DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: reference numbers 21 (introducer needle) and 23 (needle hub) are not found in the figures in ¶0045. 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference character 61 in figure 6a is not mentioned in the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 Objections
Claim 12 is objected to because of the following informalities: line 5 should be amended to - the blood pulled into the temporary discard sample syringe into a patient-. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: line 5 should be amended to - the blood pulled into the temporary discard sample syringe into the patient-. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-7 and 9-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 5:
The claim recites the limitation "the first extension tube" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 6-7 are rejected due to their dependence on claim 5.
Regarding claim 9:
The claim recites the limitation "the first extension tube" in line 20. There is insufficient antecedent basis for this limitation in the claim.
Claims 10-14 are rejected due to their dependence on claim 9.
Regarding claim 15:
The claim recites the limitation "the first extension tube" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claims 16-20 are rejected due to their dependence on claim 15.
Regarding claim 17:
The claim recites the limitation "the second port" in line 2 There is insufficient antecedent basis for this limitation in the claim.
Claim 18 is rejected due to its dependence on claim 17.
Regarding claim 19:
The claim recites the limitation "the pressure transducer" in line 5 There is insufficient antecedent basis for this limitation in the claim.
Claim 20 is rejected due to its dependence on claim 19.
Claim Rejections - 35 USC § 102
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 1-2, 4 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5002528 A to Palestrant.
Palestrant discloses:
Regarding claim 1:
A catheter system (figure 2), comprising:
a catheter adapter (35), comprising a distal end (see end A in figure 1 below), a proximal end (see end B in figure 1 below), a lumen (see the fluid line C in figure 1 below) extending through the distal end (A in figure 1 below) of the catheter adapter (35) and the proximal end (B in figure 1 below) of the catheter adapter (35);
a catheter (36) extending from the distal end (A in figure 1 below) of the catheter adapter (35);
a three-port connector (32), comprising a distal port (34), a proximal port (38), and a side port (30) between the distal port (34) and the proximal port (38), wherein the distal port (34) and the proximal port (38) are aligned with a longitudinal axis (as shown in figure 2) of the three-port connector (32), with respect to the longitudinal axis of the three-port connector (32), wherein the proximal end (B in figure 1 below) of the catheter adapter (35) is coupled to the distal port (34) of the three-port connector (32) (as shown in figure 1 below); and
an extension tube (26) comprising a distal end (D in figure 1 below) and a proximal end (E in figure 1 below), wherein the distal end (D in figure 1 below) of the extension tube (26) is integrated with the side port (30) of the three-port connector (32) (as shown in figure 2 below); and
a three-way stopcock valve (20; column 3, lines 50-57), wherein the three-way stopcock valve (20) comprises a first port (28), a second port (24) opposite the first port (28), and a third port (18), wherein the proximal end (E in figure 1 below) of the extension tube (26) is coupled to the first port (28) of the three-way stopcock valve (20).
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Figure 1 – figure 2 of Palestrant, annotated by the examiner
Regarding claim 2:
The catheter system of claim 1, wherein the proximal port (38) comprises an integrated connector (as shown in figure 2).
Regarding claim 4:
The catheter system of claim 1, wherein the proximal end (E in figure 1 above) of the extension tube (26) is integrated (see the extension tube 26 is connected to the first port 28) with the first port (28).
Regarding claim 5:
The catheter system of claim 1, wherein the catheter system comprises a fluid pathway (column 3, lines 58-68) within the catheter (36), the catheter adapter (35), the first extension tube (26), the three-port connector (20), and the extension tube (26), wherein the second port (24), the third port (18), and the proximal port (38) of the three-port connector (32) are configured to provide access to the fluid pathway of the catheter system (fluid communication between 36, 35, 26, 20, 26, 24, 18 and 38 as shown in figures 2).
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5002528 A to Palestrant as applied to claim 1 above, and further in view of US 20200078564 A1 to Blanchard et al. (Blanchard).
Regarding claim 8:
Palestrant fails to disclose:
The catheter system of claim 1, wherein the proximal end of the extension tube is integrated with an adapter, wherein the adapter is coupled to a needleless connector, wherein a proximal end of the adapter comprises a single port or a dual port.
Blanchard teaches:
A catheter system (figure 5) that includes needles/catheters (40) and extension tubes (94a or 94b). Further, the extensions tubes are connected to adapters coupled to needleless connectors (92; ¶0049) that has a single port.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Palestrant to further include replacing the connector for the extension tube in Palestrant with an adapter coupled to a needleless connector as taught by Blanchard. This is a simple substitution of one known element (connector for the extension tube in Palestrant) for another (adapter and needless connector as taught by Blanchard) to obtain predictable results (to connect the extension tube to the three-way stopcock valve).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200230315 A1 to Ma et al. (Ma) in view of US 4819653 A to Marks.
Regarding claim 9:
Ma discloses:
A method of blood collection (¶0002; figure 3c), comprising:
coupling a pre-filled flush device (270) and a temporary discard sample syringe (200) to a catheter system (250/260/280), wherein the catheter system (250/260/280) comprises:
a catheter adapter (280), comprising a distal end (see the distal end G in figure 2 below), a proximal end (see the proximal end H in figure 2 below), a lumen (see fluid line I in figure 2 below) extending through the distal end (G in figure 2 below) of the catheter adapter (280) and the proximal end (H in figure 2 below) of the catheter adapter (280);
a catheter (see F in figure 1 below; ¶0049) extending from the distal end (G in figure 2 below) of the catheter adapter (280);
an extension tube (250) comprising a distal end (see the distal end J in figure 2 below) and a proximal end (see the proximal end K in figure 2 below), wherein the distal end (J in figure 2 below) of the extension tube (250) is integrated with the proximal end (H in figure 2 below) of the catheter adapter (280); and
a three-way stopcock valve (245), wherein the three-way stopcock valve (245) comprises a first port (225), a second port (210) opposite the first port (225), and a third port (see port L in figure 2 below), wherein the proximal end (K in figure 2 below) of the extension tube (250) is coupled to the first port (225) of the three-way stopcock valve (245; as shown in figure 2 below), wherein the catheter system (250/260/280) comprises a fluid pathway (see the fluid communication as shown in figure 3c between 270, 200 and 280) within the catheter (see F in figure 1 below; ¶0049), the catheter adapter (280), the first extension tube (250), and the extension tube (250), wherein the second port (210) and the third port (see port L in figure 2 below) are configured to provide access to the fluid pathway (these ports provide a communications between 200, 270 and 280) of the catheter system (250/260/280), wherein coupling the pre-filled flush device (270) and the temporary discard sample syringe (200) to the catheter system (250/260/280) comprises coupling the pre-filled flush device (270) to the second port (210) such that closing the second port (210) prevents fluid communication between the pre-filled flush device (270) and the fluid pathway (valve 245 allows fluid communication between 270 and 200/215 and block fluid communication between 270 and 250; ¶0040) and coupling the temporary discard sample syringe (200) to the third port (see port L in figure 2 below) such that closing of the third port (see port L in figure 2 below) prevents fluid communication between the syringe (200) and the fluid pathway (valve 245 allows fluid communication between 270 and 200/215 and block fluid communication between 205 and 250; ¶0040);
closing the second port (210; valve 245 is actuated to block the second port 210 and allow fluid communications between 215 and 225; ¶0039); and
after closing the second port (210), pulling blood (¶0039 indicated blood is drawn into 200/215) into the temporary discard sample syringe (200).
Ma fails to disclose:
A three-port connector, comprising a distal port, a proximal port, and a side port between the distal port and the proximal port, wherein the distal port and the proximal port are aligned with a longitudinal axis of the three-port connector, wherein the proximal end (H in figure 2 below) of the catheter adapter (280) is coupled to the distal port of the three-port connector;
wherein the distal end (J in figure 2 below) of the extension tube is integrated with the side port of the three-port connector
the proximal port of the three-port connector is configured to provide access to the fluid pathway of the catheter system;
Marks teaches:
A catheter system (figure 1) that includes a catheter adapter (20) with a catheter, a three-port connector (12), a three-way stopcock valve (14) and a pressure transducer (21). The three-port connector (12) allows for fluid communications (as shown in figure 2) between the catheter (20) and the pressure transducer (21), allows for flushing of the catheter (as shown in figure 3), allows for an establishing of a zero baseline for the pressure transducer (figure 4) and for forcing out bubbles from the pressure transducer (fig. 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma to include a three-port connector between the catheter adapter and the three-way stopcock valve and fluidly connected a pressure transducer with the system as taught by Marks to allow for a measuring of the blood pressure of the patient and allow for flushing the catheter fluid line in the assembly (Marks, column 1, lines 10-25; column 2, lines 60-68). This would include connecting the proximal end (H in figure 2 below) of the catheter adapter (280) is coupled to the distal port of the three-port connector, the distal end (J in figure 2 below) of the extension tube is integrated with the side port of the three-port connector, and the proximal port of the three-port connector is configured to provide access to the fluid pathway of the catheter system.
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Figure 2 – figure 3c of Ma, annotated by the examiner
Allowable Subject Matter
Claims 15-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Furthermore, the prior art of record does not teach “advancing a secondary catheter of a catheter advancement device through the catheter, wherein the catheter advancement device is coupled to the proximal port of the three-port connector” as within the context of the claimed invention as disclosed and within the context of the other limitations present in claim 15.
Therefore, the prior art of record cannot anticipate Applicant' s claimed invention by a single reference nor render Applicant' s claimed invention obvious by the combination of more than one reference.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 6, 7 and 10-14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20120065502-A1
Levy
See the 4 port connector 16
US-5807312-A
Dzwonkiewicz
See the three port connector 26
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783