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
The amendment filed on 02/17/2026 has been entered. Claims 1, 5-6, 8-9 and 12-13 have been amended. New Claims 14-16 have been added. Claims 1-16 remain pending.
The previously raised rejections under 35 U.S.C. 112(b) for Claims 5-6 and 8-9 are withdrawn because the issues have been properly corrected.
Response to Arguments
On Pages 6-7 of Remarks, Applicant argues that, regarding amended Claim 1, references Martin and Garbini do not teach the catheter tube having a distal end defining a beveled end-surface bonding surface, and a catheter tip joined to the beveled end-face bonding surface. This argument is moot in view of the new grounds of rejection which relies on the combination of Martin and Gilman (US 20170035989 A1) to disclose these limitations in the claim.
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, 5-6 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Martin et al (US 5135599 A; hereafter Martin), in view of Gilman (US 20170035989 A1; hereafter Gilman), and further in view of Garbini et al (US 20130199019 A1; hereafter Garbini).
With regard to Claim 1, Martin discloses a catheter comprising:
a catheter tube (Martin, Column 5, Lines 13-16; “the catheter 20 passes through the dressing 22 and, as can be seen in broken outline, and elongate and flexible cylindrical body 26, formed of a polyurethane extrusion …”) having a distal end defining a beveled end-face bonding surface (Martin, Column 8, Lines 29-35; “… FIG. 12 which shows the engagement of the tubes 32, 34 and 35 in the connector 30. These tubes have their engagement ends deformed to thin the wall and this is done by conical deformations so that the outer surface of the tubes are slightly conical to engage the corresponding internal cones 94, 96 and 98 shown in FIG. 11 …”. As shown in Fig. 12 cited below, in the same disclosed catheter, the disclosed tubes 32, 34 and 35 have beveled end-face bonding surface, and have increased bonding surface with the engaged connecter 30 when compared with non-beveled surface. Such design would result in easier manufacturing process and relative smooth internal surface);
Fig. 12 of Martin
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a catheter tip (Martin, Column 5, Lines 18-19; “The catheter 20 has at its distal end 28 a conical tapered tip 29 …”);
a seal (Martin, Column 6, Lines 34-36; “… a second insert 60 immediately adjacent the last of several return apertures 45.”),
the catheter tube comprising a main lumen (lumen 54 in Fig. 3 and 4) and at least one secondary lumen (lumen 52 in Fig. 3 and 4) (Martin, Column 6, Lines 11-15; “As best seen in FIG. 4, a bulbous middle portion 53 of the spectum 48 projects into the lumens 50, 52 and contains the intravenous (IV) lumen 54 which extends along the longitudinal axis of the body portion 26 from the proximal end to the distal end.”),
the main lumen (lumen 54) and the at least one secondary lumen (lumen 52) each being elongate between a proximal tube end and a distal tube end (Martin, Column 6, Lines 13-15; “the intravenous (IV) lumen 54 which extends along the longitudinal axis of the body portion 26 from the proximal end to the distal end.”) (Martin, Column 6, Lines 6-9; “The body 26 comprises an outer wall 46 and an integral septum 48 extending diametrically across the body 26 and defining an extraction lumen 50 and a return lumen 52, … ”. This disclosure indicates the secondary lumen extends from between the proximal and distal tube ends.),
the at least one secondary lumen (lumen 52) having a lateral opening (apertures 45) arranged between the proximal tube end and the distal tube end in an axial direction of the catheter tube (Martin, Column 6, Lines 34-36; “The return lumen 52 is similarly blocked by a second insert 60 immediately adjacent the last of several return apertures 45.”),
the lateral opening extending through a tube casing (the outer wall 46) of the catheter tube (the body 26) in a radial direction of the catheter tube (Martin, Column 7, Lines 21-22; “The apertures 44, 45 are then cut or otherwise formed in the outer wall 46 of the body 26.”), and
the seal (insert 60) being introduced into the at least one secondary lumen (lumen 52) distally behind the lateral opening (aperture 45) and sealing the at least one secondary lumen at least partially (Martin, Column 6, Lines 34-36; “The return lumen 52 is similarily blocked by a second insert 60 immediately adjacent the last of several return apertures 45.”. Fig. 3 shows that the insert 60 is distally behind the aperture 45.).
Martin does not clearly and explicitly disclose
introducing a catheter tip to the distal tube end by bonding, and
a seal being formed from a sealing compound introduced into a location in a viscous state and cured at the location.
Gilman in the same field of endeavor discloses introducing a catheter tip to the distal tube end by bonding (Gilman, Para 0021; “A formed tip 24 is then injection molded onto the end portion 14 of the tubing 12 using a mold as shown in FIG. 4.”) (Gilman, Para 0023; “… a strong bond forms between the injected tip material and the end face 16 of the tubing 12.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Martin, as suggested by Gilman, in order to introduce and bond a tip to the distal end of the catheter tube. One of ordinary skill in the art would have been motivated to make the modification for the benefit of avoiding potential distortion of tubing layers in conventional die-heating method of tip formation (Gilman, Para 0010; “The injection-molded tip also maintains the integrity of a multi-layer tube construction, assuring that the outer layer material of the tubing remains on the exterior of the catheter where it can accept a hydrophilic coating.”).
Martin and Gilman do not clearly and explicitly disclose a seal being formed from a sealing compound introduced into a location in a viscous state and cured at the location.
Garbini in the same field of endeavor discloses a seal being formed from a sealing compound introduced into a location in a viscous state and cured at the location (Garbini, Para 0083; “… The heated material flows to fill gaps and seal the hole. In alternative embodiments, a viscous material, such as ultra-violet curable silicone, is added and cured to seal.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Martin and Gilman, as suggested by Garbini, in order to seal the lumen by introducing viscous material and then curing it within the lumen. One of ordinary skill in the art would have been motivated to make the modification for the benefit of easy introduction of viscous material into a lumen of different shapes and achieving optimal sealing effect by curing.
With regard to Claim 3, Martin, Gilman and Garbini disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the sealing compound is and/or contains silicone.
Garbini further discloses wherein the sealing compound is and/or contains silicone (Garbini, Para 0083; “… a viscous material, such as ultra-violet curable silicone, is added and cured to seal.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Martin, Gilman and Garbini, as further suggested by Garbini, in order to include silicone in the sealing compound. One of ordinary skill in the art would have been motivated to make the modification for the benefit of silicon being a curable material so that, before solidification, silicon can be conveniently introduced into a lumen in its liquid or viscous state and then be cured into a desired shape for optimal sealing purpose.
With regard to Claim 5, Martin, Gilman and Garbini disclose all the limitations of Claim 1 as discussed above. Martin further discloses wherein the catheter tube is made of a meltable plastics material (Martin, Column 11, Lines 67-68; “… the material used to form the tube and inserts may be any suitable medical grade thermoplastic.”), and wherein the at least one secondary lumen in a region of the distal tube end (the distal end 128) further comprises a material plug (inserts 156, 160) that is integrally connected to the catheter tube and closes the at least one secondary lumen (Martin, Column 9, Lines 48-50; “The distal end 128 and tip 129 of a catheter has inserts 156, 160 which extend to fill the unused portions of the extraction and return lumens.”), the material plug being formed by melted and resolidified plastics material of the distal tube end (Martin, Column 9, Lines 52-54; “When the end 128 is heated in the mould 168 the inserts 156, 160 are softened and deformed and the outer wall 146 collapes to merge with the septum 148.”).
With regard to Claim 6, Martin, Gilman and Garbini disclose all the limitations of Claim 5 as discussed above. Martin further discloses wherein the material plug forms a section of the beveled end-face bonding surface (Martin, Fig. 17 cited below shows that the portion 216 acts as a plug that closes the distal opening of lumen 226, and has beveled end-face surface).
Fig. 17 of Martin
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With regard to Claim 14, Martin, Gilman and Garbini disclose the catheter according to Claim 1. Martin further discloses a method for producing the catheter comprising the steps of:
forming the catheter tube (Martin, Column 6, Lines 51-52; “The catheter 20 is made from a length of cylindrical polyurethane extrusion forming the cylindrical body 26.”); and
forming the beveled end-face bonding surface at the distal end of the catheter tube (Martin, Column 7, Lines 2-4; “The end of the body assumes a conical tapered shape with a radiused end and the material masses in the lumens 50, 52 forming ends 70, 72.” See Fig. 3.).
Martin, Gilman and Garbini as discussed above do not explicitly and clearly disclose molding the catheter tip to the end-face bonding surface.
Gilman further discloses molding the catheter tip to the end-face bonding surface (Gilman, Para 0006; “A formed tip that facilitates insertion of the catheter into the body is fabricated on one end of the tube by an insert molding process.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Martin, Gilman and Garbini, as further suggested by Gilman, in order to mold a tip to the distal end of a catheter tube. One of ordinary skill in the art would have been motivated to make the modification for the benefit of avoiding potential distortion of tubing layers in conventional die-heating method of tip formation (Gilman, Para 0010; “The injection-molded tip also maintains the integrity of a multi-layer tube construction, assuring that the outer layer material of the tubing remains on the exterior of the catheter where it can accept a hydrophilic coating.”).
With regard to Claim 15, Martin, Gilman and Garbini disclose the method according to Claim 14. Martin further discloses wherein forming the beveled end-face bonding surface comprises melting and resolidifying a portion of the distal end of the catheter tube (Martin, Column 6 Line 67 to Column 7 Line 8; “The extrusion is heated by R. F. and as it softens … The now tapered tip is cooled to some extent”) in a mold having a beveled mold wall corresponding to the beveled end-face bonding surface (Martin, Column 6; Lines 66-67; “… a conical tapered mould 68 (shown in chain-dotted outline in FIG. 3)”).
With regard to Claim 16, Martin, Gilman and Garbini disclose the method according to Claim 14. Martin further discloses:
inserting the needle into the main lumen of the catheter tube (Martin, Column 6; Lines 62-67; “A cylindrical wire 66 (shown in chain dotted outline) … is inserted through the IV lumen 54 to extend from the distal end of the tubing which is then located in a conical tapered mould 68 (shown in chain-dotted outline in FIG. 3).”. Examples are shown in Fig. 3, Fig. 13 and Fig. 18); and
moving the distal end of the catheter tube while heating to form the catheter tip (Martin, Column 6 Line 67 to Column 7 Line 1; “The extrusion is heated by R. F. and as it softens it is pushed into the mould such that the outer wall 46 and the septum 48 merge at the tip 29.”)
Martin, Gilman and Garbini as discussed above do not clearly and explicitly disclose inserting catheter tip material into a mold, and bonding the catheter tip to the beveled end-face bonding surface.
Gilman further discloses inserting catheter tip material into a mold (Gilman, Para 0046; “injecting molten thermoplastic polymer material under pressure into the mold cavity”), and bonding the catheter tip to the beveled end-face bonding surface (Gilman, Para 0046; “the molten thermoplastic polymer material solidifies and forms a tip bonded to the plug and to the tubing end”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Martin, Gilman and Garbini, as further suggested by Gilman, in order to introduce additional material to form a tip bonded to the distal end of catheter tube. One of ordinary skill in the art would have been motivated to make the modification for the benefit of maintaining the integrity of a multiple layer tube construction (Gilman, Para 0010; “The injection-molded tip also maintains the integrity of a multi-layer tube construction …”).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Martin, Gilman and Garbini, in view of Zadno-Azizi et al (20010016704 A1; hereafter Zadno-Azizi).
With regard to Claim 2, Martin, Gilman and Garbini disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the sealing compound is and/or contains cyanoacrylate.
Zadno-Azizi in the same field of endeavor discloses wherein the sealing compound contains cyanoacrylate (Zadno-Azizi, Para 0038; “The plug may be molded or extruded, and attached to the catheter by adhesives such as cyanoacrylate”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Martin, Gilman and Garbini, as suggested by Zadno-Azizi, in order to include cyanoacrylate in the sealing compound. One of ordinary skill in the art would have been motivated to make the modification for the benefit of cyanoacrylate being a quick-setting adhesive and safe for medical use, and therefore being widely used for sealing purposes in manufacturing catheters.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Martin, Gilman and Garbini, in view of Burnham (US 4764324 A; hereafter Burnham).
With regard to Claim 4, Martin, Gilman and Garbini disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the sealing compound is and/or contains a crosslinkable polymer.
Burnham in the same field of endeavor discloses wherein the sealing compound is and/or contains a crosslinkable polymer (Burnham, Column 9, Lines 62-66; “the polymer may be hardened by curing by cross-linking under the application of ultra-violet light, or by ionizing radiation”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Martin, Gilman and Garbini, as suggested by Burnham, in order to include a crosslinkable polymer in the sealing compound. One of ordinary skill in the art would have been motivated to make the modification for the benefit of crosslinkable polymer being a curable material so that, before being crosslinked, the material can be conveniently introduced to the application site and then being cured to a desired shape (Burnham, Column 9, Line 67 to Column 10, Line 2; “Such curable polymers may possess a sufficiently semi-rigid body characteristic prior to curing to permit penetration into, or deformation of, the surface by the application …”).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Martin, Gilman and Garbini, in view of McGregor et al (US 5429869 A; hereafter McGregor).
With regard to Claim 7, Martin, Gilman and Garbini disclose all the limitations of Claim 1 as discussed above, including forming the seal within the at least one secondary lumen, but do not clearly and explicitly disclose wherein the seal is formed from an expandable thermoplastic elastomer material.
McGregor in the same field of endeavor discloses wherein the seal (McGregor, Column 9, Lines 6-8; “The thread 30a of FIG. 7A comprises a core 32 of pre-expanded polymer/microspheres housed within a sheath 34.”) is formed from an expandable thermoplastic elastomer material (McGregor, Column 4, Lines 55-57; “PTFE may be expanded by employing expandable microspheres blended into a PTFE composition”; Column 20, Lines 25-31; “the compositions of the present invention can be formed with various fillers … elastomers particulates (including particles, rods, or flakes) …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Martin, Gilman and Garbini, as suggested by McGregor, in order to using a thermoplastic elastomer material for sealing. One of ordinary skill in the art would have been motivated to make the modification for the benefit of achieving ideal sealing effect by expanding thermoplastic elastomer material at the site to be sealed (McGregor, Column 8, Lines 55 – 60; “once the thread is in place, microsphere activation energy (e.g. heat through conduction, convention, or electrical resistance) is transmitted …, causing the thread to expand in place.”).
With regard to Claim 8, Martin, Gilman, Garbini and McGregor disclose all the limitations of Claim 7 as discussed above. Martin further discloses wherein the catheter tube is made of a meltable plastics material (Martin, Column 11, Lines 67-68; “… the material used to form the tube and inserts may be any suitable medical grade thermoplastic.”), and wherein the at least one secondary lumen in a region of the distal tube end (the distal end 128) is sealed at least partially by a material plug (inserts 156, 160) that is integrally connected to the catheter tube (Martin, Column 9, Lines 48-50; “The distal end 128 and tip 129 of a catheter has inserts 156, 160 which extend to fill the unused portions of the extraction and return lumens.”), the material plug being formed by melted and resolidified plastics material of the distal tube end (Martin, Column 9, Lines 52-54; “When the end 128 is heated in the mould 168 the inserts 156, 160 are softened and deformed and the outer wall 146 collapes to merge with the septum 148.”).
With regard to Claim 9, Martin, Gilman, Garbini and McGregor disclose all the limitations of Claim 8 as discussed above. Martin further discloses wherein the material plug forms a section of the beveled end-face bonding surface (Martin, Fig. 17 cited above shows that the portion 216 acts as a plug that closes the distal opening of lumen 226, and has beveled end-face surface).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Martin, Gilman and Garbini, in view of Cooper (US 4328806 A; hereafter Cooper).
With regard to Claim 10, Martin, Gilman and Garbini disclose all the limitations of Claim 1 as discussed above, including the steps of introducing the sealing compound into the at least one secondary lumen; and curing the sealing compound to form the seal. However, Martin, Gilman and Garbini do not clearly and explicitly disclose introducing the sealing compound through a lateral opening of a lumen.
Cooper in the same field of endeavor discloses introducing the sealing compound through a lateral opening of a lumen (Cooper, Column 6, Lines 16-18; “After aperture 49 has been formed, sealant may be injected from a nozzle 56 into lumen 43, again using port 36 as an access opening (FIG. 8).”. In this disclosure, “port 36” corresponds to “lateral opening” of the Application). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Martin, Gilman and Garbini, as suggested by Cooper, in order to introduce the sealant through the lateral opening. One of ordinary skill in the art would have been motivated to make the modification for the benefit of easy introduction of such sealant to the desired position when such position is far from the distal or proximal end of the catheter tube (Cooper, Column 4, Lines 53-58; “… port 36 is actually located in an intermediate position. Thus, in a typical catheter having a total body length of approximately 110 centimeters, the distance between the proximal lumen and the distal tip would ordinarily fall within the range of approximately 15 to 35 centimeters, …”).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Martin, Gilman and Garbini, further in view of Cooper and McGregor.
With regard to Claim 11, Martin, Gilman, Garbini and McGregor disclose all the limitations of Claim 7 as discussed above, including the steps of introducing the thermoplastic elastomer material into the at least one secondary lumen and expanding the thermoplastic elastomer material to form the seal. However, Martin, Gilman, Garbini and McGregor do not clearly and explicitly disclose introducing the material through a lateral opening of a lumen.
Cooper in the same field of endeavor discloses introducing the material through a lateral opening of a lumen (Cooper, Column 6, Lines 16-18; “After aperture 49 has been formed, sealant may be injected from a nozzle 56 into lumen 43, again using port 36 as an access opening (FIG. 8).”. In this disclosure, “port 36” corresponds to “lateral opening” of the Application). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Martin, Gilman, Garbini and McGregor, as suggested by Cooper, in order to introduce the sealing material through the lateral opening. One of ordinary skill in the art would have been motivated to make the modification for the benefit of easy introduction of such sealant to the desired position when such position is far from the distal or proximal end of the catheter tube (Cooper, Column 4, Lines 53-58; “… port 36 is actually located in an intermediate position. Thus, in a typical catheter having a total body length of approximately 110 centimeters, the distance between the proximal lumen and the distal tip would ordinarily fall within the range of approximately 15 to 35 centimeters, …”).
With regard to Claim 12, Martin, Gilman, Garbini, McGregor and Cooper disclose all the limitations of Claim 11 as discussed above, including using thermoplastic elastomer material and introducing the sealing compound into the at least one secondary lumen through the lateral opening, but do not clearly and explicitly disclose processing particles of the material to form a shaped cord pressed from the particles or a cushion structure having an elastic shell filled with the particles.
McGregor further discloses processing particles of the material to form a shaped cord pressed from the particles (McGregor, Column 8, Lines 33-34; “… forming a thread from a composition of polymer and unexpanded microspheres …”. Here “thread” is a shaped cord.) or a cushion structure having an elastic shell filled with the particles (McGregor, Column 6, Lines 58-62; “… property of the present invention is its ability to "puff" into a resilient cushion-like coherent mass with substantial proportions of open air spaces therein. The mass can expand in all dimensions …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Martin, Gilman, Garbini, McGregor and Cooper, as further suggested by McGregor, in order to form the sealing material into a shaped cord or a cushion structure. One of ordinary skill in the art would have been motivated to make the modification for the benefit of making the material to be thin or deformable so as to be easily introduced through small opening (McGregor, Column 8, Lines 23-28; “… the needle creates an opening larger than the thread. In those instances where leakage is a concern (e.g. in waterproof fabrics or in a medical procedure), the seam must then be sealed or wrapped through one or more various time-consuming procedures.”) (McGregor, Column 7, Lines 1-3; “The "puffed" mass of the present invention has proven to be remarkably elastic and resilient to deformation.”).
With regard to Claim 13, Martin, Gilman, Garbini, McGregor and Cooper disclose all the limitations of Claim 11 as discussed above, but do not clearly and explicitly disclose wherein the step of expanding the thermoplastic elastomer material to form the seal comprises activating a blowing agent present in the thermoelastic elastomer material, the blowing agent being activated by an energy input.
McGregor further discloses wherein the step of expanding the thermoplastic elastomer material to form the seal comprises activating a blowing agent (unexpanded microspheres) present in the thermoplastic elastomer material (McGregor, Column 8, Lines 50-51; “… the thread 24a comprises a composition 26 of polymer/unexpanded microspheres …”), the blowing agent being activated by an energy input (McGregor, Column 8, Lines 55 – 60; “once the thread is in place, microsphere activation energy (e.g. heat through conduction, convention, or electrical resistance) is transmitted …, causing the thread to expand in place.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Martin, Gilman, Garbini, McGregor and Cooper, as further suggested by McGregor, in order to expand the sealing compound by activating a blowing agent by an energy input. One of ordinary skill in the art would have been motivated to make the modification for the benefit of easily minimizing leakage by expanding the seal material at its application location (McGregor, Column 8, Lines 28 – 30; “By forming threads using the present invention, the need for seam-sealing may be significantly reduced or eliminated.”).
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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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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