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 .
Response to Amendment
The 112 rejections are withdrawn in view of the amendments.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 46, 48-50, 52-53, 57-65 are rejected under 35 U.S.C. 103 as being unpatentable over Browne et al (US20200208190A1 published 07/02/2020; hereinafter Browne) in view of Shiraiwa et al (US20010052491A1 published 12/20/2001; hereinafter Shiraiwa).
Regarding claim 46, Browne teaches a filtration assembly (assembly 100 – Fig. 4), comprising:
a) a funnel (a funnel – Fig. 13A);
b) a membrane frame (film with fiducial markers – Fig. 1A, 5A-B) comprising a porous membrane (the film is attached to a membrane – Fig. 1A and paragraph 61);
c) a base (a filtration base – Fig. 13A) comprising a membrane support (a mesh support – Fig. 13A) and an outlet (opening in the filtration base – Figs. 13A, 14B and paragraph 61);
wherein the membrane frame is releasably attached to the funnel (the film is separate from the funnel – Figs. 5A and 13A) and the base is releasably attached to the funnel (the filtration base is separate from the funnel – Fig. 13A); wherein, during filtration, liquid flows from the funnel through the membrane and membrane support to the outlet (a liquid sample flows through the funnel, mesh support, membrane and filtration base – Figs. 13A, 14B and paragraph 36); wherein the membrane support has a height configured to keep the membrane (the mesh support having a height – Fig. 13A) and the membrane support in conformal contact to keep the membrane flat during filtration (the membrane is supported by a mesh support pad to maintain flatness during filtration and capable of being in conformal contact with the mesh support pad during filtration – paragraph 61),
and wherein a cavity is formed between the membrane support and the membrane (a space between the mesh support and the membrane – Fig. 13A), into which the membrane is drawn during filtration (the membrane is capable of being drawn into the space during filtration – Fig. 13A).
However, Browne does not teach the membrane support is shaped with edges that taper upwards around a central flat disc area to create the cavity.
Shiraiwa teaches a filtration device for microorganisms wherein the membrane support (a holder 1 – Fig. 1) is shaped with edges that taper upwards around a central flat disc area to create the cavity (the holder 1 having a double-wall construction 9 tapering upward around a central filter receiving section 2 – Fig. 1). Shiraiwa teaches to use a double-wall construction 9 to create a liquid-tight engagement between a funnel 13 and the holder 1 with a silicone sealer 11 (paragraph 46).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the mesh support, as taught by Browne, with the doubled walled construction, taught by Shiraiwa, to gain the ability to use a silicone sealer to create a liquid-tight engagement. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Browne and Shiraiwa teach filtration devices for microorganisms.
Regarding claim 48, Browne, modified by Shiraiwa, teaches the filtration assembly of claim 46, wherein the porous membrane is ultrasonically bonded or heat staked to the membrane frame (The membrane may be installed by heat sealing to the base and the film allows for heat fusion to the membrane without damaging the membrane – Browne paragraph 45).
Regarding claim 49, Browne, modified by Shiraiwa, teaches the filtration assembly of claim 46, wherein the membrane frame is releasably attached to the funnel (the film is capable of forming a recess and interlocking with an edge on the bottom of the funnel – Browne Fig. 11) by an interlocking arrangement of a raised lip on the funnel (an edge on the bottom of the funnel – Fig. 13A) and a recess in the membrane frame (a recess can be formed in the film – Browne Fig. 11).
Regarding claim 50, Browne, modified by Shiraiwa, teaches the filtration assembly of claim 46, wherein the membrane frame comprises a protruding ring that interlocks with tabs on a cassette base (the film has an outer edge that may be heat sealed to a circular tab on the rim of a cassette base – Browne Figs. 3A-B and paragraph 45).
Regarding claim 52, Browne, modified by Shiraiwa, teaches the filtration assembly of claim 46, wherein the membrane support is attached to the filter base (the mesh support is attached to the filtration base – Browne Fig. 13A).
Regarding claim 53, Browne, modified by Shiraiwa, teaches the filtration assembly of claim 46, wherein the filter base comprises a plurality of supports (a plurality of ridges on the filtration base – Browne Fig. 13A) configured to promote fluid flow to the outlet or to support the membrane support (the plurality of ridges on the filtration base is capable of supporting the mesh support – Browne Fig. 13A).
Regarding claim 57, Browne, modified by Shiraiwa, teaches the filtration assembly of claim 46, further comprising a cavity or a shim between the membrane and membrane support (a space between the membrane and mesh support – Browne Fig. 13A).
Regarding claim 58, Browne, modified by Shiraiwa, teaches the filtration assembly of claim 57, wherein the membrane support or the base are shaped to create the cavity (the mesh support is the same circular shape of the space between the membrane and mesh support – Browne Fig. 13A).
Regarding claim 59, Browne, modified by Shiraiwa, teaches a system for filtering and culturing cells, comprising: the filtration assembly of claim 46;
a cassette (a cassette – Browne claim 49 and Fig. 1A), comprising:
a cassette base (a circular base – Browne claim 49 and Fig. 1A), comprising:
i. a base layer (a bottom surface – Browne claim 49 and Fig. 3A) comprising an outer wall (outside facing side of the base outside of the lid – Browne Fig. 3A), a first inner wall comprising a plurality of radially disposed gaps (an inner facing side of the base engaging the lid with a plurality of detents – Browne Figs. 3A and 6), and a second inner wall (an inner side wall of the base holding the media – Browne Fig. 3A) comprising an outside ledge (edge where the film is heat sealed – Browne Fig. 3B) and defining a well (the space with media – Browne Figs. 2A-3A), wherein the first inner wall is disposed between the outer wall and the second inner wall (the inner facing side of the base is between the outside facing side and the inner side wall – Browne Figs. 2A-3A);
ii. solid or semi-solid nutrient media disposed in the well (a nutrient media in the space formed by the inner side wall – Browne Figs. 2A-3A) and having a flat growth area (the nutrient media has a flat growth area – Browne paragraph 46 and Figs. 2A-3A), wherein the growth area is higher than the second inner wall (nutrient media is higher than the inner side wall – Browne Figs. 2A-3A); and
a cassette lid releasably sealable to the cassette base (lid 4 sealable to the circular cassette base – Browne Figs. 2A-3A);
wherein the membrane frame is configured to detach from the base of the filtration assembly (the film is detachable from the assembly 100 – Browne Figs. 5A and 13A), attach to the cassette base (the film is attachable to the cassette base – Browne Figs. 2A-3A), and to detach from the funnel once attached to the cassette base (the film is detachable from the funnel – Browne Figs. 1A and 13A).
Regarding claim 60, Browne, modified by Shiraiwa, teaches the system of claim 59, wherein attaching the membrane frame to the cassette base places the membrane in conformal contact with the flat growth area (growth area provides a surface where a porous membrane, e.g., exposed, to a sample may be overlaid – Browne paragraph 46).
Regarding claim 61, Browne, modified by Shiraiwa, teaches a method for determining the presence of microorganisms, comprising:
attaching the filtration assembly claim 46 (kits for capturing and culturing microorganisms – Browne paragraph 6);
flowing a sample fluid through the filtration assembly (filter a liquid sample, thus collecting any contaminating microorganisms on the membrane – paragraph 61), wherein any cells in the fluid are retained on the membrane (thus collecting any contaminating microorganisms on the membrane – Browne paragraph 61);
detaching the funnel from the base (the funnel is detached from the base – Browne Fig. 14C);
attaching the membrane frame to a cassette base (the film attached to a cassette – Browne Figs. 5A, 14C);
detaching the funnel from the membrane frame (the funnel and the film are separate – Browne Figs. 5A and 14C); and
incubating the cassette (The membrane and device are then covered, incubated, and imaged – Browne paragraph 61).
However, Browne, modified Shiraiwa, does not teach a source of vacuum, the funnel attached to the membrane frame.
Shiraiwa teaches a filtration device for microorganisms comprising a source of vacuum (the drainpipe 7 is connected to a vacuum pump which applies a suction power to the membrane filter 3 – paragraph 36), wherein the funnel is attached to the membrane frame (the membrane filter 3 is attached to the funnel 13 by a packing ring 4 – Fig. 1). Shiraiwa father teaches to use a vacuum and a manifold with multiple filters to filter multiple sample solution at the same time (paragraph 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system, taught by Browne, with a vacuum and manifold, taught by Shiraiwa, to filter multiple sample solutions at the same time. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Browne and Shiraiwa teach filtration devices for microorganisms.
Regarding claim 62, Browne, modified Shiraiwa, teaches the method of claim 61, further comprising imaging the membrane to detect any colonies formed from the retained cells (the membrane and device are then covered, incubated, and imaged – Browne paragraph 61).
Regarding claim 63, Browne, modified Shiraiwa, teaches the method of claim 61, wherein the filtration assembly comprises a cavity (a space between the funnel and filtration base – Browne Fig. 13A) and step (a) comprises applying pressure to cause the membrane to conform to a shape of the cavity (the funnel and filtration base applies pressure to the membrane in the space between the funnel and filtration base – Browne Figs. 13A-B).
Regarding claim 64, Browne, modified Shiraiwa, teaches the method of claim 61, wherein during step (d) the membrane frame is initially lowered onto the base at an angle between 1˚ and 75˚ relative to the flat growth area (the film overlaying the nutrient media and has a circumferential area that slopes from the edge of the flat growth area to the base between 1˚ and 75˚ – Browne Fig. 3A and paragraph 8).
Regarding claim 65, Browne, modified Shiraiwa, teaches the method of claim 61, wherein the cassette comprises a feature (a circumferential groove in the base of the cassette to heat seal the film and membrane – Fig. 3A-B and paragraph 45) that engages the membrane frame to position the membrane to contact the flat growth area at an angle between 1˚ and 75˚ relative to the flat growth area as the membrane frame is lowered onto the cassette base (the film overlaying the nutrient media and has a circumferential area that slopes from the edge of the flat growth area to the base between 1˚ and 75˚ – Browne Fig. 3A and paragraph 8).
Claim 47, 51, and 54-56 are rejected under 35 U.S.C. 103 as being unpatentable over Browne, modified by Shiraiwa, in view of Sklar et al (US Pat No. 5,308,483 published 05/03/1994; hereinafter Sklar).
Regarding claim 47, Browne, modified by Shiraiwa, teaches the filtration assembly of claim 46.
However, Browne, modified by Shiraiwa, does not teach wherein the funnel is attached to the base by a locking mechanism that releases when a portion of an exterior wall of the base is pressed.
Sklar teaches a microfiltration device wherein the funnel is attached to the base by a locking mechanism (the upper body 10 is locked to the lower body 30 via locking slots 16 in the upper body – Fig. 2) that releases when a portion of an exterior wall of the base is pressed (upper body 10 is released from the lower body 30 when the pair of tabs 38 on the lower body 30 are pressed – Fig. 1 and column 3 lines 29-30). Sklar further teaches to use a lock fit with the locking slot means to align the upper and lower bodies (column 1 lines 56-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the funnel and base, as taught by Browne, with the tabs 38 and locking slot 16, taught by Sklar, to align the upper and lower bodies. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Browne, Shiraiwa, and Sklar teach sample filtration with filtration funnels.
Regarding claim 51, Browne, modified by Shiraiwa, teaches the filtration assembly of claim 46, further comprising an opening to the funnel (the open top of the funnel – Fig. 13A).
However, Browne, modified by Shiraiwa, does not teach a funnel lid that covers the funnel.
Sklar teaches a microfiltration device comprising a funnel lid that covers the funnel (a cap 50 covering the upper body 10 – Fig. 2). Sklar teaches that the cap 50 seals the opening of the upper body 10 (column 1 lines 62-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the funnel, as taught by Browne as modified by Shiraiwa, with the cap 50, taught by Sklar, to seal the open top of the funnel. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Browne, Shiraiwa, and Sklar teach sample filtration with filtration funnels.
Regarding claim 54, Browne, modified by Shiraiwa, teaches the filtration assembly of claim 46.
However, Browne, modified by Shiraiwa, does not teach wherein the filtration assembly further comprises a washer.
Sklar teaches a microfiltration device comprising a washer (annular gasket or resilient seal ring 35 supporting a filter pad 36 – Fig. 2). Sklar teaches that the annular gasket is compressed and allows for air and fluid tight filtration under vacuum (column 2 lines 30 and 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the mesh support, as taught by Browne as modified by Shiraiwa, with an addition of the annular gasket, taught by Sklar, to gain the function of air and fluid tight filtration under vacuum. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Browne, Shiraiwa, and Sklar teach sample filtration with filtration funnels.
Regarding claim 55, Browne, as modified by Shiraiwa modified by Sklar, teaches the filtration assembly of claim 54, wherein:
a) the washer is attached to the membrane support (the annular gasket or resilient seal ring 35 is integral with the filter pad 36 – Sklar Fig. 2 and column 3 line 14) or is a thin film: or
b) the washer and membrane support are a single molded part.
Regarding claim 56, Browne, as modified by Shiraiwa modified by Sklar, teaches the filtration assembly of claim 54, wherein the washer comprises a spring (the outer rim of the annular gasket is compressed by the upper body – Sklar claim 15 and Fig. 3) (the outer rim is compressible and resilient; therefore, the outer rim behaves like a spring).
Response to Arguments
Applicant’s addition arguments with respect to the 102 and 103 rejections of the claims have been considered, and the prior art rejection has been modified in order to address the amended claim language.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TINGCHEN SHI whose telephone number is (571)272-2538. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.C.S./Examiner, Art Unit 1796
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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