DETAILED ACTION
Applicant’s arguments, filed on 02/06/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 02/06/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 4-6, 8-11, and 13-17 are the current claims hereby under examination.
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 .
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, 4-6, 8-11, and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20200230353) in view of Carter (US 10046155).
Regarding independent claim 1, Burkholz teaches an integrated catheter system (Abstract: “A catheter system may include a catheter assembly and a catheter delivery device”) comprising:
a catheter adapter comprising a catheter and an inlet ([0008]: “the catheter assembly may include a catheter adapter”; Fig. 3D, reference character 41 is the inlet), the catheter configured to be inserted into a patient's vasculature ([0007]: “The present disclosure relates generally to a catheter delivery device to deliver a secondary catheter through a catheter assembly and into vasculature of a patient”);
a needle-free connector comprising a first port, a second port positioned opposite the first port, and a side port positioned between the first port and the second port, the needle-free connector comprising a first portion and a second portion ([0069]: “a needleless connector 59 may be disposed at various locations within the catheter system”; [0068]: “the extension set may include a connector 57, which may include a Y-connector or a T-connector”; Fig. 3D, see annotated figure below.);
intermediate tubing extending between the inlet of the catheter adapter and the first port of the needle-free connector (Fig. 3D, reference character 53);
extension tubing extending from the side port of the needle-free connector (Fig. 3D, reference character 55);
second indicia provided on at least one of the first portion and the second portion of the needle-free connector, the second indicia comprising at least one of a maximum pressure rating marking, a flow rate capability marking, and a catheter length marking ([0057]: “an outer surface of the housing 14 may include one or more markings 27, which may indicate to the clinician a position of the secondary catheter distal end 22 within the catheter assembly or beyond a primary catheter of the catheter assembly”; Fig. 1A).
However, Burkholz does not teach the second port comprising a valve member and first indicia provided on the first portion or the second portion of the needle-free connector, the first indicia comprising a first color.
Carter discloses a luer connector for connecting a catheter. Specifically, Carter teaches the second port comprising a valve member (Column 6, lines 42-44: “a catheter adapter 34 may include additional or alternative access sites, clamps, parallel intravenous lines, valves … ”), and first indicia provided on at least one of the first portion and the second portion of the needle-free connector (Column 8, lines 31-45: “As shown in FIG. 6, the larger sizing of the luer connector 40 can provide an increased surface area onto which a label can be provided. A label 80 can present information to the practitioner each time he or she looks at the luer connector 40 to connect it to another device. In some instance, the label 80 can include product specifications, including the maximum flow rate 82, 84 for which the luer connector and/or a down line catheter adapter are configured. As explained above, in some instances, product specifications are included in product literature, which is not generally present to a practitioner when using the device. This information, even if it is critical, can be forgotten temporarily or permanently by a practitioner. By disposing the label 80 in this accessible location, it can remind the practitioner of the labeled information each time the luer connector 40 is used or observed.”), the first indicia comprising a first color (Column 8, line 52 – Column 9, line 10: “the label 80 includes the maximum flow rates based on the temperature of the infusant. In some configurations, depictions of a thermometer 84, 86 can indicate high or low temperature rates. As shown, a depiction of thermometer 86 with a low level of mercury can assist to designate the low temperature rate. A depiction of thermometer 84 with a high level of mercury can assist to designate the high temperature rate. Additionally or alternatively, the low temperature rate can be made with a blue text, blue commonly indicating a cool or cold temperature. And, the high temperature rate can be made with a red text, red commonly indicating a warm or hot temperature. These text, symbols, and colors can provide clearly visible information and/or reminders to a clinician of product specifications or other important product information, which is presented at the time it is needed. In some configurations, a portion or all of the luer connector 40 is colored purple. This portion can be the flexible material 64, the rigid material 66, the grip portion 50, and/or the label 80. A survey of power injector clinicians has revealed that clinicians relate the color purple to power injection devices over other colors. Accordingly, a purple-colored luer connector 40 can be recognized, even at a distance, as the luer connector 40 of a power injector device. This purple color can provide rapid recognition of a luer connector 40 even when it is located across a room or located with various other devices.”). Burkholz and Carter are analogous arts as they are both related to systems used with catheters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the valve member from Carter into the second port from the system from Burkholz as it allows for more control over the catheter system and what fluids are injected or withdrawn. Additionally, the inclusion of the first indicia from Carter into the system from Burkholz would also be obvious as it allows the system to display more information that would otherwise not be visible on the device, which ensures the user has the proper information necessary for use of the catheter.
The Burkholz/Carter combination teaches wherein the first portion of the needle-free connector includes the first port and the side port, and wherein the second portion of the needle-free connector includes the second port, and wherein the first indicia is provided on the first portion of the needle-free connector (Burkholz, Figure 3D. see annotated figure below.).
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Regarding claim 4, the Burkholz/Carter combination teaches the system of claim 1.
However, the Burkholz/Carter combination does not teach wherein the first color of the first indicia is indicative of high pressure injection capability.
Carter teaches wherein the first color of the first indicia is indicative of high pressure injection capability (Column 1, lines 30-34: “Power injection procedures generate high pressures within the infusion system, thereby requiring some specialized vascular access devices, extension sets, media transfer sets, pump syringes, and bulk or pre-filled contrast media syringes”; Column 3, lines 33-42: “A label may be disposed on an exterior surface of the connector body. The label may have text that conveys information relating to a product specification of the luer lock connector or to a down line vascular access device. The text may have a text size of 12 point font or larger. The intravenous line may be further coupled to a catheter adapter. The catheter adapter may have a label disposed on an exterior surface of the catheter adapter. The label may have text that conveys information relating to a product specification of the catheter adapter.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the indicia that indicates high pressure injection capability from Carter into the Burkholz/Carter combination as Carter discloses including indications of important information related to the product specification, which can display information that would not otherwise be visible, which can ensure the user is informed of the capabilities of the device.
Regarding claim 5, the Burkholz/Carter combination teaches the system of claim 1, wherein the second indicia comprises the catheter length marking provided on the first portion of the needle-free connector (Burkholz, [0057]: “the secondary catheter 12 may be configured to move distally to an advanced position in response to a fluid pressure provided by a fluid delivery device, which may be coupled to the housing proximal end 18. In some embodiments, the housing 14 may be transparent. In some embodiments, an outer surface of the housing 14 may include one or more markings 27, which may indicate to the clinician a position of the secondary catheter distal end 22 within the catheter assembly or beyond a primary catheter of the catheter assembly.”).
Regarding claim 6, the Burkholz/Carter combination teaches the system of claim 5, wherein the second indicia comprises the maximum pressure rating marking and the flow rate capability marking provided on the second portion of the needle-free connector (Carter, Column 9, lines 1-11: “portion or all of the luer connector 40 is colored purple. This portion can be the flexible material 64, the rigid material 66, the grip portion 50, and/or the label 80. A survey of power injector clinicians has revealed that clinicians relate the color purple to power injection devices over other colors. Accordingly, a purple-colored luer connector 40 can be recognized, even at a distance, as the luer connector 40 of a power injector device. This purple color can provide rapid recognition of a luer connector 40 even when it is located across a room or located with various other devices.”; Column 8, lines 48-49: “a label indicating maximum flow rates can have a font size of 12 point font”; Figs 6-9).
Regarding claim 8, the Burkholz/Carter combination teaches the system of claim 1, wherein the first indicia comprises a second color different than the first color, wherein the first color of the first indicia is provided on the second portion of the needle-free connector, and wherein the second color of the first indicia is provided on the first portion of the needle-free connector (Carter, Column 8, line 52 – Column 9, line 10: “the label 80 includes the maximum flow rates based on the temperature of the infusant. In some configurations, depictions of a thermometer 84, 86 can indicate high or low temperature rates. As shown, a depiction of thermometer 86 with a low level of mercury can assist to designate the low temperature rate. A depiction of thermometer 84 with a high level of mercury can assist to designate the high temperature rate. Additionally or alternatively, the low temperature rate can be made with a blue text, blue commonly indicating a cool or cold temperature. And, the high temperature rate can be made with a red text, red commonly indicating a warm or hot temperature. These text, symbols, and colors can provide clearly visible information and/or reminders to a clinician of product specifications or other important product information, which is presented at the time it is needed. In some configurations, a portion or all of the luer connector 40 is colored purple. This portion can be the flexible material 64, the rigid material 66, the grip portion 50, and/or the label 80. A survey of power injector clinicians has revealed that clinicians relate the color purple to power injection devices over other colors. Accordingly, a purple-colored luer connector 40 can be recognized, even at a distance, as the luer connector 40 of a power injector device. This purple color can provide rapid recognition of a luer connector 40 even when it is located across a room or located with various other devices.”; Fig. 6).
Regarding claim 9, the Burkholz/Carter combination teaches the system of claim 8.
However, the Burkholz/Carter combination does not teach wherein the first color of the first indicia is indicative of high pressure injection capability, and wherein the second color of the second indicia is indicative of blood draw capability.
Carter teaches wherein the first color of the first indicia is indicative of high pressure injection capability (Column 1, lines 30-34: “Power injection procedures generate high pressures within the infusion system, thereby requiring some specialized vascular access devices, extension sets, media transfer sets, pump syringes, and bulk or pre-filled contrast media syringes”; Column 3, lines 33-42: “A label may be disposed on an exterior surface of the connector body. The label may have text that conveys information relating to a product specification of the luer lock connector or to a down line vascular access device. The text may have a text size of 12 point font or larger. The intravenous line may be further coupled to a catheter adapter. The catheter adapter may have a label disposed on an exterior surface of the catheter adapter. The label may have text that conveys information relating to a product specification of the catheter adapter.”), and wherein the second color of the second indicia is indicative of blood draw capability (Column 8, lines 34-45: “A label 80 can present information to the practitioner each time he or she looks at the luer connector 40 to connect it to another device. In some instance, the label 80 can include product specifications, including the maximum flow rate 82, 84 for which the luer connector and/or a down line catheter adapter are configured. As explained above, in some instances, product specifications are included in product literature, which is not generally present to a practitioner when using the device. This information, even if it is critical, can be forgotten temporarily or permanently by a practitioner. By disposing the label 80 in this accessible location, it can remind the practitioner of the labeled information each time the luer connector 40 is used or observed.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the indicia that indicates high pressure injection capability and blood draw capability from Carter into the Burkholz/Carter combination as Carter discloses including indications of important information related to the product specification and including different colors to indicate different conditions, which can display information that would not otherwise be visible, which can ensure the user is informed of the capabilities of the device.
Regarding claim 10, the Burkholz/Carter combination teaches the system of claim 9, wherein the second indicia comprises the catheter length marking provided on the first portion of the needle-free connector (Burkholz, [0057]: “the secondary catheter 12 may be configured to move distally to an advanced position in response to a fluid pressure provided by a fluid delivery device, which may be coupled to the housing proximal end 18. In some embodiments, the housing 14 may be transparent. In some embodiments, an outer surface of the housing 14 may include one or more markings 27, which may indicate to the clinician a position of the secondary catheter distal end 22 within the catheter assembly or beyond a primary catheter of the catheter assembly.”).
However, the Burkholz/Carter combination does not teach the flow rate capability marking provided on the second portion of the needle-free connector.
Carter teaches the flow rate capability marking provided on the second portion of the needle-free connector (Column 8, lines 48-49: “a label indicating maximum flow rates can have a font size of 12 point font”; Figs 6-9).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the indicia that indicates the flow rate capability from Carter into the Burkholz/Carter combination as Carter discloses including indications of important information related to the product specification, which can display information that would not otherwise be visible, which can ensure the user is informed of the capabilities of the device.
Regarding claim 11, the Burkholz/Carter combination teaches the system of claim 1.
However, the Burkholz/Carter combination does not teach wherein the first indicia is provided on the first portion of the needle-free connector, and wherein the first color of the first indicia is indicative of blood draw capability.
Carter teaches wherein the first color of the first indicia is indicative of blood draw capability (Column 8, lines 34-45: “A label 80 can present information to the practitioner each time he or she looks at the luer connector 40 to connect it to another device. In some instance, the label 80 can include product specifications, including the maximum flow rate 82, 84 for which the luer connector and/or a down line catheter adapter are configured. As explained above, in some instances, product specifications are included in product literature, which is not generally present to a practitioner when using the device. This information, even if it is critical, can be forgotten temporarily or permanently by a practitioner. By disposing the label 80 in this accessible location, it can remind the practitioner of the labeled information each time the luer connector 40 is used or observed.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the indicia that indicates blood draw capability from Carter into the Burkholz/Carter combination as Carter discloses including indications of important information related to the product specification and including different colors to indicate different conditions, which can display information that would not otherwise be visible, which can ensure the user is informed of the capabilities of the device.
Regarding claim 13, the Burkholz/Carter combination teaches the system of claim 1, comprising at least one of a maximum pressure rating marking, a flow rate capability marking, and a catheter length marking (Burkholz, [0057]: “an outer surface of the housing 14 may include one or more markings 27, which may indicate to the clinician a position of the secondary catheter distal end 22 within the catheter assembly or beyond a primary catheter of the catheter assembly”; Fig. 1A).
However, the Burkholz/Carter combination does not teach further comprising third indicia provided on the intermediate tubing, wherein the third indicia comprises at least one of a maximum pressure rating marking, a flow rate capability marking, and a catheter length marking.
Carter teaches further comprising third indicia provided on the intermediate tubing, wherein the third indicia comprises at least one of a maximum pressure rating marking, a flow rate capability marking, and a catheter length marking (Column 8, line 52 – Column 9, line 11: “the label 80 includes the maximum flow rates based on the temperature of the infusant. In some configurations, depictions of a thermometer 84, 86 can indicate high or low temperature rates. As shown, a depiction of thermometer 86 with a low level of mercury can assist to designate the low temperature rate. A depiction of thermometer 84 with a high level of mercury can assist to designate the high temperature rate. Additionally or alternatively, the low temperature rate can be made with a blue text, blue commonly indicating a cool or cold temperature. And, the high temperature rate can be made with a red text, red commonly indicating a warm or hot temperature. These text, symbols, and colors can provide clearly visible information and/or reminders to a clinician of product specifications or other important product information, which is presented at the time it is needed. In some configurations, a portion or all of the luer connector 40 is colored purple. This portion can be the flexible material 64, the rigid material 66, the grip portion 50, and/or the label 80. A survey of power injector clinicians has revealed that clinicians relate the color purple to power injection devices over other colors. Accordingly, a purple-colored luer connector 40 can be recognized, even at a distance, as the luer connector 40 of a power injector device. This purple color can provide rapid recognition of a luer connector 40 even when it is located across a room or located with various other devices.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the third indicia from Carter into the system from the Burkholz/Carter combination as it allows the device to display more information to the user, which can ensure they are getting additional information that would usually not be visible to the user, and can ensure the device is being used properly.
Regarding claim 14, the Burkholz/Carter combination teaches the system of claim 1, wherein a body of the needle-free connector is opaque or transparent (Burkholz, [0020]: “the housing and/or other components of the catheter system may be transparent”).
Regarding claim 15, the Burkholz/Carter combination teaches the system of claim 1, wherein the catheter comprises a fenestrated tip (Burkholz, Fig. 3B and Figs. 10A-10E; [0088]: “the secondary catheter distal end 22 may include any suitable tip”).
Regarding claim 16, the Burkholz/Carter combination teaches the system of claim 1, wherein the needle-free connector comprises a body defining a longitudinal axis extending between the first port and the second port, and wherein the side port extends from the body at an angle of 30-150 degrees relative to the longitudinal axis of the body (Burkholz, Figs. 3A-3D).
Regarding claim 17, the Burkholz/Carter combination teaches, in light of the 112(b) rejections above, the system of claim 1, wherein the needle-free connector comprises a body defining a longitudinal axis extending between the first port and the second port, and wherein the side port is offset from the longitudinal axis of the body of the needle-free connector (Burkholz, Figs. 3A-3D).
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant's arguments filed 02/06/2026 have been fully considered but they are not persuasive. With regards to the first portion and the second portion, Examiner has included an annotated figure to indicate the ports and the first portions and the second portions in Figure 3D even though such a depiction is not necessary to understand the full rejection given the textual description of the combination with respect to the rejection of claim 1. Applicant argues that no reason is provided to include the first indicia, however as stated in the rejection above, including the indicia allows the system to display more information that would otherwise not be visible on the device, which ensures the user has the proper information necessary for use of the catheter. This ensures that the user is capable of clearly reading and identifying the important information regarding the catheter, which allows for safer and easier use. Applicant also argues that there is no motivation to combine the valve from Carter into the second port because Burkholz already includes a valve. However, Burkholz does not include a valve, and as stated in the rejection above, including the valve from Carter into the second port from Burkholz allows for more control over the catheter system and what fluids are injected or withdrawn.
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.
[AltContent: textbox (needle free connector)]Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN K MCCORMACK whose telephone number is (703)756-1886. The examiner can normally be reached Mon-Fri 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at 5712727540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.K.M./ Examiner, Art Unit 3791
/MATTHEW KREMER/ Primary Examiner, Art Unit 3791
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