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
Claims 2-5, 7-11, 13-15, and 17-23 are objected to because of the following informalities:
Claims 2-5, 7-11, 13-15, and 17-23 should recite “The blood collection device…”. 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 11 and 14 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.
The term “substantially” in claim 11 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. The claim is indefinite because the degree of roundness of the hub cannot determined.
The term “substantially” in claim 14 line 3 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. The claim is rendered indefinite as the texture of the contact surfaces between the dispenser part and the receiver part cannot be determined.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5, 10-11, 14-15, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bullington (US 20140155782 A1).
Regarding claim 1, teaches a blood collection device, comprising:
a dispenser part [Fig. 15 Item 303] having a plurality of independent outlet fluid passages [Fig. 15 Items 303a-d], each terminating at a respective outlet port [Fig. 15 Item 335 a-d] for coupling with a detachable storage container [Fig. 20 Item 390]; and
a receiver part [Fig. 15 Item 340] having an inlet fluid passage [0099 “…first aperture 344a of the seal member 341 establishes fluid communication between the inlet port 321 and the first outlet aperture 303a while fluidically isolating the inlet port 321 from the outlet apertures 303b, 303c, 303d, and 303e which in turn, fluidically isolates the inlet port 321 from the flow channels 335a-335d”…] associated with an inlet port [Fig. 15 Item 321] for coupling with a blood transfer tube [0098 “…the inlet port 321 can be configured to selectively place the pre-sample reservoir 370, the first sample reservoir 380, the second sample reservoir 380', the third sample reservoir 390, and the fourth sample reservoir 390' in fluid communication with the patient…”], the receiver part being operatively coupled with [see Fig. 20], and moveable relative to [0099 “…the dial 345 is movable between the first, the second, the third, the fourth, and the fifth positions”], the dispenser part so that the inlet fluid passage is moveable to align with any of the outlet fluid passages to form a connected fluid pathway therebetween [0098].
Regarding claim 3, Bullington teaches a blood collection device according to claim 1, wherein the receiver part is configured to be rotatable relative to the dispenser part [0099 “…the dial 345 is movable between the first, the second, the third, the fourth, and the fifth positions”].
Regarding claim 5, Bullington teaches a blood collection device according to claim 1, wherein the receiver part comprises a handle [Fig. 15 Item 345] to assist a user with moving the receiver part relative to the dispenser part in use [0099 “…the dial 345 is movable between the first, the second, the third, the fourth, and the fifth positions”].
Regarding claim 10, Bullington teaches a blood collection device according to claim 1, wherein the receiver part [Fig. 15 Item 340] is mounted within a cavity [see Fig. 15] of the dispenser part [Fig. 15 Item 303].
Regarding claim 11, Bullington teaches a blood collection device according to claim 1, wherein the dispenser part [Fig. 15 Item 303] is in the form of a substantially round hub with downwardly-oriented outlet ports [Fig. 15 Item 303].
Regarding claim 14, Bullington teaches a blood collection device according to claim 1, wherein contact surfaces between the dispenser part and the receiver part are configured to be substantially smooth [see Fig. 15, see also 0099 “…the dial 345 is movable between the first, the second, the third, the fourth, and the fifth positions”. The examiner notes that the system of Bullington has “substantially smooth” contact surfaces required to facilitate proper adjusting during alignment of the inlet and the multiple ports].
Regarding claim 15, Bullington teaches a blood collection device according to claim 1, wherein the dispenser part comprises a circumferential wall [see Examiner Figure 1 below with interpretation of this element in regard to Bullington Fig. 15] with sideway projections proximate the location of each respective outlet port [See Examiner Fig. 1].
Examiner Figure 1
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Regarding claim 20, Bullington teaches a blood collection device according to claim 1, wherein a gasket seal [Fig. 15 Item 341] having a single opening [Fig. 15 Item 344a, b, c, or d, depending on alignment] for allowing fluid flow between the inlet fluid passage [Fig. 15 Item 321] and the outlet fluid passage [Fig. 15 Item 303a, b, c, or d depending on alignment] is provided between the receiving part [Fig. 15 Item 340] and the dispensing part [Fig. 15 Item 303], when assembled.
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.
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 2, 7, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bullington (US 20140155782 A1) as applied to claim 1 above, and further in view of Holmes (US 10248765 B1).
Regarding claim 2, Bullington teaches a blood collection device according to claim 1, wherein the dispenser part comprises multiple ports, but fails to teach an air channel located proximate each respective port, the air channel being configured to form part of an airflow pathway between a storage container coupled to the respective outlet port and the ambient, during use.
Holmes teaches an air channel proximate to a port [col. 90 ln. 35 “…one or more ports, such as but not limited to a port…”], the air channel being configured to form part of an airflow pathway between a storage container coupled to the respective outlet port and the ambient, during use [col. 90 lns. 35-37 “…one or more vents, such as but not limited to a port, to allow air escape as the channels in the collection device are filled with sample”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bullington and incorporate the teachings of Holmes to include an air channel proximate to a port, the air channel being configured to form part of an airflow pathway between a storage container coupled to the respective outlet port and the ambient, during use. Doing so improves blood sample quality by preventing hemolysis and clotting during the draw by maintaining optimal flow and pressure, ensuring that blood remains in its natural state, which is critical for accurate results.
Regarding claim 7, Bullington teaches a blood collection device according to claim 1, wherein Bullington teaches the receiver part and a central cavity [Fig. 15 Item 366 “recess”], but fails to teach the central cavity is configured to allow passage of airflow.
Holmes teaches the central cavity is configured to allow passage of airflow [col. 90 ln. 35 “…one or more ports, such as but not limited to a port…”, see also col. 90 lns. 35-37 “…one or more vents, such as but not limited to a port, to allow air escape as the channels in the collection device are filled with sample”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bullington and incorporate the teachings of Holmes to include an air channel proximate to a port, the air channel being configured to form part of an airflow pathway between a storage container coupled to the respective outlet port and the ambient, during use. Doing so improves blood sample quality by preventing hemolysis and clotting during the draw by maintaining optimal flow and pressure, ensuring that blood remains in its natural state, which is critical for accurate results.
Regarding claim 17, Bullington and Holmes teach a blood collection device according to claim 2, wherein the combination teaches the air channel leads to a central cavity [Bullington Fig. 15 Item 366 “recess”] of the receiver part [Bullington Fig. 15 Item 340] and the airflow pathway extends out of an opening of the receiver part [Holmes col. 90 ln. 35 “…one or more ports, such as but not limited to a port…”, see also col. 90 lns. 35-37 “…one or more vents, such as but not limited to a port, to allow air escape as the channels in the collection device are filled with sample”].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bullington as applied to claim 1 above, and further in view of Garstein (US 6652478 B1).
Regarding claim 4, Bullington teaches a blood collection device according to claim 1, wherein the receiver part is frictionally coupled to the dispenser part by way of a circumferential seal [Fig. 15 Item 341], and wherein the seal is a biocompatible o-ring [0096 “The seal member 341 can be made of any number of materials that are biocompatible…”], but fails to teach the seal is made of a fluorocarbon.
Garstein teaches a biocompatible protection layer that can include fluorocarbons [col. 38 lns. 57-61].
In the same field of body-fluid sampling, it would have been obvious to one skilled in the art at the filing date of the invention to modify the material of the o-ring to be a fluorocarbon as taught by Garstein, since it has been held to be within the general skill of a worker in the art to select a known component or material on the basis of suitability for the intended use as a matter of obvious mechanical design expediency. In re Leshin, 125 USPQ 416. Also see MPEP 2144.07. Sinclair & Carroll Co. v. Interchemical Corp. states "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.). It is noted that a fluorocarbon is known to be used in biocompatible seals.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bullington and Holmes as applied to claim 7 above, and further in view of Mui (US 20140080113 A1).
Regarding claim 8, Bullington and Holmes teach a blood collection device according to claim 7, wherein Bullington teaches the central cavity, but fails to teach the central cavity is covered with a filter unit comprising an air-permeable filter material.
Mui teaches a filter unit comprising an air-permeable filter material [0023 “…a sterile filter 42 to filter air passing into the reservoir…”, Fig. 3 Item 42].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bullington and Holmes and incorporate the teachings of Mui to include the central cavity is covered with a filter unit comprising an air-permeable filter material. Doing so configures the system to “…maintain sterility while allowing gas to exit the reservoir when it is being filled and displacement gas to enter when it is being emptied…”, as recognized by Mui para. 0029.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bullington as applied to claim 1 above, and further in view of Angelescu (US 20140212986 A1) and Garstein.
Regarding claim 9, Bullington teaches a blood collection device according to claim 1, wherein Bullington teaches an inlet port, but fails to teach an end of the inlet fluid passage opposing the inlet port comprises an outlet seal, and wherein the outlet seal is a fluorocarbon type o-ring.
Angelescu teaches an end of the inlet fluid passage opposing the inlet port comprises an outlet seal [0260 “…sampling device 2301 orientation may be in any direction, but a purpose of the O-ring seal 3002 is to protect the sampling inlet ports from contact with the ocean environment while in standby mode”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bullington and incorporate the teachings of Angelescu to include an end of the inlet fluid passage opposing the inlet port comprises an outlet seal. Doing so configures the system to protect the inlet ports from contact with the environment, as recognized by Angelescu para. 0260.
The combination of Bullington and Angelescu teach the o-ring seal, but fail to teach the outlet seal is a fluorocarbon type o-ring.
In the same field of body-fluid sampling, it would have been obvious to one skilled in the art at the filing date of the invention to modify the material of the o-ring to be a fluorocarbon as taught by Garstein, since it has been held to be within the general skill of a worker in the art to select a known component or material on the basis of suitability for the intended use as a matter of obvious mechanical design expediency. In re Leshin, 125 USPQ 416. Also see MPEP 2144.07. Sinclair & Carroll Co. v. Interchemical Corp. states "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.). It is noted that a fluorocarbon is known to be used in biocompatible seals.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bullington as applied to claim 1 above, and further in view of Tennican (US 20130345626 A1).
Regarding claim 13, Bullington teaches a blood collection device according to claim 1, wherein each of the respective outlet ports comprises a part-side wall of slanted geometry [Fig. 15 Items 335 a-d] to assist with removal of a docked storage container [Intended use recitation. The examiner notes the housing (Fig. 15 Item 301) of Bullington is capable of being gripped to assist in the removal of storage containers (Fig. 20 Item 390)], but fails to teach removal of the storage container is by a twist-release action.
Tennican teaches removal of the storage container is by a twist-release action [0063 “…vial or container 400 can include a twist type fitting…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bullington and incorporate the teachings of Tennican to include removal of the storage container is by a twist-release action. Doing so configures the system to provide for an accessible means to remove the containers by manipulating the container within the housing in a preferred manner, as recognized by Tennican para. 0063.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bullington as applied to claim 1 above, and further in view of Allen (US 20120323142 A1).
Regarding claim 18, Bullington teaches a blood collection device according to claim 1, wherein the receiving part is operatively coupled to the dispensing part [0098 “The dial 345 of the flow controller 340 is rotatably coupled to the housing 301…”], but fails to teach the connection is made by a plurality of prongs.
Allen teaches a connection is made by a plurality of prongs [0223 “…the tabs 228 of the housing 206 can be configured to engage (e.g., by a snap connection with the clasps 229) the shoulder 259 of the intermediate member 208, thereby substantially permanently coupling the housing 206 and the intermediate member 208”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bullington and incorporate the teachings of Allen to include a connection is made by a plurality of prongs. Doing so configures the system to provide a stable location on the device for a person to use as a handhold, as recognized by Allen para. 0223.
Regarding claim 19, Bullington and Allen teach a blood collection device according to claim 18, wherein one or more of said prongs [Allen Fig. 17 Item 228] are provided with a recess at its tip portion [see Allen Fig. 17 Item 228] for receiving a corresponding lip projection [Allen Fig. 19D Item 259] of the dispensing part [Allen Fig. 19D Item 208] by frictional engagement [Allen 0223 “…the tabs 228 of the housing 206 can be configured to engage (e.g., by a snap connection with the clasps 229) the shoulder 259 of the intermediate member 208, thereby substantially permanently coupling the housing 206 and the intermediate member 208”].
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Bullington in view of Holmes.
Regarding claim 21, Bullington teaches a blood collection system, comprising:
a blood collection device according to claim 1 [see claim 1 rejection above];
a needle connected to a blood transfer tube for coupling with the inlet port of the receiver part [0098 “The inlet port 321 can be fluidically coupled to a medical device (not shown) that defines a fluid flow pathway for withdrawing and/or conveying bodily-fluid from a patient to the collection device 300“, see also 0098 “…the inlet port 321 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing)…”]; and
one or more detachable storage containers [Fig. 20 Item 390] for coupling with the outlet port of the dispenser part [See Fig. 20].
Bullington fails to explicitly teach the needle is a butterfly needle.
Holmes teaches the needle is a butterfly needle [col. 87 lns. 7-8 “…a butterfly needle 2104 is coupled to a fluid connection pathway…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Bullington and incorporate the teachings of Holmes to include the needle is a butterfly needle. Doing so configures the system to use a needle that has high versatility in procedural use and improved accuracy and control with the winged design.
Regarding claim 22, Bullington and Holmes teach a blood system according to claim 21, wherein the or each detachable storage containers [Bullington 0108 “…a collection device can include and/or can be coupled to any suitable number of sample reservoirs (e.g., one, two, three, four, five, six, or more)”] are not vacuum-sealed containers [Holmes col. 72 lns. 59-60 “…a sample vessel 1800 that may be utilized with a sample collection device…”, see Figs. 18A-B Item 1800].
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Bullington and Holmes as applied to claim 21 above, and further in view of Sammartino (US 20190142320 A1).
Regarding claim 23, Bullington and Holmes teach a blood collection system according to claim 21, wherein blood is collected from a patient during use of the system [Bullington abstract], but fails to teach the blood is collected by passive venous pressure.
Sammartino teaches the blood is collected by passive venous pressure [0010 “…fluid to be passively collected…”, see also 0098 “The blood is sampled without the use of suction…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Bullington and Holmes with the teachings of Sammartino to include the blood is collected by passive venous pressure. Doing so configures the system to collect the sample “…without the use of suction which can cause small and fragile veins to collapse”, as recognized by Sammartino para. 0098.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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/JONATHAN M HANEY/Examiner, Art Unit 3791 /JUSTIN XU/Primary Examiner, Art Unit 3791
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