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 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 5-9 and 12-18 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.
The term “relatively larger than other parts of the wire lumen” in claims 5, 12, 17 and 18 is a relative term which renders the claim indefinite. The term “relatively larger” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to what other parts of the wire lumen the claim refers to in comparison of the branching lumen, and/or how large is relatively larger. Appropriate clarification or amendment 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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mahurkar, US 5,374,245.
Regarding claim 1, Mahurkar discloses a catheter (dual-lumen catheter 10, Figs. 1-7, 13-28) having a shaft (11, col. 5, lines 15-30), the shaft comprising: a wire lumen (lumen 14, broadest reasonable interpretation “BRI” of claim is that lumen is capable of having a wire, no wire is positively recited, col. 5, lines 15-30) that extends in a longitudinal direction of the shaft; a sensor lumen (lumen 13, BRI of claim is that lumen is capable of having a sensor, no sensor is positively recited, col. 5, lines 15-30) that is arranged side by side with the wire lumen (Fig. 2, col. 5, lines 15-30, parallel lumens 13/14); a projection part (tip 15, Figs. 3-4, col. 5, lines 30-40) that includes the wire lumen (14), projects to a more distal side than a distal end of the sensor lumen (Figs. 3-4, col. 5, lines 30-40), and has a distal end opening (16, Figs. 2-4, col. 5, lines 43-50) in communication with the wire lumen (14) at a distal end of the projection part (col. 5, lines 43-50); and a first notch (aperture 17) that is a notch formed on a more proximal end side than the projection part, and is in communication with the wire lumen, wherein the first notch is formed on a side surface of the shaft (see Fig. 5 side of body 11, col. 5, lines 43-55), the side surface being positioned on an opposite side of the sensor lumen (13) relative to a center axis of the wire lumen (see Fig. 5), and the shaft includes, in a section including the first notch, a bottom portion (see Fig. 5) facing the first notch and a pair of side walls (see Fig. 5, walls of aperture 17) extending from the bottom portion to the opposite side of the sensor lumen (col. 5, lines 43-54).
Regarding claim 3, Mahurkar discloses the catheter according to claim 1, wherein the shaft (11) further comprises a second notch (aperture 18, Figs. 3-4, col. 5, lines 40-50) that is a notch formed on a more distal end side or the more proximal end side than the first notch (col. 5, lines 43-55), and is in communication with the wire lumen (14), the second notch is formed on the side surface of the shaft, the side surface being on a same side as the first notch (see Fig. 2), and the shaft includes, in a section with the second notch, a bottom portion (see Fig. 2) facing the second notch and a pair of side walls (see Fig. 5, 18 is same as 17) extending from the bottom portion to the opposite side of the sensor lumen (see Fig. 2).
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, 4, 10, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mahurkar in view of Makino et al, US 2013/0053763 A1.
Regarding claim 2, Mahurkar discloses the catheter according to claim 1, but does not expressly teach wherein the first notch has an elliptical shape including a first long axis extending along the center axis of the wire lumen and a first short axis extending vertically to the center axis in side view of the wire lumen, and a length of the first short axis is equal to an inner diameter of the wire lumen.
However, Makino, in the same field of art, teaches a catheter (1, see Figs. 2-4, para [0049]) having a shaft (12) with a first lumen (16a) and a second lumen (16b), and a projection part (11) that projects to a more distal end than the first lumen, where a first notch (23) is formed on a side surface of the shaft, a bottom portion facing the first notch and a pair of side walls extending from the bottom portion to the opposite side of the second lumen (see Fig. 2), and where the first notch has an elliptical shape (para [0049]) including a first long axis (see Fig. 3) extending along the center axis of the wire lumen and a first short axis (d2) extending vertically to the center axis in side view of the wire lumen (Fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the aperture/notch of Mahurkar with an elliptical shape having a first long axis and a first short axis as taught by Makino in order to provide the stated advantages of providing adequate flow path for blood flow and preventing suction and closure of the hole (see Makino, paras [0050]-[0052]); and also because a change in shape/size is an obvious matter of design choice within the skill of the art and an elliptical shape would function the same as an aperture with a circular shape. MPEP 2144.04(IV)(A).
Makino is silent as to a length of the first short axis is equal to an inner diameter of the wire lumen. 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 device of Mahurkar to have a length of the first short axis equal to an inner diameter of the wire lumen since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Mahurkar would not operate differently with the claimed diameter and since the shape of the opening/aperture to allow blood flow and/or passage of wires would function appropriately having the claimed diameter.
Regarding claim 10, Mahurkar as modified discloses the catheter according to claim 2, and Mahurkar further teaches wherein the shaft (11) further comprises a second notch (aperture 18, Figs. 3-4, col. 5, lines 40-50) that is a notch formed on a more distal end side or the more proximal end side than the first notch (col. 5, lines 43-55), and is in communication with the wire lumen (14), the second notch is formed on the side surface of the shaft, the side surface being on a same side as the first notch (see Fig. 2), and the shaft includes, in a section with the second notch, a bottom portion (see Fig. 2) facing the second notch and a pair of side walls (see Fig. 5, 18 is same as 17) extending from the bottom portion to the opposite side of the sensor lumen (see Fig. 2).
Regarding claims 4 and 11, Mahurkar discloses the catheter according to claim 3, but does not expressly teach wherein the second notch has an elliptical shape including a second long axis extending along the center axis of the wire lumen and a second short axis extending vertically to the center axis in side view of the wire lumen, and a length of the second short axis is equal to the inner diameter of the wire lumen and a length of the second long axis is shorter than a length of the first long axis of the first notch.
However, Makino, in the same field of art, teaches a catheter (1, see Figs. 2-4, para [0049]) having a shaft (12) with a first lumen (16a) and a second lumen (16b), and a projection part (11) that projects to a more distal end than the first lumen, where a first notch (23) is formed on a side surface of the shaft, a bottom portion facing the first notch and a pair of side walls extending from the bottom portion to the opposite side of the second lumen (see Fig. 2), and where the first notch has an elliptical shape (para [0049]) including a first long axis (see Fig. 3) extending along the center axis of the wire lumen and a first short axis (d2) extending vertically to the center axis in side view of the wire lumen (Fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the aperture/notch of Mahurkar with an elliptical shape having a second long axis and a second short axis as taught by Makino in order to provide the stated advantages of providing adequate flow path for blood flow and preventing suction and closure of the hole (see Makino, paras [0050]-[0052]); and also because a change in shape/size is an obvious matter of design choice within the skill of the art and an elliptical shape would function the same as an aperture with a circular shape. MPEP 2144.04(IV)(A).
Mahurkar and Makino are silent as to a length of the second short axis is equal to the inner diameter of the wire lumen and a length of the second long axis is shorter than a length of the first long axis of the first notch. 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 device of Mahurkar to have a length of the second short axis is equal to the inner diameter of the wire lumen and a length of the second long axis is shorter than a length of the first long axis of the first notch since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Mahurkar would not operate differently with the claimed diameter and/or lengths and since the shape of the opening/aperture to allow blood flow and/or passage of wires would function appropriately having the claimed diameter and/or different lengths where one length is longer or shorter than the other length.
Claims 5-9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mahurkar in view of Bonnette et al, US 2006/0129091 A1.
Regarding claims 5 and 17, Mahurkar discloses the catheter according to claims 1 and 3, but is silent as to wherein the shaft further comprises, between a distal end and a proximal end of the shaft, a branching lumen that extends from the wire lumen, and a branching part that is formed at a connection portion between the wire lumen and the branching lumen, a distal end side of the branching lumen is connected to the wire lumen, a proximal end side of the branching lumen is positioned on the more proximal end side of the shaft than a distal end side, the proximal end side of the branching lumen is in communication with an outside through a port formed on a side surface of the shaft, the branching part includes a large diameter portion with an inner diameter of a lumen relatively larger than other parts of the wire lumen, and a boundary wall separating the wire lumen and the branching lumen from each other on the more proximal end side than the large diameter portion.
However, Bonnette, in the same field of art, teaches the a catheter (see Fig. 5, para [0068]) with a shaft (18) having a wire lumen (110) and further comprises, between a distal end and a proximal end of the shaft, a branching lumen (82) that extends from the wire lumen (110), and a branching part (62) that is formed at a connection portion (portion of 12 that connects both 82 and 62, see Fig. 5) between the wire lumen and the branching lumen, a distal end side of the branching lumen (82) is connected to the wire lumen (110, Fig. 5), a proximal end side of the branching lumen is positioned on the more proximal end side of the shaft than a distal end side (proximal side of 82, Fig. 5), the proximal end side of the branching lumen is in communication with an outside through a port (72) formed on a side surface of the shaft, the branching part includes a large diameter portion (see annotated Fig. 5) with an inner diameter of a lumen relatively larger than other parts of the wire lumen (inner diameter of 62 is larger than 110, Fig. 5), and a boundary wall (see annotated Fig. 5) separating the wire lumen and the branching lumen from each other on the more proximal end side than the large diameter portion (see annotated Fig. 5 below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the branching lumen of Bonnette with the catheter of Mahurkar in order to provide the advantages of providing a junction being suitably effected to provide for a smooth and continuous coupling of the catheter tubes (see Bonnette, para [0068]), and because it would involve use of one known type of proximal catheter handle structure for another that leads to predictable results and a reasonable expectation of success.
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Regarding claim 6, Mahurkar as modified by Bonnette teaches the catheter according to claim 5, and Bonnette further teaches wherein the port (72) is inclined relative to the center axis of the shaft (axis of 12), and a distal end of the boundary wall is positioned at the same position as a distal end of the port or on the more distal end side than the distal end of the port in the longitudinal direction of the shaft (see annotated Fig. 5 above).
Regarding claim 7, Mahurkar as modified by Bonnette teaches the catheter according to claim 5, however, Bonnette is silent as to wherein a length in the longitudinal direction of the shaft of the boundary wall is equal to or longer than a length in the longitudinal direction of the shaft of the port. 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 device of Mahurkar as modified by Bonnette to have a length in the longitudinal direction of the shaft of the boundary wall is equal to or longer than a length in the longitudinal direction of the shaft of the port since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Mahurkar as modified by Bonnette would not operate differently with the claimed lengths and would function appropriately having the claimed lengths.
Regarding claim 8, Mahurkar as modified by Bonnette teaches the catheter according to claim 5, and Bonnette further teaches wherein the branching part (62) further includes a raised portion (wall on distal side of 62 that is tapered between 72 and 82) that is raised toward a side of the extending branching lumen, in an area on the more distal end side than the large diameter portion and on the opposite side of the extending branching lumen, in an inner peripheral surface defining the wire lumen (see annotated Fig. 5 above).
Regarding claim 9, Mahurkar as modified by Bonnette teaches the catheter according to claim 8, and Bonnett further teaches wherein, in a first case that a wire is inserted to the wire lumen from the distal end opening, a proximal end portion of the wire is brought into contact with the raised portion and guided toward the branching lumen (see para [0068]), and in a second case that a wire is inserted to the wire lumen from the proximal end side of the shaft, the distal end portion of the wire is brought into contact with the boundary wall to suppress advancement of the distal end portion of the wire toward the branching lumen (see para [0068], since structure is identical, then Bonnette is capable of performing both functions in each case as stated above).
Claims 12-16, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mahurkar and Makino as applied to claims 2 and 4 above, and further in view of Bonnette.
Regarding claims 12 and 18, Mahurkar as modified by Makino teaches the catheter according to claims 2 and 4, but does not expressly teach wherein the shaft further comprises, between a distal end and a proximal end of the shaft, a branching lumen that extends from the wire lumen, and a branching part that is formed at a connection portion between the wire lumen and the branching lumen, a distal end side of the branching lumen is connected to the wire lumen, a proximal end side of the branching lumen is positioned on the more proximal end side of the shaft than a distal end side, the proximal end side of the branching lumen is in communication with an outside through a port formed on a side surface of the shaft, the branching part includes a large diameter portion with an inner diameter of a lumen relatively larger than other parts of the wire lumen, and a boundary wall separating the wire lumen and the branching lumen from each other on the more proximal end side than the large diameter portion.
However, Bonnette, in the same field of art, teaches the a catheter (see Fig. 5, para [0068]) with a shaft (18) having a wire lumen (110) and further comprises, between a distal end and a proximal end of the shaft, a branching lumen (82) that extends from the wire lumen (110), and a branching part (62) that is formed at a connection portion (portion of 12 that connects both 82 and 62, see Fig. 5) between the wire lumen and the branching lumen, a distal end side of the branching lumen (82) is connected to the wire lumen (110, Fig. 5), a proximal end side of the branching lumen is positioned on the more proximal end side of the shaft than a distal end side (proximal side of 82, Fig. 5), the proximal end side of the branching lumen is in communication with an outside through a port (72) formed on a side surface of the shaft, the branching part includes a large diameter portion (see annotated Fig. 5) with an inner diameter of a lumen relatively larger than other parts of the wire lumen (inner diameter of 62 is larger than 110, Fig. 5), and a boundary wall (see annotated Fig. 5) separating the wire lumen and the branching lumen from each other on the more proximal end side than the large diameter portion (see annotated Fig. 5 below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the branching lumen of Bonnette with the catheter of Mahurkar in order to provide the advantages of providing a junction being suitably effected to provide for a smooth and continuous coupling of the catheter tubes (see Bonnette, para [0068]), and because it would involve use of one known type of proximal catheter handle structure for another that leads to predictable results and a reasonable expectation of success.
Regarding claim 13, Makurkar as modified discloses the catheter according to claim 12, and Bonnette further teaches wherein the port (72) is inclined relative to the center axis of the shaft (axis of 12), and a distal end of the boundary wall is positioned at the same position as a distal end of the port or on the more distal end side than the distal end of the port in the longitudinal direction of the shaft (see annotated Fig. 5 above).
Regarding claim 14, Makurkar as modified discloses the catheter according to claim 12, but is silent as to wherein a length in the longitudinal direction of the shaft of the boundary wall is equal to or longer than a length in the longitudinal direction of the shaft of the port. 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 device of Mahurkar as modified by Bonnette to have a length in the longitudinal direction of the shaft of the boundary wall is equal to or longer than a length in the longitudinal direction of the shaft of the port since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Mahurkar as modified by Bonnette would not operate differently with the claimed lengths and would function appropriately having the claimed lengths.
Regarding claim 15, Makurkar as modified discloses the catheter according to claim 12, and Bonnette further teaches wherein the branching part further includes a raised portion that is raised toward a side of the extending branching lumen, in an area on the more distal end side than the large diameter portion and on the opposite side of the extending branching lumen, in an inner peripheral surface defining the wire lumen.
Regarding claim 16, Makurkar as modified discloses the catheter according to claim 15, and Bonnette further teaches wherein, in a first case that a wire is inserted to the wire lumen from the distal end opening, a proximal end portion of the wire is brought into contact with the raised portion and guided toward the branching lumen (see para [0068]), and in a second case that a wire is inserted to the wire lumen from the proximal end side of the shaft, the distal end portion of the wire is brought into contact with the boundary wall to suppress advancement of the distal end portion of the wire toward the branching lumen (see para [0068], since structure is identical, then Bonnette is capable of performing both functions in each case as stated above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATRINA M STRANSKY whose telephone number is (571)270-3843. The examiner can normally be reached Monday-Friday 8:30 am-5:00 pm EST.
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/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700