DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “outlet” of the sub-tube of claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-4 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 the limitation "the ostium" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 2-4 are rejected by dependency.
Claim 1 recites the limitation "the heart" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 2-4 are rejected by dependency.
Claim 1 recites the limitation "the outer circumference" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claims 2-4 are rejected by dependency.
Claim 1 recites the limitation "the boundary" in line 5. There is insufficient antecedent basis for this limitation in the claim. Claims 2-4 are rejected by dependency.
Claim 2 recites the limitation "the outer circumference" in line 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 3 is rejected by dependency.
Claim 3 recites the limitation "the outer circumference" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the heart" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the outer wall" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the ostium" in lines 3 and 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the heart" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the inner wall" in line 4. There is insufficient antecedent basis for this limitation in the claim.
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 the ostium of a blood vessel of the 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 the 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 coupled to a balloon (Fig. 1, balloon 12) provided on the main tube at the boundary with the balloon (Fig. 3, balloon 12 comprises groove 26 which provides a sliding path for the second wire 24 with which it engages (col. 4-5, lines 62-9)).
Regarding claim 4, Sahota teaches
wherein the guide wire is introduced into a 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 the outer wall of the ostium of the blood vessel of the heart or the 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 the outer circumference of the balloon.
Jahrmarkt teaches a guidewire and catheter system wherein a stent is attached to the 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2014/0188044 A1, JP 2001510072.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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/G.G.R./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799