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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 2-5 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.
Regarding claim 2, the claim recites the limitation “a second region” in line 1. It is unclear if this second region is the same second region recited in claim 1 or a different second region. For examination purposes, the first interpretation was used.
Claims 3-5 are also rejected by virtue of being dependent on claim 2.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 3, the claim recites that the second material section extends spirally along the second region. As set forth in the claim interpretation for claim 2, the “second region” recited in claim 2 is interpreted to be the same “second region” recited in claim 1. Claim 1 recites “a second material section extending spirally along a second region”. As such, claim 3 fails to further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McFerran (US 20060089618).
Regarding claim 1, McFerran discloses a catheter tubing (catheter 10 in fig. 1) comprising:
a tubular body having an axial length (tubular shaft 12 in fig. 1), the tubular body comprising at least a base material having a base material structural property (paragraph 22 discloses first outer layer segment 42 can comprise a PEBAX material which would have a structural property);
a first material section (coil layers 64 in fig. 2) extending spirally along a first region of the axial length and within a wall of the tubular body (the wires forming coils 64 would extend spirally along a region extending from first location 44 to location 66 in fig. 2; fig. 2 shows the coils 64 embedded in a wall of tubular shaft 12), the first material section comprising a first structural property (the coils would necessarily have a structural property), where the first structural property and the base material structural property are different (it is understood that the structural property of the coils 64 and that of the PEBAX segment 42 would differ);
a second material section (coil layer 68 in fig. 2) extending spirally along a second region of the axial length and within the wall of the tubular body (fig. 2 shows that the wire forming coil layer 68 would extend spirally from location 66 to location 58; fig. 2 shows the coil layer 68 embedded within shaft 12), the second material section comprising a second structural property (the coil layer 68 would necessarily have a structural property), where the second structural property is different than the first structural property (paragraph 28 discloses that the material of the coils can be varied between the different segments so that the structural properties between coil layers 64 and coil layer 68 would differ); and
where at an end of the first region the first material section ends and is replaced by the second material section (paragraphs 26 and 27 discloses that the coil layers 64 terminate at location 66 at which location the coil layer 68 distally extends).
Regarding claim 2, McFerran discloses the tubular body comprises a second region (the region extending between location 66 and location 58) having a second base material (paragraph 22 discloses that second outer layer segment 48 is made from a PEBAX material) and where the second base material is joined to an end of the base material (fig. 2 shows that the two outer layer segments 42 and 48 are joined at location 46 so that the base materials are joined).
Regarding claim 3, McFerran discloses at least the second material section extends spirally along the second region (wire forming coil 68 would extending spirally from location 66 to location 58).
Regarding claim 4, McFerran discloses the base material structural property and the second base material structural property are different (paragraph 22 discloses that first outer layer segment 42 can be made from PEBAX 5533 and second outer layer segment 48 can be made from PEBAX 4033 so that the two base materials have different durometers, equated to the claimed “structural property”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over McFerran, as applied to claims 1 and 2 above, and further in view of Wilson (US 6197015).
Regarding claim 5, McFerran discloses all of the claimed limitations set forth in claims 1 and 2, as discussed above. McFerran further discloses that the material of the tubular body can be varied to active a desired strength, flexibility, hardness, or other desired characteristic (paragraph 21).
However, McFerran does not teach or disclose the base material structural property and the second base material structural property are the same and where the base material is visually distinguishable from the second base material.
Wilson is directed towards a catheter (fig. 4) comprising a tubular body (body of catheter 30 in fig. 4) comprising a base material (material of section 32 in fig. 6) and a second base material (material of section 36 in fig. 6) which comprise a base material structural property and a second base material structural property, respectively, which are the same (4:45-49 discloses the sections can be made from different materials having the same durometer). Wilson further teaches that the base material is visually distinguishable from the second base material (4:51-52 discloses the axial sections are color coded to identify different sections).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the base material and the second base material of McFerran to be made from different materials having the same material structural property and to color-code the base material and the second base material, as taught by Wilson. Wilson teaches that this modification would provide for a desired flex characteristic (4:45-49) and would enable a user to identify sections having different properties (4:51-52).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783