DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The preliminary amendment filed June 4, 2025 has been entered. Claims 21-40 are currently pending.
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 28-40 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 28 recites “wherein the cannula assembly comprises a head, a shaft extending distally from the head along a central axis, a plunger, a latch, and a deployable protrusion coupled to the shaft and the plunger”. However, the claim continues with steps (a) piercing the tissue with the distal tip of the obturator, (b) inserting the obturator such that the shaft extends through the tissue, etc. The Examiner suggests amending the claim to recite “…wherein the obturator comprises a head, a shaft extending distally from the head along a central axis, a plunger, a latch, and a deployable protrusion coupled to the shaft and the plunger…” for consistency with the remainder of the claim and support in the disclosure.
Claims 29-34 are rejected due to their dependency on claim 28.
Claim 35 recites in step (d) “directing the suture proximally from the cavity through the obturator while the remains in the deployed position…”. It is unclear what remains in the deployed position. The Examiner suggests amending the claim to recite “…directing the suture proximally from the cavity through the obturator while the protrusion remains in the deployed position..”
Claims 36-40 are rejected due to their dependency on claim 35.
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) 35-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malkowski et al. (US 2015/0038997, hereinafter “Malkowski”).
Regarding claim 35, Malkowski discloses a method of suturing a tissue opening in a tissue of a patient with an obturator (1000) and a suture (S), wherein the obturator includes a removable proximal head (1010), a distal tip (1030) configured to penetrate tissue of a patient, a shaft (1020) extending from the proximal head to the distal tip and receivable within a working channel of a cannula assembly (100), a latch (tabs 1017 which engage with apertures 111) movable relative to the proximal head, and a protrusion (arms 1034 or 1036) configured to transition between a retracted position (Fig 24E) and a deployed position (Fig 24D), the method comprising:
(a) inserting the obturator (1000) through the tissue such that the shaft extends through a tissue opening and the distal tip is positioned within a cavity of the patient (shown in alternate embodiment Fig 30C; para [0151-0152]);
(b) deploying the protrusion within the cavity such that the protrusion advances laterally away from a central axis of the shaft (Fig 24D; para [0152]);
(c) directing the suture distally through the obturator and into the cavity while the protrusion remains in the deployed position such that the suture captures a first portion of the tissue (para [0152]);
(d) directing the suture proximally from the cavity through the obturator while the protrusion remains in the deployed position such that the suture captures a second portion of the tissue (para [0152]);
(e) removing the obturator from the tissue opening while the suture continues to the capture the first and second portions of the tissue (Fig 24E; para [0153]); and
(f) closing the tissue opening with the suture (para [0153]).
Regarding claim 36, wherein deploying the protrusion to the deployed position comprises moving the latch laterally outwardly relative to the central axis (when engagement tabs 1017 engage with apertures 111, protrusion deploys outwardly as the obturator reaches the fully deployed position – para [0152]).
Regarding claim 37, further comprising: (a) removing the head as a result of moving the latch (proximal head removed along with obturator after moving latch to disengaged position Fig 24E; para [0153]).
Regarding claim 38, in an alternate embodiment deploying the protrusion to the deployed position (obturator fully inserted through cannula to fully deployed position – para [0152], Fig 24D) comprises moving the latch rotationally relative to an axis about 90 degrees relative to the working channel (latch may comprise threading 317 which engages upon rotation – Fig 8A; para [0114]).
Regarding claim 39, further comprising: (a) removing the head as a result of moving the latch (proximal head removed along with obturator after moving latch to disengaged position Fig 24E; para [0153] analogous to threaded latch mechanism Fig 8A; para [0114]).
Regarding claim 40, wherein deploying the protrusion (1034, 1036) anchors the obturator in place relative to the tissue (para [0152]).
Allowable Subject Matter
Claims 21-27 are allowed.
The following is an examiner’s statement of reasons for allowance: The prior art fails to teach and/or disclose a method of suturing or closing a tissue opening with a cannula assembly, obturator, and a suture, wherein the obturator includes a proximal head including a latch, a distal tip configured to penetrate tissue of a patient, a shaft extending from the proximal head to the distal tip and received within a working channel of the cannula assembly, and at least one deployable protrusion on a distal portion of the shaft, wherein the latch of the proximal head is movable between a first position in which the latch is configured to secure the proximal head to the shaft, and a second position in which the latch is configured to permit the proximal head to be separated from the shaft and including the steps of inserting the assembly through tissue, moving the latch, inserting a suture along first and second paths, and closing the tissue opening with the suture, as claimed, particularly including the step of moving the latch from the first position to the second position, thereby releasing the proximal head from the shaft and permitting the obturator to advance distally relative to the cannula assembly. Of the closest prior art, Malkowski (US 2015/0038997) teaches releasing the proximal head from the shaft permits the obturator to be retracted proximally relative to the cannula assembly.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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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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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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