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 .
Response to Amendment
This office action is responsive to the amendment filed on 07/03/2026. As directed by the amendment: claims 1, 3, 11 & 18 have been amended. Claims 4-9, 16, 17, 19 and 20 have been cancelled.
Thus, claims 1-3, 10-15 & 18 are pending in this application.
Applicant’s amendments to the specification have overcome each and every objection previously set forth in the Non-final Office Action mailed on 04/03/2026.
Applicant’s amendments to the claims have overcome each and every 112(b)-claim rejection previously set forth in the Non-final Office Action mailed on 04/03/2026.
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 1-3, 10-15 & 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan (US 20020173689 A1) in view of Rafiee et al (US 20060074308 A1).
Regarding claim 1, Kaplan discloses a catheter ((102); fig 4B) comprising an elongate tubular body (body of 102) having a side wall defining a lumen (lumen of 102) extending between a proximal region and a distal region (fig 4B, 7A and para 0044), wherein the distal region comprises a tip portion (102b) capable of deflecting way from the proximal region when the tip portion is unconstrained (fig 4B, para 0042, claim 1), thereby forming a curved shape of the tip portion (para 0022 and 0047, claim 2); and wherein the side wall of the elongate tubular body axially terminates at the tip portion with a slant cut (116, para 0044 and 0050, fig 4B), thereby forming an end surface of the tip portion defining an opening in a non-circular shape (fig 4B).
Kaplan fails to teach wherein the catheter further comprises at least one stretch resistant filament extending from the proximal region to the distal region of the elongate tubular body, wherein the at least one stretch resistant filament is arranged such that a distal portion of the at least one stretch resistance filament extends along inside the curved shape of the tip portion.
However, Rafiee et al disclose a catheter ((100); fig 1) comprising an elongate tubular body (102) having a distal region (110) and a proximal region (120) and a tip portion having a curved shape (111) and the catheter further comprises at least one stretch resistant filament (145) extending from the proximal region to the distal region of the elongate tubular body (fig 1), wherein the at least one stretch resistant filament (145) is arranged such that a distal portion of the at least one stretch resistance filament extends along inside the curved shape of the tip portion (fig 1, para 0019).
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 catheter of Kaplan to comprise at least one stretch resistant filament extending from the proximal region to the distal region of the elongate tubular body, wherein the at least one stretch resistant filament is arranged such that a distal portion of the at least one stretch resistance filament extends along inside the curved shape of the tip portion. This would provide the benefit of having a braided high-strength polymer filaments or metal wires to enhance torsional strength and to inhibit kinking of catheter during advancement through the patient's body (para 0019).
Regarding claim 2, Kaplan in view of Rafiee et al discloses the limitations of claim 1 as discussed above but fails to expressly teach wherein the tip portion is configured to deflect away from a longitudinal axis of the proximal region at an angle ranging from 5 degrees to 315 degrees.
However, Kaplan discloses the tip portion is configured to deflect away to various curvatures (para 0047).
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 catheter of Kaplan to have the tip portion configured to deflect away from a longitudinal axis of the proximal region at an angle ranging from 5 degrees to 315 degrees 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 catheter of Kaplan would not operate differently with the claimed angle and since the tip portion is configured to deflect away to various curvatures, the catheter would function appropriately having the claimed angle. Further, applicant places no criticality on the range claimed, indicating simply that the angle ranging from 5 degrees to 315 degrees (specification pp. [0032]).
Regarding claim 3, Kaplan in view of Rafiee et al fails to expressly teach wherein the inclined end surface of the tip portion forms an angle ranging from 20 degrees to 80 degrees relative to an inner or outer surface of the side wall of the tubular body.
However, Kaplan discloses an end surface of the tip portion forming an angle (117, fig 4B, para 0044).
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 catheter of Kaplan to have the inclined end surface of the tip portion forms an angle ranging from 20 degrees to 80 degrees relative to an inner or outer surface of the side wall of the tubular body 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 catheter of Kaplan would not operate differently with the claimed angle and since the slant end surface of the tip portion forms an angle, the catheter would function appropriately having the claimed angle. Further, applicant places no criticality on the range claimed, indicating simply that the angle ranging from 20 degrees to 80 degrees (specification pp. [0033]).
Regarding claim 10, Kaplan in view of Rafiee et al discloses the catheter of claim 1 as discussed above, but fails to teach wherein the lumen of the catheter has a diameter ranging from 0.164 inches to 0.295 inches.
However, Kaplan discloses said catheter is an 18 gauge needle (para 0051, note: an 18-gauge needle has a diameter of approximately 1.27 mm (0.050 inches)).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the catheter of Kaplan by making the lumen of the catheter has a diameter ranging from 0.164 inches to 0.295 inches as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 11, Kaplan discloses a catheter device ((100), fig 4B), comprising: a first catheter (104) having a lumen (para 0046); and a second catheter (102) configured to be positioned within the lumen of the first catheter and longitudinal movable relative to the first catheter (fig 4B, para 0046), wherein the second catheter (102) comprises an elongate tubular body having a side wall defining a lumen (para 0046) extending between a proximal region and a distal region of the elongate tubular body (figs 4B and 7A), wherein the distal region of the tubular body comprises a tip portion (102b) capable of deflecting away from the proximal region of the tubular body when the tip portion is unconstrained by the first catheter (fig 4B, para 0042, claim 1), thereby forming a curved shape of the tip portion (para 0022 and 0047, claim 2); and wherein the side wall of the elongate tubular body axially terminates at the tip portion with a slant cut (116, para 0044 and 0050, fig 4B), thereby forming an end surface of the tip portion defining an opening in a non-circular shape (fig 4B).
Kaplan fails to teach wherein the second catheter further comprises at least one stretch resistant filament extending from the proximal region to the distal region of the elongate tubular body, wherein the at least one stretch resistant filament is arranged such that a distal portion of the at least one stretch resistance filament extends along inside the curved shape of the tip portion.
However, Rafiee et al disclose a catheter ((100); fig 1) comprising an elongate tubular body (102) having a distal region (110) and a proximal region (120) and a tip portion having a curved shape (111) and the catheter further comprises at least one stretch resistant filament (145) extending from the proximal region to the distal region of the elongate tubular body (fig 1), wherein the at least one stretch resistant filament (145) is arranged such that a distal portion of the at least one stretch resistance filament extends along inside the curved shape of the tip portion (fig 1, para 0019).
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 second catheter of Kaplan to comprise at least one stretch resistant filament extending from the proximal region to the distal region of the elongate tubular body, wherein the at least one stretch resistant filament is arranged such that a distal portion of the at least one stretch resistance filament extends along inside the curved shape of the tip portion. This would provide the benefit of having a braided high-strength polymer filaments or metal wires to enhance torsional strength and to inhibit kinking of catheter during advancement through the patient's body (para 0019).
Regarding claim 12, Kaplan in view of Rafiee et al discloses the catheter device of claim 11,
Kaplan further discloses wherein the first catheter (104) comprises a side wall defining the lumen of the first catheter (fig 4B), the side wall of the first catheter axially terminating with a straight cut (126), forming an end surface of the first catheter defining an opening in a generally circular shape (fig 4B, para 0045).
Regarding claim 13, Kaplan in view of Rafiee et al discloses the catheter device of claim 11 as discussed above, but fails to teach wherein the lumen of the first catheter has a diameter ranging from 0.190 inches to 0.320 inches, and the lumen of the second catheter has a diameter ranging from 0.164 inches to 0.295 inches.
However, Kaplan discloses said first catheter (104) would be of an inner diameter (bore) gauge greater than the needle, but not greater than 17 gauge (para 0067, note: a 17-gauge needle has a nominal outer diameter of approximately 0.058 inches or 1.47 mm) and said second catheter is an 18 gauge needle (para 0051, note: an 18-gauge needle has a diameter of approximately 1.27 mm (0.050 inches)).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the catheter device of Kaplan by making the lumen of the first catheter has a diameter ranging from 0.190 inches to 0.320 inches, and the lumen of the second catheter has a diameter ranging from 0.164 inches to 0.295 inches as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, Kaplan in view of Rafiee et al discloses the limitations of claim 11 as discussed above but fails to expressly teach wherein the tip portion of the second catheter is configured to deflect away from a longitudinal axis of the proximal region of the second catheter at an angle ranging from 5 degrees to 315 degrees.
However, Kaplan discloses the tip portion is configured to deflect away to various curvatures (para 0047).
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 catheter device of Kaplan to have the tip portion of the second catheter configured to deflect away from a longitudinal axis of the proximal region of the second catheter at an angle ranging from 5 degrees to 315 degrees 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 catheter device of Kaplan would not operate differently with the claimed angle and since the tip portion is configured to deflect away to various curvatures, the catheter would function appropriately having the claimed angle. Further, applicant places no criticality on the range claimed, indicating simply that the angle ranging from 5 degrees to 315 degrees (specification pp. [0032]).
Regarding claim 15, Kaplan in view of Rafiee et al fails to expressly teach wherein the end surface of the tip portion of the second catheter forms an angle ranging from 20 degrees to 80 degrees relative to an inner or outer surface of the side wall of the second catheter.
However, Kaplan discloses an end surface of the tip portion forming an angle (117, fig 4B, para 0044).
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 catheter device of Kaplan to have the end surface of the tip portion of the second catheter forms an angle ranging from 20 degrees to 80 degrees relative to an inner or outer surface of the side wall of the second catheter 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 catheter device of Kaplan would not operate differently with the claimed angle and since the end surface of the tip portion forms an angle, the catheter would function appropriately having the claimed angle. Further, applicant places no criticality on the range claimed, indicating simply that the angle ranging from 20 degrees to 80 degrees (specification pp. [0033]).
Regarding claim 18, Kaplan in view of Rafiee et al discloses the catheter device of claim 11 as discussed above but fails to expressly teach wherein the at least one stretch resistant filament is configured to provide a tensile strength ranging from 5 pounds to 25 pounds.
However, Rafiee et al disclose at least one stretch resistant filament (para 0019).
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 at least one stretch resistant of Rafiee et al configured to provide a tensile strength ranging from 5 pounds to 25 pounds 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 catheter device of Kaplan in view of Rafiee et al would not operate differently with the claimed tensile strength, the catheter device would function appropriately having the claimed angle. Further, applicant places no criticality on the range claimed, indicating simply that the tensile strength ranging from 5 pounds to 25 pounds (specification pp. [0041]).
Response to Arguments
Applicant’s arguments, see Remarks filed on 07/03/2026, with respect to the rejection(s) of claim(s) 1-20 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kaplan (US 20020173689 A1) in view of Rafiee et al (US 20060074308 A1).
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 09/09/2026
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