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Claims 1-17 are withdrawn
Claims 1 and 8-10 are amended.
Claims 1-16 are presently pending in this application.
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) being deflectable (Fig. 2, deflectable portion 16 is shown to be deflectable) and 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); 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 the dilator body (12), 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.
Response to Arguments
Applicant’s arguments, see page 9-10, filed 22 April 2026, with respect to objection to the drawings have been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant’s arguments, see page 10-11, filed 22 April 2026, with respect to the rejections of claims 1-16 under 35 USC 112(b) have been fully considered and are persuasive. The rejections of claims 1-16 under 35 USC 112(b) has been withdrawn.
Applicant’s arguments, see page 11-14, filed 22 April 2026, with respect to 1-16 under 35 USC 102(b) and 35 USC 103 have been fully considered but are not persuasive.
Applicant argues:
“The word "repeatedly" in Miller's context means that the distal tip elastically returns to its original, undeflected configuration each time the pull wire tension is released, the opposite of the claimed reshapeable stiffening member, which plastically deforms and maintains the shape selected by the physician without requiring continued application of force. Miller's spine 36 does not allow the physician to manually reshape the proximal portion of the device to a desired curvature and hold that curvature; it functions only to control the plane of pull-wire-actuated elastic deflection in the distal segment. This is a fundamental functional and structural distinction that cannot be bridged by the Office Action's characterization.”
The broadest reasonable interpretation of the word “reshapeable” is an object that can be shaped into different configurations repeatably. An object being elastically deflectable, as disclosed by Miller, would allow to be shaped differently and, thus, be “reshapeable”. There is no claim language that recites structure that would implicitly require that reshaping not require continued application of force.
Applicant also argues:
“Miller does not disclose or suggest a distal tip configured to cooperate with a tissue-puncturing crossing device that protrudes beyond the distal tip. The Office Action maps Miller's tapered distal tip 55 of dilator 52 to this limitation; however, Miller's dilator 52 is a separate removable component used for initial percutaneous vessel access, having "a tapered distal end 55 and a plurality of fluid discharge openings 56," which is "in the retracted position so that openings 56 are hidden within the sheath to avoid any abrasion with the vessel lumen" during delivery. Miller, paragraphs [0065]-[0066]. This separate dilator component is used for skin penetration and initial vessel access, not for providing a smooth profile transition with a tissue-puncturing crossing device that protrudes from within a dilator lumen. Miller does not teach any element corresponding to a hybrid dilator with an integrated distal tip providing a smooth transition with a crossing device for tissue puncturing as recited in claim 1.”
In response to applicant's argument that the tapered distal tip of Miller is not for providing a smooth profile transition with a crossing device, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. It is clear that Miller’s distal tip 55 is, in fact, tapered (Fig. 4L, distal portion 16 has a tapered distal tip) and the device of Miller is used for guidewire placement (para. 0080-0082).
Applicant also argues:
“The Smith reference therefore arises from the same field of transseptal hybrid dilators - the very device type that Miller's introducer sheath system is not. Since Miller does not teach the base hybrid dilator structure of claim 1, there is no rational basis to combine Miller with Smith's hypotube torque layer to arrive at the claimed invention. Incorporating Smith's hypotube into Miller's fundamentally different introducer sheath would not yield a hybrid dilator for tissue puncturing procedures with the reshapeable proximal stiffening member and tissue-puncturing distal tip of claim 1”
In response to applicant's argument that Smith is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, applicant is arguing that the hypotube of Miller is not analogous to the device of Smith. The test for analogous art is a comparison of the prior art to the present invention, not a comparison of the individual prior art references to each other.
Applicant also argues:
“Wilson's catheter is designed to be advanced over a dilator and into the left ventricle to deliver an implant. It is not a tissue- puncturing hybrid dilator. Because Miller fails to teach the base hybrid dilator structure of claim 1, combining Miller with Wilson's dual pull ring steering arrangement would not yield the claimed hybrid dilator for tissue puncturing procedures. There is no motivation grounded in the prior art to add Wilson's steering configuration to Miller's introducer sheath to arrive at the hybrid dilator structure recited in claim 1. Claims 9 and 10 depend from claim 1 and are patentable for at least the same reasons.”
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the dual pull ring would have allowed for multiple points of steerability for alignment (Wilson: para. 0078). Wilson was merely used to teach the dual pull ring arrangement, and need not teach every aspect of the primary reference.
Applicant also argues that the design choice rationale is improper as “the specification discloses specific French size ranges in the context of the transseptal hybrid dilator's functional requirements, providing clinical significance to this range.”
The specification of the present invention states “may vary based on application and clinical use”, which does not specifically state the criticality of the range specified and why any other range would be improper or render the invention inoperable. The specification fails to disclose any stated reason for the specifically stated range of 12-20 French.
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 LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
Prosecution Insights