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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 1/12/26. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow. Regarding the amendment(s) filed 1/12/26, the Examiner respectfully notes claims 1 and 14 were merely amended to incorporate the previously rejected scopes of now cancelled claims 4 and 17, respectively. The scope(s) of depending claims 2, 3, 5-13, 15, 16, and 18-20 are newly presented.
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.
Claim(s) 1-3, 5-16, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson (WO 2018/136741 A1).
For claim 1, Olson discloses a catheter (Figs 1-3) ([0021-0046]), comprising:
an elongated body (12) sized to traverse vasculature (Figs 1-3) ([0021-0046]), defining a longitudinal axis (Figs 1-3) ([0021-0046]), and comprising:
an outer surface (outer surface of 12) (Figs 1-3) ([0021-0046]); and
a proximal end and a distal end disposed on opposite sides thereof (Figs 1-3) ([0021-0046]);
an orientation lumen (381, 382) formed in the elongated body (Figs 1-3) ([0021-0046]) and defining a curved path extending proximally from the distal end towards the proximal end and about the longitudinal axis (Figs 1-3) ([0021-0046]);
an orientation insert (58, 36) disposed within the orientation lumen (Figs 1-3) ([0021-0046]), the elongated body being rotationally restricted about the longitudinal axis relative to the orientation insert (Figs 1-3) ([0021-0046]) and radially rotatable in accordance with a radial rotation of the orientation insert (Figs 1-3) ([0021-0046]), the orientation insert attached to the distal end of the elongated body configured to deflect the distal end to form a curve (Figs 1-3) ([0021-0046]); and
a flexible circuit (14, 44, and flexible circuit therefor in [0036]) disposed on the outer surface of the elongated body (Figs 1-3) ([0021-0046]), the elongated body being substantially rotationally fixed about the longitudinal axis relative to the orientation insert such that the flexible circuit is disposed toward an outer bend of the curve when the orientation insert deflects the distal end (Figs 1-3) ([0021-0046]).
For claim 2, Olson discloses the catheter of claim 1, the catheter having a delivery stage and a deployed stage (Figs 1-3) ([0021-0046]), and the orientation insert being operable to transition the catheter from the delivery stage to the deployed stage (Figs 1-3) ([0021-0046]).
For claim 3, Olson discloses the catheter of claim 2, wherein in the deployed stage, the distal end of the elongated body is curved forming a generally circular shape (Figs 1-3) ([0021-0046]).
For claim 5, Olson discloses the catheter of claim 1 further comprising a component lumen (20) formed in the elongated body (Figs 1-3) ([0021-0046]) and defining a second path extending proximally from the distal end towards the proximal end (Figs 1-3) ([0021-0046]).
For claim 6, Olson discloses the catheter of claim 1, the orientation lumen comprising: a standard portion (proximal-most portion of 381, 382) substantially rotatable about a first portion of the orientation insert; and an orientation portion (distal orientation portion of 381, 382 near 56) substantially rotationally fixed about a second portion of the orientation insert (Figs 1-3) ([0021-0046]).
For claim 7, Olson discloses the catheter of claim 6, the second portion being disposed at the distal end of the elongated body (Figs 1-3) ([0021-0046]).
For claim 8, Olson discloses the catheter of claim 6, the first portion comprising a substantially cylindrical geometry (Figs 1-3) ([0021-0046]).
For claim 9, Olson discloses the catheter of claim 1, a cross-section of the orientation insert substantially conforming to at least one from among a square, a rectangle, a triangle, an oval, a semi-circle, circular with one or more notches, circular with one or more protrusions, and lobular (Figs 1-3) ([0021-0046]).
For claim 10, Olson discloses the catheter of claim 1, the elongated body comprising a flexible portion on which the flexible circuit is disposed (Figs 1-3) ([0021-0046]), and the orientation insert being operable to deflect the flexible portion (Figs 1-3) ([0021-0046]).
For claim 11, Olson discloses the catheter of claim 10, the elongated body being substantially rotationally fixed about the orientation insert such that the flexible circuit is positioned on an outward bend of a deflection of the flexible portion (Figs 1-3) ([0021-0046]).
For claim 12, Olson discloses the catheter of claim 1, the orientation insert comprising a nitinol wire (0028) configured to deflect the distal end to form a curve (Figs 1-3) ([0021-0046]).
For claim 13, Olson discloses the catheter of claim I, the orientation insert comprising an oriented pull-wire such that the flexible circuit is disposed toward an outer bend of the curve when the oriented pull- wire is tightened (Figs 1-3) ([0021-0046]).
For claim 14, Olson discloses a navigable sheath (Figs 1-3) ([0021-0046]), comprising:
an elongated body (12) sized to traverse vasculature (Figs 1-3) ([0021-0046]), defining a longitudinal axis (Figs 1-3) ([0021-0046]), and comprising:
an outer surface (outer surface of 12) (Figs 1-3) ([0021-0046]), a proximal end and a distal end disposed on opposite sides thereof (Figs 1-3) ([0021-0046]), and a
shaft (shaft length of 12) (Figs 1-3) ([0021-0046]) extending distally from the proximal end to the distal end (Figs 1-3) ([0021-0046]);
an orientation lumen (381, 382) formed in the elongated body along the shaft (Figs 1-3) ([0021-0046]) and defining a curved path extending proximally from the distal end towards the proximal end and about the longitudinal axis (Figs 1-3) ([0021-0046]), the elongated body being substantially rotationally fixable about an orientation insert (58,36) disposed within the orientation lumen (Figs 1-3) ([0021-0046]) and radially rotatable in accordance with a radial rotation of the orientation insert (Figs 1-3) ([0021-0046]), the orientation insert attached (via at least 56) to the distal end of the elongated body configured to deflect the distal end to form a curve (Figs 1-3) ([0021-0046]); and
a flexible circuit (14, 44, and flexible circuit therefor in [0036]) disposed on the outer surface of the elongated body (Figs 1-3) ([0021-0046]), the elongated body being substantially rotationally fixed about the longitudinal axis relative to the orientation insert such that the flexible circuit is disposed toward an outer bend of the curve when the orientation insert deflects the distal end (Figs 1-3) ([0021-0046]).
For claim 15, Olson discloses the navigable sheath of claim 14, the navigable sheath having a delivery stage and a deployed stage (Figs 1-3) ([0021-0046]), and the orientation insert being operable to transition the navigable sheath from the delivery stage to the deployed stage (Figs 1-3) ([0021-0046]).
For claim 16, Olson discloses the navigable sheath of claim 15, in the deployed stage, the distal end of the elongated body being curved forming a generally circular shape (Figs 1-3) ([0021-0046]).
For claim 18, Olson discloses the navigable sheath of claim 14 further comprising a component lumen (20) formed in the elongated body and defining a second path extending proximally from the distal end towards the proximal end (Figs 1-3) ([0021-0046]).
For claim 19, Olson discloses the navigable sheath of claim 14, the orientation lumen comprising: a standard portion (proximal-most portion of 381, 382) substantially rotatable about a first portion of the orientation insert (Figs 1-3) ([0021-0046]); and an orientation portion (distal orientation portion of 381, 382 near 56) substantially rotationally fixed about a second portion of the orientation insert (Figs 1-3) ([0021-0046]).
For claim 20, Olson discloses the navigable sheath of claim 14, a cross-section of the orientation lumen substantially conforming to at least one from among a square, a rectangle, a triangle, an oval, a semi-circle, circular with one or more notches, circular with one or more protrusions, and lobular (Figs 1-3) ([0021-0046]).
Response to Arguments
Applicant's arguments filed 1/12/26 have been fully considered but they are not persuasive. Applicant argues the anticipatory rejection of the claims under Olson, specifically arguing the following:
“The Office Action appears to assert that the pull wires and pull ring of Olson read on the claimed orientation insert. However, Olson is silent to the shaft of sheath being rotationally restricted about the longitudinal axis relative to the pull wires and pull ring and radially rotatable in accordance with a radial rotation of the pull wires and pull ring. While the pull wires disclosed in Olson may be utilized deflect the distal end of the sheath, Olson does not disclose or suggest the sheath being radially rotatable by a radial rotation of the pull wires/pull ring. In fact, Olson discloses that rotation of the actuator causes the pull wires to be pushed or pulled, thereby deflecting the shaft to create a curve. In contrast, in some examples disclosed in the present Application, in addition to manipulating the pull- wire to deflect the distal shaft to form the curve (see the Application, as published, e.g., at paragraph [0085]), when "the control handle 101 is rotated, the tubular body 103, including the proximal shaft 104 and distal shaft 106, rotate in a corresponding manner. See the Application, as published, at paragraph [0079]). For example, FIGS 2A-2C of the present Application, which are reproduced and annotated below, depict the distal shaft of the elongated body being "rotationally restricted about the longitudinal axis relative to the orientation insert and radially rotatable in accordance with a radial rotation of the orientation insert", as recited in claim 1.”
The Examiner respectfully disagrees, maintains the updated rejection set forth hereinabove, and in response notes the following:
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “control handle is rotated”, “tubular body”, “distal shaft“) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that Olson fails to disclose “the elongated body being substantially rotationally fixable about an orientation insert disposed within the orientation lumen and radially rotatable in accordance with a radial rotation of the orientation insert.”, 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. In the instant case, and as further elaborated upon below, Olson discloses the intended use, and/or the structural equivalent, and/or is more than inherently capable of performing the intended function.
The examiner respectfully notes that not only is Olson capable of performing the intended use, Olson’s disclosed and cited device is configured therefor. Olson’s elongate body 12 is particularly configured to traverse tortuous vasculature with particular concern for navigating to the heart, while simultaneously executing heart pacing, monitoring, mapping, and/or visualization via flexible circuit elements of electrodes 14 and electrical traces 44. The inclusion of pull wires 58 and braided wire assembly 36 in Olson’s elongate body 12 and in the orientation lumens explicitly provides for structural integrity, torque transfer, deflection, and steering. For example at least, Olson’s elongate device forms a curve while steering when radially rotating, i.e. curving, about a longitudinal axis in accordance with the rotation/deflection/steering of the cited orientation inserts while the cited orientation inserts also remain fixed rotatably with respect to the longitudinal axis, i.e. not rotating circularly around the longitudinal axis.
Thus, elements 36 and 58 provide what may be reasonably considered to be at least “the elongated body being substantially rotationally fixable about an orientation insert (58,36) disposed within the orientation lumen (Figs 1-3) ([0021-0046]) and radially rotatable in accordance with a radial rotation of the orientation insert (Figs 1-3) ([0021-0046]), the orientation insert attached (via at least 56) to the distal end of the elongated body configured to deflect the distal end to form a curve (Figs 1-3) ([0021-0046])”, and/or are the structural equivalents thereof as broadly as structurally and/or functionally claimed.
In support thereof, the Examiner respectfully notes Olson explicitly states the inter alia the following (emphasis added):
[0027] The outer layer can further comprise a braided wire assembly 36 disposed adjacent to and between both the inner liner 24 and an external surface 46 of the sheath 10. In one embodiment, the arrangement and configuration of the braided wire assembly 36 and the outer layer 26 is such that the polymeric material of the tube or tracing support melts and flows into the braid of the braided wire assembly 36 during a reflow process performed on the shaft 12. In another embodiment, the arrangement and configuration of the braided wire assembly 36 and the outer layer 26 is such that the polymeric material of the tube or tracing support melts and flows into a portion exterior the braid of the braided wire assembly 36 during a reflow process performed on the shaft 12. In this embodiment, the reflowed outer layer does not flow as deep as the braid is situated within the shaft. The braided wire assembly 36, which can extend the entire length of the shaft 12 (i.e., from the proximal end 16 to the distal end 18) or less than the entire length of the shaft 12, maintains the structural integrity of the shaft 12, and also provides an internal member to transfer torque from the proximal end 16 to the distal end 18 of the shaft 12.
[0028] In one embodiment, the braided wire assembly 36 comprises a stainless steel braid wherein each wire of the braid has a rectangular cross-section with the dimensions of 0.002 inches x 0.006 inches (0.051 mm x 0.152 mm). It will be appreciated by those having ordinary skill in the art, however, that the braided wire assembly can be formed of material other than, or in addition to, stainless steel. For example, in another embodiment, the braided wire assembly comprises a nickel titanium (also known as Nitinol) braid. Additionally, the braided wire assembly can have dimensions or wire sizes and cross-sectional shapes other than those specifically provided above, such as, for example, a round or circular cross- sectional shape, and also include varying braid densities throughout. Different braid wire sizes allow different shaft torque and mechanical characteristics. Accordingly, braided wire assemblies comprising materials other than stainless steel, and/or dimensions other than those set forth above, remain within the spirit and scope of the present disclosure.
[0029] As briefly described above, in one embodiment, the outer layer 26 further includes one or more minor lumens 38.sub.1; 38.sub.2 disposed therein and coupled thereto. Each minor lumen is adapted to receive and house a deflectable element, such as a pull wire 58, of the steering mechanism of the sheath 10. In one embodiment, the sheath 10 includes one or more extruded tubes, each one of which defines a corresponding minor lumen. The tubes, which are also known as spaghetti tubes, can be formed of a number of materials known in the art, such as, for example and without limitation, PTFE. In one embodiment, the tubes are formed a material having a melting point higher than that of the material in polymer tube so that the tubes will not melt when the shaft is subjected to a reflow process The tubes can be affixed or bonded to the outer surface 30 of the inner layer 24. The tubes can be affixed in a number of ways, such as, for example, using an adhesive. One suitable adhesive is cyanoacrylate. One the shaft 12 is subjected to a reflow process, the polymeric material of the tube surrounds and encapsulates the spaghetti tubes resulting in the spaghetti tubes, and therefore the minor lumens, being disposed within the outer layer of the shaft.
[0041] In one embodiment, the handle 54 includes an actuator 60 disposed thereon or in close proximity thereto, that is coupled to the pull wires 58 of the steering mechanism. The actuator 60 is configured to be selectively manipulated to cause the distal end 18 to deflect in one or more directions. More particularly, the manipulation of the actuator 60 causes the pull wires 58 to be pushed or pulled (the length of the pull wires is increased or decreased), thereby effecting movement of the pull ring 56, and thus, the shaft 12. The actuator 60 can take a number of forms known in the art. For example, the actuator 60 can comprise a rotatable actuator, as illustrated in FIG. 1, that causes the sheath 10, and the shaft 12 thereof, in particular, to be deflected in one direction when rotated one way, and to deflect in another direction when rotated in the other way. Additionally, the actuator 60 can control the extent to which the shaft 12 is able to deflect. For instance, the actuator 60 can allow the shaft 12 to deflect to create a soft curve of the shaft. Additionally, or in the alternative, the actuator 60 can allow the shaft 12 to deflect to create a more tight curve (e.g., the distal end 18 of the shaft 12 deflects 180 degrees relative to the shaft axis 22. It will be appreciated that while only a rotatable actuator is described in detail here, the actuator 60 can take on any form known the art that effects movement of the distal portion of a sheath or other medical device.
[0042] The actuator 60 is coupled to the pull wires 58 of the steering mechanism. In one embodiment, the pull wires 58 are located within the outer layer 26 of the shaft 12. More particularly, the pull wires 58 are disposed within the minor lumens 38.sub.1; 38.sub.2 in the outer layer, and are configured to extend from the handle 54 to the pull ring 56 (best shown in FIG. 3). In one embodiment, the pull wires 58 have a rectangular cross-section. In other embodiments, however, the pull wires 58 can have a cross-sectional shape other than rectangular, such as, for example and without limitation, a round or circular cross-sectional shape.
[0043] The steering mechanism can comprise a number of different pull wire arrangements. For instance, the steering mechanism can includes four pull wires 58. In that embodiment, the pull wires 58 are disposed 90 degrees apart from each other. In another embodiment, the steering mechanism comprises two pull wires 58. In such an embodiment, the pull wires 58 are spaced 180 degrees apart from each other.
[0044] The pull wires 58 are coupled at a first end to the actuator 60 and at the second end to the pull ring 56. FIG. 3 is a depiction of a portion of the shaft 12 having the outer layer 26 surrounding the pull ring 56 cut away. As illustrated in FIG. 3, the pull ring 56 is anchored to the shaft 12 at or near the distal end 18 thereof. One means by which the pull ring 56 is anchored is described in U. S. Patent Publication No. 2007/0199424 entitled "Steerable Catheter Using Flat Pull Wires and Method of Making Same" filed on December 29, 2006, the entire disclosure of which was incorporated by reference above. Accordingly, as the pull wires 58 are pulled and/or pushed, the pull wires 58 pull and push the pull ring 56, thereby causing the shaft 12 to move (e.g., deflect). Accordingly, the physician manipulates the actuator 60 to cause the distal end 18 of the shaft 12 to move in a certain direction. The actuator 60 pulls and/or pushes the correct pull wires 58, which then causes the pull ring 56, and therefore the shaft 12, to move as directed.
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 Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791