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 .
Election/Restrictions
Applicant’s election without traverse of Group II Species 1A (claims 22, 25-27, 30, 32-34) in the reply filed on 03/01/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/14/2023, 05/27/2025 was filed before the mailing date of the FAOM. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 30 is objected to because of the following informalities:
Claim 30 last line – the claim ends with a semicolon and should amended to a period.
Appropriate correction is required.
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 25, 27, 30, 32-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 25 recites “that flow is created from a test solution inlet to an outlet” and is unclear whether “a test solution inlet” and “an outlet” are positively recited structures of the filtration and concentration microfluidic apparatus. For prosecution, the limitation is interpreted as intended use of the device and deemed to read on a channel capable of holding suction pressure.
Claim 25 recites “a pore size of the porous membrane filter can be selected with different sizes” and is unclear because a pore size refers to a single size while the claim references multiple pore sizes. For prosecution, the limitation is interpreted to mean filters of different sized pores can be used.
Claim 27 recites “a cultivation chamber in a lower portion of the cultivation chamber” and is unclear whether a cultivation chamber is the same or a separate structure from the cultivation chamber. For prosecution, the limitation is interpreted to mean that there is only one cultivation chamber wherein the cultivation chamber has a lower portion.
Claim 27 recite “results in media from a first media reservoir to flow into the lower portion of the cultivation chamber” and is unclear whether “media” and “a first media reservoir” are positively recited elements of the claim. For prosecution, the limitation is interpreted to be an intended use recitation of the second outlet port.
Claim 27 recites “moving all microbial and other contaminants from the filtration and concentration microfluidic apparatus to the cultivation chamber and resuspending the microbial and other contaminants” and is unclear how the filter is capable of moving and resuspended in contaminants. For prosecution, the limitation is interpreted to be an intended use recitation of the porous membrane filter.
Claim 27 recites “operable to be automated by at least one of a controller or an automation system comprising components” and is unclear a controller or an automation system comprising components that are optically transparent is positively recited. For prosecution, the limitation is interpreted to be an intended use recitation of the device component.
Claim 27 line 21 recites “the microfluidic channel ” and is unclear whether “the microfluidic channel” refers to a microfluidic channel of line 2 or a microfluidic channel of line 20. For prosecution, the limitation is interpreted to refer to the microfluidic channel of line 20.
Claim 30 recites “a planar electrode design”, “a top-bottom electrode design”, and “a three-dimensional electrode design” and is unclear how the electrode is capable of having all three mutually exclusive designs at the same time. For prosecution, the limitation will be interpreted to mean that the electrode has one of the claimed designs.
Claim 32 recites “wherein two or more apparatuses are placed in parallel” and is unclear whether “apparatuses” refer to the filtration and concentration microfluidic apparatus or the cultivation microfluidic apparatus. For prosecution, the limitation is interpreted to mean that the filtration and concentration microfluidic apparatus and the cultivation microfluidic apparatus are capable of being placed in parallel.
Claim 32 recites “a single microvalve controller can control the two or more apparatuses simultaneously” and is unclear whether “apparatuses” refer to the filtration and concentration microfluidic apparatus, the cultivation microfluidic apparatus, or the single impedance sensing apparatus. For prosecution, the limitation will be interpreted as the microvalve controller is capable of controlling flow to any two of the three apparatuses above.
Claim 33 recites “a media reservoir is replaced with a buffer reservoir” and is unclear whether the media reservoir and the buffer reservoir are positively recited elements of the claim. For prosecution, the limitation will be interpreted to not positively recite the elements and the media reservoir and the buffer reservoir are interpreted to be connectable to the cultivation chamber.
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.
Claims 22, 25-27, 30, and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Bashir et al (US20090263856A1 published 10/22/2009; hereinafter Bashir) in view of Li et al (US20100120016A1 published 05/13/2010; hereinafter Li).
Regarding claim 22, Bashir teaches a device for evaluation of sterility or bioburden (a micro-fabricated device with an integrated filter and growth detection circuitry – paragraph 2), the device comprising:
a filtration and concentration microfluidic apparatus (an integrated filter and growth detector 20 – Figs. 1-4) to filter and concentrate microbial contaminants from a solution using a filtration structure (“to filter and concentrate microbial contaminants from a solution using a filtration structure” is an intended use recitation of the apparatus and per MPEP2115 is interpreted to read on a device capable of performing the claimed filtration) (the filter and growth detector 20 comprising filters 70 and71 that filter microbial contaminants from a solution – Figs. 1-4 and paragraph 9);
wherein the filtration structure comprises a porous membrane filter (a filter membrane to capture a sample. The filter membrane is then manually moved to a growth area to grow the cells trapped on the membrane – paragraph 9 and Fig. 4);
wherein a pore size in the membrane filter is similar or smaller than a size of the microbial contaminants such that particles or microorganisms can be trapped by the filtration structure (The filter includes a first physical barrier with apertures of a first size and a second physical barrier with apertures of a second size smaller than the first size to isolate the cell sample on the filter – paragraph 9) (the examiner points out that in order to isolate cells the filter must have pores similar or smaller than a size of the captured cells);
a microfluidic channel (a channel 54 – Fig. 2-4) comprising at least one integrated impedance sensing electrode array (the channel 54 connected to electrodes 84 – Fig. 2-4) (the growth is detected electronically. In one embodiment impedance changes over time are used to detect the growth – paragraph 32) to detect single cells passing through an electrode of the electrode array for label-free single-cell-resolution flow through counting of the particles or microorganisms (“to detect single cells passing through an electrode of the electrode array for label-free single-cell-resolution flow through counting of the particles or microorganisms” an intended use recitation of the apparatus and per MPEP2115 is interpreted to read on a device capable of performing the claimed cell detection) (the electrodes 84 are capable of being used to detect cells – Fig. 2-4 and paragraph 32);
a cultivation microfluidic apparatus (a detector end 52 comprising a measurement chamber 82 – paragraph 82), wherein filtered, concentrated, and enumerated particles or microorganisms (“particles or microorganisms” are not positively recited elements of the device and do not impart patentability to the claim, per MPEP2115 the particles or microorganisms are deemed to be articles worked upon by the device) are operable to be moved (recover the bacteria from the filter 70 and move the bacteria to the measurement chamber 82. The bacteria may be further concentrated in the measurement chamber 82 – paragraph 32) into one or more cultivation chambers comprising one or more different microbial cultivation media to allow growth of microorganisms for varying durations (The bacteria may also be provided with growth media to facilitate rapid growth – paragraph 32);
at least one of a series of microfluidic valves placed in each microfluidic channel operable to control closing and opening of each microfluidic channel, or a series of valving mechanisms (a fluidic control device 24 comprising valves 48 – Figs. 1-4) to control flow of fluid on-chip (valves 48 are used to control the fluid flow – paragraph 26 and Fig. 2);
wherein valving mechanisms have a location selected from the group consisting of on-chip, off-chip, between components, integrated at varying locations between tubing interconnects, and combinations thereof (the fluidic control device 24 is integrated at varying locations between tubing interconnects – Fig. 2).
However, Bashir does not teach a software interface operable to count differences in a number of detected contaminant particles before and after cultivation, wherein any increase in number of contaminant particles indicate the solution is non-sterile.
Li teaches an impedance biosensor is provided for detecting a contaminant comprising a software interface (LCD 36 and an input device or keypad 40 – Fig. 1 and paragraph 40) operable to count differences in a number of detected contaminant particles before and after cultivation (“operable to count differences” is an intended use limitation and interpreted to read on a user interface capable of being used to count cells to indicate a solution is non-sterile), wherein any increase in number of contaminant particles indicate the solution is non-sterile (the LCD 36 and an input device or keypad 40 are operable to count differences in a number of detected contaminant particles before and after cultivation – Fig. 1 and paragraph 40). Li further teach that such input and output devices are conventional in the art (paragraph 45).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device, as taught by Bashir, with the LCD 36 and an input device or keypad 40, taught by Li, via routine optimization because such input and output devices are conventional in the art. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Bashir and Li teach devices for sample analysis through impedance measurement.
Regarding claim 25, Bashir, modified by Li, teaches the device of claim 22, wherein the filtration and concentration microfluidic apparatus (detector 20 – Fig. 4) comprises:
a bottom microfluidic channel (an input port 62 – Fig. 4) through which microbial contaminants flow into a porous membrane filter region (input port 62 is capable of directing microbial contaminants flow into a porous membrane filter region – Fig. 4);
a first microfluidic chamber (an input port 60 – Fig. 4 and paragraph 31) comprising a porous membrane filter as the top portion of the first microfluidic chamber (when the orientation of Fig. 4 is flipped upside down the filter 71 is at the top of the input port 60 – Fig 4);
wherein the porous membrane filter comprises pore sizes similar or smaller than microbial contaminants to be concentrated (the filter 71 having pore sizes pore sizes of the pre-filters are preferably in the range of 4-8 µm and is deemed to be capable of filtering microbial contaminants greater than 4-8 µm – paragraph 37);
a top microfluidic channel (an output port 64 is on top of the input port 62 when the orientation of Fig. 4 is flipped upside down – Fig. 4) and chamber (a filter chamber between filters 71 and 70 – Fig. 4), wherein suction pressure can be applied such (a suction pressure can be applied to the outlet port 64 – Fig. 4) that the flow is from the bottom microfluidic channel, through the porous membrane filter, and into the top microfluidic channel such that all microbial contaminants are trapped in the bottom microfluidic channel (a sample can flow from the input port 62, through the filter 71, and into the outlet 64 while microbial contaminants are trapped input port 62 by the filter 71 – Fig. 4);
a media reservoir in fluid communication with the top microfluidic chamber through a microfluidic channel (a growth media reservoir 40 connected to the filter chamber via the input port 62);
an outlet channel (an opening to the output port 64 – Fig. 4), wherein suction pressure can be applied so that flow is created from a test solution inlet to an outlet (a suction pressure can be applied at the opening to the output port 64 – Fig. 4; see 112b rejection above);
wherein a pore size of the porous membrane filter can be selected with different sizes to maximize trapping efficiency while further maximizing flow rate through the porous membrane filter (the filters 70, 71 having multiple pore sizes, and a range of pore sizes be selected to maximize trapping efficiency while further maximizing flow rate – paragraph 37; see 112b);
at least one of a series of microfluidic valves that are placed in each microfluidic channel to control closing and opening of the microfluidic channels, or a series of valving mechanisms to control flow of fluid on-chip (a series of valves 48 is connected to the filter and growth detector 20 control flow to the input port 62 and the growth media reservoir 44 – Fig. 4); and
wherein valving mechanisms have a location selected from the group consisting of on-chip, off-chip, between components, integrated at varying locations between tubing interconnects (the series of valves integrated at varying locations between tubing interconnects – Fig. 4), and combinations thereof.
Regarding claim 26, Bashir, modified by Li, teaches the device of claim 22, comprising an impedance counting electrode (one of the electrodes 84 – Figs. 3-4) disposed between an inlet (inlet port 60 – Fig. 4) and the filtration and concentration microfluidic apparatus (the filter and growth detector 20 – Fig. 4) operable to count the number of incoming particle contaminants (one of the electrodes 84 is capable of being used to count the number of incoming particle contaminants – Figs. 3-4).
Regarding claim 27, Bashir, modified by Li, teaches the device of claim 22, comprising:
a microchannel (an outlet 110 – Fig. 4) with integrated electrodes (the outlet 110 with electrodes 84 – Fig. 4) that connects the filtration and concentration microfluidic apparatus to the cultivation microfluidic apparatus (the outlet 110 connects the detector 20 to the detector end 52 – Fig. 4);
a cultivation chamber in a lower portion of the cultivation chamber (a measurement chamber 82 with a lower portion – Fig. 4), wherein microbial and other contaminants can be trapped by the porous membrane filter placed on top of the cultivation chamber (microbial and other contaminants can be trapped by the porous membrane filter 71 and then placed on the measurement chamber 82 – Fig. 4 and paragraph 32);
an upper microfluidic chamber placed on top of the porous membrane filter (a chamber between filter 71 and filter 70 – Fig. 4);
a second outlet (an output port 64 – Fig. 4) in fluid communication with the upper microfluidic chamber of the cultivation chamber such that suction pressure can be applied (the output port 64 is connected to the chamber and is capable of having suction pressure applied – Fig. 4);
wherein applying the suction pressure through the second outlet results in media from a first media reservoir to flow into the lower portion of the cultivation chamber, take any concentrated microbial and other contaminants, and flow into the cultivation chamber (“wherein applying the suction pressure through the second outlet results in media from a first media reservoir to flow into the lower portion of the cultivation chamber, take any concentrated microbial and other contaminants, and flow into the cultivation chamber” is an intended use recitation of the second outlet, and is therefore deemed to read on an outlet capable of receiving suction pressure) (the output port 64 is capable of receiving suction pressure – Fig. 4);
wherein flow moves through the porous membrane filter allowing continuous flow (the filter 70 is capable of allowing continuous flow – Fig. 4) while all concentrated microbial and other contaminants remain in the cultivation chamber thereby moving all microbial and other contaminants from the filtration and concentration microfluidic apparatus to the cultivation chamber and resuspending the microbial and other contaminants (“moving all microbial and other contaminants from the filtration and concentration microfluidic apparatus to the cultivation chamber and resuspending the microbial and other contaminants” is interpreted as an intend to use recitation of the filter membrane, and deemed to read on a filter capable of trapping contaminants) into the microbial cultivation media (the filter 70 is capable of removing all microbial and other contaminants from the detector 20 and allows bacteria from the filter 70 to be moved to the measurement chamber 82 – Fig. 4 and paragraph 32; see 112b rejection above);
at least one of a series of microfluidic valves that are placed in all microfluidic channels to control closing and opening of all microfluidic channels, or a series of valving mechanisms to control the flow of fluid on-chip (a series of valves 48 is connected to the filter and growth detector 20 control flow to an input port 62 and a growth media reservoir 44 – Fig. 4);
wherein valving mechanisms have a location selected from the group consisting of on-chip, off-chip, between components, integrated at varying locations between tubing interconnects (the series of valves integrated at varying locations between tubing interconnects – Fig. 4), and combinations thereof; and
a device component (a glass or quartz cover 114 mounted on a printed circuit board – paragraph 31 and Fig. 4) operable to be automated by at least one of a controller or an automation system comprising components that are optically transparent (glass or quartz cover 114 is deemed to be optically transparent – paragraph 31) thereby allowing simultaneous interrogation of microbial contaminants using optical and impedance directed approaches (glass or quartz cover 114 is mounted on a printed circuit board; therefore, the cover 114 is capable of being used in an automated interrogation process by a fluidic control module 36 – paragraph 24 and Fig. 1; see 112b above),
a microfluidic channel in fluid communication with the cultivation chamber and to an outlet (an input port 62 is connected to the measurement chamber 82 and an outlet of the outlet port 64 – Figs. 1-4)
However, Bashir (Fig. 1-4) does not teach wherein the porous membrane filter that covers the ceiling of the cultivation chamber; wherein impedance sensing electrodes are integrated into the input port 62.
Bashir teaches another embodiment wherein a microchannel comprises integrated impedance electrode (electrodes 164 formed in the input port 144 for impedance measurements – paragraph 34 and Fig. 5), wherein the porous membrane filter that covers the ceiling of the cultivation chamber (a first mechanical filter 140 covers the ceiling of a second wafer 132 – paragraph 34 and Fig. 5). Bashir further teaches that voltages may be applied to the electrodes 164 to divert bacteria into smaller chambers for measurements (paragraph 35).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the input port 62 and measurement chamber 82, as taught by Bashir (Figs. 1-4), with the electrodes 164 and second wafer 132 arrangement, taught by Bashir (FIG. 5), to gain the ability to divert bacteria into smaller chambers for measurements. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Bashir teaches different embodiments of the same invention.
Regarding claim 30, Bashir, modified by Li, teaches the device of claim 22, wherein the at least one integrated impedance sensing electrode array comprises (the electrode array is interpreted to have one of a planar electrode design, a top bottom electrode design, or three-dimensional electrode design; see 112b rejection above):
a planar electrode design (the electrodes 84 are in a planar arrangement – Figs. 1-4) having one pair of electrodes close together and placed on a bottom portion of the microfluidic channel (a pair of the electrodes 84 are close together and placed in a bottom portion of the channel 54 – Fig. 2-4) to detect an object passing above the planar electrode through changes in impedance at various applied voltages and frequencies (“to detect an object passing above” is an intended use recitation of the electrodes and is deemed to read on electrodes capable of being used for impedance measurement) (the electrodes 84 are capable of being used for impedance measurement – paragraph 32);
wherein the planar electrode design that has two or more electrodes in an interdigitated form;
a top-bottom electrode design, wherein one or more electrodes are placed on the surface of the microfluidic channel and one or more electrodes are placed on the ceiling of the microfluidic channel;
wherein the location of the electrodes have an orientation selected from the group consisting of stacked directly on top of each other and stacked at some distance apart from each other;
a three-dimensional electrode design, wherein one or more electrodes are on one side of the microfluidic channel and another electrode is on an opposite side of the microfluidic channel; and
wherein the electrodes comprise at least one of metals, liquid metals, conductive solutions or materials, or combinations thereof;
Regarding claim 32, Bashir, modified by Li, teaches the device of claim 22, wherein two or more apparatuses are placed in parallel to test microbial cultivation under two or more cultivation conditions in parallel (the integrated filter and growth detector 20 and the detector end 52 are capable of being arranged in parallel – Figs. 1-4; see 112b rejection above);
wherein impedance sensing electrodes are integrated into two or more microfluidic channels (the electrodes 84 are arranged in the channel 54 and the outlet 110 – Fig. 2-4) so that cells flowing in the two or more microfluidic channels can be counted using only a single impedance sensing apparatus (“can be counted using only a single impedance sensing apparatus” is an intended use of the electrodes and deemed to read on electrodes capable of counting cells from two or more microfluidic channels) (the electrodes 84 are capable of counting cells from both the channel 54 and the outlet 110 – Fig. 2-4); and
wherein a single microvalve controller can control the two or more apparatuses simultaneously (the fluidic control module includes executable instructions to control the operation of the fluidic control device 24 and is capable of controlling flow to the integrated filter and growth detector 20 and the detector end 52 – paragraph 24; see 112b rejection above).
Regarding claim 33, Bashir, modified by Li, teaches the device of claim 22, wherein cultivation media is pre-loaded into a cultivation chamber (the measurement chamber 82 is capable of being pre-loaded with growth media from a growth media reservoir 44 – paragraph 22 and Fig. 2), and wherein a media reservoir is replaced with a buffer reservoir (the growth media reservoir 44 is connectable to the measurement chamber 82 – Fig. 2; see 112b rejection above).
Regarding claim 34, Bashir, modified by Li, teaches the device of claim 22, comprising a device where impedance is controlled (the growth is detected electronically and impedance changes over time are used to detect the growth – paragraph 32) by at least one of an automated controller (growth rate signals are routed to an external device, such as computer 26 through electrodes 84 – paragraph 28), an automated system, or combinations thereof.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20120181184A1 – microfluidic device with electrodes for impedance measurement
US20130203086A1 – three parallel channels with pours membrane and electrode of impedance response
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.C.S./Examiner, Art Unit 1796
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
Prosecution Insights