DETAILED ACTION
Response to Amendment
The amendment filed July 21, 2025 has been entered. Claims 1, 2, 5, 8, 11-15, 18, 19, and 21-23 have been amended and claims 1, 2, 5, 8, 10, 11-15, 18, 19, and 21-23 are currently pending in the application.
Response to Arguments
Applicant's arguments filed July 21, 2025 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that the amended claims overcome the cited prior art, the Examiner respectfully disagrees. Regarding Applicant’s arguments that the prior art fails to teach a malleable cannulated member, the Examiner points to paragraph [0050] of Taylor which teaches an exemplary shaft section formed from a number of possible polymers. Such a sheath would have at least some malleability as thermoplastic elastomers and would therefore meet the claim limitations. Regarding Applicant’s arguments as to the use of the cannula as a suction or irrigation member, the Examiner respectfully disagrees. The claims are directed to a method of applying a liner member to a cannulated member. There is no disclosure of the cannula being used as a suction or irrigation device and as such, any cannulated member with a lumen is considered sufficient to be used as a suction or irrigation catheter. The amendments fail to limit the method of applying the liner member to a cannulated member. For these reasons, the rejection is maintained as set forth below.
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) 1-5, 8, 11, 17, and 18-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2008/0154296) in view of Rydell et al. (US 4,806,182) in view of Schaeffer et al. (US 2011/0060276), and further in view of Taylor (US 6,523,574).
Regarding claim 1, Taylor et al. (henceforth Taylor) discloses (Figure 1) a method of forming an instrument system comprising: providing a malleable (see e.g., paragraph [0050] which discloses the materials for forming an exemplary cannula of the cited embodiments) cannulated suction or irrigation member (e.g., 110; the claims are directed to a method of applying a liner and the requirement for the cannulated member to perform suction or irrigation is not considered to substantially limit the structure of the cannula member) extending from a first member end to a second member end. Taylor does not explicitly disclose a liner member extending from the first end to the second end or the method for applying the liner.
Rydell et al. (henceforth Rydell) teaches (e.g., Figures 1-3) a cannulated member (guide catheter 12) and a liner member (24) bonded thereto (e.g., Figures 1-3) and wherein the liner member extends from between a first member end to a second member end (it extends the length of the cannula; the first and second member ends to not require separate first and second discreet element portions; the language only requires a single member in scope; however, Taylor teaches first and second members as set forth below); and further wherein the bonded liner inhibits debris from the cannulated member from exiting the cannulated member (as it decreases the inner diameter of the cannula it will inhibit debris from exiting the cannula; the method of forming the device only requires the application of the liner member); and wherein the liner member is configured to remain bonded to the cannulated member during suction or irrigation (as set forth above, the method is for applying a liner and does not require the device to be limited to a specific use case; it is noted that Rydell intendeds the bonded catheter liner to resist delaminating during use).
Schaeffer et al. (henceforth Schaeffer) teaches a balloon catheter device comprising a plurality of lumen formed with liner members (e.g., Figure 2B, liners 202 and 212); and which liners are bonded to the lumen via the application of heat and pressure to an inside of the liner and cannulated member (paragraph [0038] and Figures 2A to 2C the liner members are applied within the catheter shaft assembly via heat and pressure as claimed).
Taylor (henceforth Taylor ‘574) teaches a method of applying a liner member (10) to a tubing which comprises sealing one end of the cannulated member and liner member (e.g., via 88 in Figure 6c); wherein an external wall of the liner is in contact with the internal wall of the cannulated member (Figure 6c); and applying a fluid into the liner positioned within the cannulated member so as to provide a pressurized fluid source for adhering the liner member to the tubing (see e.g., claims 9 and 10; Col. 4, lines 58-67) by pressurizing the fluid inside the liner member to apply a force against the internal wall of the cannulated member by the pressurized fluid (Col. 6, lines 43-49 disclose using a pressurized fluid to drive the pig which also locates the fluid within the inner lumen of the liner and wherein it will apply a force to the liner member to aid in securing it to the inner lumen of the catheter as claimed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cannulated member of Taylor by using the liner member of Rydell so as to provide a low friction internal surface for the cannulated member as taught by Rydell. In addition, it would have been obvious to apply the liner member via heat and the simultaneous application of pressure to the liner member as Schaeffer teaches it is a known method for securing a liner member to a tubular member. For this reason, it would have been obvious to use such a method to apply the liner member of Rydell to the device of Taylor. Furthermore, it would have been obvious to one of ordinary skill in the art to apply the liner member via fluid pressure as Taylor ‘574 teaches that such a method is known in liner application to ensure the liner experiences less axial strain during installation.
Regarding claim 2, Taylor further discloses a first cannulated suction or irrigation member (110) inserted into a second cannulated suction or irrigation member (130) wherein the first and second cannulated members define a single internal bore (it can be seen in Figure 1C that the cutting insert 130 forms a continuous lumen with the first cannulated member); wherein the second cannulated suction or irrigation member is stiffer than the first (it’s a metal cutting end and is substantially stiffer than the catheter body; paragraphs [0008] and [0037]) and further comprising an aluminum (paragraph [0008] sets forth aluminum carbide as an abrasive).
Regarding claim 5, Taylor/Rydell/Schaeffer further teach bonding the liner to first and second internal walls of the first and second cannulated suction or irrigation members (in the cited combination elements 110 and 130 would both comprise the liner member).
Regarding claim 8, Schaeffer further teaches the step of etching the wall of the liner before applying it to the lumen. It would have been obvious to one of ordinary skill in the art at the time of filing to modify the lumen of the device to comprise the etched portion as it is known from Schaeffer that etching one of the surfaces to be bonded will aid in adhering the liner to the lumen (e.g., paragraph [0058]).
Regarding claims 11, Taylor/Rydell/Schaeffer further teach bonding the liner to at least a portion of an external wall of the cannulated suction or irrigation member near one of the ends (e.g., Figure 2C of Rydell depicts the liner having been rolled over the end of the cannulated suction or irrigation member before being pressed into the hub). Regarding claim 13, it would have been obvious to one of ordinary skill in the art to duplicate the process on the opposite end of the cannulated member to further inhibit delamination as taught by Rydell.
Regarding claim 17, Taylor/Rydell/Schaeffer further teach that the cannulated member is bendable and the liner member is bonded to the cannulated suction or irrigation member to resist coming lose during bending (the intent of the liner of Rydell is to prevent delamination of the liner member from the cannulated member and this would include at least some bending during use as no specific values are specified in the claim).
Regarding claim 18, Taylor further discloses wherein the first cannulated suction or irrigation member is attached to the second cannulated suction or irrigation member by way of adhesive (e.g., paragraph [0035]).
Regarding claim 19, Taylor further discloses attaching a handle (120) manipulable by a user to the cannulated suction or irrigation member (paragraph [0035] discloses element 120 as a handle which is, by definition, manipulable by a user).
Regarding claim 20, Taylor further discloses wherein the cannulated suction or irrigation member is bendable (e.g., paragraph [0033]); it is noted that the use of the cannulated member as a suction or irrigation tube is not relevant to the method of making the device which is being claimed and it will not be given any patentable weight).
Regarding claim 21, Taylor ‘574 further teaches sealing one end of the cannulated member (via 88) prior to introducing the fluid into the liner member within the cannulated suction or irrigation member (the end is sealed so as to provide fluid pressure through 90 to drive 86 to apply the liner; Col. 6, lines 50-56).
Regarding claim 22, Taylor ‘574 further teaches after a selected period of time, the pressure is removed by removing the fluid from within the liner member and the cannulated suction or irrigation member (e.g., after driving 86 through the cannula it is removed along with the fluid pressure to leave the lined tubular member clear for use).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor in view of Rydell in view of Schaeffer in view of Taylor ‘574 as evidenced by Gargiulo (US 5,346,658)
Regarding claim 23, the cited references fail to explicitly disclose the claimed pressure and temperatures. Taylor ‘574 further discloses the variables of temperature and pressure are dependent on several factors governing installation of the liner (see e.g., Col. 5, lines 44-57 which discloses the temperature and Col. 3, lines 28-34 disclosing how an applied fluid pressure is provided so as to force the liner through the tube). Furthermore, Gargiulo teaches (Col. 2, lines 8-33) the known variation of temperature and pressure during liner installation into a cylindrical body depend on the materials being bonded. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to apply the claimed pressure and temperature for applying the liner, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). The prior art teaches the general use of heat and pressure during liner installation and that such variables depend on the materials and environment of the liner installation. One of ordinary skill in the art would understand that the optimization of the pressure and temperature during liner installation and would optimize the values depending on such an installation based upon the disclosure of the cited prior art.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor in view of Rydell in view of Schaeffer in view of Taylor ‘574, as applied to claim 1 above, and further in view of Sparks et al. (US 2002/0133141).
Regarding claim 10, Taylor/Rydell teach the claimed invention substantially as set forth above for claim 1, but do not explicitly disclose the liner being formed from the claimed polymers.
Sparks et al. (henceforth Sparks) teaches an instrument shaft which utilizes a liner member formed from Pebax (e.g., claim 55).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the liner member of the device of Taylor/Rydell to be formed from Pebax as Sparks teaches that such a material is suitable for use in liner members for cannulated elements.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor in view of Rydell in view of Schaeffer in view of Goldman (US 2004/0081780), and further in view of Burg et al. (US 2011/0270081).
Regarding claim 12, Taylor et al. (henceforth Taylor) discloses (Figure 1) a method of forming an instrument system comprising: providing a cannulated suction or irrigation member (e.g., 110; the method is directed applying a liner and the requirement for the cannulated member to perform suction or irrigation is not considered to substantially limit the structure of the cannula member) extending from a first member end to a second member end, the cannulated member formed of at least a first material (e.g., paragraph [0035]). Taylor does not explicitly disclose the cannula as formed from a malleable aluminum, a liner member extending from the first end to the second end or the method for applying the liner.
Burg et al. (henceforth Burg) teaches a surgical cannula formed from malleable aluminum (paragraph [0034]).
Rydell et al. (henceforth Rydell) teaches (e.g., Figures 1-3) a cannulated member (guide catheter 12) and a liner member (24) having an inner surface and an outer surface (e.g., a wall thickness) bonded thereto (e.g., Figures 1-3) and wherein the liner member extends from a first end to a second end (it extends the length of the cannula); and further wherein the bonded liner inhibits debris from the cannulated member from exiting the cannulated member (as it decreases the inner diameter of the cannula it will inhibit debris from exiting the cannula; the method of forming the device only requires the application of the liner member); and wherein the liner member is configured to remain bonded to the cannulated member during suction or irrigation (as set forth above, the method is for applying a liner and does not require the device to be limited to a specific use case; it is noted that Rydell intendeds the bonded catheter liner to resist delaminating during use)..
Schaeffer et al. (henceforth Schaeffer) teaches a balloon catheter device comprising a plurality of lumen formed with liner members (e.g., Figure 2B, liners 202 and 212); and which liners are bonded to the lumen via the application of heat and pressure (paragraph [0038]).
Goldman teaches that it is known to form a liner member for a cannulated member as a co-extrusion of an exterior sticky material (e.g., adhesive) and in internal smooth material (paragraphs [0008], [0012], and [0017]-[0019]) forming the inner surface and bonding the external wall of the liner to the internal wall of the cannula.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cannulated member of Taylor by using a malleable aluminum as taught by Burg as Burg teaches that such a material is known for use in a surgical cannula so as to aid in reaching a target site during a procedure. In addition, it would have been obvious to utilize the liner member of Rydell so as to provide a low friction internal surface for the cannulated member as taught by Rydell. In addition, it would have been obvious to apply the liner member via heat and the simultaneous application of pressure to the liner member as Schaeffer teaches it is a known method for securing a liner member to a tubular member. For this reason, it would have been obvious to use such a method to apply the liner member of Rydell to the device of Taylor. Furthermore, it would have been obvious to one of ordinary skill in the art to form the liner member of Taylor/Rydell/Schaeffer via a co-extrusion of a sticky layer and smooth hard layer to facilitate attaching the liner member to the cannula during the forming of the device as taught by Goldman.
Regarding claim 13, Taylor/Rydell/Schaeffer further teach the step of bonding the liner to at least a portion of an external wall of the cannulated suction or irrigation member near one of the ends (e.g., Figure 2C of Rydell depicts the liner having been rolled over the end of the cannulated suction or irrigation member before being pressed into the hub). For this reason, it would have been obvious to one of ordinary skill in the art to duplicate the process on the opposite end of the cannulated suction or irrigation member to further inhibit delamination as taught by Rydell.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor in view of Rydell in view of Schaeffer in view of Goldman in view of Burg, as applied to claim 12 above and further in view of Macaulay et al. (US 5,234,416).
Macaulay et al. (henceforth Macaulay) teaches an intravascular catheter device comprises a heat-shrinkable jacked applied to the outer surface of the cannulated suction or irrigation member (e.g., Col. 4, lines 35-44).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cannulated member of Taylor/Rydell/Schaeffer to comprise a step of heat-shrinking a jacket to the cannulated member so as to provide a pressure means for attaching the jacket to an inner element to secure the jacket thereto as taught by Macaulay.
Conclusion
THIS ACTION IS MADE FINAL. 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 JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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