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 .
Claim Objections
Claim 30 is objected to because of the following informalities:
Regarding claim 30, line 2, the recitation “a width to thickness ratio” appears to be amended to recite “the width to thickness ratio” in order to refer to “a width to thickness ratio” recited in claim 29, line 7.
Appropriate correction is required.
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.
Claims 1-3, 6, 8-15, 19, 29 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McDaniel et al. (US 2011/0218492 A1).
Regarding claim 1, McDaniel teaches a steerable catheter assembly (figure 1, including the embodiments shown in figures 6, 7, 7a, 8, 12, 15) comprising:
an elongated catheter shaft section 12 having a distal end (end of element 14 comprising element 38), a proximal end (end of element 12 connected to element 16), and a centerline 15 (figure 6) that extends between the distal end (end of element 14 comprising element 38) and the proximal end (end of element 12 connected to element 16);
one or more planarity members 17 disposed within and attached to the elongated catheter shaft section 12 and extending along the centerline 15, wherein the one or more planarity members 17 have a cross-sectional area perpendicular to the centerline 15, wherein the cross-sectional area has a minimum principal area moment of inertia (paragraph 0040, lines 13-14, 1/12WT3 where W=0.07 and T=0.005) and a maximum principal area moment of inertia (paragraph 0040, lines 13-14, 1/12TW3 where W=0.07 and T=0.005), wherein the maximum principal area moment of inertia is at least 5 times the minimum principal area moment of inertia (the maximum principle area moment of inertia is at least 5 times the minimum area moment of inertia when calculating the ratio of (1/12TW3)/(1/12WT3));
a deflection lumen (hollow portion inside element 42) offset from the one or more planarity members 17; and
a pull wire 32 disposed within the deflection lumen and operable to induce deflection (paragraph 0041, lines 3-5) of the elongated catheter shaft section 12.
Regarding claim 2, McDaniel teaches wherein each of the one or more planarity members 17 has a solid cross-sectional area (figure 6, paragraph 0040, lines 5-7, element 17 is not a hollow structure) without a closed cell (see figure 6).
Regarding claim 3, McDaniel teaches wherein the maximum principle area moment of inertia is at least 50 times the minimum principal area moment of inertia (paragraph 0040, the maximum principle area moment of inertia is at least 50 times the minimum principal area moment of inertia when calculating the ratio of (1/12TW3)/(1/12WT3)).
Regarding claim 6, McDaniel teaches wherein the minimum principal area moment of inertia is less than 0.0001 inches4 (paragraph 0040, lines 13-14, the minimum principal area moment of inertia is less than 0.0001 inches4).
Regarding claim 8, McDaniel teaches further comprising:
a second deflection lumen (other of two hollow portions inside element 42, figure 6) disposed on an opposite side of the one or more planarity members 17 relative to the deflection lumen (one of two hollow portions inside element 42); and
a second pull wire (other of two elements 32) disposed within the second deflection lumen (other of two hollow portions inside element 42) and operable to induce deflection of the elongated catheter shaft section (paragraph 0041, lines 3-5).
Regarding claim 9, McDaniel teaches further comprising:
a third lumen 23 (figure 6) disposed on a first side (side where element 23 is present) of the one or more planarity members 17; and
a fourth lumen 25 (figure 6) disposed on a second side (side where element 25 is present) of the one or more planarity members 17 opposite to the first side,
wherein each of the third lumen and the fourth lumen (elements 23 and 25 accommodate element 42 thereby having larger cross-sectional area compared to element 42) has a cross-sectional area that is greater than a cross-sectional area of each of the deflection lumen and the second deflection lumen (hollow portion inside element 42).
Regarding claim 10, McDaniel teaches further comprising a fifth lumen 26 and a sixth lumen 31 (or element 28), wherein each of the fifth lumen 26 and the sixth lumen 31 (or element 28) is offset from the centerline 15 of the elongated catheter shaft section 12.
Regarding claim 11, McDaniel teaches wherein each of the fifth lumen 26 and the sixth lumen 28 is disposed on the same side of the one or more planarity members 17 and have a cross-sectional area (cross-sectional areas of element 26 and 28 are smaller than elements 23 and 25) that is smaller than the cross-sectional area of each of the third lumen 23 and the fourth lumen 25.
Regarding claim 12, McDaniel teaches wherein the fifth lumen 26 is disposed on the first side (side where element 26 is present) of the one or more planarity members 17 and the sixth lumen 31 is disposed on the second side (side where element 31 is present) of the one or more planarity members 17.
Regarding claim 13, McDaniel teaches wherein the one or more planarity members 17 comprises a first planarity member 17i (one of two elements in figure 12) and a second planarity member 17i (second of two elements in figure 12) that is offset from and aligned with the first planarity member 17i.
Regarding claim 14, McDaniel teaches each of the one or more planarity members 17 has a substantially rectangular cross-section (see figure 6).
Regarding claim 15, McDaniel teaches wherein the one or more planarity members comprise a primary planarity member having a rectangular cross-section with a width in a range of 0.025 to 0.120 inches and a thickness in a range of 0.002 to 0.008 inches (paragraph 0040, lines 13-14).
Regarding claim 19, McDaniel teaches wherein each of the one or more planarity members 17 is formed from a material (paragraph 0040, lines 5-11, “stainless steel” and “ceramic” would have Young’s modulus greater than 20,000 psi) having a Young’s modulus of at least 20,000 psi.
Regarding claim 29, McDaniel teaches a bi-directional steerable catheter assembly (figure 1, including the embodiments shown in figures 6, 7, 7a, 8, 12, 15) comprising:
an elongated catheter shaft section 12 having a distal end (end of element 14 comprising element 38), a proximal end (end of element 12 connected to element 16), and a centerline 15 (figure 6) that extends between the distal end (end of element 14 comprising element 38) and the proximal end (end of element 12 connected to element 16);
at least one planarity member 17 disposed within and attached to the elongated catheter shaft section 12 and extending along the centerline 15, wherein the at least one planarity member 17 has a solid cross-sectional area perpendicular to the centerline (figure 6, paragraph 0040, lines 5-7, element 17 is not a hollow structure) without a closed cell (see figure 6),
wherein the cross- sectional area has a width to thickness ratio of at least 5 to 1 (paragraph 0040, lines 13-14, 0.07/0.005 = 14);
a first deflection lumen (one of the two elements 42 in figure 6) offset from the at least one planarity member 17;
a second deflection lumen (other of two elements 42 in figure 6) offset from the at least one planarity member 17;
a first pull wire (element 32 in one of the two elements 42) disposed within the first deflection lumen and operable to induce deflection of the elongated catheter shaft section in a first direction (paragraph 0065, the direction along which the catheter shaft section gets deflected); and
a second pull wire (element 32 in other of two elements 42) disposed within the second deflection lumen and operable to induce deflection of the elongated catheter shaft section in a second direction (paragraph 0065, the direction along which the catheter shaft section gets deflected).
Regarding claim 30, McDaniel teaches wherein the cross- sectional area of the at least one planarity member has a width to thickness ratio of at least 10 to 1 (paragraph 0040, lines 13-14, 0.07/0.005 = 14).
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 16 is rejected under 35 U.S.C. 103 as being unpatentable over McDaniel et al. (US 2011/0218492 A1).
Regarding claim 16, McDaniel discloses a design of a steerable catheter assembly, as disclosed above in claim 1. While McDaniel teaches wherein each of the one or more planarity members 17 has a length, McDaniel is silent regarding the specifics of a range of 1 inches to 5 inches.
There is no evidence of record that establishes that changing the length of each of the one or more planarity members will result in a difference in function of the McDaniel device. Further, a person having ordinary skill in the art, being faced with modifying the steerable catheter of McDaniel would have a reasonable expectation of success in making such a modification and it appears the steerable catheter would function as intended being given the claimed range. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the range “may” be within the claimed range by offering the claimed range as being optional (see page 24, lines 11-12, “Optionally, … 5 inches”) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of McDaniel to have the range between 1 inches and 5 inches as an obvious matter of design choice within the skill of the art.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over McDaniel et al. (US 2011/0218492 A1) in view of Selkee (US 2014/0135687 A1).
Regarding claims 17 and 18, McDaniel discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 17. McDaniel is silent regarding wherein each of the one or more planarity members comprises at least one row of holes extending along a length of a planarity member and fixedly attaching the planarity member to the elongated catheter shaft section, wherein each of the one or more planarity members comprises a first row of holes and a second row of holes, wherein each of the first row of holes and the second row of holes extends along the length of the planarity member.
However, Selkee teaches a design of a catheter (figure 1) with deflectable distal end wherein each of the one or more members 66A, 66B comprises at least one row of holes 68 extending along a length of a member 66A, 66B and fixedly attaching the member to the elongated catheter shaft section 12, wherein each of the one or more members 66A, 66B comprises a first row of holes (see “F” in figure 3B below) and a second row of holes (see “S” in figure 3B below), wherein each of the first row of holes and the second row of holes extends along the length of the member 66A, 66B for the purpose of creating a very strong interlocking bond between the member and catheter shaft (paragraph 0036, lines 17-20).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the one or more planarity member of McDaniel to incorporate wherein each of the one or more planarity members comprises at least one row of holes extending along a length of a planarity member and fixedly attaching the planarity member to the elongated catheter shaft section, wherein each of the one or more planarity members comprises a first row of holes and a second row of holes, wherein each of the first row of holes and the second row of holes extends along the length of the planarity member as taught by Selkee for the purpose of creating a very strong interlocking bond between the member and catheter shaft (paragraph 0036, lines 17-20).
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Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over McDaniel et al. (US 2011/0218492 A1) in view of Matsuura et al. (US 6,450,948 B1).
Regarding claim 21, McDaniel teaches bi-directional steerable catheter assembly (figure 1, including the embodiments shown in figures 6, 7, 7a, 8, 12, 15) comprising:
an elongated catheter shaft section 12 having a distal end (end of element 14 comprising element 38), a proximal end (end of element 12 connected to element 16), and a centerline 15 (figure 6) that extends between the distal end (end of element 14 comprising element 38) and the proximal end (end of element 12 connected to element 16);
at least one planarity member 17 disposed within and attached to the elongated catheter shaft section 12 and extending along the centerline 17, wherein the at least one planarity member 17 has a substantially rectangular cross-sectional area perpendicular (see figure 6) to the centerline 15;
a first deflection lumen (one of the two elements 42 in figure 6) offset from the at least one planarity member 17;
a second deflection lumen (other of two elements 42 in figure 6) offset from the at least one planarity member 17;
a first pull wire (element 32 in one of the two elements 42) disposed within the first deflection lumen and operable to induce deflection of the elongated catheter shaft section in a first direction (paragraph 0065, the direction along which the catheter shaft section gets deflected); and
a second pull wire (element 32 in other of two elements 42) disposed within the second deflection lumen and operable to induce deflection of the elongated catheter shaft section in a second direction (paragraph 0065, the direction along which the catheter shaft section gets deflected).
McDaniel is silent regarding at least one row of holes extending along a length of the planarity member and fixedly attaching the planarity member to the elongated catheter shaft section.
However, Matsuura teaches a design of a steering catheter (figure 1) comprising at least one row of holes 455 (figure 15) extending along a length of the planarity member 454A, 454B and fixedly attaching the planarity member to the elongated catheter shaft section for the purpose of securely adhering the planarity member and imparting the flexibility as desired (column 6, lines 22-31).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the one or more planarity member of McDaniel to incorporate at least one row of holes extending along a length of the planarity member and fixedly attaching the planarity member to the elongated catheter shaft section as taught by Matsuura for the purpose of securely adhering the planarity member and imparting the flexibility as desired (column 6, lines 22-31).
Regarding claim 22, McDaniel discloses wherein a material of the at least one planarity member has a higher durometer than a material of the elongated catheter shaft section (paragraph 0035, lines 1-8, “polyurethane”, paragraph 0040, lines 5-11, at least “stainless steel” and “ceramic” will have higher durometer than “polyurethane”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Taylor et al. (US 5,676,653): discloses a design of a catheter assembly comprising deflectable member.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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