DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/18/2026 has been entered.
Claims 1-4, 28-31, and 34-35 remain pending and under prosecution.
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim elements are interpreted under 112(f).
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.
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 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon et al (US Pub No. 20140364766) in view of Woehr et al (US Pub No. 20160175563).
In regard to Claim 1, Devgon et al disclose a catheter extension set 7200, comprising:
a distal end 7130, comprising a luer adapter 7131 (0124) configured to couple to a catheter adapter 7400 (connects to catheter 7425), best seen in Figure 18 (0127);
a proximal end 7221, comprising a blood collection device 7270, best seen in Figure 18 (0126, 0130); and
an extension tube 7220, 7160, 7150, 7100 extending between the distal end and the proximal end and defining a fluid pathway from the distal end to the proximal end, best seen in Figure 18 (0123, 0125, 0126).
Devgon et al disclose the invention above but do not expressly disclose an inner surface of the extension tube in the fluid pathway that defines a lumen of the extension tube comprises an absorbent material defining a portion of the inner surface of the extension tube, with the absorbent material positioned within a cut-out formed in a sidewall of the extension tube while not extending radially beyond the sidewall to obstruct the lumen, and wherein blood within the fluid pathway of the extension tube is configured to flow over and past the absorbent material and flow proximate the absorbent material.
Woehr et al teach that it is well-known in the art to provide an analogous catheter extension set 100 with extension tube 110 (needle) with distal and proximal ends, best seen in Figure 1,
comprising an absorbent material 130 (flashback indicator – “the flashback indicator can be made from a medical grade absorbable material or paper” 0011), best seen in Figure 2,
that defines a lumen of the extension tube, the absorbent material defining a portion of the inner surface of the extension tube, with the absorbent material positioned within a cut-out 120 (notch) formed in a sidewall of the extension tube while not extending radially beyond the sidewall to obstruct the lumen, best seen in Figure 2-4 and 21A-B – “the flashback indicator can be located in the notch and at least partly in the needle lumen” (0041-0043),
wherein blood within the fluid pathway of the extension tube is configured to flow over and past the absorbent material 130 – to enable flashback of the blood by absorption of the blood, and
flow proximate the absorbent material – after the needle is retracted in catheter 140, blood continues to flow proximate the absorbent material, best seen in Figure 21A-B (0177-0179).
Woehr et al also teach the absorbent material is visible to a user to enable visualization of an absorption of blood by the absorbent material – “The notch 120 and the flashback indicator 130 of the needle 110 can be seen through the transparent or semi-opaque wall surface of the catheter tube 140” (0156). In other words, Woehr et al teach using a transparent material to enable a visual of the absorbent material by the user, thus providing a visual indicator.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Devgon et al such that an inner surface of the extension tube in the fluid pathway that defines a lumen of the extension tube comprises an absorbent material positioned within a cut-out formed in a sidewall of the extension tube while not extending radially beyond the sidewall to obstruct the lumen, wherein blood within the fluid pathway of the extension tube is configured to flow proximate the absorbent material as taught by Woehr et al to effectively provide a flashback indicator for the blood flow.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Devgon et al by using a transparent material such as for the extension tube such that the absorbent material is visible through the extension tube as taught by Woehr et al to effectively provide a visual indicator to of a location of blood flow within the extension tube, including if the blood flow has reached the absorbent material.
4. Devgon et al disclose the catheter extension set of claim 1, wherein the extension tube comprises a distal end and a proximal end, wherein the distal end of the extension tube is integrated with the luer adapter 7131, wherein the proximal end of the extension tube is integrated with the blood collection device 7270, best seen in Figure 18 (0123-0128).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon et al in view of Woehr et al as applied to claim 1, further in view of Davis et al (US Pub No. 20110009717 – cited by applicant).
Devgon et al in combination with Woehr et al disclose the invention above but do not expressly disclose a clamp disposed on the extension tube, wherein the clamp is configured to move between a clamped position and an unclamped position.
Davis et al teach that it is well-known in the art to provide an analogous catheter extension set comprising a clamp 110 disposed on the extension tube 108, wherein the clamp is configured to move between a clamped position and an unclamped position to control the blood flow as desired during the collection procedure, best seen in Figure 1 (0041, 0043, 0048).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Devgon et al as modified by Woehr et al to include a clamp disposed on the extension tube as taught by Davis et al to effectively move the clamp between a clamped position and an unclamped position to control the blood flow as desired during the collection procedure.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon et al in view of Woehr et al as applied to claim 1, further in view of Hwang et al (US Pub No. 20090259201 – cited by applicant).
Devgon et al as modified disclose the catheter extension set of claim 1, wherein the luer adapter is a first luer adapter 7131, best seen in Figure 18 (0124),
a third luer adapter 7221 coupled to the blood collection device 7270, best seen in Figure 18 (0126),
wherein the extension tube 7220, 7160, 7150, 7100 comprises a distal end and a proximal end, best seen in Figure 18,
wherein the distal end of the extension tube 7150 is integrated with the first luer adapter 7131, best seen in Figure 18 (0124),
wherein the proximal end of the extension tube 7220 is integrated with the third luer adapter 7221, best seen in Figure 18 (0126).
However, Devgon et al in combination with Woehr et al do not expressly disclose the blood collection device comprises a second luer adapter.
Hwang et al teach that it is well-known in the art to provide an analogous extension tube 3 with a proximal end 17, 21 defining an analogous claim-defined third luer adapter (0031) such as a female luer connector that can mate with a male luer connector of a syringe to effectively couple the syringe to the proximal end of the extension tube as desired such as for medication infusion, best seen in Figure 1 (0031). Thus, Hwang et al disclose the syringe with an analogous claim-defined second luer adapter to engage the claim-defined third luer adapter of the extension tube.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Devgon et al as modified by Woehr et al such that the blood collection device comprises a second luer adapter as taught by Hwang et al as an effective mechanism to couple the blood collection device to the proximal end of the extension tube by coupling the third luer adapter of the extension tube of Devgon et al to the second luer adapter, when incorporated by Hwang et al with the blood collection device.
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon et al in view of Woehr et al as applied to claim 1, further in view of Rogers et al (US Pub No. 20200305780).
Devgon et al in combination with Woehr et al disclose the invention above but do not expressly disclose the extension tube comprises an island.
Rogers et al teach that it is well-known in the art to provide an analogous catheter extension set 201 with extension tube (defined by inlet 102, housing 120, outlet 104) with distal and proximal ends with fluid pathway 106 and 110, wherein the extension tube comprises an island (forming path 110) adjacent absorbent material 108 disposed within the fluid pathway, the island narrowing a diameter of the fluid pathway to direct the fluid flow as desired, best seen in Figure 2 and 4.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Devgon et al in combination with Woehr et al such that the extension tube comprises an island as taught by Rogers et al to effectively direct the fluid flow as desired, wherein in combination the island would be disposed adjacent the absorbent material of Woehr et al so as to be spaced apart from the absorbent material, with blood flowing around the island in a distal to proximal direction, when modified as such for said desired fluid flow.
Claims 30-31 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon et al in view of Blanchard et al (US Pub No. 20160331938).
In regard to Claim 30, Devgon et al disclose a catheter extension set 7200, comprising:
a distal end 7130, comprising a luer adapter 7131 (0124) configured to couple to a catheter adapter 7400 (connects to catheter 7425), best seen in Figure 18 (0127);
a proximal end 7221, comprising a blood collection device 7270, best seen in Figure 18 (0126, 0130); and
an extension tube 7220, 7160, 7150, 7100 extending between the distal end and the proximal end and defining a fluid pathway from the distal end to the proximal end, the extension tube having a sidewall that defines a lumen or inner volume, best seen in Figure 18 (0123, 0125, 0126).
However, Devgon et al do not expressly disclose the sidewall of the extension tube in the fluid pathway that defines the lumen of the extension tube comprises an indicator tube formed entirely within the sidewall, the indicator tube comprising a plurality of markers, wherein the indicator tube comprises markers that provide a visual indicator of a flow of blood through the indicator tube, and wherein blood within the fluid pathway of the extension tube is configured to flow through the indicator tube.
Blanchard et al teach that it is well-known in the art to provide an analogous extension tube that comprises a sidewall that defines a lumen with an indicator tube 134 formed entirely within the sidewall – “the channel 134 defines a wavy, back-and-forth pathway 136 on a surface of the advancement member” (0084), best seen in Figure 19-21 and 23-25,
the indicator tube comprising a plurality of markers (grooves of the channel 134) that provide a visual indicator of a flow of blood through the indicator tube, wherein blood within the fluid pathway of the extension tube is configured to flow through the indicator tube – “a distal end of the channel 134 is in fluid communication with the lumen of the needle of the insertion device (or other medical device) so that blood may exit the needle lumen and enter the pathway 136 defined by the channel” (0084), “the flash indicator 80 is employed to indicate the presence of blood in the lumen of the needle 16 during use of the device 10, thus assuring that proper access has been made by the needle into a vein or other desired blood-carrying vessel” (0063).
Blanchard et al also teach that “though shown here as being defined on the advancement member 48 of the catheter insertion device, the channel 134 can be included on other structures, including the hub or other portion of the catheter, the housing of the catheter insertion device/medical device/component, a valve assembly, etc. Further, though shown here as defined on a surface of the advancement member, the channel in other embodiments can include at least a portion of a tunnel or pathway defined below the surface of the advancement member/medical device/component” (0084). Thus, Blanchard et al teach that the indicator tube, which is taught in a similar manner as applicant’s Figure 11A-B, can be disposed in various locations of the fluid pathway.
Blanchard et al also teach the indicator tube 134 is visible to a user through the extension tube, to enable visualization of a blood flow therethrough and relative to the markers – " A user can observe the blood within the pathway 136 defined by the channel 134 to confirm that the distal tip of the needle 16 is disposed in the vein or other desired blood-carrying vessel of the patient. As the pathway 136 is relatively lengthy, the progress of the blood as it proceeds in the channel enables the flash indicator 80 to function as a continuous flash indicator” (0083). “Observe” implies a visual indication.
Additionally, Blanchard et al teach a translucent component can be used to visualize and thus provide a visual indicator of blood flow – “The flash indicator 80 is employed to indicate the presence of blood in the lumen of the needle 16 during use of the device 10, thus assuring that proper access has been made by the needle into a vein or other desired blood-carrying vessel. As shown, the flash indicator 80 includes a translucent chamber 82 that is generally cylindrical in shape, sealed at either end, and disposed about a portion of the needle 16 such that the needle protrudes out from either sealed end” (0063). “As the blood fills the chamber 82, a user can observe the translucent chamber through the translucent housing 12 of the insertion device 10 and view the blood therein, thus confirming that the vessel access has been achieved” (0066). In other words, Blanchard et al teach using a translucent material to enable a visual of the blood flow by the user, thus providing a visual indicator.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Devgon et al such that the sidewall of the extension tube in the fluid pathway that defines the lumen or inner volume of the extension tube comprises an indicator tube formed entirely within the sidewall, the indicator tube comprising a plurality of markers that provide a visual indicator of a flow of blood through the indicator tube, as taught by Blanchard et al to effectively provide a visual indicator of a flow of blood through the extension tube.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Devgon et al by using a translucent material such as for the extension tube such that the indicator tube of Blanchard et al is visible through the extension tube as taught by Blanchard et al to effectively provide a visual indicator to of a location of blood flow within the extension tube, including if the blood flow has reached the absorbent material.
31. Blanchard et al disclose the markers 134 comprise grooves that collect blood therein, best seen in Figure 19-21 and 23-25 (0083-0086).
35. Blanchard et al disclose a diameter of a lumen defined by the indicator tube is smaller than a diameter of the lumen of the extension tube since the channel 134 is formed and defined on advancement member 48, best seen in Figure 19-21 and 23-25, which thus would have a larger lumen, and wherein when combined with Devgon et al would similarly result as the indicator tube does not take up the space of the entire extension tube of Devgon et al and thus would have a smaller diameter.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon et al in view of Blanchard et al, further in view of McFarlane (US Pat No. 4908021).
Devgon et al in combination with Blanchard et al disclose the invention above including the indicator tube comprises an inlet, wherein blood enters the indicator tube from the fluid pathway of the extension tube at a first location, but do not expressly disclose the indicator tube has an outlet and exits the indicator tube back into the fluid pathway of the extension tube at a second location that is proximal to and downstream from the first location.
McFarlane teach that it is well-known in the art to provide an analogous flashback assembly for a catheter comprising an extension tube 40 with an indicator tube, defined as chamber 41 (from among chambers 40-53) comprising an inlet and outlet ports 70, shown by arrows in Figure 7, wherein blood enters the indicator tube 41 from the fluid pathway of the extension tube at a first location, e.g. bottom right side of chamber 41, and exits the indicator tube back into the fluid pathway of the extension tube at a second location, e.g. top left port, that is proximal to and downstream from the first location, best seen in Figure 7, to effectively define the consecutive filling of the chambers of the extension tube as desired (Col.4: 22-35, abst).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Devgon et al as modified by Blanchard et al such that the indicator tube has an outlet and exits the indicator tube back into the fluid pathway of the extension tube at a second location that is proximal to and downstream from the first location as taught by McFarlane to effectively enable fluid flow through the indicator tube in a consecutive and linear manner as desired.
Response to Arguments
Applicant's arguments filed with respect to Woehr et al and Blanchard et al have been fully considered but they are not persuasive. In regard to Claim 1, applicant contends that Woehr et al do not disclose an absorbent material that is “equivalent” to that in claim 1 along a portion of the extension tube because Woehr et al do not disclose “an extension tube provided between a catheter adapter and a blood collection device” (Remarks pg. 8).
However, it is submitted that Woehr et al is not relied upon to teach the extension tube disposed as claimed, since Devgon et al already disclose said extension tube, as broadly as has been claimed. Modification of Devgon et al with Woehr et al would simply involve disposing the absorbent material of Woehr et al within a cut-out formed in a sidewall of the extension tube of Devgon, which in combination, would thus be located between a catheter adapter and a blood collection device. Providing a cut-out in the extension tube of Devgon et al to provide the absorbent material would be simple and straightforward to a skilled artisan. The modification does not require the absorbent material be within a needle, even though that is taught by Woehr et al, given the broad language of the structure of the extension tube. Furthermore, the claims do not preclude a needle as part of the extension tube or recite any structure relating to a needle and where it may or may not be placed within the catheter extension set.
Applicant also contends that Woehr et al do not teach the visual indicator as claimed because “flashback indicator 130 only functions to verify proper placement of a needle and catheter in a blood vessel” (Remarks pg. 9). Applicant appears to contend that a flashback indicator is different from the visual indicator of the absorbent material. However, this is not persuasive because a flashback indicator, as known in the art, is meant for visual indication of the vein penetration and blood flow through the needle. This is clearly the same as providing the visual indicator of a location of blood flow within the extension tube, which would be indicated when the blood has reached the absorbent material – similarly to a flashback indicator – as recited. Woehr et al is also set forth to teach that it is transparent material that allows the visual indication. Therefore, modification to provide the transparent material in the area of extension tube having the absorbent material of Woehr et al when it is positioned within a cut-out formed in a sidewall of the extension tube, would provide the visual indicator as broadly as has been claimed.
Again, it is submitted that that the location of the absorbent material of Woehr et al in needle 110 does not teach away from the limitations being taught by Woehr et al, namely, the absorbent material positioned within a cut-out formed in a sidewall of the extension tube to provide a visual indicator of a location of blood flow within the extension tube including if the blood flow has reached the absorbent material. When combined with Devgon et al, said positioning of the absorbent material in the extension tube of Devgon et al would thus be located between a catheter adapter and a blood collection device, as already taught by Devgon et al.
Applicant also contends that Blanchard et al do not disclose the extension tube provided between a catheter adapter and a blood collection device. However, it is submitted that the same logic and obviousness applied to Woehr et al applies to Blanchard et al; when combined with Devgon et al, said positioning of the indicator tube of Blanchard et al in the extension tube of Devgon et al would thus be located between a catheter adapter and a blood collection device, as already taught by Devgon et al.
Additionally, Blanchard et al teach using a translucent material to enable visualization of blood flow (newly cited above), thus providing a visual indicator of a location of blood flow within the extension tube, and it would have been obvious to a skilled artisan to provide the indicator tube of Blanchard et al in the extension tube of Devgon et al in a straightforward manner.
Regarding the contention that that Blanchard et al does not disclose an indicator tube “formed in a sidewall of the extension tube in the fluid pathway that defines a lumen of the extension tube,” it is noted that the teaching of Blanchard et al recites “though shown here as being defined on the advancement member 48 of the catheter insertion device, the channel 134 can be included on other structures, including the hub or other portion of the catheter, the housing of the catheter insertion device/medical device/component, a valve assembly, etc. Further, though shown here as defined on a surface of the advancement member, the channel in other embodiments can include at least a portion of a tunnel or pathway defined below the surface [emphasis added] of the advancement member/medical device/component” (0084). Thus, Blanchard et al teach that the indicator tube, which is taught in a similar manner as applicant’s Figure 11A-B, can be disposed in various locations of the fluid pathway. It is submitted that a skilled artisan would thus be able to dispose the indicator tube of Blanchard et al in in a sidewall of the extension tube in the fluid pathway that defines a lumen of the extension tube of Devgon et al, as an obvious location for the indicator tube, especially since that the indicator tube must be located in a portion of the device containing fluid flow since that is the manner of operation of the indicator tube. Additionally, said catheter extension sets disclosed by Devgon et al and Blanchard et al both constitute, in use, closed fluid loops. Therefore, the fluid must flow to every portion of the device, i.e. including the advancement member of Blanchard et al, which thus constitutes a fluid pathway that defines a lumen of the extension tube as broadly as has been claimed. Such modification would be straightforward and thus obvious to a skilled artisan. Therefore, the rejection as modified above, is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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/H Q NGUYEN/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791