DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This Office action is responsive to an amendment filed February 3, 2026. Claims 36-41 are pending. Claims 1-35 have been canceled. Claims 36-41 have been amended.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heuser (US 2006/0047222) in view of Wijayarathna et al. (US 4,563,181).
In regards to claim 36, Heuser discloses a method for using a guidewire system in patient, the method comprising:
advancing a tubular member (26, 40) over a guidewire 12 such that at least a proximal portion of the guidewire 12 is disposed within an internal lumen in the tubular member (26, 40) (see at least abstract and figs. 1, 3A-B & 4-5);
moving a first handle 54 of the tubular member 26 in a longitudinal direction such that a tapered region 60 of the first handle 54 interlocks with a recess 62 of a second handle 56 of second tubular member 40 to (rotationally) lock the first tubular member 26 to the second tubular member 40 (see also at least abstract, figs. 3A-B & 4-5 and par 0020);
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advancing the first tubular member 26 and the guidewire 12 to a target region within a vascular system of the patient (see at least figs. 3A-B & 4-5); and
advancing a catheter 58 over the tubular member 26 into the vascular system (e.g., the Office notes that the step does not necessarily require advancing the catheter over both the first and second tubular members) (see at least abstract, figs. 5-6 and par 0019-0020 & 0024).
Heuser discloses a method, as described above, that fails to explicitly teach a method comprising a tubular member, wherein the tubular member has a first flexibility and comprises a distal tip having a second flexibility and a second proximal region having a second flexibility, the first flexibility being less than the second flexibility.
However, Wijayarathna teaches that it is known to provide a method comprising a tubular member 12, wherein the tubular member 12 has a first flexibility and
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comprises a distal tip 18 having a second flexibility and a second proximal region 4 having a second flexibility, the first flexibility being less than the second flexibility (see at least abstract, figs. 1-2 and col. 2, lines 1-19 & 35-47).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Heuser comprising a tubular member, wherein the tubular member has a first flexibility and comprises a distal tip having a second flexibility and a second proximal region having a second flexibility, the first flexibility being less than the second flexibility as taught by Wijayarathna since such a modification would amount to applying a known technique (i.e., as taught by Wijayarathna) to a known device (i.e., as taught by Heuser) ready for improvement to achieve a predictable result such as providing a catheter having excellent torqueability and pushability while avoiding damage to blood vessels in which the catheter is being inserted (see at least col. 2, lines 35-60 of Wijayarathna)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 37, Heuser discloses the method of claim 36, further comprising:
advancing the guidewire 12 into the vascular system; and
advancing the first tubular member 26 over the guidewire 12 in situ (see at least abstract, figs. 3A-B & 4-6 and par 0019-0020).
Claims 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heuser (‘222) as modified by Wijayarathna (‘181) further in view of Burney (US 4,986,814).
While Heuser discloses a method comprising advancing the first tubular member 26 over the guidewire 12; (rotationally) locking the first tubular member 26 to the guidewire 12; and advancing the first tubular member (i.e., portions 29 & 30 of sleeve 14) and the guidewire 12 together to the target region in the vascular system of the patient (see at least abstract, figs. 3A-B & 4-6 and par 0019-0020), Heuser as modified by Wijayarathna and Kring fails to explicitly teach a method further comprising: advancing the tubular member over the guidewire outside of the patient; locking the tubular member to the guidewire outside of the patient; and advancing the tubular member and the guidewire together to the target region in the vascular system of the patient.
However, Burnley teaches that it is known to provide a method further comprising: advancing the first tubular member 36 over the guidewire 26 outside of the patient; locking the first tubular member 36 to the guidewire 26 outside of the patient; and advancing the first tubular member 36 and the guidewire 26 together to the target region (see at least abstract, fig. 1; col. 2, lines 20-65, col. 3, lines 46-58 and col. 4, lines 1-2).
Therefore, since Heuser teaches that the first tubular member 26 and guidewire 12 can be coupled together (see at least abstract and par 0020) depending on the desired attributes needed in maneuvering across different types of bends and intersections and along blood vessels of varying sizes to reach the treatment or diagnostic site (see at least par 0003 thereof), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Heuser as modified by Wijayarathna further comprising: advancing the first tubular member over the guidewire outside of the patient; locking the first tubular member to the guidewire outside of the patient; and advancing the first tubular member and the guidewire together to the target region, as taught by Burnley, in the vascular system of the patient as taught by Burnley since such a modification would amount to applying a known technique (i.e., as taught by Burnley) to a known device (i.e., as taught by Heuser) ready for improvement to achieve a predictable result such as providing a catheter system the components of which can be locked together for one-step insertion (see at least col. 1, lines 28-32 of Burnley)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claims 39-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heuser (‘222) as modified by Wijayarathna (‘181) further in view of Adams (US 5,246,009).
In regards to claim 39, Heuser as modified by Wijayarathna and Kring discloses the method of claim 36, that fails to explicitly teach a method wherein a distal portion of the first tubular member comprises a hydrophilic coating. However, Adams teaches that it is known to provide a method wherein a distal portion of the first tubular member comprises a hydrophilic coating (see at least col. 8, lines 48-54). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the method of Heuser as modified by Wijayarathna wherein a distal portion of the first tubular member comprises a hydrophilic coating as taught by Adams in order to reduce friction between coaxially slidable components to facilitate their interaction.
In regards to claim 40, Heuser as modified by Wijayarathna discloses the method of claim 36, wherein the outer diameter of the first tubular member is about 0.035 cm. However, Adams teaches that it is known to provide a method wherein the outer diameter of the first tubular member is about 0.035 cm (i.e., 0.014 inch) (see at least fig. 2 and col. 6, lines 48-52). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the method of Heuser as modified by Wijayarathna wherein the outer diameter of the first tubular member is about 0.035 cm as taught by Adams in order to allow said tubular member to be accommodated inside a catheter having a larger inside diameter since Wijayarathna discloses a catheter that is not limited to its disclosed exemplary sizes (see at least par 0037 thereof).
In regards to claim 41, Heuser as modified by Wijayarathna discloses the method of claim 36, that fails to explicitly teach a method wherein an inner diameter of the lumen of tubular member is greater than about 0.014 cm. However, Adams teaches that it is known to provide a method wherein an inner diameter of the lumen of the first tubular member 14 is greater than about 0.014 cm (i.e., 0.007 inch or 0.008 inch) (see at least fig. 2 and col. 6, lines 13-29). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the method of Heuser as modified by Wijayarathna wherein an inner diameter of the lumen of the first tubular member 14 is greater than about 0.014 cm as taught by Adams in order to allow said tubular member to accommodate a guidewire having a smaller diameter since Wijayarathna discloses a catheter that is not limited to its disclosed exemplary sizes (see at least par 0037 thereof).
Response to Arguments
Applicant's arguments filed February 3, 2026 have been fully considered but they are not persuasive. Applicant contends that Heuser “does not teach the step of moving a first handle of the tubular member in a longitudinal direction such that a tapered region of the first handle interlocks with a recess of a second handle of second tubular member to lock the first tubular member to the second tubular member.” The Office respectfully traverses. For example, as shown at least at fig. 1 thereof, Heuser discloses handles (54, 56), wherein handle 54 includes a tapered wing 60 that rotationally interlocks with a recess 62 in handle 56. The instant claim(s) saliently fail(s) to state that the interlocking locks the movement of the handles in a longitudinal direction.
In view of the foregoing, the rejections over at least Heuser are maintained.
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 RENE T TOWA whose telephone number is (313)446-6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
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/RENE T TOWA/ Primary Examiner, Art Unit 3791
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