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 .
Acknowledgment
Claim(s) 1, 17 are amended and filed on 12/4/20255.
Claims 2-3 are canceled and claim 21 is newly added.
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.
Claim(s) 1, 4-5, 11-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkholz et al. (US. 20190321599A1) (“Burkholz”).
Re claim 1, Burkholz discloses a vascular access system (Fig. 1a-2d, ¶0038) comprising: a catheter adapter (12, ¶0039) comprising a body (body of 12) and a catheter (20, ¶0039) configured to be inserted into a patient's vasculature (¶0046), the body having a distal end (close to 14) and a proximal end positioned opposite the distal end (close to 34); and a blood collection device in fluid communication with the catheter (collection that can be connected to 46, ¶0047), the blood collection device comprising a flow restriction device (clamp 39 and tube 44, ¶0045) configured to reduce a blood collection flow rate to be equal to or less than a blood supply flow rate of a patient's blood vessel (the clamp can block or reduce the flow), wherein the flow restriction device comprises a flexible extension set including tubing (44, ¶0046) and wherein an inner diameter and length of the tubing is configured to reduce the blood collection flow rate ( length of 44 and inner diameter with regards to clamp 39 is capable to reduce the blood collection flow rate, Fig. 1b).
Re claim 4, Burkholz discloses wherein the flow restriction device is configured to reduce a max shear stress compared to a max shear stress of the catheter (the length and inner diameter of 44 are capable to reduce the max shear stress as the diameter and length as the shear is related to the length and inner diameter and fluid viscosity).
Re claim 5, Burkholz discloses wherein the flow restriction device has a geometric factor, Gf, configured to deliver a predetermined blood collection flow rate reduction, wherein Gf=L/D4, wherein L is a length of a flow path of the flow restriction device, and wherein D is an inner diameter of the flow restriction device (length of 44 and diameter of 44 has geometric factor that is capable to deliver a predetermined blood collection flow reduction).
Re claim 11, Burkholz discloses wherein the blood collection device comprises a luer lock access device configured to receive an evacuated blood collection container (46, ¶0047).
Re claim 12, Burkholz discloses wherein the blood collection device comprises a luer connector configured to be connected to a syringe barrel (46, ¶0047, infusion means or collection device can be a syringe).
Re claim 13, Burkholz discloses further comprising an instrument advancement device (48, 24, 50, ¶0050)coupled to the catheter adapter, wherein the instrument advancement device comprises an instrument (24, 50, and wherein the instrument advancement device is configured to advance the instrument from a retracted position to an advanced position beyond a distal end of the catheter (¶0050).
Re claim 14, Burkholz discloses further comprising an advancement member (30) configured to be grasped by a healthcare technician, wherein movement of the advancement member moves the instrument between the retracted position and the advanced position (¶0050).
Re claim 15, Burkholz discloses a vascular access system (Fig. 1a-2d, ¶0038) comprising: a catheter adapter (12) comprising a body ( body of 12) and a catheter (20) configured to be inserted into a patient's vasculature (20, ¶0039), the body having a distal end (14, Fig. 2c) and a proximal end( close to 34) positioned opposite the distal end (Fig. 2c); a first blood collection device configured to be in fluid communication with the catheter (device connected to 44, ¶0047) the first blood collection device comprising a first flow restriction device configured to reduce a blood collection flow rate to a first predetermined blood collection flow rate (Fig. 2d, 44 and clamp 39 are capable to reduce the flow rate to a predetermined rate, ¶0047); and a second blood collection device (device connected to 50, ¶0050) configured to be in fluid communication with the catheter (¶0050), the second blood collection device comprising a second flow restriction device (50 and clamp) configured to reduce a blood collection flow rate to a second predetermined blood collection flow rate (50 and are capable to reduce the flow rate to a predetermined rate, ¶0050), wherein the first predetermined blood collection flow rate is larger than the second predetermined blood collection flow rate (first rate capable to be more than zero and second flow fluid rate capable to be zero as 50 is clamped).
Re claim 16, Burkholz discloses wherein the first flow restriction device comprises a flexible extension set including tubing (44), and wherein the second flow restriction device comprises a flexible extension set including tubing (50).
Re claim 17, Burkholz discloses a blood collection device (¶0047, that connected to 44) comprising the flow restriction device (39 and 44) configured to reduce a blood collection flow rate to be equal to or less than a blood supply flow rate of a patient's blood vessel( clamp 39 and tube 44, ¶0045, are capable to reduce a blood collection flow rate to be equal to or less than a blood supply flow rate of a patient's blood vessel such as to block or reduce the flow).
Re claim 18, Burkholz discloses wherein the flow restriction device comprises a flexible extension set including tubing (44, ¶0046).
Re claim 19, Burkholz discloses wherein an inner diameter and length of the tubing is configured to reduce the blood collection flow rate (inner dimeter and length of 44 are capable to reduce the flow rate, Fig.1b).
Re claim 20, Burkholz discloses wherein the flow restriction device is configured to reduce a max shear stress compared to a max shear stress of the catheter (the length and inner diameter of 44 are capable to reduce the max shear stress as the diameter and length as the shear is related to the length and inner diameter and fluid viscosity).
Re claim 21, Burkholz discloses wherein the blood collection device includes a male connector at a first end of the tubing (30, ¶0040) and a female connector at a second end of the tubing (46, ¶0047).
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) 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (US. 20190321599A1) (“Burkholz”) in view of Burkholz et al. (US. 20210213245A1) (“Burkholz (II)”).
Re claim 6, Burkholz fails to disclose wherein the geometric factor, Gf, is at least 3.87E6 to 8.38E6.
However, Burkholz (II) discloses a blood extension system (Fig. 18) and a flow restriction device (105, 185) and wherein the geometric factor, Gf, is at least 3.87E6 to 8.38E6 (more than 7.34E+6 (¶0058).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the Geometry Factor of Burkholz so that the geometric factor, Gf, is at least 3.87E6 to 8.38E6 as taught by Burkholz (II) for the purpose of optimizing the hemolysis during collection (Burkholz (II), ¶0054).
Re claim 7, Burkholz fails to disclose wherein the geometric factor, Gf, is at least 3.87E6.
However, Burkholz (II) discloses a blood extension system (Fig. 18) and a flow restriction device (105, 185) and wherein the geometric factor, Gf, is at least 3.87E6 (more than 7.34E+6 (¶0058).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the Geometry Factor of Burkholz so that the geometric factor, Gf, is at least 3.87E6 as taught by Burkholz (II) for the purpose of optimizing the hemolysis during collection (Burkholz (II), ¶0054).
Re claim 8, Burkholz fails to disclose wherein the geometric factor, Gf, is at least 4.35E6.
However, Burkholz (II) discloses a blood extension system (Fig. 18) and a flow restriction device (105, 185) and wherein the geometric factor, Gf, is at least 4.35E6 (more than 7.34E+6 (¶0058).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the Geometry Factor of Burkholz so that the geometric factor, Gf, is at least 4.35E6as taught by Burkholz (II) for the purpose of optimizing the hemolysis during collection (Burkholz (II), ¶0054).
Re claim 9, Burkholz fails to disclose wherein the geometric factor, Gf, is at least 5.80E6.
However, Burkholz (II) discloses a blood extension system (Fig. 18) and a flow restriction device (105, 185) and wherein the geometric factor, Gf, is at least 5.80E6 (more than 7.34E+6 (¶0058).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the Geometry Factor of Burkholz so that the geometric factor, Gf, is at least 5.80E6as taught by Burkholz (II) for the purpose of optimizing the hemolysis during collection (Burkholz (II), ¶0054).
Re claim 10, Burkholz fails to disclose wherein the geometric factor, Gf, is at least 8.38E6.
However, Burkholz (II) discloses a blood extension system (Fig. 18) and a flow restriction device (105, 185) and wherein the geometric factor, Gf, is at least 8.38E6 (more than 7.34E+6 (¶0058).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the Geometry Factor of Burkholz so that the geometric factor, Gf, is at least 8.38E6 as taught by Burkholz (II) for the purpose of optimizing the hemolysis during collection (Burkholz (II), ¶0054).
Response to Arguments
Applicant's arguments filed 12/4/2025 have been fully considered but they are not persuasive.
The applicant argues with regards to claim 1 that Burkholz fails to disclose that the tube 44 with inner diameter and a length are capable to reduce the blood collection flow rate. This is found not persuasive as the inner diameter of tube 44 is capable to be squeeze by the clamp 39, which reduce the flow rate.
The applicant argues with regards to claim 15 that Burkholz fails to disclose that the tube 44 is not capable to reduce the blood collection flow rate from the first predetermined rate to a second predetermined rate . This is found not persuasive as fully opening the inner diameter of tube 44 due to the unclamping clamp 39 to the tube to zero rate as the clamp 39 is squeezed to prevent the flow.
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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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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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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783