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 Arguments
Applicant’s argument on Page 6 regarding the objection to the specification has been fully considered. The objection to the specification is withdrawn in view of the amendments.
Applicant’s argument on Page 6 regarding the objection to Claim 23 has been fully considered. The objection to Claim 23 is withdrawn in view of the amendments.
Applicant’s argument on Pages 6-7 regarding the rejection of Claims 2-3 under 35 U.S.C. 112(b) has been fully considered. The rejection of Claims 2-3 under 35 U.S.C. 112(b) is withdrawn in view of the amendments.
Applicant’s argument on Page 9 regarding the rejection of Claims 1 and 8 under 35 U.S.C. 103 over Romo in view of Vidlund has been fully considered but is not persuasive under new grounds of rejection as below.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Page 9 relies on the supposed deficiencies with respect to the rejection of parent Claim 1. Applicant’s argument is moot for the same reasons detailed above.
While differences between the prior art and the instant application are appreciated, they are not embodied in the claims in such a way as to differentiate.
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, 23-24, and 26-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fung et al. (US 20180085130).
Regarding Claim 1, Fung teaches probe guide device for facilitating passage across an anatomical boundary, ([0065] “closure device (200) that may be used to close the left atrial appendage.”), comprising:
a) a wire sheath ([0069] “snare 308”);
b) a guide catheter at a distal end of the wire sheath, (Fig. 3A and [0069] “elongate body 304”), the guide catheter comprising:
i) a first opening on a distal end of the guide catheter (Fig. 4E); and
ii) a second opening on the distal end of the guide catheter (Fig. 4E);
c) a probe configured to be disposed within the guide catheter, ([0087] “an imaging device (not depicted) positioned within the vacuum tube”), wherein the probe is longitudinally translatable relative to the guide catheter to move a distal end of the probe out of the first opening on the distal end of the guide catheter, ([0090] “The imaging device (1912) may be fixed relative to the vacuum tube or may be slidably positioned within a lumen of the vacuum tube (1904).”), wherein the distal end of the probe comprises a steerable section ([0112] “the vacuum tube (430) may be steerable (e.g., using pull wires) regardless of whether an imaging device is used.”); and
d) a retaining wire structure configured to be disposed within the wire sheath and the guide catheter, ([0069] “the snare loop assembly (302) may comprise […] a suture loop (310)”),
i) wherein the retaining wire structure comprises a looped portion at a distal end of the retaining wire structure, (Fig. 3A), wherein a distal end of the retaining wire structure is configured to be longitudinally translatable relative to the wire sheath and the guide catheter to be moved out of the second opening on the distal end of the guide catheter when a proximal portion of the retaining wire structure is positioned in the wire sheath ([0067] “Generally, a portion of the snare may be housed in the elongate body, and another portion of the snare may extend outside of the distal end of the elongate body to at least partially define the loop and aperture of the snare loop assembly” and [0069] “the retention member (312) may be configured to release the suture loop (310) from the snare loop assembly (302) upon application of a sufficient force to suture loop (310).”), and
ii) wherein the probe is configured to be longitudinally translatable through the looped portion of the retaining wire structure when the looped portion of the retaining wire structure is positioned distal of the second opening on the distal end of the guide catheter such that a proximal portion of the probe is adjacent to the wire sheath and the steerable section of the probe is positioned distal to the first opening (Fig. 5B).
Regarding Claim 2, Fung teaches all limitations of Claim 1, as discussed above. Furthermore, Fung teaches wherein a width of the looped portion is adjustable from a proximal end of the retaining wire structure ([0070] “advancement of the snare through the elongate body may increase the size of the loop and the aperture of the snare loop assembly, while retraction of the snare through the elongate body may decrease the size of the loop and the aperture of the snare loop assembly.”).
Regarding Claim 3, Fung teaches all limitations of Claim 2, as discussed above. Furthermore, Fung teaches wherein the width of the looped portion is adjustable by partially retracting the retaining wire structure, wherein the looped portion is wider when the retaining wire structure is distally farther from the second opening on the distal end of the guide catheter ([0070] “advancement of the snare through the elongate body may increase the size of the loop and the aperture of the snare loop assembly, while retraction of the snare through the elongate body may decrease the size of the loop and the aperture of the snare loop assembly.”).
Regarding Claim 4, Fung teaches all limitations of Claim 1, as discussed above. Furthermore, Fung teaches wherein the distal end of the guide catheter comprises a dilator-tip extrusion ([0205] “a dilator may be advanced through a sheath”).
Regarding Claim 5, Fung teaches all limitations of Claim 1, as discussed above. Furthermore, Fung teaches wherein the guide catheter is steerable from a proximal end of the guide catheter ([0116] “the handle (550) may be used to move the snare loop assembly (504) between open and closed configurations, steer the elongate body (502) and vacuum tube (530)”).
Regarding Claim 6, Fung teaches all limitations of Claim 1, as discussed above. Furthermore, Fung teaches wherein a probe catheter configured to be disposed within the guide catheter, wherein the probe catheter comprises the probe ([0087] “an imaging device (not depicted) positioned within the vacuum tube”).
Regarding Claim 7, Fung teaches all limitations of Claim 6, as discussed above. Furthermore, Fung teaches wherein the probe catheter is steerable from a proximal end of the probe catheter ([0116] “the handle (550) may be used to move the snare loop assembly (504) between open and closed configurations, steer the elongate body (502) and vacuum tube (530)”).
Regarding Claim 9, Fung teaches all limitations of Claim 1, as discussed above. Furthermore, Fung teaches wherein the looped portion is configured to be disengaged by retracting one end of the retaining wire structure from a proximal end of the retaining wire structure ([0069] “the retention member (312) may be configured to release the suture loop (310) from the snare loop assembly (302) upon application of a sufficient force to suture loop (310)” and [0116] “the handle (550) may be used to […] release the suture loop from the snare loop assembly (504).”).
Regarding Claim 10, Fung teaches all limitations of Claim 1, as discussed above. Furthermore, Fung teaches a removable obturator configured to fill the first opening on the distal end of the guide catheter ([0010] “The balloon may define a third lumen operatively coupled to the second lumen.”).
Regarding Claim 23, Fung teaches all limitations of Claim 1, as discussed above. Furthermore, Fung teaches wherein the guide catheter comprises a tapered distal tip on the distal end ([0082] “elongate body may be […] tapered”).
Regarding Claim 24, Fung teaches all limitations of Claim 1, as discussed above. Furthermore, Fung teaches wherein the first opening has a cross-sectional size larger than a cross-sectional size of than the second opening (Fig. 4E).
Regarding Claim 26, Fung teaches all limitations of Claim 1, as discussed above. Furthermore, Fung teaches a puncture needle configured to be longitudinally translatable through the looped portion ([0219] “The needle may be advanced in the superior direction (using fluoroscopic imaging), until the needle pierces the pericardium (3104).”).
Regarding Claim 27, Fung teaches all limitations of Claim 1, as discussed above. Furthermore, Fung teaches wherein the guide catheter comprises a first lumen in fluid communication with the first opening, and wherein the proximal portion of the probe is proximal to a proximal end of the first lumen and offset from and outside of the wire sheath (Figs. 4E-4H and [0096] “A distal end of the first lumen (2504) may be coupled to and in fluid communication with the third lumen (2512) such that the third lumen (2512) may be inflated using fluid directed through the first lumen (2504).”).
Regarding Claim 28, Fung teaches a probe guide device for facilitating passage across an anatomical boundary, ([0065] “closure device (200) that may be used to close the left atrial appendage.”), comprising:
a) a wire sheath ([0069] “snare 308”);
b) a guide catheter at a distal end of the wire sheath, (Fig. 3A and [0069] “elongate body 304”), the guide catheter comprising:
i) a probe opening on a distal end of the guide catheter (Fig. 4E); and
ii) a wire opening on the distal end of the guide catheter (Fig. 4E);
c) a probe configured to be disposed within the guide catheter, ([0087] “an imaging device (not depicted) positioned within the vacuum tube”), wherein the probe is longitudinally translatable relative to the guide catheter to move a distal end of the probe out of the probe opening on the distal end of the guide catheter, ([0090] “The imaging device (1912) may be fixed relative to the vacuum tube or may be slidably positioned within a lumen of the vacuum tube (1904).”), wherein the distal end of the probe comprises a steerable section ([0112] “the vacuum tube (430) may be steerable (e.g., using pull wires) regardless of whether an imaging device is used.”); and
d) a wire configured to be disposed within the wire sheath and the guide catheter, ([0069] “the snare loop assembly (302) may comprise […] a suture loop (310)”), wherein a distal end of the wire is configured to be longitudinally translatable relative to the wire sheath and the guide catheter to be moved out of the wire opening on the distal end of the guide catheter when a proximal portion of the wire is positioned in the wire sheath, ([0067] “Generally, a portion of the snare may be housed in the elongate body, and another portion of the snare may extend outside of the distal end of the elongate body to at least partially define the loop and aperture of the snare loop assembly” and [0069] “the retention member (312) may be configured to release the suture loop (310) from the snare loop assembly (302) upon application of a sufficient force to suture loop (310).”), and
e) wherein the probe is configured to be longitudinally translatable through the guide catheter such that a proximal portion of the probe is adjacent to the wire sheath and the steerable section of the probe is positioned distal to the probe opening (Fig. 5B).
Regarding Claim 29, Fung teaches all limitations of Claim 28, as discussed above. Furthermore, Fung teaches wherein the wire comprises a looped portion at a distal end of the wire, (Fig. 3A), and wherein the probe is configured to be longitudinally translatable through the looped portion of the wire when the looped portion of the wire is positioned distal of the wire opening on the distal end of the guide catheter (Fig. 5B).
Regarding Claim 30, Fung teaches all limitations of Claim 28, as discussed above. Furthermore, Fung teaches wherein the guide catheter is steerable from a proximal end of the guide catheter ([0116] “the handle (550) may be used to move the snare loop assembly (504) between open and closed configurations, steer the elongate body (502) and vacuum tube (530)”).
Regarding Claim 31, Fung teaches all limitations of Claim 28, as discussed above. Furthermore, Fung teaches wherein a probe catheter configured to be disposed within the guide catheter, wherein the probe catheter comprises the probe ([0087] “an imaging device (not depicted) positioned within the vacuum tube”).
Regarding Claim 32, Fung teaches all limitations of Claim 31, as discussed above. Furthermore, Fung teaches wherein the probe catheter is steerable from a proximal end of the guide catheter ([0116] “the handle (550) may be used to move the snare loop assembly (504) between open and closed configurations, steer the elongate body (502) and vacuum tube (530)”).
Regarding Claim 33, Fung teaches all limitations of Claim 28, as discussed above. Furthermore, Fung teaches wherein the guide catheter comprises a probe lumen in fluid communication with the probe opening, and wherein the proximal portion of the probe is proximal to a proximal end of the probe lumen and offset from and outside of the wire sheath (Figs. 4E-4H and [0096] “A distal end of the first lumen (2504) may be coupled to and in fluid communication with the third lumen (2512) such that the third lumen (2512) may be inflated using fluid directed through the first lumen (2504).”).
Regarding Claim 34, Fung teaches all limitations of Claim 28, as discussed above. Furthermore, Fung teaches wherein the wire opening is in fluid communication with a wire lumen extending through the guide catheter and the wire sheath ([0171] “The various components of the imaging device may be housed within any lumen of the vacuum tube. The various components of the snare loop assembly may be housed within any lumen or lumens of the elongate body. For example, in some variations, all of the components of the snare loop assembly may be housed in a single lumen. In other variations, different portions of the snare loop assembly may be at least partially housed in different lumens.”).
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 25 is rejected under 35 U.S.C. 103 as being unpatentable over Fung et al. (US 20180085130) in view of Caswell et al. (US 20200359997).
Regarding Claim 25, Fung teaches all limitations of Claim 1, as discussed above. However, Fung does not explicitly teach wherein a cross-sectional shape of the guide catheter is elliptical.
In an analogous transesophageal echocardiography field of endeavor, Caswell teaches a probe guide device for facilitating passage across an anatomical boundary, ([0055] “the ultrasound device 110 is a TEE probe. In some embodiments, the ultrasound device is a catheter, a guide catheter, or a guide wire.”), wherein a cross-sectional shape of the guide catheter is elliptical ([0055] “All or a portion of the flexible elongate member 137 may have any suitable geometric cross-sectional profile (e.g., […] elliptical, etc.)”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Fung with the shape of Caswell because the modification allows for easier insertion into the patient and across the boundary, minimizing trauma or damage, when compared less-rounded cross-sections.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA CHRISTINA TALTY/ Examiner, Art Unit 3797
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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