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
This Office Action is in response to the Applicant’s amendment filed 28 January 2026 wherein claims 1, 7, 8, 10, 12, and 17 are amended, Claim 13 is cancelled, no claims are newly added, and claims 3 – 5 and 19 are previously withdrawn. Therefore, Claims 1 – 12 and 14 – 20 are currently pending wherein Claims 3 – 5 and 19 are withdrawn therefrom.
The Applicant’s amendments to the Specification and Drawings dated 28 January 2026 have been fully considered and entered. These amendments have overcome each Drawing and Specification Objection set forth in the Non-Final Rejection dated 29 October 20255 (hereinafter referred to as the “Non-Final Rejection”). Therefore, each Drawing and Specification Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendments to the claims dated 28 January 2026 has overcome each Claim Objection and Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection. Therefore, each Claim Objection and Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection are withdrawn.
Response to Arguments
Applicant’s arguments, see pages 3 – 4, filed 28 January 2026, with respect to the rejection(s) of independent claim(s) 1 and 12 and their respective dependent claims under 35 U.S.C. §§ 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Johnson (US 5,049,136 A) in view of Ang et al. (US 2016/0008581 A1).
Drawings
The drawings are objected to because of the following:
Figures 17A – C, 17E – 17G, and 19A contain either or both of reference numeral 104, 106. These reference numerals refer to the distal end 104 and proximal end 106 of the blood shield 102. However, these figures reverse the location of the reference numerals. In other words, where reference numeral 104 is labeled should be amended to be reference numeral 106 and vice versa. Amending the figures in this manner creates consistency with regards to the directions of distal and proximal (distal meaning towards the patient while proximal meaning towards the medical practitioner) within the figures, specification, and claims. The Examiner has provided an annotated figure below to help explain the objection. 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 17A – C, 17E – 17G, and 19A 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.
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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.
Allowable Subject Matter
Claims 12, 14 – 18, and 20 are allowed.
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, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 5,049,136 A) in view of Ang et al. (US 2016/0008581 A1; hereinafter referred to as “Ang”).
Johnson is cited in the Notice of References Cited form dated 29 October 2025.
With regards to claim 1, Johnson discloses (Figs. 10 and 14 – 18) a catheter system (45), comprising:
a catheter hub (48), comprising a distal end (see at 50 in Fig. 17), a proximal end (see near 52 in Fig. 17), and a catheter hub lumen (see at 52 in Fig. 17) extending through the distal end of the catheter hub and the proximal end of the catheter hub (see Fig. 17);
a catheter (46) extending distally from the distal end of the catheter hub (see Fig. 17 and Col. 9, lines 12 – 26);
a blood shield (40) secured within the catheter hub lumen (see Col. 9, lines 27 – 45 “The tapered front end 41 of protective sheath member 40 is sized to be frictionally received and engaged in bore 52 of the base member 48 of the catheter 46”), wherein the blood shield comprises a distal end (see near 33 in Fig. 16), a proximal end (see near 43 in Fig. 16), a blood shield lumen (see at 43 in Fig. 16) 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 (see at 43 in Fig. 16), wherein the inner wall comprises a shield bump (42) (see Col. 10, lines 3 – 13); and
an introducer needle (32) comprising a sharp distal tip (33) and a needle bump (35), wherein the introducer needle extends through the catheter and the blood shield (see Fig. 15), wherein in response to proximal retraction of the introducer needle, the needle bump is configured to contact the shield bump to pull the blood shield proximally out of the proximal end of the catheter hub (see Figs. 15 – 17 and Col. 9, line 63 – Col. 10, line 13), wherein the sharp distal tip is disposed within the blood shield when the needle bump contacts the shield bump (see Figs. 15 – 17 and Col. 9, line 63 – Col. 10, line 13).
However Johnson is silent with regards to the blood shield being entirely disposed within the catheter hub lumen.
Nonetheless Ang, which is within the analogous art of needle safety devices and related methods (see abstract and title)¸teaches (see Figs. 1 – 4) the blood shield (102) being entirely disposed within the catheter hub lumen (see Fig. 4, [0029], and [0040] “The assembly 170 is shown with a needle guard 102 disposed in an interior cavity 180 of the catheter hub 172”).
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 size and location of the blood shield of the catheter system of Johnson in view of a teaching of Ang such that the blood shield being entirely disposed within the catheter hub lumen. One of ordinary skill in the art would have been motivated to make this modification because incorporating the blood shield inside the catheter hub maintains sterility of the operating field. When a portion of the blood shield is disposed outside of the catheter hub, as disclosed by Johnson, allows for microbes to attain access to the internal lumen of the catheter hub. Additionally, a person of ordinary skill in the art would have been motivated to make this modification because incorporating the blood shield inside the catheter hub also prevents misalignment of the blood shield and needle if contact is made to the device. See Figure 4, [0029], and [0040] of Ang.
The catheter system of Johnson modified in view of a teaching of Ang will hereinafter be referred to as the catheter system of Johnson and Ang.
With regards to claim 9, the catheter system of Johnson and Ang teaches the claimed invention of claim 1, and Johnson further teaches (Figs. 10 and 14 – 18) wherein the inner wall (see at 43 in Fig. 9) of the blood shield (40) further comprises a distal cylindrical shape (see near 33 in Fig. 10) distal to the shield bump (42) (see at 35 in Fig. 10) and a proximal cylindrical shape (see at 43 in Fig. 10) proximal to the shield bump.
With regards to claim 10, the catheter system of Johnson and Ang teaches the claimed invention of claim 9, and Johnson further teaches (Figs. 10 and 14 – 18) wherein the sharp distal tip (33) is disposed within the distal cylindrical shape (see the location of 33 in Fig. 10) when the needle bump (35) contacts the shield bump (42).
Claim(s) 2, 6, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson and Ang 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”).
Breindel is cited in the Notice of References Cited form dated 29 October 2025.
With regards to claim 2, the catheter system of Johnson and Ang teaches the claimed invention of claim 1, however, Johnson is silent with regards to 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 Johnson and Ang 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 regards to claim 6, the catheter system of Johnson and Ang teaches the claimed invention of claim 1, however, Johnson is silent with regards to the shield bump being annular.
Nonetheless Breindel, which is within the analogous art of catheter assemblies (see abstract), teaches (Fig. 2b) wherein the shield bump (318) is annular (see Fig. 2b which shows the shield bump 318 being annular).
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 of the shield bump of the blood shield of the catheter system of Johnson and Ang in view of a teaching of Breindel such that the shield bump is annular. One of ordinary skill in the art would have been motivated to make this modification because Breindel teaches that an annular shape allows for the safety device to be further pulled proximally with the needle and away from the catheter (see [0017] of Breindel). Further a change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976); MPEP 2144.04 (B).
With regards to claim 11, the catheter system of Johnson and Ang teaches the claimed invention of claim 9, however Johnson 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 Johnson and Ang 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 Johnson and Ang as applied to claim 1 above, and further in view of Isaacson (US 2019/0160264 A1).
Isaacson is cited in the Notice of References Cited form dated 29 October 2025.
With regards to claim 7, the catheter system of Johnson and Ang teaches the claimed invention of claim 1, however Johnson is silent with regards to the catheter system 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 Johnson and Ang 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 Johnson and Ang modified in view of a teaching of Isaacson will hereinafter be referred to as the catheter system of Johnson, Ang, and Isaacson.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson, Ang, and Isaacson as applied to Claim 7 above, and further in view of Brimhall (US 6,224,569 B1).
Brimhall is cited in the Notice of References Cited form dated 29 October 2025.
With regards to claim 8, the catheter system of Johnson, Ang, and Issacson teaches the claimed invention of claim 7, however Johnson 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 Johnson, Ang, 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).
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 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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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
04/02/2026