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 .
Claims 1-7 are cancelled.
Claims 8-15 are added.
Claims 8-15 are being examined in this Office Action.
Claim Objections
Claims 8-15 are objected to because of the following informalities:
Regarding claim 8, line 2 “hu-mans” should read “humans”, line 3 there should be a comma at the end of the of the limitation “a multi-lumen catheter shaft”, line 8 “aspi-ration” should read “aspiration”.
All remaining claims are objected to by virtue of their dependance on an objected claim.
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 9-12 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 9 states the limitation “wherein one of the tubes includes a first tube for a guide wire”, it is unclear if there is an additional tube located within one of the occlusion balloons lumen, aspiration pore lumen, or treatment balloon lumen or if one of these lumens is the first tube. Examiner interprets the first tube to be a separate tube within one of the tubes which the guide wire is located within.
All remaining claims are rejected by virtue of their dependency on claim 9.
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.
Claim(s) 8-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alnidelik (WO 2019027380 A1) in view of Mertens (US 20030163082 A1).
Regarding Claim 8, Alnidelik discloses a catheter system for use in the treatment and cleaning of arteries, veins, other circulatory channels in the circulatory system of hu-mans and animals (Fig. 1, Page 7 Paragraph 3), comprising:
a multi-lumen catheter shaft (105)
a distal occlusion balloon (100),
a proximal occlusion balloon (102),
a central treatment balloon (101), and
an aspiration orifice (121) in the distal end region of the catheter shaft (Fig. 3),
an occlusion balloons lumen (112), an aspi-ration pore lumen (122), and a treatment balloon lumen (110) provided by tubes (108, Page 5 Paragraph 1).
Alnidelik does not expressly disclose wherein the occlusion balloons lumen, the aspi-ration pore lumen, and the treatment balloon lumen of the catheter shaft are assembled to each other by adhesive force such that their respective centers are corners of an equilateral triangle, and wherein tubes are encapsulated by an outer wall.
Mertens teaches tubes (26, Fig. 9) assembled, to each other by an adhesive force (30, 50 “Engagement area 30 may be formed by any known means of engaging materials to one another. Such engagement methods include, but are not limited to physical and chemical bonding such as by the formation of a weld, adhesive bond, mechanical engagement, or other engagement means” – Paragraph [0030], 50 also being an engagement area) such that their respective centers are corners of an equilateral triangle (centers of 26 are corners of an equilateral triangle overlayed on top of Fig. 9), and wherein the tubes are encapsulated by an outer wall (28, Fig. 9).
Therefore it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter system disclosed by Alnidelik wherein an occlusion balloons lumen, an aspi-ration pore lumen, and a treatment balloon lumen of the catheter shaft are provided by tubes, assembled to each other by adhesive force such that their respective centers are corners of an equilateral triangle, and wherein tubes are encapsulated by an outer wall as taught by Mertens so that the tubing may be configured to any configuration desired (Mertens, Paragraph [0037]).
Regarding Claim 9, modified Alnidelik in view of Mertens discloses the catheter system of claim 8, wherein one of the tubes includes a first tube (Mertens, any one of 26 in Fig. 9) for a guidewire (Alnidelik, 115).
Examiner interprets that a guidewire is able to fit through one of the tubes (Mertens, 26, Paragraph [0005]).
Furthermore, if Applicant disagrees with the interpretation using Figure 9 of Mertens, Examiner interprets that a guide wire could be included within tube 26a of Figure 10 in Mertens (Mertens, Paragraph [0041]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter system disclosed by Alnidelik wherein one of the tubes includes a first tube for a guidewire as taught by Mertens so that the catheter system may include a lumen for a guide wire (Mertens, Paragraph [0005]).
Regarding Claim 10, modified Alnidelik in view of Mertens discloses the catheter system of claim 9, wherein the central treatment balloon (Alnidelik, 101) is a perforated balloon (Alnidelik, “The holes (103) on the perforated balloon (101) and the aspiration hole (121) on the catheter shaft (105) are shown in FIG. 2.” – Page 5 Paragraph 1).
Regarding Claim 11, modified Alnidelik in view of Mertens discloses the catheter system of claim 10, wherein one or more of the tubes (Mertens, 26, Fig. 9) includes a multi-layered tube wall (Mertens, 28, Fig. 9, Inner tubes 26 surrounded by an outer tube 28 forming multiple layers).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter system disclosed by Alnidelik wherein one or more of the tubes includes a multi-layered tube wall as taught by Mertens so that the catheter may include lumens expressly for inflation or a guide wire (Mertens, Paragraph [0005]).
Regarding Claim 12, modified Alnidelik in view of Mertens discloses the catheter system of claim 9, wherein one or more of the tubes (Mertens, 26, Fig. 9) includes a multi-layered tube wall (Mertens, 28, Fig. 9, Inner tubes 26 surrounded by an outer tube 28 forming multiple layers).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter system disclosed by Alnidelik wherein one or more of the tubes includes a multi-layered tube wall as taught by Mertens so that the catheter may include lumens expressly for inflation or a guide wire (Mertens, Paragraph [0005]).
Regarding Claim 13, modified Alnidelik in view of Mertens discloses the catheter system of claim 8, wherein the central treatment balloon (Alnidelik, 101) is a perforated balloon (Alnidelik, “The holes (103) on the perforated balloon (101) and the aspiration hole (121) on the catheter shaft (105) are shown in FIG. 2.” – Page 5 Paragraph 1).
Regarding Claim 14, modified Alnidelik in view of Mertens discloses the catheter system of claim 13, wherein one or more of the tubes (Mertens, 26, Fig. 9) includes a multi-layered tube wall (Mertens, 28, Fig. 9, Inner tubes 26 surrounded by an outer tube 28 forming multiple layers).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter system disclosed by Alnidelik wherein one or more of the tubes includes a multi-layered tube wall as taught by Mertens so that the catheter may include lumens expressly for inflation or a guide wire (Mertens, Paragraph [0005]).
Regarding Claim 15, modified Alnidelik in view of Mertens discloses the catheter system of claim 8, wherein one or more of the tubes (Mertens, 26, Fig. 9) includes a multi-layered tube wall (Mertens, 28, Fig. 9, Inner tubes 26 surrounded by an outer tube 28 forming multiple layers).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter system disclosed by Alnidelik wherein one or more of the tubes includes a multi-layered tube wall as taught by Mertens so that the catheter may include lumens expressly for inflation or a guide wire (Mertens, Paragraph [0005]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Piccagli (Pub. No. US 20170105758 A1) is considered relevant prior art with regards to a
Catheter system comprising: a multi-lumen catheter shaft, a distal balloon, a proximal balloon, a central treatment balloon, a tube for a guidewire, and a multi-layered wall.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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