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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 13 April 2026 has been entered.
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 14-15, and 18-20 are rejected under 35 U.S.C. 103 over U.S. Patent App. Pub. No. 2016/0158497, by Tran et al. (“Tran”).
Tran describes a steerable catheter substantially as claimed by Applicant, as follows.
Claim 14: A steerable catheter assembly comprising:
an outer sheath (52) having a distal end (Fig. 2A, left end) and a proximal end (Fig. 2A, right end) and a lumen extending therebetween (inner catheter 10 extends through outer catheter 52), the outer sheath having an articulation region adjacent the distal end that is configured to be articulated into a first curve lying in a first plane (Fig. 2A, portion of 52 with curved arrow); and
an inner shaft (10) slidable within the lumen of the outer sheath ([0041], “freely rotatable”), the inner shaft having a lumen (32) defined by an inner shaft wall (14), the inner shaft having a proximal portion (Fig. 2A, right end), a distal portion (Fig. 2A, left end), and a length extending therebetween (the portion in between), the inner shaft having a pullwire extending along the length of the inner shaft (Fig. 6, 104, 106; Fig. 9, 208, 210) and coupled to the inner shaft wall (at the distal end), wherein the pullwire is configured to articulate the distal portion of the inner shaft into a second curve lying in a second plane when the distal portion is moved distally out of the outer sheath, wherein the second plane is at an angle of 45 degrees to 135 degrees to the first plane ([0041]: because both of Tran’s inner and outer shafts are capable of articulating in a plane at any angle relative to the common longitudinal axis of the assembly, they are fully “articulatable” into the claimed configuration). Finally, the purpose of the pullwire is to change the bend, i.e. bend it into a tighter curve. It is presumed, in the absence of evidence to the contrary, that at least some degree of curve tightening is achieved without kinking.
Tran does not, however, disclose that the transition zone has a length of 0.5 to 2 inches and is positioned 2 to 5 inches from a distal tip of the catheter shaft.
See above concerning Tran and the newly added dimensional features with respect to Claim 1.
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 device of Tran to have a transition zone with a length of 0.5 inch to 2.0 inches and positioned 2.0 inches to 5.0 inches from a distal end of the inner shaft, 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); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, the device of Tran would not operate differently with the claimed length and distance from the distal end of the shaft, because the length and distal position of the transition zone only affects the location and size of that articulating zone, but not the fact that it will still articulate, and thus the devices would function appropriately having the claimed dimensional limitations as those claimed. Further, Applicant assigns no criticality on the claimed dimensional limitations claimed, indicating simply that the claimed dimensional limitations “may” be within the claimed ranges (Specification @ pg. 12, lines 12-18); see also the discussion above concerning the unclaimed flexibility of the catheter at the accused location.
Claim 15: (The steerable catheter assembly of claim 14,) wherein the pullwire has a proximal section extending along the proximal portion of the inner shaft in a first circumferential position (Fig. 6, at 108; Fig. 10, at 212), a distal section extending along the distal portion of the inner shaft in a second circumferential position (Fig. 6, at 112, 114; Fig. 10, distal of 214, 216), and a transition zone connecting the proximal section and the distal section (portion between), wherein the second circumferential position is offset circumferentially from the first circumferential position (Fig. 7).
Claim 18: (The steerable catheter assembly of claim 15,) wherein the second circumferential position is offset 20 degrees to 190 degrees from the first circumferential position ([0049], 120 degrees is 33.33%).
Claim 19: (The steerable catheter assembly of claim 15,) wherein the outer sheath has a steering member extending longitudinally within a wall of the outer sheath ([0040], describing steering mechanisms and pull wires, including those of the documents incorporated by reference), the steering member configured to articulate the articulation region into the first curve (id.), wherein the steering member and the pullwire are separately actuatable to articulate the outer sheath and the inner shaft independently ([0040]-[0041]).
Claim 20: A steerable catheter assembly comprising:
an outer sheath (52) having a distal end (Fig. 2A, left end) and a proximal end (Fig. 2A, right end) and a lumen extending therebetween (catheter 10 extends through catheter 52), the outer sheath having an articulation region adjacent the distal end (Fig. 2A, portion of 52 with curved arrow), and a steering member configured to articulate the articulation region into a first curve lying in a first plane ([0040]-[0041]); and
an inner shaft slidable (10) within the lumen of the outer sheath (Fig. 2A), the inner shaft having a proximal portion (Fig. 2A, right end), a distal portion (Fig. 2A, left end), and a length extending therebetween (portion between), the inner shaft having a pullwire coupled thereto (Fig. 6, 104, 106; Fig. 9, 208, 210), the pullwire having a proximal section extending along the proximal portion of the inner shaft in a first circumferential position (Fig. 6, at 108), a distal section extending along the distal portion of the inner shaft in a second circumferential position (Fig. 6, at 112, 114), and a short transition zone connecting the proximal section and the distal section (portion between),
wherein the second circumferential position is offset circumferentially from the first circumferential position ([0048] and Fig. 7),
wherein the pullwire is configured to articulate the distal portion of the inner shaft into a second curve lying in a second plane when the distal portion is moved distally out of the outer sheath ([0041]: because both of Tran’s inner and outer shafts are capable of articulating in a plane at any angle relative to the common longitudinal axis of the assembly, they are fully “articulatable” into the claimed configuration),
wherein the first plane and the second plane are different (id.).
Furthermore, the purpose of the pullwire is to change the bend, i.e. bend it into a tighter curve. It is presumed, in the absence of evidence to the contrary, that at least some degree of curve tightening is achieved without kinking.
Tran does not, however, disclose that the transition zone has a length of 0.5 to 2 inches and is positioned 2 to 5 inches from a distal tip of the catheter shaft.
See above concerning Tran and the newly added dimensional features with respect to Claim 1.
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 device of Tran to have a short transition zone with a length of 0.5 inch to 2.0 inches and positioned 2.0 inches to 5.0 inches from a distal end of the inner shaft, 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); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, the device of Tran would not operate differently with the claimed length and distance from the distal end of the shaft, because the length and distal position of the transition zone only affects the location and size of that articulating zone, but not the fact that it will still articulate, and thus the devices would function appropriately having the claimed dimensional limitations as those claimed. Further, Applicant assigns no criticality on the claimed dimensional limitations claimed, indicating simply that the claimed dimensional limitations “may” be within the claimed ranges (Specification @ pg. 12, lines 12-18); see also the discussion above concerning the unclaimed flexibility of the catheter at the accused location.
Claim 21: A steerable catheter assembly comprising:
A steerable outer sheath (52) having a distal end (Fig. 2A, left end) and a proximal end (Fig. 2A, right end) and a lumen extending therebetween (inner catheter 10 extends through outer catheter 52), the outer sheath having an articulation region adjacent the distal end that is configured to be articulated into a first curve lying in a first plane (Fig. 2A, portion of 52 with curved arrow); and
A steerable inner catheter (10) slidable within the lumen of the outer sheath ([0041], “freely rotatable”), the inner shaft having a lumen (32) defined by an inner shaft wall (14), the inner shaft having a proximal portion (Fig. 2A, right end), a distal portion (Fig. 2A, left end), and a length extending therebetween (the portion in between), the inner shaft having a pullwire extending along the length of the inner shaft (Fig. 6, 104, 106; Fig. 9, 208, 210) and coupled to the inner shaft wall (at the distal end), wherein the pullwire is configured to articulate the distal portion of the inner shaft into a second curve lying in a second plane when the distal portion is moved distally out of the outer sheath, wherein the second plane is at an angle of 45 degrees to 135 degrees to the first plane ([0041]: because both of Tran’s inner and outer shafts are capable of articulating in a plane at any angle relative to the common longitudinal axis of the assembly, they are fully “articulatable” into the claimed configuration). Finally, the purpose of the pullwire is to change the bend, i.e. bend it into a tighter curve. It is presumed, in the absence of evidence to the contrary, that at least some degree of curve tightening is achieved without kinking.
Tran does not, however, disclose that the transition zone has a length of 0.5 to 2 inches and is positioned 2 to 5 inches from a distal tip of the catheter shaft.
See above concerning Tran and the newly added dimensional features with respect to Claim 1.
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 device of Tran to have a transition zone with a length of 0.5 inch to 2.0 inches and positioned 2.0 inches to 5.0 inches from a distal end of the inner shaft, 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); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, the device of Tran would not operate differently with the claimed length and distance from the distal end of the shaft, because the length and distal position of the transition zone only affects the location and size of that articulating zone, but not the fact that it will still articulate, and thus the devices would function appropriately having the claimed dimensional limitations as those claimed. Further, Applicant assigns no criticality on the claimed dimensional limitations claimed, indicating simply that the claimed dimensional limitations “may” be within the claimed ranges (Specification @ pg. 12, lines 12-18); see also the discussion above concerning the unclaimed flexibility of the catheter at the accused location.
Claims 16, 22 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Tran as applied against Claim 15, and further in view of Sutermeister.
Tran describes a device substantially as claimed by Applicant; see above. It does not, however, describe that the inner shaft is at least partially defined by a plurality of braided or woven filaments, wherein the pullwire is braided or woven into the plurality of braided or woven filaments.
Sutermeister relates to reinforced, steerable pull wire catheters and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Sutermeister teaches that the pull wires 114 of such catheters can be constructed with a plurality of braided or woven filaments (109, 109’), in which the pullwire is braided or woven into the plurality of braided or woven filaments ([0030]: “In some embodiments, the reinforcing braid 108 may enhance torque control, column strength, crush and/or circumferential collapse resistance, and/or anti-kink ability of the guide catheter 100 for proper positioning of the guide catheter 100 within the patient's vasculature.”).
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 Tran’s inner shaft so that it is at least partially defined by a plurality of braided or woven filaments, wherein the pullwire is braided or woven into the plurality of braided or woven filaments, because Sutermeister teaches doing so in a very closely related catheter, for the foregoing reasons.
Claims 23-27 are rejected under 35 U.S.C. 103 over U.S. Patent App. Pub. No. 2016/0158497, by Tran et al. (“Tran”) in view of US Pre-Grant Publication 2019/0298460 to Al-Jadda et al. (Al-Jadda).
Claims 23-27:
Tran teaches the limitations of the catheter of claim 22 as discussed above, but is silent to PIC counts. Al-Jadda teaches another medical instrument generally, and particularly teaches that PIC count is variable to adjust stiffness (paragraph 7, (i)-(j)). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to vary the PIC counts and stiffness as taught by Al-Jadda in order to adjust the stiffness of the catheter and adapt the catheter more particularly to a given application. The examiner notes that this constitutes only the routine optimization of stiffness as disclosed by Al-Jadda according to known result-effective variables to achieve a known and predictable result. See MPEP 2144.05.
Claims 30-31:
Al-Jadda teaches that more than one pullwire may be used to adjust shape in a medical instrument (paragraph 7, (i)). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a second pullwire as taught by Al-Jadda in order to increase the articulation possible with the catheter of Tran. Such a pullwire would have a circumferentially offset distal end region similar to the previously provided wire of Tran in order to provide the articulation.
Response to Arguments
Applicant's arguments filed 13 April 2026 have been fully considered but they are not persuasive.
With respect to the argument that Tran does not teach bending into a tighter curve, the examiner notes that this limitation has no relation to the curve described by Tran. That is, to any extent which applicant intends for the curve to be tighter than the prior art in the form of Tran, this is not specified, nor it is clear that such a limitation would be definite or supported.
With respect to the argument regarding the short transition zone of claim 20, the same logic applies.
Finally, the examiner notes that he has inherited this case from the former examiner, and further that he is open to standard interview practice to discuss any issues of substance or possible amendments.
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 Monday-Friday, 8a-4p.
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.
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. Visithttps://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.
/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 27 September 2026
