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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/15/2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 8-10, filed 12/15/2025, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Fung et al. (US 2016/0120549).
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) 1-3, 6-9, 13-17, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fung et al. (US 2016/0120549).
Regarding claim 1, Fung et al. discloses a device (FIG 21) for passing a guidewire around an anatomical structure of interest within a body ([0060] discloses passing a guidewire through lumen 2110. [0037-0038] generally discloses the anatomical structure of interest within a body), the device comprising: a catheter including an elongated tube (2100) having at least a first lumen (2110) and a second lumen (2106); a guidewire configured to pass through the first lumen of the catheter ([0060] discloses passing a guidewire through lumen 2110); and a snare configured to pass through the second lumen of the catheter ([0061] discloses a snare loop assembly may be housed within any lumen of the elongate body, such as lumen 2106); wherein a first exit of one of the first lumen and the second lumen is positioned at or near a distal tip of the catheter (First exit of the second lumen is seen in FIG 21), wherein a second exit of another of the first lumen and the second lumen is positioned on a side of the catheter at a distance proximal to a distal tip of the catheter (Second exit of the first lumen is shown extending form the side of the catheter and proximal to the distal tip 2103); a portion of the catheter distal to the second exit (2104) is configured to loop around at least a portion of the anatomical structure of interest within the body and towards the second exit ([0058-0059] disclose the flexible curvature of 2104. This portion is at least configured to bend around at least some target tissue and bend to the extent that the curved portion extends backwards towards the second exit. There steerability and flexibility of this region is interpreted as sufficient evidence that the device is at least capable of being used in the claimed manner i.e. bending towards a proximal end of the device), wherein one or more of a first portion of the catheter proximal to the first exit (Tip portion 2103 is interpreted as the first portion), or a second portion of the catheter proximal to the first portion (2104 is interpreted as the second portion and is proximal to the first portion 2103), are configured to bend around at least the portion of the anatomical structure of interest within the body and towards the second exit (The second portion formed by 2104 is at least configured to bend around at least some target tissue and bend to the extent that the curved portion extends backwards towards the second exit. There steerability and flexibility of this region is interpreted as sufficient evidence that the device is at least capable of being used in the claimed manner i.e. bending towards a proximal end of the device), the second portion being more flexible than the first portion (Due to the second portion being significantly longer than tip 2103, it has higher flexibility).
Regarding claim 2, Fung et al. discloses wherein the first lumen is a central lumen of the catheter (2110 passes through main tubular body 2100 and therefore is central to the catheter) with the first exit positioned at or near the distal tip of the catheter (First exit at the distal tip as outline above), and wherein the second lumen is a side lumen of the catheter (Second lumen 2106 runs along the side of first lumen 2110 and therefore is interpreted as a side lumen of the catheter) with the second exit positioned on the side of the catheter at the distance proximal to the distal tip of the catheter (The second exit is proximal to the first exit. Examiner notes that as written the claim does not specify or further define the first and second exits corresponding to the first and second lumen).
Regarding claim 3, Fung et al. discloses the second lumen is a central lumen of the catheter (2106 passes through main tubular body 2100 and therefore is central to the catheter) with the first exit positioned at or near the distal tip of the catheter (First exit at the distal tip as outline above), and wherein the first lumen is a side lumen of the catheter (first lumen 2110 runs along the side of second lumen 2106 and therefore is interpreted as a side lumen of the catheter) with the second exit positioned on the side of the catheter at the distance proximal to the distal tip of the catheter (The second exit is proximal to the first exit. Examiner notes that as written the claim does not specify or further define the first and second exits corresponding to the first and second lumen).
Regarding claim 6, Fung et al. discloses portion of the catheter distal to the second exit includes at least one of a pre-shaped portion, a flexible portion, a steerable portion, or a portion with bending properties ([0058-0059] disclose the curved portion can be preshaped to have a curvature via tube or mandrel, or be steerable via pull wires).
Regarding claim 7, Fung et al. discloses the portion of the catheter distal to the second exit includes at least one of a metal wire braid, a metal wire coil, a cut hypotube, a non-metal braid, a pullwire, a pre-shaped polymer, or a pre-shaped shape- memory component ([0058-0059] disclose the portion 2104 to have at least a pullwire or a pre-shaped memory component).
Regarding claim 8, Fung et al. discloses a portion of the catheter between the first exit and the second exit is configured to position the first exit and the second exit such that the guidewire and the snare exiting the first and second lumens engage each other (Because the portion is precurved to form a C shape as shown in FIG 21, it is configured to place the first exit and the second exit in proximity to one another, such that the snare and guidewire can engage each other).
Regarding claim 9, Fung et al. discloses the snare is pre-loaded within the second lumen of the catheter ([0061] discloses the snare can be loaded in the second lumen 2106), and wherein a handle of the catheter ([0061] discloses the free end of the snare may pass to the handle portion through a second lumen) includes a snare wire pusher mechanism for exposing, positioning, and retracting the snare (Control of the snare via the handle is disclosed in exemplary handle members FIGS 4-9 wherein 410, 502, 602, 702, 802, 902 are all disclosed as snare controls, [0115-0124]).
Regarding claim 13, Fung et al. discloses s a distal portion of the guidewire is pre-shaped to facilitate engaging a distal end of the guidewire with the snare (The distal end of the guidewire being elongate is interpreted as being preshaped to facilitate engaging a distal end of the guidewire with the snare because the guidewire must be of a small enough diameter and have an elongated length in order to receive the snare loop around it).
Regarding claim 14, Fung et al. discloses the snare includes at least one of a snare sleeve or a snare wire (FIG 1 shows a snare wire 102, [0041]), and wherein a distal portion of at least one of the snare wire or the snare sleeve is pre-shaped to facilitate engaging a distal end of the guidewire with the snare (The distal end of 102 is preshaped to have a loop 1044, which facilitates engagement with a guidewire because it can loop around said guidewire).
Regarding claims 15-17, Fung et al. discloses an inner catheter (108, FIG 1, [0041]) configured to pass through a central lumen of the catheter (Upon insertion of the snare assembly though a lumen as disclosed in [0057, 0061]), wherein: the guidewire or the snare is configured to pass through a lumen of the inner catheter (FIG 1, snare 102 passes through 108), a distal end of the inner catheter extends past the distal tip of the catheter (In order to extend the snare out of the lumen through which it is delivered, for example FIGs 23B, 23C, 25D), and the distal end of the inner catheter is configured to aid in positioning a distal end of the guidewire or the snare (Because the snare extends through the inner catheter, it therefore aids in the positioning of the snare), wherein the distal end of the inner catheter is pre-shaped (distal end 110 is ‘preshaped’ to have the shape shown in FIG 1) and wherein the distal end of the inner catheter is steerable (the inner catheter can be steered because it is insertable through a lumen of the curved portion 2104, which is steerable).
Regarding claim 22, Fung et al. discloses the first portion is at least one of a pre-shaped portion or a steerable portion (2103 is steerable, [0059]).
Claim Rejections - 35 USC § 103
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 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(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fung et al. (US 2016/0120549).
Regarding claim 4-5, Fung et al. discloses the invention substantially as claimed, as set forth above for claim 1.
Fung et al. is silent regarding the distance between the second exit and the distal tip of the catheter, specifically regarding this distance being between 5 and 15cm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to position the second exit between about 5 and 15cm proximally from the distal tip since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Fung et al. would not operate differently with the claimed lengths and since the distal tip should have sufficient length to form a curved section, device would function appropriately having the claimed dimensions. Further, applicant places no criticality on the range claimed, indicating simply that the distance “may” be within the claimed ranges (specification pp. [0008]).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fung et al. (US 2016/0120549) in view of Brauon et al. (US 2020/0015971).
Regarding claims 18-19, Fung et al. discloses the invention substantially as claimed, as set forth above for claim 9. Fung et al. further discloses the snare wire pusher mechanism for exposing, positioning, and retracting the snare is configured such that the snare wire travels through a channel (FIG 1, snare 102 travels through a channel of 108 as shown).
Fung et al. is silent regarding a diameter of the snare and therefore is silent regarding a diameter of the channel receiving the snare being less than 6 mm.
However, Brauon et al. teaches a vascular tool (300, FIG 5B) for deploying a snare (350) to capture a wire (226) wherein a diameter of the snare is 0.15-0.5 mm ([0391]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify a diameter of the snare wire to be 0.15-0.5 mm, as taught by Brauon et al., for the purpose of selecting a commonly known snare size for use in vascular procedures. In the device as modified, the channel receiving the snare is less than 6mm in order to securely house and retain the outer diameter of the snare.
Claim(s) 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fung et al. (US 2016/0120549) in view of Mercereau et al. (US 6,652,537).
Regarding claims 10 and 20, Fung et al. discloses the invention substantially as claimed, as set forth above for claim 9. Fung et al. further discloses a snare sleeve/outer tube (108, FIG 1), a snare wire (102) within the snare sleeve/outer tube (FIG 1), and wherein the snare wire pusher mechanism for exposing, positioning, and retracting the snare includes a second slider (410) configured to control a movement of the snare wire ([0115]).
Fung et al. is silent regarding the snare wire pusher mechanism for exposing, positioning, and retracting the snare including a first slider configured to control a movement of the snare sleeve (claim 10) and wherein the snare wire pusher mechanism for exposing, positioning, and retracting the snare is configured such that the snare wire travels through a channel comprising an inner tube tube, and wherein the outer tube is configured to slide over the inner tube (claim 20).
However, Mercereau teaches a device (10) for operating a snare (16) wherein the snare wire travels through a channel comprising an inner tube (64, FIG 15 and 19) which is slidably received within an outer tube (14, col 5 lines 23-26 disclosing the slidability), and having a snare wire pusher mechanism for exposing, positioning, and retracting the snare (handle 30, specifically thumb slide 34 and thumb wheel 46) including a first slider (46) configured to control a movement of the snare sleeve (col 6 lines 19-20) and a second slider (34) for controlling movement of the snare wire (col 4 lines 43-54, FIG 16-17 show translation of 34 controls the extension and retraction of the snare wire 16).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the snare of Fung et al. such that it is further received within an inner tube slidably received within the outer tube, as taught by Mercereau, because Mercereau teaches that arranging an inner and outer tube around a snare wire is interchangeable with having the snare wire travel only though an outer tube (col 6 lines 51-56). Further, it would have been obvious to one of ordinary skill in the art at the time of filing to utilize a first and second slider in order to control the advancing and retracting of the snare sleeve and snare wire, because such a mechanism is commonly known in the art for providing the user with a manual actuation mechanism to extend and retract the snare wire and also articulate the snare loop.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 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 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771