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 .
Status of Claims
The claim set submitted on 03 JULY 2026 is acknowledged and considered.
In the claim set, Claims 1-20 are ‘Canceled’; Claims 21-40 are ‘New’.
Current pending claims are Claims 21-40 and are considered on the merits below.
Response to Amendment/Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because Applicant has cancelled all previous claims and have resubmitted a new set of claims. However, based on amendment to the claims, the rejection below has been modified but relies on the same prior art.
Specification/Abstract
The abstract of the disclosure is objected to because the abstract should not improperly include trademarks, MPEP 1826. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 31-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) system for examining an effect of an antimicrobial test reagent on microorganisms in a sample, comprising: (a) the device of claim 21; (b) an imager comprising a camera and a light source configured to image the microorganisms in the control zone and the experimental zone while the sample is in the layer of substantially uniform thickness; and (c) a processor comprising electronics, signal processors, hardware, and software configured to receive and process images from the imager, identify the microorganisms in the images, and determine the effect of the antimicrobial test reagent by comparing a change of the microorganisms in the experimental zone with a corresponding change of the microorganisms in the control zone in Claim 31.
Step 2A, Prong 1: Identify the law of nature/natural phenomenon/abstract ideas.
The claim recites to ‘receive and process images from the imager’ then ‘comparing a change’ These concepts of to receive, process and compare are steps that could be performed by observation by a user and are mental steps.
Step 2A Prong 2: Has the exception been integrated into a particular practical application?
No. Once the comparison step is performed then nothing is done.
The steps of using the images from the imager is data gathering to be used in the abstract idea. Note that data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). Data gathering steps do not impart any significance to the abstract idea, nor the claim when viewed as a whole.
The claims recite the abstract ideas being performed by a “processor comprising electronics, signal processors, hardware and software…”, which are just components of a computer. Therefore, the mental steps are done by a general-purpose computer, which is not a particular machine. See MPEP 2106.05(b).
The independent Claim 31 as a whole does not include any additional steps within the claim to transform the claim into something that integrates the abstract idea into a practical application of the abstract idea.
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
No. The claims require a system and a device that includes an imaging sensor and a processor with hardware. In the art of analysis and examination with a device with an imager and processor/hardware would be something that is well-understood, routine, and conventional (WURC).
Dependent Claim 32 and 36 further defines limitations of the imager which merely recite how the imager acquires the images to view, which does not add any practical application or any limitation which is significantly more.
Dependent Claims 33-34 further defines limitations of the processor which does not define any practical application nor does not include a limitation of the processor which is significantly more.
Dependent Claim 35 further defines the change which is to be detected, which known in the art and at least taught by METZGER.
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 21-40 are rejected under 35 U.S.C. 103 as being unpatentable over METZGER, US Patent 9,657,327.
Applicant’s invention is directed towards a device.
Regarding Claim 21, the reference METZGER discloses a device for examining an effect of antimicrobial test reagent on microorganisms in a sample, Figure 1A-L, Figure 3A-F, Column 6 line 3-11, amount of microorganisms analyzed indicating effect of agent, comprising:
a first plate, a second plate, and spacers, Figure 3A-F, Column 15 line 24-Column 16 line 2, Column 56 line 51-58, wherein:
(i) the first plate has a first sample surface and a first sample contact area on the first sample surface, Figure 1L, substrate 535 with surface 520, Column 15 line 24-33, and the second plate has a second sample surface and a second sample contact area on the second sample surface, Figure 1B, C, F, G, K, Column 16 line 29-34, the first and second sample contact areas being configured to contact the sample comprising the microorganisms, Figure 1D, E; (ii) the first plate and the second plate are movable relative to each other into different configurations, including an open configuration and a closed configuration, Column 5 line 62 – Column 6 line 25; (iii) one or both of the first and second plates comprise the spacers fixed to the respective sample contact area, Column 15 line 55-60, gasket, Figure 3A-F, gasket 540, Column 4 line 26-36, Example 5, the spacers having a predetermined substantially uniform height, and at least one of the spacers being inside the respective sample contact area, Figure 1B, 1C, 3B, 3C, gasket 540 are of uniform height; and (iv) one or both of the first and second sample contact areas comprise a control zone and an experimental zone, Column 53 line 48-51, the experimental zone comprising the antimicrobial test reagent coated thereon and configured, upon contacting the sample, to dissolve into and diffuse in a portion of the sample in the experimental zone, Column 13 line 7-20, Column 27 line 42-50, Column 57 line 33-39, and the control zone comprising no such antimicrobial test reagent, Column 53 line 48-51; wherein, in the open configuration, the first and second plates are partially or entirely separated apart, and spacing between the first and second plates is not regulated by the spacers, so that the sample is deposited on one or both of the first and second plates; wherein, in the closed configuration, the first plate and the second plate are configured to confine at least part of the sample into a layer of substantially uniform thickness spanning the control zone and the experimental zone, the thickness of the layer being confined by the first and second sample surfaces and regulated by the first and second plates and the spacers, Figure 1A-F, 2A-3F; and wherein the substantially uniform thickness is selected such that the microorganisms are confined in a single layer between the first and second plates without being compressed by the first and second plates, Figure 1A-F, 2A-3F, Column 3 line 62 – Column 4 line 14.
9. Additional Disclosure Included are: Claim 22: wherein the device of claim 21, wherein the antimicrobial test reagent comprises an antibiotic or an antifungal reagent, Claim 1, Column 3 line 41-48, Column 4 line 2-8, Column 12 line 2-13.; Claim 23: wherein the device of claim 21, wherein the experimental zone comprises a plurality of experimental sub-zones that comprise different antimicrobial test reagents, Column 11 line 66-Column 12 line 13, matrix of different agents.; Claim 24: wherein the device of claim 21, wherein the experimental zone comprises a plurality of experimental sub-zones that comprise different concentrations of the antimicrobial test reagent, Figure 2A-2D, Column 4 line 2-14.; Claim 25: wherein the device of claim 21, wherein the control zone and the experimental zone are fluidically isolated from one another by one or more wall structures on the respective sample contact area, Column 15 55-60, Column 16 line 29-34.; Claim 26: wherein the device of claim 21, wherein the control zone and the experimental zone are not fluidically isolated from one another and are separated by limited lateral diffusion in the layer of substantially uniform thickness during a time period of examination, Column 15 55-60, Column 16 line 29-34, Figure 1F, detection surfaces 520.; Claim 27: wherein the device of claim 21, wherein the height of the spacers is in the range of 75% to 125% of an average dimension of the microorganisms, Column 15 line 14-23, Column 30 line 8-35.; Claim 28: wherein the device of claim 21, wherein at least one of the first and second plates is transparent to permit optical imaging of the microorganisms in the layer of the substantially uniform thickness, Column 64 line 35-64, detector, lenses, illuminators implies that at least part of the plate is transparent for detection.; Claim 29: wherein the device of claim 21, wherein one or both of the first and second plates comprise, on the respective sample contact area, a dye that, upon contacting the sample, is dissolved in the sample and stains the microorganisms, Figure 1-A-L, 3A-F, Column 25 line 14-44, Column 26 line 45-67, Column 33 line 45-67. Examiner Note: The instant claim language is directed towards the material worked upon or to be added to onto the device and does not structurally define the invention. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). ; Claim 30: wherein the device of claim 29, wherein the cell viability dye comprises propidium iodide, SYTO9, 7-aminoactinomycin D, trypan blue, calcein AM, resazurin, formazan, or a combination thereof, Column 50 line 22-31, 35-53, Column 65-66 Example 3, Column 67 line 50-51, Column 68 line 7.
9. Applicant’s invention is directed towards a system.
10. Regarding Claim 31, the reference METZGER discloses a system for an effect of an antimicrobial test reagent on microorganisms in a sample, Column 6 line 3-11, amount of microorganisms analyzed indicating effect of agent, comprising:
(a) a device of claim 21, see Rejection to Claim 21 above;
(b) an imager, comprising a camera and a light source for imaging the microorganism in the control layer and the experimental zone while the sample is in the layer of substantially uniform thickness, Column 63 line 8-46, Column 64 line 35-58; and
(c) a processor, comprising electronics, signal processors, hardware and software configured to receive and process images from the imager, and identify the microorganisms in the images, and determine the effect of the antimicrobial test reagent by comparing a change of the microorganisms in the experimental zone with a corresponding change of the microorganisma in the control zone. and analyzing the microorganisms in the images, Column 64 line 35-58, Column 34 line 53-64.
11. Additional Disclosure Included are: Claim 32: wherein the system of claim 31, wherein the imager is configured to acquire a series of images of the control zone and the experimental zone at discrete time points, Column 42 line 27-45, Claim 1.; Claim 33: wherein the system of claim 32, wherein the processor is configured to identify and count the microorganisms in at least a first area of the experimental zone and at least a second area of the control zone in each of the series of images, Column 42 line 27-45, Claim 1.; Claim 34: wherein the system of claim 33, wherein the processor is configured to determine a concentration of the microorganisms based on an area of interest in an image and the substantially uniform thickness of the layer, Claim 10, Column 7 line 59-63, Column 9 line 7-23.; Claim 35: wherein the system of claim 31, wherein the change comprises a change in total number, concentration, proliferation, morphology, motility, uptake of a staining dye, or any combination thereof, Column 7 line 59-63, Column 9 line 7-23, 60, Column 77 line 45-60.; and Claim 36: wherein system of claim 31, wherein the imager is configured to acquire a video comprising a series of images of the microorganisms over a first time period, Column 42 line 27-45, and wherein the processor is configured to identify and track at least a portion of the microorganisms in the video and evaluate changes of the tracked microorganisms over at least a portion of the first time period, Column 42 line 27-45, Claim 1.
12. Applicant’s invention is directed towards a system.
13. Regarding Claim 37, the reference METZGER discloses a system for examining an effect of an antimicrobial test reagent on microorganisms in a sample, Column 6 line 3-11, amount of microorganisms analyzed indicating effect of agent, comprising:
(a) a device of claim 21, see Rejection to Claim 21 above;
(b) a mobile communication device, , Column 34 line 53-64, Column 45 line 24-30, Column 48 line 1-4, comprising:
(i) an imager that comprising one or a plurality of cameras configured to image the microorganisms in the control zone and the experimental zone while the sample is in the layer of substantially uniform thickness, Column 63 line 8-46, Column 64 line 35-58;
(ii) a processor that comprises electronics, signal processors, hardware and software configured to receive or process images of the microorganisms and to communicate test results to a remote location, Column 64 line 35-58, Column 34 line 53-64; and
(c) a light source from either the mobile communication device or an external source, wherein the light source is configured to provide illumination to the sample for imaging with the cameras, Column 64 line 35-58.
14. Additional Disclosure Included are: Claim 38: wherein the system of claim 37, further comprising a housing configured to hold the device and to be mounted to the mobile communication device, Figure 2B, Column 9 line 7-23.; Claim 39: wherein the system of claim 38, wherein the housing comprises optics for facilitating the imaging or signal processing of the sample by the mobile communication device and a mount configured to hold the optics on the mobile communication device, Column 33 line 5-18, Column 34 line 8-33.; and Claim 40: wherein the system of claim 37, wherein the mobile communication device is a mobile phone configured to communicate the test results to a medical processional , a medical facility or an insurance company, Column 34 line 53-64, Column 45 line 24-30, Column 48 line 1-4.
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 CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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, LYLE ALEXANDER can be reached at (571) 272-1254. 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.
CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
