Office Action 1: Non-Final Rejection (2024-11-19)
Rejection types: 103 - Obviousness, 112 - Written Description/Enablement

CLAIMS:
CLAIMS:

1\. A microvolume 3-way stopcock for use in a blood sampling system comprising: SVG {EMBED HERE} 0.16 1.9
a cylindrical-shaped central chamber;
an inlet fluid passage extending from the central chamber to a male luer connector;
a blood sample fluid passage extending from the central chamber to a female luer connector; and
a waste fluid passage extending from the central chamber to a female luer connector;
a rotatable flow control member disposed within the central chamber and comprising a T- shaped fluid passage, wherein the rotatable flow control member provides adjustable fluid communication between the inlet fluid passage, the blood sample fluid passage, and/or the waste fluid passage; and
a lever connected to the rotatable flow control member to permit selective rotation of the rotatable flow control member and control fluid flow between the fluid passages, wherein the inlet, blood sample, waste, and T-shaped fluid passages have an inner cross-sectional area in the range from 0.3 to 2.0 square millimeters.

2\. The microvolume 3-way stopcock for use in a blood sampling system according to claim 1, wherein the microvolume 3-way stopcock has a fluid volume dead space in the range of 0.02 to 0.20 mL.

3\. The microvolume 3-way stopcock for use in a blood sampling system according to claim 1, wherein the microvolume 3-way stopcock has a fluid volume dead space in the range of 0.02 to 0.15 mL.

4\. The microvolume 3-way stopcock for use in a blood sampling system according to claim 1, wherein the microvolume 3-way stopcock has a fluid volume dead space in the range of 0.02 to 0.10 mL.
5\. The microvolume 3-way stopcock for use in a blood sampling system according to claim 1, wherein the inlet fluid passage comprises a cannula insert inserted into the male luer, the blood sample fluid passage comprises a blood sample cone inserted into the female luer of the blood sample fluid passage, and the waste fluid passage comprises a waste cone inserted into the female luer of the waste fluid passage, wherein the cannula insert, the blood sample cone, and
the waste cone comprise lengthwise fluid pathways having an inner cross-sectional area in the range from 0.3 to 2.0 square millimeters.

6\. The microvolume 3-way stopcock for use in a blood sampling system according to claim 5, wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.24 mL.

7\. The microvolume 3-way stopcock for use in a blood sampling system according to claim 5, wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.19 mL.

8\. The microvolume 3-way stopcock for use in a blood sampling system according to claim 5, wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.14 mL.

9\. A blood sampling system comprising:
a microvolume 3-way stopcock according to claim
1;
a cannula connected to the male luer;
a self-venting blood sample syringe connected to the female luer of the blood sample fluid passage; and
a self-venting waste syringe connected to the female luer of the waste fluid passage.
10\. A method for obtaining a clean blood specimen comprising:
assuring a sterile septum connector is connected to an arterial line;
obtaining a microvolume 3-way stopcock comprising:
an inlet fluid passage having a male luer connector and a cannula attached to the male luer connector;
a blood sample fluid passage having a female luer connector;
a waste fluid passage having a female luer connector; and
a rotatable flow control member configured to provide adjustable fluid communication between the inlet fluid passage, the blood sample fluid passage, SVG {EMBED HERE} 0.16 5.17 cannula have a dead space volume in the range from 0.03 to 0.24 mL. connecting a self-venting first blood sample syringe to the female luer connector of the blood sample fluid passage and connecting a self-venting waste syringe to the female luer connector of the waste fluid passage;
inserting the cannula into the septum connector;
rotating the flow control member to permit fluid flow between the inlet fluid passage and the waste fluid passage and to allow waste blood into the waste syringe;
rotating the flow control member to permit fluid flow between the inlet fluid passage and the blood sample fluid passage and to allow a desired first blood sample into the first blood sample syringe;
rotating the flow control member to permit fluid flow between the inlet fluid passage and the waste fluid passage; and
returning the waste blood from the waste syringe to the patient.

11\. The method for obtaining a clean blood specimen according to claim 10, further comprising:
rotating the flow control member to close fluid flow from the arterial line;
removing the cannula from the septum connector; and
removing the first blood sample syringe from the female luer connector of the blood sample fluid passage.
12\. The method for obtaining a clean blood specimen according to claim 10, wherein the arterial line comprises an indwelling umbilical catheter.

13\. The method for obtaining a clean blood specimen according to claim 10, wherein the arterial line comprises a peripheral arterial line.

14\. The method for obtaining a clean blood specimen according to claim 10, wherein after connecting the self-venting first blood sample syringe to the female luer connector of the blood sample fluid passage, setting the self-venting first blood sample syringe to a desired blood sample volume.

15\. The method for obtaining a clean blood specimen according to claim 10, wherein after connecting the self-venting waste syringe to the female luer connector of the waste fluid passage, setting the self-venting waste syringe to a desired waste blood volume.

16\. The method for obtaining a clean blood specimen according to claim 10, wherein following the step of rotating the flow control member to permit fluid flow between the inlet fluid passage and the blood sample fluid passage and to allow a desired first blood sample into the first blood sample syringe:
rotating the flow control member to close fluid flow from the arterial line;
removing the first blood sample syringe from the female luer connector of the blood sample fluid passage;
connecting a self-venting second blood sample syringe to the female luer connector of the blood sample fluid passage; and
rotating the flow control member to permit fluid flow between the inlet fluid passage and the blood sample fluid passage and to allow a desired second blood sample into the second blood sample syringe.

17\. The method for obtaining a clean blood specimen according to claim 16, wherein the steps of claim 16 are repeated to obtain a desired number of blood samples in additional blood sample syringes.
18\. The method for obtaining a clean blood specimen according to claim 10, wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.19 mL.

19\. The method for obtaining a clean blood specimen according to claim 10, wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.14 mL. 13 14 15 16 17

OFFICE ACTION:
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
Claim(s) 1 and 10 is/are objected to because of the following informalities:
Claim 1 should read “an inlet fluid passage configured to extend[[ing]]” [line 4].
Claim 1 should read “a blood sample fluid passage configured to extend[[ing]]” [line 6].
Claim 1 should read “a waste fluid passage configured to extend[[ing]]” [line 8].
Claim 1 should read “wherein the rotatable flow control member is configured to provide[[s]]” [line 11].
Claim 1 should read “a lever connected to the rotatable flow control member configured to permit” [line 14].
Claim 6 should read “wherein the 3-way microvolume stopcock and the cannula” [line 2].
Claim 7 should read “wherein the 3-way microvolume stopcock and the cannula” [line 2].
Claim 8 should read “wherein the 3-way microvolume stopcock and the cannula” [line 2].
Claim 10 should read “from 0.03 to 0.24 mL[[.]];” [line 11].
Claim 18 should read “wherein the 3-way microvolume stopcock and the cannula” [lines 1-2].
Claim 19 should read “wherein the 3-way microvolume stopcock and the cannula” [lines 1-2].
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA  35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.  The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph:
(A)	the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B)	the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C)	the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.  Such claim limitation(s) is/are: “rotatable flow control member” in claim(s) 1, 10, and those dependent therefrom.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The Examiner’s interpretation(s) of the claim limitation(s) that invoke interpretation under § 112(f) are as follows:
Claim(s) 1, 10, and those dependent therefrom recite(s) the limitation “rotatable flow control member”, which recites a generic placeholder [“member”], modified by functional language [claimed functions of the rotatable flow control member], wherein in claim 1 and those dependent therefrom, the identified generic placeholder is further modified by sufficient structure, material, or acts for performing the claimed function, such that “rotatable flow control member” in claims 1 and those dependent therefrom does not invoke interpretation under § 112(f). However, in claim 10 and those dependent therefrom, the identified generic placeholder is NOT further modified by sufficient structure, material, or acts for performing the claimed function. As such, the Examiner has interpreted the claimed “rotatable flow control member” of claim 10 and those dependent therefrom as comprising an internal T- shaped fluid passage [Applicant’s Specification ¶0007], or an equivalent therefrom.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, applicant may:  (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1-4, 6-8, and 17-19 is/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 “a female luer connector” [lines 8-9], which is considered indefinite, as claim 1 already previously defines “a female luer connector” [lines 6-7], such that it is not clear whether the indefinite female luer connector is meant to define a new female luer connector or refer to the previously defined female luer connector. For examination purposes, the Examiner has interpreted the female luer connector of lines 8-9 to define a new female luer connector. Claim 10 is considered to recite similar indefinite subject matter [line 7] that is rejected and interpreted mutatis mutandis to the rejection of claim 1 above.
Claims 2-4 each recite the limitation “wherein the micro-volume 3-way stopcock has a fluid volume dead space” [line 2 in each of claims 2-4], which is considered indefinite, as the microvolume 3-way stopcock is considered to comprise several elements, such that it is not clear whether the dead space is meant to be defined by the entirety of each fluid passage of the claimed microvolume 3-way stopcock or may be defined by any of the claimed fluid passages. As such, the Examiner has interpreted the indefinite limitation to refer to either interpretation in light of any prior art applied under § 102 or § 103.
Claims 6-8 each recite the limitation “cannula” [line 2 in each of claims 6-8], which is considered to lack antecedent basis, as there is no previously defined “cannula” in any of claims 1 or 5-8, respectively. The limitation of “cannula” is further considered to be indefinite, as it is not clear whether “cannula” is meant to define a cannula or refer to the previously defined “cannula insert” of claim 5 [line 2]. For examination purposes, the Examiner has interpreted the recited “cannula” of each of claims 6-8 to refer to the previously recited “cannula insert” of claim 5.
Claims 6-8 and 18-19 each recite the limitation “wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume” [lines 2-3 in each of claims 6-8; lines 1-2 in each of claims 18-19], which is considered indefinite, as the microvolume 3-way stopcock is considered to comprise several elements, such that it is not clear whether the dead space is meant to be defined by the entirety of each fluid passage of the claimed microvolume 3-way stopcock and the cannula or may be defined by any of the claimed fluid passages with the cannula. As such, the Examiner has interpreted the indefinite limitation to refer to either interpretation in light of any prior art applied under § 102 or § 103.
Claim 17 recites the limitation “wherein the steps of claim 16 are repeated to obtain a desired number of blood samples in additional blood sample syringes” [lines 1-3], which is considered indefinite, as claim 16 recites “removing the first blood sample syringe from the female luer connector of the blood sample fluid passage” [lines 6-7] and “connecting a self-venting second blood sample syringe to the female luer connector of the blood sample fluid passage” [lines 8-9], as well as additional steps with respect to the second blood sample syringe, such that claim 16 is written in such a way to define steps for only the first blood sample syringe and the second blood sample syringe. As such, it is not clear whether “repeating” the steps of claim 16 is meant to refer to repetitively performing steps using the same first blood sample syringe and the second blood sample syringe or if “repeating” the steps of claim 16 is meant to refer to “removing a current blood sample syringe from the female luer connector of the blood sample fluid passage; connecting a new self-venting blood sample syringe to the female luer connector of the blood sample fluid passage; and rotating the flow control member to permit fluid flow between the inlet fluid passage and the blood sample fluid passage and to allow a desired new blood sample into the new blood sample syringe”. For examination purposes, the Examiner has interpreted “repeating” the steps of claim 16 to refer to the latter interpretation regarding a current blood sample syringe and a new blood sample syringe.
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) 1, 5, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clarke (US-4447235-A) in view of Ellingson (US- 6217556-A) and Langevin (US-6156019-A).
Regarding claim 1, Clarke teaches
A microvolume 3-way stopcock for use in a blood sampling system comprising:
a stopcock body comprising:
a cylindrical-shaped central chamber [hollow, intermediate barrel 36 (Clarke Figures 1, 7-8)];
an inlet fluid passage [hollow arm 33 (Clarke Figures 1, 7-8)] extending from the central chamber to a connector [The valve bore 57 is also in communication with a hollow side arm 59 which extends laterally of and is between aligned arms 33, 35 (Clarke Col 2, line 68-Col 3, line 1)];
a blood sample fluid passage [hollow arm 35 (Clarke Figure 1)] extending from the central chamber to a connector [Clarke Col 2, line 68-Col 3, line 1]; and
a waste fluid passage [hollow side arm 59 (Clarke Figures 1, 7-8)] extending from the central chamber to a connector [The valve bore 57 is also in communication with a hollow side arm 59 which extends laterally of and is between aligned arms 33, 35 (Clarke Col 4, lines 7-9)];
a rotatable flow control member disposed within the central chamber and comprising a T- shaped fluid passage [stopcock 61 is provided with a central bore 64 and with three radial ports 65, 67, 69, ports 65 and 69 being aligned and disposed 90.degree. to either side of port 67 (Clarke Col 4, lines 15-17, Figures 7-8)], wherein the rotatable flow control member provides adjustable fluid communication between the inlet fluid passage, the blood sample fluid passage, and/or the waste fluid passage [In a first position of the stopcock 61, shown in FIG. 8, arm 33 and side arm 59 are communicated by ports 67, 69 and bore 64 while communication to the arm 35 is blocked. In a second position, shown in FIG. 7, ports 69 and 65 which are aligned with each other are also aligned and communicated with arms 33, 35, respectively. In this position, arms 33, 35 are in communication with one another through ports 65, 69 and bore 64 while communication to the side arm 59 is blocked. The external end of stopcock 61 may be provided with indicia, here, arrows 71, 73, 75 which are aligned with ports 65, 67, 69 respectively, to indicate the position of these ports (Clarke Col 4, lines 17-30, Figures 7-8)]; and
a lever [external lever 63 (Clarke Figure 1)] connected to the rotatable flow control member to permit selective rotation of the rotatable flow control member and control fluid flow between the fluid passages [Clark Col 4, lines 15-30; see also Claim 7 of Clarke].
However, Clarke fails to disclose wherein the inlet fluid passage connector is a male luer connector, wherein the blood sample fluid passage connector is a female luer connector, and wherein the waste fluid passage connector is a female luer connector.
Ellingson discloses a microvolume 3-way stopcock for use in a blood sampling system [entire disclosure – see at least abstract], wherein Ellingson discloses the use of male and female luer connectors for connecting a stopcock body to a catheter needle [At the end of the catheter 16 opposite the catheter needle tip 14, a Luer connector 18 is provided. The Luer connector 18 includes housing 20 which defines a female Luer cavity. The outer surface of the female Luer housing defines a threaded bolt portion for threaded engagement with a male Luer connector (Ellingson, Col 2, lines 30-35)], as well as for connecting the stopcock body to a syringe [A male Luer connector 59 is provided in a syringe 61 which can be removably secured to the needle hub 53 by mating the female Luer cavity with the male Luer member 59 and threadingly engaging the Luer lock connector 55 (Ellingson, Col 2, lines 60-64)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microvolume 3-way stopcock of Clarke so as to incorporate wherein the inlet fluid passage connector is a male luer connector, wherein the blood sample fluid passage connector is a female luer connector, and wherein the waste fluid passage connector is a female luer connector, as Ellingson discloses male and female luer connectors as known types of connectors for connecting a stopcock to other devices [Ellingson, Col 2, lines 30-35, 60-64], such that this modification would amount to mere simple substitution of one known element [inlet fluid passage connector, blood sample fluid passage connector, waste fluid passage connector of Clarke] for another [male luer connector, female luer connector, and female luer connector, respectively] to obtain predictable results [allow for connection of the stopcock to other devices] [MPEP § 2143(I)(B)].
However, Clarke fails to explicitly disclose wherein the inlet, blood sample, waste, and T-shaped fluid passages have an inner cross-sectional area in the range from 0.3 to 2.0 square millimeters.
Langevin discloses devices and methods for blood sampling [entire disclosure – see at least abstract], wherein Langevin discloses fluid passages having an inner cross-sectional area in the range from 0.3 to 2.0 square millimeters [For example, an inner diameter of approximately 1.0 millimeter can provide approximately 1 milliliter per hour of fluid through the blood collection means (Langevin Col 5, lines 58-63), wherein it is understood that a diameter of 1 mm is considered to mathematically define a circular cross-sectional area of ~0.78 mm2], and wherein Langevin further defines the diameter/cross-sectional area of a fluid passage as being a result effective variable to affect flow rate through the passage [The flow rate of the fluid being administered can be controlled by providing a particular inner diameter of the second channel or other suitable resistor. For example, an inner diameter of approximately 1.0 millimeter can provide approximately 1 milliliter per hour of fluid through the blood collection means. This flow rate can be adjusted by increasing or decreasing as desired the inner diameter of the second channel or alternate resistor. It has been found that a flow rate of approximately 1 milliliter per hour can maintain patency of the blood collection system (Langevin Col 5, lines 58-67)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microvolume 3-way stopcock of Clarke so as to incorporate wherein the inlet, blood sample, waste, and T-shaped fluid passages have an inner cross-sectional area in the range from 0.3 to 2.0 square millimeters, as a matter of routine optimization [see Langevin Col 5, lines 58-67] since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), as well as to maintain patency of the fluid passages [Langevin Col 5, lines 58-67].
Regarding claim 5, Clarke in view of Ellingson and Langevin teaches
The microvolume 3-way stopcock for use in a blood sampling system according to claim 1, wherein the inlet fluid passage comprises a cannula insert inserted into the male luer [An adaptor 29 is fixed to the proximate end 27 of the catheter 23 and fits snugly on the arm 33 (Clarke Col 3, lines 2-3), wherein under the current modification by Ellingson, the cannula insert would be inserted into the modified male luer], the blood sample fluid passage comprises a blood sample cone inserted into the female luer of the blood sample fluid passage [the connector 48 joins the proximate end 46 of the needle 45 to a hollow projection 50 on the end of a tube 47 forming part of a syringe 49 (Clarke Col 3, lines 42-44), wherein under the current modification by Ellingson, the blood sample cone would be inserted into the modified female luer], and the waste fluid passage comprises a waste cone inserted into the female luer of the waste fluid passage [A tube 82 is connected at one end to the side arm 59 by an adaptor 83 and its other end is provided with an adapter 85 (FIG. 1) which is used to connect the tube 82 to a vacuum source such as a vacuum bottle or the like (Clarke Col 5, lines 12-16), wherein under the current modification by Ellingson, the waste cone would be inserted into the modified female luer].
However, Clarke fails to explicitly disclose wherein the cannula insert, the blood sample cone, and the waste cone comprise lengthwise fluid pathways having an inner cross-sectional area in the range from 0.3 to 2.0 square millimeters.
Langevin discloses devices and methods for blood sampling [entire disclosure – see at least abstract], wherein Langevin discloses fluid passages having an inner cross-sectional area in the range from 0.3 to 2.0 square millimeters [For example, an inner diameter of approximately 1.0 millimeter can provide approximately 1 milliliter per hour of fluid through the blood collection means (Langevin Col 5, lines 58-63), wherein it is understood that a diameter of 1 mm is considered to mathematically define a circular cross-sectional area of ~0.78 mm2], and wherein Langevin further defines the diameter/cross-sectional area of a fluid passage as being a result effective variable to affect flow rate through the passage [The flow rate of the fluid being administered can be controlled by providing a particular inner diameter of the second channel or other suitable resistor. For example, an inner diameter of approximately 1.0 millimeter can provide approximately 1 milliliter per hour of fluid through the blood collection means. This flow rate can be adjusted by increasing or decreasing as desired the inner diameter of the second channel or alternate resistor. It has been found that a flow rate of approximately 1 milliliter per hour can maintain patency of the blood collection system (Langevin Col 5, lines 58-67)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microvolume 3-way stopcock of Clarke so as to incorporate wherein the inlet, blood sample, waste, and T-shaped fluid passages have an inner cross-sectional area in the range from 0.3 to 2.0 square millimeters, as a matter of routine optimization [see Langevin Col 5, lines 58-67] since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), as well as to maintain patency of the fluid passages [Langevin Col 5, lines 58-67].
Regarding claim 9, Clarke in view of Ellingson and Langevin teaches
A blood sampling system comprising:
a microvolume 3-way stopcock according to claim 1;
a cannula connected to the male luer [An adaptor 29 is fixed to the proximate end 27 of the catheter 23 and fits snugly on the arm 33 (Clarke Col 3, lines 2-3), wherein under the current modification by Ellingson, the cannula insert would be inserted into the modified male luer];
a self-venting blood sample syringe connected to the female luer of the blood sample fluid passage [the connector 48 joins the proximate end 46 of the needle 45 to a hollow projection 50 on the end of a tube 47 forming part of a syringe 49. A plunger 51 is slidable within the tube 47 and is provided with a grommet 52 which slidably engages the inner surface of the tube 47 so that when the plunger 51 is withdrawn outwardly of the tube 47 (or toward the left as seen in FIGS. 3 and 4), a negative pressure is applied to the needle 45 (Clarke Col 3, lines 42-50), wherein under the current modification by Ellingson, the blood sample cone would be inserted into the modified female luer]; and
a bodily fluid collection device connected to the female luer of the waste fluid passage [A tube 82 is connected at one end to the side arm 59 by an adaptor 83 and its other end is provided with an adapter 85 (FIG. 1) which is used to connect the tube 82 to a vacuum source such as a vacuum bottle or the like (Clarke Col 5, lines 12-16), wherein under the current modification by Ellingson, the waste cone would be inserted into the modified female luer].
However, Clarke fails to explicitly disclose wherein the bodily fluid collection device is a self-venting waste syringe. Clarke does disclose elsewhere the use of a self-venting syringe connected to the stopcock for blood collection [Clarke Col 3, lines 42-50] that is not explicitly connected to the female luer of the waste fluid passage.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blood sampling system of Clarke so as to incorporate wherein the bodily fluid collection device is a self-venting waste syringe, as Clarke discloses the use of self-venting syringes to be connected to the stopcock [Clarke Col 3, lines 42-50], as this modification would amount to mere simple substitution of one known element [vacuum bottle or the like (see Clarke Col 5, lines 12-16)] for another [self-venting syringe] to obtain predictable results [allow for blood collection] [MPEP § 2143(I)(B)].
Claim(s) 2-4 and 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clarke in view of Ellingson and Langevin as applied to claim 1 above, and further in view of Altman (US-6416510-B1).
Regarding claim 2, Clarke in view of Ellingson and Langevin teaches
The microvolume 3-way stopcock for use in a blood sampling system according to claim 1.
However, Clarke fails to explicitly disclose wherein the microvolume 3-way stopcock has a fluid volume dead space in the range of 0.02 to 0.20 mL.
Altman discloses fluid delivery devices [entire disclosure – see at least abstract], wherein Altman discloses that dead space is a known property of fluid passages [The dead space is the volume of the fluid pathway between the reservoir of therapeutic agent and the discharge point at the distal tip of the catheter (Altman Col 21, lines 5-7), wherein it is noted that while Altman is directed towards fluid delivery, the dead space as disclosed in Altman may still apply to the fluid collection of Clarke]. Altman further discloses that dead space in fluid passages may be considered result effective variable, as minimizing dead space results in less fluid being trapped within the dead space [The dead space in many catheters will be equivalent to the amount of drug in a proximally located reservoir that is not effectively delivered to the tissue. This dead volume will cause inaccuracy in dosing, which can be important when small volumes are delivered. It is desirable to have the dead space be small, and the preferred inner diameter of the drug delivery tubing is preferably less than 0.03 cm (0.012). (In a catheter of 100 cm length, this amounts to a dead space volume of 0.07 milliliters, and in a catheter of 135 cm length, it results in a dead space of about 0.09 milliliters. Preferably, the volume of the dead space is in the range of 0.05 ml and 0.25 ml.) (Altman Col 21, lines 8-21)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microvolume 3-way stopcock of Clarke so as to incorporate wherein the microvolume 3-way stopcock has a fluid volume dead space in the range of 0.02 to 0.20 mL, as a matter of routine optimization [see Altman Col 21, lines 8-21] since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 3, Clarke in view of Ellingson and Langevin teaches
The microvolume 3-way stopcock for use in a blood sampling system according to claim 1.
However, Clarke fails to explicitly disclose wherein the microvolume 3-way stopcock has a fluid volume dead space in the range of 0.02 to 0.15 mL.
Altman discloses fluid delivery devices [entire disclosure – see at least abstract], wherein Altman discloses that dead space is a known property of fluid passages [The dead space is the volume of the fluid pathway between the reservoir of therapeutic agent and the discharge point at the distal tip of the catheter (Altman Col 21, lines 5-7), wherein it is noted that while Altman is directed towards fluid delivery, the dead space as disclosed in Altman may still apply to the fluid collection of Clarke]. Altman further discloses that dead space in fluid passages may be considered result effective variable, as minimizing dead space results in less fluid being trapped within the dead space [The dead space in many catheters will be equivalent to the amount of drug in a proximally located reservoir that is not effectively delivered to the tissue. This dead volume will cause inaccuracy in dosing, which can be important when small volumes are delivered. It is desirable to have the dead space be small, and the preferred inner diameter of the drug delivery tubing is preferably less than 0.03 cm (0.012). (In a catheter of 100 cm length, this amounts to a dead space volume of 0.07 milliliters, and in a catheter of 135 cm length, it results in a dead space of about 0.09 milliliters. Preferably, the volume of the dead space is in the range of 0.05 ml and 0.25 ml.) (Altman Col 21, lines 8-21)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microvolume 3-way stopcock of Clarke so as to incorporate wherein the microvolume 3-way stopcock has a fluid volume dead space in the range of 0.02 to 0.15 mL, as a matter of routine optimization [see Altman Col 21, lines 8-21] since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4, Clarke in view of Ellingson and Langevin teaches
The microvolume 3-way stopcock for use in a blood sampling system according to claim 1.
However, Clarke fails to explicitly disclose wherein the microvolume 3-way stopcock has a fluid volume dead space in the range of 0.02 to 0.10 mL.
Altman discloses fluid delivery devices [entire disclosure – see at least abstract], wherein Altman discloses that dead space is a known property of fluid passages [The dead space is the volume of the fluid pathway between the reservoir of therapeutic agent and the discharge point at the distal tip of the catheter (Altman Col 21, lines 5-7), wherein it is noted that while Altman is directed towards fluid delivery, the dead space as disclosed in Altman may still apply to the fluid collection of Clarke]. Altman further discloses that dead space in fluid passages may be considered result effective variable, as minimizing dead space results in less fluid being trapped within the dead space [The dead space in many catheters will be equivalent to the amount of drug in a proximally located reservoir that is not effectively delivered to the tissue. This dead volume will cause inaccuracy in dosing, which can be important when small volumes are delivered. It is desirable to have the dead space be small, and the preferred inner diameter of the drug delivery tubing is preferably less than 0.03 cm (0.012). (In a catheter of 100 cm length, this amounts to a dead space volume of 0.07 milliliters, and in a catheter of 135 cm length, it results in a dead space of about 0.09 milliliters. Preferably, the volume of the dead space is in the range of 0.05 ml and 0.25 ml.) (Altman Col 21, lines 8-21)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microvolume 3-way stopcock of Clarke so as to incorporate wherein the microvolume 3-way stopcock has a fluid volume dead space in the range of 0.02 to 0.10 mL, as a matter of routine optimization [see Altman Col 21, lines 8-21] since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 6, Clarke in view of Ellingson and Langevin teaches
The microvolume 3-way stopcock for use in a blood sampling system according to claim 5.
However, Clarke fails to explicitly disclose wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.24 mL.
Altman discloses fluid delivery devices [entire disclosure – see at least abstract], wherein Altman discloses that dead space is a known property of fluid passages [The dead space is the volume of the fluid pathway between the reservoir of therapeutic agent and the discharge point at the distal tip of the catheter (Altman Col 21, lines 5-7), wherein it is noted that while Altman is directed towards fluid delivery, the dead space as disclosed in Altman may still apply to the fluid collection of Clarke]. Altman further discloses that dead space in fluid passages may be considered result effective variable, as minimizing dead space results in less fluid being trapped within the dead space [The dead space in many catheters will be equivalent to the amount of drug in a proximally located reservoir that is not effectively delivered to the tissue. This dead volume will cause inaccuracy in dosing, which can be important when small volumes are delivered. It is desirable to have the dead space be small, and the preferred inner diameter of the drug delivery tubing is preferably less than 0.03 cm (0.012). (In a catheter of 100 cm length, this amounts to a dead space volume of 0.07 milliliters, and in a catheter of 135 cm length, it results in a dead space of about 0.09 milliliters. Preferably, the volume of the dead space is in the range of 0.05 ml and 0.25 ml.) (Altman Col 21, lines 8-21)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microvolume 3-way stopcock of Clarke so as to incorporate wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.24 mL, as a matter of routine optimization [see Altman Col 21, lines 8-21] since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 7, Clarke in view of Ellingson and Langevin teaches
The microvolume 3-way stopcock for use in a blood sampling system according to claim 5.
However, Clarke fails to explicitly disclose wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.19 mL.
Altman discloses fluid delivery devices [entire disclosure – see at least abstract], wherein Altman discloses that dead space is a known property of fluid passages [The dead space is the volume of the fluid pathway between the reservoir of therapeutic agent and the discharge point at the distal tip of the catheter (Altman Col 21, lines 5-7), wherein it is noted that while Altman is directed towards fluid delivery, the dead space as disclosed in Altman may still apply to the fluid collection of Clarke]. Altman further discloses that dead space in fluid passages may be considered result effective variable, as minimizing dead space results in less fluid being trapped within the dead space [The dead space in many catheters will be equivalent to the amount of drug in a proximally located reservoir that is not effectively delivered to the tissue. This dead volume will cause inaccuracy in dosing, which can be important when small volumes are delivered. It is desirable to have the dead space be small, and the preferred inner diameter of the drug delivery tubing is preferably less than 0.03 cm (0.012). (In a catheter of 100 cm length, this amounts to a dead space volume of 0.07 milliliters, and in a catheter of 135 cm length, it results in a dead space of about 0.09 milliliters. Preferably, the volume of the dead space is in the range of 0.05 ml and 0.25 ml.) (Altman Col 21, lines 8-21)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microvolume 3-way stopcock of Clarke so as to incorporate wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.19 mL, as a matter of routine optimization [see Altman Col 21, lines 8-21] since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 8, Clarke in view of Ellingson and Langevin teaches
The microvolume 3-way stopcock for use in a blood sampling system according to claim 5.
However, Clarke fails to explicitly disclose wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.14 mL.
Altman discloses fluid delivery devices [entire disclosure – see at least abstract], wherein Altman discloses that dead space is a known property of fluid passages [The dead space is the volume of the fluid pathway between the reservoir of therapeutic agent and the discharge point at the distal tip of the catheter (Altman Col 21, lines 5-7), wherein it is noted that while Altman is directed towards fluid delivery, the dead space as disclosed in Altman may still apply to the fluid collection of Clarke]. Altman further discloses that dead space in fluid passages may be considered result effective variable, as minimizing dead space results in less fluid being trapped within the dead space [The dead space in many catheters will be equivalent to the amount of drug in a proximally located reservoir that is not effectively delivered to the tissue. This dead volume will cause inaccuracy in dosing, which can be important when small volumes are delivered. It is desirable to have the dead space be small, and the preferred inner diameter of the drug delivery tubing is preferably less than 0.03 cm (0.012). (In a catheter of 100 cm length, this amounts to a dead space volume of 0.07 milliliters, and in a catheter of 135 cm length, it results in a dead space of about 0.09 milliliters. Preferably, the volume of the dead space is in the range of 0.05 ml and 0.25 ml.) (Altman Col 21, lines 8-21)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microvolume 3-way stopcock of Clarke so as to incorporate wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.14 mL, as a matter of routine optimization [see Altman Col 21, lines 8-21] since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 10-12 and 14-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ellingson in view of Jho (US-20180207398-A1) and Altman.
Regarding claim 10, Ellingson teaches
A method for obtaining a clean blood specimen comprising:
obtaining a microvolume 3-way stopcock comprising:
an inlet fluid passage having a male luer connector and a cannula attached to the male luer connector [The Luer connector 25 includes a protruding male Luer member 27 which is surrounded by a threaded nut member 29 for threadingly engaging the Luer connector 18 of the catheter 16. The male Luer member 27 defines the inflow of the stop cock 23 (Ellingson Col 3, lines 8-12, Figure 3A)];
a blood sample fluid passage having a female luer connector [The stop cock 23 includes the female Luer cavity 33 defined in housing 35… The female Luer cavity 33 defines the first outflow position of the stop cock 23 (Ellingson Col 3, lines 2-3 and 6-7, Figure 3A)];
a waste fluid passage having a female luer connector [The second outflow is defined by a side port 69 of the stop cock 23. The side port 69 extends perpendicularly to an axis defined by the inflow and first outflow (Ellingson Col 3, lines 13-15, Figure 3A)]; and
a rotatable flow control member configured to provide adjustable fluid communication between the inlet fluid passage, the blood sample fluid passage, and/or the waste fluid passage [A stop cock handle 71 is provided. The position of the stop cock handle 71 controls the direction of the flow of fluid within the stop cock 23. The stop cock handle 71 is movable from a first position, where the flow of fluid through the stop cock 23 is closed, to a second position, where the flow of fluid through the first outflow is allowed. When the stop cock handle 71 is placed in a third position, flow is allowed from the inflow to the second outflow (Ellingson Col 3, lines 15-23, Figures 3A-B)],
connecting a self-venting first blood sample syringe to the female luer connector of the blood sample fluid passage [The exterior of the housing 35 further defines a threaded nut member 29 for threadingly engaging the Luer connector 42 of the self-sealing valve 44 (Ellingson Col 3, lines 3-5), which as seen in Figures 1-2 the male luer connector 42 is connected to syringe 61; Fluid samples can then be withdrawn from the side port 69 of the stop cock 23 and by withdrawing the plunger 66 of the syringe 61 (Ellingson Col 3, lines 63-65)];
rotating the flow control member to permit fluid flow between the inlet fluid passage and the waste fluid passage and to allow blood to be withdrawn from the waste fluid passage [The female Luer cavity 33 defines the first outflow position of the stop cock 23 (Ellingson Col 3, lines 6-7); a second position, where the flow of fluid through the first outflow is allowed (Ellingson Col 3, lines 20-23)];
rotating the flow control member to permit fluid flow between the inlet fluid passage and the blood sample fluid passage and to allow a desired first blood sample into the first blood sample syringe [The second outflow is defined by a side port 69 of the stop cock 23 (Ellingson Col 3, lines 13-15); When the stop cock handle 71 is placed in a third position, flow is allowed from the inflow to the second outflow (Ellingson Col 3, lines 21-23); Fluid samples can then be withdrawn from the side port 69 of the stop cock 23 and by withdrawing the plunger 66 of the syringe 61 (Ellingson Col 3, lines 63-65)];
rotating the flow control member to permit fluid flow between the inlet fluid passage and the waste fluid passage [Ellingson Col 3, lines 21-23].
However, Ellingson fails to explicitly disclose assuring a sterile septum connector is connected to an arterial line; and inserting the cannula into the septum connector.
Jho discloses systems and methods for accessing an umbilical vein of a patient [entire disclosure – see at least abstract], wherein Jho discloses a sterile septum connector that is connected to an arterial line [a port 115 is positioned at the proximal end of the elongated body. The port 115 fluidly communicates with the proximal opening of the elongated body and provides a proximal access location via which a clinician can access the internal lumen of the catheter 110 (Jho ¶0012)], wherein a cannula may be inserted into the septum connector [The clinician can aspirate, infuse or inject material from or into the catheter using the access port 115. In this regard, the clinician can insert a cannula through the septum of the access port such that the cannula communicates with the reservoir of the access port 115. The clinician can then use the cannula to aspirate or infuse fluid from or into the catheter via the access port 115 (Jho ¶0019)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ellingson so as to incorporate the steps of assuring a sterile septum connector is connected to an arterial line and inserting the cannula into the septum connector, as taught by Jho, so as to maintain sterility when the cannula is not inserted into the septum connector [The umbilical vein catheter includes a proximal access port that is closed with a septum. The septum provides a closed system to reduce the risk of air embolism and intraluminal infection via the catheter (Jho ¶0010)] and would further amount to merely applying a known technique [septum connector of Jho] to a known device (method, or product) ready for improvement [method of Ellingson] to yield predictable results [allow for access to the umbilical vein while maintain sterility] [MPEP § 2143(I)(D)].
However, Ellingson fails to disclose wherein the waste fluid passage connector is a female luer connector. Ellingson discloses the use of male and female luer connectors for connecting a stopcock body to a syringe [A male Luer connector 59 is provided in a syringe 61 which can be removably secured to the needle hub 53 by mating the female Luer cavity with the male Luer member 59 and threadingly engaging the Luer lock connector 55 (Ellingson, Col 2, lines 60-64)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microvolume 3-way stopcock of Ellingson so as to incorporate wherein the waste fluid passage connector is a female luer connector, as Ellingson discloses male and female luer connectors known types of connectors for connecting a stopcock to other devices [Ellingson, Col 2, lines 30-35, 60-64], such that this modification would amount to mere simple substitution of one known element [waste fluid passage connector of Ellingson] for another [female luer connector] to obtain predictable results [allow for connection of the stopcock to other devices] [MPEP § 2143(I)(B)].
However, Ellingson fails to explicitly disclose wherein the microvolume 3-way stopcock and cannula have a dead space volume in the range from 0.03 to 0.24 mL. Altman discloses fluid delivery devices [entire disclosure – see at least abstract], wherein Altman discloses that dead space is a known property of fluid passages [The dead space is the volume of the fluid pathway between the reservoir of therapeutic agent and the discharge point at the distal tip of the catheter (Altman Col 21, lines 5-7), wherein it is noted that while Altman is directed towards fluid delivery, the dead space as disclosed in Altman may still apply to the fluid collection of Clarke]. Altman further discloses that dead space in fluid passages may be considered result effective variable, as minimizing dead space results in less fluid being trapped within the dead space [The dead space in many catheters will be equivalent to the amount of drug in a proximally located reservoir that is not effectively delivered to the tissue. This dead volume will cause inaccuracy in dosing, which can be important when small volumes are delivered. It is desirable to have the dead space be small, and the preferred inner diameter of the drug delivery tubing is preferably less than 0.03 cm (0.012). (In a catheter of 100 cm length, this amounts to a dead space volume of 0.07 milliliters, and in a catheter of 135 cm length, it results in a dead space of about 0.09 milliliters. Preferably, the volume of the dead space is in the range of 0.05 ml and 0.25 ml.) (Altman Col 21, lines 8-21)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ellingson so as to incorporate wherein the microvolume 3-way stopcock has a fluid volume dead space in the range of 0.03 to 0.24 mL, as a matter of routine optimization [see Altman Col 21, lines 8-21] since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
However, Ellingson fails to explicitly disclose connecting a waste blood collection device to the female luer connector of the waste fluid passage, such that rotating the flow control member to permit fluid flow between the inlet fluid passage and the waste fluid passage allows for waste blood into the waste syringe. Ellingson does disclose elsewhere the use of a self-venting syringe connected to the stopcock for blood collection [The exterior of the housing 35 further defines a threaded nut member 29 for threadingly engaging the Luer connector 42 of the self-sealing valve 44 (Ellingson Col 3, lines 3-5), which as seen in Figures 1-2 the male luer connector 42 is connected to syringe 61] that is not explicitly connected to the female luer of the waste fluid passage.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method so as to incorporate wherein the bodily fluid collection device is a self-venting waste syringe, as Ellingson discloses the use of self-venting syringes to be connected to the stopcock [Ellingson Col 3, lines 3-5], as this modification would amount to mere simple substitution of one known element [undisclosed fluid sampling means for side port 69] for another [self-venting waste syringe] to obtain predictable results [allow for blood collection] [MPEP § 2143(I)(B)].
However, Ellingson fails to explicitly disclose returning the waste blood from the waste syringe to the patient. However, it also understood that syringes are operable to both withdraw a volume of fluid to be stored in the body of the syringe, as well as deliver a volume of fluid that is stored in the body of the syringe.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ellingson so as to incorporate wherein the waste blood from the waste syringe is returned to the patient, as this modification would amount to merely applying a known technique [fluid delivery via a syringe] to a known device (method, or product) [waste syringe] ready for improvement to yield predictable results [deliver fluid from the waste syringe] [MPEP § 2143(I)(D)].
Regarding claim 11, Ellingson in view of Jho and Altman teaches
The method for obtaining a clean blood specimen according to claim 10, further comprising:
rotating the flow control member to close fluid flow from the arterial line [The stop cock handle 71 is movable from a first position, where the flow of fluid through the stop cock 23 is closed (Ellingson Col 3, lines 18-20)];
removing the cannula from the septum connector [see § 103 modification of claim 10 above, wherein based on the modification by Jho, the cannula is removable from the septum connector (Jho ¶0019)]; and
removing the first blood sample syringe from the female luer connector of the blood sample fluid passage [A male Luer connector 59 is provided in a syringe 61 which can be removably secured to the needle hub 53 by mating the female Luer cavity with the male Luer member 59 and threadingly engaging the Luer lock connector 55 (Ellingson Col 2, lines 60-64)].
Regarding claim 12, Ellingson in view of Jho and Altman teaches
The method for obtaining a clean blood specimen according to claim 10, wherein the arterial line comprises an indwelling umbilical catheter [The catheter 110 may remain coupled to the umbilical vein for a period of time, such as for about ten days. The duration for which the catheter remains coupled to the umbilical vein can be as needed and can also be dictated by the clinician (Jho ¶0020); see § 103 modification of claim 10 above].
Regarding claim 14, Ellingson in view of Jho and Altman teaches
The method for obtaining a clean blood specimen according to claim 10, wherein after connecting the self-venting first blood sample syringe to the female luer connector of the blood sample fluid passage, setting the self-venting first blood sample syringe to a desired blood sample volume [The catheter assembly is advanced into the patient until fluid can be aspirated through the catheter needle 12 into the syringe 61. The catheter needle 12 is then withdrawn, thus retaining the catheter 16 in the patient. Fluid samples can then be withdrawn from the side port 69 of the stop cock 23 and by withdrawing the plunger 66 of the syringe 6 (Ellingson Col 3, lines 62-65)].
Regarding claim 15, Ellingson in view of Jho and Altman teaches
The method for obtaining a clean blood specimen according to claim 10, wherein after connecting the self-venting waste syringe to the female luer connector of the waste fluid passage, setting the self-venting waste syringe to a desired waste blood volume [Ellingson Col 3, lines 62-65; wherein based on the § 103 modification of claim 10 above, the method comprises connecting a self-venting waste syringe to the female luer connector of the waste fluid passage].
Regarding claim 16, Ellingson in view of Jho and Altman teaches
The method for obtaining a clean blood specimen according to claim 10, wherein following the step of rotating the flow control member to permit fluid flow between the inlet fluid passage and the blood sample fluid passage and to allow a desired first blood sample into the first blood sample syringe:
rotating the flow control member to close fluid flow from the arterial line [The stop cock handle 71 is movable from a first position, where the flow of fluid through the stop cock 23 is closed (Ellingson Col 3, lines 18-20)];
removing the first blood sample syringe from the female luer connector of the blood sample fluid passage [A male Luer connector 59 is provided in a syringe 61 which can be removably secured to the needle hub 53 by mating the female Luer cavity with the male Luer member 59 and threadingly engaging the Luer lock connector 55 (Ellingson Col 2, lines 60-64)].
However, while Ellingson fails to explicitly disclose the steps of connecting a self-venting second blood sample syringe to the female luer connector of the blood sample fluid passage and rotating the flow control member to permit fluid flow between the inlet fluid passage and the blood sample fluid passage and to allow a desired second blood sample into the second blood sample syringe; Ellingson does disclose the steps of connecting the self-venting first blood sample syringe to the female luer connector of the blood sample fluid passage [A male Luer connector 59 is provided in a syringe 61 which can be removably secured to the needle hub 53 by mating the female Luer cavity with the male Luer member 59 and threadingly engaging the Luer lock connector 55 (Ellingson Col 2, lines 60-64)]; and rotating the flow control member to permit fluid flow between the inlet fluid passage and the blood sample fluid passage and to allow the desired first blood sample into the first blood sample syringe [The second outflow is defined by a side port 69 of the stop cock 23 (Ellingson Col 3, lines 13-15); When the stop cock handle 71 is placed in a third position, flow is allowed from the inflow to the second outflow (Ellingson Col 3, lines 21-23); Fluid samples can then be withdrawn from the side port 69 of the stop cock 23 and by withdrawing the plunger 66 of the syringe 61 (Ellingson Col 3, lines 63-65)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ellingson so as to incorporate a self-venting second blood sample syringe, as this would amount to mere duplication of parts [duplication of the self-venting first blood sample syringe] [MPEP § 2144.04(VI)(B)], and further incorporate connecting the self-venting second blood sample syringe to the female luer connector of the blood sample fluid passage and rotating the flow control member to permit fluid flow between the inlet fluid passage and the blood sample fluid passage and to allow a desired second blood sample into the second blood sample syringe, as this modification would amount to merely applying a known technique [connecting the self-venting first blood sample syringe to the female luer connector of the blood sample fluid passage and rotating the flow control member to permit fluid flow between the inlet fluid passage and the blood sample fluid passage and to allow the desired first blood sample into the first blood sample syringe] to a known device (method, or product) [the self-venting second blood sample syringe] ready for improvement to yield predictable results [collecting a desired blood sample] [MPEP § 2143(I)(D)].
Regarding claim 17, Ellingson in view of Jho and Altman teaches
The method for obtaining a clean blood specimen according to claim 16.
However, Ellingson fails to explicitly disclose wherein the steps of claim 16 are repeated to obtain a desired number of blood samples in additional blood sample syringes.
However, based on the § 103 modification of claim 16 above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ellingson so as to incorporate wherein the steps of claim 16 are repeated to obtain a desired number of blood samples in additional blood sample syringes so as to incorporate additional blood sample syringes, as this would amount to mere duplication of parts [duplication of the self-venting first blood sample syringe] [MPEP § 2144.04(VI)(B)], and further incorporate repeating the steps of claim 16, as this modification would amount to merely applying a known technique [the steps as defined in claim 16] to a known device (method, or product) [the additional blood sample syringes] ready for improvement to yield predictable results [collecting a desired number of blood samples] [MPEP § 2143(I)(D)].
Regarding claim 18, Ellingson in view of Jho and Altman teaches
The method for obtaining a clean blood specimen according to claim 10.
However, Ellingson fails to explicitly disclose wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.19 mL.
Altman discloses that dead space is a known property of fluid passages [The dead space is the volume of the fluid pathway between the reservoir of therapeutic agent and the discharge point at the distal tip of the catheter (Altman Col 21, lines 5-7), wherein it is noted that while Altman is directed towards fluid delivery, the dead space as disclosed in Altman may still apply to the fluid collection of Clarke]. Altman further discloses that dead space in fluid passages may be considered result effective variable, as minimizing dead space results in less fluid being trapped within the dead space [The dead space in many catheters will be equivalent to the amount of drug in a proximally located reservoir that is not effectively delivered to the tissue. This dead volume will cause inaccuracy in dosing, which can be important when small volumes are delivered. It is desirable to have the dead space be small, and the preferred inner diameter of the drug delivery tubing is preferably less than 0.03 cm (0.012). (In a catheter of 100 cm length, this amounts to a dead space volume of 0.07 milliliters, and in a catheter of 135 cm length, it results in a dead space of about 0.09 milliliters. Preferably, the volume of the dead space is in the range of 0.05 ml and 0.25 ml.) (Altman Col 21, lines 8-21)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ellingson so as to incorporate wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.19 mL, as a matter of routine optimization [see Altman Col 21, lines 8-21] since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 19, Ellingson in view of Jho and Altman teaches
The method for obtaining a clean blood specimen according to claim 10.
However, Ellingson fails to explicitly disclose wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.14 mL.
Altman discloses that dead space is a known property of fluid passages [The dead space is the volume of the fluid pathway between the reservoir of therapeutic agent and the discharge point at the distal tip of the catheter (Altman Col 21, lines 5-7), wherein it is noted that while Altman is directed towards fluid delivery, the dead space as disclosed in Altman may still apply to the fluid collection of Clarke]. Altman further discloses that dead space in fluid passages may be considered result effective variable, as minimizing dead space results in less fluid being trapped within the dead space [The dead space in many catheters will be equivalent to the amount of drug in a proximally located reservoir that is not effectively delivered to the tissue. This dead volume will cause inaccuracy in dosing, which can be important when small volumes are delivered. It is desirable to have the dead space be small, and the preferred inner diameter of the drug delivery tubing is preferably less than 0.03 cm (0.012). (In a catheter of 100 cm length, this amounts to a dead space volume of 0.07 milliliters, and in a catheter of 135 cm length, it results in a dead space of about 0.09 milliliters. Preferably, the volume of the dead space is in the range of 0.05 ml and 0.25 ml.) (Altman Col 21, lines 8-21)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ellingson so as to incorporate wherein microvolume 3-way stopcock and cannula have a combined dead space fluid volume in the range from 0.03 to 0.14 mL, as a matter of routine optimization [see Altman Col 21, lines 8-21] since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 13 [written to include dependency from claim 10] is/are rejected under 35 U.S.C. 103 as being unpatentable over Ellingson in view of Chelak (US-20190275312-A1) and Altman.
Regarding claim 13, Ellingson teaches
A method for obtaining a clean blood specimen comprising:
obtaining a microvolume 3-way stopcock comprising:
an inlet fluid passage having a male luer connector and a cannula attached to the male luer connector [The Luer connector 25 includes a protruding male Luer member 27 which is surrounded by a threaded nut member 29 for threadingly engaging the Luer connector 18 of the catheter 16. The male Luer member 27 defines the inflow of the stop cock 23 (Ellingson Col 3, lines 8-12, Figure 3A)];
a blood sample fluid passage having a female luer connector [The stop cock 23 includes the female Luer cavity 33 defined in housing 35… The female Luer cavity 33 defines the first outflow position of the stop cock 23 (Ellingson Col 3, lines 2-3 and 6-7, Figure 3A)];
a waste fluid passage having a female luer connector [The second outflow is defined by a side port 69 of the stop cock 23. The side port 69 extends perpendicularly to an axis defined by the inflow and first outflow (Ellingson Col 3, lines 13-15, Figure 3A)]; and
a rotatable flow control member configured to provide adjustable fluid communication between the inlet fluid passage, the blood sample fluid passage, and/or the waste fluid passage [A stop cock handle 71 is provided. The position of the stop cock handle 71 controls the direction of the flow of fluid within the stop cock 23. The stop cock handle 71 is movable from a first position, where the flow of fluid through the stop cock 23 is closed, to a second position, where the flow of fluid through the first outflow is allowed. When the stop cock handle 71 is placed in a third position, flow is allowed from the inflow to the second outflow (Ellingson Col 3, lines 15-23, Figures 3A-B)],
connecting a self-venting first blood sample syringe to the female luer connector of the blood sample fluid passage [The exterior of the housing 35 further defines a threaded nut member 29 for threadingly engaging the Luer connector 42 of the self-sealing valve 44 (Ellingson Col 3, lines 3-5), which as seen in Figures 1-2 the male luer connector 42 is connected to syringe 61; Fluid samples can then be withdrawn from the side port 69 of the stop cock 23 and by withdrawing the plunger 66 of the syringe 61 (Ellingson Col 3, lines 63-65)];
rotating the flow control member to permit fluid flow between the inlet fluid passage and the waste fluid passage and to allow blood to be withdrawn from the waste fluid passage [The female Luer cavity 33 defines the first outflow position of the stop cock 23 (Ellingson Col 3, lines 6-7); a second position, where the flow of fluid through the first outflow is allowed (Ellingson Col 3, lines 20-23)];
rotating the flow control member to permit fluid flow between the inlet fluid passage and the blood sample fluid passage and to allow a desired first blood sample into the first blood sample syringe [The second outflow is defined by a side port 69 of the stop cock 23 (Ellingson Col 3, lines 13-15); When the stop cock handle 71 is placed in a third position, flow is allowed from the inflow to the second outflow (Ellingson Col 3, lines 21-23); Fluid samples can then be withdrawn from the side port 69 of the stop cock 23 and by withdrawing the plunger 66 of the syringe 61 (Ellingson Col 3, lines 63-65)];
rotating the flow control member to permit fluid flow between the inlet fluid passage and the waste fluid passage [Ellingson Col 3, lines 21-23].
However, Ellingson fails to explicitly disclose assuring a sterile septum connector is connected to an arterial line; and inserting the cannula into the septum connector; wherein the arterial line comprises a peripheral arterial line.
Chelak discloses systems for managing vascular access [entire disclosure – see at least abstract], wherein Chelak discloses a sterile septum connector that is connected to an arterial line [the flow housing 540 may have a split septum port 560 for receiving a medical implement 610 (e.g., a blunt cannula or other medical device or connector). As the name suggests, the split septum port 560 includes a septum 562 that obstructs the port 560 and normally seals off the interior of the flow housing 540 (e.g., it seals off the flow path 542 from the environment/exterior of the flow housing 540 (Chelak ¶0095], wherein a cannula may be inserted into the septum connector [To allow for connection of the medical implement 610, the septum 562 may include an aperture or a slit extending through it. To that end, during connection of the medical implement 610 to the flow housing 540, the end 612 (e.g., the distal tip) of the medical implement 610 deforms the septum 562, thus opening the aperture/slit to allow the medical implement 610 to extend through the septum 562 (Chelak ¶0095], wherein the arterial line comprises a peripheral arterial line [the user may need to access to a peripheral vein through the indwelling catheter 210 to introduce sensors for detecting a patient condition, introduce delivery lines for certain medicaments/agents, and/or introduce tubing for direct blood withdrawal (Chelak ¶0095)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ellingson so as to incorporate the steps of assuring a sterile septum connector is connected to an arterial line and inserting the cannula into the septum connector, as taught by Chelak, so as to maintain sterility when the cannula is not inserted into the septum connector [Chelak ¶0095] and would further amount to merely applying a known technique [septum connector of Chelak] to a known device (method, or product) ready for improvement [method of Ellingson] to yield predictable results [allow for access to the peripheral artery while maintain sterility] [MPEP § 2143(I)(D)].
However, Ellingson fails to disclose wherein the waste fluid passage connector is a female luer connector. Ellingson discloses the use of male and female luer connectors for connecting a stopcock body to a syringe [A male Luer connector 59 is provided in a syringe 61 which can be removably secured to the needle hub 53 by mating the female Luer cavity with the male Luer member 59 and threadingly engaging the Luer lock connector 55 (Ellingson, Col 2, lines 60-64)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microvolume 3-way stopcock of Ellingson so as to incorporate wherein the waste fluid passage connector is a female luer connector, as Ellingson discloses male and female luer connectors known types of connectors for connecting a stopcock to other devices [Ellingson, Col 2, lines 30-35, 60-64], such that this modification would amount to mere simple substitution of one known element [waste fluid passage connector of Clarke] for another [female luer connector] to obtain predictable results [allow for connection of the stopcock to other devices] [MPEP § 2143(I)(B)].
However, Ellingson fails to explicitly disclose wherein the microvolume 3-way stopcock and cannula have a dead space volume in the range from 0.03 to 0.24 mL. Altman discloses fluid delivery devices [entire disclosure – see at least abstract], wherein Altman discloses that dead space is a known property of fluid passages [The dead space is the volume of the fluid pathway between the reservoir of therapeutic agent and the discharge point at the distal tip of the catheter (Altman Col 21, lines 5-7), wherein it is noted that while Altman is directed towards fluid delivery, the dead space as disclosed in Altman may still apply to the fluid collection of Clarke]. Altman further discloses that dead space in fluid passages may be considered result effective variable, as minimizing dead space results in less fluid being trapped within the dead space [The dead space in many catheters will be equivalent to the amount of drug in a proximally located reservoir that is not effectively delivered to the tissue. This dead volume will cause inaccuracy in dosing, which can be important when small volumes are delivered. It is desirable to have the dead space be small, and the preferred inner diameter of the drug delivery tubing is preferably less than 0.03 cm (0.012). (In a catheter of 100 cm length, this amounts to a dead space volume of 0.07 milliliters, and in a catheter of 135 cm length, it results in a dead space of about 0.09 milliliters. Preferably, the volume of the dead space is in the range of 0.05 ml and 0.25 ml.) (Altman Col 21, lines 8-21)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ellingson so as to incorporate wherein the microvolume 3-way stopcock has a fluid volume dead space in the range of 0.03 to 0.24 mL, as a matter of routine optimization [see Altman Col 21, lines 8-21] since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
However, Ellingson fails to explicitly disclose connecting a waste blood collection device to the female luer connector of the waste fluid passage, such that rotating the flow control member to permit fluid flow between the inlet fluid passage and the waste fluid passage allows for waste blood into the waste syringe. Ellingson does disclose elsewhere the use of a self-venting syringe connected to the stopcock for blood collection [The exterior of the housing 35 further defines a threaded nut member 29 for threadingly engaging the Luer connector 42 of the self-sealing valve 44 (Ellingson Col 3, lines 3-5), which as seen in Figures 1-2 the male luer connector 42 is connected to syringe 61] that is not explicitly connected to the female luer of the waste fluid passage.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method so as to incorporate wherein the bodily fluid collection device is a self-venting waste syringe, as Ellingson discloses the use of self-venting syringes to be connected to the stopcock [Ellingson Col 3, lines 3-5], as this modification would amount to mere simple substitution of one known element [undisclosed fluid sampling means for side port 69] for another [self-venting waste syringe] to obtain predictable results [allow for blood collection] [MPEP § 2143(I)(B)].
However, Ellingson fails to explicitly disclose returning the waste blood from the waste syringe to the patient. However, it also understood that syringes are operable to both withdraw a volume of fluid to be stored in the body of the syringe, as well as deliver a volume of fluid that is stored in the body of the syringe.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ellingson so as to incorporate wherein the waste blood from the waste syringe is returned to the patient, as this modification would amount to merely applying a known technique [fluid delivery via a syringe] to a known device (method, or product) [waste syringe] ready for improvement to yield predictable results [deliver fluid from the waste syringe] [MPEP § 2143(I)(D)].
Conclusion


NEXT OFFICE ACTION: DETAILED ACTION
This action is responsive to Amendment and Applicant’s Remarks filed 10 February 2025. The Examiner acknowledges the amendments to claims 1-4, 6-11 and 14-19, the cancellation of claim 5, and the addition of new claim 20. Claims 1-4 and 6-20 are pending.
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 .
EXAMINER'S AMENDMENT
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
Authorization for this examiner’s amendment was given in an interview with Evan Witt on 3 April 2025.
The application has been amended as follows:
1.	(Currently Amended) A microvolume 3-way stopcock for use in a blood sampling system comprising:
a stopcock body comprising:
a cylindrical-shaped central chamber;
an inlet fluid passage configured to extend from the central chamber to a male luer connector;
a cannula insert disposed within the inlet fluid passage comprising a lengthwise inlet fluid pathway;
a blood sample fluid passage configured to extend from the central chamber to a blood sample female luer connector;
a blood sample cone disposed within the blood sample fluid passage comprising a lengthwise blood sample fluid pathway;
a waste fluid passage configured to extend from the central chamber to a waste fluid female luer connector; and
a waste cone disposed within the waste fluid passage comprising a lengthwise waste fluid pathway;
a rotatable flow control member disposed within the central chamber and comprising a T-shaped fluid passage, wherein the rotatable flow control member is configured to provide adjustable fluid communication between the inlet fluid passage, the blood sample fluid passage, and/or the waste fluid passage; and
a lever connected to the rotatable flow control member configured to permit selective rotation of the rotatable flow control member and control fluid flow between the fluid passages, wherein the inlet fluid pathway, the blood sample fluid pathway, and the waste fluid pathway each have an inner cross-sectional area in the range from 0.3 to 2.0 square millimeters.
6. 	(Currently Amended) The microvolume 3-way stopcock for use in a blood sampling system according to claim 1, further comprising a cannula attached to the male luer connector, wherein the microvolume 3-way stopcock and the cannula have a combined dead space fluid volume which is an internal fluid volume of the microvolume 3-way stopcock defined by the inlet fluid pathway, the blood sample fluid pathway, the waste fluid pathway, [[and]] the T-shaped fluid passage and the cannula which must be filled with blood before blood can flow into a blood specimen collection device, wherein the microvolume 3-way stopcock and the cannula have a combined dead space fluid volume in the rage of 0.03 to 0.24 mL.
7. 	(Currently Amended) The microvolume 3-way stopcock for use in a blood sampling system according to claim 1, further comprising a cannula attached to the male luer connector, wherein the microvolume 3-way stopcock and the cannula have a combined dead space fluid volume which is an internal fluid volume of the microvolume 3-way stopcock defined by the inlet fluid pathway, the blood sample fluid pathway, the waste fluid pathway, [[and]] the T-shaped fluid passage and the cannula which must be filled with blood before blood can flow into a blood specimen collection device, wherein the microvolume 3-way stopcock and the cannula have a combined dead space fluid volume in the rage of 0.03 to 0.19 mL.
8. 	(Currently Amended) The microvolume 3-way stopcock for use in a blood sampling system according to claim 1, further comprising a cannula attached to the male luer connector, wherein the microvolume 3-way stopcock and the cannula have a combined dead space fluid volume which is an internal fluid volume of the microvolume 3-way stopcock defined by the inlet fluid pathway, the blood sample fluid pathway, the waste fluid pathway, [[and]] the T-shaped fluid passage and the cannula which must be filled with blood before blood can flow into a blood specimen collection device, wherein the microvolume 3-way stopcock and the cannula have a combined dead space fluid volume in the rage of 0.03 to 0.14 mL.
10.	(Currently Amended) A method for obtaining a clean blood specimen comprising:
assuring a sterile septum connector is connected to an arterial line;
obtaining a microvolume 3-way stopcock comprising:
an inlet fluid passage having a male luer connector and a cannula attached to the male luer connector;
a cannula insert disposed within the inlet fluid passage comprising a lengthwise inlet fluid pathway;
a blood sample fluid passage having a blood sample female luer connector;
a blood sample cone disposed within the blood sample fluid passage comprising a lengthwise blood sample fluid pathway;
a waste fluid passage having a waste fluid female luer connector; and
a waste cone disposed within the waste fluid passage comprising a lengthwise waste fluid pathway;
a rotatable flow control member configured to provide adjustable fluid communication between the inlet fluid passage, the blood sample fluid passage, and/or the waste fluid passage,
wherein pathway, the blood sample fluid pathway, the waste fluid pathway, [[and]] the rotatable flow control member and the cannula which must be filled with blood before blood can flow into a blood specimen collection device, wherein the microvolume 3-way stopcock and the cannula have a combined dead space fluid volume in the range from 0.03 to 0.24 mL;
connecting a self-venting first blood sample syringe to the blood sample female luer connector of the blood sample fluid passage and connecting a self-venting waste syringe to the waste fluid female luer connector of the waste fluid passage;
inserting the cannula into the septum connector;
rotating the flow control member to permit fluid flow between the inlet fluid passage and the waste fluid passage and to allow waste blood into the waste syringe;
rotating the flow control member to permit fluid flow between the inlet fluid passage and the blood sample fluid passage and to allow a desired first blood sample into the first blood sample syringe;
rotating the flow control member to permit fluid flow from the inlet fluid passage and the waste fluid passage; and
returning the waste blood from the waste syringe to the patient.
Claim Interpretation
Examiner Notes: the Examiner’s interpretations of claim limitations that invoked interpretation under § 112(f) are maintained from the previous Office Action [see Non-Final Rejection dated 19 November 2024].
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance:
Regarding the previously applied claim objections, the claim amendments filed 10 February 2025 and the Examiner’s Amendments authorized 3 April 2025 amended subject matter to overcome the previously applied claim objections.
Regarding the previously applied rejections under § 112(b), the claim amendments filed 10 February 2025 and the Examiner’s Amendments authorized 3 April 2025 amended subject matter to overcome the previously applied rejections under § 112(b).
Regarding the previously applied art under § 103, claim 1 was amended in the claims filed 10 February 2025 to incorporate subject matter not considered to be taught by prior art, and claim 10 was amended in the Examiner’s Amendments authorized 3 April 2025 to incorporate similar subject matter, such that the claims are considered to overcome the previously applied rejections under § 103. The Examiner notes that the closest prior art of record with respect to claim 1 is Clarke (US-4447235-A, previously presented) in view of Ellingson (US- 6217556-A, previously presented) and Langevin (US-6156019-A, previously presented), which fails to teach, disclose, or suggest, alone or in combination, the amended limitations of claim 1 of “a cannula insert disposed within the inlet fluid passage comprising a lengthwise inlet fluid pathway”, “a blood sample cone disposed within the blood sample fluid passage comprising a lengthwise blood sample fluid pathway”, and “a waste cone disposed within the waste fluid passage comprising a lengthwise waste fluid pathway”. It would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Clarke, Ellingson, or Langevin, alone or in combination, to employ or incorporate the noted limitations of claim 1 without the benefit of hindsight. The Examiner additionally notes that with respect to claim 10, the closest prior art of record is Ellingson in view of Jho (US-20180207398-A1, previously presented) and Altman (US-6416510-B1, previously presented), which fails to teach, disclose, or suggest, alone or in combination, the amended limitations of claim 10 of “a cannula insert disposed within the inlet fluid passage comprising a lengthwise inlet fluid pathway”, “a blood sample cone disposed within the blood sample fluid passage comprising a lengthwise blood sample fluid pathway”, and “a waste cone disposed within the waste fluid passage comprising a lengthwise waste fluid pathway”. It would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ellingson, Jho, or Altman, alone or in combination, to employ or incorporate the noted limitations of claim 10 without the benefit of hindsight.
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.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Liu (US-20160213911-A1) discloses a 3-way stopcock for use in a blood sampling system [stopcock medical connector 10], wherein Liu discloses inserts provided in fluid flow channels that interface between a rotatable fluid flow control member of the 3-way stopcock and inflow/outflow passages [stopcock medical connector 10 is shown with antimicrobial inserts 100 seated within a portion of annular bore 32. Antimicrobial inserts 100 may comprise any shape, cross-sectional shape, or size that is compatible for use in stopcock medical connector 10. As shown, in some embodiments antimicrobial inserts 100 comprise an annular ring having an outer diameter that is approximately equal to, or slightly larger than the diameter of annular bore 32, wherein antimicrobial inserts 100 are retained within annular bore 32 via a friction fit (Liu ¶0041, Figures 2-3)]

CITED REFERENCE SUMMARIES: Ref US4447235A: Claims:
What is claimed is: 1. A thoracentesis device comprising an elongated flexible catheter having a distal end and a proximate end, means defining an elongated conduit including a value means and connected to the proximate end of said catheter and in line therewith, seal means at the distal end of said elongated conduit means continuously sealing said conduit means and the proximate end of said catheter from the atmosphere, a hollow needle having a sharpened distal end adapted to penetrate said seal means and to extend through said conduit means and said catheter and beyond the distal end thereof, means connected to the proximate end of said hollow needle for applying negative pressure to said needle, said needle being operable for complete withdrawl from said elongated conduit means and said seal means, said seal means being self-sealing and re-sealing said conduit means upon complete withdrawal of said needle from said conduit means and separation of said needle from said conduit means, said valve means being between said seal means and said catheter and said valve means movable to a first position where it connects said catheter to a side conduit means connected to and extending laterally of said elongated conduit means, and to a second position where it blocks communication between said elongated conduit means and said side conduit means. 2. A thoracentesis device as claimed in claim 1, said negative pressure applying means including a syringe connected to the proximate end of said needle. 3. A thoracentesis device as claimed in claim 1, including a vacuum source connected to said side conduit means for removal of fluid from the pleural cavity when the catheter distal end is in the pleural cavity, the needle withdrawn, and the valve means in the first position. 4. A thoracentesis device as claimed in claim 1, said elongated conduit means comprising a pair of hollow aligned arms joined by a hollow, intermediate barrel, said valve means comprising a stopcock rotatable in said intermediate barrel and formed with a pair of aligned radial ports which are aligned with said aligned arms in said second valve means position, whereby said needle can pass through said aligned arms and said aligned ports. 5. A thoracentesis device as claimed in claim 4, said side conduit means comprising a hollow arm connected to said hollow barrel and extends laterally of and is between said aligned arms, said stopcock having a third radial port which is between and disposed 90° with respect to said pair of radial ports. 6. A thoracentesis device as claimed in claim 5, said stopcock ports communicating only the side conduit lateral arm with the aligned arm between said intermediate barrel and said catheter in said first valve position, said stopcock ports communicating only said aligned arms in said second valve position. 7. A thoracentesis device as claimed in claim 5, said stopcock having a lever fixed thereto and disposed externally of said intermediate barrel for manipulation of said stopcock, said lever including indicia means indicating the positions of said stopcock ports. 8. A thoracentesis device as claimed in claim 4, said seal means including an elastomeric member in one of said hollow arms between said intermediate barrel and said negative pressure applying means, said elastomeric member being adapted to seal around said hollow needle when penetrated therethrough. 9. A thoracentesis device as claimed in claim 6, said seal means including a thickened body of material formed with an elongated plug which sealingly fits into said one of said hollow arms, said seal further including a stretchable sleeve which is adapted to be folded back over the thickened body and said one hollow arm after the plug is inserted into said arm. 10. A thoracentesis device as claimed in claim 9, said seal further including a heat sensitive shrink tubing which is placed over the sleeve portion to hold it in place on said one arm. 11. A thoracentesis device as claimed in claim 1, said catheter having side ports therein adjacent to its distal end.
A thoracentesis device comprising an elongated flexible catheter having a distal end and a proximate end, means defining an elongated conduit including a value means and connected to the proximate end of said catheter and in line therewith, seal means at the distal end of said elongated conduit means continuously sealing said conduit means and the proximate end of said catheter from the atmosphere, a hollow needle having a sharpened distal end adapted to penetrate said seal means and to extend through said conduit means and said catheter and beyond the distal end thereof, means connected to the proximate end of said hollow needle for applying negative pressure to said needle, said needle being operable for complete withdrawl from said elongated conduit means and said seal means, said seal means being self-sealing and re-sealing said conduit means upon complete withdrawal of said needle from said conduit means and separation of said needle from said conduit means, said valve means being between said seal means and said catheter and said valve means movable to a first position where it connects said catheter to a side conduit means connected to and extending laterally of said elongated conduit means, and to a second position where it blocks communication between said elongated conduit means and said side conduit means.
A thoracentesis device as claimed in claim 1, said negative pressure applying means including a syringe connected to the proximate end of said needle.
A thoracentesis device as claimed in claim 1, including a vacuum source connected to said side conduit means for removal of fluid from the pleural cavity when the catheter distal end is in the pleural cavity, the needle withdrawn, and the valve means in the first position.
A thoracentesis device as claimed in claim 1, said elongated conduit means comprising a pair of hollow aligned arms joined by a hollow, intermediate barrel, said valve means comprising a stopcock rotatable in said intermediate barrel and formed with a pair of aligned radial ports which are aligned with said aligned arms in said second valve means position, whereby said needle can pass through said aligned arms and said aligned ports.
A thoracentesis device as claimed in claim 4, said side conduit means comprising a hollow arm connected to said hollow barrel and extends laterally of and is between said aligned arms, said stopcock having a third radial port which is between and disposed 90° with respect to said pair of radial ports.
A thoracentesis device as claimed in claim 5, said stopcock ports communicating only the side conduit lateral arm with the aligned arm between said intermediate barrel and said catheter in said first valve position, said stopcock ports communicating only said aligned arms in said second valve position.
A thoracentesis device as claimed in claim 5, said stopcock having a lever fixed thereto and disposed externally of said intermediate barrel for manipulation of said stopcock, said lever including indicia means indicating the positions of said stopcock ports.
A thoracentesis device as claimed in claim 4, said seal means including an elastomeric member in one of said hollow arms between said intermediate barrel and said negative pressure applying means, said elastomeric member being adapted to seal around said hollow needle when penetrated therethrough.
A thoracentesis device as claimed in claim 6, said seal means including a thickened body of material formed with an elongated plug which sealingly fits into said one of said hollow arms, said seal further including a stretchable sleeve which is adapted to be folded back over the thickened body and said one hollow arm after the plug is inserted into said arm.
A thoracentesis device as claimed in claim 9, said seal further including a heat sensitive shrink tubing which is placed over the sleeve portion to hold it in place on said one arm.
A thoracentesis device as claimed in claim 1, said catheter having side ports therein adjacent to its distal end.
Ref US6217556B1: [content unavailable]
Ref US6156019A: Claims:
In an intravenous apparatus having a cannula with a first end upstream and a second end downstream, said second end connectable to a patient, a device for infection-resistant blood sampling from the patient, comprising: a directional valve disposed between said first and second ends of said cannula to selectively direct the flow of blood to a blood collection means in fluid communication therewith, said blood collection means comprising a uni-directional flow inhibitor disposed within said blood collection means between a blood collection port and said valve to inhibit re-entry of fluids into said cannula from said port.
a directional valve disposed between said first and second ends of said cannula to selectively direct the flow of blood to a blood collection means in fluid communication therewith, said blood collection means comprising a uni-directional flow inhibitor disposed within said blood collection means between a blood collection port and said valve to inhibit re-entry of fluids into said cannula from said port.
The device, according to claim 1, further comprising a reservoir for temporary storing of blood during sampling, said reservoir disposed upstream of said blood collection means, between said blood collection means and said first end of said cannula.
The system, according to claim 2, wherein said system further comprises a means for continuous flushing of said cannula without introducing a source of infection.
The device, according to claim 3, wherein said flushing means comprises a second channel having a first end upstream and a second end downstream, wherein said first end is in fluid communication with said cannula and said second end communicates with said blood collection means.
The device, according to claim 4, wherein said first end of said second channel communicates with said cannula upstream of said reservoir.
The device, according to claim 5, wherein said second end of said second channel is in fluid communication with said blood collection means downstream of said uni-directional flow inhibitor.
The device, according to claim 6, wherein said blood collection means comprises two uni-directional flow inhibitors, and said second end of said second channel is in fluid communication with said blood collection means between said uni-directional flow inhibitors.
A method for infection-resistant blood collection from a patient, said method comprising the steps of: (a) providing a device of claim 1; (b) connecting said device to the blood supply of the patient; and (c) drawing blood through said blood collection means.
(a) providing a device of claim 1;
(b) connecting said device to the blood supply of the patient; and
(c) drawing blood through said blood collection means.
The method, according to claim 8, wherein said method further comprises flushing of said cannula or said blood collection means on a selectable continuous basis.
Ref US6416510B1: Claims:
The method of delivery of a therapeutic agent selected from the set of macromolecule, gene therapy preparation, microspheres, or micelles to a depth within the myocardium including the steps of:
providing a catheter adapted for insertion into the heart, said catheter having a proximal end and a distal end, said catheter having a fixating penetrating element secured to the distal end thereof, said catheter having a drug delivery lumen extending from the proximal end to the distal end of the catheter and a drug delivery port at the distal end of the catheter communicating from the drug delivery lumen to the exterior of the catheter;
inserting the catheter into the heart, and manipulating the fixating penetrating element to engage the heart wall and releasably connect the catheter distal tip to the heart wall;
manipulating the fixating penetrating element to cause it to penetrate the heart wall; and
infusing the therapeutic agent to a depth within the heart wall.
The method of claim 1 further comprising the steps of:
providing the fixating penetrating element comprising a helical structure; and
manipulating the fixating penetrating element to engage the heart wall by screwing the helical structure into the heart wall.
providing the fixating penetrating element comprising a plurality of intersecting penetrating elements; and
manipulating the intersecting penetrating elements to engage the heart wall by forcing the intersecting penetrating elements into the heart wall.
providing the fixating penetrating element comprising a plurality of jaws operable from the proximal end of the catheter to open and close and a penetrating needle longitudinally movable from the catheter into the heart wall; and
manipulating the jaws to engage the heart wall and pushing the penetrating needle into the heart wall.
The method of claim 1 , 2 , 3 or 4 in which a confirmatory step occurs after the catheter is attached and before the agent is infused into the tissue, in which contrast agent is infused into the heart chamber to visually confirm that the catheter is positioned appropriately.
The method of claim 1 , 2 , 3 or 4 in which a confirmatory step occurs after the catheter is attached and before the agent is infused into the tissue, in which contrast agent is infused into the heart tissue to visually confirm that the catheter is positioned appropriately.
The method of claim 1 , 2 , 3 or 4 further comprising the step of:
confirming the position of the catheter distal end within the heart by infusing contrast agent into the heart chamber through the catheter.
The method of claim 5 in which the contrast is delivered through an outer guide catheter system.
The method of claim 7 further comprising the steps of:
providing a guide catheter adapted for percutaneous insertion into the heart, said guide catheter having a proximal end and a distal end and a lumen extending from the proximal end to the distal end;
inserting the guide catheter into the heart;
inserting the catheter through the guide catheter lumen and into the heart;
delivering contrast agent through the guide catheter lumen to the heart.
The method of claim 1 in which the contrast is delivered through a distal port in the drug delivery catheter which is fixed to the heart wall.
infusing a passive agent in a volume equivalent to 1 to 5 times the volume of the drug delivery lumen.
The method of claim 1 in which the volume of the drug delivery lumen in the delivery catheter is between 0.05 and 0.25 milliliters.
A catheter for interstitial delivery that has two lumens which connect to one another prior to the distal penetrating element.
A drug delivery catheter for injection of small doses of a therapeutic agent into the heart wall, said drug delivery catheter comprising:
a catheter tube adapted for percutaneous insertion into the heart, said catheter having a distal end adapted for insertion in to the heart and a proximal end housed within a housing;
a first lumen extending through the catheter, said lumen having a distal end adapted for fluid injection into the heart and a proximal end adapted for connection to one or more fluid reservoirs;
a first fluid reservoir releasably secured to the housing;
a second fluid reservoir releasably secured to the housing;
a valve communicating with the proximal end of the first lumen, said valve permitting selective connection of the fluid sources to the proximal end of the first lumen;
a first fluid connection connecting the first fluid reservoir to the valve;
a second fluid connection connecting the second fluid reservoir to the valve;
a first actuator for forcing fluid from the first fluid reservoir through the valve and into the first lumen;
a second actuator operably connected to the second fluid reservoir for forcing fluid from the second fluid reservoir through the valve and into the first lumen; and
a penetrating needle disposed on the distal tip of the first lumen, said penetrating needle adapted to penetrate the heart wall.
The device of claim 14 wherein the first fluid connection comprises a length of distensible tubing.
The device of claim 14 further comprising:
a second lumen extending from the housing to the distal end of the catheter, and a third fluid connection in fluid communication with the proximal end of second lumen and adapted for connection to a fluid source, and a fluid port in the catheter at the distal end of the catheter providing a fluid pathway between the second lumen and the exterior of the catheter.
A method of injecting therapeutic agents in to the body, said method comprising:
providing a drug delivery catheter for injection small doses of therapeutic agent into the body, said drug delivery catheter comprising:
a first fluid reservoir releasably secured within the housing;
a second fluid reservoir releasably secured within the housing;
a second actuator operably connected to the second fluid reservoir for forcing fluid from the second fluid reservoir through the valve and into the first lumen;
placing a first fluid in the first fluid reservoir;
placing a second fluid in the second fluid reservoir;
forcing a predetermined volume of the first fluid from the first fluid reservoir into the first lumen; and
forcing a volume of the second fluid from the second fluid reservoir into the first lumen.
The method of claim 17 wherein;
the step of forcing a volume of second fluid from the second fluid reservoir into the first lumen precedes the step of forcing a predetermined volume of the first fluid from the first fluid reservoir into the first lumen.
the step of forcing a volume of second fluid from the second fluid reservoir into the first lumen is repeated after the step of forcing a predetermined volume of the first fluid from the first fluid reservoir into the first lumen.
The method of claim 17 further comprising:
providing a therapeutic agent in the first fluid;
providing a passive agent in the second fluid.
providing an activating agent in the second fluid, wherein said activating agent interacts with the first fluid to alter the first fluid.
providing a therapeutic agent in the first fluid, wherein said therapeutic agent comprises a therapeutic compound encapsulated in a liposome capsule;
providing an activating agent in the second fluid, wherein said activating fluid has a pH which destabilizes the liposome capsules in the first fluid.
a catheter tube adapted for insertion into the heart, said catheter having a distal end adapted for insertion into the heart and a proximal end housed within a housing;
a first lumen extending through the catheter, said lumen having a distal end adapted for fluid injection into the heart through a fixating penetrating element, said fixating penetrating element having a base, and a proximal end connected to a first at least one fluid reservoir; and
a second lumen extending through the catheter, said second lumen having a proximal end connected to a second at least one fluid reservoir, and said lumen having a distal end terminating at the base of a fixating penetrating element.
A catheter as in claim 23 where the fixating penetrating element is a hollow helix.
Ref US20180207398A1: [content unavailable]
Ref US20190275312A1: Claims:
A vascular access site management system for receiving a medical implement, the vascular access site management system comprising: a stabilization body having a base, and an upper portion having a first end configured to be connected to a vascular access device and a second end configured to receive the medical implement, the stabilization body also having a flow path connecting the first end and the second end along a substantially linear pathway; a port located at the second end of the upper portion of the stabilization body and configured to connect with the medical implement, the medical implement having a distal tip and a passage extending through a 
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