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 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makower et al. (US 20230248234 A1) (hereon referred to as Makower).
Regarding claim 1, Makower teaches a medical instrument, comprising a body (6056) and a shaft (6054) assembly extending distally relative to the body, the shaft assembly comprising:
an outer sheath (6058);
a dilation catheter (6062) assembly comprising a dilator (6048, see Para. [0165], noting that a variety of therapeutic tools may be inserted therein) positioned along a first longitudinal axis (see labelled diagram of Fig. 6Q below); and
a first guide feature (6064) extending distally relative to the outer sheath (6058) and defining a second longitudinal axis (see labelled diagram of Fig. 6Q below) that is laterally offset relative to the first longitudinal axis (see Fig. 6Q), the dilation catheter (6062) assembly being translatable along the first guide feature (see Para. [0165]).
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Regarding claim 2, Makower teaches the medical instrument of Claim 1, further comprising an actuator (6066) that is movable relative to the body (6056) to drive translation of the dilation catheter assembly along the first guide feature (6060, see Para. [0165]).
Regarding claim 3, Makower teaches the medical instrument of Claim 1, wherein the dilation catheter assembly (6062) comprises a distal shaft portion (6046), the dilator being positioned on the distal shaft portion (see Fig. 6N), and a proximal shaft portion (6068, see Fig. 6Q), at least part of which is positioned within the outer sheath (see Fig. 6Q).
Regarding claim 4, Makower teaches the medical instrument of Claim 3, wherein the proximal shaft portion comprises a first outer diameter, and the distal shaft portion (6046) comprises a second outer diameter that is smaller than the second outer diameter (see Fig. 6N).
Regarding claim 5, Makower teaches the medical instrument of Claim 3, wherein the proximal shaft portion (6068) defines a first lumen, and the first guide feature is slidably disposed in the first lumen (see Para. [0165]).
Regarding claim 6, Makower teaches the medical instrument of Claim 3, wherein the proximal shaft portion (6068) defines a third longitudinal axis that is laterally offset relative to the second longitudinal axis (see labelled diagram of Fig. 6Q above).
Regarding claim 7, Makower teaches the medical instrument of Claim 6, wherein the first longitudinal axis is offset relative to the third longitudinal axis (see labelled diagram of Fig. 6Q above).
Regarding claim 8, Makower teaches the medical instrument of Claim 6, wherein the distal shaft portion (6046) defines a fourth longitudinal axis that is laterally offset relative to the third longitudinal axis or coaxial with the third longitudinal axis (see labelled diagram of Fig. 6Q above, noting that distal shaft 6046 is configured to be placed in shaft portion 6062).
Regarding claim 9, Makower teaches the medical instrument of Claim 3, wherein the dilation catheter assembly further comprises a hub (6050), the proximal shaft portion (6068) extends proximally relative to the hub (6050), the distal shaft portion (6046) extends distally relative to the hub, and the hub defines a fifth longitudinal axis that is coaxial with the first longitudinal axis (see labelled diagram of Fig. 6Q above, noting that hub 6050 is configured to be placed in shaft portion 6062).
Regarding claim 10, Makower teaches the medical instrument of Claim 9, wherein the proximal shaft portion (6046) comprises an outer diameter, and the hub (6050) comprises an outer diameter that is larger than the outer diameter of the proximal shaft portion (note that when expanded, hub member 6050 is larger than its respective sheath, see Fig. 6O).
Regarding claim 11, Makower teaches the medical instrument of Claim 9, the distal shaft portion (6046) having an outer diameter, and the hub (6050) comprises an outer diameter that is larger than the outer diameter of the distal shaft portion (see Fig. 6N).
Regarding claim 14, Makower teaches the medical instrument of Claim 9, wherein the second longitudinal axis is laterally offset relative to the fifth longitudinal axis (see labelled diagram of Fig. 6Q above).
Regarding claim 15, Makower teaches the medical instrument of Claim 1, wherein the shaft assembly further comprises a second guide feature (6060) having a distal end and an indicator element at or near the distal end, the indicator element comprising one or more of a position sensor or an illumination source (see Para. [0165]).
Regarding claim 16, Makower teaches the medical instrument of Claim 15, wherein the second guide feature (6060) is disposed in and translatable relative to the dilation catheter assembly (see Para. [0165]).
Regarding claim 17, Makower teaches the medical instrument of Claim 16, wherein the second guide feature (6060) defines a sixth longitudinal axis (aligned with the third) that is laterally offset relative to the first longitudinal axis (see labelled diagram of Fig. 6Q above).
Regarding claim 19, Makower teaches the medical instrument of Claim 1, wherein the dilator comprises a balloon (6050) configured to:
transition between a non-inflated state and an inflated state (see Para. [0163]);
be spaced away from the first guide feature when the balloon is in the non-inflated state (see Para. [0163]);
engage the first guide feature when the balloon is in the inflated state (see Para. [0163]); and
deform around the guide feature when the balloon is in the inflated state (see Para. [0163]).
Regarding claim 20, Makower teaches the medical instrument of Claim 1, wherein the first guide feature (6064) is fixedly secured relative to the outer sheath (6058; see Para. [0165]).
Allowable Subject Matter
Claims 12, 13, and 18 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:
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in dependent claims 12, 13, 18. In particular, none of the cited references teach or suggest the proximal shaft portion (6046) and the distal shaft portion (6068) define a single, continuous tubular structure that passes through the hub, the first guide feature is slidably disposed in the hub, and wherein the first guide feature comprises a guide rail, at least a distal portion of which comprises a malleable region, as required by claims 12, 13, and 18.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form PTO-892.
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 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773