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 .
Status of Claims
This office action is responsive to the application filed 20 January 2023.
Claims 1-20 are presently pending in this application.
Election/Restrictions
Applicant’s election without traverse of species I in the reply filed on 23 December 2025 is acknowledged. Claims 17-20 were withdrawn. Claims 1-16 are considered below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because of the following reference character:
“1460” has been used to designate both “deflectable distal portion” and deflectable distal end portion” (para. 0160).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-16 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 1 recites the limitation "the catheter" in line 20 of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the catheter” is interpreted to mean –the hybrid dilator--.
Claim 1 recites the limitation “a distal portion” and “a deflectable distal end portion” in lines 8 and 16 of the claim respectively. It is unclear if the “deflectable distal end portion” is meant to be the same as the “distal portion. Therefore, for the purposes of examination, examiner will interpret “a deflectable distal end portion” to mean –wherein the distal portion is deflectable--. All instances of “the deflectable distal end portion” in claim 1 and claims dependent from claim 1 are also interpreted to mean –the distal portion--.
Claims 2-16 are rejected as they depend from independent claim 1.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4, 6-8, 11, and 13-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Miller (US Patent Publication No. 20120123327 A1), hereinafter Miller.
Regarding claim 1, Miller teaches a hybrid dilator (Miller: Fig. 1, steerable system 10) for use with a crossing device in tissue puncturing procedures (needle puncture and guidewire placement; para. 0082), the hybrid dilator (10) comprising: a dilator body (Fig. 1, introducer sheath 12) comprising a dilator shaft (Fig. 1, comprising segment 18 and deflectable portion 16) defining a lumen (Fig. 3, inner surface of tube 24) for receiving a crossing device (para. 0082) therethrough, the dilator shaft (12) being structured to provide support for the crossing device (provides structure; para. 0062 and 0082) when the crossing device is used to create a puncture in a tissue (para. 0082), the dilator shaft (12) comprising a proximal portion (Fig. 1, segment 18) and a distal portion (Fig. 1, deflectable portion 16); the proximal portion (18) comprising at least one stiffening member (Fig. 3, comprising cover 34 and spine 36), wherein the at least one stiffening members (34 and 36) is reshapeable (cover 34 and spine 36 are repeatably deflectable; para. 0033 and 0039); the distal portion (16) comprising a distal tip (Fig. 4L, distal portion 16 has a tapered distal tip) having an outer diameter (Fig. 4L, outer diameter of potion 16 before the tapered distal tip is shown) which tapers down to an outer diameter of the crossing device (para. 0082) for providing a smooth transition between the crossing device (para. 0082) and the distal tip (16 tapered distal tip) when the crossing device (para. 0082) is inserted through the lumen (para. 0082) and protrudes beyond the distal tip (para. 0082); wherein the distal portion (16) is deflectable (Fig. 2, deflectable portion 16 is shown to be deflectable); and at least one pull wire (Fig. 3A, pull wire 20); and a steering handle (Fig. 1, handle 14 comprises a lever 22 which can steer system 10; para. 0029) connected to a proximal end portion (Fig. 1, segment 18 is a proximal end portion; para. 0029) of a catheter body (Fig. 1, sheath 12 is the body of a catheter; para. 0027-0028), the steering handle (14) operatively connected to the at least one pull wire (Fig. 7A-B, handle 14 is operatively connected to pull wire 20) for steering the distal portion (16) of the hybrid dilator (10) in at least one direction (Fig. 2; para. 0029).
Regarding claim 3, Miller teaches the hybrid dilator above, where the stiffening members (Fig. 3, spine 36) is at least one stiffening wire (Fig. 3, spine 36 is a wire; para. 0038).
Regarding claim 4, Miller teaches the hybrid dilator above, wherein the hybrid dilator (10) comprises two stiffening members (Fig. 3, comprising cover 34 and 36).
Regarding claim 6, Miller teaches the hybrid dilator above, further comprising a torque layer (Fig. 3, braid 32; provides desirable torque transmission; para. 0033).
Regarding claim 7, Miller teaches the hybrid dilator above, wherein the torque layer (32) is a braided material (Fig. 3, braid 32 is a braid; para. 0033).
Regarding claim 8, Miller teaches the hybrid dilator above, wherein the distal portion (16) comprises at least one pull ring (Fig. 3, pull wire ring 28) attached to the at least one pull wire (Fig. 3, ring 28 is connected to pull wire 20; para. 0033).
Regarding claim 11, Miller teaches the hybrid dilator above, wherein the stiffening member (Fig. 3, spine 36) terminates at a distal end (Fig. 3, spine 36 ends at a distal end of length b, which comprises the segment 18) of the proximal portion (18).
Regarding claim 13, Miller teaches the hybrid dilator above, wherein the dilator shaft (16) comprises an outer layer (Fig. 3, cover 34) and an inner layer (Fig. 3, inner tube 24).
Regarding claim 14, Miller teaches the hybrid dilator above, wherein the outer layer (34) is fixed to the inner layer (cover 34 is fused to the inner tube 24; para. 0055).
Regarding claim 15, Miller teaches the hybrid dilator above, wherein the outer layer (34) is fixed to the inner layer (24) by a reflow process (hot air is used to melt, flow, and bond the cover 34 to the inner tube 24; para. 0055). Examiner notes that this is a product claim that defines the claimed product in terms of the process by which it is made (see Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 1354, 117 USPQ2d 1733, 1739 (Fed. Cir. 2016); In re Luck, 476 F.2d 650, 177 USPQ 523 (CCPA 1973); In re Pilkington, 411 F.2d 1345, 162 USPQ 145 (CCPA 1969); and In re Steppan, 394 F.2d 1013, 156 USPQ 143 (CCPA 1967)).
Regarding claim 16, Miller teaches the hybrid dilator above, wherein the stiffening member (Fig. 3, spine 36) is positioned between the inner layer (24) and outer layer (Fig. 3, spine 36 is shown between the cover 34 and the inner layer 24).
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.
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Smith et al. (US Patent Publication No. 20190015644 A1), hereinafter Smith.
Regarding claim 2, Miller teaches the hybrid dilator above
Miller does not expressly disclose that the stiffening member is a hypotube.
Smith teaches a stiffening member (Smith: Fig. 8, torque layer 704) is a hypotube (layer 704 is a hypotube; para. 0059).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the stiffening member of Miller such that it was a hypotube as taught by Smith in order to provide stiffness to the shaft, allowing for pushability (Smith: para. 0059).
Regarding claim 5, Miller teaches the hybrid dilator above, wherein a second stiffening member (Fig. 3, spine 36) is at least one stiffening wire (Fig. 3; para. 0038).
Mill does not expressly disclose a first stiffening member is a hypotube.
Smith teaches a stiffening member (Smith: Fig. 8, torque layer 704) is a hypotube (layer 704 is a hypotube; para. 0059).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the stiffening member of Miller such that it was a hypotube as taught by Smith in order to provide stiffness to the shaft, allowing for pushability (Smith: para. 0059).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Wilson et al. (US Patent Publication No. 20100022948 A1), hereinafter Wilson.
Regarding claim 9, Miller teaches the hybrid dilator above.
Miller does not expressly disclose two pull wires and the distal portion comprises two pull rings, a first pull ring attached to a first pull wire and a second pull ring distal to the first pull ring attached to a second pull wire.
Wilson teaches two pull wires (Wilson: Fig. 20A-D, wires 220) and a distal portion (Fig. 21-24, distal region 240) comprises two pull rings (Fig. 21-24, steerable devices 210 and 212, which are pull rings; para. 0080), a first pull ring (Fig. 21-24, pull ring 210) attached to a first pull wire (actuation device 218a is connected to first pull ring 210 via one of wires 220; para. 0079) and a second pull ring (Fig. 21-24, pull ring 212) distal to the first pull ring (Fig. 21-24, ring 212 is shown distal of ring 210) attached to a second pull wire (actuation device 218n is connected to second pull ring 212 via one of wires 220; para. 0079).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the hybrid dilator of Miller such that it comprised two pull wires and the distal portion comprises two pull rings, a first pull ring attached to a first pull wire and a second pull ring distal to the first pull ring attached to a second pull wire as taught by Wilson in order to allow for multiple points of steerability for alignment (Wilson: para. 0078).
Regarding claim 10, Miller in view of Wilson disclose the hybrid dilator above, comprising a first handle control (Miller: Fig. 1, lever 22) operatively connected to the first pull wire (Fig. 7A-B, lever 22 is operatively connected to pull wire 20) for steering the distal potion (Fig. 2, portion 16 is steered via lever 22; para. 0029).
Miller does not expressly disclose a second handle control operatively connected to the second pull wire for steering the distal portion.
Wilson teaches a second handle control (Wilson: Fig. 21-24, actuation device 218n) operatively connected to a second pull wire (actuation device 218n is connected to second pull ring 212 via one of wires 220; para. 0079) for steering a distal portion (Fig. 21-24, deflection of distal region 240 is controlled via actuation of 218n).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Miller such that it comprised a second handle control operatively connected to the second pull wire for steering the distal portion as taught by Wilson in order to allow for multiple points of steerability for alignment (Wilson: para. 0078).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Miller.
Regarding claim 12, Miller teaches the hybrid dilator above, wherein the dilator shaft (12) has an outer diameter from about 12 French to about 20 French (introducer sheath 12 has a wall thickness of less than 0.60 mm. The inner diameter of the inner tube is 0.25-10 mm. Therefore, the outer diameter of the sheath 12 is 0.25-10 mm, or 1-30 French).
Miller does not expressly disclose a specific outer diameter from about 12 to about 20 French.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the dilator shaft of Miller such that it had an outer diameter from about 12 to about 20 French in order to have an inner diameter of the same outer diameter of a mandrel (para. 0049). Furthermore, it would have been an obvious matter of design choice to modify the dilator shaft of Miller to be about 12 to about 20 French in diameter, since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the dilator shaft is range 12-20 French in diameter, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Conclusion
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783