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 3 is objected to because of the following informalities: lines 2- 3- “wherein torque applied at the proximal end of the catheter is configured to rotate the sidewall 360 degrees about the longitudinal axis” should be amended to - - wherein the torque applied at the proximal end of the catheter is configured to rotate the sidewall 360 degrees about the longitudinal axis - - since it is clear that “torque applied to the sidewall at the proximal end of the catheter” is the same torque recited in claim 3, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: line 1- “a proximal end of the catheter” should be amended to - - [[a]] the proximal end of the catheter - - since it is clear that applicant is referring to the same proximal end of the catheter recited in claim 14 at line 2, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8, 13 and 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.
Claim 8 recites the limitation "the longitudinal axis" in lines 1- 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the blood vessel" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the blood vessel" in lines 2- 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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) 9 is/are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Ito et al. (US Pub. No. 2021/0308416 A1).
Regarding claim 9, Ito discloses an intravascular catheter, comprising:
a tubular sidewall (24) (Figs. 3- 6), having a longitudinal axis, the sidewall (24) comprising a first number of first wires (25A) (Figs. 3- 5) and a second number of second wires (25B, 26) (Figs. 3- 5) (P. [0038] - - In the exemplary embodiment, all the second wire filaments 26 and all the thin wire filaments 25B have the same outer diameter and cross-sectional area. All the first wire filaments 25 and the second wire filaments 26 are formed of the same material; it is noted that since filaments 25B and 26 are equivalent structures, filaments 25B and 26 are considered the second number of wires), the second number greater than the first number (Ps. [0033], [0038] - - among the first wire filaments 25, four are thick wire filaments 25A, and four are thin wire filaments 25B; the number of second wire filaments 26 is eight; it is noted that since the number of second wires (25B, 26) equal 12 and the number of first wires (25A) equal 4, the second number greater than the first number), wherein:
the first wires (25A) have a first cross-sectional area and are helically wrapped around the longitudinal axis in a first direction (Y1) (Fig. 2) without crossing over one another (See Figs. 2, 5) (P. [0032] - - The first wire filaments 25 are helically wound in a first direction Y1 of a circumferential direction Y toward a distal end direction X1 of the tubular body 2), and the second wires (25B, 26) have a second cross-sectional area less than the first cross-sectional area (Ps. [0033], [0038] - - The thick wire filaments 25A have cross sections larger than those of the thin wire filaments 25B; all the second wire filaments 26 and all the thin wire filaments 25B have the same outer diameter and cross-sectional area), wherein the second wires (25B, 26) comprise (a) a first group (25B) wound in the first direction (Y1) and that do not cross over the first wires (25A), and (b) a second group (26) wound in a second direction (Y2) (Fig. 2) opposite the first direction (Y1) (P. [0032] - - The second wire filaments 26 are wound in a second direction Y2, which is a direction opposite to the first direction Y1, of the circumferential direction Y toward the distal end direction X1 of the tubular body 2), and wherein the wires in the second group (26) are interwoven with the first wires (25A) and the first group (25B) of the second wires (25B, 26) (See Fig. 5) (P. [0032] - - a plurality of second wire filaments 26 intersecting with the first wire filaments 25 … The first wire filaments 25 and the second wire filaments 26 intersect with each other by being wound in opposite directions).
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(s) 1, 3- 4 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okamura et al. (US Pub. No. 2022/0203070 A1).
Regarding claim 1, Okamura discloses an intravascular catheter, comprising:
an elongate tubular sidewall (2, 22) (Figs. 1, 3, 5, 7) defining a lumen (21) (Figs. 1, 5, 7) extending therethrough and having a proximal end, a distal end, and a length between the proximal and distal ends, the sidewall (2, 22) comprising a plurality of filaments, at least some of the filaments being interwoven with other filaments of the plurality of filaments (P. [0049] - - In the tubular body 22, a reinforcing body may or may not be embedded in a range from the proximal end to a predetermined position in the distal direction. The reinforcing body can be formed by braiding a plurality of strands into a tubular shape), wherein the catheter is configured to be positioned around a turn in a blood vessel (104) (Figs. 4B, 9B, 10) having a radius of curvature no greater than 24 mm, and wherein, while the distal end of the catheter (30) (Figs. 2A- 2C, 4A- 4B, 6A-6C, 9A- 12) is distal of the turn, the lumen remains at least 70 percent patent while torque applied to the sidewall at the proximal end of the catheter is transmitted to the distal end (Ps. [0044], [0078] - - when a proximal end portion of the catheter 1 is rotated in a direction in which the catheter 1 is wound toward the distal side, a rotational force is efficiently transmitted to the distal side, and thus the catheter 1 may be rather easily pushed in the distal direction; For example, as illustrated in FIG. 10, even when the second bending portion 27 has the radius of curvature R2 of about 10 mm to 20 mm and is rapidly bent, kinking of the catheter 1 can be prevented due to the presence of the reinforcing body 40).
It is noted that even though Okamura does not explicitly disclose a blood vessel having a radius of curvature no greater than 24 mm, Okamura discloses a distal end of the catheter having a radius of curvature of about 10 mm to 20 mm and as such, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention that a distal end of the catheter having a radius of curvature of about 10 mm to 20 mm is capable of predictably navigating through a blood vessel having a radius of curvature no greater than 24 mm. It is further noted that since the distal end of the catheter is rapidly bent, without kinking as the proximal end of the catheter is rotated, the catheter lumen is capable of remaining at least 70 percent patent while torque applied to the sidewall at the proximal end of the catheter is transmitted to the distal end.
Regarding claim 3, Okamura further discloses wherein the sidewall (2, 22) comprises a longitudinal axis extending along its length, and wherein torque applied at the proximal end of the catheter is configured to rotate the sidewall 360 degrees about the longitudinal axis (P. [0081] - - the rotational force can be rather efficiently transmitted to the distal side along a spiral of the shaped portion 24, and as illustrated in FIG. 11; it is noted that the rotating arrow shown in Fig. 11 is rotating 360 degrees).
Regarding claim 4, Okamura further discloses wherein, when the catheter is positioned around the turn and the torque is applied while the lumen remains at least 70 percent patent, an inserted length of the catheter is at least 50 percent (P. [0050] - - An effective length of the tubular body 2 is preferably 800 mm to 1800 mm, more preferably 1000 mm to 1800 mm, and still more preferably 1000 mm to 1500 mm … The effective length of the tubular body 2 is a length of a portion that is insertable into a blood vessel, a sheath, or the like. In the present embodiment, the effective length is a length from a distal end of the anti-kink protector 4 to a distal end of the tubular body 2).
Regarding claim 7, Okamura further discloses wherein the turn in the blood vessel has a bend angle that is greater than or equal to 120 degrees (P. [0078] - - For example, as illustrated in FIG. 10, even when the second bending portion 27 has the radius of curvature R2 of about 10 mm to 20 mm and is rapidly bent, kinking of the catheter 1 can be prevented due to the presence of the reinforcing body 40).
It is noted that even though Okamura does not explicitly disclose wherein the turn in the blood vessel has a bend angle that is greater than or equal to 120 degrees, Okamura discloses a distal end of the catheter having a radius of curvature of about 10 mm to 20 mm and as such, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention that a distal end of the catheter having a radius of curvature of about 10 mm to 20 mm is capable of predictably navigating through a the blood vessel has a bend angle that is greater than or equal to 120 degrees).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ito et al. (US Pub. No. 2021/0308416 A1).
Regarding claim 10, Ito discloses the apparatus of claim 9, Ito further disclosing wherein the second number (25B, 26) is at least three times greater than the first number (25A) (Ps. [0033], [0038] - - among the first wire filaments 25, four are thick wire filaments 25A, and four are thin wire filaments 25B; the number of second wire filaments 26 is eight; it is noted that since the number of second wires (25B, 26) equal 12 and the number of first wires (25A) equal 4, the second number greater than the first number and the second number (25B, 26) is at least three times greater than the first number (25A)) AND Ito further discloses the number of thick wires and thin wires is not particularly limited (P. [0036), but Ito does not explicitly disclose
(claim 10) wherein the second number is at least five times greater than the first number.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Ito to have a ratio of wherein the second number is at least five times greater than the first 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 Ito would not operate differently with the claimed ratio and since the number of first number filaments and second number filaments are not particularly limited (P. [0036]). Further, applicant places no criticality on the ratio claimed, indicating simply that “at least 5, 6, 7, 8, 9 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 times as many first filaments 130 as second filaments132” (See P. [0029] of applicant’s Specification).
Claim(s) 11- 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ito et al. (US Pub. No. 2021/0308416 A1) in view of Truckai (US Pat. No. 5,019,057).
Regarding claim 11- 12, Ito discloses the apparatus of claim 9, Ito further disclosing depending on the wire filaments, the first wire filaments 25 and the second wire filaments 26 may have different outer diameters, cross-sectional areas, and the like, and may be made of different materials (P. [0038]) and cross-sectional shapes of the first wire filaments 25 and the second wire filaments 26 are not limited to a circle, and may be, for example, an ellipse, a square, a rectangle, an oval, or the like (P. [0039]), but Ito does not explicitly disclose
(claim 11) wherein a cross-sectional shape of the first wires is different than a cross-sectional shape of the second wires;
(claim 12) wherein the first wires have a rectangular cross-sectional shape and the second wires have a circular cross-sectional shape.
However, Truckai teaches a catheter having reinforcing strands in the same field of endeavor (Abstract)
(claim 11) wherein a cross-sectional shape of the first wires (18b, 20b) (Fig. 3) is different than a cross-sectional shape of the second wires (24, 26) (Fig. 3);
(claim 12) wherein the first wires (18b, 20b) have a rectangular cross-sectional shape and the second wires (24, 26) have a circular cross-sectional shape (Col. 4, l. 44- 53 - - As a further advantage of this embodiment, the excellent torsional and longitudinal stiffness of the flat wires 18b, 20b is provided to the catheter, while the interstices between the wires to expose inner tubular layer 12b can be relatively enlarged by the presence of the mixed types of wire, for better bonding between inner layer 12b and outer layer 22. Round wires 24, 26 can lift the flat wires away from the surface of tubular layer 12b, to cause plastic material from outer layer 22 to find more surface contact with layer 12b).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the first wires and second wires such that the first wires have a rectangular cross-sectional shape and the second wires have a different circular cross-sectional shape according to the teachings of Truckai because the flat wires would provide excellent torsional and longitudinal stiffness while the round wires would allow for better bonding to the catheter layers by lifting the flat wires away from the surface of a first tubular layer, to cause plastic material from outer layer to find more surface contact with the first tubular layer (Truckai - - Col. 4, l. 44- 53).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ito et al. (US Pub. No. 2021/0308416 A1) in view of Tsukumo et al. (US Pub, No. 2010/0057052 A1).
Regarding claim 13, Ito discloses the apparatus of claim 9, but Ito does not disclose
(claim 13) wherein the sidewall defines a lumen, and wherein a proximal end of the catheter is configured to be fluidly coupled to a negative pressure source to aspirate occlusive material within the blood vessel into and through the lumen.
However, Tsukumo teaches a catheter having reinforcing strands in the same field of endeavor (Abstract)
(claim 13) wherein the sidewall defines a lumen, and wherein a proximal end of the catheter is configured to be fluidly coupled to a negative pressure source to aspirate occlusive material within the blood vessel into and through the lumen (Ps. [0001], [0002], [0094] - - a medical catheter tube for example for … for thrombotic suction; Catheter tubes are hollow medical devices that are used as inserted in the cavity, duct, blood vessel, and others in the body, specifically for … thrombotic suction … There are a variety of requirements on these catheter tubes, but such a catheter mainly demands superior usability allowing rapid, accurate and selective insertion thereof, for example, into thin complicated-patterned blood vessel).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the device of Ito such that the sidewall defines a lumen, and wherein a proximal end of the catheter is configured to be fluidly coupled to a negative pressure source to aspirate occlusive material within the blood vessel into and through the lumen according to the teachings of Tsukumo because it would allow for thrombotic suction (Tsukumo - - Ps. [0001], [0002], [0094]).
Claim(s) 14- 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ito et al. (US Pub. No. 2021/0308416 A1) in view of Tsukumo et al. (US Pub, No. 2010/0057052 A1) as evidenced by Edwards (US Pat. No. 3,416,531).
Regarding claim 14 and claim 18, Ito discloses an intravascular catheter, comprising:
a proximal end, a distal end, and a longitudinal axis extending therebetween;
a tubular sidewall (24) (Figs. 3- 6) defining a lumen (21) (Fig. 3), the sidewall (24) comprising a plurality of wires (25, 26) (Figs. 3- 5) embedded in a material (22, 23) (Figs. 3- 4) (P. [0027] - - a reinforcement body 24 positioned between the inner layer 22 and the outer layer 23), the plurality of wires (25, 26) comprising a first number of first wires (25A) (Figs. 3- 5) and a second number of second wires (25B, 26) (Figs. 3- 5) (P. [0038] - - In the exemplary embodiment, all the second wire filaments 26 and all the thin wire filaments 25B have the same outer diameter and cross-sectional area. All the first wire filaments 25 and the second wire filaments 26 are formed of the same material; it is noted that since filaments 25B and 26 are equivalent structures, filaments 25B and 26 are considered the second number of wires), the second number greater than the first number (Ps. [0033], [0038] - - among the first wire filaments 25, four are thick wire filaments 25A, and four are thin wire filaments 25B; the number of second wire filaments 26 is eight; it is noted that since the number of second wires (25B, 26) equal 12 and the number of first wires (25A) equal 4, the second number greater than the first number), wherein:
the first wires (25A) are helically wrapped around the longitudinal axis in a first direction (Y1) (Fig. 2) without crossing over one another (See Figs. 2, 5) (P. [0032] - - The first wire filaments 25 are helically wound in a first direction Y1 of a circumferential direction Y toward a distal end direction X1 of the tubular body 2), the first wires (25A) being configured to resist radial collapse of the sidewall (24) (Ps. [0054] - - catheter 1 has the thick wire filaments 25A, which are relatively rigid; it is noted rigid, thick wire filaments 25A of reinforcement braid are configured to resist radial collapse of the sidewall in comparison with a catheter that does not include any reinforcement wires), and
the second wires (25B, 26) comprise (a) a first group (25B) wound in the first direction (Y1) and that do not cross over the first wires (25A), and (b) a second group (26) wound in a second direction (Y2) (Fig. 2) opposite the first direction (Y1) (P. [0032] - - The second wire filaments 26 are wound in a second direction Y2, which is a direction opposite to the first direction Y1, of the circumferential direction Y toward the distal end direction X1 of the tubular body 2), wherein the second wires are configured to engage the first wires to resist radial expansion of the first wires, thereby providing improved torqueability of the sidewall as evidenced by Edwards (Edwards - - Col. 4, l. 30- 39 - - When the catheter tube is twisted, the spiral strands in one direction, those under tension, tend to contract inwardly and the spiral strands in the opposite direction, those under compression, tend to expand outwardly. The braiding interlocks the tension and compression strands so that there is no contraction or expansion in the tube … to achieve torsional rigidity; it is noted that it is well-known in the art of catheter reinforcement that oppositely helically wrapped first and second wires are configured to resist radial expansion of one of the first wires and second wires).
Ito does not disclose
(claim 14) wherein the proximal end of the catheter is configured to be fluidly coupled to a negative pressure source for application of suction through the lumen;
(claim 18) wherein a proximal end of the catheter is configured to be fluidly coupled to a negative pressure source to aspirate occlusive material within the blood vessel into and through the lumen.
However, Tsukumo teaches a catheter having reinforcing strands in the same field of endeavor (Abstract)
(claim 14) wherein the proximal end of the catheter is configured to be fluidly coupled to a negative pressure source for application of suction through the lumen (Ps. [0001], [0002], [0094] - - a medical catheter tube for example for … for thrombotic suction; Catheter tubes are hollow medical devices that are used as inserted in the cavity, duct, blood vessel, and others in the body, specifically for … thrombotic suction … There are a variety of requirements on these catheter tubes, but such a catheter mainly demands superior usability allowing rapid, accurate and selective insertion thereof, for example, into thin complicated-patterned blood vessel);
(claim 18) wherein a proximal end of the catheter is configured to be fluidly coupled to a negative pressure source to aspirate occlusive material within the blood vessel into and through the lumen (Ps. [0001], [0002], [0094] - - a medical catheter tube for example for … for thrombotic suction; Catheter tubes are hollow medical devices that are used as inserted in the cavity, duct, blood vessel, and others in the body, specifically for … thrombotic suction).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the device of Ito such that the sidewall defines a lumen, and wherein a proximal end of the catheter is configured to be fluidly coupled to a negative pressure source to aspirate occlusive material within the blood vessel into and through the lumen according to the teachings of Tsukumo because it would allow for thrombotic suction (Tsukumo - - Ps. [0001], [0002], [0094]).
Regarding claim 15, Ito in view of Tsukumo discloses the apparatus of claim 14, Ito further disclosing wherein the material (22, 23) is a first material (23) and the plurality of wires (25, 26) and first material (23) together comprise a first layer (23, 25, 26), and wherein the sidewall (24) further comprises a second layer (22) radially inward of the first layer (23, 25, 26) (See Fig. 3) (Ps. [0027], [0028], [0031] - - The tubular body 2 includes an inner layer 22 forming an inner surface in the lumen 21, an outer layer 23 forming an outer surface, a reinforcement body 24 positioned between the inner layer 22 and the outer layer 23; Examples of a constituent material for the outer layer 23 can include various thermoplastic elastomers … and one or a combination (polymer alloy, polymer blend, laminate, and the like) of two or more of above elastomers can be used; The resin of the outer layer 23 or the inner layer 22 can enter gaps between the plurality of wire filaments in the reinforcement body 24; it is noted that since the resin of either the outer layer 23 or the inner layer 22 can enter gaps between the plurality of wires (25, 26), a combination of 23, 25 and 26 can form its own individual layer).
Regarding claim 16, Ito in view of Tsukumo discloses the apparatus of claim 14, Ito further disclosing wherein the material is a first material (23) and the plurality of wires (25, 26) and first material (23) together comprise a first layer (23, 25, 26), and wherein the sidewall (24) further comprises a second layer (23) radially outward of the first layer (23, 25, 26) (Ps. [0027], [0031] - - The tubular body 2 includes an inner layer 22 forming an inner surface in the lumen 21, an outer layer 23 forming an outer surface, a reinforcement body 24 positioned between the inner layer 22 and the outer layer 23; The resin of the outer layer 23 or the inner layer 22 can enter gaps between the plurality of wire filaments in the reinforcement body 24; it is noted that since the resin of either the outer layer 23 or the inner layer 22 can enter gaps between the plurality of wires (25, 26), a combination of 23, 25 and 26 can form its own individual layer).
Regarding claim 17, wherein the material is a first material (23) and the plurality of wires (25, 26) and first material (23) together comprise a first layer (23, 25, 26), and wherein the sidewall (24) further comprises a second layer (22) radially inward of the first layer (23, 25, 26) and a third layer (23) radially outward of the first layer (23, 25, 26) (Ps. [0027], [0031] - - The tubular body 2 includes an inner layer 22 forming an inner surface in the lumen 21, an outer layer 23 forming an outer surface, a reinforcement body 24 positioned between the inner layer 22 and the outer layer 23; The resin of the outer layer 23 or the inner layer 22 can enter gaps between the plurality of wire filaments in the reinforcement body 24; it is noted that since the resin of either the outer layer 23 or the inner layer 22 can enter gaps between the plurality of wires (25, 26), a combination of 23, 25 and 26 can form its own individual layer).
Regarding claim 19, Ito in view of Tsukumo discloses the apparatus of claim 14, Ito further disclosing wherein the tubular sidewall (24) has an outer diameter of at least 8 Fr (P. [0042] - - An outer diameter of the tubular body 2 is not particularly limited, and the outer diameter can be, for example, 0.7 mm to 3.2 mm; it is noted that since 10 Fr is 3.33 mm, the disclosed outer diameter range of 0.7 mm to 3.2 mm falls within the claimed range of at least 8 Fr).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ito et al. (US Pub. No. 2021/0308416 A1) in view of Tsukumo et al. (US Pub, No. 2010/0057052 A1) as evidenced by Edwards (US Pat. No. 3,416,531) as applied to claim 14 above, and further in view of Leeflang et al. (US Pub. No. 2016/0158490 A1).
Regarding claims 20, Ito in view of Tsukumo discloses the apparatus of claim 14, Ito further disclosing an outer diameter of the tubular body 2 is not particularly limited, and the outer diameter can be, for example, 0.7 mm to 3.2 mm) (P. [0042]), Ito does not explicitly disclose
(claim 20) wherein the tubular sidewall has an outer diameter of at least 12 Fr.
However, Leeflang teaches a braid reinforcement catheter in the same field of endeavor (Abstract)
Leeflang further discloses that the reinforced catheter is used for introduction into a body lumen (not shown), e.g., for performing a diagnostic and/or therapeutic procedure within a patient's body having an outer diameter between about four and twenty-four French (4-24 Fr or 1.33-8.0 mm) (P. [0031]). As such, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (catheter having an outer diameter between about 4 and 24 Fr) for another (catheter having an outer diameter that is not particularly limited - -Ito - - P. [0042]) since the substitution would have yielded predictable results, namely, introducing into a body lumen for performing a diagnostic and/or therapeutic procedure within a patient's body. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Allowable Subject Matter
Claims 2, 5- 6 and 8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph and any claim informalities, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, (Jackie) Tan-Uyen Ho can be reached at 571 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771