DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed 8/21/25 has been entered and fully considered.
Claims 1, 3-14, 16 are pending, of which claim 16 is new.
Terminal Disclaimer
The terminal disclaimer filed on 9/20/24 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Pat. Nos. 9745546, 10801004, 11788046 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 1, 3-14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over OLIVIER (US 2008/0268422) in view of BROWNE (US 2007/0212747) further in view of CLEMENS (US 2008/0200343), all as previously cited.
With respect to claim 1, 3-4, OLIVIER discloses a microbiological analysis assembly and method comprising assembling a filtration unit with growth cassette (cell culture device) having a lid which may be transparent (having optically clear window) (0134, Fig-10), having an inlet aperture (sample injection port) fluidically connected a duct leading to a funnel shaped portion of wall (fluid distribution channel) (Fig 4, 0077), a cassette (base) with a gel growth medium (porous media pad) (0079-80, 0087), a membrane covers the surface of the gel-growth medium (0087) and several apertures (one or more outlet ports) surrounding the perimeter of the media pad (0089, fig 8); connects the inlet to a filling pipe (mating a first connector of a tube set to the sample injection port), the liquid then passes along the duct into the reception volume (introducing sample media through tube into sample injection port) (0091-98), placing the assembly in an incubation chamber for long enough to grow microorganisms (placing culturing device into incubator) (0131), and after incubation is complete (predefined internal) counting the colonies (0134), but does not explicitly disclose the steps of automatically retrieving the device from the incubator, automatically sending it through an imaging station, subjecting it to excitation light, and capturing an image of the fluorescence.
However, BROWNE discloses a method of capturing and culturing cells comprising a cassette containing a solid growth medium (cell culturing device) with a transparent lid, in which an automated system is used for automated handling and automated imaging of fluorescent microbial colonies (causing device to be subjected to light by imaging station to cause fluorescence, capturing an image of the fluorescence) in the cassette (0028-30), comprising the cassette being handled by an automated handling to transfer it to an automated imaging instrument (automatically retrieving the cell culturing device, automatically sending it through an imaging station), the cassette cycled through for imaging repeatedly (capturing additional images for measurement over a time period) (0033-35, 0039, 0041, 0059, 0065) and rapidly analyze the samples for contamination by microorganisms (measurements meet growth criteria, characterize as colony) . It would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the method of OLIVIER to include the automated handling and imaging steps of the cassette as taught by BROWNE because it allows for repeatability in returning the same cassette to the same location for automated imaging (0033, 0059).
OLIVIER discloses the filtration chamber inside of the cassette is subjected to pressure to cause liquid to fill the reception volume and being passing through the membrane over its entire thickness in the axial direction of filtration (0058, 0095-98), and a valve 9, that opens above a certain pressure (predetermined maximum pressure) connected to aperture 25 in the base (one or more channels in the base) that allows the pressure inside to gradually return to balance external pressure (provides a pressure relief to the cell culturing device above the medium) (0058, 0112, Fig 4-5).
OLIVIER does not explicitly disclose pumping air into the device after introducing the sample media or other fluid is the method used to pressurize the cell culturing device. However, CLEMENS discloses a fluidic device used in diagnostic methods for measuring analytes in samples comprising a cartridge with multiple chambers (0134) having an inlet port for the introduction of a sample (0137) and the means by which fluid can be moved in the device is air pumps for building up pressure in the chamber (pumping air into device to pressurize device) to move liquid out of a chamber (after introducing liquid) (0153-156). It would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the method of OLIVIER to include the air pumping of CLEMENS because it allows for the liquid to be forced out of the chamber (0153-154, 0160).
With respect to claim 5, modified OLIVIER does not explicitly disclose introducing at least two liters of sample media. However, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the method of OLIVIER to include adding at least two liters of media so that the colonies would be perfused with fresh nutrients allowing them to fully grow to a detectable stage.
WITH respect to claim 6, 8, 9, OLIVIER discloses the device comprises an additional port 23, fluidically connected to the growth media pad (Fig. 10) which could be used as a media injection port or removal port or drainage port. OLIVIER does not explicitly disclose pumping media to the pad via this port nor removal of excess sample, however, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the method of OLIVIER to include pumping media via a second injection port or removing excess media as claimed because this would allow for perfusing the colonies on the growth media for as long as the growth and imaging period requires while removing any unnecessary fluid to prevent it spilling out while transferring the cassette for imaging.
With respect to claim 7, With respect to claim 2, OLIVIER discloses the inside of the cassette is subjected to pressure (0058).
With respect to claim 10, OLIVIER does not explicitly disclose introducing a pre rinse or post rinse fluid through the injection port. However, CLEMENS discloses a fluidic device used in diagnostic methods for measuring analytes in samples comprising a cartridge with multiple chambers (0134) having an inlet port and treating the sample using known techniques such as using buffers or other solutions (0127, 0053). It would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the method of OLIVIER to include the introduction of a pre-rinse or post-rinse fluid as taught by CLEMENS because it allows the cassette to be used for a variety of techniques or washing.
With respect to claim 11, OLIVIER discloses the inside of the cassette is subjected to pressure (0058) but does not explicitly disclose pumping air into the device after introducing the sample media or other fluid. However, CLEMENS discloses a fluidic device used in diagnostic methods for measuring analytes in samples comprising a cartridge with multiple chambers (0134) having an inlet port for the introduction of a sample (0137) and air pumps for building up pressure in the chamber (pumping air into device to pressurize device) (0153-156). It would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the method of OLIVIER to include the air pumping of CLEMENS because it allows for the liquid to be forced out of the chamber (0153-154, 0160).
With respect to claim 12, modified OLIVIER does not explicitly disclose introducing at least two liters of sample media. However, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the method of OLIVIER to include adding at least two liters of fluid such as wash buffer in order to fully clean the cassette.
With respect to claim 13, OLIVIER discloses the body is adapted to seal against the lid (0064, 0121).
With respect to claim 14, OLIVIER discloses sterilizing the unit (0078).
Claim 16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over OLIVIER (US 2008/0268422) in view of BROWNE (US 2007/0212747) in view of CLEMENS (US 2008/0200343), all as previously cited, further in view of OLDHAM (US 20050226779) or LEMONNIER (US 5340741) both newly cited.
With respect to claim 16, OLIVIER discloses a microbiological analysis assembly and method comprising assembling a filtration unit with growth cassette (cell culture device) having a lid which may be transparent (having optically clear window) (0134, Fig-10), having an inlet aperture (sample injection port) fluidically connected a duct leading to a funnel shaped portion of wall (fluid distribution channel) (Fig 4, 0077), a cassette (base) with a gel growth medium (porous media pad) (0079-80, 0087), a membrane covers the surface of the gel-growth medium (0087) and several apertures (one or more outlet ports) surrounding the perimeter of the media pad (0089, fig 8); connects the inlet to a filling pipe (mating a first connector of a tube set to the sample injection port), the liquid then passes along the duct into the reception volume (introducing sample media through tube into sample injection port) (0091-98), placing the assembly in an incubation chamber for long enough to grow microorganisms (placing culturing device into incubator) (0131), and after incubation is complete (predefined internal) counting the colonies (0134), but does not explicitly disclose the steps of automatically retrieving the device from the incubator, automatically sending it through an imaging station, subjecting it to excitation light, and capturing an image of the fluorescence.
However, BROWNE discloses a method of capturing and culturing cells comprising a cassette containing a solid growth medium (cell culturing device) with a transparent lid, in which an automated system is used for automated handling and automated imaging of fluorescent microbial colonies (causing device to be subjected to light by imaging station to cause fluorescence, capturing an image of the fluorescence) in the cassette (0028-30), comprising the cassette being handled by an automated handling to transfer it to an automated imaging instrument (automatically retrieving the cell culturing device, automatically sending it through an imaging station), the cassette cycled through for imaging repeatedly (capturing additional images for measurement over a time period) (0033-35, 0039, 0041, 0059, 0065) and rapidly analyze the samples for contamination by microorganisms (measurements meet growth criteria, characterize as colony) . It would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the method of OLIVIER to include the automated handling and imaging steps of the cassette as taught by BROWNE because it allows for repeatability in returning the same cassette to the same location for automated imaging (0033, 0059).
OLIVIER does not explicitly disclose pumping air into the device after introducing the sample media or other fluid is the method used to pressurize the cell culturing device. However, CLEMENS discloses a fluidic device used in diagnostic methods for measuring analytes in samples comprising a cartridge with multiple chambers (0134) having an inlet port for the introduction of a sample (0137) and the means by which fluid can be moved in the device is air pumps for building up pressure in the chamber (pumping air into device to pressurize device) to move liquid out of a chamber (after introducing liquid) (0153-156). It would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the method of OLIVIER to include the air pumping of CLEMENS because it allows for the liquid to be forced out of the chamber (0153-154, 0160).
OLIVIER discloses the filtration chamber inside of the cassette is subjected to pressure to cause liquid to fill the reception volume and being passing through the membrane over its entire thickness in the axial direction of filtration (0058, 0095-98), and a valve 9, that opens above a certain pressure (predetermined maximum pressure) connected to aperture 25 in the base that allows the pressure inside to gradually return to balance external pressure (0058, 0112, Fig 4-5) but does not explicitly disclose the pressure relief valve located in the lid or in a tube of the tube set.
However, OLDHAM discloses a microplate (cell culturing device) in which a pressure relief valve is located in fluid communication (in tube) with input coupling (first connector of tube set) with a preset maximum pressure (maintains pressure below predetermined maximum pressure)(0606, Fig. 207). Alternatively, LEMONNIER discloses a device for incubating a sample containing microorganisms comprising a lid 2, above the medium, with vent holes 22 to release the excess pressure (pressure relief valve in lid) to maintain a positive pressure in the container (maintains pressure below predetermined maximum) (Col. 4, lines 29-41, Fig 1, 3). It would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the location of the pressure relief valve of OLIVIER to be located in a tube of the tube set as taught by OLDHAM because it allows for maintenance of pressure in the system at the connection point for a supply of fluid while allowing the filtered fluid to vent to the exterior (OLDHAM 0606) or to be located in the lid as taught by LEMONNIER because it allows for venting excess pressure that builds up in the container during incubation without contamination from the outside environment (LEMONNIER Col. 4, lines 29-41, Col. 1, lines 44-51).
Response to Arguments
Applicant's arguments filed 8/21/25 have been fully considered but they are not persuasive.
In response to applicant’s argument that the aperture 25 of OLIVIER does not meet the claimed language of a channel in the base configured to provide pressure relief, the examiner respectfully disagrees. OLIVIER discloses the pressure relief valve 9 in a duct connected to the aperture 25 that is the start of a channel in the base (seen in Fig 5). While the valve is the moving mechanism that relieves the pressure, the channel and aperture are necessary components to allow for pressure relief by creating a pathway for the excess pressure to escape the device in the form of air. Therefore, the examiner maintains that the aperture 25 and connected channel meet the claim limitation of “one or more channels in the base configured to provide pressure relief”. It is noted the claim does not currently require the pressure relief valve itself to be located in the base, merely channels configured to provide pressure relief.
As for the alternative locations of pressure relief valve claimed in claim 1 and newly added claim 16, these locations are taught by OLDHAM and LEMONNIER as detailed in the rejection of claim 16.
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 DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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