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 Amendments filed 08/15/2025 have been entered.
Claims 1, 8 and 20 have thereby been amended.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-5, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gandras (US 20140276628) in view of Farooqui (US 20170347926).
Regarding claim 1, Gandras discloses a catheter comprising: a catheter body having a tubular shape (actuation member in tubular structure; page 1, para. [0010], sentence 1); and a wire mesh attached to and encircling the catheter body (122), wherein the wire mesh is configured for radially expanding away from the catheter body (radial expansion demonstrated in Fig. 4 compared to Fig. 3). Although Gandras does not explicitly disclose the wire mesh used to facilitate removal of the catheter body from a patient, the recitation of this limitation is an intended use limitation and as such is given no patentable weight, as the disclosed structures of Gandras would be capable of expanding to open the tissue around a catheter and therefore would be capable to be used to aid in the removal of the catheter from a patient. However, Gandras fails to disclose a cuff for facilitating fibrous tissue growth included on the catheter body.
Farooqui teaches an analogous catheter with anchoring means, with a cuff encircling the catheter body (332), wherein the cuff is configured for facilitating fibrous tissue growth (page 4, para. [0046], sentence 6). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the cuff taught by Farooqui into the catheter of Gandras in order to anchor the catheter at insertion site in order to stabilize the catheter for extended-dwell use and help prevent infection at the insertion site (page 4, para. [0046], sentence 6-7). It directly follows that upon incorporating the cuff taught by Farooqui into the catheter configuration of Gandras, it would be obvious to combine the elements such that the cuff and wire mesh be positioned adjacent one another.
Regarding claim 4, Gandras in view of Farooqui teaches the catheter of claim 1, as described above, wherein the cuff is formed of polyethylene terephthalate (Farooqui: page 4, para. [0046], sentence 2-3).
Regarding claim 5, Gandras in view of Farooqui teaches the catheter of claim 1, as described above, wherein the wire mesh has a stent configuration (Gandras: Fig. 3, 322).
Regarding claim 10, Gandras in view of Farooqui teaches the catheter of claim 1, as described above, wherein the wire mesh has a distal end and a proximal end, and wherein the distal end of the wire mesh is fixedly attached to the catheter body (Gandras: page 6, para. [0077], sentence 2).
Regarding claim 11, Gandras in view of Farooqui teaches the catheter of claim 10, as described above, wherein the wire mesh is configured for radially expanding away from the catheter body by advancing the proximal end of the wire mesh toward the distal end of the wire mesh (Gandras: radial expansion via advancing the proximal end towards the distal end demonstrated in Fig. 4 compared to Fig. 3).
Regarding claim 12, Gandras in view of Farooqui teaches the catheter of claim 10, as described above, wherein the proximal end of the wire mesh is removably attached to the catheter body (Gandras: Figs. 3-4, proximal end of mesh 322/422 movable therefore not fixedly attached to catheter 330/430).
Regarding claim 13, Gandras in view of Farooqui teaches the catheter of claim 1, as described above, further comprising a collar fixedly attached to the wire mesh and encircling the catheter body (Gandras: shaft 120/320/420).
Regarding claim 14, Gandras in view of Farooqui teaches the catheter of claim 13, as described above, wherein the collar is removably attached to the catheter body (Gandras: Figs. 3-4, collar 320/420 movable relative to catheter body 330/430; page 2, para. [0012], sentence 6).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gandras (US 20140276628) in view of Farooqui (US 20170347926) in further view of Edwards (US 7184827).
Regarding claim 3, Gandras in view of Farooqui teaches the catheter of claim 1, as described above, but fails to explicitly teach that the Dacron or PET material of the cuff is in a knitted or woven configuration.
Edwards teaches an analogous catheter system, with Dacron formed of a knitted or woven material (col. 3, lines 16-18). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Dacron cuff of the Gandras-Farooqui catheter system with the woven Dacron material taught by Edwards, in order to incorporate a biologically inert material (col. 3, lines 16-18) in a more cost-effective woven configuration.
Claims 2 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Gandras (US 20140276628) in view of Farooqui (US 20170347926) in further view of Herscu (US 20170056045).
Regarding claim 2, Gandras in view of Farooqui teaches the catheter of claim 1, as described above, but does not explicitly teach the catheter being a tunneled catheter.
Herscu teaches an analogous extended-dwell catheter system with a cuff that facilitates fibrosis and subsequent anchoring at the insertion site, wherein the catheter is a tunneled catheter (page 1, para. [0019], sentence 1). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Gandras-Farooqui catheter system by incorporating the application of a tunneled catheter taught by Herscu, in order to allow the catheter system to be used in a wider range of treatment applications such as for venous catheters (page 1, para. [0018], sentences 2) and to be able to allow for longer term access (page 1, para. [0002], sentences 1-2).
Regarding claim 6, Gandras in view of Farooqui teaches the catheter of claim 1, as described above, but does not teach the placement of the cuff such that the wire mesh extends over it. Upon the combination Gandras and Farooqui as described above, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the cuff taught by Farooqui to the portion of the Gandras catheter that is within the mesh portion (122), wherein the wire mesh extends over the cuff and is configured for radially expanding away from the cuff. This arrangement upon the combination would have allowed the expanding mesh apparatus of Gandras to expand around the cuff to separate the surrounding fibrotic growth, while allowing the cuff to facilitate anchoring prior to expansion. The obviousness and motivation of this combination is evidenced by Herscu, which teaches an analogous dwelling catheter with a cuff (504) that facilitates fibrosis and subsequent anchoring at the insertion site, just as Farooqui. Herscu teaches a catheter extraction device (Fig. 1: 100) which is inserted between the cuff and the fibrotic sheath surrounding it, and expanded (page 2, para. [0025], sentence 1) in order to separate the fibrotic sheath from the cuff and allow for the removal of the catheter without requiring surgery (page 1, para. [0019], sentence 1). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the cuff taught by Farooqui underneath the wire mesh portion of the Gandras catheter system in order to separate, upon its expansion, the fibrotic sheath formed around the cuff, in order to achieve the same less invasive and faster extraction technique taught by Herscu (page 1, para. [0019], sentence 1), but without requiring an additional tool or insertion procedure.
Regarding claim 7, Gandras in view of Farooqui teaches the catheter of claim 6, as described above, wherein the cuff is fixedly attached to the catheter body (Farooqui: fixed such that it prevents movement of the catheter body; page 4, para. [0046], sentence 6-7).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gandras (US 20140276628) in view of Farooqui (US 20170347926) in further view of Davis (US 7972372).
Regarding claim 8, Gandras in view of Farooqui teaches the catheter of claim 1, as described above, but fails to teach that the mesh is positioned between the cuff and catheter body or that the cuff breaks upon expansion of the wire mesh.
Davis teaches an analogous catheter system with an expandable balloon and stent, wherein the wire mesh (210+220) extends between the catheter body and the cuff (Fig. 7A: 210 extends between catheter 240 and cuff 260) and is configured for breaking the cuff upon radial expansion of the wire mesh (col. 9, lines 30-32). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Gandras-Farooqui catheter system to rearrange the placement of the Gandras-Farooqui cuff with the Davis teachings of the breakable cuff placed over the wire mesh in order to hold down and fix the wire mesh to the catheter so that it does not open unintentionally or accumulate slack upon its insertion (col. lines 9-15).
Regarding claim 9, Gandras in view of Farooqui in further view of Davis teaches the catheter of claim 8, as described above, wherein the cuff is removably attached to the wire mesh (Davis: col. 9, lines 30-32).
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Gandras (US 20140276628) in view of Vale (US 20170105743) in further view of Farooqui (US 20170347926) in further view of Herscu (US 20170056045).
Regarding claim 15, Gandras discloses a catheter system comprising: a catheter comprising: a catheter body having a tubular shape (actuation member in tubular structure; page 1, para. [0010], sentence 1); a wire mesh attached to and encircling the catheter body (122), and a collar attached to the wire mesh and encircling the catheter body (shaft 120/320/420); and a tool (332) configured for positioning over a portion of the catheter body (Fig. 7, 732 over a portion of 730) and for coupling to the collar to facilitate radial expansion of the wire mesh (Figs. 3-4, collar 320/420 movable relative to catheter body 330/430 and tool 332; page 2, para. [0012], sentences 5-6). However, Gandras fails to disclose that the tool is removably coupled to the collar, and also fails to disclose the mesh over a cuff for facilitating fibrous tissue growth included on the catheter body.
Vale teaches an analogous catheter system with a tool (Fig. 39: 300+302) removably coupling (Fig. 42; page 10, para. [0246]) to the collar (Fig. 39: 301). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coupling of the tool and collar of Gandras with the detachable threaded coupling of the tool and collar taught by Vale, in order to allow for the tool to be removed when not in use to provide more comfort to the patient when the catheter is dwelling for an extended period of time. However, the Gandras-Vale catheter system also fails to disclose a cuff for facilitating fibrous tissue growth included on the catheter body.
Farooqui teaches an analogous catheter with anchoring means, with a cuff attached to and encircling the catheter body (332), wherein the cuff is configured for facilitating fibrous tissue growth (page 4, para. [0046], sentence 6). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the cuff taught by Farooqui into the catheter of Gandras-Vale in order to anchor the catheter at insertion site in order to stabilize the catheter for extended-dwell use and help prevent infection at the insertion site (page 4, para. [0046], sentence 6-7). However, Gandras-Vale-Farooqui does not teach the placement of the cuff such that the wire mesh extends over it.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Gandras-Vale-Farooqui catheter system by incorporating the cuff taught by Farooqui to the portion of the Gandras catheter that is within the mesh portion (122), wherein the wire mesh extends over the cuff and is configured for radially expanding away from the cuff. This arrangement upon the combination would have allowed the expanding mesh apparatus of Gandras to expand around the cuff to separate the surrounding fibrotic growth, while allowing the cuff to facilitate anchoring prior to expansion. The obviousness and motivation of this combination is evidenced by Herscu, which teaches an analogous dwelling catheter with a cuff (504) that facilitates fibrosis and subsequent anchoring at the insertion site, just as Farooqui. Herscu teaches a catheter extraction device (Fig. 1: 100) which is inserted between the cuff and the fibrotic sheath surrounding it, and expanded (page 2, para. [0025], sentence 1) in order to separate the fibrotic sheath from the cuff and allow for the removal of the catheter without requiring surgery (page 1, para. [0019], sentence 1). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the cuff taught by Farooqui underneath the wire mesh portion of the Gandras-Vale catheter system in order to separate, upon its expansion, the fibrotic sheath formed around the cuff, in order to achieve the same less invasive and faster extraction technique taught by Herscu (page 1, para. [0019], sentence 1), but without requiring an additional tool or insertion procedure.
Regarding claim 16, Gandras in view of Vale in further view of Farooqui in further view of Herscu teaches the catheter system of claim 15, as described above, wherein the tool is configured for removably coupling to the collar via a twist-lock mechanism (Vale: twisting and locking via threaded/screw coupling; Fig. 42; page 10, para. [0246]).
Regarding claim 17, Gandras in view of Vale in further view of Farooqui in further view of Herscu teaches the catheter system of claim 15, as described above, wherein the collar comprises a plurality of protrusions (Fig. 42: 309), and wherein the tool comprises a plurality of slots (Fig. 42: 306) configured for receiving the protrusions to removably couple the tool to the collar.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Herscu (US 20170056045) in view of Gandras (US 20140276628).
Regarding claim 18, Herscu discloses a method for removing a catheter from a patient, the catheter including a catheter body (Figs. 5A-C: 502), a cuff with fibrous tissue growth Figs. 5A-C: (504; page 1, para. [0019], sentence 4), an expandable tool encircling the catheter body (Figs. 5A-C: 308), the method comprising: radially expanding the expandable tool away from the catheter body (page 2, para. [0025], sentence 1); and pulling at least the catheter body out of the patient (page 2, para. [0025], sentence 5). However, Herscu discloses the expandable tool as a separate device, and fails to disclose the expanding member as a wire mesh.
Gandras teaches an analogous catheter system and method with a wire mesh encircling the catheter body (122) wherein the user can radially expand the wire mesh away from the catheter body (radial expansion demonstrated in Fig. 4 compared to Fig. 3). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter system and method of Herscu by incorporating the wire mesh in order to achieve the same less invasive and faster extraction technique taught by Herscu (page 1, para. [0019], sentence 1), but without requiring an additional tool or insertion procedure. Upon this combination, due to the attachment of the wire mesh to the catheter body as taught by Gandras, pulling the catheter body out of the patient would result in pulling at least the catheter body and the wire mesh out of the patient.
Regarding claim 19, Herscu in view of Gandras teaches the method of claim 18, as described above, wherein the wire mesh extends over the cuff, wherein radially expanding the wire mesh away from the catheter body (Gandras: radial expansion demonstrated in Fig. 4 compared to Fig. 3) comprises radially expanding the wire mesh away from the cuff and separating the fibrous tissue growth from the cuff (Herscu: page 2, para. [0025], sentence 1, but wherein 120 is replaced with the wire mesh of Gandras due to the combination explained above), and wherein pulling at least the catheter body and the wire mesh out of the patient comprises pulling the catheter body, the wire mesh, and the cuff out of the patient (Herscu: page 2, para. [0025], sentence 5, the cuff is fixed to the catheter).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Herscu (US 20170056045) in view of Gandras (US 20140276628) in further view of Davis (US 7972372).
Regarding claim 20, Herscu in view of Gandras teaches the method of claim 18 as described above, but fails to teach that the mesh is positioned between the cuff and catheter body or that the cuff breaks upon expansion of the wire mesh.
Davis teaches an analogous catheter system with an expandable balloon and stent and methods for its removal, wherein the wire mesh (210+220) extends between the catheter body and the cuff (Fig. 7A: 210 extends between catheter 240 and cuff 260), and wherein radially expanding the wire mesh away from the catheter body comprises breaking the cuff and separating the wire mesh from the cuff (col. 9, lines 30-32). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Herscu-Gandras catheter system and removal methods to rearrange the placement of the Herscu-Gandras cuff with the Davis teachings of the breakable cuff placed over the wire mesh in order to hold down and fix the wire mesh to the catheter so that it does not open unintentionally or accumulate slack upon its insertion (col. lines 9-15).
Response to Arguments
Applicant’s arguments, to the 112(b) rejection of claim 5, filed 08/15/2025, have been fully considered and are persuasive. The 112(b) rejection of claim 5 has been withdrawn.
Applicant's arguments to the prior art rejections of claims 1-20, filed 08/15/2025, have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues that Gandras does not teach the amended claim limitations. As described in the rejection above, although Gandras does not disclose a cuff adjacent to the wire mesh, Farooqui which teaches the cuff, would be obvious to one of ordinary skill in the art to incorporate into the Gandras device such that the cuff is positioned near/adjacent to the wire mesh. Additionally, although Gandras does not teach the wire mesh for the purpose of removing the catheter from the patient as the amended claim states, this amendment is an intended use limitation. As such, this limitation it self does not hold patentable weight and Gandras in view of Farooqui teach all the claimed structures which do hold patentable weight.
Regarding claim 15, Applicant argues that Herscu discloses a catheter extraction device separate from the claimed invention. However, as described in the rejection above, Examiner maintains that Herscu teaches the motivation for incorporating the cuff taught by Farooqui to the portion of the Gandras catheter that is within the mesh portion in the Gandras-Vale-Farooqui catheter system. Herscu is not used to teach the structures of the claimed device, but rather to motivate the placement of the device parts taught by Gandras, Valse and Farooqui.
Regarding claim 18, Applicant again argues that Herscu fails to teach an expanding wire mesh. Examiner reiterates that Herscu teaches expansion of an expandable too, not a mesh wire, but that it would be obvious to one of ordinary skill in the art to combine Herscu and Gandras such that the expanding tool of Herscu is replaced with the expandable mesh of Gandras. Therefore, Gandras provides the wire mesh structure to the method taught by Herscu.
Therefore, the amendments made to claims 1, 8 and 20 fails to overcome any of the prior art rejections, and for the reasons stated above, Examiner maintains the rejections for claims 1-20 as recited above.
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 KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783