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 .
Claim Objections
Claims 12 and 15 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 and 11-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harding (US 20200129738).
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; 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, 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).
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).
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 15, Harding teaches wherein the catheter comprises a flashback notch (28). (Paragraph [0058]).
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]).
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 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Harding in view of Isaacson (US 20190374748).
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 “separating the needle hub from the catheter adapter such that a distal end of the introducer needle is disposed within the metal wedge.”
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).
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]).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Harding in view of Krause (US 20190314614).
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]).
Conclusion
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