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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6 July 2026 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 6 July 2026 wherein Claim 1 is amended, Claims 3 – 5 and 19 are previously withdrawn, Claim 13 is previously cancelled, and no claims are newly added. Therefore, Claims 1 – 12 and 14 – 20 are currently pending.
The Applicant’s amendment to the Drawings dated 6 July 2026 has overcome some of the Drawing Objections set forth in the Final Rejection dated 6 April 2026. The outstanding Drawing Objection set forth in the Final Rejection dated 6 April 2026 is maintained and reiterated below.
Response to Arguments
Applicant’s arguments, see pages 1 – 2, filed 6 July 2026, with respect to the 35 U.S.C. § 103 rejection set forth in the Final Rejection dated 6 April 2026 have been fully considered and are persuasive. The 35 U.S.C. § 103 of the Final Rejection dated 6 April 2026 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ang et al. (US 2016/0008581 A1) in view of Kuracina et al. (US 2007/0027429 A1).
Drawings
The drawings are objected to because of the following:
Figure 17F contains reference numeral 106. This reference numeral refers to the proximal end 106 of the blood shield 102. However, the Examiner believes this reference numeral should be amended to be the distal end 104 of the blood shield 102. Currently, the claims recite that the septum 114 is disposed within the distal end of the blood shield 102 and that the proximal retraction of the introducer needle causes the septum to be uncoupled from the inner wall of the catheter hub. See Claim 12. However, based on the current reference numerals in Figures 17F the septum appears to be located in the proximal end 106. Therefore, reversing the reference numeral locations of distal end 104 and proximal end 106 is necessary to clarify this confusion while maintaining consistency with the other claim limitations recitations of direction.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 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.
Claim(s) 1, 6, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ang et al. (US 2016/0008581 A1) (hereinafter referred to as “Ang”) in view of Kuracina et al. (US 2007/0027429 A1) (hereinafter referred to as “Kuracina”).
With regard to claim 1, Ang discloses a catheter system (170), comprising:
a catheter hub (172), comprising a distal end (see Figure 4), a proximal end (see Figure 4), and a catheter hub lumen (180) extending through the distal end of the catheter hub and the proximal end of the catheter hub (see Figure 4);
a catheter (174) extending distally from the distal end of the catheter hub (see Figure 4);
a blood shield (102) secured within the catheter hub lumen (see Figure 4 and [0040] “The needle guard 102 is shown positioned in the Luer taper with the drum 112 frictionally engaged with the interior surface of the catheter hub.”), wherein an entirety of the blood shield is disposed within the catheter hub lumen (see Figure 4); and
an introducer needle (178) comprising a sharp distal tip (see [0040] “the needle tip”) and a needle bump (see [0040] “a change in profile, such as a crimp or a bulge”), wherein the introducer needle extends through the catheter and the blood shield (see [0037], [0038], [0040] and Figure 4).
However, Ang is silent with regards to:
wherein the blood shield comprises a distal end, a proximal end, a blood shield lumen extending through the distal end of the blood shield and the proximal end of the blood shield, and an inner wall forming the blood shield lumen, wherein the inner wall comprises a shield bump; and
wherein in response to proximal retraction of the introducer needle, the blood shield remains secured within the catheter hub until the shield bump is contacted by the needle bump, after which the entirety of the blood shield is withdrawn from within catheter hub together with the introducer needle, wherein the sharp distal tip is disposed within the blood shield when the needle bump contacts the shield bump.
Nonetheless Kuracina, which is within the analogous art of apparatuses for indicating or covering a percutaneous puncture site (see abstract and title), teaches (Figures 33 – 34) wherein the blood shield (223) (see [0196]) comprises a distal end (see at 227 in Figure 33), a proximal end (see at 234 in Figure 33), a blood shield lumen (see the lumen along 223 in Figure 223) extending through the distal end of the blood shield and the proximal end of the blood shield, and an inner wall (see at 231, 224, and 225 in Figure 33) forming the blood shield lumen (see Figure 33), wherein the inner wall comprises a shield bump (see at 224 in Figure 33); and
wherein the sharp distal tip (111) is disposed within the blood shield when the needle bump (130) contacts the shield bump (see Figures 33 and 34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify or replace the blood shield taught by the catheter system of Ang in view of a teaching of Kuracina such that the wherein the blood shield comprises a distal end, a proximal end, a blood shield lumen extending through the distal end of the blood shield and the proximal end of the blood shield, and an inner wall forming the blood shield lumen, wherein the inner wall comprises a shield bump; and wherein the sharp distal tip is disposed within the blood shield when the needle bump contacts the shield bump. One of ordinary skill in the art would have been motivated to make this modification because this configuration of the blood shield traps the needle tip in the blood shield while preventing any further axial movement of the needle within the blood shield. See [0196] and [0197] of Kuracina.
The catheter system of Ang modified in view of Kuracina will hereinafter be referred to as the catheter system of Ang and Kuracina.
The catheter system of Ang and Kuracina further teaches wherein in response to proximal retraction of the introducer needle, the blood shield remains secured within the catheter hub until the shield bump is contacted by the needle bump, after which the entirety of the blood shield is withdrawn from within catheter hub together with the introducer needle (see [0040] of Ang and the modification or replacement of the blood shield of Ang with the blood shield of Kuracina above).
With regard to claim 6, the catheter system of Ang and Kuracina teaches the claimed invention of claim 1, and the catheter system of Ang and Kuracina further teaches wherein the shield bump is annular (see at 224 in Figure 33 of Kuracina).
With regard to claim 9, the catheter system of Ang and Kuracina teaches the claimed invention of claim 1, and the catheter system of Ang and Kuracina further teaches wherein the inner wall (see at 231, 224, and 225 in Figure 33 of Kuracina) of the blood shield (223) (see [0196] of Kuracina) further comprises a distal cylindrical shape (see at 226 in Figure 33 of Kuracina) distal to the shield bump (see at 224 in Figure 33 of Kuracina) and a proximal cylindrical shape (see at 234 in Figure 33 of Kuracina) proximal to the shield bump.
With regard to claim 10, the catheter system of Ang and Kuracina teaches the claimed invention of claim 9, and the catheter system of Ang and Kuracina further teaches wherein the sharp distal tip (111 of Kuracina) is disposed within the distal cylindrical shape (see at 226 in Figure 33 of Kuracina) when the needle bump (103 of Kuracina) contacts the shield bump (see at 224 in Figure 33 of Kuracina).
Claim(s) 2 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ang and Kuracina as applied to claims 1 and 9 above and in further view of Breindel et al. (US 2019/0388653 A1) (hereinafter referred to as “Breindel”).
With regard to claim 2, the catheter system of Ang and Kuracina teaches the claimed invention of claim 1, however Ang is silent with regards to wherein the introducer needle comprises a notch proximal to the needle bump, wherein the notch is disposed within the blood shield when the needle bump contacts the shield bump.
Nonetheless Breindel, which is within the analogous art of catheter assemblies (see abstract), teaches (Fig. 3b) the introducer needle (302) comprises a notch (316) proximal to the needle bump (318) (see [0029] “In the example embodiment of FIGS. 2a and 2b, the notch 316 is positioned distally of the transition 318 and remains positioned internally to the containment 324 after removal from the catheter hub. It is to be appreciated, however, that other configurations are also contemplated. In the embodiment of FIGS. 3a and 3b, the notch 316 is positioned proximally of the transition and emerges from the containment during needle withdrawal.”), wherein the notch is disposed within the blood shield (330) when the needle bump (318) contacts the shield bump (see [0028] “The needle transition 318 contacts and engages the reduced diameter portion of the containment, at the bump washer, as the needle is withdrawn.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle and blood shield of the catheter system of Ang and Kuracina in view of a teaching of Breindel such that the introducer needle comprises a notch proximal to the needle bump, wherein the notch is disposed within the blood shield when the needle bump contacts the shield bump. One of ordinary skill in the art would have been motivated to make this modification because Breindel teaches that the notch allows for flashback blood to enter the annular space between a catheter tube and an introducer needle of an IV catheter. The presence of flashback blood in this annular space can provide a clinician with an early, visible indication that a needle has entered a vein (see Abstract of Breindel).
With regard to claim 11, the catheter system of Ang and Kuracina teaches the claimed invention of claim 9, however Ang is silent with regards to wherein the introducer needle comprises a notch proximal to the needle bump, wherein the notch is disposed within the proximal cylindrical shape when the needle bump contacts the shield bump.
Nonetheless Breindel, which is within the analogous art of catheter assemblies (see abstract), teaches (Fig. 3b) the introducer needle (302) comprises a notch (316) proximal to the needle bump (318) (see [0029] “In the example embodiment of FIGS. 2a and 2b, the notch 316 is positioned distally of the transition 318 and remains positioned internally to the containment 324 after removal from the catheter hub. It is to be appreciated, however, that other configurations are also contemplated. In the embodiment of FIGS. 3a and 3b, the notch 316 is positioned proximally of the transition and emerges from the containment during needle withdrawal.”), wherein the notch is disposed within the proximal cylindrical shape (see the portion of the needle safety device 320 that the transition 318 is located within Fig. 3b) when the needle bump (318) contacts the shield bump (see [0028] “The needle transition 318 contacts and engages the reduced diameter portion of the containment, at the bump washer, as the needle is withdrawn.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle and blood shield of the catheter system of Ang and Kuracina in view of a teaching of Breindel such that the introducer needle comprises a notch proximal to the needle bump, wherein the notch is disposed within the proximal cylindrical shape when the needle bump contacts the shield bump. One of ordinary skill in the art would have been motivated to make this modification because Breindel teaches that the notch allows for flashback blood to enter the annular space between a catheter tube and an introducer needle of an IV catheter. The presence of flashback blood in this annular space can provide a clinician with an early, visible indication that a needle has entered a vein (see Abstract of Breindel).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ang and Kuracina as applied to claim 1 above, and further in view of Isaacson (US 2019/0160264 A1).
With regard to claim 7, the catheter system of Ang and Kuracina teaches the claimed invention of claim 1, however Ang is silent with regards to further comprising:
a housing comprising a barrel;
a needle hub coupled to the introducer needle and movably disposed within the barrel;
a spring disposed within the housing; and
a push button, wherein in response to depression of the push button, the spring is configured to expand proximally and move the needle hub proximally within the barrel to retract the introducer needle proximally.
Nonetheless Isaacson, which is within the analogous art of catheter assemblies (see abstract), teaches (Figs. 1 – 9) the catheter system (10) further comprises:
a housing (see at 72 in Fig. 2) comprising a barrel (72);
a needle hub (80) coupled to the introducer needle (20) and movably disposed within the barrel (see Figs. 4, 5, 8, [0054], and [0059]);
a spring (82) disposed within the housing (see Figs. 4, 5, and 8); and
a push button (78), wherein in response to depression of the push button, the spring is configured to expand proximally and move the needle hub proximally within the barrel to retract the introducer needle proximally (see Figs. 4, 5, 8, [0054], and [0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle hub of the catheter system of Ang and Kuracina in view of a teaching of Isaacson such that a housing comprising a barrel; a needle hub coupled to the introducer needle and movably disposed within the barrel; a spring disposed within the housing; and a push button, wherein in response to depression of the push button, the spring is configured to expand proximally and move the needle hub proximally within the barrel to retract the introducer needle proximally. One of ordinary skill in the art would have been motivated to make this modification because Isaacson teaches the needle retraction into the barrel assembly protects the user from all hazards. Further the housing prevents the needle from re-exposure and reduces blood exposure (see [0007] of Isaacson).
The catheter system of Ang and Kuracina modified in view of a teaching of Isaacson will hereinafter be referred to as the catheter system of Ang, Kuracina and Isaacson.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ang, Kuracina, and Isaacson as applied to Claim 7 above, and further in view of Brimhall (US 6,224,569 B1).
With regard to claim 8, the catheter system of Ang, Kuracina and Isaacson teaches the claimed invention of claim 7, however Ang is silent with regards to wherein a portion of the needle hub is disposed within the catheter hub, wherein the proximal end of the blood shield is disposed within the portion of the needle hub.
Nonetheless Brimhall, which is within the analogous art of compact needle point shield (see abstract), teaches (Figs. 4 – 5) a portion (see Examiner annotated Fig. 5 below hereinafter referred to as “Fig. A”) of the needle hub (34) is disposed within the catheter hub (24), wherein the proximal end (see near 43 in Fig. 5) of the blood shield (40) is disposed within the portion of the needle hub (see Fig. 5).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shape and size of the catheter hub, needle hub, and blood shield of the catheter system of Ang, Kuracina, and Isaacson in view of a teaching of Brimhall such that a portion of the needle hub is disposed within the catheter hub, wherein the proximal end of the blood shield is disposed within the portion of the needle hub. One of ordinary skill in the art would have been motivated to make this modification because Brimhall teaches that this configuration of the blood shield, needle hub, and catheter hub provides for a snug fitting between the between the blood/needle shield and the catheter hub thereby preventing the easy removal or inadvertent removal of the blood/needle shield from the catheter hub (Col. 4, lines 17 – 30 of Brimhall).
Allowable Subject Matter
Claim 12, 14 – 18, and 20 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
09/04/2026
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