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 .
Response to Amendment
The amendment filed 01/21/2026 has been entered. Claims 1-2, 4-6, 8-22 are pending in the application, claims 11-22 are withdrawn. Applicant' s amendments to the claims not overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 10/21/2025 (See Objections below).
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5: On lines 2-3, “markings is” is grammatically incorrect and should recite “markings are”.
Appropriate correction is required.
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.
Claims 1, 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Fuller (US 10080874) in view of Griffin (US 2006/0129175) and further in view of Uihlein (US 2011/0021951).
Regarding claim 1, Fuller discloses a captivation catheter (20, Fig 3) for use with a guide catheter (11, Fig 3) and a guidewire (14, Fig 3) or a treatment catheter, comprising: an elongate member (22, Fig 3) extending from a proximal hub (28, Fig 5) to a distal end, a distal portion of the elongate member including: a surface texture ( Merriam-Webster defines texture as “ the visual or tactile surface characteristics and appearance of something”. Therefore, the distal portion of the elongate member has some surface texture even if it is a smooth surface texture. The claim does not define what the texture must be), and a captivation balloon (24, Fig 3), the captivation balloon configured for expansion within the guide catheter to secure the guidewire or the treatment catheter between an outer surface of the captivation balloon and an inner surface of the guide catheter (Col 5, line 59 - Col 6, line 4).
Fuller is silent regarding a distal portion of the elongate member including a helical cut extending through a wall of the elongate member; the captivation balloon positioned over the helical cut; and wherein the helical cut allows for inflation of the captivation balloon and increased shaft flexibility relative to a proximal portion of the elongate member; and at least a plurality of first and a plurality of second markings disposed on the elongate member adjacent to one another and placed in an alternating pattern along a proximal-to-distal direction of the elongate member and indicative of a linear position of the captivation catheter relative to the guide catheter, wherein the surface texture causes each of the first markings to be visible at a first viewing angle but each of the second markings to be not visible at the first viewing angle, and the surface texture causes each of the first markings to be not visible at a second viewing angle but each of the second markings to be visible at the second viewing angle.
Griffin teaches an analogous balloon catheter (10, Fig 1) comprising an elongate member (elongate shaft 15) wherein a distal portion of the elongate member includes a helical cut (100) extending through a wall of the elongate member (See Fig 5, Para 0017); the balloon positioned over the helical cut (See Fig 4); and wherein the helical cut allows for inflation of the balloon (Para 0023, “Unobstructed apertures 100 in the distal balloon section 25 provide fluid communication between the interior of the balloon 82 and inflation lumen 80”) and increased shaft flexibility relative to a proximal portion of the elongate member (Para 0023).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongate member to comprise a helical cut as taught by Griffin to increase flexibility under the balloon as well as allow for quick inflation/deflation of the balloon (Para 0023).
The modified invention of Fuller and Griffin discloses all of the elements of the invention as discussed above, however, is silent regarding at least a plurality of first and a plurality of second markings disposed on the elongate member adjacent to one another and placed in an alternating pattern along a proximal-to-distal direction of the elongate member and indicative of a linear position of the captivation catheter relative to the guide catheter, wherein the surface texture causes each of the first markings to be visible at a first viewing angle but each of the second markings to be not visible at the first viewing angle, and the surface texture causes each of the first markings to be not visible at a second viewing angle but each of the second markings to be visible at the second viewing angle.
Uihlein teaches an elongate member having a surface texture (the distal portion of the elongate member has some surface texture even if it is a smooth surface texture. Again, the claim does not define what the texture must be), and at least first and second markings disposed on the elongate member adjacent to one another and placed in an alternating pattern along a proximal-to-distal direction of the elongate member (See annotated Fig 1 below wherein the first markings comprise an alternating pattern and the second markings comprise an alternating pattern) and indicative of a linear position of the captivation catheter relative to the guide catheter (Para 0051), wherein the surface texture causes each of the first markings to be visible at a first viewing angle but each of the second markings to be not visible at the first viewing angle, and the surface texture causes each of the first markings to be not visible at a second viewing angle but each of the second markings to be visible at the second viewing angle. (As the first markings and second markings on the smooth surface texture are visible to the user and are 180 degrees apart in a circumferential way such that the respective markings can only be viewed from specific viewing angle ranges. Therefore, the smooth surface texture, in combination with the positioning of the markings, causes the markings to be visible/not visible as claimed.).
PNG
media_image1.png
307
533
media_image1.png
Greyscale
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongate member to include the markings as taught by Uihlein in order facilitate the detection of axial and rotational position of the member (Para 0014).
Regarding claim 4, the modified invention of Fuller, Griffin, and Uihlein discloses all of the elements of the invention as discussed above, however, is silent regarding an outer diameter of the elongate member decreases in a proximal-to-distal direction along the elongate member.
Griffin further teaches an outer diameter of the elongate member decreases in a proximal-to-distal direction along the elongate member (Para 0023-0024; the lack of polymer coating and tapering of the distal top provide a decreasing outer diameter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongate shaft to have a decreasing outer diameter a taught by Griffin in order to have a catheter with a preferred flexibility profile that can better navigate tortuous vasculature (Para 0023-0024).
Regarding claim 5, the modified invention of Fuller, Griffin, and Uihlein discloses each of the first markings are visible when the elongate member is at a first orientation but not a second orientation in a surgical field and each of the second markings are visible when the elongate member is at the second orientation but not the first orientation in the surgical field (Para 0061 -Uihlein; as the markings are 120 degrees apart in a circumferential way, the respective markings can only been viewed from specific viewing angle ranges).
Regarding Claim 6, the modified invention of Fuller, Griffin, and Uihlein discloses wherein the first markings or the second markings include a color marking (Para 0050 - Uihlein).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Fuller (US 10080874) in view of Griffin (US 2006/0129175) and further in view of Uihlein (US 2011/0021951) and further in view of Eidenschink (US 2008/0077085).
Regarding claim 2, the modified invention of Fuller, Griffin, and Uihlein discloses all of the elements of the invention as discussed above, however, is silent regarding a pitch of the helical cut decreases in a proximal-to-distal direction along the distal portion of the elongate member.
Eidenschink teaches an analogous balloon catheter comprising a helical cut wherein a pitch of the helical cut decreases in a proximal-to-distal direction along the distal portion of the elongate member (Para 0043).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pitch of the helical cut to decrease in a proximal-to-distal direction along the distal portion of the elongate member as taught by Eidenschink in order to impart a desired flexibility profile (Para 0030, 0044).
Claims 8, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Fuller (US 10080874) in view of Griffin (US 2006/0129175) and further in view of Uihlein (US 2011/0021951) and further in view of Cespedes (US 2004/0068190).
Regarding claim 8, the modified invention of Fuller, Griffin, and Uihlein discloses all of the elements of the invention as discussed above, however, is silent regarding a clip having an open first end that is attachable to the elongate member and a closed second end that is opposite the first end, wherein the open end includes a first arm including a first groove, and a second arm including a second groove, wherein the first groove and the second groove face away from each other.
Cespedes teaches a catheter (12, Fig 1) having markings (20, Fig 5A) and further comprising a clip (44, Fig 5A) having an open first end (end comprising first and second actuation levers 50 and 58, Fig 5A) that is attachable to the elongate member (See Fig 5A, the first end is at least indirectly attachable to the elongate member through jaws 58 and 56) and a closed second end (end comprising jaws 58 and 56, Fig 5A) that is opposite the first end.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter disclosed by Fuller, Griffin, and Uihlein to further include a clip as taught by Cespedes in order to demarcate the appropriate index corresponding to target insertion depth (Para 0041).
The modified invention of Fuller, Griffin, Uihlein, and Cespedes discloses all of the elements of the invention as discussed above, however, is silent regarding wherein the open end includes a first arm including a first groove, and a second arm including a second groove, wherein the first groove and the second groove face away from each other.
Nakamura teaches a clip having a first and second actuation levers (40, Fig 1), wherein the actuation levers include a first arm (one arm of gripper 40, Fig 1) including a first groove (one of grooves of 42A), and a second arm (another arm of gripper 40, Fig 1) including a second groove (one of grooves of 42B), wherein the first groove and the second groove face away from each other (See Fig 1)(Para 0026).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the clip to have grooves on the handle as taught by Nakamura in order to provide a non-slip surface to improve handling of the clip (Para 0026).
Regarding claim 9, the modified invention of Fuller, Griffin, Uihlein, Cespedes, and Nakamura discloses the clip (44, Fig 5A -Cespedes as modified by Nakamura to have the grooves) is configured to be removed from the elongate member by depressing portions of the clip adjacent the first end (Para 0038-0039 -Cespedes).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Fuller (US 10080874) in view of Griffin (US 2006/0129175) and further in view of Uihlein (US 2011/0021951) and further in view of Zhadkevich (US 2019/0167271).
Regarding claim 10, the modified invention of Fuller, Griffin, and Uihlein discloses all of the elements of the invention as discussed above, however, is silent regarding a center of the captivation balloon post-expansion is offset relative to an axis of the elongate member.
Zhadkevich teaches a balloon catheter wherein a center of the balloon post-expansion is offset relative to an axis of the elongate member (Para 0188; See Fig 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon to be offset to an axis of the elongate member post-expansion as taught by Zhadkevich in order to allow the user to control bending and twisting of the elongate member upon inflation (Para 0188-0190).
Response to Arguments
Applicant’s argument filed 01/21/2026, on pages 7-8, regarding the art of record failing to teach the claimed surface texture have been fully considered but is not persuasive. As detailed in the rejection of claim 1 above, the Merriam-Webster Dictionary defines texture as “ the visual or tactile surface characteristics and appearance of something”. Therefore, the distal portion of the elongate member has some surface texture even if it is a smooth surface texture. The claim does not specify what the texture must be. Regarding the claim “properties” of the surface texture, the surface texture must be able to cause the first and second markings to be visible/not visible depending on the viewing angle. Uihlein teaches the first markings and second markings on the smooth surface texture are visible to the user and are 180 degrees apart in a circumferential way such that the respective markings can only be viewed from specific viewing angle ranges. Therefore, the smooth surface texture, in combination with the positioning of the markings, causes the markings to be visible/not visible as claimed. Other textures could obstruct the first and second markings from view in most viewing angles, but the smooth surface texture causes the first and second markings to be visible/not visible as claimed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm 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, Kevin Sirmons can be reached on 571-272-4965. 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.
/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights