DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed March 6, 2026 in response to the Office Action of November 6, 2025 has been acknowledged and entered.
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.
Claims 1-5 and 11-14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Harding (US 20200129738) (previously cited) in view of Krause (US 20190314614) (previously cited).
Regarding claim 1, Harding teaches a catheter system (Fig. 5G), comprising: a catheter assembly (60), comprising: a catheter adapter (12), comprising a distal end, a proximal end, and a lumen (52) extending through the distal end and the proximal end; and a catheter (14) extending distally from the distal end of the catheter adapter; a needle assembly, comprising: a needle hub (18) proximate and proximal to the catheter adapter; an introducer needle (16) extending distally from the needle hub, wherein the introducer needle comprises a sharp distal tip (Paragraph [0086]); an extension tube (80), comprising a distal end and a proximal end, wherein the distal end is integrated with the needle hub (See Fig. 5G); a cannula hub (body 86), wherein a proximal end of the extension tube is integrated with the cannula hub; a cannula (needle 94) extending proximally from the cannula hub; and an elastomeric sheath (96) coupled to the cannula hub, wherein a proximal end of the cannula is enveloped within the elastomeric sheath, wherein the elastomeric sheath comprises an open distal end and a closed proximal end. (See Fig. 5G).
However, Harding does not teach “a clip disposed distal to an opening of the proximal end of the catheter adapter, the clip comprising a first arm comprising a first hole and a second arm comprising a second hole, the first arm and a second arm joined at a bend comprising a third hole, wherein the first hole, the second hole, and the third hole are configured to allow a needle to extend through the first hole, second hole, and third hole when the first hole, second hole, and third hole are aligned along a longitudinal axis of the clip and wherein the first arm and the second arm are configured to move resiliently outward such that the first hole and the second hole move away from each other responsive to the needle being proximally withdrawn from the first hole and the second hole”.
Krause illustrates (Fig. 4B) a clip (132) disposed distal to an opening of the proximal end of the catheter adapter (122), the clip comprising a first arm (148A) comprising a first hole (156A) and a second arm (148B) comprising a second hole (156B) (See Fig. 10A, 10B), the first arm (148A) and a second arm (148B) joined at a bend comprising a third hole (aperture 150), wherein the first hole, the second hole, and the third hole are configured to allow a needle to extend through the first hole, second hole, and third hole when the first hole, second hole, and third hole are aligned along a longitudinal axis of the clip (See Fig. 9A), and wherein the first arm and the second arm are configured to move resiliently outward such that the first hole and the second hole move away from each other responsive to the needle being proximally withdrawn from the first hole and the second hole. (Paragraph [0062]).
As a result, it would have been obvious to one of ordinary skill in the art to modified Harding to provide “a clip disposed distal to an opening of the proximal end of the catheter adapter, the clip comprising a first arm comprising a first hole and a second arm comprising a second hole, the first arm and a second arm joined at a bend comprising a third hole, wherein the first hole, the second hole, and the third hole are configured to allow a needle to extend through the first hole, second hole, and third hole when the first hole, second hole, and third hole are aligned along a longitudinal axis of the clip and wherein the first arm and the second arm are configured to move resiliently outward such that the first hole and the second hole move away from each other responsive to the needle being proximally withdrawn from the first hole and the second hole” as taught by Krause. Doing so improves the safety of the device.
Regarding claim 2, Harding teaches wherein the cannula (94) is configured to insert into a blood collection tube (Paragraph [0092]), wherein in response to the blood collection tube pushing the elastomeric sheath distally, the cannula pierces the elastomeric sheath. (Paragraph [0094]).
Regarding claim 3, Harding teaches wherein the catheter adapter (12) comprises a side port (68), wherein the catheter system further comprises another extension tube (70), wherein the other extension tube comprises a distal end and a proximal end, (See Fig. 5G), wherein the distal end of the other extension tube is integrated with the side port, wherein the proximal end of the other extension tube is integrated with an adapter. (See Fig. 5G).
Regarding claim 4, Harding teaches wherein the catheter comprises a flashback notch (28). (Paragraph [0058]).
Regarding claim 5, Harding teaches a needle shield (19) at least partially disposed within the catheter adapter (12), wherein in response to removing the introducer needle from the catheter adapter, the needle shield covers the sharp distal tip. (Paragraph [0086]).
Regarding claim 11, Harding teaches a catheter system (Fig. 5G), comprising: a catheter assembly (60), comprising: a catheter adapter (12), comprising a distal end, a proximal end, and a lumen (52) extending through the distal end and the proximal end; and a catheter (14) extending distally from the distal end of the catheter adapter; and a needle assembly, comprising: a needle hub (18) proximate and proximal to the catheter adapter; an introducer needle (16) extending distally from the needle hub; a cannula (94) extending proximally from the needle hub; and an elastomeric sheath (96) coupled to the needle hub, wherein a proximal end of the cannula is enveloped within the elastomeric sheath, wherein the elastomeric sheath comprises an open distal end and a closed proximal end. (See Fig. 5G).
However, Harding does not teach “a clip disposed distal to an opening of the proximal end of the catheter adapter, the clip comprising a first arm comprising a first hole and a second arm comprising a second hole, the first arm and a second arm joined at a bend comprising a third hole, wherein the first hole, the second hole, and the third hole are configured to allow a needle to extend through the first hole, second hole, and third hole when the first hole, second hole, and third hole are aligned along a longitudinal axis of the clip and wherein the first arm and the second arm are configured to move resiliently outward such that the first hole and the second hole move away from each other responsive to the needle being proximally withdrawn from the first hole and the second hole”.
Krause illustrates (Fig. 4B) a clip (132) disposed distal to an opening of the proximal end of the catheter adapter (122), the clip comprising a first arm (148A) comprising a first hole (156A) and a second arm (148B) comprising a second hole (156B) (See Fig. 10A, 10B), the first arm (148A) and a second arm (148B) joined at a bend comprising a third hole (aperture 150), wherein the first hole, the second hole, and the third hole are configured to allow a needle to extend through the first hole, second hole, and third hole when the first hole, second hole, and third hole are aligned along a longitudinal axis of the clip (See Fig. 9A), and wherein the first arm and the second arm are configured to move resiliently outward such that the first hole and the second hole move away from each other responsive to the needle being proximally withdrawn from the first hole and the second hole. (Paragraph [0062]).
As a result, it would have been obvious to one of ordinary skill in the art to modified Harding to provide “a clip disposed distal to an opening of the proximal end of the catheter adapter, the clip comprising a first arm comprising a first hole and a second arm comprising a second hole, the first arm and a second arm joined at a bend comprising a third hole, wherein the first hole, the second hole, and the third hole are configured to allow a needle to extend through the first hole, second hole, and third hole when the first hole, second hole, and third hole are aligned along a longitudinal axis of the clip and wherein the first arm and the second arm are configured to move resiliently outward such that the first hole and the second hole move away from each other responsive to the needle being proximally withdrawn from the first hole and the second hole” as taught by Krause. Doing so improves the safety of the device.
Regarding claim 12, Harding teaches wherein the catheter comprises a flashback notch (28). (Paragraph [0058]).
Regarding claim 13, Harding teaches wherein the cannula (94) is configured to insert into a blood collection tube (Paragraph [0092]), wherein in response to the blood collection tube pushing the elastomeric sheath distally, the cannula pierces the elastomeric sheath. (Paragraph [0094]).
Regarding claim 14, Harding teaches wherein the catheter adapter (12) comprises a side port (68), wherein the catheter system further comprises another extension tube (70), wherein the other extension tube comprises a distal end and a proximal end, (See Fig. 5G), wherein the distal end of the other extension tube is integrated with the side port, wherein the proximal end of the other extension tube is integrated with an adapter. (See Fig. 5G).
Regarding claim 16, Harding teaches a needle shield (19) at least partially disposed within the catheter adapter (12), wherein in response to removing the introducer needle from the catheter adapter, the needle shield covers the sharp distal tip. (Paragraph [0086]).
Regarding claim 17, Harding teaches wherein the proximal end (64) of the catheter adapter (12) comprises an opening. (See Fig. 5E).
However, Harding does not further teach “wherein the catheter assembly further comprises a clip disposed within the catheter adapter distal to the opening, wherein the clip comprises a first arm having a first hole and second arm having a second hole, wherein in response to the introducer needle being in an insertion position, the introducer needle extends through the first hole and the second hole and the arms are biased inwardly, wherein in response to the introducer needle being proximally withdrawn from the first hole and the second hole, the first arm and the second arm move resiliently outward such that the first hole and the second hole move away from each other and the clip blocks the opening.”
Krause, in a related field of endeavor, teaches (Fig. 4B) a catheter device wherein the catheter assembly (100) further comprises a clip (132) disposed within the catheter adapter (122) distal to the opening, wherein the clip comprises a first arm (148A) having a first hole (156A) and second arm (148B) having a second hole (156B), (See Fig. 10A, 10B), wherein in response to the introducer needle (106) being in an insertion position, the introducer needle extends through the first hole and the second hole and the arms are biased inwardly, wherein in response to the introducer needle being proximally withdrawn from the first hole and the second hole, the first arm and the second arm move resiliently outward such that the first hole and the second hole move away from each other and the clip blocks the opening. (Paragraph [0062]).
As a result, it would have been obvious to one of ordinary skill in the art to modified Harding to provide “wherein the catheter assembly further comprises a clip disposed within the catheter adapter distal to the opening, wherein the clip comprises a first arm having a first hole and second arm having a second hole, wherein in response to the introducer needle being in an insertion position, the introducer needle extends through the first hole and the second hole and the arms are biased inwardly, wherein in response to the introducer needle being proximally withdrawn from the first hole and the second hole, the first arm and the second arm move resiliently outward such that the first hole and the second hole move away from each other and the clip blocks the opening” as taught by Krause. Doing so improves the safety of the device.
Regarding claim 18, Harding does not teach “wherein the first arm and the second arm are joined at a first bend.”
Krause illustrates wherein the first arm (148A) and the second arm (148B) are joined at a first bend. (See Figs. 10A, 10B).
As a result, it would have been obvious to one of ordinary skill in the art to modified Harding to provide “wherein the first arm and the second arm are joined at a first bend” as taught by Krause. Doing so provides a pliant structure that has a natural bias towards a free or relaxed state which allows them to be deflected with the presence of the needle. (Paragraph [0062]).
Regarding claim 19, Harding does not teach “wherein the first arm comprises a second bend and the second arm comprises a third bend, wherein the first hole is disposed inward to the second bend, wherein the second hole is disposed inward to the third bend.”
Krause illustrates wherein the first arm (148A) comprises a second bend and the second arm (148B) comprises a third bend, wherein the first hole (156A) is disposed inward to the second bend, wherein the second hole (156B) is disposed inward to the third bend. (See annotated Fig. 10A).
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[AltContent: arrow][AltContent: arrow][AltContent: textbox (second bend)][AltContent: textbox (third bend)]
As a result, it would have been obvious to one of ordinary skill in the art to modified Harding to provide “wherein the first arm comprises a second bend and the second arm comprises a third bend, wherein the first hole is disposed inward to the second bend, wherein the second hole is disposed inward to the third bend” as taught by Krause. Doing so provides a pliant structure that has a natural bias towards a free or relaxed state which allows them to be deflected with the presence of the needle. (Paragraph [0062]).
Regarding claim 20, Harding does not teach “wherein the first arm comprises a first end, wherein the second arm comprises a second end, wherein in response to the introducer needle being proximally withdrawn from the first hole and the second hole, the first end and the second end overlap.”
Krause teaches wherein the first arm (148A) comprises a first end (152A), wherein the second arm (148B) comprises a second end (152B), wherein in response to the introducer needle being proximally withdrawn from the first hole and the second hole, the first end and the second end overlap. (Paragraphs [0062]-[0063]).
As a result, it would have been obvious to one of ordinary skill in the art to modified Harding to provide “wherein the first arm comprises a first end, wherein the second arm comprises a second end, wherein in response to the introducer needle being proximally withdrawn from the first hole and the second hole, the first end and the second end overlap” as taught by Krause. Doing so inhibits the sharp distal tip from reemergence from the apertures. (Paragraph [0062]).
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Harding in view of Krause, further in view of Isaacson (US 20190374748) (previously cited).
Regarding claim 6, Harding teaches a method of collecting blood from a patient, comprising: inserting a catheter system into a vasculature of a patient, (Paragraph [0033]), wherein the catheter system comprises: a catheter assembly (60), comprising: a catheter adapter (12), comprising a distal end, a proximal end, and a lumen (52) extending through the distal end and the proximal end; a catheter (14) extending distally from the distal end of the catheter adapter; and a metal wedge (Fig. 5F, wedge 73), wherein the wedge secures the catheter (14) within the catheter adapter (12); a needle assembly, comprising: a needle hub (18) proximate and proximal to the catheter adapter; an introducer needle (16) extending distally from the needle hub, wherein the introducer needle comprises a sharp distal tip (Paragraph [0086]); an extension tube (80), comprising a distal end and a proximal end, wherein the distal end is integrated with the needle hub (See Fig. 5G); a cannula hub (86), wherein a proximal end of the extension tube is integrated with the cannula hub; a cannula (94) extending proximally from the cannula hub; and an elastomeric sheath (96) coupled to the cannula hub, wherein a proximal end of the cannula is enveloped within the elastomeric sheath, wherein the elastomeric sheath comprises an open distal end and a closed proximal end (See Fig. 5G); collecting blood within the blood collection tube when the distal end of the introducer needle disposed within the metal wedge. (See Fig. 5G distal end of the introducer needle disposed within the metal wedge; Paragraph [0092] collecting blood within the blood collection tube).
However, Harding does not specifically teach “a clip disposed distal to an opening of the proximal end of the catheter adapter, the clip comprising a first arm comprising a first hole and a second arm comprising a second hole, the first arm and a second arm joined at a bend comprising a third hole, wherein the first hole, the second hole, and the third hole are configured to allow a needle to extend through the first hole, second hole, and third hole when the first hole, second hole, and third hole are aligned along a longitudinal axis of the clip and wherein the first arm and the second arm are configured to move resiliently outward such that the first hole and the second hole move away from each other responsive to the needle being proximally withdrawn from the first hole and the second hole” and “separating the needle hub from the catheter adapter such that a distal end of the introducer needle is disposed within the metal wedge.”
Krause teaches a (Fig. 4B) a clip (132) disposed distal to an opening of the proximal end of the catheter adapter (122), the clip comprising a first arm (148A) comprising a first hole (156A) and a second arm (148B) comprising a second hole (156B) (See Fig. 10A, 10B), the first arm (148A) and a second arm (148B) joined at a bend comprising a third hole (aperture 150), wherein the first hole, the second hole, and the third hole are configured to allow a needle to extend through the first hole, second hole, and third hole when the first hole, second hole, and third hole are aligned along a longitudinal axis of the clip (See Fig. 9A), and wherein the first arm and the second arm are configured to move resiliently outward such that the first hole and the second hole move away from each other responsive to the needle being proximally withdrawn from the first hole and the second hole. (Paragraph [0062]).
As a result, it would have been obvious to one of ordinary skill in the art to modified Harding to provide “a clip disposed distal to an opening of the proximal end of the catheter adapter, the clip comprising a first arm comprising a first hole and a second arm comprising a second hole, the first arm and a second arm joined at a bend comprising a third hole, wherein the first hole, the second hole, and the third hole are configured to allow a needle to extend through the first hole, second hole, and third hole when the first hole, second hole, and third hole are aligned along a longitudinal axis of the clip and wherein the first arm and the second arm are configured to move resiliently outward such that the first hole and the second hole move away from each other responsive to the needle being proximally withdrawn from the first hole and the second hole” as taught by Krause. Doing so improves the safety of the device.
Isaacson, in a related field of endeavor, teaches a catheter system (Fig. 6) which illustrates separating the needle hub (150) from the catheter adapter (110) such that a distal end of the introducer needle (120) is disposed within the metal wedge (130).
As a result, it would have been obvious to one of ordinary skill in the art to modified Harding to provide the step of “separating the needle hub from the catheter adapter such that a distal end of the introducer needle is disposed within the metal wedge” as taught by Isaacson. Doing so enables a lumen of the intravenous catheter to be in fluid communication with a hollow interior of the catheter adapter such that blood may be withdrawn and collected, (Paragraph [0052]), when the distal end of the introducer needle disposed within the metal wedge.
Regarding claim 7, Harding teaches wherein collecting blood within the blood collection tube when the distal end of the introducer needle (16) disposed within the metal wedge (73) (See Figs. 5F, 5G), comprises pushing the blood collection tube distally against the elastomeric sheath (96) such that the cannula (94) pierces the elastomeric sheath and a fluid pathway is formed between the cannula and the blood collection tube. (Paragraph [0094]).
Regarding claim 8, Harding teaches removing the introducer needle from the catheter adapter (12), wherein in response to removing the introducer needle from the catheter adapter, the needle shield (19) covers the sharp distal tip. (Paragraph [0086]).
Regarding claim 9, Harding teaches wherein the catheter adapter (12) comprises a side port (68), wherein the catheter system further comprises another extension tube (70), wherein the other extension tube comprises a distal end and a proximal end, (See Fig. 5G), wherein the distal end of the other extension tube is integrated with the side port, wherein the proximal end of the other extension tube is integrated with an adapter. (See Fig. 5G).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Harding in view of Wang (WO 2020247384) (previously cited).
Regarding claim 10, Harding does not teach “flushing the catheter via the other extension tube after collecting blood within the blood collection tube.”
Wang, in a related field of endeavor, teaches (Figs. 1, 2A-2C) a catheter flushing device (22) comprising flushing the catheter (14) via the other extension tube (26) after collecting blood within the blood collection tube. (Paragraphs [0028]-[0029]).
As a result, it would have been obvious to one of ordinary skill in the art to modified Harding to provide “flushing the catheter via the other extension tube after collecting blood within the blood collection tube” as taught by Wang. Doing so may clean and remove residual blood from the catheter assembly. (Paragraph [0028]).
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 3/6/2026, with respect to the rejections of claims 1-14 and 16-20 have been fully considered. However, upon further consideration, a new ground of rejection is made under 103. In the new ground of rejection, Krause is relied upon for the amended feature.
Conclusion
THIS ACTION IS MADE FINAL. 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 Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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