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 Arguments
Applicant’s arguments filed 4/8/2026 have been fully considered but they are not persuasive. Applicant argues that Patterson (US 5,391,152) fails to disclose “wherein the second shaft has a distal shape that includes a curved or bent portion at the distal end of the second catheter”, noting that the second shaft of Patterson, terminates in a tapered or blunt end as shown in fig. 1 and described in col. 4, ll. 2-6 of Patterson. However, the examiner maintains that a distal end region of the second shaft 31, which may be tapered or blunt, has a distal shape that includes a curved portion at the distal end of the second catheter. In particular, the distal end region of the second shaft of Patterson comprises a distal shape (either tapered hollow cylinder or constant-diameter hollow cylinder) that includes a curved or bent portion (curved portion: consider outer wall of distal shape, which is cylindrical and thus curved in the circumferential direction) at the distal end (this distal shape extends to the distal end of the second catheter). Thus, the rejections over Patterson in view of Hayakawa (and in further view of Lennon or Whiting or Schuermann) are maintained, but have been updated to reflect the new claim language.
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11: “the distal end of a second shaft” bridging lines 16-17 should read “the distal end of [[a]] the second shaft” since it is clear that the second shaft in line 17 is one and the same as the earlier recited second shaft. (In view of page 10 of Applicant’s remarks filed 4/8/2026 describing the amendment as addressing the previously presented objection, it is understood that the amendment changing “the second shaft” to “a second shaft” was in error). Appropriate correction is required.
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) 1-2, 6-13, 15 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patterson (US 5,391,152) in view of Hayakawa et al. (US 2020/0023168). Regarding claims 1 and 11, Patterson discloses a catheter assembly (fig. 1) comprising: a first catheter comprised of a first shaft (21) that includes a distal end and a proximal end at opposite axial ends of the first shaft, the first shaft including a first distal end opening at the distal end of the first shaft and a first proximal end opening at the proximal end of the first shaft, the first catheter including a first lumen (26) extending between the first distal end opening and the first proximal end opening (fig. 1, 6); a second catheter (31; fig. 1) comprised of a second shaft that includes a distal end and a proximal end at opposite axial ends of the second shaft, the second shaft including a second distal end opening at the distal end of the second shaft and a second proximal end opening at the proximal end of the second shaft, the second catheter including a second lumen (36) extending between the second distal end opening and the second proximal end opening (fig. 1), the second catheter including a second hub (35) at the proximal end of the second shaft and communicating with the second lumen, the second catheter (31) having both an outer diameter and an inner diameter at the second distal end opening; the first catheter positioned in the second lumen of the second shaft and configured to be axially positionable relative to the second shaft such that a distal portion of the first shaft extends distally beyond the distal end of the second shaft (fig.1); a guidewire (not illustrated, but disclosed in col. 1, ll. 30-40) located in the first lumen in the first shaft. The second shaft (31) has a distal shape (tapered, hollow cylinder formed by distal end portion of shaft 31) that includes a curved or bent portion (consider any portion of the cylindrical outer wall, which is curved in the circumferential direction) at the distal end of the second catheter (tapered hollow cylinder terminates at distal end of the second catheter 31).
The first shaft (21) of Patterson has a first wall thickness “T1” ((outer diameter – inner diameter)/2) at a position of the second distal end of the second shaft, and the second shaft (31) of Patterson has a second wall thickness “T2” ((outer diameter – inner diameter)/2). Although Patterson does not disclose the exact wall thicknesses of the first and second catheters, the first wall thickness of the first catheter (21) is illustrated as being greater than the second wall thickness of the second catheter (31) in fig. 1 of Patterson, and thus one skilled in the art would have found it obvious to construct the first catheter 21 with a greater wall thickness than that of the second catheter 31 as suggested by the relative dimensions illustrated in figure 1. The first inner diameter of the first catheter (21) is constant between the first distal opening and the first proximal end opening of the first catheter as illustrated in figure. 1, noting that the taper of 22 is only formed in the outer wall as understood in view of fig. 1 of Patterson.
Patterson is silent on the clearance between an inner surface of the second shaft and an outer surface of the first shaft at the second distal opening when the first catheter is positioned in the second lumen of the second shaft and the distal portion of the first shaft extends distally beyond the distal end of the second shaft.
Hayakawa discloses another catheter assembly comprising a first (inner) catheter (40; fig. 1) having a tapered tip that is coaxially located within a second (outer) catheter (51), the first catheter having a wall thickness greater than the second catheter (as illustrated in fig. 2 and 4; see also [0075], [0081]). Hayakawa further discloses that the clearance between an inner surface of the second shaft and an outer surface of the first shaft at the second distal end opening when the first catheter is positioned in the second lumen and the distal portion of the second shaft is 0.1mm to 0.5mm ([0081]). Hayakawa further discloses ranges of thicknesses for the first and second catheters (T1 and T2, respectively), wherein the clearance CL is not equal to T1 or T2 (noting claimed ranges only require that CL is not equal to T1 or T2, but could be less than both T1 and T2, greater than both T1 and T2, or between T1 and T2).
It would have been obvious to one of ordinary skill in the art to modify the size of the first and second catheters of Patterson such that the clearance between the inner surface of the second shaft and the outer surface of the first shaft is greater than 0.1 mm and less than or equal to 0.35 mm, the clearance being a value other than T1 or T2, in view of Hayakawa’s teaching of clearances between 0.1 and 0.5mm (that may be unequal to either wall thickness) being known and suitable for coaxial catheters, since it has been held that “[i]n the case where the claimed ranges ‘overlap or line inside ranges disclosed by the prior art’ a prima facie 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).
Regarding claims 2 and 12, the first shaft (21) has a tapered distal end (22; fig.1 of Patterson).
Regarding claim 6 and 15, Patterson does not expressly disclose the distance between the first and second distal end openings, though it is noted that the first and second catheters are slidable relative to each other such that the distance can be adjusted. It would have been obvious to one of ordinary skill in the art to have modified Patterson to dimension the first and second catheters such that the distance between their distal end openings is between 10mm to 200mm, 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 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, 468 U.S. 830, 225,SPQ 232 (1984).
Regarding claims 7 and 15, it would have been obvious to one of ordinary skill in the art to modify the clearance of Patterson in view of Hayakawa from between 0.1 mm and 0.5 mm to greater than or equal to 0.15 mm and less than or equal to 0.3 mm since it has been held that “[i]n the case where the claimed ranges ‘overlap or line inside ranges disclosed by the prior art’ a prima facie 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).
Regarding claims 8-10, Patterson discloses a guidewire (not illustrated, but disclosed in col. 1, ll. 30-40) configured to be received in the first lumen of the first shaft. This guidewire can be considered an “angiographic” guide wire or a “therapeutic” guidewire as these terms are drawn to the intended use of the guidewire. Because the guidewire of Patterson in view of Hayakawa can be used during an angiographic procedure or during a therapeutic procedure, it meets this intended use recitation.
Further regarding claims 9 and 10, Patterson does not expressly disclose the size of the guidewire. However, Hayakawa teaches that the guidewire (10) may have a shaft portion (12) having an outer diameter of 0.3 to 1.0mm ([0051]), which encompasses the claimed values of 0.36mm and 0.89mm, thereby rendering them obvious since it has been held that “[i]n the case where the claimed ranges ‘overlap or line inside ranges disclosed by the prior art’ a prima facie 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).
Regarding claim 13, the second catheter (31) of Patterson is a guiding catheter having a distal tip configured to introduce a treatment catheter (noting catheter 21 can be removed and a treatment catheter may be placed within catheter 31, which guides the treatment catheter through puncture opening).
Regarding claim 21, the clearance is greater than 0.1mm and less than or equal to 0.18mm. In particular, Hayakawa teaches that the clearance between an inner surface of the second shaft and an outer surface of the first shaft at the second distal end opening when the first catheter is positioned in the second lumen and the distal portion of the second shaft is 0.1mm to 0.5mm ([0081]), which encompasses the claimed range, and it has been held that “[i]n 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. Circ. 1990)).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patterson in view of Hayakawa as applied to claim 1 above and further in view of Lennon et al. (US 2016/0000499). Patterson in view of Hayakawa disclose the invention substantially as stated above including that the second catheter (31) is a guiding catheter having a distal tip configured to introduce a treatment catheter (noting dilator 21 can be removed and a treatment catheter may be placed within catheter 31, which guides the treatment catheter through puncture opening), but fails to expressly disclose that the distal tip includes a reinforcing body.
Lennox discloses another catheter assembly comprising a second (outer) catheter (15/76; fig. 9) coaxial with a first (inner) catheter (62). Lennox discloses that the tip of the second catheter includes a thin-walled ring of radiopaque metal (77; [0141]). As understood by one of ordinary skill in the art, such a marker facilitates visualization of the distal end of the second catheter once it is placed in the body. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Patterson to include a thin-walled ring of radiopaque metal at the distal tip of the second catheter as taught by Lennox in order to allow visualization of the distal end of the second catheter while it is inserted into a patient’s body. The metal ring can be considered a reinforcing body since it reinforces the polymeric tip as compared to a similar polymeric tip having no metal ring.
Claim(s) 5 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patterson in view of Hayakawa as applied to claims 4 and 11 above and further in view of Whiting et al. (US 2006/0009737). Patterson does not expressly disclose that the distal shape of the distal end of the second shaft has a Judkins shape.
Whiting discloses another catheter assembly (fig. 1) and further teaches that the outer guiding catheter (12) of the catheter assembly can have a Judkins shape ([0027]), which is useful depending on the initial access point for the procedure on the patient. It would have been obvious to one of ordinary skill in the art to have modified the distal shape of the distal end of the second shaft of Patterson to have a Judkins shape in view of Whiting’s teaching that such a shape is useful as a guiding catheter depending on the initial access point.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patterson in view of Hayakawa as applied to claim 11 above and further in view of Schuermann (US 2016/0175501). Patterson in view of Hayakawa discloses the invention substantially as stated above including a guidewire received in the first lumen of the first shaft, but fails to expressly disclose a second guidewire configured to be received in the first lumen of the first shaft.
Schuermann discloses that a kit comprising a cannula (20) and a guidewire (30) configured to be received in a lumen of the cannula. Schuermann further discloses that the kit can comprise multiple guidewires having various lengths in order to accommodate the type of approach desired by an operator (e.g., transaortic versus transfemoral: [0022]). It would have been obvious to one of ordinary skill in the art to have further modified the prior art of Patterson in view of Hayakawa to include at least a second guidewire having a different length than the first guidewire, the second guidewire configured to be received by the first lumen in the first shaft, in view of Schuermann such that the operator may choose a guidewire having a length best suited for the approach desired by the operator.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 5/14/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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