DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Note: the second non-final rejection has been filed to address the 35 USC 103 rejection of the claims in the non-final filed 2/5/25.
Claim Objections
Claim 34 is objected to because of the following informalities: line 16 should be amended to -exposed within the elongated lumen such that the luminal metal wire directly-. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 41, 43, 57 and 71 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 41:
The claim is unclear because of the limitation “The tube-containing medical device kit of claim 1, wherein the” (emphasis added by the examiner) in line 1. It’s unclear what this claim depends on since claim 1 has been canceled. For the sake of examination, the office has assumed that this claim depends on claim 34. However, the applicant should amend the claim to clarify.
Claim 43 is rejected due to its dependence on claim 41.
Regarding claim 57:
The claim recites the limitation "the bioactive agent" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 71:
The claim is unclear because of the limitation “the luminal metal wire is uncoated such that the luminal metal wire is” in line 1. The claim is incomplete and therefore it’s not clear what is required. For the sake of examination, the office has interpreted the claim to require that the luminal metal wire is uncoated. However, the applicant should amend the claims to clarify.
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) 34, 36, 38, 40-41, 43-44, 48, 50, 52-54, 56-57, and 71-72 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20060058737 A1 to Herweck et al. (Herweck) in view of WO 0197721 A2 to Boucher et al. (Boucher).
Regarding claim 34:
Herweck discloses:
A tube-containing medical device kit (vascular access system (200); Fig.2), comprising:
a tube-containing medical device (250) including an access opening (260) positionable exterior with respect to a subject (¶0044, ¶0052, ¶0055), a fluid communication opening (275) positionable within the subject to fluidically communicate with a body fluid (¶0043 and ¶0052) of the subject, and an elongated lumen (252) therebetween; and
a luminal metal wire (150; shape memory metal; ¶0056) insertable within the elongated lumen (252) (as shown in figure 2), wherein:
the luminal metal wire (150) has a length that is within 5% to 100% of the elongated lumen (252) (the stylet (150) has a length that is 100% of the lumen (252) of the catheter (250) as seen in Fig.3), and has an x-y-dimensional cross-sectional area occupying an average of 7% to 90% of an x-y-dimensional cross-sectional area of the elongated lumen (252) (the diameter of the stylet is fully capable of being within 7% to 90% of the diameter of the lumen (252), since the stylet is a small diameter stylet and the stylet can have any suitable size and shape; ¶0057), and is sufficiently small to allow fluid to flow therebetween at locations where the luminal metal wire (150) is fully inserted or insertable within the elongated lumen (252) (figures 2-4 and ¶0052-¶0054),and
the luminal metal wire (150) when inserted in the elongated lumen (252) is at least partially exposed within the elongated lumen (252) (the stylet (150) is always exposed within the lumen (252), since the stylet is not covered by any member within the lumen as seen in Fig.2; ¶0053) such that the luminal wire directly contacts the fluid when introduced into the elongated lumen (252) (the stylet (150) directly contacts the fluid within the lumen (252), since the fluid flows out of the end hole (270) when the stylet (150) extends out of the end hole (270); ¶0053).
Herweck fails to disclose:
The luminal metal wire is a solid metal or metal alloy wire, wherein the solid metal or metal alloy wire is an antimicrobial material selected from copper, silver, zinc, gold, tin, or an alloy thereof.
Boucher teaches:
A tube-containing medical device kit (figure 5) that includes a tube-containing medical device (50/108) with an access port (see fluid source in figure 4) and a luminal metal wire (108). Further, the luminal metal wire can be made of shape memory alloy, such as nickel-titanium (Nitinol) or copper or iron based alloys (see page 40 lines 20-25).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Herweck to replace the shape memory wire with copper as taught by Boucher. This is a simple substitution of one known element (luminal metal wire made of shape memory metal) for another (luminal metal wire made of copper as taught by Boucher) to obtain predictable results (to form the body and support structure of the luminal wire). Further, the applicant’s disclosure indicates that the luminal wires made from copper are antimicrobial (page 19, lines 15-20; page 14, lines 20-25; page 15, lines 1-5 of the applicant’s specification).
Regarding claim 35:
Herweck discloses:
The tube-containing medical device kit of claim 34, wherein the luminal metal wire extends at least from the access opening and through the elongated lumen such that a distal tip of the luminal metal wire is positioned short of the fluid communication opening by a distance of 0.1 cm to 55 cm (the diameter of the stylet is fully capable of being positioned short of the fluid communication opening by a distance of 0.1 cm to 55 cm, since the stylet can have any suitable size and shape; ¶0057).
Regarding claim 36:
Herweck discloses:
The tube-containing medical device kit of claim 34, wherein the access opening (260) includes a hub connector (mounting portion of 260).
Regarding claim 38:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 34 by Herweck and Boucher:
The tube-containing medical device kit of claim 34, wherein the luminal metal wire (150 of Herweck) is copper or a copper alloy (see the modification of making the wire of copper instead of a shape memory material), and wherein the luminal metal wire (150 of Herweck) is a contact killer of microbial organisms (applicants disclosure indicates copper is a contact killer (see page 15 of the specification) and therefore the copper material modification by Boucher reads on the claim).
Regarding claim 40:
Herweck discloses:
The tube-containing medical device kit of claim 34, wherein the tube-containing medical device kit is assembled as a tube-containing medical device assembly with the luminal metal wire (150) is inserted within the elongated lumen (252)(see figures 2-4 which should the wire 150 within the lumen 252).
Regarding claim 41:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 34 by Herweck and Boucher:
The tube-containing medical device kit of claim 1, wherein the luminal metal wire (150 of Herweck) further comprises a bioactive agent (copper material of the metal wire as taught by Boucher and incorporated into Herweck) associated with a portion of the luminal metal wire (150 of Herweck), wherein the bioactive agent includes an antimicrobial agent (copper material is antimicrobial agent as indicated in the applicants disclosure), anti-thrombogenic agent, a thrombolytic agent, a drug, or a combination thereof, and wherein the bioactive agent is located on the luminal metal wire (150 of Herweck) at locations other than where the luminal metal wire (150 of Herweck) is exposed (exposed portions of the wire are copper).
Regarding claim 43:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 34 by Herweck and Boucher:
The tube-containing medical device kit of claim 41, wherein the bioactive agent is selected from vancomycin, clindamycin, rifampin, minocycline, amoxicillin, tetracycline, chlorhexidine, iodine, silver, silver alloy, copper (see the copper material of the wire as taught by taught by Boucher and incorporated into Herweck), copper alloy, zinc, zinc alloy, gold, gold alloy, curcumin, curcumin derivatives, gentamycin, cephalosporin, heparin, direct thrombin inhibitors, Factor Xa inhibitors, aspirin, EDTA, citrate, platelet glycoprotein IIb inhibitors, platelet glycoprotein IIIa inhibitors, antiplatelet agents, direct P2YR inhibitors, Nitric oxide and precursors, tissue plasminogen activator, urokinase, streptokinase, plasmin, or a combination thereof.
Regarding claim 44:
Herweck discloses:
The tube-containing medical device kit of claim 34, wherein the luminal metal wire has a z-dimension length to x-y-dimension cross-sectional diameter ratio of 50:1 to 3,000:1 (the diameter of the stylet is fully capable of z-dimension length to x-y-dimension cross-sectional diameter ratio of 50:1 to 3,000:1 of the lumen (252), since the stylet can have any suitable size and shape; ¶0057).
Regarding claim 48:
Herweck discloses:
The tube-containing medical device kit of claim 34, wherein the luminal metal wire (150) is surface textured (¶0057 indicates the stylet can have a rough surface finish (textured)).
Regarding claim 50:
Herweck discloses:
The tube-containing medical device kit of claim 34, wherein the tube-containing medical device (250) is a urinary catheter, a vascular catheter (catheter system for vascular access as indicated in ¶0052), a shunt, a drain, tracheal tube, or a feeding tube.
Regarding claim 52:
Herweck discloses:
The tube-containing medical device kit of claim 34, further comprising the fluid, wherein the fluid is a fluid lock solution (“safe injectable liquid catheter solution” in ¶0039) for loading in the elongated lumen (252).
Regarding claim 53:
Herweck discloses:
The tube-containing medical device kit of claim 34, wherein the tube-containing medical device (250) is a catheter (250) with the fluid communication opening (275) positioned on a side wall (as shown in figure 2) of the elongated lumen (252), wherein the luminal metal wire (150) is of a length to extend beyond the fluid communication opening (275) but still remain within the elongated lumen (252)(at stages between figure 2 and figure 3 where the wire is extending through 252).
Regarding claim 54:
Herweck discloses:
The tube-containing medical device kit of claim 34, wherein the tube-containing medical device (250) includes multiple hubs including a first hub (see the “first hub” in figure 1 below) with an access opening (end of first hub) for inserting or removing the luminal metal wire (150) from the elongated lumen (252) that is separate from a second hub (see the “second hub” in figure 1 below) with a second access opening (end of second hub) used for introducing or removing fluid from the elongated lumen (252) (the therapeutic agent (120) is delivered through the stylet (parag. [0043], lines 2-5), and the hubs are separate as seen below) (the catheter can be a multi-lumen catheter with two hubs as seen in Fig.8A) (parag. [0065]).
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Figure 1 - figure 8a of Herweck, annotated by the examiner
Regarding claim 57:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 34 by Herweck and Boucher:
The tube-containing medical device kit of claim 34, wherein the bioactive agent is activatable by a lock solution (see the “safe injectable liquid catheter solution” in ¶0039 ) when introduced into the elongated lumen (252 of Herweck) and comes in contact with the bioactive agent (the copper material of Boucher incorporated into Herweck is “activated” or effective at any point since it is exposed and is therefore is activated when the lock solution is in the lumen).
Regarding claim 71 (as best understood by the examiner, see the 35 USC 112(b) rejection above for the claim interpretation):
Herweck discloses:
The tube-containing medical device kit of claim 34, wherein the luminal metal wire (150) is uncoated (see ¶0057 which indicates the wire 150 can be monolithic (without coating)) such that the luminal metal wire (150) is.
Regarding claim 72:
Herweck discloses:
The tube-containing medical device kit of claim 34, wherein the luminal metal wire (150) is substantially non-eluting (smooth and non-porous surface as indicated in ¶0057 which indicates it is non-eluting).
Allowable Subject Matter
Claim 56 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments, see remarks, filed 8/10/26, with respect to the rejection(s) of claim(s) 34-36, 38, 40-41, 43, 44, 48, 50, 52-54, 57, 71 and 72 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Herweck and Boucher.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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