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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 11th 2025 has been entered.
Response to Amendment
The amendment filed December 11th 2025 has been entered. Claims 1-18 are pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Final Office Action mailed September 15th 2025.
Claim Objections
Claims 1-6 are objected to because of the following informalities:
Regarding claim 1, the second recitation of “an inner diameter of the introducer sheath” should be corrected to “the inner diameter of the introducer sheath” and “an inner surface of the introducer sheath” should be corrected to “the inner surface of the introducer sheath” for claim language consistency and both instances of “with entire circumference” should be corrected to “with an entire circumference” for clarity.
Regarding claims 2-6, all recitations of “relatively stiff angulated kinks” and “relatively flexile angulated kinks” should be corrected to “stiff angulated kinks” and “flexible angulated kinks” for claim language consistency. Or, all recitations of “stiff angulated kinks” and “flexible angulated kinks” in claim 1 should be changed to “relatively stiff angulated kinks” and “relatively flexile angulated kinks” for claim language consistency.
Appropriate correction is required.
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.
Claim(s) 1-4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Itou (US 20050015007 A1), in view of Jadwizak (US 20160303365 A1), and further in view of Bowe (US 20030144657 A1).
Regarding claim 1, Itou discloses a wiggle catheter to advance an introducer sheath through an adverse anatomy of a tortuous and/or a diseased lumen inside a body of a patient (inner catheter 6A configured to aid in the introduction of outer catheter 2 through an adverse anatomy of a tortuous lumen inside a body of a patient, [0001], [0127], and [0138]-[0139] & Fig. 2 and 8-11B), the wiggle catheter comprising: a proximal section, a distal section, and an intermediate section disposed between the proximal section and the distal section (inner catheter 6A comprising a proximal portion 71, a soft tip 77 which is being interpreted as the distal section, and a distal end portion 73A which is being interpreted as the intermediate section, [0076] and [0129] & Fig. 9); the intermediate section consisting essentially of a plurality of kinks along a long axis of the catheter (distal end curved portion 73A consisting essentially of first curved portion 732 and second curved portion 733, [0129]-[0132] & Fig. 9), said plurality of kinks are angulated and are not spiral, sinusoidal or helical (first and second curved portions 732 and 733 are disclosed as assuming a shape gradually curved and rapidly curved (bent), [0131]-[0132] & Fig. 9; the two curved portions are being interpreted as two angulated kinks); the wiggle catheter configured for placement inside the introducer sheath to form a composite of the wiggle catheter and the introducer sheath, wherein the composite acquires the angulated shape of the wiggle catheter (“The catheter assembly according to this embodiment shown in FIG. 8 is the same as in the first embodiment, except for the configuration of the inner catheter. The catheter assembly 1A according to the present invention comprises an outer catheter 2 and an inner catheter 6A. Of these members, the outer catheter 2 is the same as that in the first embodiment. As shown in FIG. 9, the inner catheter 6A is composed of an inner catheter main body 7A which can be inserted in the outer catheter main body 3”, [0127]-[0128] & Fig. 2 and 8-9; “Therefore, when the distal end portion 73 (the inner catheter main body 7) is inserted in the distal end portion 33 (the outer catheter main body 3), the distal end portion 33 of the outer catheter 2 is rectified by the shape of the distal end portion 73 of the inner catheter 6 (in other words, it depends on the shape of the distal end portion 73), and the shape of the distal end portion 33 is changed in accordance to the shape of the distal end portion 73.”, [0086] & Fig. 1-3; inner catheter 6A is inserted into outer catheter 2 forming a composite, catheter assembly 1A, wherein the outer catheter 2 takes the angulated shape of the inner catheter 6A) and wherein an inner diameter of the introducer sheath is substantially equal to an outer diameter of the wiggle catheter (“it is preferable that the ratio of the outside diameter of the inner catheter main body 7 to the inside diameter of the outer catheter main body 3 mentioned above is in the range of from 0.9 to 0.99.”, [0067] and [0127] & Fig. 8);
said plurality of kinks have substantially a same diameter at an outer edge of the kinks (first and second curved portions 732 and 733 are seen having substantially the same diameter at an outer edge of the bends, see Fig. 9; the Examiner notes that the term substantially allows for a broad interpretation of the limitation), said diameter of the outer edge of the plurality of kinks being substantially same as an inner diameter of the introducer sheath whereby the wiggle catheter may be positioned inside the introducer sheath with entire circumference of the outer edges of the plurality of kinks in close proximity to entire circumference of an inner surface of the introducer sheath (when in the assembled state of catheter assembly 1A, seen in Fig. 8, the diameter of the outer edge of curved portions 732 and 733 are substantially the same as the inner diameter of outer catheter 2 with an entire circumference of the outer edges of portions 732 and 733 in close proximity to an entire circumference of the inner lumen of outer catheter 2, see Fig. 8-9 and [0128]);
whereby a distal edge of the introducer sheath intermittently curves and straightens laterally as the composite of the wiggle catheter and the introducer sheath is advanced (outer catheter 2 is capable of intermittently curving and straightening laterally as catheter assembly 1A is advanced through the femoral artery, [0138] & Fig. 11A-11B; outer catheter 2 capable of intermittently curving and straightening as guidewire 13 is inserted and removed and/or inner catheter 6A is inserted and removed, [0138]-[0140] & Fig. 8-11B);
whereby when the composite of the wiggle catheter and the introducer sheath is advanced over a guide wire (“the guide wire 13 is inserted in a lumen 9 of the catheter assembly 1A (inner catheter main body 7A) in the assembled state, the catheter assembly 1A in this condition is inserted into the catheter introducer 11, and then, while causing the guide wire 13 to proceed, the distal end portion 10A of the catheter assembly 1A is advanced through the abdominal aorta 105 to the ascending aorta 100.”, [0138] & Fig. 11A-11B) and a resistance point is met, manipulation of a distal end of the wiggle catheter by any form of movement, allows for navigation of the distal end of the wiggle catheter through the adverse anatomy (“…while causing the guide wire 13 to proceed, the distal end portion 10A of the catheter assembly 1A is advanced through the abdominal aorta 105 to the ascending aorta 100… the catheter assembly 1A in the assembled condition is once slowly advanced to the vicinity of the aortic valve 102 deeper than the right coronary artery port 101, so as to bring the distal end of the catheter assembly 1A into contact with the right inside wall 103 of the ascending aorta 100…”, [0138]-[0139] & Fig. 11A-11B; catheter assembly 1A, including the distal end of inner catheter 6A, is capable of being manipulated by any form of movement to allow for navigation of the catheter assembly, including the distal end of inner catheter 6A, through adverse anatomy).
Itou further discloses “the inner catheter main body 7 may be composed in the above-mentioned laminate structure or a laminate structure free of the reinforcement layer, or may be composed of a single layer.” (see [0079]). The main body 7A of inner catheter 6A may be composed of a laminate portion having layers. Outer layer 35 may comprise a first, second, third, and fourth region 351, 352, 353, and 354, with each region being less flexible than the last as the regions move proximally along the catheter ([0049]-[0051] & Fig. 7). “Besides, examples of the material for constituting these regions (the first region 351, the second region 352, the third region 353, and the fourth region 354) include various thermoplastic elastomers based on styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, trans-polyisoprene, fluororubber, chlorinated polyethylene or the like, and combinations (polymer alloys, polymer blends, laminates, etc.) of two or more of these thermoplastic elastomers.” ([0051]).
However, Itou fails to explicitly disclose a wiggle catheter comprising the plurality of kinks further consisting essentially of stiff angulated kinks and flexible angulated kinks, the stiff angulated kinks and the flexible angulated kinks alternate along the long axis of the intermediate section, the stiff angulated kinks configured to contact an inner surface of introducer sheath while the flexible angulated kinks configured to either not contact the inner surface of the introducer sheath or contact it with less pressure; and
wherein the wiggle catheter is configured to protrude beyond the distal edge of the introducer sheath when the wiggle catheter is placed inside the introducer sheath; whereby manipulation of a distal protruding end of the wiggle catheter by any other form of movement, allows for navigation of the distal protruding end of the wiggle catheter through the adverse anatomy,
and further comprising alternating the relatively stiff angulated kinks adjacent the relatively flexible angulated kinks; and wherein the relatively stiff angulated kinks and the relatively flexible angulated kinks comprise a material which is altered discontinuously along a length, the plurality of kinks comprise of different materials having differing mechanical properties.
However, Jadwizak teaches a wiggle catheter (abstract) comprising a plurality of kinks (shaping parts 50.5’ and 50.6’, [0047] & Fig. 3B; the shaping part formed in a U-shape, [0026]) further consisting essentially of stiff angulated kinks and flexible angulated kinks (shaping parts 20A/B/C having stiff segments (sections 20A.1/B.1/C.1, including end portion lumens 20b, not colored in having a high Shore hardness of 70-80) adjacent flexible segments (colored sections 20A.2/B.2/C.2 having a Shore hardness of 30-80), [0039]-[0040], [0042], and [0044] & Fig. 2A-2G; Shore hardness being related to flexibility), the stiff angulated kinks and the flexible angulated kinks alternate along the long axis of the intermediate section (sections 20A.1/B.1/C.1 and 20A.2/B.2/C.2 of shaping parts 50.0’ and 50.6’ alternate along the long axis of the intermediate section, [0043] and [0047] & Figs. 2A-2G and 3B; the intermediate section being the portion of catheter 50.1’ between the distal end portion and the section furthest from the end portion, see Fig. 3B), alternating the relatively stiff angulated kinks adjacent the relatively flexible angulated kinks (sections 20A.1/B.1/C.1 adjacent sections 20A.2/B.2/C, [0039]-[0040], [0042], and [0044] & Fig. 2A-2G), and wherein the relatively stiff angulated kinks and relatively flexible angulated kinks comprise a material which is altered discontinuously along the length, the plurality of kinks comprise of different materials having differing mechanical properties (sections 20A.1/B.1/C.1 and 20A.2/B.2/C.2 are made of two different silicone, or other polymer, materials of different Shore hardness resulting in different mechanical properties, [0027], [0042], and [0044] & Fig. 2A-2G).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the plurality of kinks of Itou with Jadwizak to include stiff angulated kinks and flexible angulated kinks, the stiff angulated kinks and the flexible angulated kinks alternate along the long axis of the intermediate section, alternating the relatively stiff angulated kinks adjacent the relatively flexible angulated kinks, wherein the relatively stiff angulated kinks and the relatively flexible angulated kinks comprise a material which is altered discontinuously along a length, the plurality of kinks comprising different materials having differing mechanical properties,
since such a modification would provide desired flexibility and hardness to the wiggle catheter to create desirable curvature and yield predictable results pertaining to return moment force generation in the event of deformation ([0023]-[0025] of Jadwizak). Jadwizak teaches the configuration to be an art effective means for shaping a catheter (abstract, [0032], and [0043] of Jadwizak). As modified, the first and second curved portions 732 and 733 of inner catheter 6A of Itou would each be formed of sections 20A.1/B.1/C.1 and sections 20A.2/B.2/C.2, like catheter 50.1’ of Jadwizak.
As combined, the stiff angulated kinks (sections 20A.1/B.1/C.1) would be configured to contact an inner surface of outer catheter 2 while the flexible angulated kinks (sections 20A.2/B.2/C.2) would be configured to either not contact the outer catheter 2 or contact it with less pressure considering sections 20A.1/B.1/C.1 face outward toward the inner surface of outer catheter 2, imparting force onto outer catheter 2 to change its shape, and sections 20A.2/B.2/C.2 would face inward and away from the inner surface of outer catheter 2 (see Figs. 2A-2G of Jadwizak and [0086] and Figs. 8-9 of Itou).
Further, Bowe teaches a wiggle catheter (abstract and [0002]) wherein the wiggle catheter is configured to protrude beyond the distal edge of the introducer sheath when the wiggle catheter is placed inside the introducer sheath (inner catheter 7 configured to distally extend from the outer catheter 2, [0053] & Fig. 1 and 5-6); whereby manipulation of a distal protruding end of the wiggle catheter by any form of movement, allows for navigation of the distal protruding end of the wiggle catheter through the adverse anatomy (“the advantageous control of catheter tip shape by the relative extension and rotation of inner and outer catheters 7, 2 is illustrated.”, [0055]; “The catheter assembly end shapes illustrated in FIGS. 5 and 6 demonstrate how the combination of relative rotation and extension of the catheters 7 and 2 can create a selectable plurality of two- and three-dimensional shapes useful for finding and cannulating a vessel of interest.”, [0058]; inner catheter 7, along with its distal protruding end, may be manipulated to allow for navigation of the distal protruding end of inner catheter 7 through adverse anatomy).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the wiggle catheter of Itou, as modified, with Bowe to include the wiggle catheter being configured to protrude beyond the distal edge of the introducer sheath when the wiggle catheter is placed inside the introducer sheath, whereby manipulation of a distal protruding end of the wiggle catheter by any other form of movement, allows for navigation of the distal protruding end of the wiggle catheter through the adverse anatomy,
since such a modification would lengthen the distal end of the catheter assembly to aid in locating a vessel of interest and provide means to further adjust the angle of the preformed curve of the outer catheter and would yield predictable results pertaining to vessel navigation and catheter curvature control (see [0053] of Bowe). As modified, the soft tip 77 of inner catheter 6A of Itou would be modified to at least partially extend past outer catheter 2.
Regarding claim 3, Itou, as modified, discloses all the limitations of claim 2. As modified, Itou further discloses the wiggle catheter wherein the plurality of kinks comprises alternating cross-sectional areas for the relatively stiff angulated kinks and the relatively flexible angulated kinks (end portion lumen 20b, which is being interpreted as part of sections 20A.1/B.1/C.1, has a different cross-sectional area than sections 20A.2/B.2/C.2, see [0043] and Figs. 2C-2G of Jadwizak; sections 20A.1/B.1/C.1 have a different cross sectional area than sections 20A.2/B.2/C.2).
Regarding claim 4, Itou, as modified, discloses all the limitations of claim 2. As modified, Itou further discloses the wiggle catheter wherein the plurality of kinks comprises alternating lengths of the relatively stiff angulated kinks and the relatively flexible angulated kinks along the long axis of the wiggle catheter (the length of sections 20A.1/B.1/C.1 and sections 20A.2/B.2/C.2 alternate along the long axis of shaping parts 20A/B/C, see Figs. 2C-2G of Jadwizak; the end portions 20b being interpreted as part of sections 20A.1/B.1/C.1).
Regarding claim 6, Itou, as modified, discloses all the limitations of claim 1. As modified, Itou further discloses the wiggle catheter further comprising alternating the relatively stiff angulated kinks adjacent the relatively flexible angulated kinks (sections 20A.1/B.1/C.1 and sections 20A.2/B.2/C are adjacent and alternate, [0039]-[0040], [0042], and [0044] & Fig. 2A-2G of Jadwizak); and
wherein the relatively stiff angulated kinks and the relatively flexible angulated kinks comprise an intermittently heat-treated material, said intermittently heat-treated material alternating along the long axis of the intermediate section (the materials, which may be variable, that make up the shaping parts are curved into a finished state through the process of annealing after coextrusion, [0024], [0042], and [0044]; annealing is a form of heat-treating).
The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Itou (US 20050015007 A1), in view of Jadwizak (US 20160303365 A1), in view of Bowe (US 20030144657 A1), and further in view of Smits (US 20020065544 A1).
Regarding claim 5, Itou, as modified, discloses all the limitations of claim 2. Itou discloses altering material and flexibility of the catheter (see [0049]-[0051] of Itou) but fails to explicitly disclose the wiggle catheter wherein the plurality of kinks comprises alternating a bending rigidity of the material forming the relatively stiff angulated kinks and the material forming the relatively flexible angulated kinks.
However, Smits teaches a wiggle catheter (abstract and [0006]) wherein the plurality of kinks comprises alternating a bending rigidity of the material forming the relatively stiff angulated kinks and the material forming the relatively flexible angulated kinks (lead 10 being formed of stiff sections 2 and flexible section 4, these sections defined by their differences in bending stiffness, [0048] & Fig. 4A-4C; “the material from which lead body 12 is formed may be varied compositionally or otherwise as a function of axial distance x, to thereby effectuate changes in the bending stiffness,” [0083]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the plurality of kinks of Itou, as modified, with Smits to include alternating a bending rigidity of the material forming the relatively stiff angulated kinks and the material forming the relatively flexible angulated kinks since such a modification would provide a number of different minimum mechanical energy storage positions which the catheter may assume within the venous anatomy of a patient ([0051] of Smits). The modification provides predictable results pertaining to variable catheter configuration and positioning while traveling through a vessel ([0051] of Smits).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gibson (US-20080139999-A1), Sos (US-11376400-B2), Johnson (US-8100883-B1), Takemura (US-20220016389-A1), Nathan (US-20210346654-A1), McFerran (US-20060089618-A1), and KUBOKI (WO-2022024201-A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783