Office Action 2: Notice of Allowance (2025-04-16)

CLAIMS:
Listing of Claims:

Amendments to the ClaimsThis listing of claims will replace all prior versions, and listings, of claims in the application:

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 SVG {EMBED HERE} 0.152.027 from the central chamber to a male luer connector;SVG {EMBED HERE} 0.155.297SVG {EMBED HERE} 0.151.287a blood sample fluid passage SVG {EMBED HERE} 0.151.807 from the central chamber to a SVG {EMBED HERE} 0.150.88 female luer connector;SVG {EMBED HERE} 0.155.447SVG {EMBED HERE} 0.152.937a waste fluid passage SVG {EMBED HERE} 0.1472.027 from the central chamber to aSVG {EMBED HERE} 0.1130.72 female luer connector; andSVG {EMBED HERE} 0.155.183SVG {EMBED HERE} 0.151.383a rotatable flow control member disposed within the central chamber and comprising a T- shaped fluid passage, wherein the rotatable flow control member -sSVG {EMBED HERE} 0.150.883SVG {EMBED HERE} 0.1430.78 adjustable fluid communication between the inlet fluid passage, the blood sample fluid passage, and/or the waste fluid passage; anda lever connected to the rotatable flow control member SVG {EMBED HERE} 0.150.643 to permit selective rotation of the rotatable flow control member and control fluid flow between the fluid passages, wherein the inletSVG {EMBED HERE} 0.151.183bloodsamplSVG {EMBED HERE} 0.152.877e
SVG {EMBED HERE} 0.1471.137

fluid have an inner cross-sectional area in the range from 0.3 to 2.0 square millimeters.
2\. (Currently Amended) The microvolume 3-way stopcock for use in a blood sampling system according to claim 1, wherein the microvolume 3-way stopcock has a dead space SVG {EMBED HERE} 0.1172.487\_Ime~oSVG {EMBED HERE} 0.152.30SVG {EMBED HERE} 0.156.423------------------------------------------------------------------------------------------- ----- ------- ------ ----------SVG {EMBED HERE} 0.156.283SVG {EMBED HERE} 0.156.187vSVG {EMBED HERE} 0.0970.403 in the range of 0.02 to 0.20 mL.SVG {EMBED HERE} 0.110.843
3\. (Currently Amended) The microvolume 3-way stopcock for use in a blood sampling system according to claim 1, wherein the microvolume 3-way stopcock has a flhAemdead space SVG {EMBED HERE} 0.155.55SVG {EMBED HERE} 0.156.427SVG {EMBED HERE} 0.156.29SVG {EMBED HERE} 0.1476.173SVG {EMBED HERE} 0.110.48 in the range of 0.02 to 0.15 mL.SVG {EMBED HERE} 0.110.107
4\. (Currently Amended) The microvolume 3-way stopcock for use in a blood sampling system according to claim 1, wherein the microvolume 3-way stopcock has a dead space SVG {EMBED HERE} 0.1174.447wSVG {EMBED HERE} 0.1430.73SVG {EMBED HERE} 0.156.43-----------'---SVG {EMBED HERE} 0.156.273SVG {EMBED HERE} 0.156.18SVG {EMBED HERE} 0.1130.49 in the range of 0.02 to 0.10 mL.SVG {EMBED HERE} 0.1130.85

5\. (Cancelled).

6\. (Currently Amended) The microvolume 3-way stopcock for use in a blood sampling system according toclaim h0,i1Bt°;\_oitpningd3aaalenohciie wherein themicrovolume 3-way stopcock and SVG {EMBED HERE} 0.0830.033ecannula have a combined dead space fluid volume SVG {EMBED HERE} 0.1132.617SVG {EMBED HERE} 0.152.2271,ni.totheSVG {EMBED HERE} 0.156.32SVG {EMBED HERE} 0.154.317SVG {EMBED HERE} 0.1171.723bSVG {EMBED HERE} 0.156.233SVG {EMBED HERE} 0.152.313 n the range from 0.03 to 0.24 mL.SVG {EMBED HERE} 0.1370.997
7\. (Currently Amended) The microvolume 3-way stopcock for use in a blood sampling system according to The microvolume 3-way stopcock for use in a blood sampling system according toSVG {EMBED HERE} 0.111.097ga1SVG {EMBED HERE} 0.1371.31thr wherein SVG {EMBED HERE} 0.110.19 microvolume 3-way stopcock and =e cannula have a combined dead space fluid volume wSVG {EMBED HERE} 0.154.487SVG {EMBED HERE} 0.0970.1531h.isnitheSVG {EMBED HERE} 0.156.32SVG {EMBED HERE} 0.156.457SVG {EMBED HERE} 0.153.283om00SVG {EMBED HERE} 0.0770.137o0.1SVG {EMBED HERE} 0.151.973SVG {EMBED HERE} 0.152.487 the range from 0.03 to 0.19 mL.SVG {EMBED HERE} 0.151.303
8\. (Currently Amended) The microvolume 3-way stopcock for use in a blood sampling system according to claim wherein SVG {EMBED HERE} 0.110.19 microvolume 3-way stopcock and SVG {EMBED HERE} 0.0870.187 cannula have a combined dead space fluid volume wSVG {EMBED HERE} 0.154.3071.ckdituytheSVG {EMBED HERE} 0.156.32--N-i--v-'aSVG {EMBED HERE} 0.156.457SVG {EMBED HERE} 0.156.233SVG {EMBED HERE} 0.152.313 in the range from 0.03 to 0.14 mL.SVG {EMBED HERE} 0.154.503
9\. (Currently Amended) A blood sampling system comprising:
a microvolume 3-way stopcock according to claim 1;a cannula connected to the male luer SVG {EMBED HERE} 0.0870.623;
SVG {EMBED HERE} 0.0870.633SVG {EMBED HERE} 0.100.717

a self-venting blood sample syringe connected to the SVG {EMBED HERE} 0.1470.883 female luer SVG {EMBED HERE} 0.090.623 of the blood sample fluid passage; anda self-venting waste syringe connected to the female luer of the waste fluid passage.

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 blood sample fluid passage having a bloodSVG {EMBED HERE} 0.1330.457 female luer connector;a waste fluid passage having a SVG {EMBED HERE} 0.1130.583di 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,and/or the waste fluid passage,wherein SVG {EMBED HERE} 0.111.373totlSVG {EMBED HERE} 0.1031.593gthe microvolume 3-way stopcock and cannula have a SVG {EMBED HERE} 0.1070.397neW.dead space SVG {EMBED HERE} 0.1130.297\_\_\_ volume SVG {EMBED HERE} 0.070.073j:iielhSVG {EMBED HERE} 0.1173.093wSVG {EMBED HERE} 0.1370.583YSVG {EMBED HERE} 0.155.40SVG {EMBED HERE} 0.155.49....:.....SVG {EMBED HERE} 0.155.43SVG {EMBED HERE} 0.151.92~SVG {EMBED HERE} 0.151.773SVG {EMBED HERE} 0.110.623N~lC.)'volumeC in the range from 0.03 to 0.24 mL connecting a self-venting first blood sample syringe to the SVG {EMBED HERE} 0.1470.887 female luer connector of the blood sample fluid passage and connecting a self-venting waste syringe to the SVG {EMBED HERE} 0.1130.533idJ: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\. (Currently Amended) 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; andSVG {EMBED HERE} 0.150.877removing the first blood sample syringe from the female luer connector of the blood sample fluid passage.

12\. (Original) The method for obtaining a clean blood specimen according to claim 10, wherein the arterial line comprises an indwelling umbilical catheter.

13\. (Original) The method for obtaining a clean blood specimen according to claim 10, wherein the arterial line comprises a peripheral arterial line.
14\. (Currently Amended) The method for obtaining a clean blood specimen according to claim 10, wherein after connecting the self-venting first blood sample syringe to the bSVG {EMBED HERE} 0.1470.453 female luer connector of the blood sample fluid passage, setting the self-venting first blood sample syringe to a desired blood sample volume.SVG {EMBED HERE} 0.1130.28
15\. (Currently Amended) The method for obtaining a clean blood specimen according to claim 10, wherein after connecting the self-venting waste syringe to the wasSVG {EMBED HERE} 0.1130.297\_ female luer connector of the waste fluid passage, setting the self-venting waste syringe to a desired waste blood volume.

16\. (Currently Amended) 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 SVG {EMBED HERE} 0.1470.887female luer connector of the blood sample fluid passage;connecting a self-venting second blood sample syringe to the SVG {EMBED HERE} 0.1470.87 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\. (Currently Amended) The method for obtaining a clean blood specimen according to claim 1.....m.etSVG {EMBED HERE} 0.1470.96SVG {EMBED HERE} 0.156.03SVG {EMBED HERE} 0.156.36SVG {EMBED HERE} 0.155.447SVG {EMBED HERE} 0.154.91SVG {EMBED HERE} 0.155.727n-ddtiSVG {EMBED HERE} 0.1374.223
SVG {EMBED HERE} 0.152.267SVG {EMBED HERE} 0.155.627SVG {EMBED HERE} 0.153.257SVG {EMBED HERE} 0.155.92SVG {EMBED HERE} 0.156.16SVG {EMBED HERE} 0.1471.02318. (Currently Amended) The method for obtaining a clean blood specimen according to claim 10, wherein -;e:microvolume 3-way stopcock and SVG {EMBED HERE} 0.110.193 cannula have a combined dead space fluid volume in the range from 0.03 to 0.19 mL.

Reply to Office Action of November 19, 2024
19\. (Currently Amended) The method for obtaining a clean blood specimen according to claim 10, wherein :he microvolume 3-way stopcock and \_cannula have a combined dead space fluid volume in the range from 0.03 to 0.14 mL.SVG {EMBED HERE} 0.0970.187

20\. (New) The microvolume 3-way stopcock for use in a blood sampling system according to claim 1, wherein T-shaped fluid passage has an inner cross-sectional area in the range from 0.3 to 2.0 square millimeters.

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)]

APPLICANT REBUTTAL: REMARKS/ARGUMENTS
Claims 1-11 and 14-19 are amended for clarity. New claim 20 is added. Support for claim 20 may be found in original claim 1. The specification is amended to correct several clerical errors and to be consistent with claim expressions. Applicant respectfully requests favorable reconsideration.
Examiner Interview
Applicant expresses appreciation to Examiner Lopez for discussing the pending
application and Office Action with Applicant's attorney on January 24, 2025. The deficiencies in the cited prior art, particularly the Langevin and Ellingson references, were presented. Regrettably, Examiner Lopez confessed he had insufficient time to consider Applicant's interpretation of the prior art and the deficiencies of his "result effective variable" legal theories advanced in the Office Action. No agreement was reached.
Claim Objections
The Office objected to claims 1, 6-8, 10, 18, and 19 because of minor informalities. The claims have been amended to address the informalities. Applicant respectfully requests withdrawal of the claim objections.
Claim Rejections - 35 U.S.C. § 112
The Office rejected claims 1-4, 6-8, and 17-19 under 35 U.S.C. 112(b) as being
indefinite. The claims have been amended to provide proper antecedent basis and clarity to address the issues identified in the Office Action. Applicant respectfully requests withdrawal of the rejection under 35 U.S.C. 112(b).
Claim Rejections - 35 U.S.C. § 103
The Office rejected claims 1, 5, and 9 under 35 U.S.C. 103 as being unpatentable over Clarke (U.S. Patent No. 4,447,235) in view of Ellingson (U.S. Patent No. 6,217,556) and Langevin (U.S. Patent No. 6,156,019).
The Office based these rejections on the application of legal precedent that the claimed inner cross sectional area is a "result effective variable" that would have been obvious to "optimize." Applicant respectfully submits that the present facts do not support proper application of the asserted legal precedent. MPEP 2144 states that legal precedent may be used to support obviousness only if the facts of the case are sufficiently similar to those of the application.
The Office acknowledges that Clarke fails to disclose that the recited inlet, blood sample, and waste fluid passages have an inner cross-sectional area in the range from 0.3 to 2.0 square millimeters. The Office cited Langevin (Col. 5, lines 58-63) as disclosing the second channel 10 having an inner cross-sectional area from 0.3 to 2.0 square millimeters.
F G. 1A
As shown in Langevin's Fig. lA, Langevin's second channel 10 does not correspond to the claimed "inlet fluid passage," "blood sample fluid passage," and "waste fluid passage" of the stopcock body. Langevin discloses second channel 10 bypassing at least two 3-way stopcocks, the three-way stopcock 5 and the double barreled stopcock 7. Thus, Langevin clearly discloses that the second channel 10 is not intended to correspond to any fluid passage of a 3-way stopcock.
Recognizing this deficiency, the Office argues that the cross-sectional area of the "inlet fluid passage," "blood sample fluid passage," and "waste fluid passage" is a "result effective variable" that can be optimized and modified as a matter of "routine optimization." Applicant respectfully disagrees for at least two reasons.
First, the Office has failed to establish that the cross-sectional area of the "inlet fluid
passage," "blood sample fluid passage," and "waste fluid passage" is a result effective variable. The Office has merely established that the cross-sectional area of Langevin's second channel 10 can be modified to control the flow rate through Langevin's second channel 10. However, Langevin's second channel 10 is not an "inlet fluid passage," "blood sample fluid passage," and "waste fluid passage" of a microvolume 3-way stopcock. Therefore, there is no evidence in the record that Langevin recognized the cross-sectional area of the "inlet fluid passage," "blood sample fluid passage," and "waste fluid passage" to be a result effective variable.
Second, a person skilled in the art of fluid dynamics understands when one fluid channel is divided into two parallel fluid channels, as disclosed by Langevin, that the flow rate within the divided channels is controlled by the cross-sectional area of the respective fluid channels. This principle is relevant to Langevin's device, but it is irrelevant to the presently claimed invention which does not utilize parallel fluid flow channels. Thus, cross-sectional area may be a result effective variable in the parallel fluid flow structure of Langevin, but it is NOT a result effective variable in the "inlet fluid passage," "blood sample fluid passage," and "waste fluid passage" of Applicant's claimed microvolume 3-way stopcock.
The Office has failed to clearly articulate why a person having ordinary skill in the art would have modified the cross-sectional area of Clarke's "inlet fluid passage," "blood sample
fluid passage," and "waste fluid passage" based upon the Langevin's second channel 10. Therefore, the Office has failed to establish prima facie obviousness under 35 U.S.C. 103.
Regarding claim 5, claim 1 has been amended to expressly recite the cannula insert, the blood sample cone, and the waste cone. The Office Action asserted that Clarke's adapter 29 fixed to the proximate end 27 of the catheter 23 (Clarke, col. 3, lines 2-3) corresponds to the "cannula insert". Applicant respectfully disagrees. Clarke's catheter adapter 29 is merely the structure located at the proximate end 27 of the catheter 23 which enables the catheter to be snugly fit on the exterior surface of the arm 33. It is not
disposed within the inlet fluid passage;
instead, it is essentially a female connector
disposed on the exterior
of the male connector (arm 33).
The Office Action further asserts that Clark's connector 48 located at the proximate end of the needle 45 (Clarke, col. 3, lines 42-44) corresponds to the "blood sample cone." Applicant respectfully disagrees. Clarke's connector 48 is merely the adapter structure which enables the needle to be attached to the hollow projection 50 at the end of a syringe 47, 49. It is not
disposed within the blood sample fluid passage;
instead, it is essentially a female connector
disposed on the exterior
of the male connector (hollow projection 50 at the end of syringe 49).
The Office Action further asserts that Clarke's adapter 83 used to connect tube 82 to the side arm 59 (Clarke, col. 5, lines 12-16; Fig. 1) corresponds to the "waste cone." Applicant respectfully disagrees. Clarke's adapter 83 is merely the structure which enables the tube 82 to be snugly fit on the exterior surface of the arm 59. It is not
disposed within the waste fluid
passag
e;
instead, it is essentially a female connector
disposed on the exterior
of the male connector (arm 59).
The Office has failed to identify any structures in the cited prior art which reasonably correspond to the claimed cannula insert, blood sample cone, and waste cone. Applicant respectfully submits that amended claim 1 would not have been obvious under 35 U.S.C. 103 from Clarke in view of Ellingson and Langevin. Applicant respectfully requests withdrawal of the rejection and allowance of claim 1 and its respective dependent claims 2-4, 6-10, and 20.
The Office rejected claims 10-12 and 14-19 under 35 U.S.C. 103 as being unpatentable over Ellingson in view of Jho (U.S. Publication No. 2018/0207398) and Altman. These claims are directed to a specific
method for obtaining a clean blood specimen.
Ellingson in view of Jho and Altman fail to disclose the specifically claimed method. Ellingson in view of Jho and Altman disclose some apparatus elements that may be manipulated in different methods, but the claimed method for obtaining a clean blood specimen is not disclosed or suggested in the cited prior art. For instance, the Office Action does not identify at least the following method steps in the cited prior art:
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 syrin
ge;
...; and
returning the waste blood from the waste syrin
g
e to the patient.
Applicant respectfully submits that claim 11 would not have been obvious under 35 U.S.C. 103 from Ellingson in view of Jho and Altman. Applicant respectfully requests withdrawal of the rejection and allowance of claim 11 and its respective dependent claims 12-19.
Applicant respectfully requests that a timely Notice of Allowance be issued in this case. If there are any remaining issues preventing allowance of the pending claims that may be clarified by telephone, the Examiner is requested to call the undersigned.
Respectfully submitted,


CITED REFERENCE SUMMARIES: Ref US20160213911A1: Claims:
An antimicrobial insert device for placement within a fluid pathway of a stopcock tap.
The device of claim 1 , wherein the antimicrobial insert is comprised of an antimicrobial material.
The device of claim 1 , wherein the antimicrobial insert is coated with an antimicrobial material.
The device of claim 1 , comprising an annulus shape having an outer circumference defining an outer surface, and an inner circumference defining a fluid pathway through the antimicrobial insert.
The device of claim 4 , wherein the outer circumference is selected to compatible seat the antimicrobial insert within the fluid pathway of the stopcock tap.
The device of claim 5 , wherein the fluid pathway of the stopcock tap comprises an annular bore.
The device of claim 1 , comprising a three-dimensional matrix forming a frame structure and having a plurality of apertures.
The device of claim 7 , wherein the insert is comprised of an antimicrobial material.
The device of claim 7 , wherein the insert is coated with an antimicrobial material.
The device of claim 1 , further comprising an antimicrobial composition that either comprises or coats the insert, wherein the antimicrobial composition is selected from the group consisting of chlorhexidine diacetate, chlorhexidine gluconate, alexidine, silver sulfadiazine, silver acetate, silver citrate hydrate, cetrimide, cetyl pyridium chloride, benzalkonium chloride, o-phthalaldehyde, and silver element.
A stopcock medical connector device, comprising: a housing having a proximal opening, a distal end, and an inner lumen extending therebetween, the housing further comprising a plurality of side ports extending outwardly from the inner lumen, each side port having a hollow interior in fluid communication with the inner lumen; a tap rotatably seated in the inner lumen of the housing and comprising an annular bore forming a fluid pathway through a shaft portion of the tap, wherein the tap is rotated within the inner lumen to align the plurality of side ports with the annular bore to provide fluid communication between the plurality of side ports and the annular bore; and an antimicrobial insert seated within the annular bore in proximity to the inner lumen.
a housing having a proximal opening, a distal end, and an inner lumen extending therebetween, the housing further comprising a plurality of side ports extending outwardly from the inner lumen, each side port having a hollow interior in fluid communication with the inner lumen;
a tap rotatably seated in the inner lumen of the housing and comprising an annular bore forming a fluid pathway through a shaft portion of the tap, wherein the tap is rotated within the inner lumen to align the plurality of side ports with the annular bore to provide fluid communication between the plurality of side ports and the annular bore; and
an antimicrobial insert seated within the annular bore in proximity to the inner lumen.
The device of claim 11 , wherein the antimicrobial insert comprises an annulus shape having an outer circumference defining an outer surface, and an inner circumference defines a fluid pathway through the antimicrobial insert, wherein the annular bore is in fluid communication with the plurality of side ports via the fluid pathway of the antimicrobial insert.
The device of claim 11 , wherein the plurality of side ports each comprise an inner diameter that is less than the outer circumference, and greater than the inner circumference of the antimicrobial insert.
The device of claim 13 , further comprising a plurality of annular bores.
The device of claim 14 , further comprising a plurality of antimicrobial inserts.
The device of claim 11 , wherein the antimicrobial comprises a three-dimensional matrix forming a frame structure having a plurality of apertures.
The device of claim 16 , wherein the insert is comprised of an antimicrobial material.
The device of claim 16 , wherein the insert is coated with an antimicrobial material.
A method for manufacturing a stopcock medical connector device, the method comprising steps for: providing a housing having a proximal opening, a distal end, and an inner lumen extending therebetween, the housing further comprising a plurality of side ports extending outwardly from the inner lumen, each side port having a hollow interior in fluid communication with the inner lumen; rotatably seating a tap in the inner lumen of the housing, the tap comprising an annular bore forming a fluid pathway through a shaft portion of the tap, wherein the tap is rotated within the inner lumen to align the plurality of side ports with the annular bore to provide fluid communication between the plurality of side ports and the annular bore; and inserting an antimicrobial insert within the annular bore and in proximity to the inner lumen.
providing a housing having a proximal opening, a distal end, and an inner lumen extending therebetween, the housing further comprising a plurality of side ports extending outwardly from the inner lumen, each side port having a hollow interior in fluid communication with the inner lumen;
rotatably seating a tap in the inner lumen of the housing, the tap comprising an annular bore forming a fluid pathway through a shaft portion of the tap, wherein the tap is rotated within the inner lumen to align the plurality of side ports with the annular bore to provide fluid communication between the plurality of side ports and the annular bore; and
inserting an antimicrobial insert within the annular bore and in proximity to the inner lumen.
The method of claim 19 , wherein the antimicrobial insert comprises an annulus shape having an outer circumference defining an outer surface, and an inner circumference defines a fluid pathway through the antimicrobial insert, wherein the annular bore is in fluid communication with the plurality of side ports via the fluid pathway of the antimicrobial insert.
Ref US20180207398: Claims:
1. A system for accessing an umbilical blood vessel, comprising:
an elongated catheter having a proximal end and a distal end and an internal lumen, the elongated catheter also having a distal opening that communicates with the internal lumen and a proximal opening that communicates with the internal lumen, and wherein a distal region of the catheter is sized and shaped to be inserted into the umbilical blood vessel; an access port on the proximal end of the elongated catheter, the access port providing access to the internal lumen of the catheter, wherein the access port includes a seal that prevents entry of fluid into the catheter.
2. A system as in claim 1, wherein the access port is removably attached to the catheter.
3. A system as in claim 1, wherein the access port is fixedly attached to the catheter.
4. A system as in claim 1, wherein the seal of the port prevents entry of fluid into the catheter until the seal is broken.
5. A system as in claim 1, wherein the blood vessel is an umbilical vein.
6. A system as in claim 1, wherein the seal is a septum.
7. A system as in claim 1, wherein the septum is made of a material that can be pierced by a cannula to provide access to an internal reservoir of the access port.
8. A method of accessing an umbilical vein, comprising:
cutting an umbilical cord of a patient to expose a blood vessel of the umbilical cord; inserting a catheter into the blood vessel, wherein the catheter includes an access port located on a distal region of the catheter, wherein the access port includes a seal that provides access to a lumen of the umbilical vessel via a catheter lumen of the catheter; maintaining the access port external to the patient; treating the blood vessel via the catheter.
9. A method as in claim 1, wherein the blood vessel is an umbilical vein.
10. A method as in claim 1, further comprising attaching the access port to the catheter prior to inserting the catheter into the blood vessel.
11. A method as in claim 1, wherein the access port is pre-attached to the catheter prior to inserting the catheter into the blood vessel.
12. A method as in claim 11, wherein a user does not attach the access port to the catheter.
13. A method as in claim 11, wherein a user must break the seal of the access port to gain access to the blood vessel via the catheter.
Ref US20160213911: Claims:
1. An antimicrobial insert device for placement within a fluid pathway of a stopcock tap.
2. The device of claim 1, wherein the antimicrobial insert is comprised of an antimicrobial material.
3. The device of claim 1, wherein the antimicrobial insert is coated with an antimicrobial material.
4. The device of claim 1, comprising an annulus shape having an outer circumference defining an outer surface, and an inner circumference defining a fluid pathway through the antimicrobial insert.
5. The device of claim 4, wherein the outer circumference is selected to compatible seat the antimicrobial insert within the fluid pathway of the stopcock tap.
6. The device of claim 5, wherein the fluid pathway of the stopcock tap comprises an annular bore.
7. The device of claim 1, comprising a three-dimensional matrix forming a frame structure and having a plurality of apertures.
8. The device of claim 7, wherein the insert is comprised of an antimicrobial material.
9. The device of claim 7, wherein the insert is coated with an antimicrobial material.
10. The device of claim 1, further comprising an antimicrobial composition that either comprises or coats the insert, wherein the antimicrobial composition is selected from the group consisting of chlorhexidine diacetate, chlorhexidine gluconate, alexidine, silver sulfadiazine, silver acetate, silver citrate hydrate, cetrimide, cetyl pyridium chloride, benzalkonium chloride, o-phthalaldehyde, and silver element.
11. A stopcock medical connector device, comprising:
a housing having a proximal opening, a distal end, and an inner lumen extending therebetween, the housing further comprising a plurality of side ports extending outwardly from the inner lumen, each side port having a hollow interior in fluid communication with the inner lumen; a tap rotatably seated in the inner lumen of the housing and comprising an annular bore forming a fluid pathway through a shaft portion of the tap, wherein the tap is rotated within the inner lumen to align the plurality of side ports with the annular bore to provide fluid communication between the plurality of side ports and the annular bore; and an antimicrobial insert seated within the annular bore in proximity to the inner lumen.
12. The device of claim 11, wherein the antimicrobial insert comprises an annulus shape having an outer circumference defining an outer surface, and an inner circumference defines a fluid pathway through the antimicrobial insert, wherein the annular bore is in fluid communication with the plurality of side ports via the fluid pathway of the antimicrobial insert.
13. The device of claim 11, wherein the plurality of side ports each comprise an inner diameter that is less than the outer circumference, and greater than the inner circumference of the antimicrobial insert.
14. The device of claim 13, further comprising a plurality of annular bores.
15. The device of claim 14, further comprising a plurality of antimicrobial inserts.
16. The device of claim 11, wherein the antimicrobial comprises a three-dimensional matrix forming a frame structure having a plurality of apertures.
17. The device of claim 16, wherein the insert is comprised of an antimicrobial material.
18. The device of claim 16, wherein the insert is coated with an antimicrobial material.
19. A method for manufacturing a stopcock medical connector device, the method comprising steps for:
providing a housing having a proximal opening, a distal end, and an inner lumen extending therebetween, the housing further comprising a plurality of side ports extending outwardly from the inner lumen, each side port having a hollow interior in fluid communication with the inner lumen; rotatably seating a tap in the inner lumen of the housing, the tap comprising an annular bore forming a fluid pathway through a shaft portion of the tap, wherein the tap is rotated within the inner lumen to align the plurality of side ports with the annular bore to provide fluid communication between the plurality of side ports and the annular bore; and inserting an antimicrobial insert within the annular bore and in proximity to the inner lumen.
20. The method of claim 19, wherein the antimicrobial insert comprises an annulus shape having an outer circumference defining an outer surface, and an inner circumference defines a fluid pathway through the antimicrobial insert, wherein the annular bore is in fluid communication with the plurality of side ports via the fluid pathway of the antimicrobial insert.
Ref US4447235: Claims:
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.
Ref US6217556: Claims:
1. A catheter assembly, comprising:
a catheter;
a needle removably contained within the catheter;
a first valve secured to the catheter; and
a self-sealing valve secured to the first valve;
the first valve being removably secured to the catheter, the first valve being additionally removably secured to the self-sealing valve;
whereby the catheter can be disassembled from the first valve and the first valve can be disassembled from the self-sealing valve.
2. The catheter assembly of claim 1, further wherein the first valve is removable secured by a Luer connection.
3. The catheter assembly of claim 1, further wherein the self-sealing valve is removably secured by a Luer connection.
4. The catheter assembly of claim 1, wherein the self-sealing valve comprises a biased ball check valve.
5. The catheter assembly of claim 1, wherein the first valve comprises a three way valve.
6. The catheter assembly of claim 5, wherein the three way valve is a stop cock.
7. A catheter assembly, comprising:
a catheter comprising a Luer connection;
a needle removably contained with the catheter; and
a sealing valve comprising a Luer connection, the Luer connection of the self-sealing valve cooperating with the Luer connection of the catheter to removably secure the self-sealing valve to the catheter;
whereby the catheter can be dissembled from the self-sealing valve.
8. The catheter assembly of claim 2, wherein the self-sealing valve comprises a biased ball check valve.
9. The catheter assembly of claim 2, further including a first valve removably secured to the catheter and to the self-sealing valve.
10. The catheter assembly of claim 9, further wherein the first valve is removably secured by a Luer connection.
11. The catheter assembly of claim 9, wherein the first valve comprises a three way valve.
12. The catheter assembly of claim 11, wherein the three way valve is a stop cock.
Ref US6156019: Claims:
1. 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.
2. 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.
3. 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.
4. The device, according to claim 3, wherein said flushing means comprises a second channel having 
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