DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election of 1) the Effector cell and FDC cell groups for the first gene expression signature, scored by 2) a ssGSEA technique, and 3) the Naïve B Cell and Centrocyte groups for the second gene expression signature, scored by 4) a first statistical technique in the reply filed on 1/6/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
This election encompasses claims 1-2, 9-19, 45, 48, 52 and 53. These claims are under examination to the extent they read on the elected species.
Claims 36 and 46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/6/2026.
The preliminary amendment filed 2/24/2022 was entered.
The original drawings (other than Figs 9 and 12) filed 12/10/2021, and the replacement drawings of Fig 9 and Fig 12 filed 2/24/2022, are suitable for examination.
The executed OATH filed 2/24/2022 has been entered.
This application claims priority to a US provisional application, filed 12/11/2020. However, this provisional application does not provide support for the elected groups of Naïve B cell gene expression data and centrocyte group gene expression data, using the specific genes associated with those groups as illustrated in claim 12. As such, the effective filing date for the elected species is 12/10/2021.
This application has published as US PG-Pub 2022/0186318 A1, 6/16/2022.
Multiple IDS statements have been entered and considered. Please see the annotated copies, included.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See at least p28.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation (BRI) using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
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 1-2, 9-19, 36, 45, 48, 52 and 53 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of mental steps, mathematic concepts, organizing human activity, or a natural law without significantly more.
Applicant is directed to MPEP 2106 and the Federal Register notice (FR89, no 137 (7/17/2024) p 58128-58138) for the most current and complete guidelines in the analysis of patent- eligible subject matter. The current MPEP is the primary source for the USPTO’s patent eligibility guidance.
With respect to step (1): YES, the claims are drawn to statutory categories: Processes, a computer system, and a computer program product comprising instructions.
With respect to step (2A) (1): YES, the claims recite an abstract idea, law of nature and/or natural phenomenon. The claims explicitly recite elements that, individually and in combination, constitute one or more judicial exceptions (JE).
Mathematic concepts, Mental Processes or Elements in Addition (EIA) in the claim(s) include:
1. (Original) A method for determining a follicular lymphoma (FL) tumor microenvironment (TME) type for a subject having, suspected of having, or at risk of having a follicular lymphoma (FL), the method comprising:
using at least one computer hardware processor to perform:
(EIA: preamble, setting forth the method, and the goal of the method. EIA: using a routine computer processor.)
(a) obtaining RNA expression data for the subject, the RNA expression data indicating first RNA expression levels for genes in a first plurality of gene groups and second RNA expression levels for genes in a second plurality of gene groups different from the first plurality of gene groups, wherein genes in the second plurality of gene groups are associated with B cells;
(EIA: step of data gathering, of a type of data, in two groups, by any means.)
(b) generating an FL TME signature for the subject using the RNA expression data, the FL TME signature comprising:
a first gene expression signature comprising first gene group expression scores for respective gene groups in the first plurality of gene groups, and
a second gene expression signature comprising second gene group expression scores for respective gene groups in the second plurality of gene groups associated with B cells,
the generating comprising:
determining the first gene expression signature by determining the first gene group expression scores using the first RNA expression levels, and
determining the second gene expression signature by determining the second gene group expression scores using the second RNA expression levels; and
(Mathematic concept of scoring the gene expression levels for each group of genes. MPEP 2106.04(a)(2) subgroup I. Scoring defined in specification for First group = GSEA, ssGSEA p6, p37; Second group = first statistical model/ “initial score as a dot product…” p7, “logistic regression” p21; “generalized linear model” p39)
(c) identifying, using the FL TME signature and from among a plurality of FL TME types, an FL TME type for the subject.
(Mental Process of observing a signature and making a judgement as to the FL TME type by qualitative characteristics: Specification, p47 and p61 (MPEP 2106.04(a) subsection III); or alternatively, a Mathematic Concept of mathematically clustering signature data, and performing distance or other calculated metric to classify the FL TME type. Specification, P46; (MPEP 2106.04(a) subsection I.))
52. (Original) A system, comprising:
at least one computer hardware processor; and
at least one computer-readable storage medium storing processor-executable instructions that, when executed by the at least one computer hardware processor, cause the at least one computer hardware processor to perform a method for determining a follicular lymphoma (FL) tumor microenvironment (TME) type for a subject having, suspected of having, or at risk of having a follicular lymphoma (FL), the method comprising: [See analysis of claim 1]
(EIA- routine computer system, described at a high level of generality.)
53. (Original) At least one computer-readable storage medium storing processor-executable instructions that, when executed by at least one computer hardware processor, cause the at least one computer hardware processor to perform a method for determining a follicular lymphoma (FL) tumor microenvironment (TME) type for a subject having, suspected of having, or at risk of having a follicular lymphoma (FL), the method comprising: [See analysis of claim 1]
(EIA- routine computer storage medium, described at a high level of generality.)
Natural law embraced by the claim(s):
The claims correlate naturally occurring gene expression levels to naturally occurring phenotypes of a cancer, which is a gene/phenotype correlation that exists whether or not it is measured. MPEP 2106.04(b).
With respect to step 2A (2): NO, the identified judicial exception is not integrated into a practical application. (MPEP 2106.04(d)). The claimed additional elements are analyzed alone, or in combination to determine if the JE is integrated into a practical application (MPEP 2106.05(a-c, e, f and h)).
Claim(s) 1, 2, 9-15, 17-18, 26, 45, 52, 53 recite the additional non-abstract element(s) of data gathering, or a description of the data gathered.
Data gathering steps are not an abstract idea, they are extra-solution activity, as they collect the data needed to carry out the JE. The data gathering does not impose any meaningful limitation on the JE, or how the JE is performed. The additional limitation (data gathering) must have more than a nominal or insignificant relationship to the identified judicial exception. (MPEP 2106.04/.05, citing Intellectual Ventures LLC v. Symantec Corp, McRO, TLI communications, OIP Techs. Inc. v. Amason.com Inc., Electric Power Group LLC v. Alstrom S.A.).
Claim(s) 48 recite the additional non-abstract element (EIA) of selecting a treatment or prophylaxis: the treatment is not administered.
The identified treatment step fails to integrate the JE into a practical application, as the step does not “affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition” see (MPEP 2106.04(d)(2)).
Claim(s) 1, 52, 53 recite the additional non-abstract element (EIA) of a general-purpose computer system or parts thereof.
The EIA do not provide any details of how specific structures of the computer elements are used to implement the JE. The claims require nothing more than a general-purpose computer to perform the functions that constitute the judicial exceptions. The computer elements of the claims do not provide improvements to the functioning of the computer itself (as in DDR Holdings, LLC v. Hotels.com LP); they do not provide improvements to any other technology or technical field (as in Diamond v. Diehr); nor do they utilize a particular machine (as in Eibel Process Co. v. Minn. & Ont. Paper Co.). Hence, these are mere instructions to apply the JE using a computer, and therefore the claim does not recite integrate that JE into a practical application.
Dependent claim(s) 16, 19, 22, 48 recite(s) an abstract limitation to the JE reciting additional mathematic concepts, or mental processes. Additional abstract limitations cannot provide a practical application of the JE as they are a part of that JE.
In combination, the limitations of data gathering, for the purpose of carrying out the JE, using a general-purpose computer merely provide extra-solution activity, and fail to integrate the JE into a practical application.
With respect to step 2B: NO, the claims do not provide a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). The additional elements were considered individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to claim(s) 1, 2, 9-15, 17-18, 26, 45, 52, 53: The limitation(s) identified above as non-abstract elements (EIA) related to data gathering do not rise to the level of significantly more than the judicial exception.
Garraway et al (US 2018/0100201 A1) obtains RNA-seq data to assess tumor and tumor microenvironment gene expression at least at [0016, 0081, 0170, 0207 et al.] including obtaining from TCGA databases at [0098].
Bagaev et al. (US 2018/0357378 A1) obtains RNA expression data of multiple types, to classify tumor types, including whole exome sequencing, total RNA, mRNA, targeted sequencing, deep RNA sequencing etc. [0008, 0173, 0188, 0191 et al.] including obtaining the data from database sources at [0197].
Bowden et al. (US 10,900,086 B2) obtains RNA expression data from tumor, and tumor microenvironment to diagnose and prognose a type of cancer, by mRNA sequencing, Gene expression profiling, microarray, RNA-seq, at col 35-36.
These elements meet the BRI of the identified data gathering limitations. As such, the prior art recognizes that this data gathering element is routine, well understood and conventional in the art (as in Alice Corp., CyberSource v. Retail Decisions, Parker v. Flook).
In the specification at [p27-32] it is disclosed that the steps identified as data gathering can be met using the routine, well-understood, and conventional sequencing techniques including bulk RNA sequencing (RNA-seq, scRNA-seq), whole transcriptome sequencing, total RNA sequencing, mRNA sequencing, targeted RNA sequencing, RNA exome capture sequencing, next generation sequencing, deep RNA sequencing, microarray, etc. (p28) The data can also be obtained from database sources, (p29-30).
Activities such as data gathering do not improve the functioning of a computer, or comprise an improvement to any other technical field. The limitations do not require or set forth a particular machine, they do not effect a transformation of matter, nor do they provide an unconventional step (citing McRO and Trading Technologies Int’l v. IBG). Data gathering steps constitute a general link to a technological environment. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception are insufficient to provide significantly more (as discussed in Alice Corp.,).
With respect to claim(s) 1, 52, 53: the limitations identified above as non-abstract elements (EIA) related to general-purpose computer systems do not rise to the level of significantly more than the judicial exception.
Each of Garraway, Bagaev and Bowden disclose computer systems or computing elements which meet the BRI of the claimed computer system or computer system elements, comprising input, output/ display, a processor, and memory.
As such, the prior art recognizes that these computing elements are routine, well understood and conventional in the art.
The specification, at [68-72] discloses the use of routine general-purpose computers for carrying out the invention, and/or the use of commercially available computer system elements.
These elements do not improve the functioning of the computer itself, or comprise an improvement to any other technical field (Trading Technologies Int’l v IBG, TLI Communications). They do not require or set forth a particular machine (Ultramercial v. Hulu, LLC., Alice Corp. Pty. Ltd v. CLS Bank Int’l), they do not effect a transformation of matter, nor do they provide an unconventional step. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception are insufficient to provide significantly more (as discussed in Alice Corp., CyberSource v. Retail Decisions, Parker v. Flook, Versata Development Group v. SAP America).
Dependent claim(s) 16, 19, 22, 48 each recite a limitation requiring additional mathematic concepts or mental processes. Additional abstract limitations cannot provide significantly more than the JE as they are a part of that JE (MPEP 2106.05).
In combination, the data gathering steps providing the information required to be acted upon by the JE, performed in a generic computer or generic computing environment fail to rise to the level of significantly more than that JE. The data gathering steps provide the data for the JE, which is carried out by the general-purpose computers. No non-routine step or element has clearly been identified.
The claims have all been examined to identify the presence of one or more judicial exceptions. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether the additional limitations integrate the judicial exception into a practical application. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether those additional limitations provide an inventive concept which provides significantly more than those exceptions. 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.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 9-10, 12-14, 36, 52 and 53 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Wang et al (2019).
Wang et al. Compositions and methods for evaluating and modulating immune responses. US 2019/0262399 A1, published 8/29/2019, with priority as early as 9/2017.
Applicant elected 1) the Effector cell and FDC cell groups for the first gene expression signature, scored by 2) a ssGSEA technique, and 3) the Naïve B Cell and Centrocyte groups for the second gene expression signature, scored by 4) a first statistical technique. The independent claims are not limited to these embodiments.
With respect to claim 1 and determining the TME signature for Follicular Lymphoma (FL), Wang addresses investigation of FL at [0254], and TME signatures at [0139, 0148, 0844, 0847 et al.].
With respect to claim 1 step (a), Wang obtains RNA-seq data, which can be single cell RNA-seq data, or bulk RNA sequencing data (meeting claim 2) [0134, 0139, 0145, 0148-0149, 0153, 0176, 0220] to obtain RNA-expression data, for multiple groups of genes.
With respect to claim 1 step (b) and (c), Wang determines TME signatures, by analysis of the gene expression levels of two groups of genes, one of which is associated with B cells, and scoring the levels of expression, to assess the presence or type of tumor (claim 36).
Wang uses GSEA, or other statistical techniques in the analysis. [0799, 0808 and Table 2]
Wang discloses the following genes, corresponding to the following groups:
Effector cell genes: IFNG, EOMES, TBX21, CD8A
FDC: SERPINE2, LTBR, BST1
B cells: CD200, CD27, IRF4, KIF18A, ENTPD1
Centrocytes: DNAJB9, ENTPD1
As such claims 9-10, 12-14 are anticipated.
With respect to claim 16, Wang uses a gene set enrichment analysis (GSEA) in scoring at least one group.
With respect to claims 52-53, computer-implementation and instructions are provided throughout.
Claim(s) 1-2, 9-10, 12-14, 52 and 53 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Garraway et al. (2018)
Garraway et al. Tumor and microenvironment gene expression, compositions of matter and methods of use thereof. US 2018/0100201 A1, published 4/2018, with priority to at least 12/2017.
Applicant elected 1) the Effector cell and FDC cell groups for the first gene expression signature, scored by 2) a ssGSEA technique, and 3) the Naïve B Cell and Centrocyte groups for the second gene expression signature, scored by 4) a first statistical technique. The independent claims are not limited to these embodiments.
With respect to claim 1 and determining the TME signature for Lymphoma, Garraway addresses investigation of lymphomas in general at [0014, 0016], and TME signatures at [0098, 0161-0173, et al.].
With respect to claim 1 step (a), Garraway obtains RNA-seq data, which can be single cell RNA-seq data, or bulk RNA sequencing data (meeting claim 2) [0013, 0016, 0020, 0081, 0095, 0098, 0128-0129 et al.] to obtain RNA-expression data, for multiple groups of genes.
With respect to claim 1 step (b) and (c), Gallaway determines TME signatures, by analysis of the gene expression levels of two groups of genes, one of which is associated with B cells, and scoring the levels of expression, to assess the presence or type of tumor.
Gallaway uses GSEA, or other statistical techniques in the analysis. [GSEA: 0706, Z-score 0096, cell type scores, cytotoxic scores, exhaustion scores 0099-0100 et al.]
Gallaway discloses the following genes, corresponding to the following groups:
Effector cell genes: GZMK, PRF1, ZAP70, CD8A, CD8B
FDC: CLU, PRNP, C4A, serpine2, C1S
B cells: CD200, CD27, NAAA, SIGLEC6, IRF4, KIF18A
Centrocytes: DHRS9, EGR3, DNAJB9, AHNAL, ENTPD1
As such claims 9-10, 12-14 are anticipated.
With respect to claim 16, Gallaway uses a gene set enrichment analysis (GSEA) in scoring at least one group.
With respect to claims 52-53, computer-implementation and instructions are provided throughout.
Claim(s) 1-2, 9-19, 26, 36, 52, 53 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Bagaev et al (2018).
Bagaev, et al. Systems and methods for generating, visualizing and classifying molecular functional profiles. US 2018/0357378 A1, published 12/2018, with priority to at least 6/2018.
Applicant elected 1) the Effector cell and FDC cell groups for the first gene expression signature, scored by 2) a ssGSEA technique, and 3) the Naïve B Cell and Centrocyte groups for the second gene expression signature, scored by 4) a first statistical technique. The independent claims are not limited to these embodiments.
With respect to claim 1 and determining the TME signature for Follicular Lymphoma (FL), Bagaev addresses investigation of FL at [0220, 0222], and TME signatures at [0008, 0011, 0013, 0017, 0184 et al.].
With respect to claim 1 step (a), Bagaev obtains RNA-seq data, which can be single cell RNA-seq data, or bulk RNA sequencing data (meeting claim 2) [0008-0047, 0168, 0173, 0191, 0360 et al.] to obtain RNA-expression data, for multiple groups of genes.
With respect to claim 1 step (b) and (c), Bagaev determines TME signatures, by analysis of the gene expression levels of two groups of genes, one of which is associated with B cells, and scoring the levels of expression, to assess the presence or type of tumor (claim 36).
Bagaev uses GSEA, ssGSEA, in the analysis. [0156, 0193, 0196, 0361, 0445, 0448, 0467, et al.] or other scoring methods [enrichment score 0103, functional process scores 0122-0123, Z-scores 0137, 0153-0155 et al.].
Bagaev discloses the following groups: [0033, 0217] a gene group expression level for each gene group in a first set of gene groups associated with cancer malignancy, proliferation rate group, the tumor suppressors group, the metastasis signature group, the anti-metastatic factors group, and the mutation status group; and determining, a gene group expression level for each gene group in a second set of gene groups associated with cancer microenvironment and consisting of the MHCI group, the MHCII group, the effector cells group, the T cell traffic group, the T cells group, the B cells group, the M1 signatures group, the Th1 signature group, the antitumor cytokines group, the Treg group, the MDSC group, the granulocytes group, the M2 signature group, the Th2 signature group, the protumor cytokines group, the cancer associated fibroblasts group, the angiogenesis group, and the complement inhibition group…
Bagaev discloses determining the expression levels of at least three genes from the following groups:
Effector cells module: IFNG, GZMA, GZMB, PRF1, LCK, GZMK, ZAP70, GNLY, FASLG, TBX21, EOMES, CD8A, and CD8B;
Effector T cell module: IFNG, GZMA, GZMB, PRF1, LCK, GZMK, ZAP70, GNLY, FASLG, TBX21, EOMES, CD8A, and CD8B
Follicular dendritic cells module: CR1, FCGR2A, FCGR2B, FCGR2C, CR2, FCER2, CXCL13, MADCAM1, ICAM1, VCAM1, BST1, LTBR, and TNFRSF1A;
B cells module: CD19, MS4A1, TNFRSF13C, CD27, CD24, CR2, TNFRSF17, TNFRSF13B, CD22, CD79A, CD79B, BLK, FCRL5, PAX5, and STAP1;
B cell traffic module: CXCL13 and CXCR5;
Benign B cells module: CD19, MS4A1, TNFRSF13C, CD27, CD24, CR2, TNFRSF17, TNFRSF13B, CD22, CD79A, CD79B, and BLK;
Malignant B cell marker module: MME, CD70, CD20, CD22, and PAX5
Centrocytes: FCER2
Major histocompatibility complex I (MHCI) module: HLA-A, HLA-B, HLA-C, B2M, TAP1, and TAP2;
Major histocompatibility complex II (MHCII) module: HLA-DRA, HLA-DRB1, HLA-DOB, HLA-DPB2, HLA-DMA, HLA-DOA, HLA-DPA1, HLA-DPB1, HLA-DMB, HLA-DQB1, HLA-DQA1, HLA-DRB5, HLA-DQA2, HLA-DQB2, and HLA-DRB6;
T cell traffic module: CXCL9, CXCL10, CXCR3, CX3CL1, CCR7, CXCL11, CCL21, CCL2, CCL3, CCL4, and CCL5;
T cells module: EOMES, TBX21, ITK, CD3D, CD3E, CD3G, TRAC, TRBC1, TRBC2, LCK, UBASH3A, TRAT1, CD5, and CD28
Regulatory T cells (Treg) module: TGFB1, TGFB2, TGFB3, FOXP3, CTLA4, IL10, TNFRSF18, TNFR2, and TNFRSF1B;
Treg traffic module: CCL17, CXCL12, CXCR4, CCR4, CCL22, CCL1, CCL2, CCL5, CXCL13, and CCL28
M1 signatures module: NOS2, IL12A, IL12B, IL23A, TNF, IL1B, and SOCS3;
M2 signature module: IL10, VEGFA, TGFB1, IDO1, PTGES, MRC1, CSF1, LRP1, ARG1, PTGS1, MSR1, CD163, and CSF1R
Th1 signature module (CD4+): IFNG, IL2, CD40LG, IL15, CD27, TBX21, LTA, and IL21;
Th2 signature module (CD8+): IL4, IL5, IL13, IL10, IL25, and GATA3;
Follicular B helper T cells module: CXCR5, B3GAT1, ICOS, CD40LG, CD84, IL21, BCL6, MAF, and SAP;
Proliferation rate (or Tumor proliferation rate) module: MKI67, ESCO2, CETN3, CDK2, CCND1, CCNE1, AURKA, AURKB, E2F1, MYBL2, BUB1, PLK1, PRC1, CCNB1, MCM2, MCM6, CDK4, and CDK6
Lymphatic endothelium module: VEGFA, NOS3, KDR, FLT1, VCAM1, VWF, CDH5, and MMRN1, CCL21 and CXCL12
Oncogenes: MDM2, MYC, AKT1, BCL2, MME, and SYK
As such claims 9-15, 17-18 are anticipated.
With respect to claim 16-17, Bagaev uses a single sample gene set enrichment analysis (ssGSEA) in scoring at least one group [0156]. Vector and dot product analysis is disclosed at [0156, Table 1, 0470] meeting claim 19 and 26.
With respect to claims 52-53, computer-implementation and instructions are provided throughout.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 9-19, 36, 45, 48, 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,311,967 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims identify cancer relevant phenotypes, using sets of RNA-seq data from patient tumor and tumor microenvironment samples, which include the cell types elected in the instant application for follicular lymphoma. FL is a type of cancer.
Claims 1-2, 9-19, 36, 45, 48, 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,395,761 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims identify cancer relevant phenotypes, using sets of RNA-seq data from patient tumor and tumor microenvironment samples, which include the cell types elected in the instant application for follicular lymphoma. FL is a type of cancer.
Claims 1-2, 9-19, 36, 45, 48, 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,580,517 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims identify cancer relevant phenotypes, using sets of RNA-seq data from patient tumor and tumor microenvironment samples, which include the cell types elected in the instant application for follicular lymphoma. FL is a type of cancer.
Claims 1-2, 9-19, 36, 45, 48, 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,650,911 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims identify cancer relevant phenotypes, using sets of RNA-seq data from patient tumor and tumor microenvironment samples, which include the cell types elected in the instant application for follicular lymphoma. FL is a type of cancer.
Claims 1-2, 9-19, 36, 45, 48, 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,302,420 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims identify cancer relevant phenotypes, using sets of RNA-seq data from patient tumor and tumor microenvironment samples, which include the cell types elected in the instant application for follicular lymphoma. FL is a type of cancer.
Claims 1-2, 9-19, 36, 45, 48, 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,322,226 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims identify cancer relevant phenotypes, using sets of RNA-seq data from patient tumor and tumor microenvironment samples, which include the cell types elected in the instant application for follicular lymphoma. FL is a type of cancer.
Claims 1-2, 9-19, 36, 45, 48, 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,367,509 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims identify cancer relevant phenotypes, using sets of RNA-seq data from patient tumor and tumor microenvironment samples, which include the cell types elected in the instant application for follicular lymphoma. FL is a type of cancer.
Claims 1-2, 9-19, 36, 45, 48, 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,430,545 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims identify cancer relevant phenotypes, using sets of RNA-seq data from patient tumor and tumor microenvironment samples, which include the cell types elected in the instant application for follicular lymphoma. FL is a type of cancer.
Claims 1-2, 9-19, 36, 45, 48, 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,984,200 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims identify cancer relevant phenotypes, using sets of RNA-seq data from patient tumor and tumor microenvironment samples, which include the cell types elected in the instant application for follicular lymphoma. FL is a type of cancer.
Claims 1-2, 9-19, 36, 45, 48, 52 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,205,675 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims identify cancer relevant phenotypes, using sets of RNA-seq data from patient tumor and tumor microenvironment samples, which include the cell types elected in the instant application for follicular lymphoma. FL is a type of cancer.
Claims 1-2, 9-19, 36, 45, 48, 52 and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/474113 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because Both sets of claims identify gene expression data for at least three genes for at least a subset of the gene groups, to identify a tumor microenvironment for a patient with cancer. The instant application is directed to follicular lymphoma, while the ‘113 is not limited to cancer type.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 9-19, 36, 45, 48, 52 and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 17/733,941 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because Both sets of claims identify gene expression data for at least three genes for at least a subset of the gene groups, to identify a tumor microenvironment for a patient with cancer. The instant application is directed to follicular lymphoma and is generic to ML algorithms, while the ‘941 is not limited to cancer type.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 9-19, 36, 45, 48, 52 and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-40 of copending Application No. 18/628,544 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because Both sets of claims identify gene expression data for at least three genes for at least a subset of the gene groups, to identify a tumor microenvironment for a patient with cancer. The instant application is directed to follicular lymphoma, while the ‘544 is not limited to cancer type.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 9-19, 36, 45, 48, 52 and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-40 of copending Application No. 17/699018 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because Both sets of claims identify gene expression data for at least three genes for at least a subset of the gene groups, to identify a tumor microenvironment for a patient with cancer. The instant application is directed to follicular lymphoma, while the ‘018 is not limited to cancer type.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/MARY K ZEMAN/ Primary Examiner, Art Unit 1686