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 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.
Claim 22 is 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 22 recites two sets of effective lengths of the tubular body without any particular reason why one range is different from the other. It is unclear which range of effective length is being claimed.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 7, 8, 21, 22, and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2014/0025041 to Fukuoka et al. (“Fukuoka”) in view of U.S. Patent No. 5,603,704 to Brin et al. (“Brin”) and U.S. Patent Publication No. 2018/0093068 to Nagao et al. (“Nagao”).
Regarding claim 1, Fukuoka teaches a catheter (Fig. 1) comprising a tubular body (20) having a lumen that communicates from a proximal end to a distal end (Fig. 1), wherein the tubular body includes a substantially linear base portion (21) and a shaped portion (22) connected to a distal side of the base portion, the shaped portion includes a first bending portion (e to d, Fig. 1) that is bent at a distal side relative to the base portion, a first intermediate portion (25) that is located on a distal side relative to the first bending portion, a second bending portion (C to R2, Fig. 2) that is bent at a distal side relative to the first intermediate portion, a second intermediate portion (portion between R2 and R3 in Fig. 1)that is located on a distal side relative to the second bending portion, a third bending portion (Fig. 1, R3 to R4) that is bent at a distal side relative to the second intermediate portion, and a distal end portion that is located on a distal side relative to the third bending portion (Fig. 1, between R4 and a) and has a distal end opening formed in the distal end portion (opening at a), the first bending portion and the first intermediate portion are located on a first plane (Fig. 2, portions before c are in the same plane), the second bending portion and the second intermediate portion are located on a second plane different from the first plane (C to R3 are in a separate plane), an axis of the distal end portion (Fig. 2, axis formed by at least a and b) is different from an extension line of an axis of the second intermediate portion (Fig. 2, axis formed by 26), but appears to teach an angle formed by the first intermediate portion with respect to an extension line extending from a portion of the base portion on the distal side to a distal direction being between 10° and 30° instead of between 40° and 85° as claimed and does not teach the lubricating coating.
Brin teaches an angle formed by the first intermediate portion with respect to an extension line extending from a portion of the base portion on the distal side to a distal direction is between 40° and 85° (the first arcuate portion 12 is equivalent to the portion where an angled is formed by the first intermediate portion and base portion of the claim; the first arcuate portion is between 135° and 225° or between 45° and -45° relative to the extension line of extending from the base portion 11). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the angle formed by the first intermediate portion with respect to an extension line extending from a portion of the base portion of Fukuoka to be at least 45° as taught by Brin to yield the predictable result of allowing a catheter to enter the vasculature of a patient for treatment. As demonstrated by the range of the initial bend of Brin, the initial bend in a catheter used in heart treatments may vary depending on the particular intended vascular structure or unique anatomy of the patient.
Nagao teaches a shaped portion (33, Fig. 4) of a tubular body (30) of a catheter being coated with a lubricating coating extending from a distal opening of the catheter in a proximal direction along an axial direction ([0069]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end of the catheter of Fukuoka and Brin with the coating as taught by Nagao to yield the predictable result of providing lubricity ([0069]) in order to ease transition of the catheter into the biological tract of the patient.
Regarding claim 2, Fukuoka, Brin, and Nagao teach the catheter according to claim 1 as shown above, Fukuoka further teaching the third bending portion is bent to a side away from the first plane from a proximal side toward the distal side (27 which includes the third bending portion, is bent away from plane A in Fig. 2).
Regarding claim 3, Fukuoka, Brin, and Nagao teach the catheter according to claim 1 as shown above, Fukuoka further teaching the third bending portion is bent to a side where the base portion is located with respect to the second plane (Fig. 1, R3-R4 bends back towards the base 21), from the proximal side toward the distal side.
Regarding claim 7, Fukuoka, Brin, and Nagao teach the catheter according to claim 1 as shown above, Fukuoka further teaching a radius of curvature of the second bending portion (R2 is 20 mm, [0038]) is smaller than a radius of curvature of the first bending portion (R1 is 60 mm, [0036]), and a radius of curvature of the third bending portion (R3 is 10, [0038]) is smaller than the radius of curvature of the second bending portion.
Regarding claim 8, Fukuoka, Brin, and Nagao teach the catheter according to claim 7 as shown above, Fukuoka further teaching the third bending portion (27, Fig. 2) is bent to a side away from the first plane (A) from a proximal side toward the distal side.
Regarding claim 21, Fukuoka, Brin, and Nagao teach the catheter according to claim 1 as shown above, but do not specify the range of the coating length. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the coating taught by Nagao to have a 400 mm or less, since it has been held that where the only difference between the prior art and the claims is 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 is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Fukuoka, Brin, and Nagao would not operate differently with the claimed coating length, as this length would be suitable for adequately providing an easy transition of the tip of the catheter into the treatment area of the body.
Regarding claim 22, Fukuoka, Brin, and Nagao teach the catheter according to claim 1 as shown above, Fukuoka further teaching the tubular body of the catheter has an effective length of 800 mm to 1800 mm, the effective length of the tubular body of the catheter being a length of a portion of the tubular body that can be inserted into a blood vessel or a sheath ([0033]), and the effective length of the tubular body of the catheter is 1000 mm to 1500 mm ([0033]).
Regarding claim 24, Fukuoka, Brin, and Nagao teach the catheter according to claim 1 as shown above, Fukuoka further teaching an outer diameter of the tubular body of the catheter is 1 mm to 2.5 mm ([0031]).
Regarding claim 25, Fukuoka, Brin, and Nagao teach the catheter according to claim 1 as shown above, Nagao further teaching the lubricating coating being a combination of one or more of: a copolymer of an epoxy group-containing monomer which is glycidyl acrylate, glycidyl methacrylate, 3,4-epoxycyclohexylmethyl acrylate, 3,4-epoxycyclohexylmethyl methacrylate, 3-methylglycidyl methacrylate, or allyl glycidyl ether; a hydrophilic monomer which is N-methylacrylamide, N,N-dimethylacrylamide, or acrylamide; a (co)polymer composed of the hydrophilic monomer; a cellulose-based polymer substance which is hydroxypropyl cellulose or carboxymethyl cellulose; a polysaccharide; polyvinyl alcohol; a methyl vinyl ether-maleic anhydride copolymer; poly (2-hydroxyethyl (meth) acrylate); polyethylene glycol; polyacrylamide; or polyvinyl pyrrolidone ([0069]).
Regarding claim 26, Fukuoka, Brin, and Nagao teach the catheter according to claim 1 as shown above, Fukuoka further teaching a material of the tubular body is a combination of one or more of: thermoplastic elastomers of styrene, polyolefin, polyurethane, polyester, polyimide, polybutadiene, trans-polyisoprene, fluororubber, or chlorinated polyethylene; polyether ketone; or polyimide ([0044]).
Regarding claim 27, Fukuoka, Brin, and Nagao teach the catheter according to claim 1 as shown above, Fukuoka further teaching the shaped portion of the tubular body includes a flexible portion not provided with a reinforcing body on a distal side of a reinforcing portion where the reinforcing body is embedded ([0046]).
Claims 1, 3, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,445,625 to Voda in view of U.S. Patent No. 7,867,218 to Voda (“Voda2”) and Nagao.
Regarding claim 1, Voda teaches a catheter comprising a tubular body (64, Figs. 4A-4B) having a lumen (lumen of 64) that communicates from a proximal end to a distal end, wherein the tubular body includes a substantially linear base portion (66) and a shaped portion connected to a distal side of the base portion (portions distal to 66), the shaped portion includes a first bending portion (A1) that is bent at a distal side relative to the base portion, a first intermediate portion (68) that is located on a distal side relative to the first bending portion, a second bending portion (70) that is bent at a distal side relative to the first intermediate portion, a second intermediate portion (72) that is located on a distal side relative to the second bending portion, a third bending portion (A3) that is bent at a distal side relative to the second intermediate portion, and a distal end portion (74) that is located on a distal side relative to the third bending portion and has a distal end opening formed in the distal end portion (Fig. 4A), the first bending portion and the first intermediate portion are located on a first plane (plane formed between 66/68/A1, Fig. 4B), the second bending portion and the second intermediate portion are located on a second plane (plane formed by 70/72) different from the first plane (the planes are different as seen in Fig. 4B), and an axis of the distal end portion is different from an extension line of an axis of the second intermediate portion (axis of 74 and axis of 72 are different, Fig. 4B). Voda is unclear as to the angle formed by the first intermediate portion with respect to an extension line extending from a portion of the base portion on the distal side to a distal direction, although it possible that the claimed range is anticipated by Voda. Furthermore, Voda does not teach the coating.
In any case, Voda2 teaches an angle formed by the first intermediate portion with respect to an extension line extending from a portion of the base portion on the distal side to a distal direction is between 40° and 80° (angle αh represents the angle between a base portion 4 and first intermediate portion 12, which is between 140° and 180°, making the angle relative to an extension line between 40° and 0°). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the angle formed by the first intermediate portion with respect to an extension line extending from a portion of the base portion of Voda to be at least 40° as taught by Voda to yield the predictable result of allowing a catheter to enter the vasculature of a patient for treatment. As demonstrated by the range of the initial bend of Voda2, the initial bend in a catheter used in heart treatments may vary depending on the particular intended vascular structure or unique anatomy of the patient.
Nagao teaches a shaped portion (33, Fig. 4) of a tubular body (30) of a catheter being coated with a lubricating coating extending from a distal opening of the catheter in a proximal direction along an axial direction ([0069]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end of the catheter of Voda and Voda2 with the coating as taught by Nagao to yield the predictable result of providing lubricity ([0069]) in order to ease transition of the catheter into the biological tract of the patient.
Regarding claim 3, Voda, Voda2, and Nagao teach the catheter according to claim 1 as shown above, Voda further teaching the third bending portion (74) is bent to a side where the base portion is located with respect to the second plane (Fig. 4B, 74 bends towards the base 66), from the proximal side toward the distal side.
Regarding claim 5, Voda, Voda2, and Nagao teach the catheter according to claim 1 as shown above, Voda further teaching a direction in which the second bending portion is bent is a counterclockwise direction from the proximal end to the distal end when the catheter is viewed from the distal side in parallel to an extending direction of the base portion (when viewed from the distal side of a line extending from 66, 70 bends counterclockwise).
Response to Arguments
Applicant’s arguments and amendments with respect to the art rejections of claim 1 in view of Fukuoka and Brin have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Fukuoka, Brin, and Nagao.
Applicant’s arguments and amendments with respect to the art rejections of claim 1 in view of Voda and Voda2 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Voda, Voda2, and Nagao.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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