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 without traverse of Group 1 (claims 1-6) in the reply filed on 05/15/2026 is acknowledged.
Claims 7-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/15/2026.
Claim Status
Claims 1-6 are pending and under examination. Claims 7-9 are withdrawn.
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 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (abstract idea) without significantly more.
With regards to Step 1, claim(s) 1 and 2-6 are considered to be in a statutory category of process.
With regards to Step 2A, prong 1, claim(s) 1 and 2-6, the claims as a whole are directed towards estimating the microbial growth rate based on measurements data obtained from images, which constitutes an abstract idea. Specifically, under the 2019 Revised Patent Subject Matter Eligibility Guidance (PEG), it falls into the group of mental process.
With regards to Step 2A, prong 2, regarding claim(s) 1 and 2-6, in addition to the recitation of estimating steps the claims are directed to imaging microbial growth under a microscope, digitizing the images, and using a computer to analyze the images and perform calculations to estimate the growth. These steps obtain and process the data that is used in performing the mental process of estimating growth rate. The claims do not recite any improvement to the technology, nor do they apply the judicial exception in a manner that integrates it into a practical application.
With regards to Step 2B: in claim(s) 1 and 2-6, imaging using a microscope and digitizing captured images, over time, through automated systems and/or computer analysis to calculate an estimation of growth rate, are additional elements. They are well known, understood, routine and conventional at the time of the invention as evidenced by Straus et al., (US 20170029864 A1; published 2017-02-02). As such, the claims do not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
Regarding the dependent claims, the additional limitations do not overcome the 101 Rejection for the following reasons:
Regarding claims 2,3, and 5-6, the dependent claims recite additional elements (digitizing image area(s) for image analysis by computer and growth estimation calculated by computer) which are performed through automation and/or well-understood, routine, and conventional methods in the relevant field. These elements do not meaningfully limit the abstract idea or transform it into patent-eligible subject matter.
Regarding claim 4, the dependent claim further recites predicting the time required for microorganisms to reach an unacceptable number, using estimated microbial growth rate(s). There are no additional elements in the claim that uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to incorporating measurements into calculations to make prediction(s), which do not meaningfully limit the abstract idea.
For the forgoing reasons, the claims are not deemed to encompass patent eligible subject matter under 35 USC § 101.
Claim Rejections - 35 USC § 102
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 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Straus, D. et al., (Rapid detection of replicating cells; US 20170029864 A1; published 2017-02-02).
Regarding claims 1 and 4 Straus et al., discloses using membrane filtration to deposit cells on a roughly planar membrane detection surface, placed on a growth medium (which reads on, a sample of food) (paragraph 0208) and further describes a typical embodiment with a porous membrane filter on a solidified nutrient growth medium in a petri dish to support free diffusion of nutrients and water across the membrane (which reads on a hydrophilic membrane filter), while supporting microbial growth on the filter (paragraph 0208). In a preferred embodiment, Straus et al., discloses imaging microbial growth from microorganisms collected from ground beef where serial dilutions passage through membrane filters were then incubated on tryptic soy agar (TSA) plates and growth was analyzed with image capture using a charge-coupled device (CCD) based camera (paragraph 0316-0323, Example 11) . The digitized image was analyzed and compared to traditional colony-counting methods, for growth rates collected at time points (0h, 6h, 16h, 24h, and 48h or more) reported in Figure 16 (Sheet 16, Figure 16 associated to Example 11). Example 11 by Straus et al., depicts testing for total viable bacteria counts in raw meat, to prevent early food spoilage, thus evaluating shelf-life to determine unacceptable microbial growth rates (paragraph 0317).
Regarding claims 2-6 Straus et al., disclose computer-based image analysis to quantify the results of imaging membranes (paragraph 0160), where the growth rate of cells is further calculated using computer software (paragraph 0232) and detailed analysis of enumeration and accuracy from images as compared with traditional methods is described in Example 7 (paragraph 0284-0290).
Conclusion
No claims are deemed patentable.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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