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 in response to the amendment filed on 6/26/2026. Currently claims 1-20 are pending with claims 14-20 withdrawn based on a previous restriction.
Response to Arguments
Applicant’s arguments, see pg. 1, filed 6/26/2026, with respect to the previous objections of claims 5 and 8-9 have been fully considered and are persuasive based on the amendment to the claims. The previous objections of claims 5 and 8-9 has been withdrawn.
Applicant's arguments, see pgs. 1-3, filed 6/26/2026 have been fully considered but they are not persuasive. Even though the grounds of rejection has been amended to account for the additional limitation added in claim 1, the grounds of rejection uses the same prior art. Therefore, applicant’s arguments will briefly be addressed. The main arguments are directed to independent claim 1 which was rejected by Zaugg.
The first crux of applicant’s arguments is that the device is not an introducer lock apparatus and would not be capable of being used as such because the suturing device enter deep within the anatomy of the patient during use.
The second crux of applicant’s arguments is that it is not clear that the labelled “catheter channel” is actually channel within the body of the device.
The third crux of applicant’s arguments is that because of how the device is used the main body or hinged foot would not be secured to an introducer and doing so would render the device unsatisfactory for it’s intended purpose would not be configured.
Finally, applicant specifies that the newly added limitation of the sheath connector being releasably engaged with a proximal end region of an introducer sheath further defines the claimed invention over Zaugg implying that Zaugg fails to teach this limitation as well [see pgs. 1-3 of applicant’s arguments]
In response, these arguments are not persuasive. First applicant appears to be relying on the disclosed features related to use of introducer lock in surgeries. Nothing in the pending claims require the device be used in surgery so applicant’s arguments here are not commensurate with the scope of the claims. Second this is an apparatus claim which means specifically the structure matters not how the device is intended to be used [see MPEP 2114]. This refutes the first and third cruxes applicant argues.
Second the labeled “catheter channels” are clearly empty spaces through which tubular structures can / are placed. To further demonstrate this applicant is directed to Fig. 18B which shows tubular structures extending from the body in spaces within the body and these tubes extend to the foot (element 314 in this figure). Given that the claim never positively recites catheters being placed inside or specific characteristics of channels (i.e. size, shape, length or etc.), the spaces in which this tubular structures can be placed recite “catheter channels” under broadest reasonable interpretation a channel is a passage of some sort. Thus, this argument is not persuasive. This refutes applicant’s second crux.
Finally with respect to the newly added limitation. If the connector is releasably engaged to the entire introducer sheath than the connector is releasably-engaged to the proximal end of region. Zaugg’s connector may not be directly releasably engaged with a proximal end region which seems to be what applicant is implying, but the claim as written is broader than what applicant appears to be arguing. Thus, Zaugg and the previously used references still apply in a very similar way as outlined in the rejection 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.
Claim(s) 1, 4-7 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zaugg et al (US 20130310853) hereafter known as Zaugg,
Independent claim
Claim 1:
Zaugg discloses
An introducer lock apparatus [see Fig. 17A and Fig 21 element 300 and para 195-196… “suturing device 300”], the apparatus comprising:
a first body [see labelled first body in labelled figure(s) directly below rejection to this claim] comprising a catheter channel extending proximally to distally in a first axis [see labelled catheter channel and first a in labelled figure(s) directly below rejection to this claim],
wherein the catheter channel is configured to seat a catheter therein [see space forming catheter channel showing capability to seat a catheter];
a sheath connector at a distal end of the first body, the sheath connector at least partially surrounding the catheter channel and is configured to releasably engage with a proximal end region of an introducer sheath [see labelled “sheath connector” in labelled figure(s) below rejection to this claim and Fig. 17A which shows elements 310, 310a and 312 (i.e. introducer sheath) that can be reliably engaged with the entire sheath connector (which includes the proximal end region)];
a second body hingeably coupled to the first body [see labelled second body in labelled figure(s) directly below the rejection to this claim]; and
a clamping channel extending through a lateral side of the second body, the clamping channel forming an angle relative to the second body, so that the clamping channel has an apparent diameter through the clamping channel in the first axis that is at a maximum when the second body is bent at a first angle relative to the first body, further wherein the apparent diameter through the clamping channel in the first axis decreases as the angle relative to the second body increases [see labelled clamping channel in labelled figure(s) below. The ability to direct the second body and thereby the clamping channel inside the second body to different angles relative to the first axis demonstrates at the very least structurally capability to position the clamping channel relative to the first axis as claimed]
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Regarding claim 4, see labelled figure directly below rejection to claim which shows a structural configuration via rotational movement capable of reciting the claimed structural relationship.
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Regarding claims 5-6, see labelled figure directly below rejection to these claims.
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Regarding claim 7, see labelled figure(s) directly below rejection to claim 1 above which shows the sheath connector only bordering on one side of the catheter channel (i.e. partially surrounding the catheter channel).
Regarding claim 11, see labelled figure(s) directly below rejection to claim 1 above and para 197 of Zaugg [see “Once the penetrator tip 308 detaches from the elongate body 306 via the push mandrel 315, or other means previously described, the user rotates the foot 319 into the orientation shown with reference to FIG. 22B”] which shows the structural capability to form an angle between 120-130 degrees as claimed.
Regarding claim 12, see Figs. 22A-22C element 319 and para 195 of Zaugg [see “Embodiments of the suturing device of the invention may also include additional configurations for a foot, as shown with reference to FIGS. 22A through 22C. In this embodiment, the suturing device 300 includes a foot 319 having cuff pockets 319a and 319b.”] which describe element 319 (i.e. the second body) as being a foot which is understood to be rigid.
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) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zaugg in view of Walen et al (US 20200383697) hereafter known as Walen.
Regarding claim 2:
Zaugg discloses the invention substantially as claimed including all the limitations of claim 1. Also, Zaugg discloses element 308 (i.e. the clamping channel) as connecting with a penetrator tip [see Fig. 17C element 308 and para 196… “The connector also includes ends 322a and 322b that facilitate connection with the penetrator tip 308 and the needle tip 308' of the elongate bodies 306' and 306.”]
However, Zaugg fails to disclose “one or more teeth extending into the clamping channel from a wall of the clamping channel” as recited by claim 2.
Walen discloses in the analogous art of surgical devices [see para 2… “This invention is generally related to a medical or surgical tool that has elongated shaft that can be bent so as to have a specific curvature.”] using teeth that mesh with corresponding slots strengthens the connection between different components thereby making the components less likely to experience overloading forces such as sideloading [see para 272… “Each arm 816 and 838 abuts the surface of the respective socket 828 and 850 in which the arm is seated. More specifically, the arm teeth engage the teeth that extend into the socket 828 or 850. This meshing of teeth reduces the likelihood that, when exposed to side loading, a link or the tip will pivot relative to the arm 816 or 838 against which the link or tip is pressed.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Zaugg by including meshing teeth and slots between the clamping channel and the penetrator tip similarly to that disclosed by Walen because this will strengthen the connection between the channel and piercing tip connecting with the channel.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Zaugg in view of Walen by placing the teeth extending from wall inside the channel which is on the second body because there are a limited number of places to place the teeth (i.e. on the wall inside the channel, on the piercing body, or extending from an outer surface) and this is one of those limited number of places.
Regarding claim 3:
Zaugg discloses the invention substantially as claimed including all the limitations of claim 1. Also, Zaugg discloses element 308 (i.e. the clamping channel) as connecting with a penetrator tip [see Fig. 17C element 308 and para 196… “The connector also includes ends 322a and 322b that facilitate connection with the penetrator tip 308 and the needle tip 308' of the elongate bodies 306' and 306.”]
However, Zaugg fails to disclose “a locking tooth extending out of the clamping channel and projecting from an outer surface of the second body at a locking angle” as recited by claim 3.
Walen discloses in the analogous art of surgical devices [see para 2… “This invention is generally related to a medical or surgical tool that has elongated shaft that can be bent so as to have a specific curvature.”] using teeth that mesh with slots at an angle (i.e. a locking angle) strengthens the connection between different components thereby making the components less likely to experience overloading forces such as sideloading [see para 272… “Each arm 816 and 838 abuts the surface of the respective socket 828 and 850 in which the arm is seated. More specifically, the arm teeth engage the teeth that extend into the socket 828 or 850. This meshing of teeth reduces the likelihood that, when exposed to side loading, a link or the tip will pivot relative to the arm 816 or 838 against which the link or tip is pressed.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Zaugg by including meshing teeth and slots between the clamping channel and the penetrator tip similarly to that disclosed by Walen because this will strengthen the connection between the channel and piercing tip connecting with the channel.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Zaugg in view of Walen by placing the teeth extending from an outer surface of the channel which is on the second body because there are a limited number of places to place the teeth (i.e. inside the channel, on the piercing body, or extending from an outer surface) and this is one of those limited number of places.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zaugg in view of Kaplan et al (US 20060247618) hereafter known as Kaplan.
Zaugg discloses the invention substantially as claimed including all the limitations of claim 1.
However, Zaugg fails to disclose “wherein the sheath connector comprises a Leur fitting” as recited by claim 8 or “wherein the sheath connector comprises a partial Leur fitting” as recited by claim 9.
Kaplan discloses in the analogous art of minimally invasive surgery [see para 17… “Another variation of the invention includes a treatment system in which the minimally invasive access device such as an endoscope or similar device is configured to minimize misalignment as described herein.”] using a luer fitting (i.e. a leur fitting and inclusive of at least a partial leur fitting) to lock different components together in a set configuration [see para 28… “As a lock, fittings (e.g. leur fittings), clips, clamps, etc. may be employed.” And para 119… “Alternatively, as illustrated in connection with FIG. 16C, a clamping device could include a leur fitting 362 so that once it is set in position upon the treatment catheter body, that the fitting is locked with a complimentary fitting piece 364 on the access device 18/240 to fix their relative position, rather than simply bottoming-out a stop surface 366 against the access device.”].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Zaugg’s sheath connector to including a luer fitting similarly to that disclosed by Kaplan as this will allow a specification configuration of the sheath and the catheter channel to be locked together.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zaugg in view of Gregg et al (US 20200345493) hereafter known as Gregg.
Regarding claim 10:
Zaugg discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above which includes a first body, second body and angle that as claimed as outlined above. Also, Zaugg discloses using a pin assembly rotation to form said claimed angle [see para 196… “FIG. 22C shows the hinge 320, which allows rotation of the foot 319 in a direction indicated by directional arrow Y. The hinge 320 may be any device capable of rotatably coupling the foot 319 to the suturing device 300, such as pin assembly or the like.”].
However, Zaugg fails to disclose “a stop on the first body, limiting the angle between the first body and the second body” as recited by claim 10.
Gregg discloses in the analogous art of surgical catheter devices [see abstract… “A prosthetic valve delivery device includes a handle and a delivery catheter.”] using a stop as a means of preventing over rotation in a pin assembly [see para 42… “The pins 695 can hit travel stops 696 to prevent over-rotation that might damage the pullwires and/or catheter during use.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Zaugg by including a stop similarly to that disclosed by Gregg because this will help prevent damage from potential over rotation of Zaugg’s pin assembly.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Zaugg in view of Gregg to place the stop on the first body because there are only a limited number of possible places to place the stop (i.e. place the stop on the first body or place the stop on the second body) and the first body is one of those limited number of places.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zaugg in view of Hess et al (US 20170055971) hereafter known as Hess.
Regarding claim 13:
Zaugg discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above which includes a first body, second body and angle that as claimed as outlined above.
However, Zaugg fails to disclose “a bias configured to hold the second body at the first angle relative to the first body” as recited by claim 13.
Hess discloses in the analogous art of surgical catheter devices [see abstract… “Surgical devices and methods are described. The loading devices can include an elongate shaft extending distally from a housing and a hinge can be disposed between the elongate shaft and an articulating distal portion.”] using leaf springs (i.e. a bias) to attach two different angled components together in an interference fit [see Fig. 1 and para 46… “While the engagement feature may vary, in an exemplary embodiment a plurality of leaf springs (not shown) can be disposed within the distal portion 204 and can provide an interference fit with an end effector to frictionally hold the end effector in the distal portion 204 of the loader 200.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Zaugg by including leaf springs similarly to that disclosed by Hess as this will allow for the first and second body at a set angle be held together thereby maintaining whatever desired angle configuration to be maintained.
Conclusion
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.
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
