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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11, drawn to catheter system in the reply filed on 08/03/2026 is acknowledged.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/03/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the side port (32) being aligned with the first extension tube (20) and the access connector (26) in claim 2 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 recites that the first extension tube, the access connector, AND the side port are aligned to form a straight path. However, as shown in the drawings, the side port (32) is not aligned with the first extension tube (20) and the access connector (26), thereby failing to providing support for such a limitation. For examination purposes, only the first extension tube and the access connector will be understood as being aligned to form a straight path.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4, 5, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication No. 2020/0230353 to Burkholz et al. (“Burkholz”).
Regarding claim 1, Burkholz teaches a catheter system (Fig. 3A) comprising a catheter adapter (40), comprising a distal end (distal end of 40), a proximal end (proximal end of 40), a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter (lumen of 40), a side port (41) between the distal end of the catheter adapter and the proximal end of the catheter adapter and in fluid communication with the lumen (Fig. 3D), a catheter (48) extending from the distal end of the catheter adapter, a first extension tube (53) comprising a distal end and a proximal end, wherein the distal end of the first extension tube is integrated with the side port of the catheter adapter (Fig. 3C), an access connector (16), comprising a distal port (57), a proximal port (28), and a side port (between 55 and 57) between the distal port and the proximal port, wherein the distal port and the proximal port are aligned with a longitudinal axis of the access connector (Fig. 3C), wherein the side port is angled with respect to the longitudinal axis of the access connector (Fig. 3C, the side port is angled), wherein the proximal end of the first extension tube is integrated with the distal port of the access connector (proximal end of 53 is integrated with 57), and a second extension tube (55) comprising a distal end and a proximal end, wherein the distal end of the second extension tube is integrated with the side port of the access connector (distal end of 55 is integrated with the side port as defined), wherein the first extension tube (53) is shorter than the second extension tube (55, as seen in Fig. 3C).
Regarding claim 2, Burkholz teaches the catheter system of claim 1 as shown above, Burkholz further teaching the longitudinal axis of the access connector (16) and the first extension tube (53)
Regarding claim 4, Burkholz teaches the catheter system of claim 1, Burkholz further teaching the proximal port (28) comprises a female luer (Fig. 3C).
Regarding claim 5, Burkholz teaches the catheter system of claim 1, Burkholz further teaching a blood sampling device (63) coupled to the proximal port (28).
Regarding claim 11, Burkholz teaches the catheter system of claim 1, Burkholz further teaching the proximal end of the second extension tube (55) is integrated with an adapter (the winged section distal to 59), wherein the adapter is coupled to a needleless connector (59), wherein a proximal end of the adapter comprises a single port (Fig. 3A).
Claim 3 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication No. 2020/0230353 to Burkholz et al. (“Burkholz”) as evidenced by U.S. Patent Publication No. 2021/0085927 to Howell.
Regarding claim 3, Burkholz teaches the catheter system of claim 2, although Burkholz doesn’t specify the material or material characteristics, although the common materials used for components such as extensions tubes in catheter systems are understood as inherently being either rigid or semi-rigid given the broadest reasonable interpretation. In any case, Howell is cited as an evidentiary reference showing the construction of catheter bodies including an analogous extension tube 12 made out a plastic, polymer, silicon rubber, or similar suitable material or combinations thereof ([0025]) that would be considered rigid or semi-rigid.
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.
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 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of U.S. Patent No. 5,002,066 to Simpson et al. (“Simpson”).
Regarding claim 6, Burkholz teaches the catheter system of claim 1 as shown above, but does not teach the stopcock coupled to the second extension tube.
Simpson teaches a three-way stopcock valve (11), wherein the three-way stopcock valve comprises a first port (21), a second port (22) opposite the first port, and a third port (23), wherein a proximal end of a second extension tube (10) is coupled to the first port of the three-way stopcock valve. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have coupled a three-way stopcock valve to the second extension tube of Burkholz as taught by Simpson to yield the predictable result of providing additional treatment options such as taking blood samples, providing saline, providing a flush valve to clean the system, and preventing contamination (column 2) as known in the art.
Regarding claim 7, Burkholz and Simpson teach the catheter system of claim 6 as shown above, once combined, the proximal end of the second extension tube of Burkholz would be integrated with the first port (via 10 in Fig. 1 of Simpson).
Regarding claim 8, Burkholz and Simpson teach the catheter system of claim 6, Burkholz further teaching the catheter system comprises a fluid pathway within the catheter, the catheter adapter, the first extension tube, the access connector, and the second extension tube (Fig. 3D, all the components are fluidly connected) and Simpson teaching the second port, the third port, and the proximal port of the access connector (via 10 in the combination) are configured to provide access to the fluid pathway of the catheter system (all the ports provide access to the fluid pathway via the stopcock).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Simpson as applied to claim 8 above, and further in view of U.S. Patent No. 5,308,322 to Tennican et al. (“Tennican”).
Regarding claim 9, Burkholz and Simpson teach the catheter system of claim 8 as shown above, Simpson further teaching a pre-filled flush system (15/16/17) coupled to the second port (22) such that closing of the second port prevents fluid communication between the pre-filled flush system and the fluid pathway, and a syringe (50) coupled to the third port such that closing of the third port prevents fluid communication between the syringe and the fluid pathway, wherein the syringe is configured for temporary blood withdrawal (column 3, lines 51-62). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the flush system and syringe of Simpson in the catheter system of Burkholz and Simpson to yield the predictable result of providing additional treatment options such as blood sampling and flushing, as are commonly used in such catheter systems for treatment and reducing contamination. The flushing system of Simpson uses a pre-filled IV and valve instead of a pre-filled syringe as claimed.
Tennican teaches a pre-filled syringe used for flushing (abstract). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the IV and valve-based flush system of Simpson with the syringe-based flush system of Tennican to yield the predictable result of proving a means for flushing a catheter system. Both Simpson and Tennican use a flushing system to flush the catheter system, Tennican merely showing a well-known obvious alternative flushing system for accomplishing the same result.
Regarding claim 10, Burkholz, Simpson, and Tennican teach the catheter system of claim 9 as shown above, Simpson further teaching a pressure monitoring device (12) disposed between the second port (22) and pre-filled flush system (15/16/17 or pre-filled syringe once combined with Tennican).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KOO whose telephone number is (703)756-1749. The examiner can normally be reached M-F 8am-5pm EST.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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