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 .
Applicant's Amendment/Request for Reconsideration-After Non-Final Rejection filing of 23 July 2025, has been entered and fully considered.
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.
Withdrawn Rejections/Objections
The rejection to claims 1-20 under 35 U.S.C. 102(a)(1) in the Office action posted 4/23/2025 is withdrawn in view of claim amendments filed 7/23/2025.
Regarding the 35 U.S.C. 102/103:
Claims 1-20 are free from the prior art because independent claims 1, 8 and 15 recite the following non-obvious combination:
determining, by an intelligent selection machine, an optimal selection plan to perform the 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;
evaluating each candidate combination of the possible pooling size and the possible prevalence using the pooled testing objective function based on the number of initial tests and the number of retests; and
determining the optimal selection plan based on the evaluation of each candidate combination of the possible pooling size and the possible prevalence.
In this regard, Applicant’s Remarks filed 7/23/2025 (pages 16-25) supports the withdrawn of art rejections.
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 directed to a 101 process, here a "method," for selecting samples to perform a pooled testing for a pathogen.
Claims 8-14 are directed to a 101 machine and manufacturer, here a "system," with structural components.
Claims 15-20 are directed to a 101 machine and manufacturer, here a " computer-program product tangibly embodied in a non-transitory machine-readable storage medium."
Step 2A Prong One: Identification of an Abstract Idea
The claim(s) recite(s):
Determining a prevalence of the pathogen in the samples from each region or population of the plurality of regions or populations (Claims 1, 8 and 16).
This step recites “determining a prevalence of the pathogen in the sample”, which is interpreted as a decision-making activity in the human mind. Therefore this step equates to an abstract idea of mental processes.
Determining, by an intelligent selection machine, an optimal selection plan to perform the 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 possible pooling sizes and a set of possible 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 possible pooling size in the set of the possible 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 possible pooling size in the set of the possible pooling sizes and a possible prevalence in the set of the possible 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 possible pooling size and the possible 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 possible pooling size and the possible 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:
Claim 1 recites:
Obtaining samples from a plurality of regions or populations, wherein the samples from each region or population form a sample selection candidate set (Claims 1, 8 and 16).
Combining the selected samples to form the combined sample set with the optimal prevalence (Claims 1, 8 and 16).
Aliquoting the samples in the combined sample set based on the optimal pooling design (Claims 1, 8 and 16).
Pooling the samples in the combined sample set based on the optimal pooling design (Claims 1, 8 and 16).
Testing 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 16).
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 well-known, routine and convention especially in the hospitals.
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 7/23/2025, Applicant argues that “under Prong 2 of Step 2A, the additional elements recited in the claims individually or in combination have integrated the alleged judicial exceptions into a practical application by providing an improvement to high-throughput pathogen testing” (page 12, penultimate para; page 13, penultimate para).
Applicant’s argument is not persuasive. As discussed above in the 101 rejection, the identified additional elements do not encompass “improvement to high-throughput pathogen testing”. The step “determining, by an intelligent selection machine, an optimal selection plan to perform the 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” may be tangentially related to intelligent high-throughput testing which reads on the implementation of a generic computer The step as a whole is directed to an abstract idea performed on a generic computer. An abstract idea cannot integrate the alleged judicial exceptions into a practical application. The “combining the selected samples ...” step and the “pooling the samples …” which follow are additional elements, but they are directed to nothing more than “just apply it” step of the pooling design. Additionally, the claim elements “determining a number of initial tests to be performed…” and “determining a number of retests to be performed …” which both are classified as judicial exceptions are not integrated in any additional elements.
Applicants argue (Remarks, page 13, par. 3) that the intelligent selection machine uses information determined by the method of claim 1 to construct and compare pooling strategies to ultimately select the strategy that is quantitatively optima for the sample population. Applicants argue (Remarks, page 14, par. 3) that the claimed method employs specific pooling strategies that increase laboratory efficiency.
In response, the recited additional elements of experimental steps such as “combining the selected samples ...” step and the “pooling the samples …” are directed to nothing more than “just apply it” of the pooling design. The claim does not recite what the optimal strategy is and what is being pooled. It is “just apply it” and does not meet the criteria for practical application There is no recited additional element that captures and reflects the judicial exceptions. Hence the claims do not integrate the judicial exceptions into a practical application.
In the remarks, Applicant argues (page 15, 2nd para) that “the additional limitations of amended Claim 1 amount to significantly more than the exception itself under Step 2B by adding specific limitations beyond the judicial exception and these steps are not well-understood, routine, or conventional in the field of high-throughput pathogen testing.” Applicant’s argument is not persuasive. As discussed above in Step 2B of the 101 rejection, the additional elements are about collecting samples, pooling, aliquoting and counting pathogen in the samples, which are well-known, routine and convention especially in the hospitals. The argued evidence such as the multi-step, data-adaptive, machine-implemented process for pooling optimization are drawn to abstract ideas. The application of generic computers is well-understood, routine, or conventional to pertinent industry. Therefore at Step 2B we don’t have additional elements that amount to “significantly more”.
Therefore, the 101 rejection is maintained.
Conclusion
No claims are allowed.
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.
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/GL/
Patent Examiner
Art Unit 1686
/Anna Skibinsky/
Primary Examiner, AU 1635
Prosecution Insights