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 .
Specification
The amendment to the specification filed 12/01/2026 has been entered into the record.
Claim Rejections - 35 USC § 112
The previous rejection of claim 1 under 35 USC 112 has been withdrawn in light of the amendment to the claims filed 12/01/2026 amending “a distal end” to “a distal tip.”
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
The previous rejection of claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2006/0089618 to McFerran et al. (“McFerran”), alone, has been withdrawn.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over McFerran in view of WO2016/191062 to W.L. Gore & Associates, Inc. (“Gore”) and in view of WO 2007/035554 to Biosense Webster, Inc. (“Biosense”).
Regarding claim 1, McFerran teaches a catheter (10 and Fig. 7), comprising: a hollow shaft (12 having lumen 20), wherein a distal end portion of the hollow shaft includes a first section (M and N) extending substantially linearly, a second section (O and P) at a distal end side of the first section and including a first curved region, and a third section (Q and R) at a distal end side of the second section and including a second curved region, a virtual plane set along an axis (L) of the first section, a first space on a first side with respect to the virtual plane being a first area, and a second space on a second side being a second area (see annotated Fig. 7 below), the first curved region and a distal end of the catheter are in the first area, the second curved region is in the second area (see annotated Fig. 7 below).
PNG
media_image1.png
380
292
media_image1.png
Greyscale
PNG
media_image2.png
380
322
media_image2.png
Greyscale
McFerran fails to explicitly show that a distance from the distal end of the catheter to the virtual plane is larger than a distance from a vertex of the first curved region to the virtual plane and a maximal curvature of the second curved region is larger than a maximum curvature of the first curved region. It is noted that at para. [0003] McFerran states, “[i]n certain applications, it may be desirable to impart a particular shape to the catheter tip to facilitate tracking of the catheter through tortuous anatomy, or to advance the catheter beyond a lesion or other obstruction within the body. In the treatment of aneurysms, for example, such shaped catheter tips can be used to reach select vascular regions within the body such as the anterior communicating artery or the posterior communicating artery. Once positioned, such tip shapes can also be used to maintain the stability of the catheter at the site of the aneurysm by using the tip shape to stabilize a portion of the catheter body against the vessel wall while maintaining the tip at the site of the aneurysm.” (emphasis added)
Gore teaches a catheter (Figs. 4-6), comprising: a hollow shaft (404), wherein a distal end portion of the hollow shaft includes a first section (see annotated Fig. 4 below) extending substantially linearly, a second section (see annotated Fig. 4 below) at a distal end side of the first section and including a first curved region (452), and a third section (see annotated Fig. 4 below) at a distal end side of the second section and including a second curved region (460), where a maximal curvature of the second curved region (460) is larger than a maximum curvature of the first curved region (452).
PNG
media_image3.png
762
378
media_image3.png
Greyscale
PNG
media_image4.png
754
470
media_image4.png
Greyscale
It is noted that at para. [003] Gore states, “[e]mbodiments relate to a shaped accessory sheath and related systems and methods for accessing a blood vessel or other portion of a patient's circulatory system. The shaped accessory sheath is shaped with or otherwise configured to adopt a default shape in the absence of a shape-altering force or structure such that the default shape may correspond to a desired location for a medical intervention within the patient's circulatory system.” (emphasis added) Additionally, Gore at para. [021] states, “Embodiments provided herein relate to catheter introducer systems that allow access to certain structures within the circulatory system of a patient. For example, some of the present embodiments are configured to allow access to the right atrium of a patient's heart to deliver an occluder or other therapy, such as to repair or treat an atrial septal defect (ASD). Some such embodiments are sized for children, while others are sized for adults, and may be sized for individuals of certain sizes (e.g., having a height of 3 feet to 4 feet, 4 feet to 5 feet, and/or the like). Others of the present embodiments can be configured to allow access to other structures or portions of the circulatory system of a patient.”
Therefore, at the time of filing, it would have been obvious to reduce the curvature of the first curved region of McFerran to less than the curvature of the second curved region and take on the overall distal end curved shape as shown by Gore resulting in both 1) a maximal curvature of the second curved region being larger than a maximum curvature of the first curved region and 2) the distance from the distal end of the catheter to the virtual plane being larger than a distance from a vertex of the first curved region to the virtual plane (due to increase in radius of curvature for first curve). See below modified Fig. 7 of McFerran incorporating reduced curvature of the first curved region to take on a shape as taught by Gore, i.e. first curve having greater radius of curvature versus second curve having smaller radius of curvature resulting in larger curvature of the second curve.
PNG
media_image5.png
380
288
media_image5.png
Greyscale
The combination is proper since both devices are analogous in the art of catheter introducer sheaths used to navigate the human vasculature. Additionally, both devices recognize the advantage of preformed catheter distal end shapes in maneuvering the catheter into position and maintaining the catheter in position since the “shape may correspond to a desired location for a medical intervention.” See Biosense, para. [003]. Catheters having different preformed distal ends for different locations within the vasculature are well known in the art. See US Pat. No. 5,800,413 (“the ‘413 patent”). See specifically the ‘413 patent at col.2, l. 3+ stating,
The distal end of a catheter used in such a procedure is sometimes preformed into a desired curvature so that by torquing the catheter about its longitudinal axis, the catheter can be manipulated to the desired location within the heart or in the arteries or veins associated with the heart. For example, U.S. Pat. No. 4,882,777 discloses a catheter with a complex curvature at its distal end for use in a specific procedure in the right ventricle of a human heart. U.S. Pat. No. 5,231,994 discloses a guide catheter for guiding a balloon catheter for the dilation of coronary arteries. U.S. Pat. No. 4,117,836 discloses a catheter for the selective coronary angiography of the left coronary artery and U.S. Pat. Nos. 5,215,540, 5,016,640 and 4,883,058 disclose catheters for selective coronary angiography of the right coronary artery. U.S. Pat. No. 5,242,441 discloses a deflectable catheter for ablation procedures in the ventricular chamber. See also U.S. Pat. No. 4,033,331. In addition, U.S. Pat. No. 4,898,591 discloses a catheter with inner and outer layers containing braided portions. The '591 patent also discloses a number of different curvatures for intravascular catheters. Thus, there are a number of patents which disclose catheters with predetermined shapes, designed for use during specific medical procedures generally associated with the heart or the vascular system. Because of precise physiology of the heart and the vascular system, catheters or introducers with precisely designed shapes for predetermined uses within the human heart and vascular system are increasingly important. (emphasis added)
The incorporation of the reduced curvature to the first curved region would have yielded predictable results, i.e., change in shape of the distal end for a specific application. Additionally, the modification would have been done in order to provide a shaped end specific to an application, i.e. treatment site in the vasculature, and expand the applications for McFerran’s device as modified by Gore for applications in the heart as evidenced and supported by US Pat. No. 5,800,413 and the prior art therein.
Additionally, McFerran fails to teach that a rigidity of the second section is larger than a rigidity of the third section. However, McFerran does teach a more rigid proximal versus distal end (see paras. [0021-0022] stating, “proximal shaft section 14 may include an outer layer segment 38 of material having a relatively high durometer whereas the distal shaft section 18 may include an outer layer segment 40 of material having a relatively low durometer. In one such embodiment, the outer layer segment 38 of the proximal shaft section 14 may comprise a relatively stiff polymeric material such as PEBAX.RTM. 7233 whereas the outer layer segment 40 of the distal shaft section 18 may comprise relatively flexible polymeric material such as PEBAX.RTM. 2533. The outer layer segments 38,40 may each comprise a single polymer, multiple polymers, or a blend of polymers, as desired…To further transition the stiffness along the length of the shaft 12, the intermediate shaft section 16 can include one or more outer layer segments comprising a material having a durometer that is intermediate to that of the proximal and distal shaft sections 14,18.” and para. [0025] stating, “The wall thickness of the various shaft sections 14,16,18 may be reduced along one or more sections of the shaft 12 to transition the flexibility, torqueability, and other desired characteristics of the catheter 10.”) Therefore, McFerran does contemplate altering the flexibility along the distal end portion 18.
Biosense discloses a catheter with a flexible pre-shaped tip section. The distal end includes a first section (distal portion of 12) extending substantially linearly, a second section (14/15) at a distal end side of the first section and including a first curved region (15), and a third section (17/19) at a distal end side of the second section and including a second curved region (19). See Fig. 1. Additionally, Biosense teaches at page 10, “as another feature of the present invention, the flexible section 19 has a bending modulus greater than that of the preformed section 15, as discussed in detail further below. This greater flexibility enables the tip assembly 17 to flex and adjust to the contour of the tissue surface independently of the curve 15 of the intermediate section 14. As shown in FIG. IA, the distal end of the catheter 10 is therefore better equipped to adjust to and withstand jarring of the tip assembly 17 as it comes into contact with protrusion 37 in the tissue surface when the tip assembly 17 is dragged along it.” Also, Biosense at page 11 teaches that “the intermediate section 14 comprises a short section of tubing 22 … The tubing 22 is made of a suitable non-toxic material that is preferably more flexible than the catheter body 12.” (emphasis added) Furthermore, Biosense teaches at page 18, “the flexible section 19 has a relatively high flexural modulus measuring on a Durometer scale no greater than about 25 D to 35D and/or no greater than about 1/2 to 1/4 of the Durometer measurement of the curve 15.”
Therefore, at the time of filing, it would have been obvious to incorporate the varying of rigidity/flexibility/stiffness of first, second and third portions as taught by Biosense into the combination of McFerran in view of Gore resulting in the first section having the most rigidity (least flexibility); the second section with the first curved region have less rigidity (more flexibility) and the third section with the second curved region having the most flexibility and least rigidity. First, all three references are analogous in the art of catheters designed to maneuver through the vasculature system; therefore, a combination is proper. Additionally, McFerran teaches the idea of varying flexibility along the distal end. See para. [0025], quoted above. The motivation to make the combination would have come from Biosense in its teaching that the “greater flexibility enables the tip assembly 17 to flex and adjust to the contour of the tissue surface independently of the curve 15 of the intermediate section 14. As shown in FIG. IA, the distal end of the catheter 10 is therefore better equipped to adjust to and withstand jarring of the tip assembly 17 as it comes into contact with protrusion 37 in the tissue surface when the tip assembly 17 is dragged along it. By increasing the flexibility of the distal end section of McFerran as taught by Biosense the maneuverability of the device of McFerran in view of Gore is enhanced thereby increasing the safety of the procedure to the patient.
Regarding claim 2, McFerran in view of Gore in view of Biosense discloses wherein a rigidity of the first section of the hollow shaft is larger than the rigidity of the second section. See McFerran paras. [0021-0022]. This is also taught by Biosense, see claim 1 above.
Regarding claims 3-4, McFerran in view of Gore in view of Biosense discloses wherein in a front view of the catheter, a distal end of the first section, a vertex of the first curved region, and a vertex of the second curved region in the hollow shaft are arranged on a straight line. McFerran does not include a figure showing the front view of the catheter; however, the catheter in Fig. 7 if viewed from the front would have the vertices of the first and second curves, along with the distal end of the first section align on a straight line.
Regarding claims 5-6, McFerran in view of Gore in view of Biosense discloses wherein a length of the first section (McFerran para. [0018] states, “the proximal shaft section 14 may be made available in 80 cm [31 in.], 105 cm [41 in.], and 125 cm [49 in.]”) is greater than a length of either of the second and third sections (para. [0047] states, “the length D6 of the second leg can be approximately 0.08 inches whereas the length D5 of the first leg can be approximately 0.36 inches. Other configurations wherein the length D6 of the second leg is greater than or substantially equal to the length D5 of the first leg can also be employed, if desired. In some embodiments, the overall length (i.e. D5+D6) of the S-shaped section 88 can be approximately 0.44 inches.”). Additionally, this disclosure in McFerran teaches that a length of the first section is greater than a combined length of both the second and third sections.
Regarding claim 7, McFerran in view of Gore in view of Biosense renders obvious wherein the distance from the vertex of the first curved region to the virtual plane is smaller than a distance from the vertex of the second curved region to the virtual plane. See claim 1 above and McFerran altered Fig. 7 above.
Regarding claim 8, McFerran discloses wherein the distance from the distal end of the catheter to the virtual plane is larger than a distance from a vertex of the second curved region to the virtual plane. See McFerran altered Fig. 7 above.
Regarding claim 9, McFerran discloses wherein a most curved portion of the second curved region is on the more distal end side in the axial direction than a vertex of the second curved region. See McFerran reference R in Fig. 7 and its end arrow being more distally located than the vertex of the second curve.
Regarding claim 10, McFerran in view of Gore and Biosense discloses wherein the first section is a first hollow shaft, the second section is a second hollow shaft, and the third section is a third hollow shaft. See McFerran transition sections (44 and 46) dividing first hollow shaft (14) from second hollow shaft (16) from third hollow shaft (18) in Fig. 2.
Regarding claim 11, McFerran in view of Gore and Biosense discloses wherein a first connection between the first hollow shaft and the second hollow shaft is in a first linear region (see dotted line in McFerran annotated Fig. 7 below).
PNG
media_image6.png
380
296
media_image6.png
Greyscale
Regarding claim 12, McFerran in view of Gore and Biosense discloses wherein a second connection between the second hollow shaft and the third hollow shaft is in a second linear region (see dotted line in McFerran annotated Fig. 7 below).
PNG
media_image7.png
380
296
media_image7.png
Greyscale
Regarding claim 13, McFerran in view of Gore and Biosense discloses wherein the first section and the second section are in a first hollow shaft and the third section is in a second hollow shaft.
PNG
media_image8.png
380
296
media_image8.png
Greyscale
Regarding claim 14, McFerran in view of Gore and Biosense discloses wherein a connection between the first hollow shaft and the second hollow shaft is in a linear region (see McFerran linear region between N and O below).
PNG
media_image6.png
380
296
media_image6.png
Greyscale
Response to Arguments
Applicant’s arguments, filed 12/01/2025, with respect to the rejection(s) of the claim(s) pertaining to the limitation of “a rigidity of the second section is larger than a rigidity of the third section” have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of McFerran in view of Gore and Biosense as presented above.
Allowable Subject Matter
Claims 15-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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, Eileen Lillis can be reached at 571-272-6928. 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.
/CATHERINE S WILLIAMS/Primary Examiner, Art Unit 3993