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 § 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) 21, 26, 27, 32, and 33 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Drewes, Jr. (US 2009/0171318). Regarding claims 21, 27 and 33, Drewes discloses a catheter shaft (10) comprising an inner layer (see examiner-annotated reproduction of fig. 1 below; inner layer shaded gray) 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 having a first durometer; and an outer layer (see examiner-annotated figure below; everything radially outward of the shaded inner layer is considered the claimed outer layer) formed by alternating first (16) and second segments (18,19; noting 18, 19 are the same material) of the first polymer and a second polymer, respectively, that alternate in a circumferential direction (fig. 1), the second polymer being different than the first polymer and having a second durometer softer than the first durometer of the first polymer ([0013]), each segment of the alternating first and second segments extending in an axial direction for substantially an entire length of the catheter shaft (as understood in view of the disclosure of Drewes, the cross-section shown in fig.1 represents the cross section along an entire length of the catheter) 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 or other wire reinforcement is disclosed) and has a uniform bending stiffness in the circumferential direction ([0005]). 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.
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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) 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) 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).
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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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 27 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,819,629. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 27 and 34 are merely broader than claim 6 of ’629 and are therefore “anticipated” by claim 6 of ‘629.
Claims 21, (22,28,35), (23,29,36), (24,30,37), (25,31,38), (26,32,39), and (33,40) are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, (2), (3), (4), (5), (8), and (7), respectively of U.S. Patent No. 11,819,629 in view of Drewes, Jr. (US 2009/0171318). Claims 1-5, 7 and 8 claim the invention of claims 21-26, 28-33 and 35-40 except for the catheter shaft having a uniform bending stiffness in a circumferential direction. In the case of claims 21-26, claims 1-5 and 8 of ‘629 also fails to expressly claim that the catheter shaft is devoid of axial wires (though it is noted that claims 1-5 and 8 of ‘629 do not recite any axial wires).
Drewes discloses another catheter (10) comprising a first polymer (16) and a second polymer (18,19), and further discloses that the stiffness modulus of the two polymers may be chosen in a manner that results in the catheter having a substantially uniform bending stiffness in a circumferential direction ([0005]; [0013]). Accordingly, 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]). The catheter of Drewes is understood to be devoid of axial wires as there are none disclosed in the specification and drawings. It would have been obvious to one of ordinary skill in the art to have modified the device of claims 1-5, 7, and 8 of ‘629 to construct the catheter devoid of axial wires and with first and second polymers that result in the catheter shaft having a uniform bending stiffness in view of Drewes such that advantageously, 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.
Allowable Subject Matter
Claims 34-40 would be allowable if a proper terminal disclaimer is filed to overcome the non-statutory double patenting rejections above. 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 28 would be allowable if a proper terminal disclaimer is filed to overcome the non-statutory double patenting rejections above and if rewritten to include all of the limitations of the base claim and any intervening claims.
Regarding claims 25 and 28, 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
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KSH 2/5/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771