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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the respective shuttle of the respective suture holder assembly" in line 14. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation has been interpreted as "a respective shuttle of a respective suture holder assembly."
Claims 2-22 are similarly rejected by virtue of dependency from claim 1.
Claim 3 recites the limitation “a substantially slack-free loop” in line 7 which renders the scope of the claim indefinite since it is unclear what differentiates a slack-free loop from a “substantially” slack-free loop. Further, the Specification does not provide any basis for understanding the scope of the term. For examination purposes, “a substantially slack-free loop” has been interpreted as “a slack-free loop.”
Claim 6 recites the limitation “a substantially constant radius” in line 2 which renders the scope of the claim indefinite since it is unclear what differentiates a constant radius from a “substantially” constant radius. Further, the Specification does not provide any basis for understanding the scope of the term. For examination purposes, “a substantially constant radius” has been interpreted as “a constant radius.”
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7, 11 and 16 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Christakis et al. (US 20200390436).
Regarding claim 1, Christakis discloses a surgical suturing device (see Fig. 1-2) for closing an incision or two layers of a target soft tissue, the suturing device comprising: a shuttle driving mechanism (220) for driving a shuttle (240) of a suture holder assembly; and a chamber (235) for receiving a set of suture holder assemblies (tissue supports 240 can be consider suture holder assemblies since they function to reinforce and retain suture, see [0041]) the suturing device defining: a soft tissue window (130) for receiving at least a portion of the target tissue; and an ejection window (230) sized and shaped to allow a suture holder assembly to be ejected out of the suturing device through the ejection window, wherein the suturing device defines at least an engaging state, and a transferring state, and wherein in the engaging state, the shuttle driving mechanism is in a first retracted position while being configured to be engaged with the respective shuttle of the respective suture holder assembly in the chamber, and in the transferring state, the shuttle driving mechanism is in a first advanced position such that at least a portion of the shuttle driving mechanism spans at least partially across the soft tissue window while being configured to be engaged with the respective shuttle of the respective suture holder assembly (the needle 220 has both a engaging state in which it engages a tissue support 240 and a transferring state in which it extends across the tissue window 130, see Fig. 1).
Regarding claim 2, Christakis discloses the suturing device according to claim 1, wherein the suturing device further defines a start state, in which the shuttle driving mechanism is in a second, different retracted position configured to be disengaged from the respective shuttle of the respective suture holder assembly (the needle is disengaged from a tissue support 240 to deploy the tissue support).
Regarding claim 3, Christakis discloses the suturing device according to claim 1, wherein the suturing device further defines a tensioning position, wherein the shuttle driving mechanism is in a second advanced state such that at least a portion of the shuttle driving mechanism spans across the soft tissue window, and the shuttle driving mechanism is configured to be engaged with the respective shuttle of the respective suture holder assembly to allow a respective suture strand of the respective suture holder assembly to form a slack-free loop around the target tissue in the soft tissue window (the needle 220 at some point in its reciprocal motion spans across the tissue window 130 to allow a suture strand to be tensioned to form a slack-free loop if desired).
Regarding claim 4, Christakis discloses the suturing device according to claim 1, wherein the suturing device comprises a feed mechanism in the chamber configured to feed the set of suture holder assemblies towards the ejection window (see [0040]), wherein the feed mechanism comprises a first biasing element (244), and wherein the first biasing element is configured as a first spring (see Fig. 2).
Regarding claim 5, Christakis discloses the suturing device according to claim 1, wherein the shuttle driving mechanism comprises a needle (220).
Regarding claim 7, Christakis discloses the suturing device according to claim 5, wherein the needle comprises a shuttle engaging tip with a first cross-sectional diameter and a main body portion with a second cross-sectional diameter, wherein the second diameter is greater than the first diameter (the tip of the needle has a neck portion with a smaller cross sectional diameter than the main body portion of the needle, see Fig. 2), and wherein the shuttle engaging tip is sized and shaped to be received in a shuttle channel in the respective shuttle of the respective suture holder assembly (the tip of the needle is received within an opening within the tissue support 240 that is created when the needle punctures the tissue support, see [0040]).
Regarding claim 11, Christakis discloses the suturing device according to claim 5, wherein the suturing device comprises a groove or device channel, and wherein the needle is received in the groove or device channel (the needle 220 is received in the channel 248, see Fig. 2).
Regarding claim 16, Christakis discloses the suturing device according to claim 1, wherein the chamber is delimited by a set of wall sections (the chamber 235 is delimited by walls, see Fig. 2), and wherein at least one of the wall sections comprises a stop element configured to engage against the respective shuttle of the respective suture holder assembly to prevent inadvertent ejection of the respective suture holder assembly out of the chamber (the device may include a cover 350 as shown in Fig 3A to prevent inadvertent ejection of a tissue support, see [0041]).
Claims 23 and 25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sauer (US 2011/0118758).
Regarding claim 23, Sauer discloses a suture holder assembly (see Fig. 12-15) comprising a shuttle (18), a suture strand attached to the shuttle (needle 18 is attached to a suture strand after it is attached to a ferrule 116), and a holder (the tip 10 of the device can be considered a holder) with a first holder end, a second holder end and a soft tissue clearance between the first and second holder ends (see annotated Fig. 12 below for first and second holder ends and soft tissue clearance), wherein the respective suture strand comprises a first suture strand end attached to the shuttle, and a second suture strand end (each suture has a first end and a second end attached to a ferrule 116 and both ends of the suture are attached to the needle 18 when the needle is engaged with the ferrule), and wherein the shuttle is configured to travel between the first and second holder ends when suturing a target tissue (the needle 18 moves back and forth to suture tissue, see [0053]).
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Regarding claim 25, Sauer discloses the suture holder assembly according to claim 23, wherein the suture holder assembly further comprises a shuttle receiving channel (see annotated Fig. 12) at the second holder end and is configured to receive the shuttle (the shuttle receiving channel receives the needle 18 when it picks up a ferrule 116).
Regarding claim 26, Sauer discloses the suture holder assembly according to any one of claim 23, wherein the suture holder assembly further comprises a suture retention element (116) for holding the second suture strand end, and wherein the suture retention element is configured to allow the shuttle to pass through the suture retention element (the needle 18 passes through an opening in the ferrule to attach to the ferrule as shown in Fig. 7).
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.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Sauer, hereinafter ‘758, in view of Sauer et al. (US 2016/0354080), hereinafter ‘080.
Regarding claim 24, ‘758 discloses the suture holder assembly according to claim 23, but fails to teach the suture holder assembly further comprises a blade for cutting off the suture strand.
‘080, in the same field of art, teaches a suture holder assembly (see Fig. 7) comprises a blade (86) for cutting off the suture strand (see [0006]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the suture holder assembly of ‘758 so that it includes a blade as taught by ‘080 since doing so would facilitated cutting trimming the suture ends.
Allowable Subject Matter
Claims 6, 8-10, 12-15, 17-22 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 6, Christakis discloses the suturing device according to claim 5 but fails to teach the needle is curved and has a substantially constant radius.
Regarding claim 8, Christakis discloses the suturing device according to claim 5 but fails to teach the shuttle comprises a driving end configured as a protrusion, wherein a shuttle driver of the shuttle driving mechanism comprises a shuttle driver channel, which is sized and shaped to receive the protrusion.
Regarding claim 9, Christakis discloses the suturing device according to claim 5 but fails to teach the shuttle driving mechanism comprises an arm coupled to the needle, and wherein the arm is arranged to rotate about a first axis.
Regarding claim 10, Christakis fails to teach the suturing device according to claim 9.
Regarding claim 12, Christakis discloses the suturing device according to claim 1 but fails to teach wherein the suturing device comprises an activation mechanism coupled to the shuttle driving mechanism, and wherein the activation mechanism comprises a lever.
Regarding claims 13 -14, Christakis fails to teach the suturing device according to claim 12.
Regarding claims 17-22, the closest prior art of record, Christakis, teaches the suturing tool of claim 1 but fails to teach a set of suture holder assemblies each comprising a shuttle, a suture stand and a holder as claimed in combination with other recited features in claim 1 and 17.
Regarding claims 18-22, Christakis fails to teach the surgical tool assembly of claim 17.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
All of the documents cited in the attached PTO-892 teach related suturing devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771