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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 22 objected to because of the following informalities: The claim recites “wherein the portion of the portion of the fluid sample collection apparatus has a female luer connector” which appears to be an unnecessary repetition of the portion. Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claim(s) 1-6, 8, 10-16, 18 and 20-27 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over WO 2020118018 to Samproni (citations to equivalent US publication US 20220023857).
Regarding Claim 1, Samproni discloses an apparatus for transferring a fluid sample having a liquid portion and a gas portion from a fluid sample collection apparatus to a liquid sample analyzer (Figs. 1-9, testing device 100/140/180/280 with fluid collection device 101/141 and fluid treatment module 106/186 connected to analysis unit 84 housing 88; ¶¶ [0057]-[0072], [0079]-[0082]), comprising: a barrel having a first end, a second end opposite the first end, a sidewall extending between the first end and the second end, and an inner surface defining an internal chamber (Figs. 1-9, lower portion 108 and upper portion 110 of fluid treatment module 106 can be tubular devices that are sealably connected to form a housing; ¶¶ [0057]-[0072], [0079]-[0082]), the first end having an inlet opening and the second end having an outlet opening (Figs. 1-9, fluid treatment module 106 with inlet at second connector portion 128 and outlet at third connector portion 130; ¶¶ [0057]-[0072], [0079]-[0082]), wherein the first end of the barrel has a barrel connection portion engageable with a portion of the fluid sample collection apparatus (Figs. 1-9, fluid treatment module 106 with second connector portion 128 connected to first connector portion 126 of fluid housing 102 of fluid collection device 101/141; ¶¶ [0057]-[0072], [0079]-[0082]), and wherein the second end of the barrel has a tubular portion configured to engage with the liquid sample analyzer (Figs. 1-9, fluid treatment module 106 with third connector portion 130 connected in slot 90 of analysis unit 84 housing 88; ¶¶ [0057]-[0072], [0079]-[0082]), so a combination of the fluid sample collection apparatus and the barrel is attachable to the liquid sample analyzer with no additional support (Figs. 1-9, testing device 100/140/180/280 with fluid collection device 101/141 and fluid treatment module 106/186 connected with third connector portion 130 connected and supported in slot 90 of analysis unit 84 housing 88; ¶¶ [0057]-[0072], [0079]-[0082]).
Regarding Claim 2, Samproni discloses the barrel connection portion comprises at least one thread lug extending radially outwardly from the sidewall of the barrel so as to be interlockingly engageable with a portion of the fluid sample collection apparatus (Figs. 1-9, fluid treatment module 106 with threads of second connector portion 128 connected to first connector portion 126 of fluid housing 102 of fluid collection device 101/141; ¶¶ [0057]-[0072], [0079]-[0082]).
Regarding Claim 3, Samproni discloses the barrel connection portion comprises a pair of thread lugs extending radially outwardly from the sidewall of the barrel so as to be interlockingly engageable with the fluid sample collection apparatus (Figs. 1-9, fluid treatment module 106 with threads of second connector portion 128 connected to first connector portion 126 of fluid housing 102 of fluid collection device 101/141; ¶¶ [0057]-[0072], [0079]-[0082]).
Regarding Claim 4, Samproni discloses the barrel connection portion is a female luer connector (Figs. 1-9, fluid treatment module 106 first connector portion 126 can be any suitable type of connector, such as a Luer connector, a male port, or a female port with second connector portion 128 of the lower portion 108 connected to the first connector portion 126; ¶¶ [0057]-[0072], [0079]-[0082])..
Regarding Claim 5, Samproni discloses the tubular portion of the barrel is a male luer connector configured to engage with the liquid sample analyzer (Figs. 1-9, fluid treatment module 106 third connector portion 130 can be a luer connector, a male port, a female port connected and supported in slot 90 of analysis unit 84 housing 88; ¶¶ [0057]-[0072], [0079]-[0082]).
Regarding Claim 6, Samproni discloses a gas-permeable, liquid-impermeable membrane secured to the barrel adjacent the second end of the barrel (Figs. 4-9, lateral flow membrane 194/210 and/or gas permeable/fluid impermeable membrane sealing the first fluid port 116 between lower portion 108 and the upper portion 110; ¶¶ [0061]-[0078]), the gas-permeable, liquid-impermeable membrane pierceable so a sample probe is configured to be passed through the gas-permeable, liquid-impermeable membrane to the internal chamber (Figs. 4-9, probe 196/212 passed through lateral flow membrane 194/210 and/or gas permeable/fluid impermeable membrane sealing the first fluid port 116 between lower portion 108 and the upper portion 110; ¶¶ [0072]-[0078]).
Regarding Claim 9, Samproni discloses a filter member disposed within the internal chamber so the filter member defines an inlet side and an outlet side of the internal chamber and so the filter member is positionable between the first end and the second end of the barrel (Figs. 1-9, gas permeable/fluid impermeable membrane sealing the first fluid port 116 between lower portion 108 and the upper portion 110; ¶¶ [0061]-[0078]), the filter member having at least one gas-permeable, liquid-impermeable membrane to permit at least a portion of the gas portion of the fluid sample to pass across the filter member from the inlet side to the outlet side of the internal chamber and to provide a fluid-tight seal across the filter member to prevent the liquid portion of the fluid sample from passing from the inlet side to the outlet side as the fluid sample is passed into the internal chamber via the inlet opening to separate at least a portion of the gas portion from the liquid portion of the fluid sample (Figs. 1-9, gas permeable/fluid impermeable membrane sealing first fluid port 116 to pass air out of fluid sample to de-aerate the fluid sample; ¶¶ [0061]-[0078]), wherein the filter member is pierceable so a probe is configured to be passed through the filter member from the outlet side to the inlet side to withdraw the liquid portion of the fluid sample from the inlet side of the internal chamber (Figs. 4-9, probe 196/212 passed through lateral flow membrane/filter 194/210; ¶¶ [0072]-[0078]).
Regarding Claims 10-16 and 18, the claims appear to differ from claims 1-6 and 8 in that the preamble recites an apparatus for transferring a fluid sample having a liquid portion and a gas portion in combination with a liquid sample analyzer having a sample probe and a fluid sample collection apparatus. Samproni discloses an apparatus for transferring a fluid sample having a liquid portion and a gas portion in combination with a liquid sample analyzer having a sample probe and a fluid sample collection apparatus (Figs. 1-9, testing device 100/140/180/280 with fluid collection device 101/141 and fluid treatment module 106/186 connected to analysis unit 84 housing 88; ¶¶ [0057]-[0072], [0079]-[0082]).
Regarding Claim 20, Samproni discloses a method of transferring a fluid sample having a liquid portion and a gas portion from a fluid sample collection apparatus to a liquid sample analyzer having a sample probe (Figs. 1-9, testing device 100/140/180/280 with fluid collection device 101/141 and fluid treatment module 106/186 connected to analysis unit 84 housing 88 with probe 196/212; ¶¶ [0057]-[0082]), the method comprising: obtaining an apparatus having a barrel with a first end, a second end, a sidewall extending between the first end and the second end, and an inner surface defining an internal chamber (Figs. 1-9, lower portion 108 and upper portion 110 of fluid treatment module 106 can be tubular devices that are sealably connected to form a housing; ¶¶ [0057]-[0072], [0079]-[0082]), the first end having an inlet opening and the second end having an outlet opening (Figs. 1-9, fluid treatment module 106 with inlet at second connector portion 128 and outlet at third connector portion 130; ¶¶ [0057]-[0072], [0079]-[0082]); engaging the first end of the barrel with a portion of the fluid sample collection apparatus (Figs. 1-9, fluid treatment module 106 with second connector portion 128 connected to first connector portion 126 of fluid housing 102 of fluid collection device 101/141; ¶¶ [0057]-[0072], [0079]-[0082]); transferring the fluid sample from the fluid sample collection apparatus to the barrel (Figs. 1-9, fluid treatment module 106 with second connector portion 128 connected to first connector portion 126 of fluid housing 102 of fluid collection device 101/141; ¶¶ [0057]-[0072], [0079]-[0082]); engaging the second end of the barrel with the liquid sample analyzer so a combination of the fluid sample collection apparatus and the barrel is attached to the liquid sample analyzer with no additional support (Figs. 1-9, fluid treatment module 106 with third connector portion 130 connected in slot 90 of analysis unit 84 housing 88 with testing device 100/140/180/280 with fluid collection device 101/141 and fluid treatment module 106/186 connected with third connector portion 130 connected and supported in slot 90 of analysis unit 84 housing 88; ¶¶ [0057]-[0072], [0079]-[0082]); and transferring the fluid sample from barrel to the liquid sample analyzer with the sample probe (Figs. 4-9, probe 196/212 passed through lateral flow membrane/filter 194/210; ¶¶ [0072]-[0078]).
Regarding Claim 21, Samproni discloses the step of engaging the first end further comprises threading the first end of the barrel with the portion of the fluid sample collection apparatus so as to interlockingly engage the barrel with the fluid sample collection apparatus (Figs. 1-9, fluid treatment module 106 with threads of second connector portion 128 connected to first connector portion 126 of fluid housing 102 of fluid collection device 101/141; ¶¶ [0057]-[0072], [0079]-[0082]).
Regarding Claim 22, Samproni discloses the first end of the barrel has a barrel connection portion that is a male luer connector (Figs. 1-9, fluid treatment module 106 first connector portion 126 can be a luer connector, a male port, a female port connected and supported in slot 90 of analysis unit 84 housing 88; ¶¶ [0057]-[0072], [0079]-[0082]), wherein the portion of the portion of the fluid sample collection apparatus has a female luer connector (Figs. 1-9, fluid treatment module 106 first connector portion 126 can be any suitable type of connector, such as a Luer connector, a male port, or a female port with second connector portion 128 of the lower portion 108 connected to the first connector portion 126; ¶¶ [0057]-[0072], [0079]-[0082]), and wherein the step of engaging the first end further comprises engaging the male luer connector of the barrel with the female luer connector of the fluid sample collection apparatus (Figs. 1-9, fluid treatment module 106 first connector portion 126 and can be a luer connector, a male port, a female port connected and supported in slot 90 of analysis unit 84 housing 88; ¶¶ [0057]-[0072], [0079]-[0082]).
Regarding Claim 23, Samproni discloses the second end of the barrel has a tubular portion that is a male luer connector, and wherein the step of engaging the second end comprises engaging the male luer connector of the barrel within a sample input port of the liquid sample analyzer (Figs. 1-9, fluid treatment module 106 third connector portion 130 can be a luer connector, a male port, a female port connected and supported in slot 90 of analysis unit 84 housing 88; ¶¶ [0057]-[0072], [0079]-[0082]).
Regarding Claim 24, Samproni discloses the steps of engaging the first end and engaging the second end further comprises axially aligning the fluid sample collection apparatus and the barrel with the sample probe (Figs. 4-9, probe 196/212 passed through lateral flow membrane/filter 194/210 and/or gas permeable/fluid impermeable membrane sealing the first fluid port 116 between lower portion 108 and the upper portion 110; ¶¶ [0061]-[0078]).
Regarding Claim 25, Samproni discloses the apparatus further comprises a gas-permeable, liquid-impermeable membrane secured to the barrel adjacent the second end of the barrel (Figs. 1-9, gas permeable/fluid impermeable membrane sealing the first fluid port 116 between lower portion 108 and the upper portion 110; ¶¶ [0061]-[0078]), and wherein the step of transferring the fluid sample from the barrel further comprises passing the sample probe through the gas-permeable, liquid-impermeable membrane to the internal chamber of the of the barrel (Figs. 4-9, probe 196/212 passed through lateral flow membrane/filter 194/210 and/or gas permeable/fluid impermeable membrane sealing the first fluid port 116 between lower portion 108 and the upper portion 110; ¶¶ [0061]-[0078]).
Regarding Claim 26, Samproni discloses causing the fluid sample to contact a filter member disposed within the internal chamber, the filter member defining an inlet side and an outlet side of the internal chamber, the filter member having a gas-permeable, liquid-impermeable membrane (Figs. 1-9, gas permeable/fluid impermeable membrane/filter sealing the first fluid port 116 between lower portion 108 and the upper portion 110; ¶¶ [0061]-[0078]); separating at least a portion of the gas portion of the liquid sample from the liquid portion of the fluid sample by causing the fluid sample to contact the gas-permeable, liquid-impermeable membrane so that at least a portion of the gas portion of the fluid sample passes across the filter member from the inlet side to the outlet side of the internal chamber and so the liquid portion of the fluid sample is prevented from passing from the inlet side to the outlet side (Figs. 1-9, gas permeable/fluid impermeable membrane sealing first fluid port 116 to pass air out of fluid sample to de-aerate the fluid sample; ¶¶ [0061]-[0078]); and collecting at least a portion of the liquid portion of the fluid sample from the inlet side of the internal chamber (Figs. 4-9, probe 196/212 passed through lateral flow membrane/filter 94/210; ¶¶ [0072]-[0078]).
Regarding Claim 27, Samproni discloses the step of transferring the fluid sample from the barrel further comprises passing the sample probe through the gas-permeable, liquid-impermeable membrane to the inlet side of the internal chamber of the barrel (Figs. 4-9, probe 196/212 passed through lateral flow membrane/filter 94/210; ¶¶ [0072]-[0078]).
Claim(s) 7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samproni as applied to claims 6 and 16 above, and further in view of US 20030236497 to Fremming.
Regarding Claims 7 and 17, Samproni discloses the apparatus of claim 6 and combination of claim 16, but is silent regarding the gas-permeable, liquid-impermeable membrane is formed from a material comprising at least one of polytetraflyorethylene, polypropylene, and polyethylene. Fremming discloses the gas-permeable, liquid-impermeable membrane is formed from a material comprising at least one of polytetraflyorethylene, polypropylene, and polyethylene (¶¶ [0010], [0029]). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Samproni by providing the gas-permeable, liquid-impermeable membrane is formed from a material comprising at least one of polytetraflyorethylene, polypropylene, and polyethylene as in Fremming in order to provide for a well-known alternative material having the hydrophobic properties for such a membrane. See, e.g., "substitution of art-recognized equivalents" as discussed in MPEP 2144.06II "An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)."
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samproni as applied to claims 8 and 18 above, and further in view of US 20080078256 to Christie.
Regarding Claims 9 and 19, Samproni discloses the apparatus of claim 8 and combination of claim 18, but is silent regarding the filter member is slidably disposed in the internal chamber of the barrel. Christie discloses the filter member is slidably disposed in the internal chamber of the barrel.( ¶¶ [0102]-[0112}). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Samproni by providing the filter member is slidably disposed in the internal chamber of the barrel as in Christie in order to provide for ease of maintenance for prevention of filter contamination.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID J BOLDUC whose telephone number is (571)270-1602. The examiner can normally be reached M-F, 10am-6pm.
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/DAVID J BOLDUC/Primary Examiner, Art Unit 2852
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