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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/8/2026 has been entered.
Acknowledgment
Claims 1, 5-10, 15, 16, 20 are amended and filed on 7/8/2026.
Claims 5, 17-19 are canceled and claims 22-23 are newly added.
Election/Restrictions
Newly submitted claim 22-23 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
-the claims to the different invention recite the mutually exclusive characteristics of such invention schuh as claim 22 require having two blood collection devices and two flow restriction devices and step of selecting the collection devices to select the first and second predetermined flow rates which can be use a by-branched catheter with a control valve on each branch . Accordingly, claims 22-23 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 1, 4, 6-14, 21 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.
Claim 1 recites the limitation “an inner diameter of the tubing” in last line. It is unclear if it refers to the limitation in line 8 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation on line 8 of claim 1.
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, 11-14, 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 (tube 44, ¶0045) with the flow restriction device consisting of tubing (44), the tubing included in a flexible extension set (¶0046) attached to the catheter adapter (12, Fig. 1c), wherein the tubing has an inner diameter and a length that provides the tubing with a geometric factor, Gf, (inner diameter of 44, ¶0010, ¶0047) capable to deliver a predetermined blood collection flow rate through the tubing that is equal to or less than a blood supply flow rate of a patient's blood vessel, wherein Gt=L/D⁴, where L is the length of tubing and D is an inner diameter of the tubing ( length of 44 and inner diameter is capable to reduce the blood collection flow rate base on the above equation, 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 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 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) 15, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (US. 20190321599A1) (“Burkholz”).
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 capable to reduce a blood collection flow rate to a first predetermined blood collection flow rate (Fig. 2d, 44 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) configured to reduce a blood collection flow rate to a second predetermined blood collection flow rate (50 is capable to reduce the flow rate to a predetermined rate, ¶0050), wherein the first flow restriction device consist of a flexible extension set including tubing (44), included in a first flexible extension set (set of 44, ¶0046) and wherein the second flow restriction device consist of a second flexible extension set including tubing (50) included in a second flexible extension set (set of 50, ¶0046) with each of the first tubing and the second tubing having an inner diameter and a length that provides the tubing with a geometric factor, Gf, configured to deliver a predetermined blood collection flow rate through the tubing that is equal to or less than a blood supply flow rate of a patient's blood vessel (both inner diameter of 44 and 50 are capable to provide a geometric factor and deliver flow rate of blood flow rate or less), wherein Gf=L/D⁴, where L is the length of the tubing and D is an inner diameter of the tubing; and wherein the first tubing has a first geometric factor that provides the first predetermined blood collection flow rate (geometric factor relate to 44) and the second tubing has a second geometric factor that provides the second predetermined blood collection flow rate (geometric factor relate to 50), but it is silent as to the specifics of the first predetermined blood collection flow rate is larger than the second predetermined blood collection flow rate. The instant disclosure describes the parameter of the rate which depends on the inner diameter see ¶0015 of the current case as being merely preferable, and does not describe the rate/ diameter as contributing any unexpected results to the system. As such, parameters such as rate and inner diameter are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the first predetermined blood collection flow rate is larger than the second predetermined blood collection flow rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Re claim 20, Burkholz discloses wherein each of the first flow restriction device and the second 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 and inner diameter and length of 50 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).
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 7/8/2026 have been fully considered but they are not persuasive.
The applicant argues with regards to claim 1 that Burkholz fails to disclose that “the first restriction device consisting of tubing … inner diameter and a length ... the geomatic factor configured to deliver flow rate equal or less than a blood supply flow rate of… blood vessel” this is found not persuasive as Burkholz has the tube 44 that is capable to make the rate equal or less than the blood vessel.
The applicant argues with regards to claim 15 that Burkholz fails to disclose that the first and second flow restriction consists of a first and a second tubes ... flow rate from the first predetermined rate to a second predetermined rate . This is found not persuasive tubes 44, 50 are capable to have such flow rates. Note if the applicant has specific geometrical factors as in claim 6-10, then Burkholz II discloses these values. The applicant is advised to further define the device structurally.
Conclusion
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
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