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 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 33 and 36 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 33 recites the limitation “the perforated plate”. There is insufficient basis for this limitation in the claim. The lack of antecedent basis causes the meaning of the claim to be unclear. A lack of clarity arises because it is unclear as to which earlier recited element (if any) the limitations reference. For the purposes of examination, the limitations are interpreted as not referring to any earlier recited elements.
Claim 36 recites the limitation “the valve hole”. There is insufficient basis for this limitation in the claim. The lack of antecedent basis causes the meaning of the claim to be unclear. A lack of clarity arises because it is unclear as to which earlier recited element (if any) the limitations reference. For the purposes of examination, the limitations are interpreted as not referring to any earlier recited elements.
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.
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 22-48 are rejected under 35 U.S.C. 103 as being unpatentable over Beretta (US 20020169408 A1; cited by applicant) in view of Bullington (US 20190365303 A1).
With respect to claim 22, Beretta discloses a device for connecting a cannula to a container under reduced pressure (see Fig. 5 and paragraph 0062 and 0070-0074, transfer device #18 that has cannula #38 that connects to containers #10 and #14 that has pressure differential), comprising:
an inflow opening configured to connect to one of the cannula and a connecting tube leading to the cannula (see Fig. 5 and paragraph 0070, opening #46 that connects cannula #38 and housing #58 that leads to cannula #38);
an outflow opening configured to connect with a hollow mandrel configured to pierce a closure of the container (see paragraph 0070-0071 and Fig. 5, opening #54 that connects to an end #50 of cannula #38 and punctions seal #24 of container #14); and
a tight fluidic connection of the inflow opening with the outflow opening (see paragraph 0070-0073, safety sheath #68,72 cover the openings #46,#54 to keep fluid sealed where the safety seals can be valves).
Beretta does not specifically disclose wherein a reservoir that contains a predetermined quantity of gas and that is separate from the fluidic connection is connected to the fluidic connection with the interposition of a valve.
Bullington teaches a reservoir that contained a predetermined quantity of gas (see paragraph 0037, sample reservoir can include a gas; and see paragraph 059, collection device #160 can be a sample reservoir; and see paragraph 0035, sample container can be VACUTAINER which is known to have a predetermined quantity of gas) that is separate from a fluidic connection and is connected to the fluidic connection with the interposition of a valve (see paragraph 0063 and Fig. 1, sample reservoir #160 is separate from fluidic connection with an inlet #112 and outlet #114 which is the fluidic connection flow path #113 where the sample reservoir #160 is connected to the fluidic connection flow path via a valve ; and see paragraph 0063-0064, one or more flow controllers such as a valve that allows flow of fluid via flow path #154).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Beretta with the teachings of Bullington to have included a reservoir with a predetermined gas quantity because it would have resulted in the predicable result of producing a negative pressure differential to draw an initial flow of fluid into the reservoir (Bullington: see [0063]).
With respect to claim 23, all limitations of claim 22 apply in which Beretta and Bullington further teaches wherein: the container is a blood culture bottle (Beretta: see paragraph 0063, container is capable of drawing blood; and Bullington: see paragraph 0178, collection device can be a blood culture bottle) ; and the valve opens towards the fluidic connection (Beretta: see paragraph 0070-0073, safety sheath #68,72 cover the openings #46,#54 to keep fluid sealed where the safety seals can be valves that open towards the fluid path; and Bullington: see paragraph 0063-0064, one or more flow controllers such as a valve that allows flow of fluid via flow path #154).
With respect to claim 24, all limitations of claim 22 apply in which Beretta further discloses wherein the outflow opening is integrally connected to the hollow mandrel (see paragraph 0070-0071 and Fig. 5, opening #54 that connects to an end #50 of cannula #38 and punctions seal #24 of container #14).
With respect to claim 25, all limitations of claim 22 apply in which Bullington further teaches wherein the quantity of gas in the reservoir is at atmospheric pressure (see paragraph 0093, atmospheric pressure) and occupies a volume of 40 cm3 to 100 cm3 (see paragraph 0033).
With respect to claim 26, all limitations of claim 22 apply in which Bullington further teaches wherein the valve is switchable by a differential pressure prevailing between the reservoir and the fluidic connection (Bullington: see paragraph 0063-0064, one or more flow controllers such as a valve that allows flow of fluid via flow path #154 based on negative differential pressure).
With respect to claim 27, all limitations of claim 22 apply in which Beretta and Bullington further teaches wherein the valve is openable by a negative pressure prevailing in the fluidic connection (Bullington: see paragraph 0063-0064, one or more flow controllers such as a valve that allows flow of fluid via flow path #154 based on negative differential pressure).
With respect to claim 28, all limitations of claim 22 apply in which Bullington further teaches wherein the valve is closable by an overpressure prevailing in the fluidic connection (Bullington: see paragraph 0063-0064, one or more flow controllers such as a valve that allows flow of fluid via flow path #154 based on negative differential pressure where it does not open if no negative differential pressure).
With respect to claim 29, all limitations of claim 22 apply in which Bullington further teaches wherein a chamber is arranged on a side of the valve that is connected to the fluidic connection, so that an overpressure prevailing in the chamber acts on a valve closure member of the valve in a closing direction (Bullington: see paragraph 0063-0064 and Fig. 1, sample reservoir #160 is separate from fluidic connection with an inlet #112 and outlet #114 which is the fluidic connection flow path #113 where the sample reservoir #160 is connected to the fluidic connection flow path via a valve; and see paragraph 0063-0064, one or more flow controllers such as a valve that allows flow of fluid via flow path #154).
With respect to claim 30, all limitations of claim 29 apply in which Bullington further teaches
wherein the reservoir has a perforated plate with at least one hole as a reservoir wall (see paragraph 0050-0052 and 0057, one or more openings can be configured to facilitate air displacement) and the at least one hole is covered by the valve closure member of the valve in a closed position of the valve on a side facing to the chamber (see paragraph 0057, one or more openings can any suitable opening in a closed position on one side of valve).
With respect to claim 31, all limitations of claim 30 apply in which Bullington further teaches wherein the perforated plate is circular (see paragraph 0057, one or more openings can any suitable opening which can be circular).
With respect to claim 32, all limitations of claim 22 apply in which Bullington further teaches wherein the reservoir is formed as an annular chamber surrounding the fluidic connection (see paragraph 0063 and Fig. 1, sample reservoir #160 can surround fluid flow path)
With respect to claim 33, all limitations of claim 32 apply in which Bullington further teaches wherein the perforated plate supports the fluidic connection (see paragraph 0057, one or more openings can any suitable opening configured to be fluidically coupled to device).
With respect to claim 34, all limitations of claim 29 apply in which Bullington further teaches wherein the valve closure member is designed as a circular, deformable disc with a valve hole (see paragraph 0057, one or more openings can any suitable opening which can be circular and deformable).
With respect to claim 35, all limitations of claim 34 apply in which Bullington further teaches wherein the valve hole is centrally formed (see paragraph 0057, one or more openings can any suitable opening and can be centrally formed).
With respect to claim 36, all limitations of claim 30 apply in which Bullington further teaches wherein:
the perforated plate and a wall of the chamber opposite the perforated plate bear against the valve closure member at an edge thereof (see paragraph 0050-0052 and 0056-0057, one or more openings can be configured to facilitate air displacement on one side of a value closure membrane); and
in a region of the valve hole, a wall of the chamber opposite the perforated plate is spaced apart from the valve closure member (see paragraph 0050-0052 and 0056-0057, one or more openings can be configured to facilitate air displacement on one side of a value closure membrane spaced apart).
With respect to claim 37, all limitations of claim 30 apply in which Bullington further teaches wherein the perforated plate and the wall of the chamber opposite the perforated plate bear against the valve closure member at an edge thereof in a clamping manner (see paragraph 0050-0052 and 0056-0057, valve and the one or more openings can be made from any suitable material in any manner).
With respect to claim 38, all limitations of claim 29 apply in which Bullington further teaches wherein the valve closure member is made of a material selected from the group consisting of rubber, silicone and polyolefins (see paragraph 0050-0052 and 0056-0057, valve and the one or more openings can be made from any suitable material; and see paragraph 0039, silicones and polyolefins).
With respect to claim 39, all limitations of claim 22 apply in which Bullington further teaches wherein the valve is configured to open at a negative pressure of the fluidic connection with respect to the reservoir of 0.3 bar to 0.8 bar (see paragraph 0063-0065, one or more flow controllers such as a valve that allows flow of fluid via flow path #154 based on negative differential pressure at a first magnitude)
With respect to claim 40, all limitations of claim 22 apply in which Bullington further teaches wherein the valve is designed to close at an overpressure of the fluidic connection with respect to the reservoir of 0.1 bar to 0.4 bar (see paragraph 0063-0065, one or more flow controllers such as a valve that allows flow of fluid via flow path #154 based on negative differential pressure at a first magnitude and modulates it to close when not)
With respect to claim 41, Beretta discloses a method of connecting a cannula to a container under reduced pressure (see Fig. 5 and paragraph 0062 and 0070-0074, transfer device #18 that has cannula #38 that connects to containers #10 and #14 that has pressure differential), comprising:
providing a connecting device for connecting the cannula to the container being under reduced pressure (see Fig. 5 and 0062-0074, transfer device #18 that has cannula #38 that connects to containers #10 and #14 that has pressure differential) in particular a connecting device according to claim 22;
connecting the connecting device to the cannula and to the container that is under reduced pressure, thereby establishing a fluidic connection from the cannula to the container (see Fig. 5 and paragraph 0062 and 0070-0074, cannula #38 connects to containers #10 and #14).
Beretta does not specifically disclose drawing a quantity of gas from a reservoir of the connection device, which is separate from the fluidic connection, into the container, said drawing being effected by a negative pressure prevailing in the container relative to the reservoir.
Bullington teaches drawing a quantity of gas from a reservoir of the connection device, which is separate from the fluidic connection, into the container, said drawing being effected by a negative pressure prevailing in the container relative to the reservoir (see paragraph 0037, sample reservoir can include a gas; and see paragraph 059, collection device #160 can be a sample reservoir; and see paragraph 0035, sample container can be VACUTAINER which is known to have a predetermined quantity of gas; and see paragraph 0063 and Fig. 1, sample reservoir #160 is separate from fluidic connection with an inlet #112 and outlet #114 which is the fluidic connection flow path #113 where the sample reservoir #160 is connected to the fluidic connection flow path via a valve ; and see paragraph 0063-0064, one or more flow controllers such as a valve that allows flow of fluid via flow path #154).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Beretta with the teachings of Bullington to have included a reservoir with a predetermined gas quantity because it would have resulted in the predicable result of producing a negative pressure differential to draw an initial flow of fluid into the reservoir (Bullington: see [0063]).
With respect to claim 42, all limitations of claim 41 apply in which Beretta and Bullington further teaches wherein the container is a blood culture bottle (Beretta: see paragraph 0063, container is capable of drawing blood; and Bullington: see paragraph 0178, collection device can be a blood culture bottle)
With respect to claim 43, all limitations of claim 41 apply in which Bullington further teaches wherein said drawing of the quantity of gas from the reservoir into the container is carried out until one of a complete and a partial pressure equalization between the reservoir and the container (see paragraph 0037, sample reservoir can include a gas; and see paragraph 059, collection device #160 can be a sample reservoir; and see paragraph 0035, sample container can be VACUTAINER which is known to have a predetermined quantity of gas; and see paragraph 0063 and Fig. 1, sample reservoir #160 is separate from fluidic connection with an inlet #112 and outlet #114 which is the fluidic connection flow path #113 where the sample reservoir #160 is connected to the fluidic connection flow path via a valve ; and see paragraph 0063-0064, one or more flow controllers such as a valve that allows flow of fluid via flow path #154 until equalized).
With respect to claim 44, all limitations of claim 41 apply in which Bullington further teaches wherein said drawing of the gas quantity from the reservoir into the container takes place via a valve arranged between the reservoir and the fluidic connection (see paragraph 0037, sample reservoir can include a gas; and see paragraph 059, collection device #160 can be a sample reservoir; and see paragraph 0035, sample container can be VACUTAINER which is known to have a predetermined quantity of gas; and see paragraph 0063 and Fig. 1, sample reservoir #160 is separate from fluidic connection with an inlet #112 and outlet #114 which is the fluidic connection flow path #113 where the sample reservoir #160 is connected to the fluidic connection flow path via a valve ; and see paragraph 0063-0064, one or more flow controllers such as a valve that allows flow of fluid via flow path #154)
With respect to claim 45, all limitations of claim 41 apply in which Bullington further teaches wherein the reservoir is filled with a predetermined quantity of gas, which is dimensioned in such a way that the pressure prevailing in the container is increased by 30%-100% (see paragraph 0037, sample reservoir can include a gas; and see paragraph 059, collection device #160 can be a sample reservoir; and see paragraph 0035, sample container can be VACUTAINER which is known to have a predetermined quantity of gas)
With respect to claim 46, all limitations of claim 41 apply in which Bullington further teaches wherein a predetermined amount of gas is provided in the reservoir at atmospheric pressure (see paragraph 0093, atmospheric pressure) and having a volume of 40 cm3 to 100 cm3 (see paragraph 0033).
With respect to claim 47, all limitations of claim 41 apply in which Bullington further teaches wherein, after the amount of gas is drawn from the reservoir into the container, a liquid is drawn from the cannula into the container via the fluidic connection (see paragraph 0063-0064, one or more flow controllers such as a valve that allows flow of fluid via flow path #154 based on negative differential pressure where liquid is drawn into collection container).
With respect to claim 48, all limitations of claim 47 apply in which Bullington further teaches wherein said drawing of the liquid from the cannula is performed by a negative pressure prevailing in the container with respect to the liquid pressure in the cannula (see paragraph 0063-0064, one or more flow controllers such as a valve that allows flow of fluid via flow path #154 based on negative differential pressure where liquid is drawn into collection container).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791