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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/22/2024 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is 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.
Regarding claim 7, the choice is given for the valve to be either a one-way valve, a check valve, or a duck bill valve. However, the next line states that a spike connector would be engaging a duck bill valve, making the selection of a one0way valve or a check valve null.
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 1-11, 13-15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Russo et al. 10,058,481
Regarding claim 1, Russo teaches a valve unit for a fluid supply chamber (stopper 10, abstract) of a respiratory support system that provides humidified respiratory gases (Valve unit can be used within this sort of system as it does have a purpose that involves supplying fluids), the valve unit comprising:
a first port (portion above medication 24 as shown in figure 4) and a second port (Portion next to surface seal ring 16) and a fluid passageway formed therebetween (Space in between as depicted in figure 4);
a valve arranged in the fluid passageway for controlling a flow of fluid between the first port and the second port (Split septum valve 13);
a first sealing member having a first sealing surface arranged to seal against an interior surface of the fluid supply chamber proximate the first port when the valve unit is connected to the fluid supply chamber (Fins 20 are a surface that seals the valve against the interior of the medication chamber as depicted in figure 4);
and a second sealing member having a second sealing surface arranged to seal against an exterior surface of the fluid supply chamber proximate the second port when the valve unit is connected to the fluid supply chamber (Top flange 19 seals against the exterior of the medication chamber).
Regarding claim 2, Russo teaches the valve unit according to claim 1, wherein at least one of the first sealing member, the second sealing member, the valve, and the valve unit is reversibly or elastically deformable to put the valve unit under tension when connected to the fluid supply chamber (Column 4, lines 35-40, valve is made of rubber).
Regarding claim 3, Russo teaches the valve unit according to claim 1, wherein, in a non- connected resting state, the first sealing surface and the second sealing surface are arranged at a first closest distance from each other that is smaller than a second closest distance between the first sealing surface and the second sealing surface when the valve unit is connected to the fluid supply chamber (Since the stopper unit is placed tightly within the chamber, there would be some deformation of the material and stretching would occur, which would increase the distance between the two as tension would be applied to keep the tight fit, which would lead to a slight stretching of material.).
Regarding claim 4, Russo teaches the valve unit according to claim 1, wherein the valve in a resting state is closed to prevent fluid entering the first port to flow therethrough towards the second port (Column 3, lines 24-28 “leakproof seal”, depicted in figure 4 as well).
Regarding claim 5, Russo teaches the valve unit according to claim 1, wherein the valve in an engaged state is open to allow fluid entering the first port to flow therethrough towards the second port (Column 6 line 36 states “the oral enteric syringe tip 37 opens the valve 13 to permit a spill proof liquid communication path 18 by opening the leaves 35 and 36 on the split septum valve diaphragm 15 as shown.”).
Regarding claim 6, Russo teaches the valve unit according to claim 5, wherein the valve attains the engaged state when a spike connector inserted into the fluid passageway engages the valve (Syringe tip 37, figure 5).
Regarding claim 7, Russo teaches the valve unit according to claim 1, wherein the valve is a one-way valve, a check valve, or a duck bill valve arranged to open when a spike connector inserted into the fluid passageway engages the duck bill valve (Split valve 13 is a one way valve as described in Column 2 line 44-61, and it only opens once a syringe is inserted as depicted in figure 5).
Regarding claim 8, Russo teaches the valve unit according to claim 1, wherein the valve unit has a tubular or cylindrical cross-sectional shape (Figure 3).
Regarding claim 9, Russo teaches the valve unit according to claim 1, wherein at least one of the first sealing member and the second sealing member forms a flange (Figure 4 depicts fins 20 and top flange 19 as flanges).
Regarding claim 10, Russo teaches the valve unit according to claim 1, wherein the first sealing member has a first material characteristic and/or a first structural characteristic, and the second sealing member has a second material characteristic and/or a second structural characteristic (Members 19 and 20 have different structural characteristics as they have different sizes), wherein the first material characteristic and/or the first structural characteristic and the second material characteristic and/or the second structural characteristic are selected to allow for reversible deformation (Since the stopper unit is placed tightly within the chamber, there would be some deformation of the material that occurs as tension would be applied to keep the tight fit, which would lead to a slight stretching of material.).
Regarding claim 11, Russo teaches the valve unit according to claim 10, wherein the first material characteristic and the second material characteristic relate to at least one of elastic modulus and yield stress (the different sizes of the sealing members would provide a different yield stress for each).
Regarding claim 13, Russo teaches the valve unit according to claim 10, wherein the first structural characteristic relates to a first thickness of the first sealing member and/or the second structural characteristic relates to a second thickness of the second sealing member (Both sealing members 19 and 20 have different thicknesses.).
Regarding claim 14, Russo teaches the valve unit according to claim 1,wherein the valve unit is made of an elastomeric material (Column 4, lines 35-40, valve is made of rubber).
Regarding claim 15, Russo teaches the valve unit according to claim 1, wherein the first sealing surface is non-integrally formed with or detachable from the fluid supply chamber (Figure 2 depicts fins 20 as being non-integrally formed with the vale unit).
Regarding claim 17, Russo teaches the valve unit according to claim 3, further comprising a body extending between the first port and the second port, wherein the body is made of a material that is reversibly or elastically deformable to allow the first sealing surface and the second sealing surface to be arranged at the second closest distance when in the non-connected resting state, so that the valve unit is in tension when the valve unit is connected to the fluid supply chamber (Since the stopper unit is placed tightly within the chamber, there would be some deformation of the material and stretching would occur, which would increase the distance between the two as tension would be applied to keep the tight fit, which would lead to a slight stretching of material).
Regarding claim 18, Russo teaches the valve unit according to claim 1, wherein the valve further comprises:
a first flexible flap member having a first flap sealing surface extending between two respective lateral terminating ends thereof and a second flexible flap member having a second flap sealing surface extending between two respective lateral terminating ends thereof (14a and 14b extend from the wall), wherein the first flap sealing surface and the second sealing surface are arranged to: engage each other to form a seal to close the valve in a resting state, and disengage from each other to open the valve in an engaged state to allow fluid to flow through the valve (Column 6 line 2 states “The slit opening 14 includes the face-to-face edge surfaces 14A, 14B thereof that are compressively biased sealed closed by the inward compressive force being applied thereto via the housing wall 21, that is, by the press fit fin 34 within the bottle neck's opening 23 that is positioned laterally adjacent the wall 33. Accordingly, the split septum diaphragm valve 13 functions as a normally biased closed valve 13 which prevents any spillage or leakage of the bottle medication fluid contents 24 out of valve 13 during transport.”), wherein each lateral terminating end of the first flap sealing surface and the second flap sealing surface is coupled with an interior wall of the valve unit (14a and 14b extend from the wall).
Regarding claim 19, Russo teaches the valve unit according to claim 18, wherein each lateral terminating end of the first flap sealing surface is formed integral with a corresponding lateral terminating end of the second flap sealing surface (Depicted in figure 4).
Regarding claim 20, Russo teaches the valve unit according to claim 18, wherein the first flap sealing surface and the second flap sealing surface in the engaged state engage at least part of an exterior surface a spike connector when the spike connector has been inserted into the fluid passageway to engage the valve (Figure 5).
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Russo
Regarding claim 12, Russo teaches the valve unit according to claim 10, but fails to explicitly teach wherein the first material characteristic and the second material characteristic are the same. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make both material characteristics the same since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use or purpose MPEP 2144.07.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Russo in view of Korogi et al. 2006/0192164
Regarding claim 16, Russo teaches the valve unit according to claim 1, but fails to teach wherein the first sealing surface is integrally formed with the fluid supply chamber. Korogi teaches an analogous valved fluid connector that does teach wherein the first sealing surface is integrally formed with the fluid supply chamber (Figure 2 depicts a first sealing surface being integrally formed within piece 19 as shown by lower sealed surface 11). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid supply chamber of Russo to include this sealing surface as being integrally formed within as this is a design choice that would provide for a more secure connection of the valve.
Conclusion
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/ROHAN PATEL/ Examiner, Art Unit 3785
/BRANDY S LEE/ Supervisory Patent Examiner, Art Unit 3785
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