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
The terminal disclaimer filed 5/8/2026 has been accepted and the previously presented non-statutory double patenting rejections have withdrawn in view of the terminal disclaimer.
The amendments to claims 21 and 27 have overcome the previously presented 35 USC 102a1 rejections of claims 21, 26-27 and 32-33 over Drewes, Jr. (2009/0171318).
Applicant's arguments filed 5/8/2026 with respect to the amendments overcoming the previously presented 35 USC 103 rejections over Guo et al. (US 2008/0154206) in view of Drewes have been fully considered but they are not persuasive. Applicant asserts that the amendment requiring that the alternating first and second segments are fused together distinguishes the claimed invention from the prior art of Guo as modified by Drewes because the alternating first and second segments of Guo have sufficient stress concentrations formed at the interfacial zones (11) to readily act as a built-in peel groove. The term “fused” is given its ordinary meaning of “joined, blended, or connected to form a single entity”. Guo expressly discloses that the two polymer materials forming the alternating segments are adhered to each other (see [0021] – if polymer material of 1st strip is chemically in-compatible with polymer material of second strip, a polymer compatibilizer is added to at least one of the polymer materials to improve melt adhesion between the strips). Guo also discloses that the two materials are joined via a co-extrusion machine, co-injection molding machine, or a co-compression molding machine ([0015], [0058], [0061], [0076]). The fact that the first and second segments have sufficient stress concentration formed at the interfacial zones such that the catheter may be split along an interfacial zone when the sides of the tubular body apart are forced apart (see par. [0056]) does not contradict that the first and second segments are fused together.
Claim 28 was rejected under 35 USC 103 in the previous office action and that rejection is maintained. As correctly noted by Applicant, the allowable subject matter section of the previous action erroneously listed claim 28, instead of claim 31, as being allowable if the non-statutory double patenting rejections were overcome and the claim rewritten in independent form. This issue has been corrected in the current office action.
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) 21-24, 26-30, 32 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. (US 2008/0154206) in view of Drewes (US 2009/0171318). Regarding claims 21, 27, and 33, Guo discloses a catheter shaft (2) comprising an inner layer (see examiner-annotated reproduction of fig. 4E below; inner layer shaded gray) of consistent thickness, the inner layer defining an innermost circumferential surface of the catheter shaft and defining a lumen of the catheter shaft, wherein the inner layer is formed of a first polymer; and an outer layer (alternating segments 8,10 radially outward of dotted circle in annotated figure below) of consistent thickness, the outer layer formed by alternating first (10) and second segments (8) of the first polymer and a second polymer, respectively, that alternate in a circumferential direction (fig. 4E), the second polymer being different than the first polymer ([0085]), each segment of the alternating first and second segments extending in an axial direction for substantially an entire length of the catheter shaft (fig. 4E, 4F) and the alternating first and second segments collectively defining an outermost circumferential surface of the catheter shaft, wherein the catheter shaft is devoid of axial wires (noting no axial wires disclosed). The alternating first and second layers are fused together (via co-extrusion, co-injection, or co-compression as per [0058], [0061]); note also that Guo discloses that a polymer compatibilizer may be introduced into one of the polymer materials to improve melt adhesion between the first and second alternating segment if the polymer materials are chemically incompatible as per [0020]-[0021])
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Regarding claims 21 and 27, Guo does not expressly disclose that the catheter shaft has uniform bending stiffness in a circumferential direction.
Drewes discloses another catheter (10) having alternating first (16) and a second polymers (18,19) forming the outermost circumferential surface of the catheter and further discloses that the stiffness modulus of the two different polymers may be chosen in a manner that results in the catheter having a substantially uniform bending stiffness in a circumferential direction ([0005]). According to Drewes, a uniform bending stiffness is desirable because, when the catheter is flexed around a bend in a vessel, there is a reduced and even resistance to twisting and the catheter can be inserted smoothly ([0005]). It would have been obvious to one of ordinary skill in the art to have constructed the device of Guo to have a uniform bending stiffness as taught by Drewes such that, advantageously, when the catheter is flexed around a bend in a vessel, there is reduced and even resistance to twisting and the catheter can be inserted smoothly.
Further regarding claim 27, Guo does not expressly disclose that the second polymer has a second durometer softer than the first durometer of the first polymer. However, Drewes further discloses that the second polymer (18,19) present only in the outer layer of a catheter shaft having uniform bending stiffness in a circumferential direction is “softer” than the first polymer present in both the outer and inner layers of the catheter shaft (see [0013]; thus, it has a softer durometer). It would have been obvious to one of ordinary skill in the art to have modified the device of Guo such that the second polymer has a softer durometer than that of the first polymer since Drewes further discloses this is a suitable material choice for providing a catheter shaft with uniform bending stiffness in a circumferential direction, and 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 claims 22, 23, 28 and 29, Guo illustrates 4 first segments alternating with 4 second segments, but expressly discloses that “any number of each type of strip 8, 10, including more than four first strips 8 and four second strips 10” ([0061]), and thus makes obvious having between 5 and 10 first segments and between 5 and 10 second segments as understood by one of ordinary skill in the art.
Regarding claims 24 and 30, each of the first and second segments are the same size ([0062] of Guo discloses that segments 8, 10 can account for generally equal percentages of the circumference of the tubular body wall 12).
Regarding claims 26 and 32, the inner layer and the outer layer directly contact each other with the outer layer circumferentially surrounding the inner layer as understood in view of the annotated figure above.
Allowable Subject Matter
Claims 34-40 are allowed. The closest prior art of Guo and Drewes discussed above fails to disclose or fairly suggest, in combination with the remaining limitations, the second polymer having a second melting temperature lower than a first melting temperature of the first polymer.
Claims 25 and 31 would be allowable if rewritten to include all of the limitations of the base claim and any intervening claims. Regarding claims 25 and 31, the closest prior art of Guo and Drewes fails to expressly disclose, or fairly suggest, in combination with the other limitations of the claim, that the first polymer is PEEK and the second polymer is a thermoplastic polyurethane.
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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KSH 6/29/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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