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 .
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.
Response to Amendment
The amendment filed 01/28/2026 has been entered. Claims 1-8, 10-14, and 16-26 remain pending in the application.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-2, 7-8, 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 20040019359 A1 (hereafter --Worley--), in view of US 6755812 B2 (hereafter --Peterson--).
Regarding Claim 1, Worley discloses a guide catheter for cannulating a coronary sinus from a superior vena cava (see Abstract, see also paragraph [0006]), the guide catheter (see annotated guide catheter in Figures 8 and 9 below) comprising: a flexible elongate shaft comprising: a proximal portion (see paragraph [0090], the proximal portion being the portion of the elongate shaft that is to the left of the “unbiased” straight portion 100); a pre-formed distal portion (see annotated flexible elongate shaft 14 and portions in Figures 8 and 9 below, see also paragraph [0064], see also paragraph [0090] denoting that elongate element is formed into an elephant curve) comprising: a proximal straight zone (see annotated proximal straight zone 100, see also paragraph [0090]), a proximal curved zone extending along a first curved path from the proximal straight zone (see annotated proximal curved zone 102 in Figures 8 and 9 below which curves from portion 100), a distal straight zone extending along a straight path from the proximal curved zone (see annotated distal straight zone 104, see also paragraph [0090] denoting that portion 104 is straight), a distal curved zone extending along a second curved path from the distal straight zone (see annotated distal curve zone 106 and 108) and a distal tip extending from the distal curved zone, wherein the second curved path and the first curved path curve in the same direction (see annotated first and second curved paths in Figures 8 and 9 below).
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Worley fails to disclose the distal curved zone comprising a distal stiffness section and a proximal stiffness section that has a higher stiffness than the distal stiffness section.
Peterson discloses a guide catheter for cannulating a coronary sinus from a superior vena cava (see column 6, lines 15-20), the guide catheter comprising: a flexible elongate shaft (101) comprising: a proximal straight zone, a proximal curved zone, a distal straight zone, and a distal curved zone (see annotated zones in Figure 6B below). Peterson teaches one of the curved zones comprising a distal stiffness section and a proximal stiffness section that has a higher stiffness than the distal stiffness section (see column 6, lines 30-40 denoting that the catheter’s distal end has greater flexibility than the proximal end (thereby the proximal area being more “stiff”), with a transition in flexibility occurring near the preformed deflection location (curved zone) (the proximal stiffness section being the less flexible section before the bend and the distal stiffness section being the more flexible section after the bend, the entire curved zone comprising of both sections).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distal curved zone of the Worley device to have a proximal section with higher stiffness and a distal section with greater flexibility, as Peterson teaches that it is desirable for a catheter to have greater stiffness near the proximal end for control and greater flexibility at the distal end for bending and to result in a curved section and catheter that minimally deflects under normal axial loads (see column 6, lines 30-33).
Regarding Claim 2, Worley as modified discloses the guide catheter of claim 1.
The limitation “wherein the pre-formed distal portion of the flexible elongate shaft has a size and a shape selected such that the pre-formed distal portion of the flexible elongate shaft is supported on a wall of the superior vena cava when locating an ostium of the coronary sinus with the distal tip” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the device disclosed to be steered such that the distal end of element 14 reaches and locates the coronary ostium, the device has a size and shape to be supported on the wall of the superior vena cava when locating an ostium of the coronary sinus with the distal tip (see paragraphs [0006] and Abstract about vena cava, see also paragraphs [0063] and [0068]).
Regarding Claim 7, Worley as modified discloses the guide catheter of claim 1, wherein the distal straight zone has a length of approximately 32.5 millimeters plus or minus five millimeters (see paragraph [0090] denoting portion 104 has a length of 29.7 mm (1.17 inches), which is within the claimed range of plus or minus 32.5 millimeters).
Regarding Claim 8, Worley as modified discloses the guide catheter of claim 1, wherein the distal curved zone has a variable radius of curvature (see paragraph [0090] denoting that portions 106 and 108 have various radius of curvature, 106 having a radius of curvature of 2.83 inches, 108 having a radius of curvature of 1.33 inches).
Regarding Claim 10, Worley as modified discloses the guide catheter of claim 8, wherein the distal curved zone comprises a first segment extending from the distal straight zone along a first curved trajectory having a radius of curvature of approximately seventy-one millimeters plus or minus five millimeters (see annotated first segment in Figure 9 below, see paragraph [0090] denoting that the first segment, being half of the section 106, has a radius of curvature of 2.83 inches, which is 71.882 mm, which is within the claimed range). The terms “segment” and “portion” is being given its broadest reasonable interpretation, “segment” meaning “a portion cut off from a geometric figure by one or more points, lines, or planes: such as the finite part of a line between two points in the line” (see Merriam Webster online definition 1c), “portion” meaning “an often limited part of a whole” (see Merriam Webster online definition 3).
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Regarding Claim 11, Worley as modified discloses the guide catheter of claim 10, wherein the distal curved zone comprises a second segment extending from the first segment along a second curved trajectory having a radius of curvature of approximately twenty-six millimeters plus or minus five millimeters (see annotated second segment in Figure 9 above, see paragraph [0090] denoting that the second segment 108, having a radius of curvature of 1.33 inches, which is 33 mm, which is approximately within the claimed range, the second segment being half of the 108 section). The terms “segment” and “portion” is being given its broadest reasonable interpretation, “segment” meaning “a portion cut off from a geometric figure by one or more points, lines, or planes: such as the finite part of a line between two points in the line” (see Merriam Webster online definition 1c), “portion” meaning “an often limited part of a whole” (see Merriam Webster online definition 3).
Regarding Claim 12, Worley as modified discloses the guide catheter of claim 11, wherein the distal curved zone comprises a third segment extending from the second segment along a third curved trajectory having a radius of curvature of approximately thirty-six millimeters plus or minus five millimeters (see annotated third segment in Figure 9 above, see paragraph [0090] denoting that the second segment 108, having a radius of curvature of 1.33 inches, which is 33 mm, which is approximately within the claimed range, the third segment being the other portion of the 108 section). The terms “segment” and “portion” is being given its broadest reasonable interpretation, “segment” meaning “a portion cut off from a geometric figure by one or more points, lines, or planes: such as the finite part of a line between two points in the line” (see Merriam Webster online definition 1c), “portion” meaning “an often limited part of a whole” (see Merriam Webster online definition 3).
Regarding Claim 13, Worley as modified discloses the guide catheter of claim 12, wherein the distal curved zone comprises a fourth segment extending from the third segment along a fourth curved trajectory having a radius of curvature of approximately sixty-eight millimeters plus or minus five millimeters (see annotated fourth segment in Figure 9 above, see paragraph [0090] denoting that the fourth segment, being the other portion of the section 106, has a radius of curvature of 2.83 inches, which is 71.882 mm, which is within the claimed range). The terms “segment” and “portion” is being given its broadest reasonable interpretation, “segment” meaning “a portion cut off from a geometric figure by one or more points, lines, or planes: such as the finite part of a line between two points in the line” (see Merriam Webster online definition 1c), “portion” meaning “an often limited part of a whole” (see Merriam Webster online definition 3).
Regarding Claim 14, Worley as modified discloses the guide catheter of claim 13, wherein the distal curved zone comprises a fifth segment extending from the fourth segment along a fifth curved trajectory (see annotated fifth segment in Figure 9 above, see the fifth segment being another portion of the section 106). The terms “segment” and “portion” is being given its broadest reasonable interpretation, “segment” meaning “a portion cut off from a geometric figure by one or more points, lines, or planes: such as the finite part of a line between two points in the line” (see Merriam Webster online definition 1c), “portion” meaning “an often limited part of a whole” (see Merriam Webster online definition 3).
Worley fails to disclose the fifth segment having a radius of curvature of approximately one-hundred-twenty-six millimeters plus or minus five millimeters.
The Instant Application does not disclose the fifth segment having a radius of curvature of approximately one-hundred-twenty-six millimeters plus or minus five millimeters solves any problem or is for any particular purpose, nor does it place criticality on the limitation (see paragraph [00159]). It appears that Worley’s outer frame would perform equally and function as intended with a fifth segment having a radius of curvature of approximately one-hundred-twenty-six millimeters plus or minus five millimeters as claimed. Therefore, it would have been obvious to one having ordinary skill in the art to make the fifth segment having a radius of curvature of approximately one-hundred-twenty-six millimeters plus or minus five millimeters, as an obvious matter of design choice within the skill of the art.
Claims 3-6, 16, 18, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over US 20040019359 A1 (hereafter --Worley--), in view of US 6755812 B2 (hereafter --Peterson--), as applied to claim 1 above, in even further view of US 20120136350 A1 (hereafter --Gorshgarian--).
Regarding Claim 3, Worley as modified disclose the guide catheter of claim 1.
Worley fails disclose wherein the proximal curved zone has a variable radius of curvature.
Gorshgarian discloses a guide catheter that has a distal curved portion, a proximal curved portion, and a distal tip (see annotated guide catheter, curved portions, and distal tip in Figure 7D below). Gorshgarian teaches wherein the proximal curved zone has a variable radius of curvature, wherein a first segment having a first radius of curvature; and a second segment having a second radius of curvature that is smaller than the first radius of curvature (see annotated proximal curved zone, comprised of first and second flexure zones 32/34 in Figure 7D below, see paragraph [0153] denoting that the radius of curvature of zone 32 (first segment) being between 3.5 to 11.5 cm, see paragraph [0171] denoting that the zone 34 (second segment) having a radius of curvature between 3 to 25 mm).
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Therefore, it would have been obvious to an ordinary person skilled in the art before the effective filing date of the invention to have the proximal curved zone has a variable radius of curvature, wherein a first segment having a first radius of curvature; and a second segment having a second radius of curvature that is smaller than the first radius of curvature, as by doing so would enable the proximal curved zone (32,24) first segment 32 to transmit axial load and torque over a lesser length L2 of the second segment proximate to or within a respective renal artery, allowing the proximal curved zone to abruptly conform to the artery without fracture, collapse, substantial distortion, significant twisting, or straightening a guide catheter (see paragraph [0157]).
Regarding Claim 4, Worley as modified disclose the guide catheter of claim 3 wherein the proximal curved zone comprises: a first segment having a first radius of curvature; and a second segment having a second radius of curvature that is smaller than the first radius of curvature (see claim 3 rejection above).
Regarding Claim 5, Worley as modified discloses the guide catheter of claim 3.
Worley as modified fails to disclose wherein the first segment extends from the proximal straight zone along a first curved trajectory having a radius of curvature of approximately seven-hundred-ninety-four millimeters plus or minus five millimeters.
The Instant Application does not disclose the first segment having a radius of curvature of approximately seven-hundred-ninety-four millimeters plus or minus five millimeters solves any problem or is for any particular purpose, nor does it place criticality on the limitation (see paragraph [00150]). It appears that Worley’s first segment would perform equally and function as intended with a radius of curvature of approximately seven-hundred-ninety-four millimeters plus or minus five millimeters. Therefore, it would have been obvious to one having ordinary skill in the art to make the first segment section have a radius of curvature of approximately seven-hundred-ninety-four millimeters plus or minus five millimeters, as an obvious matter of design choice within the skill of the art.
Regarding Claim 6, Worley as modified discloses the guide catheter of claim 4.
Worley as modified fails to disclose wherein the second segment extends along a second curved trajectory having a radius curvature of approximately two-hundred-nineteen millimeters plus or minus five millimeters.
The Instant Application does not disclose the second segment having a radius of curvature of approximately two-hundred-nineteen millimeters plus or minus five millimeters solves any problem or is for any particular purpose, nor does it place criticality on the limitation (see paragraph [00151]). It appears that Worley’s second segment would perform equally and function as intended having a radius of curvature of approximately two-hundred-nineteen millimeters plus or minus five millimeters. Therefore, it would have been obvious to one having ordinary skill in the art to make the second segment section have a radius of curvature of approximately two-hundred-nineteen millimeters plus or minus five millimeters, as an obvious matter of design choice within the skill of the art.
Regarding Claim 16, Worley as modified discloses the guide catheter of claim 1.
Worley fails to disclose wherein the proximal curved zone comprises a first stiffness section having a first end portion that extends along a trajectory forming a first angle with the proximal curved zone of approximately ten degrees plus or minus 0.5 degrees.
Gorshgarian teaches wherein the proximal curved zone comprises a first stiffness section (30) having a first end portion that extends along a trajectory forming a first angle with the proximal straight zone of approximately ten degrees plus or minus 0.5 degrees (see paragraph [0157], see paragraph [0146] denoting that the angle between the curved zone 32, and the proximal straight zone comprising of a stiffness section (30) can deflect with respect to each other (alpha 1) in a range of 30 to 180 degrees, meaning the other side (first end portion) of the bend would be at an angle from 0 to 150 degrees, which 10 degrees is within).
Therefore, it would have been obvious to an ordinary person skilled in the art before the effective filing date of the invention to have the guide catheter have a first stiffness section having a first end portion that extends along a trajectory forming a first angle with the proximal curved zone of approximately 0 to 150 degrees, as by doing so would allow the proximal straight zone to transmit axial load and torque over a relatively long length (L1) within the vascular pathway, as taught by Gorshgarian (see paragraph [0157]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first stiffness section having a first end portion that extends along a trajectory forming a first angle with the proximal curved zone of approximately 0 to 150 degrees to about 9.5-10.5 degrees as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see [00160] indicating the angle “may” be within the claimed range).
Regarding Claim 18, Worley as modified discloses the guide catheter of claim 16.
Worley fails to disclose wherein the distal straight zone comprises a second stiffness section having a second end portion that extends along a trajectory forming a second angle with the proximal straight zone of approximately twenty-eight degrees plus or minus 0.5 degrees.
Gorshgarian teaches wherein the distal straight zone comprises a second stiffness section having a second end portion that extends along a trajectory forming a second angle with the proximal straight zone of approximately twenty-eight degrees plus or minus 0.5 degrees (see paragraph [0167] denoting that the angle between the curved zone 34, and the distal straight zone annotated in Figure 7D can deflect with respect to each other (alpha 2) in a range of 45 to 180 degrees, meaning the other side (second end portion) of the bend would be at an angle from 0 to 135 degrees, which 28 degrees is within).
Therefore, it would have been obvious to an ordinary person skilled in the art before the effective filing date of the invention to have the guide catheter have a first stiffness section having a first end portion that extends along a trajectory forming a first angle with the proximal curved zone of approximately 0 to 135 degrees, as by doing so would allow the guide catheter to accommodate flexure or bending at a preferred access angle without fracture, collapse, substantial distortion, or significant twisting of the elongated shaft (see paragraph [0182]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first stiffness section having a first end portion that extends along a trajectory forming a first angle with the proximal curved zone of approximately 0 to 135 degrees to about 27.5 to 28.5 degrees as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see [00163] indicating the angle “may” be within the claimed range).
Regarding Claim 20, Worley as modified discloses the guide catheter of 18.
Worley fails to disclose wherein the proximal stiffness section comprises a third end portion that extends along a trajectory forming a third angle with the proximal straight zone of approximately eighty-seven degrees plus or minus 0.5 degrees.
Gorshgarian teaches wherein the proximal stiffness section comprises a third end portion that extends along a trajectory forming a third angle with the proximal curved zone of approximately eighty-seven degrees plus or minus 0.5 degrees (see paragraph [0157], see paragraph [0146] denoting that the angle between the curved zone 32, and the proximal straight zone comprising of a stiffness section (30) can deflect with respect to each other (alpha 1) on one side (third end portion) in a range of 30 to 180 degrees).
Therefore, it would have been obvious to an ordinary person skilled in the art before the effective filing date of the invention to have the guide catheter have a first stiffness section having a first end portion that extends along a trajectory forming a first angle with the proximal curved zone of approximately 30 to 180 degrees, as by doing so would allow the proximal straight zone to transmit axial load and torque over a relatively long length (L1) within the vascular pathway, as taught by Gorshgarian (see paragraph [0157]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first stiffness section having a first end portion that extends along a trajectory forming a first angle with the proximal curved zone of approximately 30 to 180 degrees to about 86.5-87.5 degrees as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see [00165] indicating the angle “may” be within the claimed range).
Regarding Claim 22, Worley as modified discloses the guide catheter of claim 20.
Worley fails to disclose wherein the distal stiffness section comprises a fourth end portion that extends along a trajectory forming a fourth angle with the proximal straight zone of approximately sixty-two degrees plus or minus 0.5 degrees.
Gorshgarian teaches wherein the distal stiffness section comprises a fourth end portion that extends along a trajectory forming a fourth angle with the proximal straight zone of approximately sixty-two degrees plus or minus 0.5 degrees (see paragraph [0167] denoting that the angle between the curved zone 34, and the distal straight zone annotated in Figure 7D can deflect with respect to each other (alpha 2) on one side (fourth end portion) in a range of 45 to 180 degrees).
Therefore, it would have been obvious to an ordinary person skilled in the art before the effective filing date of the invention to have the guide catheter have a first stiffness section having a first end portion that extends along a trajectory forming a first angle with the proximal curved zone of approximately 45 to 180 degrees, as by doing so would allow the guide catheter to accommodate flexure or bending at a preferred access angle without fracture, collapse, substantial distortion, or significant twisting of the elongated shaft (see paragraph [0182]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first stiffness section having a first end portion that extends along a trajectory forming a first angle with the proximal curved zone of approximately 45 to 180 degrees to about 61.5 to 62.5 degrees as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see [00167] indicating the angle “may” be within the claimed range).
Claims 17, 19, 21, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over US 20040019359 A1 (hereafter --Worley--), in view of US 6755812 B2 (hereafter --Peterson--), in further view of US 20120136350 A1 (hereafter --Gorshgarian--), as applied to claims 1, 16, 20, and 22 above, in even further view of US 5811043 A (hereafter --Horrigan--).
Regarding Claim 17, Worley as modified discloses the guide catheter of claim 16.
Worley as modified fails to disclose wherein the first stiffness section comprises a length of approximately four-hundred-eighty-five millimeters and has a durometer of approximately 72D plus or minus 5D. The Examiner notes that Worley functions similarly to the present invention, as the invention is designed to go through a vascular pathway into the heart (see paragraph [0014]), as well as it’s noted in the specification of Worley that variations in size and shape of the elongate element 14, being either reducing or enlarging the delivery apparatus, are sometimes needed to accommodate differing patient anatomies (see paragraph [0088]).
The Instant Application does not disclose the first stiffness section having a length of approximately four-hundred-eighty-five millimeters solves any problem or is for any particular purpose, nor does it place criticality on the limitation (see paragraph [00162]). It appears that Worley’s first stiffness section would perform equally and function as intended having a length of approximately four-hundred-eighty-five millimeters. Therefore, it would have been obvious to one having ordinary skill in the art to make the first stiffness section have a length of approximately four-hundred-eighty-five millimeters, as an obvious matter of design choice within the skill of the art. Additionally, Gorshgarian teaches that renal arterial anatomy also may vary significantly from patient to patient, in that inter-patient variation may be seen, for example, in relative tortuosity, diameter, length and/or atherosclerotic plaque burden, as well as in the take-off angle at which a renal artery branches from the aorta, in which the delivery apparatus would have to account for when being made (see paragraph [0097]). Therefore, it would have been obvious to one having ordinary skill in the art to make the first stiffness section have a length of approximately four-hundred-eighty-five millimeters, as length changes to the apparatus may be necessary to account for inter-patient variation as taught by Gorshgarian (see paragraph [0097]).
Worley as modified further fails to disclose wherein the first stiffness section has a durometer of approximately 72D plus or minus 5D.
Horrigan discloses methods of manufacturing of guide catheters (see Abstract), as well as discloses a guide catheter (see annotated guide catheter in Figure 1 below). Horrigan teaches a guide catheter made from multiple durometer readings of tubing, one section having a durometer of approximately 72D (see column 4, lines 30-34).
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Therefore, it would have been obvious to an ordinary person skilled in the art before the effective filing date of the invention to have the first stiffness section to be made of a material with a durometer of approximately 72D plus or minus 5D, as by doing so would since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 19, Worley as modified discloses the guide catheter of claim 18.
Worley as modified fails to disclose wherein the second stiffness section comprises a length of approximately fifty millimeters and has a durometer of approximately 63D plus or minus 5D.
The Instant Application does not disclose the second stiffness section having a length of approximately fifty millimeters solves any problem or is for any particular purpose, nor does it place criticality on the limitation (see paragraph [00164]). It appears that Worley’s second stiffness section would perform equally and function as intended having a length of approximately fifty millimeters. Therefore, it would have been obvious to one having ordinary skill in the art to make the second stiffness section have a length of approximately fifty millimeters, as an obvious matter of design choice within the skill of the art.
Worley as modified further fails to disclose wherein the second stiffness section has a durometer of approximately 63D plus or minus 5D.
Horrigan teaches a guide catheter made from multiple durometer readings of tubing, the transition tube (15) of the catheter, having an option of durometers ranging from 50D-60D (see column 4, lines 44-47).
Therefore, it would have been obvious to an ordinary person skilled in the art before the effective filing date of the invention to have the second stiffness section to be made of a material with a durometer of approximately 50-60D, as by doing so would since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the second stiffness section from a durometer of 50D to 60D to about 58D to 68D as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see [00164] indicating the angle “may” be within the claimed range).
Regarding Claim 21, Worley as modified discloses the guide catheter of claim 20.
Worsley as modified fails to disclose wherein the proximal stiffness section comprises a length of approximately thirty-five millimeters and has a durometer of approximately 55D plus or minus 5D.
The Instant Application does not disclose the proximal stiffness section having a length of approximately thirty-five millimeters solves any problem or is for any particular purpose, nor does it place criticality on the limitation (see paragraph [00166]). It appears that Worley’s proximal stiffness section would perform equally and function as intended having a length of approximately thirty-five millimeters. Therefore, it would have been obvious to one having ordinary skill in the art to make the proximal stiffness section have a length of approximately thirty-five millimeters, as an obvious matter of design choice within the skill of the art.
Worley as modified further fails to disclose wherein the proximal stiffness section has a durometer of approximately 55D plus or minus 5D.
Horrigan teaches a guide catheter made from multiple durometer readings of tubing, the transition tube (15) of the catheter, having an option of durometers ranging from 50D-60D, preferably 55D (see column 4, lines 44-47).
Therefore, it would have been obvious to an ordinary person skilled in the art before the effective filing date of the invention to have the proximal stiffness section to be made of a material with a durometer of approximately 55D plus or minus 5D, as by doing so would since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 23, Worley as modified discloses the guide catheter of claim 22.
Worley as modified fails to disclose wherein the distal stiffness section comprises a length of approximately thirty-eight millimeters and has a durometer of approximately 35D plus or minus 5D.
The Instant Application does not disclose the distal stiffness section having a length of approximately thirty-eight millimeters solves any problem or is for any particular purpose, nor does it place criticality on the limitation (see paragraph [00168]). It appears that Worley’s distal stiffness section would perform equally and function as intended having a length of approximately thirty-eight millimeters. Therefore, it would have been obvious to one having ordinary skill in the art to make the distal stiffness section have a length of approximately thirty-eight millimeters, as an obvious matter of design choice within the skill of the art.
Worley as modified further fails to disclose wherein the distal stiffness section has a durometer of approximately 35D plus or minus 5D.
Horrigan teaches a guide catheter made from different materials with different hardness levels and therefore having multiple durometer readings of the catheter tubing, having an option of a durometer of 35D (see column 4, lines 30-34).
Therefore, it would have been obvious to an ordinary person skilled in the art before the effective filing date of the invention to have the distal stiffness section to be made of a material with a durometer of approximately 35D plus or minus 5D, as by doing so would since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 24, Worsley as modified discloses the guide catheter of claim 1.
Worley as modified fails to disclose wherein the distal tip comprises a length of approximately two millimeters and has a durometer of approximately 25D plus or minus 5D.
The Instant Application does not disclose the distal tip having a length of approximately two millimeters solves any problem or is for any particular purpose, nor does it place criticality on the limitation (see paragraph [00175]). It appears that Worley’s distal tip would perform equally and function as intended having a length of approximately two millimeters. Therefore, it would have been obvious to one having ordinary skill in the art to make the distal tip have a length of approximately two millimeters, as an obvious matter of design choice within the skill of the art.
Worley as modified further fails to disclose wherein the distal tip has a durometer of approximately 25D plus or minus 5D.
Horrigan teaches a guide catheter made from different materials with different hardness levels and therefore having multiple durometer readings of the catheter tubing, having an option of the distal tip durometer be 25D-40D (see column 5, lines 12-15).
Therefore, it would have been obvious to an ordinary person skilled in the art before the effective filing date of the invention to have the distal tip to be made of a material with a durometer of approximately 25D-40D, as doing so would give the distal end more flexibility, aiding in tip placement (see column 5, lines 12-14). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the second stiffness section having a durometer of 25D to 40D to about 20D to 30D as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see [00169] indicating the angle “may” be within the claimed range).
Claims 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over US 20040019359 A1 (hereafter --Worley--), in view of US 6755812 B2 (hereafter --Peterson--), as applied to claim 1 above, in view of US 20150141819 A1 (hereafter --Linden--).
Regarding Claim 25, Worley as modified discloses the guide catheter of claim 1.
Worley fails to disclose further comprising a fitting connected to a proximal end of the proximal portion, the fitting including indicia indicating a plane of curvature of the pre-formed distal portion.
Linden discloses a guide catheter (see annotated guide catheter in Figures 7-9). Linden teaches a fitting (340) connected to a proximal end of the proximal portion (360), the fitting including indicia (350) indicating a plane of curvature (335) of the pre-formed distal portion, the protrusion comprising an elongate body curved in a direction the pre-formed distal portion is curved (see annotated indica 350, being an elongate body with an arrow (352) that curves in the same direction as the preformed curvature 335 in Figure 10, see also paragraph [0039]).
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Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a fitting connected to a proximal end of the proximal portion, the fitting including indicia indicating a plane of curvature of the pre-formed distal portion, as by doing so would enable the device to provide an indication of the orientation of the device and more specifically the orientation of the preformed curvature, as taught by Linden (see paragraph [0039]).
Regarding Claim 26, Worley as modified discloses the guide catheter of claim 25, wherein the indicia comprises a protrusion illustrating a direction of pre-curvature of the pre-formed distal portion, the protrusion comprising an elongate body curved in a direction the pre-formed distal portion is curved (see claim 25 rejection).
Conclusion
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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