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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/17/2026 has been entered.
Claim Status
Claims 1-3, 5-7, and 16-19 are pending, under examination, and rejected.
Claim 1 is amended and independent.
No claims are allowed, new, or withdrawn.
Claims 1 and 7 are objected to.
Priority
As detailed in the 03/20/2020 filing receipt, this application is a 371 of PCT/US18/33154, filed 05/17/2018, which claims priority to Provisional Application No. 62/507,413, filed 05/17/2017. At this point in examination, all claims have been interpreted as being accorded the priority date of 05/17/2017.
Office Action Outline
Rejections applied
Abbreviations
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
x
112 Other
IDS
Information Disclosure Statement
102, 103
JE
Judicial Exception
x
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
Double Patenting
MM/DD/YYYY
date format
Overview of New/Withdrawal/Revision of Objections/Rejections
In view of the amendment and remarks received 03/17/2026:
• New objections to claims 1 and 7 are applied below.
• The 112(f) interpretation is still asserted (for the "sample preparer configured to" in claims 1, 5, 6).
• The 112(d) rejection of claims 5 and 6 is maintained as claim 5 does not yet further limit the "sample preparer" of claim 1.
• The 101 rejection is maintained with slight revision to reflect the amendment; an improvement to technology or a technical field has not yet been shown. See full discussion below in "Response to Applicant Arguments - 35 USC § 101."
Claim Objections
Claim 1 and 7 are objected to because of the following informalities:
Claim 1 recites "to apply a trimming algorithm to remove any noise that was incorrectly classified when the dynamic threshold is implemented," which recites inconsistent verb tenses. Possibly correcting to recite "to apply a trimming algorithm to remove any noise that was incorrectly classified when the dynamic threshold [[is]]was implemented," might result in withdrawal of the rejection.
Regarding the following four elements of claim 1: "to apply a forward stutter filter and", "to apply a trimming algorithm", "to detect any incorrectly detected", and "to calculate a predicted occurrence," it appears these four elements are part of the element beginning "a computer having a processor," and should be indented under the element beginning "a computer having a processor."
Additionally, in a matter related to the indentation of elements above, the word "and" should be inserted after the phrase "any low-level noise calculated," in claim 1.
Claim 1 recites the terms "allele dropout" and "allelic dropout" three times each. Claim 7 recites the term "allelic dropout" twice. It is suggested to recite consistent claim language and amend claims 1 and 7 to recite either "allele dropout" or "allelic dropout."
Appropriate correction is required.
Claim Interpretation-112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term "means" or "step" or a term used as a substitute for "means" that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term "means" or "step" or the generic placeholder is modified by functional language, typically, but not always linked by the transition word "for" (e.g., "means for") or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term "means" or "step" or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word "means" (or "step") in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word "means" (or "step") in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word "means" (or "step") are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word "means" (or "step") are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word "means," but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are: "sample preparer configured to" in claims 1, 5, and 6. The term "sample preparer" is interpreted to mean the part of the system configured to prepare the sample for DNA analysis by receipt, isolation, extraction, separation, purification, amplification, sequencing, and/or generation of sequence data, of the DNA sample. The structure of the sample preparer is sufficiently described in Specification para. [0011-0012], and [0027].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5 and 6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate.
Claim 5 does not yet further limit the "sample preparer" of claim 1, as claim 5 recites "the sample preparer is configured to amplify DNA within the sample", and amended claim 1 recites "a sample preparer configured to receive a sample containing an amount of DNA from a plurality of contributors, to amplify the amount of DNA". Amending to distinguish claim 5 from claim 1, while also properly amending claim 6, if needed, may help to overcome the rejection; alternatively possibly canceling claim 5, and amending claim 6 to depend from claim 1 may result in the withdrawal of the rejection.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-3, 5-7, and 16-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 details the following framework to analyze Subject Matter Eligibility:
• Step 1: Are the claims directed to a category of statutory subject matter (a process, machine, manufacture, or composition of matter)? (see MPEP § 2106.03)
• Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. an abstract idea, a law of nature, or a natural phenomenon? (see MPEP § 2106.04(a)). Note, the MPEP at 2106.04(a)(2) & 2106.04(b) further explains that abstract ideas and laws of nature are defined as:
• mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
• certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people);
• mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information);
• laws of nature and natural phenomena are naturally occurring principles and/or relations that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature.
• Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application? (See MPEP § 2106.04(d).)
• Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept? (See MPEP § 2106.05.)
Step 1:
Claims 1-3, 5-7, and 16-19 are directed to a 101 machine or manufacture, here a system, and therefore to a category of statutory subject matter. (See MPEP § 2106.03.) (Step 1: Yes.)
Step 2A, Prong One:
The claims are found to recite abstract ideas in the form of mental processes and mathematical concepts, as well as a law of nature, as follows:
Independent claim 1 recites a system programmed to perform mathematical concepts and mental processes of:
• implement a dynamic threshold that is calculated on a mean and a standard deviation of any noise in a region flanking each locus of a plurality of loci in the set of sequence data to detect any alleles in the set of sequence data and remove any low-level noise calculated;
• apply a forward stutter filter and a reverse stutter filter to the set of sequence data after
the dynamic threshold has been implemented;
• apply a trimming algorithm to remove any noise that was incorrectly classified when
the dynamic threshold is implemented;
• detect any incorrectly detected noise at each locus of the plurality of loci in the set of
sequence data;
• calculate a predicted occurrence of allelic dropout at a given locus by;
• assess the sequence data using an allelic dropout model (machine learning algorithm) that has been trained and that determines predicted occurrence of allelic dropout based on an amount of total DNA amplified, a peak height, a sequence count, a Phred score, a minimum number of contributors, a peak height ratio, a locus peak height, a locus peak, and a DNA template amount.
Claim 2 further limits the mathematical concept of claim 1 in reciting:
• a support vector machine algorithm.
Claim 7 recites mental processes and/or mathematical concepts of:
• assess the sequence data in the database representing DNA present in a known sample with predetermined allelic dropout probabilities;
• to develop a model for predicting allelic dropout in an unknown sample.
Claim 16-19 recites mathematical concepts and mental processes of:
• determining the mean and standard deviation of a y-coordinate data using a plurality of inter-locus ranges specified in a locus threshold dictionary and setting the dynamic threshold at four standard deviations above the mean (claim 16)
• apply the forward stutter filter and a reverse stutter filter by implementing one of a Gompertz function and an exponential rise to maximum (claim 17)
• apply the trimming algorithm by identifying a maximum locus peak and trimming any peak at any other loci in the set of sequence data are not within five percent of a peak height of the maximum locus peak (claim 18).
• apply the trimming algorithm by removing any alleles in the set of sequence data having a height that is not within a predetermined percentage of a highest peak in the set of sequence data (claim 19).
Claims 1, 2, 7, and 16-19 recite abstract ideas, characterized as mathematical concepts and mental processes, as listed above. Considering the broadest reasonable interpretation (BRI) of the claims, the mathematical concepts recited in claim 1, 2, 7, and 16-19 [e.g., implementing a dynamic threshold that is calculated on a mean and a standard deviation; applying stutter filters and trimming algorithms; detect any incorrectly detected noise; calculating a predicted occurrence of allelic dropout; applying an allelic dropout model including a machine learning algorithm (support vector machine); implementing Gompertz function; etc.] inherently recite mathematical concepts, which may include use of statistical methods and equations such as those disclosed throughout the Specification, and particularly at [0043-0072]. Additionally, the claims are considered to recite mental processes as there is no detail recited which would prevent the performance in the human mind or with pencil and paper. When considering the recited mathematical concepts and mental processes, such steps and analysis performed mentally, or with paper and pencil, may take considerable time and effort, and although a general-purpose computer can perform these steps and analysis at a rate and accuracy that can far exceed the mental performance of a skilled artisan, the nature of the activity is essentially the same, and therefore constitutes an abstract idea.
Therefore, the claims recite elements that constitute a judicial exception in the form of abstract ideas. (Step 2A, Prong One: Yes.)
Step 2A, Prong Two:
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs). Here at Step 2A, Prong Two, any remaining steps and/or elements not identified as JEs are therefore in addition to the identified JE(s), and are considered additional elements. Because the claims have been interpreted as being directed to judicial exceptions (abstract ideas in this instance) then Step 2A, Prong Two provides that the claims be examined further to determine whether the judicial exception is integrated into a practical application [see MPEP § 2106.04(d)]. A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
MPEP § 2106.04(d)(I) lists the following five example considerations for evaluating whether a judicial exception is integrated into a practical application:
(1) An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a).
(2) Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2).
(3) Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
(4) Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c).
(5) Applying or using 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, as discussed in MPEP § 2106.05(e).
Note: An explanation of a technical improvement may help to overcome a 101 rejection, as discussed at Step 2A/2nd Prong, 1st consideration of the 101 analysis in MPEP 2106.04(d) and (d)(1). Such an improvement requires detailed explanation applicable to all embodiments reasonably within the claim scope. A detailed explanation of the particular improvement may include identification of the technology field, as well as clearly stating the improvement over the technology field. Submitting persuasive arguments supported by any necessary evidence (including showing improvement by comparison to other method(s) of dropout prediction) to demonstrate that one of ordinary skill in the art would understand that the disclosed invention improves technology may be helpful in successfully showing an improvement, and therefore integrating the abstract idea into a practical application. For example, in response to a rejection under 35 U.S.C. 101, an applicant could submit a declaration under § 1.132 providing testimony on how one of ordinary skill in the art would interpret the disclosed invention as improving technology and the underlying factual basis for that conclusion. See MPEP 2106.05(a).
Continuing the Step 2A Prong Two analysis, the following additional elements have been identified:
Additional elements of data gathering recited in claims 1 and 5-7: Claims 1 and 7 recite the additional elements of receiving data (claim 1 and 7), generating data (claim 1), providing data (claim 1), and/or receiving a sample (claim 1). Claims 1, 5, and 6 recite the additional element of amplifying DNA (claims 1 and 5) and/or amplifying DNA markers (claim 6).
Data gathering steps are additional elements which perform functions of inputting, collecting, and outputting the data needed to carry out the abstract idea. These steps are considered insignificant extra-solution activity, and are not sufficient to integrate an abstract idea into a practical application as they do not impose any meaningful limitation on the abstract idea or how it is performed, nor do they provide an improvement to technology [see MPEP § 2106.04(d)(I)].
Additional elements of computer system components and sample preparation devices recited in claims 1, 2, 5-7, and 16-19: Claims 1, 7, and 16-19 recite the additional element of a processor. Claims 1 and 7 recite the additional element of a database. Claims 1 and 3 recite the additional element of an output device and/or monitor. Claims 1, 5, and 6 recite the additional element of a sample preparer.
The claims require only generically claimed computer components and generically claimed sample preparation devices, which do not improve computer or sample preparation technology, and do not integrate the recited judicial exception into a practical application [see MPEP § 2106.04(d)(I) and (d)(1); and MPEP § 2106.05(f)].
Claims 1-3, 5-7, and 16-19 have been further analyzed with respect to Step 2A, Prong Two, and no additional elements have been found, alone or in combination, that would integrate the judicial exception into a practical application. (Step 2A, Prong Two: No).
Step 2B:
Because the additional claim elements do not integrate the abstract idea into a practical application, the claims are further examined under Step 2B, which evaluates whether the additional elements, individually and in combination, amount to significantly more than the judicial exception itself by providing an inventive concept. An inventive concept is furnished by an element or combination of elements that is recited in the claim in addition to the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself (see MPEP § 2106.05).
Claims 1-3, 5-7, and 16-19 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are well-understood, routine, and conventional. Those additional elements are as follows:
Regarding the additional elements of data gathering in claims 1 and 5-7: Receiving data (claim 1 and 7), generating data (claim 1), providing data (claim 1), receiving a sample (claim 1); amplifying DNA (claims 1 and 5); and amplifying DNA markers (claim 6) do not cause the claims to rise to the level of significantly more than the judicial exception.
The courts have recognized receiving or transmitting data over a network; storing and retrieving information in memory; using polymerase chain reaction to amplify and detect DNA; analyzing DNA to provide sequence information or detect allelic variants; and amplifying and sequencing nucleic acid sequences, [see MPEP§2106.05(d)(II)], are well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as extra-solution activity.
Additionally, Butler et al., (Electrophoresis, vol. 25(10‐11), pages 1397-1412 (2004)), presents a review on use of ABI systems for sequencing and amplifying DNA markers in forensic DNA analysis (entire document).
Therefore, the data gathering steps are shown to be routine, well-understood, and conventional in the art, and as a result, do not provide an inventive concept by amounting to significantly more than the judicial exception.
Regarding the additional elements of computer system components and sample preparation devices recited in claims 1, 2, 5-7, and 16-19: The processor (claims 1, 7, and 16-19); the database (claims 1 and 7); the output device and/or monitor (claims 1 and 3); and the sample preparer (claims 1, 5, and 6) of a sample preparer are conventional computer and sample preparation components.
These conventional components are referred to in a non-specific way in the claims, as well as in specification paragraph [0010], which states "the present invention …is computationally inexpensive and can be performed using conventional hardware, such as standard desktop or laptop computer with off-the-shelf processors", while [0040] discloses "samples…were amplified (28 cycles) using the PowerPlex Fusion Human DNA amplification kit (Promega Corporation). These samples were previously run on the Applied Biosystems 3100, 3130 and 3500 series of Genetic Analyzers (ThermoFisher Scientific Inc.) across 6 laboratories".
Additionally, Butler et al. details use of the Promega kits (p.1399, table 2) and the Applied Biosystems genetic analysis platforms (entire document) in forensic DNA analysis, showing DNA sample preparation using capillary electrophoresis and PCR (p.1401-1402); genetic data and peak processing software programs and Mac and Windows computers (p.1406, col.1-2); DNA databases (p.1408, col.1). Butler et al. shows the conventionality of these biocomputational DNA sample and data processing systems used in forensic DNA analysis.
Therefore, the additional elements of a processor, database, output device, monitor, sample preparer, and sample preparation do not cause the claims to rise to the level of significantly more than the judicial exception as they do not provide an inventive concept.
Further regarding the conventionality of additional elements, the MPEP at 2106.05(b) and 2106.05(d) presents several points relevant to conventional computers and data gathering steps in regards to Step 2A Prong 2 and Step 2B, including:
• A general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions, does not qualify as a particular machine (see 2106.05(b)(I)), as in the case of claims 1, 2, 5-7, and 16-19, which are interpreted to recite conventional computer components and sample preparers.
• Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more (see 2106.05(b)(II). In the instant claims, the recited processor of claims 1, 7, and 16-19 is used in calculating a predicted occurrence of any allelic dropout method; here, the processor acts only as a tool to perform (or which is programmed to perform) the calculation.
• Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more (see 2106.05(b)(III). The processor and the sample preparer performing data gathering, outputting, and DNA amplification steps (such as recited in claims 1 and 5-7) do not impose meaningful limitations on the claims.
• The courts have recognized "analyzing DNA to provide sequence information or detect allelic variants"; "receiving or transmitting data over a network", "performing repetitive calculations", "amplifying and sequencing nucleic acid sequences", and "storing and retrieving information in memory", as well-understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (see MPEP 2106.05(d)(II)). The obtaining of data and/or the amplification of DNA in claims 1 and 5-7, are recited in a generic manner.
All limitations of claims 1-3, 5-7, and 16-19 have been analyzed with respect to Step 2B, and none provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception, and thus do not transform the judicial exception into a patent eligible application of the exceptions. (Step2B: NO.)
Therefore, the claims, when the limitations are considered individually and as a whole, are rejected under 35 U.S.C. § 101 as being directed to non patent-eligible subject matter.
Response to Applicant Arguments - 35 USC § 101
Applicant's arguments filed 03/17/2026 have been fully considered but they are not yet persuasive.
Applicant asserts on p.5 and p.6:
• "According to the Examiner, the claimed system recites an abstract idea under Step 2A, Prong One because the processor uses mathematic concepts and mental process...This determination is contrary to the prevailing case law and USPTO examples." (Remarks, p.5, ¶ 4.)
• "The invention recited...is a system that is configured to perform a very specific and detailed analysis of sequence data...The fact that the claimed system employes machine learning techniques does not make the system abstract and instead allows the claimed system to more effectively and efficiently process a large amount of data that could not otherwise be performed by human..." (Remarks, p.6, ¶ 3.)
Applicant's remarks and arguments appear to relate to 101 analysis Step 2A, Prong One regarding whether the claim is directed to a Judicial Exception. The arguments are not yet persuasive because claim 1 is explicitly directed to mathematical concepts in reciting calculations, which include calculating of: a dynamic threshold using mean and standard deviation, low-level noise, and a predicted occurrence of allelic dropout. Claims 1, 2, and 16-19 are considered to inherently recite further mathematical concepts in the stutter filters, trimming algorithms, machine learning algorithms, and support vector machine, which encompass mathematical analysis of data, and use methods and equations such as those disclosed throughout the Specification, and particularly at [0043-0072]. A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the "mathematical concepts" grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. See MPEP§ 2106.04(a)(2)(I)(C).
Additionally, when considering the recited mathematical concepts and mental processes, such steps and analysis performed mentally, or with paper and pencil, may take considerable time and effort, and although a general-purpose computer can perform these steps and analysis at a rate and accuracy that can far exceed the mental performance of a skilled artisan, the nature of the activity is essentially the same, and therefore constitutes an abstract idea.
Applicant asserts on p. 9:
• "The determination that claims 1-3, 5-7, and 16-19 do not integrate any alleged abstract
ideas into a practical application is without merit, particularly in light of the amendments." (Remarks, p. 6, ¶ 2).
• " ...claims are ...directed to a system that can predict the occurrence of allelic dropout in DNA sequence data obtained from a sample...obtained during forensic investigations... The inability to account for allelic dropout may lead to erroneous conclusions and inconclusive results." (Remarks, p. 6, ¶ 2).
• "...the claimed invention requires a series of steps where the DNA data is processed in specific manner..." (Remarks, p. 6, ¶ 4).
• "Data establishing the effectiveness of the system...was included in the specification of the present application and demonstrates that the claimed invention is a practical application of a specific machine learning approach... to achieve a result that is extremely important to and advances the highly technical field of forensic DNA science. As a result, there is a clear and direct nexus between the claimed invention and the practical application that solved the problem of identifying allelic dropout in forensic DNA analysis." (Remarks, p. 7, ¶ 1).
Applicant's remarks and arguments appear to relate to the Step 2A, Prong Two, 1st Consideration regarding an explanation of improvement in comparison to the previous state of the technology field. The arguments are not yet persuasive because the Applicant has not yet provided a sufficient explanation of improvement over the previous state of the technology field. An explanation of technical improvement may help overcome a 101 rejection, as discussed in MPEP 2106.04(d)(I) and (d)(1), and MPEP 2106.05(a).
Regarding showing an improvement to technology, it would be helpful to have a contrasting value for work representative of the previous state of the field with a citation. Arguments and evidence may be extrinsic to the original disclosure, including references available after the priority date, as long as it is clear that an argument applies to a properly supported claim.
It is noted that the Specification compares accuracy, precision, and/or recall among different methods at [0075, table 2], [0077, table 4], [0079, table 5], and [0084, table 6]; however, if an improvement is to be asserted in the future using tables 2 and 4-6, clarification should be made as to which particular method listed in tables 2 and 4-6 is implemented on the system of the claimed invention (e.g., iLSST-NR, LSST, or another method). As an example, looking at table 5 in paragraph [0079], the performance of eight different methods is tested with a modeled stutter filter and with a stock stutter filter. It is not clear which method tested represents the claimed invention, so that the asserted Step 2A comparison is not yet clear.
The disclosure and Applicant’s arguments have been analyzed for a technical explanation of the asserted improvement, to include that the claims reflect the asserted improvement, and it is considered at this time that an improvement to technology has not yet been sufficiently shown by explanation.
To reiterate from the Step 2A, Prong Two analysis section above in the 101 rejection, an explanation of a technical improvement may help to overcome a 101 rejection, as discussed at Step 2A/2nd Prong, 1st consideration of the 101 analysis in MPEP 2106.04(d) and (d)(1). Such an improvement requires detailed explanation applicable to all embodiments reasonably within the claim scope. A detailed explanation of the particular improvement may include identification of the technology field, as well as clearly stating the improvement over the technology field. Submitting persuasive arguments supported by any necessary evidence (including showing improvement by comparison to other method(s) of dropout prediction) to demonstrate that one of ordinary skill in the art would understand that the disclosed invention improves technology may be helpful in successfully showing an improvement, and therefore integrating the abstract idea into a practical application. Additionally, in response to a rejection under 35 U.S.C. 101, an applicant could submit a declaration under § 1.132 providing testimony on how one of ordinary skill in the art would interpret the disclosed invention as improving technology and the underlying factual basis for that conclusion. See MPEP 2106.05(a).
As further examples, the argument may clearly and adequately explain cause and effect leading to improvement or, for example when such cause and effect explanation is not possible, then may include evidence (e.g. experimental data) comparing a claimed result to conventional results.
Also, arguments and evidence may be extrinsic to the original disclosure, including references available after the priority date, as long as it is clear that an argument applies to all embodiments of a properly supported claim.
It is suggested that Applicant submit a detailed explanation of improvement to technology for consideration of integration of the judicial exception into a practical application at Step 2A Prong Two.
Conclusion
No claims are allowed.
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
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/M.A.V./Examiner, Art Unit 1687
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
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