DETAILED ACTION
Applicant's response, filed 2 July 2026, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 1-8, 10-12, and 14-20 are currently pending and under exam herein.
Claims 9 and 13 have been cancelled.
Claims 17-20 are newly presented.
Information Disclosure Statement
The Information Disclosure Statement filed 2 July 2026 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS is included with this Office Action.
Specification
The outstanding objections to the Specification are withdrawn in view of the amendment submitted herein.
Terminal Disclaimer
The terminal disclaimer filed on 2 July 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patents: 9,920,361 and 11,306,354 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Inventor Declaration under 1.132
The Inventor Declaration under 37 CFR 1.132 filed 2 July 2026 is insufficient to overcome the rejection of claims 1-8, 10-12, and 14-20 based upon 35 USC 101 as set forth in the last Office action. Please see below with assessment of said declaration as pertains to arguments pertaining to 35 USC 101.
In view of the below, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence.
Claim Interpretation
Claim 1 includes a system with processors and a memory, of which the memory includes instructions executable by the processor(s) and wherein the memory comprises counts of thousands to millions of nucleotide sequence reads mapped to genomic portions of a reference genomes. The sequence reads are defined as those that are of circulating cell-free nucleic acids from a test sample from a pregnant female. The sequences are further defined as generated by a non-loci-specific massively parallel sequencing process. As such, claim 1 is interpreted as a system with information stored thereon. The information includes nucleotide sequence reads. Those reads are not actively sequenced in the claim, but rather the characteristic of said reads is that they are from a sequencing process, as no active step of actual sequencing is performed. Therefore, the claim system houses information of said specific sequence data.
Claim 1, step (b) recites, “select counts for sequence reads from nucleic acid fragments that are shorter than about 150 bases to about 160 bases” wherein the claim is interpreted as fragment length that is less than a determined cutoff/threshold value, wherein the cutoff/threshold is about 150 bases to about 160 bases, as disclosed in the Specification at least at [0247].
Claim 14 recites, “wherein the sequencing process is performed at about 0.1- fold coverage, about 0.2-fold coverage, about 0.3-fold coverage, about 0.4-fold coverage, about 0.5-fold coverage, about 0.6-fold coverage, about 0.7-fold coverage, about 0.8-fold coverage, about 0.9-fold coverage, about 1-fold coverage, or greater than 1-fold coverage”. Because the claim is interpreted (see above with respect to claim 1) as not actively performing sequencing, the limitation herein is interpreted as directed to a characteristic of the housed data.
Double Patenting
The outstanding rejections under Non-statutory Double Patenting are hereby withdrawn in view of the filed Terminal Disclaimer, as acknowledged above
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 1-8, 10-12, and 14-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1 Analysis: Are claims directed to process, machine, manufacture/composition of matter
With respect to step (1): yes, the claims are directed to a system.
Step 2A, Prong 1 Analysis: Do claims recite abstract idea
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas 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); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and in conjunction with mathematical concepts (in particular mathematical relationships and formulas).
Note: The claims elements are italicized herein to highlight the judicial exceptions in the claim steps and underlined to represent the additional claim elements.
Claim 1:
A system comprising one or more processors and memory, which memory comprises instructions executable by the one or more processors and which memory comprises nucleotide sequence reads mapped to genomic portions of a reference genome, which sequence reads are reads of circulating cell-free nucleic acid from a test sample from a pregnant female bearing a fetus and which sequence reads are generated by a non-loci-specific massively parallel sequencing process, and which instructions executable by the one or more processors are configured to:
(a) map the sequence reads to portions of a reference genome, wherein steps of “mapping” are directed to mental operation whereby one can match data to a reference;
(b) count the sequence reads mapped to the portions, wherein steps directed to “counting” are those that are mathematical processes and can be performed in a mental capacity, save for computer operation wherein the computer is a tool by which to perform said math;
(c) measure the lengths of nucleic acid fragments from which the sequence reads are generated, wherein said operation is directed to mental processes whereby taking a measurement of the lengths of nucleic acid fragments can be performed using pen and paper or, alternatively, using a computer as a tool or in a computing environment to assess nucleic acid fragments from sequence reads;
(d) select counts for the nucleic acid fragments that are shorter than about 150 bases to about 160 bases, thereby generating selected counts of the thousands to millions of sequence reads, wherein the selected counts are enriched for counts of reads from fetal nucleic acid, wherein said operation is a mental process of making a selection of given data to provide a desired outcome selection and can be performed using pen and paper or, alternatively, using a computer as a tool or in a computing environment to generate said counts; and
(e) normalize the selected counts of the sequence reads for the test sample according to an experimental bias for the test sample and an experimental bias for each of multiple samples from multiple pregnant females, thereby generating normalized selected counts, wherein experimental bias in the normalized selected counts is reduced, wherein said operation is directed to mathematical concepts that include fitting calculations (see also claim 8) and see the Specification at [0391].
Claim 2:
The system of claim 1, wherein the instructions executable by the one or more processors are configured to select counts for the sequence reads from nucleic acid fragments that are shorter than about 150 bases, wherein said operations further limit the step of selection in above claim 1 and are also directed to abstract ideas.
Claim 3:
The system of claim 1, wherein the instructions executable by the one or more processors are configured to select counts for the sequence reads from nucleic acid fragments that are shorter than about 160 bases, wherein said operations further limit the step of selection in above claim 1 and are also directed to abstract ideas.
Claim 4:
The system of claim 1, wherein the lengths of the nucleic acid are measured according to positions of mapped sequence reads obtained from a paired-end sequencing process, wherein said operations further limit the step of measuring in above claim 1 and are also directed to abstract ideas.
Claim 7:
The system of claim 1, wherein the experimental bias for the test sample in (e) is a guanine and cytosine (GC) bias, and the experimental bias for each of multiple samples from multiple pregnant females in (e) is a guanine and cytosine (GC) bias, wherein said operations further limit the step of normalizing in above claim 1 and are also directed to abstract ideas.
Claim 8:
The system of claim 7, wherein the normalizing in (e) comprises 1) determining a guanine and cytosine (GC) bias coefficient for the test sample based on a fitted relation between (i) the counts of the sequence reads mapped to each of the genomic portions and (ii) GC content for each of the genomic portions, wherein the GC bias coefficient is a slope for a linear fitted relation or a curvature estimation for a non-linear fitted relation; and 2) determining a fitted relation, for each of the genomic portions, between (i) a GC bias coefficient for each of the multiple samples from multiple pregnant females and (ii) counts of sequence reads mapped to each of the genomic portions for the multiple samples, wherein said operations are further directed to limiting the normalization procedures in above claim 1 and include mathematical concepts further directed to linear fitting or curvature estimations, which are operations for modeling relationships among mathematical variables to best represent data.
Claim 10:
The system of claim 1, wherein the sequence reads are mapped to multiple chromosome portions from multiple chromosomes of the reference genome, wherein said operations are further directed to limiting the abstract steps in above claim 1 and include mental operations of mapping and counting, in a computer environment or using a computer as a tool.
Claim 11:
The system of claim 1, wherein the sequence reads are mapped to portions of a complete human reference genome, wherein said operations are further directed to limiting the abstract steps in above claim 1 and include mental operations of mapping and counting, in a computer environment or using a computer as a tool.
Claim 20:
wherein the selected counts are enriched for counts of reads from fetal nucleic acid in (d) by an in-silico process that does not include physical separation of fragments, wherein said operations are mathematical processes performed in a computing environment ( computer as a tool) and wherein the Specification includes that “in silico” enrichment is performed by establishment of thresholds or cutoff values [0230]; [0373]; [0591].
Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind (calculations by hand or pen and paper or computer as a tool) and performance by mathematical operation (normalization; curve fitting; etc.). There are no specifics as to the methodology involved in “mapping”, “counting”, “measureing” or in “selecting” and thus, under the BRI, one could simply, for example, perform said operation with pen and paper, or, alternatively with the aid of a generic computer as a tool to perform said operations. These recitations are similar to the concepts of collecting information, analyzing it and providing certain results from the collection and analysis (Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations (Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in (Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind with pen and paper, and can include mathematical concepts.
Further, see MPEP § 2106.04(a)(2), subsection III. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation (see, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674: noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016): holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind" (see Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016): holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
Step 2A, Prong 2 Analysis: Integration to a Practical Application
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (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. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the additional elements as underlined above. Specifically said steps are those that include a system and processor and memory with instructions executable by a processor. The computer memory stores the data of nucleotide sequence reads mapped to genomic portions and defined to be those that are circulating cell-free nucleic acids. Further steps directed to additional elements in the claim are those that further limit the data as in claim 1 and are those that include limitations on the data such as claims 5 and 12, and 14-19.
As the “system” includes the memory with stored data, said memory with stored data serves as the vehicle for data gathering in the claim. Additional elements in the instant claims directed to data gathering perform functions of collecting the data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or on how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Further, the system, processor, memory and instructions are part of a general purpose computer system and there are no details herein wherein of how the specific computer structures are used to implement the judicial exceptions beyond generic computing operations, i.e., the computer elements of the claims do not provide improvements to the functioning of the computer itself (see: DDR Holdings, LLC v. Hotels.com LP); they do not provide improvements to any other technology or technical field (see: Diamond v. Diehr); nor do they utilize a particular machine (see: Eibel Process Co. v. Minn. & Ont. Paper Co.). Hence, these are mere instructions to apply the judicial exception using a computer, and therefore the claim does not provide integration into a practical application of any judicial exception.
Step 2B Analysis: Do Claims Provide an Inventive Concept
The claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the claim elements directed to a computer system with sequencing information are data gathering elements as in 2A, prong 2 and that under the assessment herein under 2B encompass steps that are routine, well-understood and conventional in the art. For example, the prior art to Fan et al. (2010/0138165-IDS reference) disclose sequencing protocols that include mapping to genomic regions that serve as the basis of the additional elements herein (see Fan at least at [0021]; [0032]; [0056]). It is noted that actual sequencing steps are not performed by the instant claims (see claim interpretation above). However if sequencing were to be performed, it is a routine and conventional practice in the art (as in Fan et al.) and would further not provide for an inventive concept under 2B.
Further, the instant Specification discloses that there are numerous sequencing methodologies that can be implemented for data acquisition, such as those at [0320]-[0336], citing numerous publications for protocols. The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts 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.): determining the level of a biomarker in blood by any means (Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017)); detecting DNA or enzymes in a sample (Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017)).
With respect to the claims to the system and processor, memory and instruction, the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. Further exemplified prior art to, for example, Fan teaches that computing elements are routine, well-understood and conventional in the art for implementing methods involving sequence read data [0031]. Further, the specification also discloses that computer processors and systems, as example, are generic computing systems [0581]. The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III).
The dependent claims have been analyzed with respect to step 2B and none of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Response to Applicant’s Arguments
1. Applicant states that, “the claims are patent eligible under Step 2A, prong (2), of the patent subject matter eligibility analysis as set forth in MPEP § 2106 (hereafter "eligibility analysis"), as the claimed system demonstrates an improvement to a technology and the claims recite additional elements that integrate the alleged judicial exception(s) into a practical application” by way of “[a] the claimed system [that] provides specific benefits over conventional sequencing systems, including an in silico-based enrichment of sequence read counts from fetal nucleic acid in a cell-free maternal test sample. The primary component of a maternal sample comprising cell-free nucleic acid is maternal nucleic acid, with typically just a small amount of fetal nucleic acid present. Enriching for fetal nucleic acid can enable a more robust analysis of the fetal component of cell-free nucleic acid. Existing attempts to enrich for fetal nucleic acid involved time-consuming and costly laboratory processing of the test sample (e.g., physical separation of fetal nucleic acid fragments from maternal nucleic acid fragments). The claimed system provides an enrichment of sequence read data from fetal nucleic acid directly from the sequencing information without the need for a separate sample processing step. For example, the lengths of nucleic acid fragments in the test sample can be extrapolated from the sequence read data (e.g., genomic positions of the randomly mapped reads can indicate the lengths of the fragments from which the sequence reads are generated), and sequence read data from fragments of a certain length (i.e., fragments that are shorter than about 160 bases) is selected for analysis. Fetal nucleic acid fragments tend to be shorter in length compared to maternal nucleic acid fragments, and selection of sequence read data from fragments under a given threshold (i.e., about 160 bases) effectively enriches for data from fetal nucleic acid, allowing for a more robust analysis of the fetal nucleic acid”.
It is respectfully submitted that this is not persuasive. Specifically with respect to the underlined portions above, Applicant’s arguments are directed to the judicial exceptions themselves, i.e., fragment positions from sequence read data that are mapped and selected according to a threshold. Said operations, as described above. Are directed of mathematical and/or mental procedure, save for the operation via computer, which is a generic computing environment serving as a tool by which to perform said operations. Applicant is kindly reminded that, “because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"); Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself."). For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must "transform the nature of the claim" into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B” MPEP 2106.04, IIA, 2. It is maintained herein that mapping, counting, measureing, selecting and normalizing are steps that are judicial exceptions in the claim, as discussed above.
2. Applicant discusses the Inventor Declaration and states that, “Dr. Kim describes the typical workflow for performing non-invasive prenatal testing (NIPT), and the advantages of enriching for fetal DNA. Dr. Kim states that enriching for fetal DNA prior to sequencing "can improve accuracy of downstream fetal DNA analyses." As mentioned above, the primary component of a maternal sample comprising cell-free nucleic acid is maternal nucleic acid, and just a small amount of the cell-free DNA is fetal in origin. Thus, enriching for fetal DNA enhances the fetal DNA signal and reduces the maternal DNA background signal. Dr. Kim explains that "[s]ome workflows include a physical separation of maternal and fetal DNA to enrich for fetal DNA," and notes that "[o]ne advantage of the claimed system is an in silico enrichment of data from fetal DNA, which offers a faster and more cost-efficient way to enrich for fetal DNA."
In paragraph 7 of the Kim Declaration, Dr. Kim notes that significant costs related to physical separation of maternal and fetal DNA can be avoided by instead performing the in silico enrichment of data from fetal DNA. Specifically, Dr. Kim points out that "a typical DNA size separation method commonly performed at the time the claimed system was invented required approximately $6 in materials (e.g., beads, columns, buffers, etc.), equipment (pipettors, centrifuges, etc.), and personnel; and took approximately 6 hours per 6 sample batch to complete." Dr. Kim states that, over the course of a year, "a typical clinical laboratory processing 20,000 samples per year would realize approximately $20,000 in savings per year for the cost of materials, and approximately 20,000 accumulated hours of upfront processing time."10
In paragraph 8 of the Kim Declaration, Dr. Kim concludes that "the claimed in silico enrichment process yields improvements in efficiency, speed, and cost of cell-free fetal DNA analysis." Taken together, the Kim Declaration provides evidence that the claimed invention results in tangible and measurable cost savings, and measurable improvements in workflow efficiency and speed for a clinical lab that is processing samples and performing the claimed in silico size separation”.
It is respectfully submitted that this is not persuasive. The “system” as claimed herein is directed to reads that have been generated by massively parallel sequencing, which is a known technique in the art. Those sequences are then used in the process (data) for mapping, counting, measureing, selecting, and normalizing counts to generate normalized counts. The steps as in (a)-(e) of the claims are directed to judicial exceptions and not to any improvement in sequencing itself. There is no evidence that said operations are performed in a specific machine, for example, by which the computing operations are more efficient. Rather, the steps are directed to better math, which is still math, and still directed to judicial exceptions. Any computer, as an aid, can perform said mathematical processes. As such, the arguments and Declaration are not persuasive. As per the MPEP at 2106.04(a)(2), “It is important to note that a mathematical concept need not be expressed in mathematical symbols, because "[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). See, e.g., SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. Cir. 2018) (holding that claims to a ‘‘series of mathematical calculations based on selected information’’ are directed to abstract ideas); Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that claims to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea); and Bancorp Servs., LLC v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012) (identifying the concept of ‘‘managing a stable value protected life insurance policy by performing calculations and manipulating the results’’ as an abstract idea).”
Further, with respect to “improvement”, “it is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018))”.
Such is not apparent herein, as there is no apparent improvement to the computer itself herein, rather the computer is invoked as a tool. This is in contrast to, for example, the claims in Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). In Enfish, wherein “the court evaluated the patent eligibility of claims related to a self-referential database. Id. The court concluded the claims were not directed to an abstract idea, but rather an improvement to computer functionality. Id. It was the specification’s discussion of the prior art and how the invention improved the way the computer stores and retrieves data in memory in combination with the specific data structure recited in the claims that demonstrated eligibility. 822 F.3d at 1339, 118 USPQ2d at 1691. The claim was not simply the addition of general purpose computers added post-hoc to an abstract idea, but a specific implementation of a solution to a problem in the software arts. 822 F.3d at 1339, 118 USPQ2d at 1691”.
There is no apparent improvement to “sequencing” as the system herein is directed only to a generic computer by which said computer performs operations that any computer performs upon receipt of massively parallel sequencing data. This is in contrast to, for example, McRO, 837 F.3d at 1316, 120 USPQ2d at 1103. The basis for the McRO court's decision was that the claims were directed to an improvement in computer animation and thus did not recite a concept similar to previously identified abstract ideas. Id. The court relied on the specification's explanation of how the claimed rules enabled the automation of specific animation tasks that previously could not be automated. 837 F.3d at 1313, 120 USPQ2d at 1101. McRO, wherein the court indicated that it was “the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process. 837 F.3d at 1314, 120 USPQ2d at 1102. The McRO court also noted that the claims at issue described a specific way (use of particular rules to set morph weights and transitions through phonemes) to solve the problem of producing accurate and realistic lip synchronization and facial expressions in animated characters, rather than merely claiming the idea of a solution or outcome, and thus were not directed to an abstract idea. 837 F.3d at 1313, 120 USPQ2d at 1101”. This further in contrast to, “Using well-known standard laboratory techniques to detect enzyme levels in a bodily sample such as blood or plasma, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1355, 1362, 123 USPQ2d 1081, 1082-83, 1088 (Fed. Cir. 2017)”.
As such, the arguments of record and Declaration herein are not persuasive not overcome the rejections under 35 USC 101.
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.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lori A. Clow, whose telephone number is (571) 272-0715. The examiner can normally be reached on Monday-Thursday from 11:00AM to 9:00PM ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached on (571) 272-9047.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public.
/Lori A. Clow/Primary Examiner, Art Unit 1687
Prosecution Insights