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
Claims 20-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 20, 2026.
Applicant's election with traverse of Group I, species A and sub-species C in the reply filed on January 20, 2026 is acknowledged. The traversal is on the grounds that there would not be a serious search and/or examination burden on the examiner if restriction is not required. This is not found persuasive as to Group II because these are method claims that require additional searching for the claimed method steps. However, after searching the prior art, Examiner has found Applicant’s arguments are persuasive as to the species and sub-species restrictions which are hereby withdrawn.
The requirement is still deemed proper as to the method claims of Group II, and is therefore made FINAL.
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 1-19 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.
Claim 1 lines 8-9 recite “…wherein an initial biological fluid volume directed through the body is directed into the vented access port via the extension tube... “. It is not clear if this is a method step, or if it is a functional limitation of the claimed apparatus. MPEP 2173.05(p)(II) recites “…a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite…”. For purposes of examination, this is interpreted as “wherein the catheter extension set is configured to direct an initial biological volume through the body and into the vented access port via the extension tube…”. Claims 2-9 are rejected at least because they depend from claim 1.
Claim 10 lines 11-12 recite “…wherein an initial biological fluid volume directed through the body is directed into the extension tube via the connection port and into the vented access port…”. It is not clear if this is a method step, or if it is a functional limitation of the claimed apparatus. MPEP 2173.05(p)(II) recites “…a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite…”. For purposes of examination, this is interpreted as “…wherein the catheter extension set is configured to direct an initial biological volume through the body and into the extension tube via the connection port and into the vented access port…”. Claims 11-19 are rejected at least because they depend from claim 10.
Claim 11 lines 1-3 recite “…wherein a portion of the biological fluid is directed into the removable sample collection container after the initial blood volume is directed into the vented access port…”. It is not clear if this is a method step, or if it is a functional limitation of the claimed apparatus. MPEP 2173.05(p)(II) recites “…a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite…”. For purposes of examination, this is interpreted as “…wherein the catheter extension set is configured to direct a portion of the biological fluid into the removable sample collection container after the initial blood volume is directed into the vented access port…”.
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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (Burkholz) US 2019/0321599 A1 in view of Burkholz et al. (Burkholz 906’) US 2008/0287906 A1.
Regarding claim 1, Burkholz discloses a catheter extension set (catheter system 10, P0039 and shown in Figs. 1A-C), comprising a body (connector 30, P0040) defining a channel (channel, see annotated Fig. 1B below) to direct a biological fluid therethrough; a connection port (connection port, see annotated Fig. 1A below) defined in the body, in which an extension tube (extension tube 44, P0044) is fluidly coupled with the connection port; and a distal access port (distal access port, see annotated Fig. 1A below) defined in the body.
PNG
media_image1.png
818
580
media_image1.png
Greyscale
Burkholz does not teach a vented access port.
However, Burkholz 906’ teaches an extravascular system venting having a vented access port (ventable end cap 28 and removable vent plug 30, P0073 and shown in Figs. 13-15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the catheter extension set taper connection 46 of Burkholz with the vented access port of Burkholz 906’ for the purpose of venting the blood sample as taught by Burkholz 906’ P0063, wherein the vented access port of the modified catheter extension set is in fluid communication with the extension tube of Burkholz, the vented access port spaced apart from the connection port of Burkholz, wherein an initial biological fluid volume directed through the body is directed into the vented access port via the extension tube because that is the open fluid pathway when the distal access port is closed off as shown in Fig. 1B of Burkholz.
Regarding claim 2, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 1, further comprising a non-integrated catheter (Burkholz, catheter adapter 12, P0041, which includes catheter 20) removably couplable with the body (Burkholz, connector 34 may selectively couple the distal end 26 of the extension tube 24 to the proximal end of the catheter adapter 12, P0041).
Regarding claim 3, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 1, further comprising a stabilization platform (Burkholz, stabilization platform, see annotated Fig. 1A above) operatively connected to the body (Burkholz, Fig. 1A) to stabilize the catheter extension set on a desired surface (Burkholz, P0056).
Regarding claim 4, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 1, further comprising a luer adaptor (Burkholz, luer adapter 46, P0047), wherein the vented access port is integrated with the luer adaptor (Burkholz 906’ Figs. 13-15).
Regarding claims 5, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 4, further comprising a vent plug (Burkholz 906’, air permeable material 44, P0066) integrated with at least one of the luer adapter and the vented access port (Burkholz 906’, Figs. 13-15).
Regarding claim 6, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 1, further comprising a vent plug (Burkholz 906’, air permeable material 44, P0066) operatively connected to the vented access port (Burkholz 906’, Figs. 13-15) at an end of the extension tube opposite the connection port (Burkholz 906’, Fig. 1).
Regarding claim 7, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 1, further comprising a clamping member (Burkholz, clamp 39, P0045) disposed about a portion of the extension tube (Burkholz, Figs. 1A-B), wherein in a clamping position the clamping member is configured to occlude at least a portion of the extension tube (Burkholz, in a clamping position wherein the clamping member is clamped together, the clamping member is fully capable of occluding at least a portion of the extension tube).
Regarding claim 8, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 1, further comprising a luer lock access device (Burkholz, connector 30 may include a luer adapter, P0040) fluidically connected to the distal access port (Burkholz, Figs. 1A-C).
Regarding claim 9, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 1, wherein the vented access port comprises a dual port luer adaptor (Burkholz 906’, y adapter 18, P0061) operatively connected to an end of the extension tube opposite the connection port.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to replace the luer adapter 46 of Burkholz with a dual port luer adapter as taught by Burkholz 906’ for the purpose of providing for both an access port and vent, Burkholz 906’ P0061.
Regarding claim 10, Burkholz discloses a catheter extension set (catheter system 10, P0039 and shown in Figs. 1A-C), comprising: a body (connector 30, P0040) defining a channel (channel, see annotated Fig. 1B below) to direct a biological fluid therethrough; a connection port (connection port, see annotated Fig. 1A below) defined in the body, in which an extension tube (extension tube 44, P0044) is fluidly coupled to the connection port; a non-integrated catheter (catheter adapter 12, P0041, which includes catheter 20) removably connectable with the body (connector 34 may selectively couple the distal end 26 of the extension tube 24 to the proximal end of the catheter adapter 12, P0041) to direct a biological fluid into the body; and a distal access port (distal access port, see annotated Fig. 1A below) defined in the body, the distal access port configured to be in fluid communication with a removable sample collection container (blood collection tube, P0050 and shown in Fig. 1C).
PNG
media_image1.png
818
580
media_image1.png
Greyscale
Burkholz does not teach a vented access port.
However, Burkholz 906’ teaches an extravascular system venting having a vented access port (ventable end cap 28 and removable vent plug 30, P0073 and shown in Figs. 13-15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the catheter extension set taper connection 46 of Burkholz with the vented access port of Burkholz 906’ for the purpose of venting the blood sample as taught by Burkholz 906’ P0063, wherein the vented access port of the modified catheter extension set is in fluid communication with the extension tube of Burkholz, the vented access port spaced apart from the connection port of Burkholz, wherein an initial biological fluid volume directed through the body of Burkholz is directed into the extension tube of Burkholz via the connection port of Burkholz and into the vented access port of the modified catheter extension set because that is the open fluid pathway when the distal access port is closed off, as shown in Fig. 1B of Burkholz.
Regarding claim 11, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 10, wherein a portion of the biological fluid is directed into the removable sample collection container after the initial blood volume is directed into the vented access port (the catheter extension set is fully capable of directing a portion of the biological fluid into the removable sample collection container after the initial blood volume is directed into the vented access port by using clamp 39 to direct flow toward the removable sample collection container).
Regarding claim 12, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 10, further comprising the removable sample collection container (Burkholz, blood collection tube, P0050 and shown in Fig. 1C) in fluid communication with the distal access port (Burkholz, Fig. 1C).
Regarding claim 13, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 12, wherein the removable sample collection container is a blood culture sample collection tube (Burkholz, blood collection tube, P0050 and shown in Fig. 1C).
Regarding claim 14, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 10, further comprising a stabilization platform (Burkholz, stabilization platform, see annotated Fig. 1A above) operatively connected to the body (Burkholz, Fig. 1A) to stabilize the catheter extension set on a desired surface (Burkholz, P0056).
Regarding claim 15, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 10, further comprising a luer adaptor (Burkholz, luer adapter 46, P0047), wherein the vented access port is integrated with the luer adaptor (Burkholz 906’ Figs. 13-15).
Regarding claim 16, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 15, further comprising a vent plug (Burkholz 906’, air permeable material 44, P0066) integrated with at least one of the luer adapter and the vented access port (Burkholz 906’, Figs. 13-15).
Regarding claim 17, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 10, further comprising a clamping member (Burkholz, clamp 39, P0045) disposed about a portion of the extension tube, wherein in a clamping position the clamping member is configured to occlude at least a portion of the extension tube (in a clamping position wherein the clamping member is clamped together, the clamping member is fully capable of occluding at least a portion of the extension tube).
Regarding claim 18, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 10, further comprising a luer lock access device (Burkholz, connector 30 may include a luer adapter, P0040) fluidically connected to the distal access port (Burkholz, Figs. 1A-C).
Regarding claim 19, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 10, wherein the vented access port comprises a dual port luer adaptor (Burkholz 906’, y adapter 18, P0061) operatively connected to an end of the extension tube opposite the connection port.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to replace the luer adapter 46 of Burkholz with a dual port luer adapter as taught by Burkholz 906’ for the purpose of providing for both an access port and vent, Burkholz 906’ P0061.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783