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 .
DETAILED ACTION
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Status of Claims
Claims 1-24 are currently pending. Claims 1, 2, 5-7, 9-11, 13-18, 20 and 23 have been amended by Applicants’ amendment filed 08-21-2026. No claims have been added or canceled by Applicants’ amendment filed 07-21-2026.
A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Therefore, claims 1-24 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed October 2, 2023 is a 35 U.S.C. 371 national stage filing of International Application PCT/US2022/023361, filed April 4, 2022, which claims the benefit US Provisional Patent Application 63170063, filed April 2, 2021.
Withdrawn Objections/Rejections
Applicants’ amendment and arguments filed August 21, 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
Specification Objection
The objection to the disclosure is withdrawn because the as-filed Specification teaches “washing the sample before the step of ligation, thereby removing the unbound probes” because one of ordinary skill in the art may understand what Applicant meant.
Claim Rejections - 35 USC § 103
The rejection of claims 1-24 is withdrawn under 35 U.S.C. 103 as being unpatentable over Bava et al. (hereinafter “Bava”) (US Patent Application Publication No. 20120238662, published August 5, 2021; filed February 2, 2021; effective filing date February 3, 2020; of record) in view of Alexander Boulgakov (hereinafter “Boulgakov”) (Dissertation, The University of Texas at Austin, Austin, TX, 2019, 1-292; of record) as evidenced by Anderson et al. (hereinafter “Anderson”) (Nano Letters, 2010, 10, 788-792); and Rukshan Pramoditha (hereinafter “Pramoditha”) (Data Science, 2023, 1-24).
The combined reference of Bava and Boulgakov are not the best references for the amended claims.
In view of the withdrawn rejection, Applicant’s arguments are rendered moot.
Maintained Objections/Rejections
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1-24 is maintained under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 is indefinite for the recitation of the terms “the first library probes” and “the second library probes” such as recited in claim 1, lines 6 and 9-10. There is insufficient antecedent basis for the terms “the first library probes” and “the second library probes” in the claims because claim 1, line 2 recites the terms “a first library of probes” and “a second library of probes”. The Examiner suggests that Applicant amend the claim to recite, for example, “the first library of probes” and “the second library of probes”.
Claims 1 and 2 are indefinite for the recitation of the terms “the first and second library probes” such as recited in claim 1, line 7. There is insufficient antecedent basis for the term “the first and second library probes” in the claims because claim 1, line 2 recites the terms “a first library of probes” and “a second library of probes”. The Examiner suggests that Applicant amend the claim to recite, for example, “the first library of probes” and “the second library of probes”.
Claim 1 is indefinite for the recitation of the terms “their binding moieties” such as recited in claim 1, line 8. There is insufficient antecedent basis for the term “their binding moieties” in the claims because claim 1, lines 3-4 recites the terms “a binding moiety”. Moreover, it is unclear whose ‘binding moiety’ is being referred to by the term “their binding moieties”, and whether the term refers to the binding moieties of the library of probes and/or whether the term is referring to the binding moieties of the sample and, thus, the metes and bounds of the claim cannot be determined.
Claims 1 and 8 are indefinite for the recitation of the terms “the splinting site of the second library probes” such as recited in claim 1, line 9. There is insufficient antecedent basis for the term “the splinting site of the second library probes” in the claims because claim 1, lines 4 and 5 recites the terms “a 3’ splinting site” and “a 5’ splinting site”.
Claim 2 is indefinite for the recitation of the term “allowing binding of the first and second library probes, thereby removing probes that are not bound to the target“ such as recited in claim 2, lines 2-3 because the term “allowing binding” is not equivalent to the term “binding”, wherein the term “allowing” is defined as “permit” and “to fail to restrain” as evidenced by Merriam-Webster Dictionary (pg. 1, #1), such that it is unclear whether the library probes are bound to a target. The claim does not recite that library probes are bound to a target, such that washing can remove all probes and, thus, the metes and bounds of the claim cannot be determined.
The rejection of claim 2 is maintained as being indefinite for the recitation of the term “the step” such as recited in claim 2, line 2. There is insufficient antecedent basis for the term “the step” in the claims because claim 2 depends from instant claim 1, wherein claim 1 does not recite a “step of ligation” and, thus, the metes and bounds of the claim cannot be determined.
Claim 2 is indefinite for the recitation of the terms “probes” such as recited in claim 2, line 3. There is insufficient antecedent basis for the term “probes” in the claims because claim 1, line 2 recites the terms “a first library of probes” and “a second library of probes”.
Claims 5 and 6 are indefinite for the recitation of the term “each probe” such as recited in claim 5, line 2. There is insufficient antecedent basis for the term “each probe” in the claim 1, line 2 recites the terms “a first library of probes” and “a second library of probes”. Moreover, it is unclear which library of probes the term “each probe” is referring to, such as whether the term is referring to the probes of the first library and/or the probes of the second library. The Examiner suggests that Applicant amend the claim to recite, for example, “each probe of the first library of probes” and “each probe of the second library of probes”.
Claim 7 is indefinite for the recitation of the term “an organic or inorganic substrate of the target” such as recited in claim 7, line 2 because claim 7 depends from instant claim 1, wherein amended claim 1, does not recite the presence of a substrate (or a target substrate) and, thus, the metes and bounds of the claim cannot be determined.
Claim 9 is indefinite for the recitation of the terms “each splinting site” such as recited in claim 9, line 1. There is insufficient antecedent basis for the term “each splinting site” in the claims because claim 1, lines 4 and 5 recites the terms “a 3’ splinting site” and “a 5’ splinting site”.
Claim 11 is indefinite for the recitation of the term “the ligating step” such as recited in claim 11, line 2. There is insufficient antecedent basis for the term “the ligating step” in the claims because claim 1, line 9 recites the term “ligating”.
Claim 15 is indefinite for the recitation of the terms “identifying and quantifying data” such as recited in claim 15, lines 1-2. There is insufficient antecedent basis for the term “identifying and quantifying data” in the claims because claim 14, lines 1-2 recites the term “a step of identifying and quantifying sequencing data”. The Examiner suggests that Applicant amend claim 15 to recite, for example, “wherein the step of identifying and quantifying sequencing data”.
Claim 18 is indefinite for the recitation of the term “each sequence” such as recited in claim 18, line 2. There is insufficient antecedent basis for the terms “each sequence” in the claim because claim 15, line 9 recites the terms “sequenced amplicons” and “extracted sequences”, such that it is unclear which sequences the term “each sequence” is being referred to in claim 15 and, thus, the metes and bounds of the claim cannot be determined.
Claim 21 is indefinite for the recitation of the terms “the p-value” such as recited in claim 21, line 1. Claim 21 depends from amend claims 1, 14, 15, 18 and 20 There is insufficient antecedent basis for the term “the p-value” in the claim.
The rejection of claim 21 is maintained as being indefinite for the recitation of the term “the sequence information” such as recited in claim 21, line 2. There is insufficient antecedent basis for the term “the sequence information” in the claim. Moreover, claim 21 depends from instant claims 1, 14, 18 and 20, wherein claims 1, 15, 18 and 20 do not recite the production or presence of sequence information and, thus, the metes and bounds of the claim cannot be determined.
Claims 3, 4, 10, 12-14, 16, 17, 19, 20 and 22-24 are indefinite insofar as they ultimately depend from instant claim 1.
Response to Arguments
Applicants’ arguments filed August 21, 2026 have been fully considered but they are not persuasive. Applicants essentially asserts: (a) regarding claim 2 and the term “the step”, it is noted that claim 1 expressly recites a step of ligating, and a step of mixing, and claim 2 corresponds to a step recited in claim 1 (Applicant Remarks, pg. 9, last partial paragraph); and (b) "the sequence information of the k-mer" would be understood by a person of ordinary skill, with reasonable certainty, to mean the identity and order of the nucleotide bases constituting that kmer (Applicant Remarks, pg.13, first full paragraph).
Regarding (a), regarding claim 2 and the term “the step”. The Examiner respectfully notes that instant claim 1 does not recite “a step of ligating” and “a step of mixing”. Instead, claim 1 recites the terms “mixing” and “ligating”. Thus, there is insufficient antecedent basis for the term “the step” in the claim. Thus, the claim remains rejected.
Regarding (b), regarding claim 21 and the term “the sequence information,” there is insufficient antecedent basis for the term “the sequence information” in the claim. Moreover, regardless of whether one of ordinary skill would understand the term, claim 21 depends from instant claims 1, 14, 15, 18 and 20, wherein claims 1, 14, 15, 18 and 20 do not recite the production or presence of sequence information. Thus, the claim remains rejected.
Claim Rejections - 35 USC § 112(d)
The rejection of claims 7 and 21 is maintained under 35 U.S.C. 112(d) 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.
Claim 7 recites (in part): “wherein the binding moiety specifically binds to an organic or inorganic substrate of the target” in lines 1-2 because claim 7 depends from instant claim 1, wherein claim 1 does not recite the presence of an organic or inorganic substrate of the target. Thus, claim 7 is an improper dependent claims for failing to further limit the subject matter of the claim upon which they depend, or for failing to include all the limitations of the claim upon which they depends.
Claim 21 recites (in part): “wherein the graphic pattern represents the p-value of k-mer and the sequence information of the k-mer” in lines 1-2 because claim 21 depends from instant claims 1, 14, 15, 18 and 20, wherein claims 1, 14, 15, 18 and 20 do not recite the production and/or presence of sequence information. Thus, claim 21 is an improper dependent claims for failing to further limit the subject matter of the claim upon which they depend, or for failing to include all the limitations of the claim upon which they depends.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Response to Arguments
Applicants’ arguments filed August 21, 2026 have been fully considered but they are not persuasive. Applicants essentially asserts: (a) claim 21 restricts the graphic pattern of claim 20 to one representing the p-value of a k-mer and the sequence information of that k-mer, such that the dependent claim is narrower than its parent (Applicant Remarks, pg. 15, first partial paragraph; and first full paragraph).
Regarding (a), it is noted that claim 21 depends from instant claims 1, 14, 15, 18 and 20, wherein claims 1, 14, 15, 18 and 20 do not recite the production or presence of sequence information. Thus, the claim remains rejected.
Claim Rejections - 35 USC § 101
The rejection of claims 18-24 is maintained, and claims 14, 15 and 17 are newly rejected, as being rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. An analysis with respect to the claims as a whole reveals that they do not include additional elements that are sufficient to amount to significantly more than the judicial exception. See Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 110 U.S.P.Q.2d 1976 (2014); Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116, 106 U.S.P.Q.2d 1972 (2013); Mayo Collaborative Svcs. v. Prometheus Laboratories, Inc., 132 S. Ct. 1289, 101 U.S.P.Q.2d 1961 (2012). See also 2014 Interim Guidance on Patent Subject Matter Eligibility, available at http://www.gpo.gov/fdsys /pkg/ FR-2014- 12-16/pdf/2014-29414.pdf (“2014 Interim Guidance”), and the Office’s examples to be considered in conjunction with the 2014 Interim Guidance in examination of nature-based products, available online at http://www.uspto.gov/patents/law/exam/mdc_examples_nature-based_products.pdf (“Nature-Based Products Examples”). This rejection is proper.
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of three issues: (1) whether the claim is directed to one of the four categories recited in §101; (2) whether the claim recites or involves a judicial exception (i.e., a law of nature, natural phenomenon, or natural product); and (3) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. In the instant case, the claims are directed to a natural product, and an abstract idea. Therefore, they must each be considered to determine whether, given their broadest reasonable interpretation, they amount to significantly more than the judicial exception.
The claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 14, 15 and 17-24 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below.
In the instant case, the claims are broadly directed to a method of detecting a target in a sample by mixing a library of probes, ligating a splinting site; and further comprising performing amplification and sequencing, wherein the method further comprises: a step of identifying and quantifying sequencing data from the sequenced amplicons, thereby producing quantitative results (claim 14); wherein identifying and quantifying data from the sequenced amplicons comprises extracting sequences from the sequenced amplicons, thereby producing extracted sequences (claim 15); wherein the extracted sequences comprise binding moiety sequences (claim 17); determining a plurality of k-mers of each sequence; determining the counts of each k-mer; and calculating the p-value by comparing the frequency of each k-mer in the sample with a reference control (claim 18); wherein the p-value is calculated using binomial distribution (claim 19); further comprising translating the quantitative results into a graphic pattern (claim 20); wherein the graphic pattern represents the p-value of a k-mer and the sequence information of the k-mer (claim 21); further comprising comparing the graphical pattern to a reference control thereby identifying the target (claim 22); further comprising processing the qualified sequencing data using a dimensionality reduction algorithm (claim 23); and wherein the dimensionality reduction algorithm is principal component analysis (PCA) or t-distributed stochastic neighbor embedding (tSNE) (claim 24).
Beginning with Step I of the analysis, which asks whether the claimed invention falls within a statutory category, such that the instant claims are directed to a natural phenomenon and an abstract idea, thus, the instant claims are directed to a statutory category. Step I: [YES].
Proceeding to Step IIA – Prong One: of the analysis, which asks if the claimed invention is directed to a judicial exception. Instant claims 14, 15 and 17-24 are drawn to an abstract idea in the form of mathematical concepts (e.g., mathematical relationships, formulas or equations, and/or calculations) and mental process (e.g., observation, judgement and opinion) including identifying and quantifying sequencing data; producing quantitative results; extracting sequence data; determining k-mers of each sequence, determining k-mer counts, calculating p-values, binomial distribution, translating quantitative results producing graphic patterns, comparing to a reference control, processing qualified sequencing data using a dimensionality reduction algorithm including PCA or t-SNE, etc. The claims are broadly directed to mathematical relationships, formulas, equations and/or calculations. Step IIA – Prong One [YES].
Step IIA - Prong Two of the analysis asks whether the claim recites additional elements that integrate the exception into a practical application of the exception. In the instant case, the dependent claims are directed to a judicial exception in the form of a natural product and an abstract idea. Claims 18-24 recite: “further comprises: a step of identifying and quantifying sequencing data from the sequenced amplicons, thereby producing quantitative results” (claim 14); “wherein identifying and quantifying data from the sequenced amplicons comprises extracting sequences from the sequenced amplicons, thereby producing extracted sequences” (claim 15); “wherein the extracted sequences comprise binding moiety sequences” (claim 17); “determining a plurality of k-mers of each sequence; determining the counts of each k-mer; and calculating the p-value by comparing the frequency of each k-mer in the sample with a reference control; determining the counts of each k-mer; providing a reference control; and calculating the p-value by comparing the frequency of each k-mer in the sample with a reference control” (claim 18); “wherein the p-value is calculated using binomial distribution” (claim 19); “further comprising translating the quantitative results into a graphic pattern” (claim 20); “wherein the graphic pattern represents the p-value of a k-mer and the sequence information of the k-mer” (claim 21); “further comprising comparing the graphical pattern to a reference control thereby identifying the target” (claim 22); “further comprising processing the qualified sequencing data using a dimensionality reduction algorithm” (claim 23); and “wherein the dimensionality reduction algorithm is principal component analysis (PCA) or t-distributed stochastic neighbor embedding (tSNE)” (claim 24), which resembles “obtaining and comparing intangible data” (i.e. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 99 U.S.P.Q.2d 1690 (Fed. Cir. 2011)), and are analogous to “organizing information through mathematical correlations” (i.e. Digitech Image Techs., LLC v Electronics for Imaging, Inc., 758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)); and are examples of “collecting information, analyzing it, and displaying certain results of the collection analysis” (i.e. Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016)); and resembles “comparing information regarding a sample or test subject to a control or target data” (i.e. Univ. of Utah Research Found. v. Ambry Genetics Corp. (Also known as In re BRCA1– and BRCA2–Based Hereditary Cancer Test Patent Litigation), 774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) or Association for Molecular Pathology v. USPTO (Also known as Myriad CAFC), 689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)). Hence, these limitations are akin to an “abstract idea itself” which was at issue in Alice Corp. and has been identified among non-limiting examples to be an abstract idea. Additionally, other dependent limitations suffer from the same issue. In other words, the dependent limitations do not rectify the rejection of the independent claim. Thus, the claims do not integrate the judicial exceptions into a practical application of the exceptions. Step IIA – Prong Two [NO].
Thus, the claims do not integrate the judicial exceptions into a practical application of the exceptions. Step IIA – Prong Two [NO].
Proceeding to Step IIB of the analysis: the question then becomes what element or what combination of elements is sufficient to amount to significantly more than the abstract idea? The instant independent claim is recited at a high level of generality, such that substantially all practical applications of the judicial exception are covered. For instance, the claims are recited without any specificity as to the method of identifying; the method of quantifying; the sequencing data obtained the number and structure of sequencing amplicons; the quantitative results; the method of extracting sequences; the method of producing extracted sequences; the number, structure and location of barcode sequences; the structure of the binding moiety sequences; how the binding moiety sequences are attached; the method of determining, counting and/or calculating k-mers and p-values; the identity of the sample; the reference control; the binomial distribution method; the method of translating; the quantitative results; the method of producing a graphic pattern; the graphic patterns obtained; the sequence information of the k-mer; the targets identified; the method of processing; the qualified sequencing data; the specific dimensionality reduction algorithm, etc., wherein the steps of the method are well known, purely conventional or routine in the art. Step IIB: [NO].
For example, developing custom image-processing algorithms including for simulated deposition of DNA oligonucleotides with a defined geometrical shape; and that can identify individual fluorescent molecules within each micrograph, aligned fluorescent peaks from the same field of view, imaging across consecutive Edman cycles using fiducial markers to correct for microscope stage variation, and identifying peptides whose fluorescent signals were stable and successfully removed by the final Edman cycle, thus computationally flagging contaminating fluorescent objects and non-sequenced peptides; as well as, quantifying fluorescence intensity was known in the art. Additionally, performing rudimentary analysis of k-mer distribution in the UOI regions of oligonucleotides; and the use of binomial models with regard to oligonucleotides carrying the same Round 1 UOIs was known in the art; as well as, carrying out bleach correction and normalization was carried out using a custom python script (modified from http://imagej .net/Analyze _FRAP_movies_with_a_Jython_script), wherein plots were generated using the ggplot2 package in R. 3D projections were generated in Fiji or IMARIS; and measuring large scale shape distortion in the layout versus the actual oligonucleotide positions, we aligned the original shape and the recovered layout; wherein for each node Euclidean distance between its original and recovered positions was measured and heatmaps can be produced as evidenced by Boulgakov (Dissertation; of record; pg. 45, last full paragraph; pg. 62, last partial paragraph; pg. 96, last partial paragraph; pg. 174, first partial paragraph, lines 1-4; pg. 224, first partial paragraph; pg. 174, last partial paragraph; and Figures 6-4); and dimensionality reduction techniques including PCA and t-SNE were known in the art as evidenced by Arora (US10740656; col 7, lines 35-33; and col 8, lines 49-52). Moreover, steps of sequencing such as sequencing-by-ligation; and imaging amplicons to determine in-situ gene sequencing of the target nucleic acid in a cell in an intact tissue were known in the art; as well as, the quantification of genetic material is determined by digital PCR, wherein the genes analyzed can be compared to a reference nucleic acid extract (DNA and RNA) corresponding to the expression (mRNA) and quantity (DNA) in order to compare expression levels of the target nucleic acids was known in the art as evidenced by Bava (US20210238662; of record) (paragraphs [0007]; and [0310], lines 8-13). Additionally, methods such as Splint Nucleotide Assisted Intramolecular Ligation (SNAIL-RCA) followed by Rolling Circle Amplification, wherein mRNA present in a cell of interest serves as a scaffold for an assembly of a complex that comprises two oligonucleotides, referred to herein as Splint Primer Oligonucleotide (SPO) and Padlock Oligonucleotide (PO) including an amplification reaction mixture comprising, consisting or consisting essentially of two probes for each target sequence, and the method can be performed in the absence of additional probes for a given target sequence is known in the art as evidenced by Samusik ((S20190055594; paragraph [0014]). Thus, methods of ligating, amplifying, sequencing, determining, counting, calculating, processing, comparing and/or producing k-mers, p-values, sequencing data, graphic patterns; as well as, using dimensionality reduction algorithms such as recited in claims 18-24 are well known, purely conventional, or routine in the art including the detection and analysis of proteins associated with preeclampsia. Step IIA [YES].
In sum, when the relevant factors are analyzed, the claims as a whole do NOT recite additional elements that amount to significantly more than the judicial exception itself. Accordingly, claims 14, 15 and 17-24 DO NOT qualify as eligible subject matter.
Dependent claim(s) 14, 15 and 17-24 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because they do not add anything that makes the abstract idea recited in claim 18-24 significantly different. Thus, the claims as a whole do NOT recite additional elements that amount to significantly more than the judicial exception itself.
In light of the above consideration and the new guidance, claims 18-24 are non-statutory. This rejection is newly recited as necessitated by the new Guidance set forth in the Memorandum of July 30, 2015 updating the June 25, 2014 guidance (see June 25, 2014 memorandum from Deputy Commissioner for Patent Examination Policy Andrew Hirshfeld titled Preliminary Examination Instructions in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. (Alice Corp. Preliminary Examination Instructions) and the Revised Patent Subject Matter Eligibility Guidance (See, Federal Register, vol. 84, No. 4, January 7, 2019).
Response to Arguments
Applicants’ arguments filed August 21, 2026 have been fully considered but they are not persuasive. Applicants essentially asserts: (a) claims 18-24 depend from claim 1, which the Office has not found ineligible; such that a dependent claim cannot be ineligible where its parent is eligible (Applicant Remarks, Section A, pg.15, last full paragraph through pg. 16, second full paragraph); (b) claims 18-24 require additional steps (e.g., claim 1 recites obtaining libraries, mixing probes with a sample, enzymatically ligating a splinting site of a first library probe, amplifying a template to produce amplicons, and sequencing the amplicons), where these steps are not mental process and they are not mathematical concepts, but they are physical manipulations, such that the analysis is integrated into a practical application, the detection of a target in a sample (Applicant Remarks, Section B, pg. 16, last partial paragraph through pg. 17, first full paragraph); (c) the additional elements are not well-understood, routine or conventional as indicated by Pramoditha, which was published in 2023 and post-dates the instant application (Applicant Remarks, pg. 17, Section C, through pg. 18, first partial paragraph); and (d) the rejection contains findings that do not correspond to the present claims (Applicant Remarks, pg. 18, first full paragraph).
Regarding (a), Applicant is respectfully reminded that, as stated in MPEP § 2106.07, subject matter eligibility is evaluated on a claim-by-claim basis. MPEP § 2106.07 states:
The evaluation of whether the claimed invention qualifies as patent-eligible
subject matter should be made on a claim-by-claim basis, because claims do not automatically rise or fall with similar claims in an application. For example, even if an independent claim is determined to be ineligible, the dependent claims may be eligible because they add limitations that integrate the judicial exception into a practical application or amount to significantly more than the judicial exception recited in the independent claim. And conversely, even if an independent claim is determined to be eligible, a dependent claim may be ineligible because it adds a judicial exception without also adding limitations that integrate the judicial exception or provide significantly more. Thus, each claim in an application should be considered separately based on the particular elements recited therein (underline added).
Therefore, dependent claims 14, 15 and 17-24 can be patent ineligible even though these claims depend from instant claim 1. Thus, the claims remain rejected.
Regarding (b), contrary to Applicant’s assertion, claim 1 does not recite what Applicant asserts, including: enzymatically ligating a splinting site of a first library probe and/or detecting a target in a sample. As already indicated, claim 1 is not rejected under 35 USC 101. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). In the instant case, the preamble of claim 1 is not given patentable weight because it merely recites the purpose of a process. Instant claim 1 (as a whole) simply recites well-understood, routine, and/or conventional activities previously known to the industry, and specified at a high level of generality. Instant claims 14, 15 and 17-24 append an abstract idea to well-understood, routine, and conventional activities (e.g., obtaining a library of probes; mixing probes libraries together; ligating a library of probes; performing amplification; and sequencing). Moreover, the steps as recited in instant claims are well-known, purely conventional or routing in the art as evidenced by Boulgakov, Arora, Samusik and Bava. Instant claims 14, 15 and 17-24 do not integrate the method into a practical application of the judicial exception. Thus, the claims remain rejected.
Regarding (c), as indicated in MPEP § 2124, in certain circumstances evidentiary references can be used which post-date the application’s filing date. For instance,
In certain circumstances, references cited to show a universal fact need not be available as prior art before applicant’s filing date. In re Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA 1962). Such facts include the characteristics and properties of a material or a scientific truism. Some specific examples in which later publications showing factual evidence can be cited include situations where the facts shown in the reference are evidence "that, as of an application’s filing date, undue experimentation would have been required, In re Corneil, 347 F.2d 563, 568, 145 USPQ 702, 705 (CCPA 1965), or that a parameter absent from the claims was or was not critical, In re Rainer, 305 F.2d 505, 507 n.3, 134 USPQ 343, 345 n.3 (CCPA 1962), or that a statement in the specification was inaccurate, In re Marzocchi, 439 F.2d 220, 223 n.4, 169 USPQ 367, 370 n.4 (CCPA 1971), or that the invention was inoperative or lacked utility, In re Langer, 503 F.2d 1380, 1391, 183 USPQ 288, 297 (CCPA 1974), or that a claim was indefinite, In re Glass, 492 F.2d 1228,1232 n.6, 181 USPQ 31, 34 n.6 (CCPA 1974), or that characteristics of prior art products were known, In re Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA 1962)." In re Koller, 613 F.2d 819, 824 n.5, 204 USPQ 702, 706 n.5 (CCPA 1980) (quoting In re Hogan, 559 F.2d 595, 605 n.17, 194 USPQ 527, 537 n.17 (CCPA 1977) (emphasis in original)). See also Amgen Inc. v. Sanofi, 872 F.3d 1367, 1375, 124 USPQ2d 1354, 1359 (Fed. Cir. 2017).
In addition to the other cited references, the additional elements are well-understood, routine or conventional in the art including dimensionality reduction techniques such as PCA and t-SNE are known in the art as evidenced by Arora (US10740656) issued on August 11, 2020 (effective filing date, September 19, 2018). Thus, the claims remain rejected.
Regarding (d), the typographical error referred to by Applicant has been deleted. The claims remain rejected.
New Objections/Rejections
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and
103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for
the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over Mikkelsen et al. (hereinafter “Mikkelsen”) (US Patent Application Publication 20200239874; published July 30, 2020; effective filing date February 12, 2019) in view of Alexander Boulgakov (hereinafter “Boulgakov”) (Dissertation, The University of Texas at Austin, Austin, TX, 2019, 1-292) as evidenced by Anderson et al. (hereinafter “Anderson”) (Nano Letters, 2010, 10, 788-792; of record); and Rukshan Pramoditha (hereinafter “Pramoditha”) (Data Science, 2023, 1-24; of record). This is a new rejection necessitated by amendment of the claims in the response filed 08-21-2026.
Regarding claim 1, Mikkelsen teaches a method of analyzing a sample comprising a nucleic acid molecule, comprising: (a) providing: (i) a sample comprising said nucleic acid molecule comprising a first target region and a second target region (interpreted as binding moieties), wherein said first target region and said second target region are disposed on a same strand of said nucleic acid molecule; (ii) a first probe comprising a first probe sequence and a second probe sequence, wherein said first probe sequence of said first probe is complementary to said first target region of said nucleic acid molecule; and (iii) a second probe comprising a third probe sequence, wherein said third probe sequence of said second probe is complementary to said second target region of said nucleic acid molecule; (b) subjecting said sample to conditions sufficient to (i) hybridize said first probe sequence of said first probe to said first target region of said nucleic acid molecule, and (ii) hybridize said third probe sequence of said second probe to said second target region of said nucleic acid molecule to yield a probe-associated nucleic acid molecule; (c) subjecting said probe-associated nucleic acid molecule to conditions sufficient to yield a probe-linked nucleic acid molecule comprising said first probe linked to said second probe; and (d) within a partition, attaching a barcode sequence to said probe-linked nucleic acid molecule (interpreted as mixing first probes and second probes with a sample; binding the first probes and second probes to the sample; and barcoding, claim 1) (paragraph [0042]). Mikkelsen teaches that a barcode nucleic acid molecule can be phosphorylated at the 5' end and can associate with the ribonucleotides via a splint molecule, wherein the can then be ligated to the 3' end of the probe (interpreting a probe to comprise a splint site) (paragraph [0153]). Mikkelsen teaches that (b) comprises performing a nucleic acid reaction including, wherein (b) and (c) can comprise performing an enzymatic ligation reaction or an extension reaction; performing the extension reaction and the enzymatic ligation reaction, wherein the nucleic acid reaction comprises using an enzyme selected from the group consisting of T4 RNL2, KOD ligase, SplintR, PBCV1, DNA polymerase, and Mu polymerase, or a derivative thereof (interpreting hybridizing probes to a target region to comprise ligation, claim 1) (paragraphs [0025]; and [0054]). Mikkelsen teaches that the method further comprises: (i) providing a splint oligonucleotide comprising a first sequence complementary to said second probe sequence and a second sequence, and (ii) subjecting said partition to conditions sufficient to hybridize said first sequence of said splint oligonucleotide to said second probe sequence (interpreted as mixing probes; probes comprising a first binding region are hybridized to probes comprising a second binding region through a splint sequence, claim 1) (paragraph [0046], lines 2-6). Mikkelsen teaches that the method can comprise one or more ligation-mediated reactions (interpreted as splint ligation, claim 1) (paragraph [0114], lines 4-5). Mikkelsen teaches that a probe sequence of the probe can be capable of hybridizing with a sequence of a nucleic acid barcode molecule, which can comprise a first binding sequence that is complementary to a probe sequence of the probe (e.g., a second probe sequence), a barcode sequence, and a second binding sequence and/or one or more additional functional sequences selected from the group consisting of primer sequences, primer annealing sequences, and immobilization sequences, wherein the binding sequences can have any useful length and other characteristics (interpreting probe sequences to be random, claim 1) (paragraph [0131], lines 1-11).Mikkelsen teaches that Figure 17 shows an alternative method barcoding nucleic acid probes using adaptor nucleic acid molecules, wherein Panel 17A shows a nucleic acid molecule 1700 comprising a target region 1702, wherein nucleic acid molecule 1700 is an mRNA molecule comprising a poly A sequence at its 3' end; and probe 1706 comprises probe sequences 1708 and adaptor sequences 1710, such that probe sequence 1708 of probe 1706 is complementary to target region 1702; and Panel 17B shows probe sequence 1708 of probe 1706 hybridized to target region 1702, wherein an adaptor nucleic acid molecule 1712 comprises a sequence 1714 that hybridizes with the adaptor sequence 1710 of the nucleic acid probe 1706, and modular sequences 1716, 1718, such that modular sequences 1716, 1718 can comprise, for example, a PCR primer sequence, a barcode, a constant sequence, and/or any variants or derivatives thereof (interpreted as a probe comprising a target sequence, a primer binding sequence, a barcode, and a splint region, claim 1) (paragraph [0171], lines 1-16; and Figure 17A-B). Mikkelsen teaches in Panel 17C schematically shows a method of barcoding the probe nucleic acid 1706, wherein a barcode nucleic acid molecule 1720 comprises a hybridization sequence 1722 that hybridizes with the adaptor nucleic acid molecule 1712 and a barcode sequence 1724, such that hybridization of the barcode nucleic acid molecule can occur prior to or during partitioning, such that following hybridization, other nucleic acid reactions can be performed, such as extension using DNA polymerase, to generate double-stranded, barcoded, nucleic acid probes (not shown), wherein subsequent amplification and sequencing can be performed (interpreted as amplification and sequencing, claim 1) (paragraph [0171], lines 16-26; and Figure 17C). Mikkelsen teaches subjecting said barcoded nucleic acid molecule to conditions sufficient to conduct an amplification reaction to generate an amplification product, which amplification product comprises nucleic acid molecules comprising said sequence corresponding to said first probe, said sequence corresponding to said second probe, and said sequence corresponding to said barcode sequence (interpreted as amplifying using a primer binding site, claim 1) (paragraph [0045], lines 20-27). Mikkelsen teaches that an adapter molecule, in some cases, can be any useful nucleic acid sequence and can include, for example, a sequencing primer site, a barcode sequence, a transposition site, a restriction site, a unique molecular identifier, a binding sequence, and any/or derivatives, variations, or combinations thereof (interpreted as probes comprising adapter sequence comprising a barcode, primer binding site, etc., claim 1) (paragraph [0104], lines 7-12). Mikkelsen teaches that said amplification reaction is performed within said partition, wherein the method further comprises recovering said amplification product from said partition, and/or said amplification reaction is performed outside of said partition, wherein the method further comprises sequencing said amplification product or a derivative thereof (interpreted as amplification and sequencing, claim 1) paragraph [0045], lines 21-28 and 34-42). Mikkelsen teaches that a probe sequence of a probe (e.g., a probe of a probe-linked nucleic acid molecules) can comprise a barcode molecule; wherein the barcode molecule can comprise a first binding sequence that is complementary to a probe sequence of a probe (e.g., a second probe sequence), a barcode sequence, and a second binding sequence, wherein the binding sequence of a probe, a barcode nucleic acid, or both can be known and can bind to a target of interest, while in some cases, the binding sequence can be degenerate (i.e., randomly generated) (interpreting probe binding sequences to be random sequences, claim 1) (paragraph [0052], lines 1-12).
Regarding claim 2, Mikkelsen teaches that unhybridized probes can be optionally removed using, e.g., one or more washing steps and/or enzymatic digestion reactions, wherein Panel 9B shows
nucleic acid barcode molecule 910 comprising binding sequence 912, adapter sequence 916 and barcode sequence 914 which optionally can comprise a UMI sequence); and binding sequence 912 has a sequence complementary to probe sequence 908 and hybridizes thereto, such that adapter sequence 916 can comprise one or more functional sequences (e.g., a primer sequence/primer binding sequence, a sequencing primer sequence ( e.g., R1 or R2), a partial sequencing primer sequence (e.g., partial R1 or partial R2), a sequence configured to attach to the flow cell of a sequencer (e.g., P5 or P7, or partial sequences thereof), a barcode sequence, UMI sequence, or complements of these sequences) (interpreted as washing to remove probes not bound to the target sequence, claim 2) (paragraph [0134], lines 722; and Figure 9).
Regarding claims 3 and 7, Mikkelsen teaches in Panel 21E, a probe-linked, barcoded nucleic acid molecule (interpreting the binding moiety to be a nucleic acid; and binds to an organic substrate, claims 3 and 7) (paragraph [0090]; and Figure 21E).
Regarding claim 4, Mikkelsen teaches that the binding sequence of a probe, a barcode nucleic acid, or both can be known and can bind to a target of interest, while in some cases, the binding sequence can be degenerate (i.e., randomly generated) (interpreting probe binding sequences to be random sequences, claim 4) (paragraph [0052], lines 1-12).
Regarding claim 5, Mikkelsen teaches that the nucleic acid barcode molecule further comprises a unique molecular identifier sequence, a sequencing primer sequence, and/or a partial sequencing primer sequence (interpreted as a unique primer binding sequence, claim 5) (paragraph [0047], lines 1-4).
Regarding claim 6, Mikkelsen teaches that a barcode can be unique (interpreted as a unique barcode, claim 6) (paragraph [0099], lines 8-9).
Regarding claims 8, 9 and 12, Mikkelsen teaches in Figure 24, the length of each of the single-stranded multiplex splint sequences are equivalent to 7-8 base pairs (interpreted as single-stranded splint sequences, approximately 8 nucleotides in length on each arm, claims 8, 9 and 12) (Figure 24).
Regarding claim 10, Mikkelsen teaches the method of any one of embodiments 1-3, further comprising (i) providing a splint oligonucleotide comprising a first sequence that is complementary to said second probe sequence and a second sequence, and (ii) subjecting said partition to conditions sufficient to hybridize said first sequence of said splint oligonucleotide to said second probe sequence of said first probe (interpreting the splint comprising a first and second region that are complementary to the first and second splint sites of the probes, claim 10) (paragraph [0391]).
Regarding claim 11, Mikkelsen teaches, (c) comprises performing an enzymatic ligation reaction and/or an extension reaction comprising the use of an enzyme selected from the group consisting of T4 RNL2, SplintR, T4 DNA ligase, KOD ligase, PBCV1, DNA polymerase, and Mu polymerase (interpreted as using T4 DNA ligase, claim 11) (paragraph [0054], lines 1-6).
Regarding claim 13, Mikkelsen teaches that a target region can comprise, for example, at least 10 bases, such as at least 20, 25, 30, 35, 40, 45, 50, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 250, 300, 350, 400, 450, 500, or more base (interpreted as an amplicon at least 180 nucleotide in length, claim 13) (paragraph [0123], lines 2-8). Mikkelsen teaches that barcoded nucleic acid molecules can be analyzed by any suitable technique, including nucleic acid sequencing (e.g., Illumina sequencing) (interpreted as amplicons >180 nucleotides, claim 13) (paragraph [0137], last 4 lines).
Regarding claims 14 and 16, Mikkelsen teaches that barcodes can allow for identification and/or quantification of individual sequencing-reads (interpreted as identifying and quantifying sequencing data; and extracted sequences comprise barcode sequences, claims 14 and 16) (paragraph [0099], last 2 lines).
Regarding claim 15, Mikkelsen teaches that “sequencing” refers to methods and technologies for determining the sequence of nucleotide bases in one or more polynucleotides, where such systems can provide a plurality of raw genetic data corresponding to the genetic information of a subject (e.g., human), as generated by the systems from a sample provided by the subject; as well as, such systems provide sequencing reads (also "reads" herein), wherein a read can include a string of nucleic acid bases corresponding to a sequence of a nucleic acid molecule that has been sequenced (interpreted as extracting sequences, claim 15) (paragraph [0105], lines 2-4 and 15-22).
Regarding claim 17, Mikkelsen teaches that adapter sequence 1322 comprises a UMI such that digested product from rolling circle amplification will each comprise a UMI to identify the probe 1305 of origin (interpreted as sequences comprises binding moiety sequences, claim 17) (paragraph [0177], last 4 lines).
Mikkelsen does not specifically exemplify determining K-mers (claim 18); calculating p-value (claim 19); translating quantitative results into a graphic pattern (claim 20); where the graphic pattern represents a p-value of the k-mer (claim 21); comparing graphical patterns to a reference to identify a target (claim 22); processing data using a dimensionality reduction algorithm (claim 23); and wherein the dimensionality reduction algorithm is PCA or t-SNE (claim 24).
Regarding claims 18 and 19, Boulgakov teaches that proximity ligation assays (Weibrecht et al. 2010) are one of the technologies that leverage oligonucleotides, and our abilities to manipulate them, to detect spatial co-localization of molecules, wherein a pair of proximity probes, usually antibodies, are conjugated to oligonucleotides and then incubated with the sample of interest, such that if two labeled probe targets are in sufficiently close proximity to each other, for example in the case of two proteins participating in the same complex, the pair of conjugated oligonucleotides are able to ligate and create a contiguous template that can then be amplified by (often circular) PCR, whose products can then in turn be visualized by fluorescent probes; and that while proximity ligation is traditionally performed with one ligation step and thus captures only the pairwise proximity of individual probe pairs across the sample, the concept of proximity ligation is extended to iterative rounds of reversible ligations on a population of barcoded DNA molecules, allowing us to capture information about the relative positions not only of paired probes in isolation but of the entire population as a whole(pg. 171, last full paragraph). Boulgakov teaches that a rudimentary analysis of k-mer distribution was performed in the UOI regions of the oligonucleotides, wherein some k-mers occurred much more frequently than others, wherein for example, the 5-mer ATACA was the most frequently occurring UOI for Round 1 barcodes with 281 out of 5230 oligonucleotides containing it (5.4%), and the 5-mer GGGAG was the most frequently occurring UOI for Round 2 barcodes with 239 out of 5230 (4.6%) oligonucleotides containing it; under the assumption that all UOIs are equally probable, the chances of so many oligonucleotides carrying the same Round 1 UOIs are extremely low: for example, under the binomial model, the chances of observing a particular Round 1 UOI (out of 45 = 1024 possible ones) 281 times is:
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(interpreted as determining k-mers for each sequence; counting k-mers; calculating the p-value; and binomial distribution, claims 18 ad 19) (pg. 96, last partial paragraph). Boulgakov teaches experiments with control peptides with custom image processing algorithms; and that control oligonucleotide barcodes are provided in Table 4-1 (interpreted as providing a control, claim 18) (pg. 45, section 3.3.2; and pg. 131, Table 4-1).
Regarding claim 20, Boulgakov teaches that an image analysis pipeline was developed to perform ratiometric fluorescence sensing using common cellular phone images and an easily assembled field-deployable LEGO box, wherein pixel chromaticities for each cascade reaction were quantitatively mapped onto the CIE 1931 xyY color space and, by interpolating calibration samples, were used to infer each reaction’s analyte concentration. In essence, our device and method replace standard 96-well plate readers; and that Figure 5-4 shows a fluorescent cascade reaction chromaticity quantitatively corresponding to analyte concentration (interpreted as translating quantitative results into a graphic pattern, claim 20) (pg. 152, second 5.4; and pg. 158, Figure 5-4).
Regarding claim 21, Boulgakov teaches that using simulations, principle recover letter patterns photo-lithographed onto slide surfaces using only IPL sequencing data was demonstrated, illustrating how our technique maps complex spatial configurations into DNA sequences and then – using only this sequence information – recovers them (interpreted as the graphic pattern represents sequence information of the k-mer, claim 21) (pg. 170, Section 6-1).
Regarding claim 22, Boulgakov teaches fluorescence photo images; chromaticity for TBAF and DFP triggered self-propagating cascades, wherein Figure 5-6 shows Row 1 is a control for analyte with only probe 1 present, Row 2 is for analyte under self-propagating cascade conditions, and Row 3 is a control for interference (interpreted as comparing the graphical pattern to a control (pg. 161-162; and Figure 5-6).
Regarding claims 23 and 24, Boulgakov teaches that fluorescence recovery was recorded at ~0.20 s intervals for up to 300 frames, such that bleach correction and normalization was carried out using a custom python script (modified from http://imagej.net/Analyze_FRAP_movies_with_a_Jython _script), wherein plots were generated using the ggplot2 package in R. 3D projections were generated in Fiji or IMARIS (pg. 224, first partial paragraph), wherein PCA and t-SNE are known to be calculated in Python as evidenced by Pramoditha (pgs. 3-5). Boulgakov teaches that to measure large scale shape distortion in the layout versus the actual oligonucleotide positions, we aligned the original shape and the recovered layout; and for each node Euclidean distance between its original and recovered positions was measured (Figure 6-4B, heatmap) (interpreted as a graphic patten representing p-value or a k-mer and the sequence information, claim 21) (pg. 174, last partial paragraph; pg. 175, first partial paragraph; and Figure 6-4B). Figure 6-4B is shown below:
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“It is prima facie obvious to combine prior art elements according to known methods to yield predictable results; the court held that, "…a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950)”. Therefore, in view of the benefits of identifying and quantifying a target in a sample as exemplified by Boulgakov, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the method of analyzing target nucleic acids in a sample including by ligation reactions including reactions between entities or regions in proximity to one another using first barcoded probes and second barcoded probes bound to a target nucleic acid sequence followed by amplification; and sequencing as disclosed by Mikkelsen to include the methods of sequencing data analysis, simulation, and/or image analysis including k-mer counting, binomial distribution analysis, and/or the production of graphic patterns including using a custom Python script as taught by Boulgakov with a reasonable expectation of success in identifying and quantifying targets in a sample including nucleic acids, peptides and/or proteins; as well as, graphically illustrating the positions of the targets including target nucleic acids in a cell including a cell within an intact tissue.
Thus, in view of the foregoing, the claimed invention, as a whole, would have been obvious to one of ordinary skill in the art at the time the invention was made. Therefore, the claims are properly rejected under 35 USC §103 as obvious over the art.
Conclusion
Claims 1-24 are rejected.
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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/AMY M BUNKER/Primary Examiner, Art Unit 1684
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