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 10/08/2025 have been entered.
Claims 1, 5, 14 and 15 have thereby been amended.
Claims 1-20 are being examined in this office action.
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.
Claims 1-6, 8-11, 14-15, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bown (US 10004875) in view of Walters (US 20200391014).
Regarding claim 1, Bown discloses a catheter assembly, comprising: a catheter (90) defining a catheter proximal end (Fig. 36: proximal end of 90 at connector 14) and a catheter distal end (Fig. 36: distal end of 90 at 16), the catheter defining a central lumen extending between the catheter distal end (col. 2, lines 11-13) and a catheter connector at the catheter proximal end (Fig. 36: connector around 14); a stylet (10) inserted into the central lumen (col. 2, lines 11-13), comprising: a stylet tube (54) defining a tube lumen extending along the stylet tube between a stylet proximal end and a stylet distal end (col. 5, lines 53-55; stylet proximal end 14; stylet distal end 16), a plurality of magnets (70) disposed within the tube lumen (Fig. 8: magnets 70 withing lumen of 54; col. 6, lines 1-5). Bown discloses a pliant silicone disposed between one or more of the plurality of magnets and an inner surface of the stylet tube that enables longitudinal sliding motion the one or more of the plurality of magnets with respect to the stylet tube during insertion of the catheter into a patient vasculature (Fig. 28: silicone gaps 52; col. 6, lines 19-23). Bown fails to explicitly disclose, however, the silicone as a lubricant between the magnets and within the stylet tube.
Walters teaches an analogous catheter assembly with an analogously structured component to the magnets (Fig. 7A: sensor 190) disposed withing a stylet tube (160) and a lubricant in the form of silicone gel (194) disposed between/around the sensor and an inner surface of the stylet tube (para. [0122], 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 Bown assembly by incorporating the silicone in the form of lubricant silicone gel surrounding 190 taught by Walters, into the silicone spacers 52, such that the pliant silicone spacers of Bown are replaced with a more specific, viscous and lubricating silicone gel, in order to provide an even higher degree of movement and slidability of the magnets between each other.
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Bown, Fig. 8
Regarding claim 2, Bown in view of Walters teaches the catheter assembly according to claim 1, as described above, wherein the catheter is a peripherally inserted central catheter (Bown: col. 15, lines 34-35).
Regarding claim 3, Bown in view of Walters teaches the catheter assembly according to claim 2, as described above, wherein the catheter includes two or more extension legs (Bown: Fig. 36, two extension legs at proximal end of 90, one extension leg end at labels10, 12, and 14), each extension leg defining an extension leg lumen in fluid communication with the central lumen (Bown: Fig. 36: 14 is proximal end of inserted stylet and 16 is distal end of inserted stylet, showing fluid communication through central lumen of 90 and extension leg).
Regarding claim 4, Bown in view of Walters teaches the catheter assembly according to claim 1, as described above, wherein the stylet tube includes a polyamide material (Bown: col. 5, lines 42-46).
Regarding claim 5, Bown in view of Walters teaches the catheter assembly according to claim 1, as described above, wherein the lubricant is disposed between the plurality of magnets and the inner surface of the stylet tube (as would occur upon replacing the Bown spacers 52 with the lubricant form of silicone taught by Walters, as described above).
Regarding claim 6, Bown in view of Walters teaches the catheter assembly according to claim 1, as described above, wherein the lubricant extends between adjacent magnets of the plurality of magnets (as would occur upon replacing the Bown spacers 52 with the lubricant form of silicone taught by Walters, as described above).
Regarding claim 8, Bown in view of Walters teaches the catheter assembly according to claim 1, as described above, wherein the plurality of magnets are disposed along a magnetic region of the stylet (Bown: Fig. 8: region 20 with magnets 70), the magnetic region extending proximally away from the stylet distal end (Bown: Fig. 8: region 20 extends in direction of arrow 14 proximally from the distal end 16).
Regarding claim 9, Bown in view of Walters teaches the catheter assembly according to claim 8, as described above, wherein the lubricant is disposed along the magnetic region (as would occur upon replacing the Bown spacers 52 with the lubricant form of silicone taught by Walters, as described above; Bown magnetic region 20 within tube 54 seen in Fig. 8).
Regarding claim 10, Bown in view of Walters teaches the catheter assembly according to claim 8, as described above, wherein the lubricant is disposed along a portion of the stylet tube extending proximally away from the magnetic portion (Walters incorporation teaches the lubricant is disposed along the inner surface of stylet tube, Fig. 8 of Bown shows stylet tube 54 extending proximally away from the magnetic portion 20).
Regarding claim 11, Bown in view of Walters teaches the catheter assembly according to claim 8, as described above, wherein: each of the magnets is cylindrically shaped (Bown: col. 10, line 39), and the plurality of magnets are arranged end-to-end along the magnetic region (Bown: Fig. 8: magnets 70 arranged end-to-end, stacked; col. 6, lines 10-18).
Regarding claim 18, Bown in view of Walters teaches the catheter assembly according to claim 1, as described above, wherein the stylet includes an attachment member configured to couple with the catheter connector (Bown: attachment element being the tab element 12, that attaches at connector of extension leg seen in Fig. 36).
Regarding claim 20, Bown in view of Walters teaches the catheter assembly according to claim 18, as described above, wherein a first distance between the attachment member and the stylet distal end is substantially equal to a second distance between the catheter connector and the catheter distal end such that, when the attachment member is coupled with the connector, the stylet distal end is disposed adjacent the catheter distal end (Bown: Fig. 36, distance from 14 to 16 is substantially equal to 14 to the distal end of the catheter 90).
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Claims 7, 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Bown (US 10004875) in view of Walters (US 20200391014) in further view of Wakeford (US 20090062772).
Regarding claim 7, Bown in view of Walters teaches the catheter assembly according to claim 1, as described above, but fails to teach that each magnet has a parylene coating.
Wakeford teaches an analogous catheter-stylet assembly wherein each of the plurality of magnets includes a parylene coating (para. [0057], last sentence; para. [0073], sentence 3, magnetic materials 32 all coated). 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 Bown-Walters stylet assembly by incorporating the parylene coating of the magnets as taught by Wakeford, in order to ensure the biocompatibility of each magnet (Wakeford: para. [0057], last sentence) and further increase the lubricity of the magnets withing the tubing (para. [0073], sentence 3).
Regarding claim 12, Bown in view of Walters teaches the catheter assembly according to claim 8, as described above, wherein; the stylet includes a wire (Bown: 55) disposed within the tube lumen (Bown: Fig. 7: 55 within 54), and the wire extends longitudinally along at least the magnetic region (Bown: Fig. 7; col. 7, lines 20-22). However, Bown in its teaching of wire 55, fails to teach that the wire is stainless steel.
Wakeford teaches an analogous catheter-stylet assembly that also includes materials for reinforcement as taught by 55 of Bown, wherein the reinforcing material 72 is stainless steel (para. [0030], 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 reinforcement wire 55 of Bown in the Bown-Walters assembly by incorporating the stainless steel material of it as taught by Wakeford, in order to ensure the wire is biocompatible and is stiff to ensure necessary reinforcement (Wakeford: para. [0030], sentence 1).
Regarding claim 13, Bown in view of Walters in further view of Wakeford teaches the catheter assembly according to claim 12, as described above, wherein the stainless steel wire is wrapped at least partially around each magnet (Bown: Fig. 7, wire 55 wrapped helically around each magnet 70; col. 7, lines 20-25).
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Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bown (US 10004875) in view of Walters (US 20200391014) in further view of Tegg (US 20120035466).
Regarding claim 14, Bown in view of Walters teaches the catheter assembly according to claim 12, as described above. Although Walters teaches a sensor (190) in the stylet, Walters teaches a pressure sensor. Therefore, Bown-Walters fails to teach the stylet including a sensor which detects electrical signals specifically.
Tegg teaches an analogous catheter assembly with magnets, wherein the stylet includes one or more sensors configured to detect electrical signals (Tegg: para. [0139], electrode 201 being a sensing electrode). 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 distal electrode sensor taught by Tegg into the Bown-Walters combination device in order to provide sensing for location sensing/mapping such that the navigation and location of the catheter and stylet can be accurately tracked (Tegg: para. [0071], sentence 7).
Regarding claim 15, Bown in view of Walters in further view of Tegg teaches the catheter assembly according to claim 14, as described above, wherein the one or more sensors includes an electrode disposed at the distal end of the stylet (Tegg: Fig. 11: 201, tip electrode assembly at distal end), the electrode electrically coupled with the stainless steel wire (Tegg: Fig. 40, wrapped wire 530 coupled to electrode, para. [0133], sentence 2; upon incorporation of the electrode of Tegg into the above-described Bown-Walters combination, the wire 55 of Bown would be coupled to the electrode taught by Tegg in the same manner it is coupled to 530 of Tegg).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Bown (US 10004875) in view of Walters (US 20200391014) in further view of Sato (US 20160250442).
Regarding claim 16, Bown in view of Walters teaches the catheter assembly according to claim 1, as described above, but fails to explicitly teach the lubricant as being water soluble.
Sato teaches an analogous catheter assembly containing a lubricant wherein the lubricant is water soluble (para. [0086], water soluble lubricants including polyvinyl pyrrolidone, water-soluble Nylon, polyvinyl alcohol, etc.). 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 lubricant of the Bown-Walters combination by incorporating the water-soluble catheter lubricant taught by Sato in order to provide a lubricant less likely to cause irritation to some patients in the case of the stylet tube is accidentally broken and the lubricant is exposed.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Bown (US 10004875) in view of Walters (US 20200391014) in further view of Cohn (US 20210187242).
Regarding claim 17, Bown in view of Walters teaches the catheter assembly according to claim 1, as described above, but fails to explicitly teach the lubricant including a biological agent.
Cohn teaches an analogous catheter assembly in which the needle is coated for lubricity, wherein the lubricant includes a biologic agent (para. [0078], sentences 2-4, the Chitosan-vancomycin lubricant coating includes biological agent Chitosan for anti-bacterial purposes). 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 lubricant of the Bown-Walters combination by incorporating the Chitosan-vancomycin lubricant taught by Cohn in order to prevent infection by including bactericidal components in case the stylet tube is accidentally broken and the lubricant is exposed (Cohn: para. [0078], sentence 4, bactericidal components).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Bown (US 10004875) in view of Walters (US 20200391014) in further view of Morriss (US 20080183128).
Regarding claim 19, Bown in view of Walters teaches the catheter assembly according to claim 18, as described above, but fails to teach that the stylet attachment member or catheter connector have Luer tapers.
Morriss teaches an analogous stylet-catheter assembly with a stylet (100) attachment member, wherein the attachment member (Fig. 1: 114) includes a male Luer taper (Fig. 1: male Luer of 114; para. [0109], sentence 3 & para. [0087], sentences 2-3, describing the Luer taper) configured to engage a female Luer taper of the catheter (10) connector (Fig. 1: female Luer of 14 that 114 fits into; para. [0109], sentence 3 & para. [0087], sentences 2-3, describing the Luer taper and connection of 14 and 114). 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 Bown-Walters assembly by incorporating the Luer connection of the stylet attachment member and the catheter connector in order to provide a more secure connection that does not require torquing manipulation of the stylet that could result in unwanted kinking (Morriss: para. [0087], sentence 5).
Response to Arguments
Applicant’s arguments with respect to the rejections of claims 1-20 in view of Tegg have been considered but are moot because in light of the amendments to independent claim 1. The new ground of rejection no longer relies on the Tegg reference to teach the lubricant limitation of independent claim 1 and its depending claims, as the Applicant argues it fails to do. The new ground of rejection of independent claim 1 now relies upon Walters to teach the lubricant between the magnets during insertion/use of the device, and is structured and used in an analogous manner to Bown, which would make the combination obvious to one of ordinary skill in the art.
For these reasons, independent claim 1 (and its depending claims) stands rejected by Bown in view of Walters to teach all of the limitations as amended.
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
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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