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 .
Claim Objections
Claim 14 is objected to because of the following informalities: In order to avoid any antecedent issues, line three should be amended to read “…so as to allow the dilator” or a similar amendment. 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.
Claims 1-7, 9, 10, 12, 13, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2008/0045979 to Ma.
As to claim 1, Ma discloses a closure device for suturing a puncture (paragraph 12), the closure device comprising:
a suture (102, figure 15a-d);
an elongate support (elongate support 118), which comprises one or more shafts (support 118 is at least one shaft, figure 15a-c, paragraph 97);
a ferrule (108, paragraph 97, the detachable coupling structure can read on a ferrule), which is coupled to a distal end portion of the suture (figure 15a):
a suturing needle (106), which is removably couplable to the ferrule (paragraph 97);
a suture-positioning support (114), which is (a) coupled to a distal end portion of the elongate support (figure 14a,b, 15a-d), (b) laterally extendable with respect to the distal end portion of the elongate support (figure 14b, 15b), and (c) shaped so as to define a ferrule receptacle (116), which is configured to removably receive the ferrule (paragraph 98, 99, figure e15b), such that the suture -positioning support is configured to removably receive the suture (figure 15b-d); and
a control handle (18, figure 2a-c, paragraph 56-58, usable with the vessel closure 100 embodiment, paragraph 96), which (i) comprises a support-and-needle user control (26/20), and (ii) is configured such that actuation of the support-and-needle user control causes:
lateral extension of the suture-positioning support (paragraph 56-58, 96, ), with respect to a distal end portion of the elongate support, from (a) a delivery position (figure 15a), in which a suture-positioning support axis of the suture -positioning support forms a first angle of less than 45 degrees with a distal- support central longitudinal axis of the distal end portion of the elongate support (figure 15a), to (b) a deployed position (figure 15b) in which the suture-positioning support laterally extends from the distal end portion of the elongate support, and
distal advancement of the suturing needle (figure 15b, paragraph 100), while the suturing needle is removably coupled to the ferrule, such that the closure device directs the ferrule into the ferrule receptacle and the ferrule receptacle removably receives the ferrule while the suture- positioning support is in the deployed position (figure 15b-d).
As to claim 2, Ma discloses the control handle is configured such that the actuation of the support-and-needle user control causes at least a portion of the distal advancement of the suturing needle to occur as the suture positioning support is extended laterally (figure 15b).
As to claim 3, Ma discloses the control handle is configured such that the actuation of the support-and-needle user control causes the suture-positioning support to being extending laterally before actuating the suture needle begins advancing distally (figure 15b, paragraph 99, 56-58 the actuators are manually actuated, so the foot can be articulated first).
As to claim 4, Ma discloses the control handle is configured such that the actuation of the support-and-needle user control non-electrically causes the distal advancement of the suture needle and the lateral extension of the suture-positioning support (paragraph 56-57, the piston can be manually depressed).
As to claim 5, Ma discloses the support-and-needle user control is configured to be actuated by movement of the user control in a proximal-to-distal direction (figure 2a-c).
As to claim 6, Ma discloses wherein the control handle is configured such that:
the actuation of the support-and-needle user control to cause the lateral extension and the distal advancement of the suturing needle is initial actuation of the support-and-needle user control (figure 15a-b), and
subsequent actuation of the support-and-needle user control, after the initial actuation of the support-and-needle user control, causes:
proximal withdrawal of the suturing needle, a portion of which proximal withdrawal proximally withdraws the suturing needle from the ferrule while leaving the ferrule within the ferrule receptacle (figure 15b-d), and
transitioning of the suture -positioning support from the deployed position back to the delivery position (figure 15d-f).
As to claim 7, Ma discloses the control handle is configured such that the subsequent actuation of the support-and-needle user control causes at least a portion of the transitioning of the suture-positioning support from the deployed position back to the delivery position distal advancement of the suturing needle to occur as the suturing needle is proximally withdrawn (figure 15d-f).
As to claim 9, Ma discloses the suture is a first suture (figure 15a-b), and wherein the closure device further comprises a second suture (112, figure 15a) wherein the ferrule is a first ferrule (figure 15a), and wherein the closure device further comprises a second ferrule (other 110’), which is coupled to a distal end portion of the second suture (figure 15a), and wherein the ferrule receptacle of the suture-positioning support is configured to removably receive the second ferrule (figure 15a-d).
As to claim 10, Ma discloses wherein the suture is a first suture (figure 15a), and wherein the closure device further comprises a second suture (112), and wherein the suture-positioning support is configured to removably receive the second suture (figure 15a-d).
As to claim 12, Ma discloses an elongate dilator (the distal part of the device that is attached to the foot 114 in figure 15a, similar to 22/30, in figure 1- 5), and which has a proximal end that is coupled to the distal end portion of the elongate support (figure 15a,b).
As to claim 13, Ma discloses the dilator is shaped so as to define an atraumatic proximal tip (figure 15b).
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2008/0045979 to Ma in view of U.S. Patent Publication 2008/0109015 to Chu.
As to claim 14, Ma discloses the device above but is silent about the elongate flexible dilator connector, which couples the proximal end of the dilator to the distal end portion of the elongate support so as to allow the movement. Ma does disclose “dilator” 22 is flexible (paragraph 59) to help position the suture-positioning support (or foot 24).
Chu teaches a similar device (suturing instrument, abstract) having a elongate flexible dilator connector (114, paragraph 36, 40) in order to easily deflect distal parts of the device to the desired orientation. The connector member 114 of Chu can be used to connect the proximal end of the dilator to the distal end portion of the elongate support of Ma which can yield the predictable results of allow the dilator to be deflected as desired. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the device of Ma comprise an elongate flexible dilator connector, which couples the proximal end of the dilator to the distal end portion of the elongate support so as to allow the movement in order to easily deflect distal parts of the device to the desired orientation.
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2008/0045979 to Ma.
As to claim 15, Ma discloses the ferrule is shaped so as to define a blunt interface (308b, 330) with the distal end portion of the suture (figure 20a; 24a,b,). If it would not be known that the “blunt interfaces” of the embodiments of 308b, 330 can be used in the embodiment of figure 15a-f, it would have been obvious for the purpose of using a detachable structure with can engage with the link in order to enable efficient suturing of the incision (paragraph 97, 116, 133).
Allowable Subject Matter
Claim 11 is allowed.
Claims 8, 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Publication 2005/0149065 to Modesitt, U.S. Patent Publication 2005/0228405 to Maruyama (as cited reference 89 in the IDS filed 10/29/2024), U.S. Patent Publication 2010/0016870 to Campbell, U.S. Patent Publication 2013/0325058 to Roorda, and U.S. Patent Publication 2022/0183677 to Shattuck (as cited reference 86 in the IDS filed 10/29/2024) all disclose similar devices capable of disclosing, rendering obvious, providing evidence, and/or pertinent to the scope of the claims.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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