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 amendment filed 06/12/2026 has been entered. Claims 1-20 are pending in the application. Applicant’s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 03/19/2026.
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 13, 17, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kriesel (US 6,095,491).
Regarding Claim 13, Kriesel discloses a method for using a fluid connector device (14, Fig 1) comprising: rotating a switchable flow channel device (40, Fig 6) within the fluid connector device to switch between two modes of use (Col 4, lines 48-67), the fluid connector device comprising: a first connector (24, Fig 4) with a first alignment post (42, Fig 4) that partially extends into the switchable flow channel device (See Fig 4); and a second connector (22, Fig 4) with a second alignment post (46, Fig 4) that partially extends into the switchable flow channel device (See Fig 4), wherein the switchable flow channel device comprises two flow channels (there are at least 2 flow channels 58, See Fig 2) that are fluidly connected to the first connector and the second connector that allow for a fluid to flow in opposition directions through the switchable flow channel device (As there are no valves or structures to prevent flow in opposite directions, the flow controller allows flow in opposite directions and meet the limitations).
Regarding Claim 17, Kriesel discloses the switchable flow channel device comprises a plurality of O-rings (52, Fig 4) on each of the proximal and distal ends of the switchable flow channel device (See Fig 4).
Regarding Claim 20, Kriesel discloses when the plurality of O-rings (52, Fig 4) are rotated into position and aligned in the fluid connector device (they rotate relative to the control mechanism 40), either in an infusion mode or a blood draw mode, the fluid connector device is configured to provide a tactile response to indicate to a user that the switchable flow channel device is ready for operation (Col 4, lines 27-47; the locking member 80 moving into engagement with a groove 50a is a tactile response that shows that the switchable flow channel is aligned with one of the restrictors 58 and ready to use).
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, 8-14, 16, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 2021/0128037) in view of Baid (US 2013/0178805).
Regarding Claim 1, Burkholz discloses a fluid connector device (Device of Fig 1F), comprising: a first connector (38, 50, Fig 1F); a second connector (16, 48, Fig 1F) that combines with the first connector to form an internal chamber (fluid pathway 22, Fig 1F); and a switchable flow channel device (42, Fig 1F) with a distal and a proximal end that is contained within the internal chamber (the switchable flow channel device is at least partially contained within the fluid pathway) (Para 0068-0069), wherein an alignment post (52, Fig 1B) extends into the switchable flow channel device (Para 0071).
Burkholz is silent regarding a first alignment post and second alignment post, wherein the alignment posts extend partially into the switchable flow channel device from the first connector and the second connector to define an axis of rotation for the switchable flow channel device
Baid teaches an analogous fluid connector device (10, Fig 14) comprising a first connector (16, Fig 2) with a first alignment post (88, Fig 2) and a second connector (14, Fig 2) with a second alignment post (32, Fig 2), wherein the first alignment post and the second alignment post extend partially into the switchable flow channel device (See Fig 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pin disclosed by Burkholz to be the coupling elements described in Para 0037 (which include the alignment posts 32 and 88) of Baid in order to have a fluid connector device that is simple and economical in construction and fabrication (Para 0005).
Regarding Claim 2, the modified invention of Burkholz and Baid discloses the switchable flow channel device (42, Fig 1F -Burkholz) comprises two flow channels (44a, 44b, Fig 1D -Burkholz) that are fluidly connected to the first connector and the second connector and allow for a fluid to flow in opposite directions through the switchable flow channel device (Para 0002 -Burkholz; the catheter can infuse medication or withdraw blood. As there are no valves or structures to prevent flow in opposite directions, the flow controller is capable of flow in opposite directions and meet the limitations).
Regarding Claim 3, the modified invention of Burkholz and Baid discloses the switchable flow channel device has two modes of use, an infusion mode and a blood draw mode (Para 0068 -Burkholz, the switchable flow channel device has at least two modes of use, i.e. 44a-44d).
Regarding Claim 4, the modified invention of Burkholz and Baid discloses the switchable flow channel device is manually rotated to switch between the infusion mode towards the blood draw mode (Para 0068 -Burkholz).
Regarding Claim 5, the modified invention of Burkholz and Baid discloses the switchable flow channel device is configured to permit an intravenous (IV) fluid to flow from the first connector to the second connector (Para 0062 -Burkholz; as the second connector 16 is connected to the catheter adapter 18, fluid flowing from the first to the second connector would be IV fluid).
Regarding Claim 6, the modified invention of Burkholz and Baid discloses the switchable flow channel device is configured to permit blood flow from the second connector to the first connector (Para 0061-0062 -Burkholz; as the second connector 16 is connected to the catheter adaptor 18, fluid flowing from the second to the first connector would be blood).
Regarding Claim 8, the modified invention of Burkholz and Baid discloses the first alignment post (88, Fig 2 -Baid) and the second alignment post (32, Fig 2 -Baid) define an axis that the switchable flow channel device can rotate around (Para 0041-0042 -Baid).
Regarding Claim 9, the modified invention of Burkholz and Baid discloses the alignment posts are not aligned in a center of the fluid connector device (The alignment posts of Baid would be aligned with pin 52 of Burkholz. Therefore, the alignment posts would not be aligned with the center axis formed by the fluid pathway 22, Fig 1F of Burkholz).
Regarding Claim 10, the modified invention of Burkholz and Baid discloses the axis on which switchable flow channel is rotated is asymmetrical, or off-center from the fluid connector device (the alignment posts would not be aligned with the center axis formed by the fluid pathway 22, Fig 1F of Burkholz. Therefore, it is off-center or asymmetrical relative to the center axis).
Regarding Claim 11, the modified invention of Burkholz and Baid discloses the flow channel (44a, Fig 1D -Burkholz) that is used for the blood draw mode is smaller in diameter than the flow channel (44b, Fig 1D -Burkholz) used in the infusion mode (Para 0069 -Burkholz).
Regarding Claim 12, Burkholz discloses a blood collection system, comprising: a blood collection device (14, Fig 1A); and a fluid connector device (Device of Fig 1F, Para 0077) fluidly coupled to the blood collection device (Para 0064), the fluid connector device comprising: a first connector (38, 50, Fig 1F); a second connector (16, 48, Fig 1F) that combines with the first connector to form an internal chamber (fluid pathway 22, Fig 1F); and a switchable flow channel device (42, Fig 1F) with a distal and a proximal end that is contained within the internal chamber (the switchable flow channel device is at least partially contained within the fluid pathway) (Para 0068-0069); wherein an alignment post (52, Fig 1B) that extends into the switchable flow channel device (Para 0071).
Burkholz is silent regarding wherein alignment posts extend partially into the switchable flow channel device from the first connector and the second connector to define an axis of rotation for the switchable flow channel device
Baid teaches an analogous fluid connector device (10, Fig 14) comprising a first connector (16, Fig 2) with a first alignment post (88, Fig 2) and a second connector (14, Fig 2) with a second alignment post (32, Fig 2), wherein the first alignment post and the second alignment post extend partially into the switchable flow channel device (See Fig 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pin disclosed by Burkholz to be the coupling elements described in Para 0037 (which include the alignment posts 32 and 88) of Baid in order to have a fluid connector device that is simple and economical in construction and fabrication (Para 0005).
Regarding Claim 13, Burkholz discloses a method for using a fluid connector device (Device of Fig 1F) comprising: rotating a switchable flow channel device within the fluid connector device to switch between two modes of use (Para 0068-0069), the fluid connector device comprising: a first connector (38, 50, Fig 1F); a second connector (16, 48, Fig 1F) that combines with the first connector to form an internal chamber (fluid pathway 22, Fig 1F), and an alignment post (52, Fig 1B) that extends into the switchable flow channel device (Para 0071), wherein the switchable flow channel device comprises two flow channels (44a, 44b, Fig 1D) that are fluidly connected to the first connector and the second connector that allow for a fluid to flow in opposition directions through the switchable flow channel device (Para 0002; the catheter can infuse medication or withdraw blood. As there are no valves or structures to prevent flow in opposite directions, the flow controller allows flow in opposite directions and meet the limitations).
Burkholz is silent regarding a first alignment post and second alignment post, wherein the alignment posts extend partially into the switchable flow channel device from the first connector and the second connector to define an axis of rotation for the switchable flow channel device
Baid teaches an analogous fluid connector device (10, Fig 14) comprising a first connector (16, Fig 2) with a first alignment post (88, Fig 2) and a second connector (14, Fig 2) with a second alignment post (32, Fig 2), wherein the first alignment post and the second alignment post extend partially into the switchable flow channel device (See Fig 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pin disclosed by Burkholz to be the coupling elements described in Para 0037 (which include the alignment posts 32 and 88) of Baid in order to have a fluid connector device that is simple and economical in construction and fabrication (Para 0005).
Regarding Claim 14, the modified invention of Burkholz and Baid discloses the two modes of use are an infusion mode and a blood draw mode (Para 0002 -Burkholz; the catheter can infuse medication or withdraw blood).
Regarding Claim 16, the modified invention of Burkholz and Baid discloses the fluid flowing from the second connector to the first connector is blood (Para 0061-0062 -Burkholz; as the second connector 16 is connected to the catheter adaptor 18, fluid flowing from the second to the first connector would be blood).
Regarding Claim 18, the modified invention of Burkholz and Baid discloses an axis (axis formed by pin 52, Fig 1F -Burkholz) on which the switchable flow channel device is rotated is spaced from the center of the fluid connector device (The alignment posts of Baid would be aligned with pin 52 of Burkholz. Therefore, the alignment posts would not be aligned with the center axis formed by the fluid pathway 22, Fig 1F of Burkholz. Therefore, it is off-center or asymmetrical relative to the center axis).
Regarding Claim 19, the modified invention of Burkholz and Baid discloses the flow channel (44a, Fig 1D -Burkholz) that is used for the blood draw mode is smaller in diameter than the flow channel (44b, Fig 1D -Burkholz) used in the infusion mode (Para 0069 -Burkholz).
Claims 7, 15, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 2021/0128037) in view of Baid (US 2013/0178805) and further in view of Seagle (US 3,877,428).
Regarding Claim 7, the modified invention of Burkholz and Baid discloses all of the elements of the invention as discussed above, however, is silent regarding the switchable flow channel device comprises a plurality of O-rings on each of the proximal and distal ends of the switchable flow channel device.
Seagle teaches an analogous fluid connector device (10, Fig 3) comprising a switchable flow channel device (44, Fig 1) comprising comprises a plurality of O-rings (32, 70, Fig 1) on each of the proximal and distal ends of the switchable flow channel device (Col 3, lines 65-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the switchable flow channel device to comprise a plurality of O-rings as taught by Seagle in order to ensure a fluid tight seal through the flow channel (Col 3, lines 65-67).
Regarding Claim 15, While Burkholz’s device appears to be capable of flow in opposite directions since there are no valves or structures to prevent flow in opposite directions, Burkholz does not explicitly teach the step of fluid flowing from the first connector to the second connector is an intravenous (IV) fluid.
Seagle teaches an analogous fluid connector device (10, Fig 3) comprising a switchable flow channel device (44, Fig 1) wherein the fluid flowing from the first connector (92, Fig 1) to the second connector (16, Fig 1) is an intravenous (IV) fluid (Col 4, lines 44-55; Col 5, lines 27-37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to couple the fluid connector device to an intravenous fluid source such that fluid flowing from the first connector to the second connector is an intravenous (IV) fluid as taught by Seagle in order to selectively control the rate of administration of fluids to a patient (Abstract).
Regarding Claim 17, the modified invention of Burkholz and Baid discloses all of the elements of the invention as discussed above, however, is silent regarding the switchable flow channel device comprises a plurality of O-rings on each of the proximal and distal ends of the switchable flow channel device.
Seagle teaches an analogous fluid connector device (10, Fig 3) comprising a switchable flow channel device (44, Fig 1) comprising comprises a plurality of O-rings (32, 70, Fig 1) on each of the proximal and distal ends of the switchable flow channel device (Col 3, lines 65-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the switchable flow channel device to comprise a plurality of O-rings as taught by Seagle in order to ensure a fluid tight seal through the flow channel (Col 3, lines 65-67).
Response to Arguments
Applicant’s arguments filed 06/12/2026, on pages 8-18, regarding Burkholz and Franano failing to teach the amended limitations of the independent claims have been fully considered but are moot in view of the current rejection that relies on Baid to teach the claimed alignment posts. Franano is no longer relied on in this rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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