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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/30/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 06/30/2025. As directed by the amendment: Claims 1 and 12 have been amended, claims 6 and 8 have been cancelled, and no claims have been added. Thus, claims 1-5, 7, and 9-22 are presently pending in the application wherein claims 4-5, 7, and 13-20.
Response to Arguments
Applicant's arguments filed 06/30/2025 have been fully considered but they are not persuasive.
Applicant argues, page 6 and lines 1-3 on page 7, that Ho does not teach “an elongate tube member defining a lumen having a cross-sectional inner diameter through which the guide catheter is insertable” and that Ho teaches the opposite in that “the extension catheter 12 is smaller than the inner diameter of the guide catheter lumen 30”. Applicant states, page 7, that the office supposes that the balloon catheter 26 of Ho is somehow equivalent to the guide catheter 20 of Ho and that the interventional cardiology device and the guide catheter 20 of Ho (e.g., the balloon catheter 26 or stent 24) are separate and distinct parts that serve separate functions. Examiner disagrees, examiner uses Ho to teach an elongate tube member 12 defining a lumen having a cross-sectional inner diameter through which the guide catheter 26 and the interventional device 24 are inserted as seen in Fig. 1D, and the guide catheter lumen 30 is equivalent to the introducer sheath (claim 2) wherein the cross-sectional outer diameter of the elongate tube member 12 is inserted through the lumen 30 of the introducer sheath 20 as seen in Figs.1D and 2E.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 9, 11-12, and 21-22 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 (Fig.1D) for use with a predefined length guide catheter (26), the guide catheter having a first lumen configured to receive an interventional device (24) (Fig.1D); the guide extension catheter comprising: an elongate tube member (12) defining a second lumen (28) having a cross-sectional inner diameter through which the guide catheter (26) and the interventional device (24), when received in the first lumen, are insertable (Fig.1D) (last sentence in parag. [0056]); and a push member (18) that is rigid enough to allow the elongate tube member (12) to be urged over the guide catheter (last sentence in parag. [0051] and lines 5-8 in parag. [0055]), the push member (18) being proximal of, operably connected to, and more rigid along a longitudinal axis than the elongate tube member (last sentence in parag. [0049]), the push member (18) having a maximal cross-sectional dimension that is smaller than a cross- sectional outer diameter of the elongate tube member (the diameter of the push member 18 is smaller than the diameter of the elongate tube member 12 as seen in Fig.1A) and having a length, such that when combined with a length of the elongate tube member (12), forming a guide extension catheter length from a proximal end (end away from the patient) of the push member to a distal end (14) of the elongate tube member (12) along the longitudinal axis that is longer than the guide catheter (26) (the guide extension catheter 10 comprises the elongate tube member 13 and the push member 18 (parag. [0049]) wherein the length of the guide extension catheter 10 is longer than the introducer sheath 20 (parag. [0054]); therefore, the length of the guide extension catheter 10 (proximal end of the push member 18 to the distal end 14 of the elongate tube member 12)) is longer than the length of the guide catheter 26), wherein a proximal portion (16) of the elongate tube member (12) is received on a distal portion (portion towards the patient) of the guide catheter (26) (last sentence in parag. [0056]), and the distal end (14) of the elongate tube member (12) constricts such that the distal end (14) of the elongate tube member decreases in diameter (resting/minimal diameter) as the distal end of the elongate tube member extends beyond the distal portion of the guide catheter (lines 20-25 in parag. [0050]).
Regarding Claim 2, Ho discloses the guide extension catheter of claim 1, and further discloses wherein a cross-sectional outer diameter of the elongate tube member (12) is configured to be inserted through a lumen of an introducer sheath (20) (Figs.3-5 and parag. [0056]).
Regarding Claim 3, Ho discloses the guide extension catheter of claim 1, and further discloses wherein the elongate tube member (12) includes a longitudinal slit (13) along a length thereof (parag. [0049]), the longitudinal slit (13) biased toward a closed position (resting state) (parag. [0050]).
Regarding Claim 9, Ho discloses the guide extension catheter of claim 1, and further discloses wherein the push member (18) comprises a rod or a wire (last sentence in parag. [0049]).
Regarding Claim 11, Ho discloses the guide extension catheter of claim 1, and further discloses wherein the elongate tube member (12) comprises an inner polymer layer (15) (first sentence in parag. [0050]) and an outer polymer layer (outer coating layer) (last sentence in parag. [0055]).
Regarding Claim 12, Ho discloses the guide extension catheter of claim 1, and further discloses wherein the elongate tube member (12), when its distal end (14) is extended distally of a distal end of the guide catheter (26), provides support for delivery of the interventional cardiology device (24) in the form of a stent, a stent catheter, or a balloon catheter (parag. [0021]).
Regarding Claim 21, Ho discloses the guide extension catheter of claim 3, and further discloses wherein the elongate tube member (12) is biased to wrap around an outer surface of the guide catheter by way of its two longitudinal overlapping ends (see annotated figure below) (parag. [0050]).
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Regarding Claim 22, Ho discloses the guide extension catheter of claim 1, and further discloses wherein at least a distal portion (14) of the elongate tube member (12), when extended distally of a distal end of the guide catheter, is configured to decrease in cross-sectional diameter (resting/minimal diameter as seen in Figs.2C-2D) (lines 20-25 in parag. [0050]).
Claim Rejections - 35 USC § 103
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ho (US 2017/0028170); in view of O’Donovan (US 10485956).
Regarding Claim 10, Ho discloses all the limitations of claim 1 above.
Ho does not appear to disclose a push member comprises a longitudinal groove along the length thereof.
O’Donovan teaches it was known in the art to have a push member 108 with longitudinal groove 128 as seen in Fig.3 (lines 55-57 in column 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Ho to incorporate the teachings of O’Donovan to have a push member comprises a longitudinal groove along the length thereof in order to guide the interventional coronary device into the shaft (elongate tube member) (lines 55-60 in column 4).
Conclusion
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/T.I./ Examiner, Art Unit 3783 /BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783