DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 8, 2023 has been entered.
This Office action is responsive to an amendment filed August 19, 2026. Claims 36-41 are pending. Claims 1-35 have been canceled. Claim 36 has been amended.
Claim Objections
Claims 36-41 is/are objected to because of the following informalities:
In regards to claim 36, at line 9, the limitations “a second handle of second tubular member” should apparently read --a second handle of a second tubular member--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 36-41 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 36, at line 6, the limitations “a second flexibility” renders the claim indefinite; for example, the recitation of “a second flexibility” at line 5 of the claim, it is unclear whether or not the second/repeated “second flexibility” is the same as the initially claimed “second flexibility.”
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) further in view of Leckrone et al. (US 2004/0024435) (“Leckrone” hereinafter).
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);
PNG
media_image1.png
264
586
media_image1.png
Greyscale
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
PNG
media_image2.png
220
349
media_image2.png
Greyscale
comprises a distal tip 14 having a second flexibility and a second proximal region 14 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).
Heuser as modified by Wijayarathna discloses a method, as described above, that fails to explicitly teach a method with a step to fix the first tubular member against relative longitudinal movement with respect to the second tubular member.
However, Leckrone teaches that it is known to provide a method with a step to fix the first tubular member 210 against relative longitudinal movement with respect to the second tubular member 212 (see at least figs. 9-10 and par 0006 & 0043-0044).
Therefore, since Heuser teaches that any type of selective interlocking may be used to provide simultaneous movement of the tubular members (see par 0020), 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 with a step to fix the first tubular member against relative longitudinal movement with respect to the second tubular member as taught by Leckrone since such a modification would amount to applying a known technique (i.e., as taught by Leckrone) to a known device (i.e., as taught by Heuser) ready for improvement to achieve a predictable result such as interlocking the tubular members to permit simultaneous movement thereof (see at least par 0020 of Heuser)--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), Leckrone (‘435) 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 Leckrone 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 and Leckrone 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), Leckrone (‘435) further in view of Adams (US 5,246,009).
In regards to claim 39, Heuser as modified by Wijayarathna and Leckrone 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 and Leckrone 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 and Leckrone 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 and Leckrone 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 and Leckrone 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 and Leckrone 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 with respect to claim(s) 36-41 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
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, Jason M. Sims can be reached on 571-272-7540. 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.
/RENE T TOWA/ Primary Examiner, Art Unit 3791
