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 Arguments
Applicant's arguments filed 5/12/2026 have been fully considered.
Regarding Ho, Applicant argues that Ho does not teach the outer diameter of the extension catheter is smaller than the inner diameter of the guide catheter lumen, rather the extension catheter 12 is configured to fit within the lumen of the guide catheter. The examiner agrees with this characterization of Ho, however, the scope of the claim requires only the guide extension catheter, and does not positively recite the guide catheter – “A guide extension catheter for use with a predefined length guide catheter” [emphasis added]. Therefore, the scope of the claim requires only the guide extension catheter that is capable of being used with a guide catheter, but not the guide catheter itself. The guide extension catheter of Ho is capable of being used with a guide catheter of a suitable size such that the guide catheter can be received in the elongate tube member lumen.
Applicant’s arguments regard the claimed “introducer sheath” are similarly not convincing because the introducer sheath is not positively recited – “the elongate tubular member is configured to be inserted through a lumen of an introducer sheath” [emphasis added]. This is interpreted to be an intended use limitation wherein the introducer sheath is not positively recited.
Regarding the amendments to the claims, Applicant’s arguments are not convincing as the guide catheter is not positively recited.
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 1-3, 9-12, 21, 22 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.
Claim 1 recites, in the preamble, “A guide extension catheter for use with a predefined length guide catheter…” [emphasis added]. This is interpreted to be an intended use limitation wherein the guide catheter is not positively recited, rather only a guide extension catheter is positively recited and the scope of the claim includes a guide extension catheter that is capable of being used with a guide catheter. Claim 1 further recites “wherein the second lumen coaxially surrounds an outer surface of the guide catheter…”. This appears to be an attempt at positively reciting the guide catheter as the guide catheter is not recited in a functional manner. Therefore, the scope of the claim is not clear, particularly with regard to whether the guide catheter is positively recited and included in the scope of the claim, or if the guide catheter is only functionally recited.
For the purposes of this examination, it is assumed that the guide catheter is recited only functionally, as the claim is drawn to “a guide extension catheter”.
Claims 2-3, 9-12, 21, 22 inherit the deficiencies of claim 1.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 9, 111, 12, 21, 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho (US 2017/0028170).
Regarding claim 1, Ho discloses a guide extension catheter 12 (Figs. 1A-C). The preamble “for use with a predefined length guide catheter, the guide catheter having a first lumen configured to receive an interventional device” is interpreted to be an intended use limitation where the guide catheter is not positively recited. The guide extension catheter of Ho is capable of being used with a guide catheter. Ho further discloses that the guide extension catheter comprises an elongate tube member 12 defining a second lumen having a cross-sectional inner diameter, the inner diameter is size such that it is capable of receiving a guide catheter and an interventional device therethrough when the interventional device is received in the guide catheter lumen, and sized such that the second lumen may coaxially surround an outer surface of the guide catheter (figs. 1D); and a push member 18 that is rigid enough to allow the elongate tube member to be urged over the guide catheter (page 4, para. 0053), the push member being proximal of, operably connected to, and more rigid along a longitudinal axis than the elongate tube member (page 4, para. 0053; figs. 1A-1C), the push member having a maximal cross-sectional dimension that is smaller than a cross- sectional outer diameter of the elongate tube member and having a length, such that when combined with a length of the elongate tube member, forming a guide extension catheter length from a proximal end of the push member to a distal end of the elongate tube member along the longitudinal axis that is longer than the guide catheter, wherein a proximal portion of the elongate tube member is received on a distal portion of the guide catheter (figs. 1A-1C), and the distal end of the elongate tube member constricts such that the distal end of the elongate tube member decreases in diameter as the distal end of the elongate tube member extends beyond the distal portion of the guide catheter (page 3, para. 0050).
Regarding claim 2, the limitation “a cross-sectional outer diameter of the elongate tube member is configured to be inserted through a lumen of an introducer sheath” is interpreted to be an intended use limitation where the introducer sheath is not positively recited. The elongate tube of Ho is sized such that it is capable of being received in an introducer sheath.
Regarding claim 3, Ho discloses that the elongate tube member includes a longitudinal slit 13 along a length thereof, the longitudinal slit biased toward a closed position (page 3, para. 0050).
Regarding claim 9, Ho discloses that the push member 18 comprises a rod or a wire (figs. 1A-1C).
Regarding claim 11, Ho discloses that the elongate tube member comprises an inner polymer layer (page 4, para. 0055: inner PTFE coating) and an outer polymer layer (page 3, para. 0050: main body formed from plastic).
Regarding claim 12, the limitation “wherein the elongate tube member, when its distal end is extended distally of a distal end of the guide catheter, provides support for delivery of the interventional cardiology device in the form of a stent, a stent catheter, or a balloon catheter” is interpreted to be an intended use limitation. The elongate tube member of Ho is capable of performing this function.
Regarding claim 21, Ho discloses that the elongate tube member is biased to wrap around an outer surface of the guide catheter by way of its two longitudinal overlapping ends (Figs. 2A-2E).
Regarding claim 22, Ho discloses that at least a distal portion of the elongate tube member, when extended distally of a distal end of the guide catheter, is configured to decrease in cross-sectional diameter (figs. 2A-2C).
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ho in view of O’Donovan (US 10,485,956).
Claim 10 differs from Ho in calling for the push member to comprise a longitudinal groove along the length thereof. O’Donovan teaches a push member 108 for a catheter guide extension tube, wherein the push member includes a groove 128 (fig. 3), the groove providing a guide surface to guide a catheter into the lumen of the guide extension catheter (col. 4, lines 55-60). 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 push member of Ho to include a groove as taught by O’Donovan to provide a surface to guide the catheter inserted therethrough into the lumen of the guide extension catheter.
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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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