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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/20/2026 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Priority of US application 63/054,518 filed 07/21/2020 is acknowledged.
Status of Claims
Claims 1-20 are pending and examined on the merits.
Claim Objections
Claim 12 is objected to because of the following informalities: the step “determining an optimal combination of an optimal pooling size and an optimal prevalence, wherein the optimal combination of the optimal pooling size and the optimal prevalence yields a greatest or a smallest value of the pooled testing objective function” is recited twice. Appropriate correction is required.
Claim Rejections - 35 USC § 112—Second Paragraph
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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.
The term “optimal” in claims 1, 5, 8, 12, 15 and 19 is a relative term which renders the claim indefinite. The term “optimal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 1, 5, 8, 12, 15 and 19 are hence indefinite.
The term “optimal ratio” in claims 1, 5, 8, 12, 15 and 19 is a relative term which renders the claim indefinite. The term “optimal ratio” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, because
the claims and spec never provide the metes and bounds of what is considered “optimal”, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 1, 5, 8, 12, 15 and 19 are hence indefinite.
Similarly, the term “optimal prevalence” in claims 1, 5, 8, 12, 15 and 19 is a relative term which renders the claim indefinite. The term “optimal prevalence” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 1, 5, 8, 12, 15 and 19 are hence indefinite.
Claim 1 recites the limitation "the plurality of sample selection candidate sets" in the 4th step (page 3, the 7th line). There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites “and/or wherein” in the last line, which creates possible ambiguity over whether the assay limitation, pathogen limitation, or both are required. Claim 20 is indefinite due to ambiguity here. If both alternatives are intended, the claim split into separate dependent claims or use clean alternatives.
Claim Rejections - 35 USC § 112—First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 6, 13, and 20 recite a broad list of biochemical assay types, including hybridization assays, immunoassays, antigen detection assays and protein microarray assays. The published specification broadly mentions nucleic-acid, protein, and antibody-response detection, with the strongest worked examples are RT-PCR / SARS-CoV-2. However, the specification never mention hybridization assays, immunoassays, antigen detection assays and protein microarray assays. Therefore hybridization assays, immunoassays, antigen detection assays and protein microarray assays lack written description.
Claim Rejections - 35 USC § 101
The instant rejection is maintained from the previous Office action. Modification is necessitated by Applicant’s amendments filed 7/23/2025.
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 1-20 are rejected under 35 USC 101 because the claimed invention is directed to non-statutory subject matter.
Step 1: Process, Machine, Manufacture or Composition
Claims 1-7 are to a “method”, so a process.
Claims 8-14 are to a "system," with structural components, so a machine or a manufacturer.
Claims 15-20 are to a "computer-program product tangibly embodied in a non-transitory machine-readable storage medium." So a machine or a manufacturer.
Step 2A Prong One: Identification of an Abstract Idea
The claim(s) recite(s):
Determining a prevalence of a pathogen in each sample selection candidate set (Claims 1, 8 and 15).
This step recites “determining a prevalence of the pathogen in the sample”, which is interpreted as a decision-making activity in human mind. Therefore this step equates to an abstract idea of mental processes.
Determining, by an intelligent selection machine operatively connected to laboratory automation hardware, an optimal selection plan to perform a pooled testing on the samples, wherein the optimal selection plan comprises an optimal ratio to combine the samples from the plurality of regions or populations, an optimal prevalence in a combined sample set, and an optimal pooling design for the pooled testing.
This step recites “determining” by “an intelligent selection machine”, which is interpreted as a computer executing a set of software according to paragraph [147] in the disclosure. Although the software or algorithm is not disclosed (such as a machine learning or a rule engine program that make “intelligent” decision), and although recited as a decision made by an intelligent machine, the human is
capable of conducting a mental activity of decision-making that leads to “determining”. Therefore this step equates to an abstract idea of mental processes.
Determining a set of candidate pooling sizes and a set of candidate prevalence of the pathogen based on the sample set information.
This step recites a mental activity of decision-making based on data (sample information) observation, which equates to an abstract idea of mental processes.
Determining a number of initial tests to be performed for a candidate pooling size in the set of the candidate pooling sizes.
This step recites a mental activity of decision-making based on data (pooling size) observation, which equates to an abstract idea of mental processes.
Predicting a number of retests to be performed for a combination of a candidate pooling size in the set of the candidate pooling sizes and a candidate prevalence in the set of the candidate prevalence.
This step recites a mental activity of decision-making based on data (pooling size) observation, which equates to an abstract idea of mental processes.
Evaluating each candidate combination of the candidate pooling size and the candidate prevalence using the pooled testing objective function based on the number of initial tests and the number of retests;
This step recites a mental activity of evaluating based on existing information, which equates to an abstract idea of mental processes.
Determining an optimal selection plan based on the evaluation of each candidate combination of the candidate pooling size and the candidate prevalence.
This step recites a mental activity of decision-making based on another mental decision (evaluation of each candidate combination), which equates to an abstract idea of mental processes.
Selecting samples from the plurality of sample selection candidate set based on the optimal ratio.
“Selecting” reads on a mental activity of decision-making. Therefore this step equates to an abstract idea of mental processes.
Determining, based on the presence or absence of the detectable amount of the pathogen in each of the pooled samples, whether at least one individual sample comprises the detectable amount of the pathogen.
This step recites a mental activity of decision-making based on data (testing results) observation, which equates to an abstract idea of mental processes.
Step 2A Prong Two: Consideration of Practical Application
The claims result in a process of determining whether at least one individual sample comprises the detectable amount of the pathogen. The claims do recite additional elements but they do not integrate the judicial exception into a practical application.
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than
a drafting effort designed to monopolize the exception.
Step 2B: Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea. The recited additional elements are drawn to:
Pooling the samples in the combined sample set based on the optimal pooling design (Claims 1, 8 and 15).
Testing, using a biochemical assay, the pooled samples to determine a presence or absence of a detectable amount of the pathogen in each of the pooled samples (Claims 1, 8 and 15).
One or more data processors (Claim 8).
A non-transitory computer readable storage medium containing instructions which, when executed on the one or more data processors, cause the one or more data processors to perform (Claim 8).
A computer-program product tangibly embodied in a non-transitory machine-readable storage medium (Claim 15).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because collecting samples, pooling, aliquoting and counting pathogen in the samples are interpreted as in silico processes according to specification at [011].
The claims do not include additional elements that are sufficient to amount of significantly more than the judicial exception because it is routine and conventional to perform the acts of counting pathogens in samples. Other elements of the method include computer systems and non-transitory storage media (claims 8 and 15) which are recitations of generic computer structure that serves to perform generic computer functions that are well-understood, routine, and conventional previously known to the pertinent industry. Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
.
Response to Applicant’s Argument
In the Remarks filed 3/20/2026, Applicant argues that (page 13, 1st para) “in the present application, representative Claim 1 recite additional elements, and the additional elements and the claim as a whole integrate any alleged judicial exception(s) into a practical application at least under considerations (1), (2), and (4)”.
In response, Applicant’s argument refers to Step 2A/Prong two, relating to whether claims are integrated into a practical application or not, through one of the five criteria outlined at Step 2A/Prong two of the 35 U.S.C. §101 analysis. Applicant’s argument is not persuasive. The additional elements are about pooling, aliquoting, and testing using a biochemical assay of samples. The claims do not recite any applicable category of practical application as listed above, i.e. (1) an improvement in the functioning of a computer, or an improvement to other technology or technical field; (2) applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; or (4) effects a transformation or reduction of a particular article to a different state or thing.
There is no evidence of (1) an improvement in the functioning of a computer, or an improvement to other technology or technical field. There additional element certainly has nothing to do with (2) effect a particular treatment or prophylaxis for a disease or medical condition. The biochemical assay recited in such a general way, no (4) transformation or reduction of a particular article to a different state or thing is evidenced.
In the Remarks, Applicants list (page 13, 2nd para through page 15, 1st para) many additional elements and argues that “predicting a number of retests to be performed for a combination of the candidate pooling size in the set of the candidate pooling sizes and a candidate prevalence in the set of the candidate prevalence”; and “evaluating each candidate combination of the candidate pooling size and the candidate prevalence using the pooled testing objective function based on the number of initial tests and the number of retests” are additional elements.
In response, Applicant’s arguments are not persuasive. Applicant reads the specification into claims, hence “in such real-world laboratory environments, these steps cannot be carried out practically by a human, even with the assistance of pen and paper.” However, the claim language only claim “obtaining samples from a plurality of regions or populations”, which, according to specification at [005, 011], is interpreted as a acquiring data related to samples. Thereafter, “predicting a number of retests to be performed for a combination of the candidate pooling size in the set of the candidate pooling sizes and a candidate prevalence in the set of the candidate prevalence”; and “evaluating each candidate combination of the candidate pooling size and the candidate prevalence using the pooled testing objective function based on the number of initial tests and the number of retests” becomes achievable by a human being with the help of a pen and paper.
In the Remarks, Applicant argues (page 15, 2nd para) that “by automating the pooling and testing process and adapting the workflow to actual sample characteristics, the claimed method achieves measurable reductions in retesting, increases sample throughput, and saves both time and laboratory resources.”
In response, Applicant’s argument is not persuasive. The claims are not integrated into a practical application, due to the fact that the additional elements (the experimental steps after the intelligent selection machine operation) are not tightly linked to the JEs. Particularly, for the step “selecting samples from the plurality of sample selection candidate sets based on the optimal ratio … “, we don’t know if the “plurality of sample selection candidate sets” has anything to do with the JEs, because “the plurality of sample selection candidate sets” has no antecedent basis.
In the Remarks, Applicant argues (page 15, last para through page 16, 1st para) that “by generating actionable diagnostic information, the claimed method directly supports clinical decisions regarding treatment, isolation, or prophylaxis for infectious diseases. The workflow in Claim 1 is specifically designed for use in settings where accurate and timely detection of disease-causing agents is required for medical management and public health response.”
In response, Applicant’s argument is not responsive. Applicant reads specification into claims. The claims as presented, have no direct recitation related to treatment or prophylaxis.
In the Remarks, Applicant argues (page 16, paras 2-3) that “each of these detection modalities relies on actual chemical changes within the sample (such as enzymatic reactions, binding interactions, or the generation of a measurable signal) that convert the original biological material into a new, detectable state.”
In response, Applicant’s argument is not responsive. Applicant reads specification into claims. The recitation “triggering testing, using a biochemical assay”, reads on sending a signal to perform testing, such as outputting a command to a display to use a biochemical assay. This step is not limited to a physical testing step performed by a particular machine. The unspecified “biochemical assay” is so broad, it does not guarantee a converting of the original biological material into a new, detectable state. Even if the testing method is PCR, “converting of the original biological material into a new, detectable state’ is still arguable. Because the initial input is “obtaining samples”, A PCR reaction does not change the samples, or at least the PCR reaction does not change all the samples (some samples will have negative PCR reactions).
In the Remarks, Applicant argues (page 17, paras 2-3) that “the ordered combination of dynamic pooling protocol, automated sample handling, and physical biochemical testing distinguishes the claimed process from generic laboratory steps, and provides a technical solution that is significantly more than any alleged abstract idea.”
In response, Applicant’s argument is not responsive. It is routine and conventional to perform the acts of counting pathogens in samples, with or without the assistance of a robot (especially in a clinical lab of a hospital). Including computer systems and non-transitory storage media (claims 8 and 15) are recitations of generic computer structure that serves to perform generic computer functions are also well-understood, routine, and conventional previously known to the pertinent industry. Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself.
Therefore, the 101 rejection is maintained.
Conclusion
No claims are allowed.
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/GL/
Patent Examiner
Art Unit 1686
/Anna Skibinsky/
Primary Examiner, AU 1635
Prosecution Insights