DETAILED ACTION
Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims 1-20 are currently pending in this application.
Priority
2. No foreign priority has been claimed in this application. This application is a CON of PCT/US23/63121 filed 02/23/2023 which claims benefit to provisional application 63/314532 filed 02/28/2022.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 11/27/2024 was received. The submission is in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. Accordingly, the information disclosure statement has being considered by the examiner.
Drawings
4. The drawings submitted on 8/21/2024 are in compliance with 37 CFR § 1.81 and 37 CFR § 1.83 and have been accepted by the examiner.
Claim Rejections - 35 USC § 101 Non-Statutory
5. 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.
6. Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Specifically, representative Claim 1 recites:
A computing system for image analysis, the computing system comprising:
one or more hardware computer processors configured to execute software instructions; and
one or more storage devices storing software instructions for execution by the one or more hardware computer processors configured to cause the computing system to:
receive imaging data of at least one sample droplet of a sample and at least one reagent;
identify one or more imaging properties from the imaging data;
generate a result indicating the presence or concentration of a chemical in the sample based on the identified imaging properties; and
store the imaging data and the result
The claim limitations in the abstract idea have been highlighted in bold above; the remaining limitations are “additional elements.”
Similar limitations comprise the abstract ideas of Claim 11.
11. A computer-implemented method for image analysis, the method comprising:
receiving imaging data of at least one sample droplet of a sample and at least one reagent; identifying one or more imaging properties from the imaging data;
generating a result indicating a presence or concentration of a chemical in the sample based on the identified imaging properties; and
storing the imaging data and the result.
Under Step 1 of the analysis, claim 1 does belong to a statutory category, namely it is a process claim. Likewise, claim 8 is a system claim and claim 15 a non-transitory computer readable medium claim.
Under Step 2A, prong 1, claim 1 is found to include at least one judicial exception, that being a mathematical concept and/or mental process. This can be seen in the claim limitation of “identify one or more imaging properties from the imaging data; generate a result indicating the presence or concentration of a chemical in the sample based on the identified imaging properties”, which is the judicial exception of a mental process and/or a mathematical concept because it is merely a data evaluation including calculations, and/or judgements capable of being performed mentally.
Similar limitations comprise the abstract ideas of Claim 11.
Step 2A, prong 2 of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception(s) into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application.
In addition to the abstract ideas recited in claim 1, the claimed method recites additional elements including “receive imaging data of at least one sample droplet of a sample and at least one reagent and storing the imaging data and the result” (claims 1 and 11) which are merely data gathering and storing steps recited at a high level of generality and therefore merely amount to “insignificant extra-solution” activity(ies). See MPEP 2106.05(g) “Insignificant Extra-Solution Activity,”. The claim also recites “computer processors” (claims 1 and 11) however the “computer processors/ computer” is recited at a high level of generality, e.g. Spec. [0176] describing a variety of different types of “processors” that may be used, and merely amounts to the use of computer technology as a tool to apply the abstract idea (see MPEP 2106.05(f)) and/or the use of “processors” to perform the predictions, that are otherwise abstract, is merely an attempt at limiting the abstract to a particular field of use (See MPEP 2106.05(h)).
The generic data gathering, processing, and output steps, and other elements, are recited so generically (no details whatsoever are provided) that it represents no more than mere instructions to apply the judicial exceptions on a computer. It can also be viewed as nothing more than an attempt to generally link the use of the judicial exceptions to the technological environment of a computer. Noting MPEP 2106.04(d)(I): “It is notable that mere physicality or tangibility of an additional element or elements is not a relevant consideration in Step 2A Prong Two. As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) ("The fact that a computer ‘necessarily exist[s] in the physical, rather than purely conceptual, realm,’ is beside the point")”.
Thus, under Step 2A, prong 2 of the analysis, even when viewed in combination, these additional elements do not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception. No specific practical application is associated with the claimed system. For instance, nothing is done with the results besides storing it.
Under Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as described above with respect to Step 2A Prong 2, merely amount to a general purpose computer system that attempts to apply the abstract idea in a technological environment, limiting the abstract idea to a particular field of use, and/or merely insignificant extra-solution activity (claims 1 and 11). Such insignificant extra-solution activity, e.g. data gathering and output, when re-evaluated under Step 2B is further found to be well-understood, routine, and conventional as evidenced by MPEP 2106.05(d)(II) (describing conventional activities that include transmitting and receiving data over a network, electronic recordkeeping, storing and retrieving information from memory, and electronically scanning or extracting data from a physical document).
Therefore, similarly the combination and arrangement of the above identified additional elements when analyzed under Step 2B also fails to necessitate a conclusion that claim 1, as well as claim 11, amount to significantly more than the abstract idea.
With regards to the dependent claims, claims 2-10 and 12-20, merely further expand upon the algorithm/abstract idea and do not set forth further additional elements therefore these claims are found ineligible for the reasons described for independent claims 1 and 11.
See Supreme court decision in Alice Corporation Pty. Ltd. V. CLS Bank International, et al.
Claim Rejections - 35 USC § 102
7. 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 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.
8. 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.
9. Claims 1-9 and 11-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krauss et al. US 2019/0275518.
With regards to claims 1 and 11, Krauss et al. US 2019/0275518 teaches a computing system for image analysis, the computing system comprising:
one or more hardware computer processors configured to execute software instructions;( paragraph 0020-0021) and
one or more storage devices storing software instructions for execution by the one or more hardware computer processors configured to cause the computing system to(paragraph 0179):
receive imaging data of at least one sample droplet of a sample and at least one reagent(paragraph 0115);
identify one or more imaging properties from the imaging data; (paragraph 0116)
generate a result indicating the presence or concentration of a chemical in the sample based on the identified imaging properties; (paragraph 0119)and
store the imaging data and the result. (paragraph 0119)
With regards to claims 2 and 12, Krauss et al. US 2019/0275518 the at least one reagent is associated with at least one of: an immunoassay, a colorimetric reaction assay, and a chemical indicator. (paragraph 0009, 0107-0109)
With regards to claims 3 and 13, Krauss et al. US 2019/0275518 identifying the imaging properties based on a subset of the imaging data. (paragraph 0014)
With regards to claims 4 and 14, Krauss et al. US 2019/0275518 the computing system is configured to identify one or more image pixels to be analyzed and one or more image pixels to be excluded from being analyzed. (paragraph 0268)
With regards to claims 5 and 15, Krauss et al. US 2019/0275518 the computing system is configured to generate a result based on the identified imaging properties by applying at least one criterion associated with the at least one reagent. (paragraph 0014)
With regards to claims 6 and 16, Krauss et al. US 2019/0275518 the identified imaging properties include at least one of: a size, a location, a color, and an indicator. (paragraph 0014)
With regards to claims 7 and 17, Krauss et al. US 2019/0275518 the imaging data is convertible into a viewable image. (paragraph 0014)
With regards to claims 8 and 18, Krauss et al. US 2019/0275518 an additional device configured to at least one of: transport, aliquot, split, combine, or mix the at least one sample droplet and the at least one reagent. (paragraph 0014 & 0018)
With regards to claims 9 and 19, Krauss et al. US 2019/0275518 the additional device is one of: a test tube, a containment tube, a PCR tube, a multiple-well plate, a spot plate, a cuvette, a lateral flow assay, a test strip, pH paper, a substrate material, a reagent 3D printed into a polymeric material, a microfluidic system, and a digital microfluidic system. (paragraph 0095 and 0138)
10. Claims 1,10-11 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huff et al. US 2018/0275088.
With regards to claims 1 and 11, Huff et al. US 2018/0275088 teaches a computing system for image analysis, the computing system comprising:
one or more hardware computer processors configured to execute software instructions;( figure 9) and
one or more storage devices storing software instructions for execution by the one or more hardware computer processors configured to cause the computing system to(figure 9)(paragraph 0363):
receive imaging data of at least one sample droplet of a sample and at least one reagent(figure 51B)
identify one or more imaging properties from the imaging data; (paragraph 0486-0488)
generate a result indicating the presence or concentration of a chemical in the sample based on the identified imaging properties; (paragraph 0486)and
store the imaging data and the result. (memory; figure 9)
With regards to claims 10 and 20, Huff et al. US 2018/0275088 a microfluidic device comprising:
a substrate; (paragraph 0009)
one or more microfluidic channels arranged on or within the substrate; (paragraph 0009)
one or more electrodes arranged on or within the substrate; (paragraph 0009)
a first portion of the microfluidic device configured to receive the at least one reagent; (paragraph 0027) and
a second portion of the microfluidic device configured to receive the at least one sample droplet; (paragraph 0027) and
a microprocessor coupled to the microfluidic device configured to combine the at least one sample droplet and the at least one reagent by applying one or more electric potentials to the one or more electrodes.(figure 9)
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Colston Jr. et al. US PAT # 9,156,010 teaches a droplet-based assay system.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADITYA S BHAT whose telephone number is (571)272-2270. The examiner can normally be reached on Monday-Friday 8 am-6pm.
13. 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.
14. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shelby Turner can be reached on 571-272-6334. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADITYA S BHAT/Primary Examiner, Art Unit 2857 September 25, 2026
