DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because of the following informalities:
“indentation 58” in para. [0063] should recite “indentation 158”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 and 22 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 (claims 2-17 by virtue of dependency) recites the limitation "a patient" in line 12. It is unclear if this is referring to the same or a different patient than recited in line 3. The limitation is suggested to recite “the patient”.
The term “substantially” in claim 2 line 2 (claim 3 by virtue of dependency), claim 3 line 2, claim 4 line 2, claim 10 line 2 (claims 1-17 by virtue of dependency), and claim 22 line 2 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore the limitations “wherein blood drawn from the patient is prevented from substantially flowing through the second outlet until the blood collection means is inserted into the tube holder”; “wherein an air bubble associated with the second outlet prevents a substantial amount of blood from exiting the second outlet”; “wherein blood drawn from the patient is prevented from substantially flowing into the second needle until the blood collection means is inserted into the tube holder”; “wherein blood drawn from the patient is prevented from substantially flowing through the second outlet until the sample collection vessel is inserted into the tube holder” in claims 2, 3, 4, 10, and 22, respectively, are rendered indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kater (US 5046509 A) in view of Pizzi (US 20170319118 A1), and further in view of Mileikowsky (US 4409990 A).
Regarding claim 1, Kater discloses a system for sequestering blood and providing a blood sample (fig. 1, Abstract) comprising: a primary connector (coupling 126, fig. 1) having an inlet (connector member 134, fig. 1), a first outlet (port 140/passageway 162, fig. 1), and a second outlet (adapter sleeve 138, fig. 1, “first and second ports”, claim 1); a first needle (needle 100, fig. 1) configured for (Examiner’s Note: functional language, i.e., capable of) drawing blood from a patient (col. 4 lines 60-col. 5 line 35 & col. 5 line 54 – col. 6 line 19); a tube (tubing 122, fig. 1) extending from the first needle (as seen in fig. 1) and ending in a connector (second end 128, fig. 1) configured to (Examiner’s Note: functional language, i.e., capable of) interconnect to the inlet (as seen in fig. 1, col. 3 lines 52-66); a valve (valve 200, fig. 2, col. 4 lines 51-59) associated on one end with the first outlet (“port 140 may include valve 200”, col. 4 lines 51-59), and on a second end with a syringe (first blood storage device/syringe 130, fig. 1, “130 comprises a syringe”; “fluid communication between the shaft 136 and the first blood storage device 130”, col. 4 lines 35-59); a tube holder (“blood storage device 132 may comprise a Becton and Dickenson (BD) Vacutainer and Vacutainer Adapter”, col. 5 lines 15-22) having a first end (needle hub 156, as seen in fig. 1) configured to (Examiner’s Note: functional language, i.e., capable of) interconnect to the second outlet (“138 ... snugly receive the needle hub 156”, col. 5 lines 15-53) and a second, open end (“adaptive coupling 158 (commonly referred to as a Vacutainer Adapter)”, Examiner note: (Vacutainer Adapters have an open end to receive a Vacutainer) adapted to (Examiner’s Note: functional language, i.e., capable of) receive a means for blood collection (“Becton and Dickenson (BD) Vacutainer and Vacutainer Adapter ... blood storage chamber 152”, col. 5 lines 15-35), the tube holder further comprising a second needle (needle 154, col. 5 lines 15-35); wherein the first needle is adapted to draw blood from a patient that is directed to the primary connector and out of the first outlet (“port 140 and the blood storage device 130 coupled thereto ... blood may be withdrawn ... first portion of blood is withdrawn from the coupling 126 into the blood storage device 130”, col. 4 line 60-col. 5 line 35 & col. 5 line 54 – col. 6 line 19), and wherein blood is drawn into the syringe through the valve when a plunger of the syringe is pulled to create a negative pressure (“plunger 148 ... withdrawn ... blood drawn into the chamber ... port 140 may include a valve 200”, col. 4 lines 35-59).
Kater further discloses that the valve may be readily selected from several commercial embodiments of valves readily available to those skilled in the art and other alternative apparatus may be substituted for the valve 200 (col. 4 lines 35-59). Kater does not expressly disclose a unidirectional valve.
However, Pizzi directed to devices that can be used for taking a sample of a biological fluid from a subject discloses a unidirectional valve (valve 14a-14b, fig. 4; “one automatic-closing or one-way valve”; “non-return valves”, Abstract, para. [0044, 0048-0049]). Pizzi further discloses a connection attachment 14 for attachment 2a of the syringe 2, the connector 14 integrates or has associated an automatically operated valve, and that in the presence of a flow with suitable pressure coming from the attachment 14, the open/close element 14a can recede, overcoming the elastic reaction of the spring 14b (para. [0044, 0048, 0095]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater such that the system comprises a unidirectional valve, in view of the teachings of Pizzi, as such a modification would have been merely a substitution of the valve of Kater for the automatic-closing or one-way valve of Pizzi and would aid in preventing reflux in the opposite direction (Pizzi, para. [0044, 0048, 0095]).
Kater, as modified by Pizzi hereinabove, does not disclose the second needle extending from the first end toward the second, open end, wherein the second needle is surrounded by a selectively rupturable shroud, and wherein the second needle is adapted to rupture the shroud and puncture the means for blood collection when the means for blood collection is inserted into the tube holder.
However, Mileikowsky directed to a fluid transport assembly discloses a tube holder (collection container holder 215, fig. 2) having a first end (unlabeled, but as seen in figs. 1C & 2) and a second open end (second end 275, as seen in figs. 1C & 2), a needle extending from the first end toward the second, open end (needle 20, as seen in fig. 2), and a means for blood collection (fluid collection container 250 comprising rubber stopper 270, fig. 1D-2), wherein the second needle is surrounded by a selectively rupturable shroud (protective sheath 50, fig. 2, col. 3 lines 28-38 & col. 4 lines 5-31), and wherein the second needle is adapted to rupture the shroud and puncture the means for blood collection when the means for blood collection is inserted into the tube holder (“fluid collection container 250 is pressed against the flexible sheath ... cutting edge 125 to pierce the flexible sheath 50 and the rubber stoper 270... blood to flow”, col. 3 lines 28-38 & col. 4 lines 5-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi hereinabove, such that the second needle extends from the first end toward the second, open end, wherein the second needle is surrounded by a selectively rupturable shroud, and wherein the second needle is adapted to rupture the shroud and puncture the means for blood collection when the means for blood collection is inserted into the tube holder, in view of the teachings of Mileikowsky, as this would aid in maintaining the sterility of the needle, preventing fluid from escaping from the needle assembly, and receiving/establishing fluid communication with the fluid collection container/Vacutainer.
Regarding claim 2, Kater, as modified by Pizzi and Mileikowsky hereinabove, discloses the system of claim 1, wherein blood drawn from the patient is prevented from substantially flowing through the second outlet until the blood collection means is inserted into the tube holder (“first portion of blood is withdrawn ... device 130 ... withdraw the anaerobic blood sample, the second blood storage device 132 is coupled ... removing the sealing from the needle 154 ... flow communication”, col. 4 line 60-col. 5 line 35 & col. 5 line 54-col. 6 line 19)..
Regarding claim 3, Kater, as modified by Pizzi and Mileikowsky hereinabove, discloses the system of claim 2, wherein an air bubble associated with the second outlet prevents a substantial amount of blood from exiting the second outlet (“air trapped ... coupling 126 ... vented via plug 142 ... first portion of contaminated blood is withdrawn from the coupling ... 130”, col. 5 line 54 – col. 6 line 19).
Regarding claim 4, Kater, as modified by Pizzi and Mileikowsky hereinabove, the system of claim 1, wherein blood drawn from the patient is prevented from substantially flowing into the second needle until the blood collection means is inserted into the tube holder (“flow communication”; “seal of the needle 154 is removed ... as is known in the art ... needle 154 ... blood conducted to the blood storage chamber 152”, col. 5 lines 15-35 & col. 5 line 54 – col. 6 line 19).
Regarding claim 5, Kater, as modified by Pizzi and Mileikowsky hereinabove, discloses the system of claim 1, wherein the connector is not associated with a mechanical device for diverting blood flow from the first outlet to the second outlet (as seen in fig. 1).
Regarding claim 6, Kater, as modified by Pizzi and Mileikowsky hereinabove, discloses the system of claim 1. Kater, as modified by Pizzi and Mileikowsky hereinabove, wherein the valve is permanently interconnected on one side to the primary connector and selectively interconnected on the other end to the syringe.
However, Pizzi discloses wherein the valve is permanently interconnected on one side to the primary connector and selectively interconnected on the other end to the syringe (“valve ... integrated in the attachment 14”; “attachment 2a of the syringe 2 is coupled to the attachment 14 ... Luer type”, para. [0044, 0047-0048, 0095], as seen in fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi and Mileikowsky hereinabove, such that the valve is permanently interconnected on one side to the primary connector and selectively interconnected on the other end to the syringe, in view of the teachings of Pizzi, as this would aid in preventing reflux in the opposite direction and automatically opening and closing the valve in response to a presence of a flow with suitable pressure and an absence of a flow with suitable pressure (Pizzi, para. [0044, 0048, 0095]).
Regarding claim 7, Kater, as modified by Pizzi and Mileikowsky hereinabove, discloses the system of claim 1, wherein the connector associated with the tube is a first connector (128 & 134, as seen in fig. 1), and further comprising a second connector (140, fig. 1) positioned between the second outlet (passageway 162, fig. 1) and the valve (valve 200, fig. 2) (as seen in figs. 1-2), and a third connector (cap 144/connector member 150, fig. 1) positioned between the valve and the syringe (as seen in fig. 1, col. 4 lines 35-50).
Regarding claim 9, Kater, as modified by Pizzi and Mileikowsky hereinabove, discloses the system of claim 1, wherein the means for blood collection is a tube or blood culture bottle (“Becton and Dickenson (BD) Vacutainer ... blood storage chamber 152”, col. 5 lines 15-35).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kater in view of Pizzi and Mileikowsky, as applied to claim 1 above, and further in view of Whelan (US 20150144224 A1).
Regarding claim 8, Kater, as modified by Pizzi and Mileikowsky hereinabove, discloses the system of claim 1. Kater, as modified by Pizzi and Mileikowsky hereinabove, does not disclose wherein the tube holder is configured to receive a means for blood collection of various sizes.
However, Whelan directed to a sampling port that can accommodate different diameter sampling bottles and/or vials discloses wherein the tube holder (sampling port 10) is configured to (Examiner’s Note: functional language, i.e., capable of) receive a means for blood collection of various sizes (“accommodate different diameter sampling bottles and/or vials”, Abstract, para. [0001, 0100-0102], figs. 5-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi and Mileikowsky hereinabove, such that the tube holder is configured to receive a means for blood collection of various sizes, in view of the teachings of Whelan, as this would aid in accommodating different diameter sampling bottles and/or vials.
Claims 10, 12, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kater in view of Pizzi and Mileikowsky, as applied to claim 1 above, and further in view of Cornell (US 4079729 A).
Regarding claim 10, Kater, as modified by Pizzi and Mileikowsky hereinabove, discloses the system of claim 1. Kater, as modified by Pizzi and Mileikowsky hereinabove, does not expressly disclose wherein the means for blood collection is a tube having an open end, a cap having a puncturable seal that seals the open end, and a cover having a substantially flat outer surface interconnected to an upper surface of the cap.
However, Cornell directed to a blood collection tube discloses wherein the means for blood collection is a tube (glass test tube 28, fig. 1) having an open end (“distal end of the tube”, col. 2 lines 49-59, fig. 1), a cap (lower annular plug 48, fig. 1) having a puncturable seal that seals the open end (“48 ... tightly engage the tube walls to form a seal against the passage of air between the tube ... needle 30 ... penetrating”, col. 2 lines 49-59 & col. 3 lines 33-53), and a cover (upper annular plug 46 & upper annular flange 36, fig. 1) having a substantially flat outer surface (unlabeled, but as seen in fig. 1; “bottom of the groove 42”, col. 3 lines 33-53) interconnected to an upper surface of the cap (integral neck portion 50, as seen in fig. 1, col. 3 lines 33-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi and Mileikowsky hereinabove, such that the means for blood collection is a tube having an open end, a cap having a puncturable seal that seals the open end, and a cover having a substantially flat outer surface interconnected to an upper surface of the cap, in view of the teachings of Cornell, as such a modification would have been merely a substitution of blood storage chamber/vacutainer of Kater for the blood collection tube of Cornell to aid in drawing blood from a body vessel.
Regarding claim 12, Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, discloses the system of claim 10. Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, does not disclose wherein the outer surface includes indicia that is removed or altered when exposed to air.
However, Cornell discloses wherein the outer surface (groover 42 & integral neck portion 50, fig. 1; “bottom of the groove 42”, col. 3 lines 33-53) includes indicia (indicator 38, fig. 1) that is removed or altered when exposed to air (“air leaking ... cobalt chloride ... change composition and color from blue to pink”, col. 4 lines 3-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, such that the outer surface includes indicia that is removed or altered when exposed to air, in view of the teachings of Cornell, as this would aid in indicating when a collection tube should not be used for drawing blood due to air leaking between the stopper and the tube.
Regarding claim 14, Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, discloses the system of claim 10. Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, does not disclose wherein the outer surface includes indicia that changes when exposed to air.
However, Cornell discloses wherein the outer surface (groover 42 & integral neck portion 50, fig. 1; “bottom of the groove 42”, col. 3 lines 33-53) includes indicia (indicator 38, fig. 1) that is changes when exposed to air (“air leaking ... cobalt chloride ... change composition and color from blue to pink”, col. 4 lines 3-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, such that the outer surface includes indicia that changes when exposed to air, in view of the teachings of Cornell, as this would aid in indicating when a collection tube should not be used for drawing blood due to air leaking between the stopper and the tube.
Regarding claim 16, Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, discloses the system of claim 10. Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, does not disclose wherein the outer surface changes color when exposed to air.
However, Cornell discloses wherein the outer surface (groover 42 & integral neck portion 50, fig. 1; “bottom of the groove 42”, col. 3 lines 33-53) includes indicia (indicator 38, fig. 1) that changes color when exposed to air (“air leaking ... cobalt chloride ... change composition and color from blue to pink”, col. 4 lines 3-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, such that the outer surface includes indicia that changes color when exposed to air, in view of the teachings of Cornell, as this would aid in indicating when a collection tube should not be used for drawing blood due to air leaking between the stopper and the tube.
Claims 11, 13, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kater in view of Pizzi, Mileikowsky, and Cornell, as applied to claim 10 above, and further in view of Chung (US 20130018353 A1).
Regarding claim 11, Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, discloses the system of claim 10. Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, does not disclose wherein the outer surface includes indicia that is removed or altered when exposed to water, alcohol, or other liquid.
However, Cornell discloses wherein the outer surface (unlabeled, but as seen in fig. 1; “bottom of the groove 42”, col. 3 lines 33-53) includes indicia (indicator 38, fig. 1) that is removed or altered (“cobalt chloride ... change composition and color from blue to pink”, col. 4 lines 3-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, such that the outer surface includes indicia that is removed or altered, in view of the teachings of Cornell, as this would aid in indicating when a collection tube should not be used for drawing blood.
Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, does not disclose that the indicia is removed or altered when exposed to water, alcohol, or other liquid.
However, Chung directed to the field of containers such as containers for medical and/or biological solutions discloses indicia that is removed or altered when exposed to water, alcohol, or other liquid (“indicator material ... change color based on the presence of liquid ... allowing the user to tell whether seal 18, seal 20 or both seals 18 and 20 have been breached”, para. [0022, 0025-0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, such that the indicia is removed or altered when exposed to water, alcohol, or other liquid, in view of the teachings of Chung, as this would aid in indicating that the seal has been breached and the container/means for blood collection should be discarded.
Regarding claim 13, Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, discloses the system of claim 10. Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, does not disclose wherein the outer surface includes indicia that changes when exposed to water, alcohol, or other liquid.
However, Cornell discloses wherein the outer surface (unlabeled, but as seen in fig. 1; “bottom of the groove 42”, col. 3 lines 33-53) includes indicia (indicator 38, fig. 1) that changes (“cobalt chloride ... change composition and color from blue to pink”, col. 4 lines 3-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, such that the outer surface includes indicia that changes, in view of the teachings of Cornell, as this would aid in indicating when a collection tube should not be used for drawing blood.
Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, does not disclose that the indicia changes when exposed to water, alcohol, or other liquid.
However, Chung directed to the field of containers such as containers for medical and/or biological solutions discloses indicia that changes when exposed to water, alcohol, or other liquid (“indicator material ... change color based on the presence of liquid ... allowing the user to tell whether seal 18, seal 20 or both seals 18 and 20 have been breached”, para. [0022, 0025-0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, such that the indicia changes when exposed to water, alcohol, or other liquid, in view of the teachings of Chung, as this would aid in indicating that the seal has been breached and the container/means for blood collection should be discarded.
Regarding claim 15, Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, discloses the system of claim 10. Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, does not disclose wherein the outer surface changes color when exposed to water, alcohol, or other liquid.
However, Cornell discloses wherein the outer surface (unlabeled, but as seen in fig. 1; “bottom of the groove 42”, col. 3 lines 33-53) includes indicia (indicator 38, fig. 1) that changes color (“cobalt chloride ... change composition and color from blue to pink”, col. 4 lines 3-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, such that the outer surface includes indicia that changes color, in view of the teachings of Cornell, as this would aid in indicating when a collection tube should not be used for drawing blood.
Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, does not disclose that the indicia changes color when exposed to water, alcohol, or other liquid.
However, Chung directed to the field of containers such as containers for medical and/or biological solutions discloses indicia that changes color when exposed to water, alcohol, or other liquid (“indicator material ... change color based on the presence of liquid ... allowing the user to tell whether seal 18, seal 20 or both seals 18 and 20 have been breached”, para. [0022, 0025-0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, such that the indicia changes color when exposed to water, alcohol, or other liquid, in view of the teachings of Chung, as this would aid in indicating that the seal has been breached and the container/means for blood collection should be discarded.
Regarding claim 17, Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, discloses the system of claim 10. Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, does not disclose wherein the outer surface changes color when exposed to air, the outer surface further comprising indicia that removed or altered when exposed to water, alcohol, or other liquid.
However, Cornell discloses wherein the outer surface changes color when exposed to air and the outer surface further comprising indicia.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, such that the outer surface changes color when exposed to air and the outer surface further comprising indicia, in view of the teachings of Cornell, as this would aid in indicating when a collection tube should not be used for drawing blood due to air leaking between the stopper and the tube.
Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, does not disclose the indicia that is removed or altered when exposed to water, alcohol, or other liquid.
However, Chung directed to the field of containers such as containers for medical and/or biological solutions discloses indicia that is removed or altered when exposed to water, alcohol, or other liquid (“indicator material ... change color based on the presence of liquid ... allowing the user to tell whether seal 18, seal 20 or both seals 18 and 20 have been breached”, para. [0022, 0025-0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove, such that the outer surface further comprises indicia that removed or altered when exposed to water, alcohol, or other liquid, in view of the teachings of Chung, as this would aid in indicating that the seal has been breached and the container/means for blood collection should be discarded by incorporating the indicator material of Chung into the indicator of Kater, as modified by Pizzi, Mileikowsky, and Cornell hereinabove.
Claims 18-19 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kater in view of Mileikowsky.
Regarding claim 18, Kater discloses a system for sequestering blood and providing a blood sample (fig. 1, Abstract) comprising: a primary connector (coupling 126, fig. 1) having an inlet (connector member 134, fig. 1), a first outlet (port 140, fig. 1), and a second outlet (adapter sleeve 138, fig. 1, “first and second ports”, claim 1); a tube (tubing 122, fig. 1) adapted to (Examiner’s Note: functional language, i.e., capable of) receive blood (col. 3 line 30-43) the tube having an end that is associated with the inlet (second end 128 of the tubing 122, as seen in fig. 1, col. 3 line 51-66); a valve (valve 200, fig. 2) associated on one end with the first outlet (“port 140 may include valve 200”, col. 4 lines 51-59), and on a second end with a waste blood collection vessel (first blood storage device 130, fig. 1, “fluid communication between the shaft 136 and the first blood storage device 130”, col. 4 lines 51-59); and a tube holder (“blood storage device 132 may comprise a Becton and Dickenson (BD) Vacutainer and Vacutainer Adapter”, col. 5 lines 15-22) having a first end configured to interconnect to the second outlet (“138 ... snugly receive the needle hub 156”, col. 5 lines 15-53) and a second, open end (“adaptive coupling 158 (commonly referred to as a Vacutainer Adapter)”, Examiner note: (Vacutainer Adapters have an open end to receive a Vacutainer) adapted to (Examiner’s Note: functional language, i.e., capable of) receive a sample collection vessel (“Becton and Dickenson (BD) Vacutainer and Vacutainer Adapter ... blood storage chamber 152”, col. 5 lines 15-35), the tube holder further comprising a needle (needle 154, col. 5 lines 15-35).
Kater does not expressly disclose the needle extending from the first end toward the second, open end and wherein the needle is surrounded by a selectively rupturable shroud.
However, Mileikowsky directed to a fluid transport assembly discloses a tube holder (collection container holder 215, fig. 2) having a first end (unlabeled, but as seen in figs. 1C & 2) and a second open end (second end 275, as seen in figs. 1C & 2) and a needle extending from the first end toward the second, open end (needle 20, as seen in fig. 2), wherein the needle is surrounded by a selectively rupturable shroud (protective sheath 50, fig. 2, col. 3 lines 28-38 & col. 4 lines 5-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater such that the needle extends from the first end toward the second, open end and the needle is surrounded by a selectively rupturable shroud, in view of the teachings of Mileikowsky, as this would aid in maintaining the sterility of the needle, preventing fluid from escaping from the needle assembly, and receiving/establishing fluid communication with the fluid collection container/Vacutainer.
Regarding claim 19, Kater, as modified by Mileikowsky hereinabove, discloses the system of claim 18, wherein blood drawn from a patient that is directed to the primary connector and out of the first outlet (“port 140 and the blood storage device 130 coupled thereto ... blood may be withdrawn ... first portion of blood is withdrawn from the coupling 126 into the blood storage device 130”, col. 4 line 60-col. 5 line 35), and wherein blood is drawn into the blood collection vessel (“first portion of blood is withdrawn from the coupling 126 into the blood storage device 130”, col. 4 line 60-col. 5 line 35”). Kater, as modified by Mileikowsky hereinabove, does not expressly disclose wherein the needle is adapted to rupture the shroud and puncture the sample collection vessel is inserted into the tube holder.
However, Mileikowsky directed to a fluid transport assembly discloses the tube holder (collection container holder 215, fig. 2), the needle (needle 20, as seen in fig. 2), and the selectively rupturable shroud (protective sheath 50, fig. 2, col. 3 lines 28-38 & col. 4 lines 5-31), wherein the needle is adapted to rupture the shroud and puncture the sample collection vessel is inserted into the tube holder (“fluid collection container 250 is pressed against the flexible sheath ... cutting edge 125 to pierce the flexible sheath 50 ... blood to flow”, col. 3 lines 28-38 & col. 4 lines 5-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Mileikowsky hereinabove, such that the needle is adapted to rupture the shroud and puncture the sample collection vessel is inserted into the tube holder, in view of the teachings of Mileikowsky, as this would aid in establishing fluid communication with the fluid collection container/Vacutainer such that blood is caused to flow into the fluid collection container/Vacutainer.
Regarding claim 21, Kater, as modified by Mileikowsky hereinabove, discloses the system of claim 19, wherein the system is devoid of a device for selectively altering fluid flow (as seen in fig. 1).
Regarding claim 22, Kater, as modified by Mileikowsky hereinabove, discloses the system of claim 18, wherein blood drawn from the patient is prevented from substantially flowing through the second outlet until the sample collection vessel is inserted into the tube holder (“first portion of blood is withdrawn ... device 130 ... withdraw the anaerobic blood sample, the second blood storage device 132 is coupled ... removing the sealing from the needle 154 ... flow communication”, col. 4 line 60-col. 5 line 35 & col. 5 line 54-col. 6 line 19).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kater in view of Mileikowsky, as applied to claim 19 above, and further in view of Pizzi.
Regarding claim 20, Kater, as modified by Mileikowsky hereinabove, discloses the system of claim 19, wherein the blood collection vessel is a syringe (“first blood storage device 130 comprises a syringe”, col. 4 lines 35-37), the valve (valve 200, fig. 2), and that negative pressure is produced by the syringe (“As is known ... plunger 148 is slowly withdrawn ... blood drawn into the chamber”, col. 4 lines 35-50).
Kater further discloses that the valve may be readily selected from several commercial embodiments of valves readily available to those skilled in the art and other alternative apparatus may be substituted for the valve 200 (col. 4 lines 35-59). Kater, as modified by Mileikowsky hereinabove, does not disclose that the valve is a one-way valve that is opened when negative pressure is produced by the syringe.
However, Pizzi directed to devices that can be used for taking a sample of a biological fluid from a subject discloses that the valve is a one-way valve (valve 14a-14b, fig. 4; “one automatic-closing or one-way valve”; “non-return valves”, Abstract, para. [0044, 0048-0049]) that is opened when negative pressure is produced by the syringe (“automatically operated valve, and that in the presence of a flow with suitable pressure coming from the attachment 14, the open/close element 14a can recede, overcoming the elastic reaction of the spring 14b”; “predefined or calibrated force ... negative pressure”; “open elastically when the membrane is urged by a flow or a pressure in one direction”; “operating the plunger head ... pressure”, para. [0044, 0046, 0048, 0051, 0055, 0080, 0095]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kater, as modified by Mileikowsky hereinabove, such that the valve is a one-way valve that is opened when negative pressure is produced by the syringe, in view of the teachings of Pizzi, as such a modification would have been merely a substitution of the valve of Kater for the automatic-closing or one-way valve of Pizzi and would aid in preventing reflux in the opposite direction (Pizzi, para. [0044, 0048, 0095]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Thompson (US 20250049362 A1) directed to a bodily fluid collection system comprising a three-way male connector and a valve, see figs. 10-11;
Hopwood (US 20230329604 A1) directed to a blood collection assembly, see fig. 1;
Hyun (US 6843775 B2) directed to a blood drawing system, see fig. 1;
Yan (US 20230397859 A1) directed to a blood draw system, see figs. 10-11 & 15;
Mao (US 20080199363 A1) directed to porous barrier compositions comprising color change indicators.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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