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 .
Claim Status
Applicant’s Remarks and Amendments filed 26 May 2026 have been entered. Claims 1-4 are pending.
Response to Arguments
Applicant’s arguments, see page 6 of remarks, filed 26 May 2026, with respect to the drawings have been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant’s arguments, see page 6 of remarks, filed 26 May 2026, with respect to claims 1-4 have been fully considered and are persuasive. The 112(b) rejection of claims 1-4 has been withdrawn.
Applicant's arguments regarding the 102 and 103 rejections of the claims filed 26 May 2026 have been fully considered but they are not persuasive. Regarding Applicant’s argument that “Sahota fails to disclose or suggest ‘the support wire extends outwardly through the outlet of the sub-tube and contacts a wall of the ostium of the blood vessel to support positioning of the balloon during stenting’”, Examiner respectfully disagrees. Fig. 2 of Sahota displays a membrane forming a tube which covers second wire 24 that ends proximal to balloon 12 and therefore creates an outlet for the second wire. Sahota further teaches that the device is used in distal arteries or sever stenosis wherein the catheters are inserted into body lumens and dilated repeatedly across a stenotic region (col. 5, par. 2), therefore contacting an ostium of a blood vessel. Further, under the broadest reasonable interpretation of the claim, Merriam Webster defines “ostium” as “a mouthlike opening a bodily part (as a fallopian tube or a blood vessel)”. Under this definition of ostium, Examiner considers Sahota’s device to meet the claim limitations.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Sahota (US Pat. No. 4983167), “Sahota”.
Regarding claim 1, Sahota teaches
A catheter for rapid stenting at an ostium of a blood vessel of a heart (Fig. 1, catheter 10), comprising:
a main tube (Fig. 1, catheter shaft 14) through which a guide wire passes (Fig. 1, wire 16); and
a sub-tube of a predetermined length (Fig. 1, membrane forming tube that covers second wire 24 (col. 4, par. 9)) through which a support wire passes (Fig. 1, second wire 24) and
which is integrally attached to an outer circumference of the main tube (Fig. 1, membrane which holds second wire 24 in place is externally secured to catheter shaft 14 (col. 4, par. 9)),
wherein the sub-tube (Fig. 1, membrane forming tube that covers second wire 24 (col. 4, par. 9)) has an outlet positioned adjacent to a boundary of a balloon provided on the main tube (Fig. 2, second wire 24 covered by membrane (col. 4, par. 9) trails proximal shoulder 18 of balloon 12 (col. 5, par. 1)), and
wherein the support wire extends outwardly through the outlet of the sub-tube (Fig. 1, second wire 24 slides through groove 26 beyond the membrane which covers it (col. 4, par. 9)) and
contacts a wall of the ostium of the blood vessel to support positioning of the balloon during stenting (Fig. 1, second wire 24 is advanced through a distal artery or sever stenosis beyond a dilated segment of a blood vessel and left in place for a short period of time to ensure the lumen doesn’t collapse and allow for further use of the balloon catheter (col. 5, par. 2)).
Regarding claim 4, Sahota teaches
wherein the guide wire is introduced into the blood vessel of the heart (Fig. 1, wire 16 is designed for insertion into most distal arteries (col. 4, lines 32-36)) or a branch vessel with blood clots and
the support wire (Fig. 1, second wire 24) is supported in contact with an outer wall of the ostium of the blood vessel of the heart or an inner wall of the ostium of another one other than the branch vessel (Fig. 1, catheter 10 is meant for use in a stenotic region such as the coronary artery as well as other vessels (col. 1, par. 1)).
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Sahota (US Pat. No. 4983167), “Sahota” in view of Jahrmarkt (US 2016/0114138 A1), “Jahrmarkt”.
Regarding claim 2, Sahota teaches the balloon (Fig. 1, balloon 12), but fails to teach wherein a stent is attached to an outer circumference of the balloon.
Jahrmarkt teaches a guidewire and catheter system wherein a stent is attached to an outer circumference of the balloon (Fig. 11, balloon-expandable stent is provided around balloon 860 and its proximal end is attached fixedly to balloon 860 [0110]). Jahrmarkt discloses that the design of this guidewire subassembly comprises a small overall diameter in order to allow for its use in smaller vessels [0108]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Jahrmarkt with the balloon taught by Sahota in order to provide a device that is easily navigated through narrower vasculature.
Regarding claim 3, Sahota teaches the balloon (Fig. 1, balloon 12) and the outlet of the sub-tube (Fig. 1, membrane forming tube that covers second wire 24 (col. 4, par. 9) comprises end nearest balloon 12) but fails to teach wherein one end of the stent attached to the outer circumference of the balloon is adapted and coupled to the outlet of the sub-tube.
Jahrmarkt teaches a guidewire and catheter system wherein one end of the stent attached to the outer circumference of the balloon is adapted and coupled to the outlet of the sub-tube (Fig. 11, balloon-expandable stent is provided around ballon 860 and its proximal end is attached to distal end of transition tube 850 [0110]. Jahrmarkt discloses that the design of this guidewire subassembly comprises a small overall diameter in order to allow for its use in smaller vessels [0108]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Jahrmarkt with the balloon and sub-tube taught by Sahota in order to provide a device that is easily navigated through narrower vasculature.
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.
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/G.G.R./ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
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