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 § 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 1-11, 14-17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suehara (US 20140277072 A1).
Regarding claim 1, Suehara teaches a medical instrument (see Fig. 1), comprising a body (15) and a shaft assembly (11-14, 20) extending distally relative to the body, the shaft assembly (11-14, 20) comprising:
an outer sheath (11);
a dilation catheter assembly (13, 12) comprising a dilator (12) positioned along a first longitudinal axis (see labelled diagram of Fig. 2A below); and
a first guide feature (20) extending distally relative to the outer sheath (11) and configured to extend distally beyond the dilator (12) such that in an expanded state (see Fig. 2B), the dilator (12) expands asymmetrically about the first guide feature (see labelled diagram of Fig. 2A below), the first guide feature (20) defining a second longitudinal axis that is laterally offset relative to the first longitudinal axis (see labelled diagram of Fig. 2A below), the dilation catheter assembly being translatable along the first guide feature (see Para. [0034]).
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Regarding claim 2, Suehara teaches the medical instrument of Claim 1, further comprising an actuator (16) that is movable relative to the body (15) to drive translation of the dilation catheter (12) assembly along the first guide feature (20, see Para. [0034]).
Regarding claim 3, Suehara teaches the medical instrument of Claim 1, wherein the dilation catheter assembly (13, 12) comprises a distal shaft portion (distal end of 13, see labelled diagram of Fig. 2A below), the dilator (12) being positioned on the distal shaft portion (see Fig. 5A), and a proximal shaft portion (proximal end of 12, see labelled diagram of Fig. 2A below), at least part of which is positioned within the outer sheath (11, see Fig. 5A).
Regarding claim 4, Suehara teaches the medical instrument of Claim 3, wherein the proximal shaft portion (see labelled diagram of Fig. 5A above) comprises a first outer diameter (see labelled diagram of Fig. 2A below), and the distal shaft portion comprises a second outer diameter that is smaller than the second outer diameter (see labelled diagram of Fig. 2A below).
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Regarding claim 5, Suehara teaches the medical instrument of Claim 3, wherein the proximal shaft portion defines a first lumen (lumen where 12 and 11 meet, see Para. [0028]), and the first guide feature (20) is slidably disposed in the first lumen (see Para. [0028]).
Regarding claim 6, Suehara teaches the medical instrument of Claim 3, wherein the proximal shaft portion defines a third longitudinal axis (see labelled diagram of Fig. 2A below) that is laterally offset relative to the second longitudinal axis (see labelled diagram of Fig. 2A above).
Regarding claim 7, Suehara teaches the medical instrument of Claim 6, wherein the first longitudinal axis (see labelled diagram of Fig. 2A above) is coaxial with the third longitudinal axis (see labelled diagram of Fig. 2A below).
Regarding claim 8, Suehara teaches the medical instrument of Claim 6, wherein the distal shaft portion (distal end of 13) defines a fourth longitudinal axis that is offset from the third longitudinal axis (see labelled diagram of Fig. 2A below).
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Regarding claim 9, Suehara teaches the medical instrument of Claim 3, wherein the dilation catheter assembly further comprises a hub (where the distal end of the dilator connects the dilation catheter and the guide feature, see labelled diagram of Fig. 4B below), the proximal shaft portion extends proximally relative to the hub, the distal shaft portion extends distally relative to the hub (see labelled diagram of Fig. 4B below), and the hub defines a fifth longitudinal axis that is coaxial with the first longitudinal axis (note that the hub is centered on the first longitudinal axis, thereby making the two coaxial; see labelled diagram of Fig. 2A above).
Regarding claim 10, Suehara teaches the medical instrument of Claim 9, wherein the proximal shaft portion comprises an outer diameter, and the hub comprises an outer diameter that is larger than the outer diameter of the proximal shaft portion (note the additional space created on either side of the hub as compared to the proximal shaft portion, see labelled diagram of Fig. 4B below).
Regarding claim 11, Suehara teaches the medical instrument of Claim 9, the distal shaft portion having an outer diameter, and the hub comprises an outer diameter that is larger than the outer diameter of the distal shaft portion (note that the hub is configured to surround the distal shaft portion entirely, see labelled diagram of Fig. 4B below).
Regarding claim 14, Suehara teaches the medical instrument of Claim 9, wherein the second longitudinal axis is laterally offset relative to the fifth longitudinal axis (note that the fifth longitudinal axis of the hub aligns with the first longitudinal axis, offset from the second; see labelled diagram of Fig 2A above).
Regarding claim 15, Suehara teaches the medical instrument of Claim 1, wherein the shaft assembly further comprises a second guide feature (14) having a distal end and an indicator element (LED) at or near the distal end, the indicator element comprising one or more of a position sensor or an illumination source (see Para. [0025]).
Regarding claim 16, Suehara teaches the medical instrument of Claim 15, wherein the second guide feature (14) is disposed in and translatable relative to the dilation catheter assembly (13, 12; see Para. [0028]).
Regarding claim 17, Suehara teaches the medical instrument of Claim 16, wherein the second guide feature (14) defines a sixth longitudinal axis (adjacent to the fourth longitudinal axis) that is laterally offset relative to the first longitudinal axis (see labelled diagram of Fig. 2A above).
Regarding claim 20, Suehara teaches the medical instrument of Claim 1, wherein the first guide feature (20) is fixedly secured relative to the outer sheath (11; see Para. [0028], noting that the relationship between the two components connects them to each other due to guide feature 20 being held inside outer sheath 11).
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 21 is rejected under 35 U.S.C. 103 as being unpatentable over Suehara in view of Makower et al. (US 20230248234 A1) (hereon referred to as Makower).
Suehara teaches a medical instrument (see Fig. 1), comprising a body (15) and a shaft assembly (11-14, 20) extending distally relative to the body, the shaft assembly (11-14, 20) comprising:
an outer sheath (11);
a dilation catheter assembly (13, 12) comprising a dilator (12) positioned along a first longitudinal axis (see labelled diagram of Fig. 2A above); and
a first guide feature (20) comprising a guide rail (510, see Para. [0150]), the first guide feature (20) extending distally relative to the outer sheath and defining a second longitudinal axis (see labelled diagram of Fig. 2A above) that is laterally offset relative to the first longitudinal axis (see labelled diagram of Fig. 2A above),
however, fails to teach wherein the guide rail has a malleable region bendable to an ad hoc bending angle, wherein the dilation catheter assembly is translatable along the malleable region as the ad hoc bending angle is maintained.
Makower teaches a medical instrument (see Figs. 9-10C) comprising a guide catheter (902), wherein the guide catheter is made of a malleable material such that it is capable of being bent to a desired angle wherein said angle is maintained (see Para. [0171]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical instrument of Suehara to further comprise a bendable guide catheter as taught by Makower, as this would enable the user to configure the device as required for a given procedure (see Para. [0171]).
Allowable Subject Matter
Claims 12-13 and 18-19 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.
Claim 22 is allowed.
Response to Arguments
Applicants’ arguments with respect to claims 1-11, 14-17, and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
With regards to new claim 21, this claim stands rejected as outlined above. Because applicant did not incorporate every limitation of the allowable subject matter indicated in the non-final rejection dated 03/04/2026, these claims are not allowable. With regards to claim 21, applicant has omitted at least the limitation “the guide rail is configured to maintain the ad hoc bending angle as the dilation catheter assembly translates along the malleable region” of claim 18.
With regards to claim 22, this claim is allowed as it incorporates all of the subject matter of original claim 13.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 HOLLY J LANE whose telephone number is (703)756-4702. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/H.J.L./Examiner, Art Unit 3773 /JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
