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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Continued Examination Under 37 C.F.R. § 1.114
A request for continued examination under 37 CFR 1.114 (“RCE”), including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 December 2025 (“Reply”) has been entered.
Response to Amendment
This Action is responsive to the Reply. As directed in the Reply:
Claims 1 and 2 have been amended;
no claims have been and/or remain cancelled; and
no claims have been added.
Thus, Claims 1-15 are presently pending in this application, with Claims 12-15 having been previously withdrawn from consideration.
Applicant’s amendment to the Abstract (its slight non-conformance to the applicable rule notwithstanding) is sufficient to overcome the objections from the previous Action and are therefore withdrawn.
Response to Arguments
Applicant’s arguments with respect to Claims 1-11 have been considered but are not persuasive.
Concerning Tegg, Applicant states (Reply, pg. 10, second full paragraph), “the PTO is failing [sic] to acknowledge that Tegg consistently describes and illustrates pull wires extending in straight lines without wrapping around the sheath in its deflectable portion” (underling in original). Because the claims do not recite a “deflectable portion,” much less the limitation referenced in Applicant’s comment above, the simple reason why the Action does not address this allegation concerning Tegg’s disclosure is that it is not relevant to the claimed subject matter: the word “deflectable” or anything similar is nowhere to be found in the claims.
Repeated from the prior Action concerning the two embodiments described in Olson ‘688 at [0045], the latter of the two is one in which the pull wire 108 is “integral in the catheter shaft wall design” and is thus understood by a person of ordinary skill in the art of pull wire steerable catheters, as evinced at least by the prior art documents of record, to mean the pull wire is embedded in the catheter wall - this is the subject matter to which Applicant's remarks actually refer. The former of these two embodiments, though, is specifically differentiated from the latter as being "between two or more tubes of the catheter shaft" and, read in light of the latter embodiment, indicates to a person of ordinary skill in the art that the pull wire is not integral with, i.e., not embedded in, the catheter wall and is between two tubes - that is, in a space between the two tubes, which is a lumen of the catheter tube. Thus, at least by a preponderance of the evidence, pull wire 108 of Olson '688 is within a guide lumen.
Claim Interpretation
In light of Applicant’s comments on the record concerning the claims and the prior art, it is appropriate to discuss the interpretation of several terms and phrases in Claim 1.
“A catheter tube for a steerable catheter:” the claim’s preamble indicates that the scope of the claim is to a portion of a catheter, not an entire catheter.
“a pull element extends from a proximal portion of the catheter tube to a distal portion of the catheter tube:” the pull element extends some (longitudinal) length along the catheter tube, but is not required to extend from the proximal-most and distal-most ends of the catheter tube; instead, the pull element is only required to extend between two portions of the catheter tube, designated the “proximal portion” and the “distal portion.”
“the pull element is guided axially along the catheter tube within the tube wall via the guide lumen:” at some location along the catheter tube, a guide lumen guides the pull element axially, but does not limit at what point or along how much of the catheter tube along which this ‘guiding’ is performed. Furthermore, Claim 4, which depends from Claim 1, requires that “the guide lumen is delimited by a guide lumen tube” and thus raises the presumption (35 U.S.C. § 112(d)) that Claim 1 is not limited to the additional structural requirement of Claim 4, i.e., Claim 1 does not require an additional tube to form the guide lumen.
“the guide lumen includes a section of a helical path within the tube wall in the distal portion of the catheter tube:” however the “distal portion of the catheter tube” is designated, the guide lumen has a part that “includes a section of a helical path.” The broadest reasonable interpretation of this clause, in view of Applicant’s Specification, is that the guide lumen itself is at least partially helical, so that it follows a helical path.
“so as to guide the pull element helically around the tube lumen in the distal portion of the catheter tube:” this clause, coupled with that immediately above, requires that the pull element be within at least a portion of this helical part of the guide lumen, in the distal portion of the catheter tube, but does not require any path length, e.g., how many turns of the helix in radians or degrees.
Claim Rejections - 35 USC § 102
Claims 1-4 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent App. Pub. No. 2018/296801, by Tegg et al. (“Tegg”).
Tegg discloses a device as claimed by Applicant, as follows.
Claim 1: A catheter tube for a steerable catheter (100), comprising a tube wall (110) surrounding a tube lumen (208), the tube wall comprising the following:
- a mesh (204); and
- a guide lumen around which the mesh is braided (214) and in which a pull element (210) extends from a proximal portion of the catheter tube to a distal portion of the catheter tube ([0043]: “Pull wires 210 extend from a proximal end 310 of steerable sheath 106 to distal end 108”, Figs. 1 and 3),
wherein the pull element is guided axially along the catheter tube (at section 116 in Fig. 4) within the tube wall via the guide lumen (as shown in Fig. 2),
the pull element being connected in a tension-resistant manner to the tube wall in the distal portion ([0037]: "Pull wires 210 are connected to at least one steering ring (not shown in FIG. 2) typically located near the distal end 108 (shown in FIG. 1) of steerable introducer assembly 100"),
the guide lumen guiding the pull element at least partially around the tube lumen ([0005]-[0007], [0044]: " helical path around the circumference of the inner liner"; [0032]: " pull wires 210 rotate around a circumferential direction 220 of steerable sheath 106 as they extend along the non-deflectable portion 114 of steerable sheath 106") and wherein the guide lumen includes a section of a helical path within the tube wall in the distal portion of the catheter tube (at least at the section immediately proximal of section 116 in Fig. 4) so as to guide the pull element helically around the tube lumen in the distal portion of the catheter tube (same).
Claim 2: (The catheter tube according to claim 1,) wherein the section of the helical path within the tube wall (Figs. 3, 4) is also in the proximal portion of the catheter tube (the claim puts no other restrictions on the definition of the “proximal portion” and thus reads on a portion of the helical path on the left end of Fig. 4).
Claim 3: (The catheter tube according to claim 1,) wherein the guide lumen extends across a circumferential angle of at least 30° in the tube wall (id.).
Claim 4: (The catheter tube according to Claim 1,) wherein the guide lumen is delimited by a guide lumen tube (212).
Claim 6: (The catheter tube according to claim 1,) wherein the distal portion can be deformed three-dimensionally by an actuation of the pull element ([0032]: deflected in two opposite directions by coordinated manipulation of the pull wires 210, Fig. 3).
Claim 7: (The catheter tube according to claim 6,) wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that the distal portion is bent with respect to a main extension axis of the proximal portion (id.).
Claim 8: (The catheter tube according to claim 6,) wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that the distal portion describes at least a section of a spiral-shaped or helical path (id.).
Claim 9: (The catheter tube according to claim 6,) wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that local extension axes of the distal portion, as seen in a projection along a main extension axis of the catheter tube, pass over an angle in the range of 0 degrees to 30 degrees (id.; the angles shown include angles on the claimed range, through which the device passes on its way to reaching the illustrated angles, including an angle just slightly more than zero degrees, as claimed).
Claim Rejections - 35 USC § 103
Claims 1-3, 6-9, and 11 are rejected under 35 U.S.C. 103 over U.S. Patent App. Pub. No. 2019/0201688, by Olson (“Olson ‘688”) in view of U.S. Patent App. Pub. No. 2019/0192820, by Olson et al. (previously of record; “Olson ‘820”).
Of the fifteen (15) documents cited by the Examiner on the record, eleven (11) describe the use of an additional guide tube, in a catheter’s wall, through which a pull wire extends, for the purpose of better assuring that the pull wire does not snag on the catheter wall during retraction, e.g., by being made of a different material; however, these eleven are representative of a much larger set of patent disclosures in the art of pull wire steerable catheters which also teach this feature. Olson ‘820 is one of these eleven:
U.S. Patent No. 5,507,725, Fig. 3, tube 24
U.S. Patent App. Pub. No. 20220168041, Fig. 3Aii, tube 1254
U.S. Patent App. Pub. No. 20210121663, Fig. 2, 212
U.S. Patent App. Pub. No. 20200061340, Fig. 3Aii, tube 1254
U.S. Patent App. Pub. No. 20190192820, Fig. 2, 212
U.S. Patent App. Pub. No. 20180296801, Fig. 2, 212
U.S. Patent App. Pub. No. 20160001038, Fig. 19, tubes 1902, 1903, 1904, 1905, and 1906
U.S. Patent App. Pub. No. 20140323964, Fig. 2, tube 118b
U.S. Patent App. Pub. No. 20120232563, Fig. 3B, tube 312
U.S. Patent App. Pub. No. 20070270679, Fig. 7A, tube 31
U.S. Patent App. Pub. No. 20040122360, Fig. Fig. 8, tube 48
Olson ‘688 discloses a device substantially as claimed by Applicant, as follows.
Claim 1: A catheter tube for a steerable catheter (see [0033], [0038] - [0042], [0045]; Figs. 2-3D), comprising a tube wall (110) surrounding a tube lumen (106), the tube wall comprising the following:
- a mesh ([0042], braid); and
- a guide lumen around which the mesh is braided ([0045]; see discussion above concerning the placement of the wire between two tubes) and in which a pull element ("loop member pull wire 108") extends from a proximal portion of the catheter tube to a distal portion of the catheter tube (Fig. 2),
wherein the pull element is guided axially along the catheter tube within the tube wall via the guide lumen (Fig. 2: wire 108 is shown extending axially in section 104; the space between the “two tubes” is a lumen in which wire 108 extends, and that lumen includes a helical path, and does not require an additional tube for this function, see above),
the pull element being connected in a tension-resistant manner to the tube wall in the distal portion ("attachment point 112"),
the guide lumen guiding the pull element at least partially around the tube lumen ([0040]: "spiral configuration", Fig. 2) and
wherein the guide lumen includes a section of a helical path within the tube wall in the distal portion of the catheter tube (see discussion above; the space between the “two tubes” is a lumen in which wire 108 extends, and that lumen includes a helical path).
While Olson’ 688 describes its pull wire extending in a helical path in a space between two tubes, which are part of its catheter tube, it does not expressly indicate that it does so as to guide the pull element helically around the tube lumen in the distal portion of the catheter tube (emphasis added).
Olson ‘820 relates to catheters that are steerable through the use of pull wires and is therefore from an art which is the same as, or very closely analogous to, those of Applicant's claims. Olson '820 teaches that, when constructing such pull wire catheters, the lumen in which the pull wire(s) pass may be formed of a separate PTFE tube, to reduce sliding friction between the wire and the tube, thus making the device easier to use ([0026]).
It 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, to construct Olson’ 688’s catheter such that its guide lumen guides the pull element and comprises a lubricous coating, because Olson '820 teaches doing so in a closely-related pull wire catheter, to reduce sliding friction between the wire and the tube, thus making the device easier to use.
Claim 2: (The catheter tube according to claim 1,) wherein the section of the helical path within the tube wall (Olson’ 688 Fig. 2) is also in the proximal portion of the catheter tube (proximal portion of the tube can be the left portion of section 102 in Fig. 2 of Olson’ 688).
Claim 3: (The catheter tube according to claim 1,) wherein the guide lumen extends across a circumferential angle of at least 30° in the tube wall (id.).
Claim 6: (The catheter tube according to claim 1,) wherein the distal portion can be deformed three-dimensionally by an actuation of the pull element (Olson’ 688 Figs. 3C, 3D).
Claim 7: (The catheter tube according to claim 6,) wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that the distal portion is bent with respect to a main extension axis of the proximal portion (id.).
Claim 8: (The catheter tube according to claim 6,) wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that the distal portion describes at least a section of a spiral-shaped or helical path (id.).
Claim 9: (The catheter tube according to claim 6,) wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that local extension axes of the distal portion, as seen in a projection along a main extension axis of the catheter tube, pass over an angle in the range of 0 degrees to 30 degrees (id.; the angles shown include angles on the claimed range, through which the device passes on its way to reaching the illustrated angles, including an angle just slightly more than zero degrees, as claimed).
Claim 11: (The catheter tube according to claim1, wherein the catheter tube comprises a plurality of tube segments having differing rigidities (Olson’ 688 [0042]: “. . . the catheter shaft may include one or more layers of a polyether block amide material that transition from harder to softer along that catheter shaft from the proximal end portion to the distal end portion.”).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tegg as applied against Claim 4, above, and further in view of Olson ‘820.
Tegg discloses a device substantially as claimed by Applicant; see above. It does not, however, indicate that the guide lumen tube comprises Teflon (see treatment above; lubricious coating).
Olson ‘820 relates to catheters that are steerable through the use of pull wires and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Olson ‘820 teaches that, when constructing such pull wire catheters, the tube in which the pull wire(s) pass may be lined with PTFE (a lubricious coating), to reduce sliding friction between the wire and the tube, thus making the device easier to use ([0026]).
It 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, to form Tegg’s catheter such that its guide lumen tube comprises a lubricous coating, because Olson ‘820 teaches doing so to reduce sliding friction between the wire and the tube, thus making the device easier to use.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Olson ‘688 in view of Olson ‘820, and Tegg, as separately applied against Claim 6, above, alone.
Olson ‘688 with Olson ‘820, and Tegg, disclose a device substantially as claimed by Applicant; see above. Each is, however, silent about the radius of curvature achievable by the distal end of their devices, and thus does not expressly disclose that the catheter tube can be deformed, by an actuation of the pull element, in such a way that local extension axes of the distal portion, in a projection along a main extension axis of the catheter tube, describe at least approximately a section of a circular arc having a radius in the range of 2 mm to 100 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the devices of Olson ‘688-Olson‘820, and Tegg, to have a distal end radius of curvature, upon actuation of their pulling elements, in the range of 2 mm to 100 mm, since it has been held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984). In the instant case, the devices of Olson ‘688 and Tegg would not operate differently with the claimed radius of curvature, as they would still curve as they otherwise disclose and be useful for their stated purposes. Furthermore, Applicant assigns no criticality to the claimed distal end radius of curvature, indicating simply that, “[a] resulting radius is, for example, between 2 mm and 100 mm ” (Specification, pg. 10, lines 21-22) and “f]urthermore, as is likewise illustrated in FIG. 5, the formed distal portion 1-2, in the projection along the main extension axis Z, can at least approximately describe a section of a circular arc, wherein an associated radius R is preferably in the range of 2 mm to 100 mm” (Specification, pg. 15, lines 1-3).
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783