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 .
Election/Restrictions
Applicant's election with traverse of Claims 1-13 in the reply filed on 03/02/2026 is acknowledged. The traversal is on the alleged ground(s) that there would not be a search burden on the examiner. This is not found persuasive because while it may not appear to Applicant that a search burden may be present, the restriction requirement properly applies the principles of unity of invention under 35 USC 371 showing distinctness among the claimed groups. As such, Claims 14-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected system and method, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
Request for Information under 37 CFR 1.105
No IDS was filed for this application. The applicant and/or the assignee of this
application are required under 37 CFR 1.105 to provide the following information that
the examiner has determined is reasonably necessary to the examination of this
application (see MPEP §§ 704.10 - 704.13). In response to this requirement, please
provide a copy of any related and pertinent information, such as non-patent literature,
published application(s) or patent(s) (U.S. or foreign), that was used to assist in the
drafting of this application. The applicant is reminded of the duty to disclose information
that is material to patentability (see 37 CFR § 1.56). A complete reply to the instant
Office action must include a complete reply to this requirement. The time period for
reply to this requirement coincides with the time period for reply to the instant Office
action.
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.
Claims 1-3 and 7-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al. (Sun, Han; et al., “Reliable and reusable whole polypropylene plastic microfluidic devices for a rapid, low-cost antimicrobial susceptibility test”, Lab Chip, 2019,19, 2915-2924.), hereinafter “Sun”.
Regarding Claim 1, Sun teaches a microfluidic-based platform for implementing a one-pot antimicrobial susceptibility testing including cell culture, drug-cell incubation, and microscope-free quantitative analysis of viable cells after treatment by one or more compounds, the microfluidic-based platform comprises:
a thermal stage (See the section 3. Fabrication of the microfluidic devices: “3. Fabrication of the microfluidic devices” wherein the thermal stage is the PDMS in which the components are formed in as indicated by the claim. – Alternatively, see the “thermostat platform” of the section 5. Antimicrobial susceptibility testing.);
a light source (See the section 1. Materials and equipment: “The fluorescence microscope used in the experiment was from Nikon, equipped with an Infinity 2 digital camera (Lumenera Corporation, Canada) to capture images.” – A fluorescence microscope for fluorescent cell inspection discussed by Sun must nece3ssarily comprise a light source for enabling fluorescence excitation.); and
a visual inspection window (See the Introduction section: “Polydimethylsiloxane (PDMS) has been widely used in microfluidic device fabrication due to its flexibility and optical transparency.” – As PDMS is a transparent material, each channel/chamber structure of the device is under a visual inspection window, so as to enable the microscopy discussed by Sun.),
the thermal stage comprising a cell culture zone and a cell sensing zone (see the discussion below),
the cell culture zone comprising at least three fluid inlets and a drug concentration gradient generator downstream with respect to the at least three fluid inlets (See Fig. 1d where three inlets (red, cyan, and blue) feed a plurality of downstream branching channels.), the drug concentration gradient generator comprising a plurality of diverging fluid channels diverging fluids downstream to at least two of the fluid inlets (See Fig. 1d showing the arrangement of diverging channels creating a vertical concentration gradient.), and a plurality of micro-chambers each with one or more deepened microwells for cell culture (See Fig. 1d showing a deepened microwell downstream of the branching channel portion of the gradient generator.);
the cell sensing zone comprising a plurality of adaptive linear filter channels connecting to multiple fluid outlets of the cell culture zone via a one-piece connector (Examiner notes that the “one-piece connector” is not provided particular structure and is interpreted broadly as the downstream branching channels.), each of the adaptive linear filter channels being configured to receive cultivated cells from the cell culture zone and subsequently the received cultivated cells will accumulate at a downstream end of each of the adaptive linear filter channels (See Fig. 1d showing the linear channels and additional wells downstream of the “I” chamber receiving cultivated cells via flow from the gradient generator. – Further note that the “adaptive linear filter channels” are interpreted as mere “channels” wherein the “adaptive linear filter” aspect is taken as a mere nominal designation to the channels. Applicant may wish to particularly claim an adaptive linear filter overlaying each of the channels.),
the light source being disposed adjacent to or proximal to the downstream end of the adaptive linear filter channels for illuminating a wavelength of light towards the accumulated cultivated cells at the downstream end of each of the adaptive linear filter channels in order to visualize the accumulated cultivated cells through the visual inspection window disposed above an enclosure of the plurality of adaptive linear filter channels and image signal derived thereof being able to be directly captured by a portable device equipped with an imaging function (See the section 1. Materials and equipment: “The fluorescence microscope used in the experiment was from Nikon, equipped with an Infinity 2 digital camera (Lumenera Corporation, Canada) to capture images.” – See the section 1. Overall design of the system: “After a short culturing period, microscopic images are taken to capture the shape and density of single cells in the culture chambers” – As the images of Fig. 1c, and those used to generate that of Fig., 2a and Fig. 3c are taken of the chambers I, I’, and I’’, the light source must necessarily be proximate to those channels and chambers such that images may be obtained of the adaptive linear filter channels downstream from the gradient generator.), as in Claim 1.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Sun teaches the device discussed above wherein:
each of the adaptive linear filter channels comprises at least one main channel and at least two side channels disposed in a parallel orientation with the at least one main channel (Fig. 1d shows each of the eight adaptive filter linear channels having at least two side channels disposed in a parallel orientation with the at least one main channel, the side channels being the converging branching channels connected to each of the main channels.), and
the at least one main channel communicating with the at least two side channels through a plurality of nano-scale channelization channels disposed in an orthogonal orientation with respect to both the at least one main channel and the at least two side channels such that the fluid containing cultivated cells flowing through the at least one main channel of the adaptive linear filter channel are directed to the at least two side channels through the plurality of nano-scale channelization channels based on filtration effect (Fig. 2d shows each of the main channels communicating with the side channels through orthogonal channels of the branching channels. – Note that “nano-scale channelization channels” are interpreted herein as mere “channels” wherein the “nano-scale channelization” aspect is taken as a mere nominal designation not providing particular structure to the channels.), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Sun teaches the device discussed above wherein the at least one main channel and the at least two side channels have an identical cross-sectional area with an aspect ratio of channel height to channel width of less than 1 (Fig. 1b shows a cross section of the channels of the device, each having the identical cross-sectional area with an aspect ratio of channel height to channel width of less than 1 – channel width and channel height are not equal.), as in Claim 3.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Sun teaches the device discussed above wherein the cell sensing zone comprises at least eight adaptive linear filter channels to form an array of adaptive linear filter channels (See Fig. 1d showing the device having eight of the adaptive linear filter channels.) with various lengths of visible microbars corresponding to various quantities of cells accumulated at each of the adaptive linear filter channels after treatment with the one or more compounds at different concentrations according to different fluid channels of the diverging fluid channels of the drug concentration gradient generator at the cell culture zone (Given the commensurately structured channels of Sun, those channels would commensurately display various microbar lengths depending on the number of cells accumulated therein. Further, such flow and cell accumulation is drawn to a process recitation. As the claims are drawn to a device, such process recitations are not afforded patentable weight when the device is capable of performing such process recitations -- "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II).), as in Claim 7.
Regarding Claim 8, the prior art meets the limitations of Claim 7 as discussed above. Further, regarding: wherein the length of the visible microbar is proportional to a proliferation rate of viable cells to be accumulated at the corresponding adaptive linear filter channel after the cells being treated with the one or more compounds at a specific concentration from one of the diverging fluid channels of the drug concentration gradient generator at the cell culture zone (This recitation is drawn to a process recitation. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). As discussed above, the commensurately structured channels of Sun are fully capable of capturing cells, thereby being fully capable of displaying microbars proportional to a proliferation rate of viable cells to be accumulated at the respective channels.), as in Claim 8.
Regarding Claim 9, the prior art meets the limitations of Claim 1 as discussed above. Further, regarding: wherein a drug-containing fluid is loaded into one of the fluid inlets disposed upstream with respect to the drug concentration gradient generator while a pure fluid is loaded into another fluid inlet also disposed upstream with respect to the drug concentration gradient generator (This recitation is drawn to a process recitation. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). The commensurately structured inlets of Sun are fully capable of receiving a drug-containing liquid and a pure liquid so as to form a downstream concentration gradient.), as in Claim 9.
Regarding Claim 10, the prior art meets the limitations of Claim 2 as discussed above. Further, regarding: wherein the fluid containing cells is loaded into the fluid inlet disposed upstream with respect to the micro-chambers (This recitation is drawn to a process recitation. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). The commensurately structured inlets of Sun are fully capable of receiving a cell-containing fluid.), as in Claim 10.
Regarding Claim 11, the prior art meets the limitations of Claim 1 as discussed above. Further, regarding: wherein the accumulated cells at the adaptive linear filter channels are gram stained such that under the illumination by the light source the image signal derived from the gram stained cells is directly captured by the portable device equipped with the imaging function (This recitation is drawn to a process recitation. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). The commensurately structured inlets of Sun are fully capable of receiving a gram-stained cell-containing fluid, and the microscope of Sun is fully capable of observing and capturing images of such stained cells.), and wherein the wavelength of light illuminated by the light source is within a visible light range (Fig. 1c shows an image of the device wherein the device is illuminated by the light source in the visible range so as to produce the visible image.), as in Claim 11.
Regarding Claim 12, the prior art meets the limitations of Claim 1 as discussed above. Further, Sun teaches the device discussed above wherein at least the cell culture zone and the cell sensing zone of the thermal stage is made of one or more thermoplastic materials that are biocompatible (See the section 1. Overall design of the system: “While a variety of rapid, microfluidics-based AST methods has been reported before, reliability and accessibility have still been a bottleneck for clinical implementation, as the PDMS material commonly used for chip fabrication has a well-known fouling problem. We believe this problem can be addressed by introducing a new chip material. When developing an AST device, the fabrication material is expected to have good transparency, good tolerance to chemicals and temperature for sterilization, good reusability, and a low fabrication cost. In this work, we introduce PP as an AST chip fabrication material that meets all these requirements as well as avoids the fouling problem of PDMS. As discussed previously, PP is a thermoplastic polymer widely used in the biomedical field due to its anti-fouling property and affordable cost34,40,45,46 (Table 1).”) whilst the cells cultivated at the cell culture zone do not adhere on interior surface of the microfluidic channels of the cell culture zone when a pure fluid is loaded into one of the fluid inlets to flush the cultivated cells towards the downstream direction with respect to the fluid outlets of the cell culture zone (See the section 2. Fabrication process of the whole PP chip: “In addition, the solvent resistance and anti-fouling property of the PP chips are much better than those of the PDMS chips (Fig. S7†).” – Such anti-fowling properties of the chip prevent cells cultivated in the device from adhering to the interior walls of the device.), as in Claim 12.
Regarding Claim 13, the prior art meets the limitations of Claim 12 as discussed above. Further, Sun teaches the device discussed above wherein the thermoplastic materials comprise polypropylene (See the section 3. Fabrication of the microfluidic devices: “After cooling to room temperature, the whole PP (polypropylene) chip was obtained.”), as in Claim 13.
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 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Sun. Sun has been discussed above.
Regarding Claims 4-6, the prior art meets the limitations of Claim 1 as discussed above. Further, Sun teaches the device discussed above wherein the at least one main channel and the at least two side channels have an average channel height of about 8 μm, or 16 μm, or 800 nm, as in Claims 4-6.
However, the height and width of microfluidic channels are recognized result-effective variables because such dimensions affect fluid resistance, flow rate, shear stress, diffusion distance, cell confinement, and clogging/passage behavior.
Therefore, it would have been obvious to one of ordinary skill in the art to select and optimize the height and width of the main channel and side channels through routine experimentation in order to provide reliable cell-fluid transport, controlled drug/cell mixing, and predictable delivery of cells to the downstream/capture region. The claimed dimensions merely represent the optimization of known microfluidic channel dimensions to achieve the expected result of suitable microfluidic flow and cell handling, absent evidence of criticality or unexpected results (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Further, specifically regarding Claim 6, Sun teaches the device discussed above wherein the nano-scale channelization channels have the same channel width as that of the at least one main channel (See Fig. 1b showing a cross section of the channels of the device having the same width and height.), as in Claim 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi, can be reached at telephone number (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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