatives to “screw” will not be examined here due to being optional claim limitations), a tongue, a groove, a clip, a knob, a cam, or any combination thereof.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton and Meade as applied to claim 26 above, and further in view of Faraz et al (US 5766186 A), herein referenced to as “Faraz”.
Claim 42
The combination of Shelton and Meade teaches: The system of claim 26, see 103 rejection above. The combination of Shelton and Meade does not explicitly teach: wherein the endoscope fastener, arcuate needle guide, or arcuate needle guide cover further comprises a cable pulley that guides the cable.
However, Faraz in a similar field of invention teaches an endoscopic suturing system 10 (see Figs. 1-5) with an arcuate needle guide 16 (see Figs. 1-5), an arcuate needle guide cover 18 (see Figs. 1-5), and a cable 20 (see Figs. 1-5). Faraz further teaches: wherein the endoscope fastener (will not be examined here due to being an optional claim limitation), arcuate needle guide 16, or arcuate needle guide cover 20 further comprises a cable pulley 22 + 24 (see Figs. 1-5, col. 2, lines 63-67 and col. 3, lines 1-7) that guides the cable 20.
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 combination of Shelton and Meade to incorporate the teachings of Faraz and teach an endoscopic suturing system with the arcuate needle guide or arcuate needle guide cover further comprises a cable pulley that guides the cable. Motivation for such can be found in Faraz they ensure the cable to be in frictional contact with the needle and prevent slippage of the needle (col. 3, lines 40-50).
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton and Meade as applied to claim 26 above, and further in view of Montgomery (US 20190350584 A1), herein referenced to as “Montgomery”.
Claim 46
The combination of Shelton and Meade teaches: The system of claim 26, see 103 rejection above. The combination of Shelton and Meade does not explicitly teach: comprising two or more backstops.
However, Montgomery in a similar field of invention teaches an endoscopic suturing system 130 (see Figs. 8-15) with an arcuate needle guide cover 190 + 183 (see Figs. 8-15), an arcuate needle 170 (see Figs. 8-15), an arcuate needle guide 184 (see Figs. 8-15), and the arcuate needle guide cover 190 having a backstop 200A (see Figs. 8-15). Montgomery further teaches: comprising two or more backstops 200A-200D (see Figs. 8-15, [0051], [0054]-[0057]).
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 combination of Shelton and Meade to incorporate the teachings of Montgomery and teach an endoscopic suturing system with two or more backstops. Motivation for such can be found in Montgomery as multiple backstops assist to retain the orbiting arcuate needle in its needle track while the suture thread can pass through (see [0054]).
Claim(s) 1, 3-4, 8-16, 18-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Ainslie (US 1822330 A), herein referenced to as “Ainslie”.
Claim 1
Shelton discloses: An endoscopic suturing system 10 (see Figs. 1-2, [0067]) comprising: an endoscope fastener 17 (see [0072], 17 is a clamp which fastens to the endoscope 18), wherein the endoscope fastener 17 is configured to couple to an endoscope 18 (see Figs. 1-2, [0072]); an arcuate needle guide 26 (see Figs. 3-10, [0068]), an arcuate needle guide cover 20 functions as a needle guide cover for needle 28 (see Figs. 1-10, [0068]) coupled to the arcuate needle guide 26; an arcuate needle 28 (see Figs. 1-10, [0068]) comprising a notch 56 (see Figs. 1-10, [0088]) and a suture attachment 12 (see Fig. 1, [0087]), wherein the arcuate needle 28 has a center axis the axis that 28 rotates about in the space 44 (see Figs. 1-10), and wherein the arcuate needle 28 is disposed within the arcuate needle guide 26; 42 (see Figs. 3-10, [0070]) having a pawl 38 (see Figs. 3-10, [0070], the cable 42 is connected to 40 which is connected to 38, 38 is a pawl as it frictionally engages the needle 28 with teeth), wherein the notch 56 and the pawl 38 engage (see [0089]-[0093], the engagement member 58 is moved into and out of engagement with the needle as the radial position of 60 is altered) when the pawl translates in a first rotational direction (clockwise/proximal) about the center axis center axis that goes through 14 about which the needle 12 rotates, wherein the notch and the pawl disengage when the pawl translates in a second direction (distal/counter-clockwise) opposite the first rotational direction (clockwise/proximal).
Shelton does not explicitly disclose: wherein the cable and the pawl comprise a unitary cable pawl.
However, Ainslie in a similar field of invention teaches a suturing system (see Figs. 11-13) with an arcuate needle 12 (see Figs. 11-13), a cable 10 (see Figs. 11-13), and a pawl adjacent portion of 10 (see page 3, lines 1-5, this portion of 10 connects to a notch 12a in the arcuate needle 12, acts as a pawl by controlling the motion of the needle via a contact force). Ainslie further teaches: wherein the cable 10 and the pawl adjacent portion of 10 comprise a unitary cable pawl 10 (see Figs. 11-13, page 3, lines 1-5).
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 Shelton to incorporate the teachings of Ainslie and teach an endoscopic suturing system with the cable and the pawl comprise a unitary cable pawl. Motivation for such can be found in Ainslie as this limits the amount of space needed within the arcuate needle guide cover to allow placing of suture within a limited working space (see page 3, lines 1-10).
Claim 3
The combination of Shelton and Ainslie teaches: The system of claim 1, see 103 rejection above. Shelton further discloses: wherein the pawl 38 is engagement biased (see Figs. 1-10, [0089], described as a friction camming member, and engages via friction and biased towards engagement).
Claim 4
The combination of Shelton and Ainslie teaches: The system of claim 1, see 103 rejection above. Shelton further discloses: wherein the notch 56 is ramped in a direction (see Figs. 1-4, the notches 56 are ramped in the direction opposite the first direction being the proximal/counter-clockwise rotational direction) opposite the first direction proximal/counter-clockwise rotational direction.
Claim 8
The combination of Shelton and Ainslie teaches: The system of claim 1, see 103 rejection above. Shelton further discloses: wherein the arcuate needle 28 comprises two or more notches 56 (see Figs. 1-4, there are a plurality of notches, 2 and more).
Claim 9
The combination of Shelton and Ainslie teaches: The system of claim 1, see 103 rejection above. Shelton further discloses: wherein the endoscope fastener 17 comprises a press-fit fastener (the alternatives to “a clamp” will not be examined here due to being optional claim limitations), a clamp (see Figs. 1-2, [0072], clamp), an adhesive, a tape, a strap, a set screw, a hook and loop fastener, a magnet, or any combination thereof.
Claim 10
The combination of Shelton and Ainslie teaches: The system of claim 1, see 103 rejection above. Shelton does not explicitly disclose: wherein the endoscope has a distal outer diameter of about 5 mm to about 156 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Shelton to have the endoscope has a distal outer diameter of about 5 mm to about 156 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Shelton would not operate differently with the endoscope has a distal outer diameter of about 5 mm to about 156 mm. Further, applicant places no criticality on the range claimed, see ([0007]-[0008]) of the applicant’s patent application publication, which lists several ranges as acceptable alternatives, such as 5 mm to about 16 mm, which excludes diameters from about 17 mm to about 156, hence the range of 5 mm to about 156 mm is not critical.
Claim 11
The combination of Shelton and Ainslie teaches: The system of claim 1, see 103 rejection above. Shelton further discloses: further comprising a cable sheath (see [0070] and Figs. 47-52, a sheath covers the drive cable, 42/2542) surrounding at least a portion of the cable 42.
Claim 12
The combination of Shelton and Ainslie teaches: The system of claim 11, see 103 rejection above. Shelton further discloses: further comprising a cable fastener 2184 + 2186 (see Fig. 40, [0137]) that removably couples (see Fig. 40, 2184 is attached to 2170, which is removably coupled to the endoscope as in Fig. 1) at least a portion of the cable the drive cable within 2182 (see Fig. 40 as with Figs. 1-10) to the endoscope 2174.
Claim 13
The combination of Shelton and Ainslie teaches: The system of claim 12, see 103 rejection above. Shelton further discloses: wherein the cable fastener 2184 + 2186 comprises a press-fit fastener (the alternatives to “a set screw” will not be examined here due to being optional claim limitations), a tie, a string, a band, a hook and loop fastener, a tape, a strap, a magnet, a cinch, a press fit, a set screw (see [0137], screw threads), an adhesive, or any combination thereof.
Claim 14
The combination of Shelton and Ainslie teaches: The system of claim 11, see 103 rejection above. Shelton further discloses: wherein an angle between a center axis (see annotated Fig. 2 below) of the arcuate needle guide 26 plane (see annotated Fig. 2 below) and a distal axis of the endoscope 16 (see Fig. 2, [0067]) is about 5 degrees to about 85 degrees.
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Claim 15
The combination of Shelton and Ainslie teaches: the system of claim 14, see 103 rejection above. Shelton does not explicitly disclose: wherein the angle between the center axis of the arcuate needle guide and a proximal axis of the endoscope is adjustable within about 5 degrees to about 85 degrees.
However, Shelton in a variant embodiment (see Figs. 41-42) teaches an endoscopic suturing system 2210 (see Figs. 41-42) with an endoscope 2272 (see Figs. 41-42) and an arcuate needle guide 2214 (see Figs. 41-42). Shelton (Figs. 41-42) further teaches: wherein the angle the angle between 2272 and 2214 between the center axis of the arcuate needle guide and a proximal axis of the endoscope is adjustable within about 5 degrees to about 85 degrees (see [0142], 2282a is flexible, allowing 2214 to deflect off axis from the endoscope, hence the angle is adjustable).
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 Shelton to incorporate the teachings of a variant embodiment of Shelton (Figs. 41-42) and teach an endoscopic suturing system with the angle between the center axis of the arcuate needle guide and a proximal axis of the endoscope is adjustable within about 5 degrees to about 85 degrees. Motivation for such can be found in Shelton as this allows improving visualization of the suturing apparatus while still allowing it to deflect against the endoscope during insertion and extraction, reducing its overall profile during these activities (see [0142]).
Claim 16
The combination of Shelton and Ainslie teaches: the system of claim 1, see 103 rejection above. Shelton does not explicitly disclose: wherein at least one of the arcuate needle and an actuator are composed of plastic, metal, fiberglass, carbon fiber, wood, or any combination thereof.
However, a variant embodiment of Shelton (Fig. 39) teaches in the same field of invention an endoscopic suturing system 2010 (see Fig. 39) with an arcuate needle 2028 (see Fig. 39). Shelton (Fig. 39) further teaches: wherein at least one of the arcuate needle 2028 and an actuator (will not be examined here due to being an optional claim limitation) are composed of plastic (the alternatives to “metal” will not be examined here due to being optional claim limitations), metal (see [0132], steel, which is a metal), fiberglass, carbon fiber, wood, or any combination thereof.
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 Shelton to incorporate the teachings of a variant embodiment (Fig. 39) of Shelton and have an endoscopic suturing system with an arcuate needle composed of metal. This is due to metal being used for arcuate needle (see [0132]) is common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 18
The combination of Shelton and Ainslie teaches: the system of claim 1, see 103 rejection above. Shelton further discloses: wherein the arcuate needle 28 further comprises a suture attachment fastener (see [0087], the blunt end fastens to the suture 12, hence it is a suture attachment fastener).
Claim 19
The combination of Shelton and Ainslie teaches: the system of claim 1, see 103 rejection above. Shelton further discloses: wherein a second housing 2580 (see Figs. 47-51, [0149]) removably couples to the endoscope (see [0148], quick handle disconnect).
Claim 20
The combination of Shelton and Ainslie teaches: the system of claim 1, see 103 rejection above. Shelton does not explicitly disclose: wherein the arcuate needle guide removably couples to the endoscope fastener by a screw, a nut, a tongue, a groove, a clip, a knob, a cam, or any combination thereof.
However, a variant embodiment of Shelton (see Figs. 41-43) teaches in the same field of invention an endoscopic suturing system (see Figs. 41-43) with an arcuate needle guide 2214 (see Figs. 41-43) and an endoscopic fastener 2270 (see Figs. 41-43). Shelton (Figs. 41-43) further teaches: wherein the arcuate needle guide 2214 removably couples to the endoscope fastener 2270 by a screw 2282 + 2286 (see Figs. 41-43, [0139] and [0137], the same members 2184 + 2186 are screws), a nut (the alternatives to “a screw” will not be examined here due to being optional claim limitations), a tongue, a groove, a clip, a knob, a cam, or any combination thereof.
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 Shelton to incorporate the teachings of a variant embodiment (Figs. 41-43) of Shelton and teach an endoscopic suturing system with the arcuate needle guide removably couples to the endoscope fastener by a screw. Motivation for such can be found in Shelton as this allows the suturing apparatus to move away from the endoscope when the suturing apparatus reaches its desired location (see [0140]).
Claim 21
The combination of Shelton and Ainslie teaches: the system of claim 1, see 103 rejection above. Shelton further discloses: wherein the arcuate needle 28 is contained between (see Figs. 1-3, 28 is between 20 and 26, when 20 is covering 26 and coupled to 17) the arcuate needle guide 26 and the arcuate needle guide cover 20 when the needle guide cover 20 is coupled to the endoscope fastener 17.
Claim 22
The combination of Shelton and Ainslie teaches: the system of claim 1, see 103 rejection above. Shelton does not explicitly disclose: wherein the arcuate needle guide cover removably couples to the endoscope fastener by a screw, a nut, a tongue, a groove, a clip, a knob, a cam, or any combination thereof.
However, a variant embodiment of Shelton (see Figs. 41-43) teaches in the same field of invention an endoscopic suturing system (see Figs. 41-43) with an arcuate needle guide cover the cover of 2214 (see Figs. 41-43) and an endoscopic fastener 2270 (see Figs. 41-43). Shelton (Figs. 41-43) further teaches: wherein the arcuate needle guide the cover of 2214 removably couples to the endoscope fastener 2270 by a screw 2282 + 2286 (see Figs. 41-43, [0139] and [0137], the same members 2184 + 2186 are screws), a nut (the alternatives to “a screw” will not be examined here due to being optional claim limitations), a tongue, a groove, a clip, a knob, a cam, or any combination thereof.
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 Shelton to incorporate the teachings of a variant embodiment (Figs. 41-43) of Shelton and teach an endoscopic suturing system with the arcuate needle guide cover removably couples to the endoscope fastener by a screw. Motivation for such can be found in Shelton as this allows the suturing apparatus to move away from the endoscope when the suturing apparatus reaches its desired location (see [0140]).
Claim(s) 2, 5, 23-24, 47-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Ainslie as applied to claim 1 above, and further in view of Meade.
Claim 2
The combination of Shelton and Ainslie teaches: the system of claim 1, see 103 rejection above. The combination of Shelton and Ainslie does not explicitly teach: wherein the pawl is welded to the cable.
However, Meade in a similar field of invention teaches a suturing system (see Figs. 38-43) with a cable drive rod (see [0144]) and a pawl 302 (see Figs. 38-43). Meade further teaches: wherein the pawl 302 is welded to the cable drive rod (see [0144], weld joint).
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 combination of Shelton and Ainslie to incorporate the teachings of Meade and teach an endoscopic suturing system with the pawl is welded to the cable. Motivation for such can be found in Meade as this allows for connection such that the lateral elastic flexibility but minimal longitudinal compressibility of the cable can be maintained to allow for actuation and rotation of the needle (see [0144]).
Claim 5
The combination of Shelton and Ainslie teaches: the system of claim 1, see 103 rejection above. The combination of Shelton and Ainslie does not explicitly teach: wherein the notch is located on an inner surface of the arcuate needle.
However, Meade in a similar field of invention teaches a suturing system 50 (see Fig. 1) with an arcuate needle 120 (see Figs. 15 and 18) with a notch 132 (see Figs. 15 and 18). Meade further teaches: wherein the notch 132 is located on an inner surface inner surface of 120 (see Figs. 15 and 18, [0111]) of the arcuate needle 120.
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 Shelton to incorporate the teachings of Meade and teach a suturing system with wherein the notch is located on an inner surface of the arcuate needle. Motivation for such can be found in Meade as notches from an opposite side of which the pawl functions can be used for anti-rotation and/or backstop mechanisms (see [0111]).
Claim 23
The combination of Shelton and Ainslie teaches: the system of claim 1, see 103 rejection above. The combination of Shelton and Ainslie does not explicitly teach: wherein the arcuate needle guide cover further removably couples to the arcuate needle guide.
However, Meade in a similar field of invention teaches a suturing system 50 (see Fig. 1) with a distal assembly 56 comprising an arcuate needle guide 92 (see Fig. 3A), an arcuated needle guide cover 110 (see Fig. 3A). Meade further teaches: wherein the arcuated needle guide cover 110 (see Fig. 3A) further removably couples (see [0096], [0098], and [0109] 110 can be removed via 108 and away from 88 to remove the disposable cartridge 88) to the arcuate needle guide 92.
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 Shelton to incorporate the teachings of Meade and have an endoscopic suturing system with the arcuate needle guide cover further removably couples to the arcuate needle guide. Motivation for such can be found in Meade as this allows for a disposable needle cartridge that can be replaced when needed and be manufactured to be low-cost (see [0098] and [0169]).
Claim 24
The combination of Shelton, Ainslie, and Meade teaches: the system of claim 23, see 103 rejection above. Meade further teaches: wherein the arcuate needle guide cover 110 removably ocuples to the arcuate needle guide 92 by a screw 108 (see Figs. 3A-3B, [0098]), a nut (the alternatives to “a screw” will not be examined here due to being optional claim limitations), a tongue, a groove, a clip, a knob, a cam, or any combination thereof.
Claim 47
The combination of Shelton and Ainslie teaches: the endoscopic suturing system of claim 1, see 103 rejection above. Shelton further discloses: an endoscopic suturing platform (see Figs. 1-10).
The combination of Shelton and Ainslie does not explicitly teach: and a (b) a needle replacement mount removably coupled to the arcuate needle and the needle guide cover.
However, Meade in a similar field of invention teaches a suturing system 50 (see Fig. 1) with a distal assembly 56 comprising an arcuate needle guide 92 (see Fig. 3A), an arcuate needle 120 (see Fig. 3A), and an arcuated needle guide cover 110 (see Fig. 3A). Meade further teaches: a needle replacement mount 108 (see Fig. 3A, [0098]) removably coupled to the arcuate needle 120 and the needle guide cover 110.
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 Shelton to incorporate the teachings of Meade and teach an endoscopic suturing platform with a needle replacement mount removably coupled to the arcuate needle and the needle guide cover. Motivation for such can be found in Meade as this allows for a disposable needle cartridge that can be replaced when needed and be manufactured to be low-cost (see [0098] and [0169]).
Claim 48
The combination of Shelton, Ainslie, and Meade teaches: the endoscopic suturing platform of claim 47, see 103 rejection above. Meade further teaches: wherein the needle replacement mount 108 removably couples to the arcuate needle 120 by a screw 108 (see Fig. 3A, [0098], shoulder screw), a nut (the alternatives to “a screw” will not be examined here due to being optional claim limitations), a tongue, a groove, a clip, a knob, a cam, or any combination thereof.
Claim 49
The combination of Shelton, Ainslie, and Meade teaches: the endoscopic suturing platform of claim 47, see 103 rejection above. Meade further teaches: wherein the needle replacement mount 108 removably couples to the arcuate needle guide cover 110 by a screw 108 (see Fig. 3A, [0098], shoulder screw), a nut (the alternatives to “a screw” will not be examined here due to being optional claim limitations), a tongue, a groove, a clip, a knob, a cam, or any combination thereof.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Ainslie as applied to claim 1 above, and further in view of Faraz.
The combination of Shelton and Ainslie teaches: the system of claim 1, see 103 rejection above. The combination of Shelton and Ainslie does not explicitly teach: further comprising a cable pulley that guides the cable.
However, Faraz in a similar field of invention teaches an endoscopic suturing system 10 (see Figs. 1-5) with an arcuate needle guide 16 (see Figs. 1-5), an arcuate needle guide cover 18 (see Figs. 1-5), and a cable 20 (see Figs. 1-5). Faraz further teaches: further comprising a cable pulley 22 + 24 (see Figs. 1-5, col. 2, lines 63-67 and col. 3, lines 1-7) that guides the cable 20.
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 combination of Shelton and Meade to incorporate the teachings of Faraz and teach an endoscopic suturing system with a cable pulley that guides the cable. Motivation for such can be found in Faraz they ensure the cable to be in frictional contact with the needle and prevent slippage of the needle (col. 3, lines 40-50).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brecher et al (US 20120143248 A1) teaches an endoscopic suturing device with a flattened cable attached to a pawl which engages with a notch of a needle
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
Prosecution Insights