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. Election/Restrictions Applicant’s election without traverse of species (a) NEAT1 and ( b) PD-1 in the reply filed on 2/23/26 is acknowledged. Claims 1-20 are currently pending. Claim 4 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/ 23 /26. Claims 1-3 and 5-20 have been examined to the extent that they read the elected gene expression target (NEAT1) . The additionally recited gene expression target has been withdrawn from consideration as being directed to non-elected subject matter. Prior to allowance of the claim, any non-elected subject matter that is not rejoined with any allowed elected subject matter will be required to be removed from the claims. Claim s 8 and 9 ha ve been examined to the extent that they read the elected immune checkpoint inhibitor (PD-1) . The additionally recited immune checkpoint inhibitor has been withdrawn from consideration as being directed to non-elected subject matter. Prior to allowance of the claim, any non-elected subject matter that is not rejoined with any allowed elected subject matter will be required to be removed from the claims. Priority It is acknowledged that the instant application is a 371 of international PCT Application No. PCT/ US2022 / 021377 , filed 3/22/22. Applicant’s claim for the benefit of prior-filed application s under 35 U.S.C. 119(e) or under 35 U.S .C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) a s follows: The provisional applications filed 3/22/21 and 4/01/21 do not provide sufficient support for all limitations of the invention as claimed in the instant application. See MPEP 211.05(A). The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc. , 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No. 63/163,935 , fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional application lacks support for limitations regarding sample type and additional treatment(s). Accordingly, claims 5, 6, 10-15, and 18-20 are not entitled to the benefit of the prior application. The disclosure of the prior-filed application, Application No. 63/169,392, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional application lacks support for limitations regarding sample type and additional treatment(s). Accordingly, claims 5, 6, 10-15, and 18-20 are not entitled to the benefit of the prior application. The effective filing date for claims 1-3, 7-9, 16, and 17 is considered to be 3/22/21. The effective filing date for claims 5, 6, 10-15, and 18-20 is considered to be 3/22/22. Information Disclosure Statement Information disclosure statements from 5/17/24, 11/21/24, 4/10/25, 9/02/25, and 10/21/25 have been received. IDS entry #118 from 5/17/24 has not been considered, as it is missing a year. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claim(s) 2-3 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Scope of the Claims/Nature of the Invention Claim 2 is drawn to a method for determining if a subject who has a tumor is likely to benefit from an immunotherapy treatment. In view of the recitation of "tumor", the claim broadly encompass es ANY type of tumor. It is noted that there are more than 200 different types of cancer (malignant tumors) alone. In view of the recitation of "subject", the claim encompass es both human and non-human subjects. In view of the recitation of “immunotherapy,” the claim encompasses ANY type of immunotherapy (immune checkpoint inhibitors, CAR T-cell therapy, vaccines, immune system modulators, etc.). The claim recite s a first step of obtaining a sample comprising a plurality of cells from a tumor of the subject. In view of the recitation of “sample,” the claim encompasses ANY type of sample which contains cells an d may be extracted from a tumor (i.e. blood, cerebrospinal fluid, tumor tissue, etc.) The claim recite s a second step of determining a tumor expression level of NEAT1 in the sample. This could encompass determining mRNA or protein levels of NEAT1 . The claim recite s a third step of comparing the tumor expression level of NEAT1 to a reference expression level of NEAT1. In view of the recitation of “a reference expression level,” the claim broadly encompass es comparing tumor expression level of NEAT1 to anything. This could be level of any gene in any sample type obtained from any organisms or set of organisms, with or without any cancer type or prognosis. Claim 2 recites a wherein clause stating that the tumor expression level of NEAT1 in comparison to the reference expression level of NEAT1 indicates whether the subject is likely to benefit from treatment with immunotherapy. The claim broadly encompass es a method wherein increased and decreased levels of NEAT1 in comparison to the reference expression level are indicative of a response to immunotherapy. The claim broadly encompass es a method wherein increased and decreased levels of NEAT1 in comparison to the reference expression level are indicative of no response to immunotherapy. Claim 3 is drawn to a method for determining benefit of, selecting, and administering treatment for tumors . In view of the recitation of "tumor" in claim 1 , the claims broadly encompass ANY type of tumor. It is noted that there are more than 200 different types of cancer (malignant tumors) alone. In view of the recitation of "subject", the claims encompass both human and non-human subjects. In view of the recitation of “immunotherapy,” the claim encompasses ANY type of immunotherapy (immune checkpoint inhibitors, CAR T-cell therapy, vaccines, immune system modulators, etc.). The claims recite a first step of obtaining a sample comprising a plurality of cells from a tumor of the subject . In view of the recitation of “sample,” the claim encompasses ANY type of sample which contains cells and may be extracted from a tumor (i.e. blood, cerebrospinal fluid, tumor tissue, etc.) The claims recite a second step of determining a tumor expression level of NEAT1 in the sample . This could encompass determining mRNA or protein levels of NEAT1 . The claims recite a third step of comparing the tumor expression level of NEAT1 to a reference expression level of NEAT1 . In view of the recitation of “a reference expression level,” the claims broadly encompass comparing tumor expression level of NEAT1 to anything. This could be level of any gene in any sample type obtained from any organisms or set of organisms, with or without any cancer type or prognosis. The claims recite a fourth step of selecting an immunotherapy treatment and a fifth step of administering the immunotherapy treatment. In view of the recitation of “immunotherapy treatment,” the claims broadly encompass any type of tumor immunotherapy treatment (i.e. immune checkpoint inhibitors, CAR T-cell therapy, vaccines, immune system modulators, etc.). Claim 3 recites a wherein clause stating that the tumor expression level of NEAT1 which is above the reference expression level of NEAT1 indicates likelihood of response to the immunotherapy treatment . The claims broadly encompass a method wherein any increase from the reference levels of NEAT1 is indicative of a beneficial response to immunotherapy. The claims also broadly encompass a method wherein increased levels of NEAT1 in comparison to the reference expression level are indicative of no response or poor response to immunotherapy. The claims recite a fourth step of selecting an immunotherapy treatment for a subject w ho has a level of NEAT1 above the reference level . The claims recite a fifth step of administering the immunotherapy treatment to the subject . The nature of the invention requires reliable correlations between the expression level of NEAT1 in tumors and the efficacy of ANY type of immunotherapy. Teachings in the Specification and Examples Example 1 describes a whole-transcriptome analysis of patients with either glioblastoma or melanoma undergoing anti-PD-1 therapy (par. 101-102) . NEAT1 was identified as being upregulated in glioblastoma patients with longer survival compared to those with shorter survival (Fig. 1A, Fig. 2A-B) and melanoma patients showing complete response compared to those exhibiting partial or no response (Fig. 1B, Fig. 3A-B). NEAT1 was shown to be correlated to interferon gamma-related genes (Fig. 17 and 18) and therefore indirectly with glioblastoma and melanoma patient response to immunotherapy (par. 101) . Example 2 (par. 103-114) describes transcriptomic analysis of clinical data from the Gene Expression Omnibus (GEO) datasets from Hugo et al. (2016. Genomic and Transcriptomic Features of Response to Anti-PD-I Therapy in Metastatic Melanoma. Cell, 165(1), 35-44) and Cloughesy et al. (2019. Neoadjuvant anti-PD-I immunotherapy promotes a survival benefit with intratumoral and systemic immune responses in recurrent glioblastoma. Nature medicine, 25(3), 477-486). The Hugo cohort is a population of melanoma patients whose transcriptomes were assessed before and after anti-PD-1 therapy. Th is study identified a transcriptional signature associated with anti-PD-1 resistant tumors which was referred to as IPRES (or “I nnate anti-PD-1 Resistance ” ) . In Example 2, using data from the Hugo cohort (par. 111 ; Fig. 13a ), NEAT1 was found to be significantly downregulated in patients that did not respond to immune checkpoint blockade therapy (pembrolizumab in the Hugo study) . NEAT1 was inversely correlated with IPRES (Fig. 13b) , and therefore indirectly associated with anti-PD-1 responsiveness and likelihood of survival in melanoma patients . The Cloughesy cohort is a population of glioblastoma patients separated into groups of patients treated with anti-PD-1 drug pembrolizumab before and after surgical resection of their tumor (the neoadjuvant group) or patients treated with pembrolizumab only after resection ( the adjuvant only group ) . In Example 2, t ranscriptomes were compared and NEAT1 was found to be significantly altered in long-term survivors (par. 112 ; Fig. 14 ). High NEAT1 expression was associated with likelihood of survival in IDH-negative glioblastoma patients (Fig. 15a) . The specification states that high NEAT1 expression was associated with likelihood of survival in adjuvant-only patients alone, but does not appear to show the corresponding data. Melanoma patients with high NEAT1 “trended toward” higher survival (Fig. 15b). NEAT1 “trended toward” higher expression as well in the neoadjuvant glioblastoma group compared to the adjuvant-only group (Fig. 16) . The examiner asserts that results which “trend toward” significance are not significant. State of the Art and the Unpredictability of the Art While methods of measuring biomarker expression levels are known in the art, methods of correlating expression levels with a phenotype such as cancer prognosis are highly unpredictable. The unpredictability will be discussed below. The claims are drawn to methods of selecting and administering treatment to subjects with ANY type of tumor. In view of the recitation of “tumor,” the claims broadly encompass being able to predict immunotherapy benefit in greater than 200 different types of cancer based on NEAT1 expression. However, the specification does not teach the association between NEAT1 and immunotherapy benefit for every cancer type . Xu et al. (PloS ONE. 2010 Oct 27. 5(10):e13696, pages 1-8) teaches an attempt to identify genes which could be used as indicators for cancer generally, or for groups of cancers. Xu examined genes with at least 2-fold expression change between cancerous and corresponding control tissues, across seven different cancer types (breast, colon, kidney, lung, pancreas, prostate, and stomach). Only 85 genes were differentially expressed across 3 cancer types, 19 genes were differentially expressed across four cancer types, and 5 genes were differentially expressed across five cancer types (page 5). Thus, i t is highly unpredictable as to whether the findings in the specification regarding the NEAT1 expression in tumors from melanoma and glioblastoma subjects could be extrapolated to any of the other greater than 200 different cancers known in the art. In the instant application, t he specification only provides examples of the relationship between NEAT1 expression and prognosis in patients with either melanoma tumors or glioblastoma tumors . Teachings in the prior art include correlations between prognosis and melanoma tumor expression level of NEAT1 ( International Application No. WO 2019/070755). The relationship between NEAT1 and prognosis of immunotherapy for each cancer encompassed by the claims is unpredictable and must be obtained before the skilled artisan could practice the claimed invention. The claims broadly encompass comparing tumor expression level of NEAT1 to ANY type of reference expression level. However, it is highly unpredictable if the claimed method can be practiced using ANY reference level. The claims do not set forth what the reference level is and this could be the level of any gene, in any sample type, obtained from any organism, with or without any cancer type. The teachings in the specification are limited to the comparison between treatment/response groups of NEAT1 expression from human tumor tissues samples obtained from melanoma and glioblastoma patients . Teachings in the prior art include comparison of melanoma tumor expression level of NEAT1 from subjects treated with immune checkpoint inhibitors to tumor expression levels of NEAT1 from treatment-naïve subjects ( International Application No. WO 2019/070755 ). It is highly unpredictable if NEAT1 tumor expression level which is differentially expressed between groups with higher/lower survival or higher/lower immunotherapy response will also be differentially expressed between cancer tissue samples and ANY other type of reference level encompassed by the claims. The claims are drawn to methods of selecting and administering ANY immunotherapy treatment (i.e. immune checkpoint inhibitors, CAT T therapy, cancer vaccines, etc.) or immunotherapy in combination with additional treatments (i.e. a second immune checkpoint inhibitor, resection, chemotherapy, radiation, etc.). However, the specification only provides examples of assessing NEAT1 expression in melanoma patients treated with the anti-PD-1 therapies pembrolizumab/nivolumab (par. 111 ; Hugo: pg. 3 ) and in glioblastoma patients treated with the anti-PD-1 therapy pembrolizumab before and after tumor resection (par. 112; Cloughesy: Abstract) . In the absence of evidence to the contrary, these correlations would be highly unpredictable. The instant claims broadly encompass treating cancer in a human subject or a nonhuman subject. However, the specification’s data regarding NEAT1 tumor expression level as it relates to immunotherapy is based on the analysis of samples from human subjects. Although the specification refers to data derived from Zhang et al. ( 2016. Neuron, 89(1), 37-53) , which analyzed murine as well as human cells, Zhang’s study did not include administration of immunotherapy to subjects and the instant application’s specification does describe mouse expression levels of NEAT1. The prior art teaches that there is a large amount of unpredictability with regard to comparing results from gene expression analysis in humans to even closely related animals. For example, Coleman (Drug Discovery Today. 2003. 8: 233-235) found that gene expression patterns between mice and humans shared some degree of similarity, but that the basic patterns of gene expression differed and that there was no general rule for predicting gene expression (page 234). Coleman concluded that '(t)he validity of mouse or other animal species as a human surrogate should not be assumed." These teachings of Coleman support the finding that there is no predictable means for determining whether the gene expression profile that is predictive of cancer treatment in a human subject will also be predictive of cancer treatment in a representative number of non-human subjects. The specification only provides support for the human subjects. The claims recite a correlation between expression levels of NEAT1 and likelihood of response to immunotherapy. Claim 3 specifies that this expression level is above a reference level of NEAT1, but Claim 2 does not specify if the expression level of NEAT1 is increased or decreased relative to the reference expression level. The specification only teaches that elevated NEAT1 compared to a reference level is associated with response to anti-PD-1 therapy (par. 101-102, 111). The specification does not provide support for likelihood of immunotherapy benefit in subjects with decreased expression level compared to a reference level of NEAT1. Therefore, expression signatures of ANY kind encompassed by Claim 2 (of NEAT1 relative to a reference level) are unpredictable and must be obtained before the skilled artisan could practice the claimed invention. The instant claims broadly encompass the analysis of RNA levels and protein levels. Therefore, it is relevant to point out the unpredictability as to whether or not a measure of RNA expression is indicative of the level of protein in a sample. Haider et al. (Integrated analysis of transcriptomic and proteomic data. Curr Genomics. 2013 Apr;14(2):91-110) teaches that correlation between mRNA and protein expression can be low due to various factors (Abstract), including translation efficiency and differing half-lives (pg. 92-93: Correlation Between Transcriptomic and Proteomic Data). Therefore, it is unpredictable as to whether results pertaining to RNA expression, as presented in the instant specification, would be applicable to methods requiring or encompassing the analysis of protein expression. The claims broadly encompass predicting immunotherapy prognosis based on the expression level of NEAT1 in any tumor sample containing cells (aspirate, blood, etc.). However, the specification only provides examples of expression levels measured from tumor tissue and tumor-derived cultures. Therefore, it is highly unpredictable if the expression levels observed in tumor-derived tissue could be extrapolated to other sample types such as blood or cerebrospinal fluid, as encompassed by the claims. White head (Genome Biol. 2005; 6(2): R13) teaches that variation in gene expression is extensive among tissues (abstract). Whitehead further teaches that many different cancers have unique tissue specific patterns of gene expression (pg. 1, col. 2). The specification teaches that data was derived from the studies of Cloughesy et al and Hugo et al (see above). Cloughesy et al obtained samples from glioblastoma tumor resections (tumor tissue) and from peripheral blood (Cloughesy: pg. 10: Study design and patients). Hugo et al. obtained samples from melanoma tumor tissues, tumor-derived cultures, and normal tissue (Hugo: pg. 8: Tumor Specimens and Profiling). There is no analysis in the specification regarding the level of NEAT1 expression in other sample types obtained from patients with any type of tumor. Thus, in the absence of evidence to the contrary, it is highly unpredictable if NEAT1 is differentially expressed in other sample types obtained from subjects with tumors. The specification provides support only for tumor-derived tissue and peripheral blood. Quantity of Experimentation: The quantity of experimentation necessary is great, on the order of many man-years, and then with little if any reasonable expectation of successfully enabling the full scope of the claims. In support of this position, it is noted that the claimed methods encompass being able to select and administer ANY type of immunotherapy or ANY type of combination therapy including immunotherapy to ANY type of subject (human and non-human animals) having ANY type of tumor, wherein the tumor has expression levels of NEAT1 higher than ANY reference level. In order to practice the breadth of the claimed invention one of skill in the art would first have to gather samples from human and non-human subjects having a representative number of greater than 200 different cancers. The expression levels of NEAT1 would have to be determine d and then compared to any type of reference level from the subject non-tumor cells, from matched untreated tumor tissue, from matched non-tumor tissue, and a representative number of other reference levels. Then , sophisticated data analysis would have to be conducted to determine which immunotherapies and combinations of immunotherapies + other treatment s would be effective in patients with high tumor expression levels of NEAT1. The specification has merely provided an invitation for further experimentation. The results of such experimentation are highly unpredictable. The amount of experimentation that would be required to practice the full scope of the claimed invention and the amount of time and cost this experimentation would take supports the position that such experimentation is undue. Attention is directed to Wyeth v. Abbott Laboratories 107 USPQ2d 1273, 1275, 1276 (Fed. Cir. June 2013): Claims are not enabled when, at the effective filing date of the patent, one of ordinary skill in the art could not practice their full scope without undue experimentation. MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1380-81 [103 USPQ2d 1769] (Fed. Cir. 2012). The remaining question is whether having to synthesize and screen each of at least tens of thousands of candidate compounds constitutes undue experimentation. We hold that it does. Undue experimentation is a matter of degree. Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1253 [70 USPQ2d 1321] (Fed. Cir. 2004) (internal quotation omitted). Even "a considerable amount of experimentation is permissible," as long as it is "merely routine" or the specification "provides a reasonable amount of guidance" regarding the direction of experimentation. Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1360- 61 [47 USPQ2d 1705] (Fed. Cir. 1998) (internal quotation omitted). Yet, routine experimentation is "not without bounds." Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d 1330, 1339 [105 USPQ2d 1817] (Fed. Cir. 2013). (Emphasis added) In Cephalon, although we ultimately reversed a finding of nonenablement, we noted that the defendant had not established that required experimentation "would be excessive, e.g., that it would involve testing for an unreasonable length of time." 707 F .3d at 1339 (citing White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 713 F.2d 788, 791 [218 USPQ 961] (Fed. Cir. 1983)). Finally, in In re Vaeck, we affirmed the PTO's nonenablement rejection of claims reciting heterologous gene expression in as many as 150 genera of cyanobacteria. 947 F.2d 488, 495-96 [20 USPQ2d 1438] (Fed. Cir. 1991). The specification disclosed only nine genera, despite cyanobacteria being a "diverse and relatively poorly understood group of microorganisms," with unpredictable heterologous gene expression. Id. at 496. (Emphasis added) Additionally, attention is directed to Cephalon at 1823, citing White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 218 USPQ 961, that work that would require 18 months to 2 years so to enable the full scope of an invention, even if routine, would constitute undue experimentation. As stated therein: Permissible experimentation is, nevertheless, not without bounds. This court has held that experimentation was unreasonable, for example, where it was found that eighteen months to two years' work was required to practice the patented invention. See, e.g., White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 713 F.2d 788, 791 [218 USPQ 961] Fed. Cir.1983). (Emphasis added) Attention is also directed to MPEP 2164.06(b) and In re Vaeck, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). Where, as here, a claimed genus represents a diverse and relatively poorly understood group of microorganisms, the required level of disclosure will be greater than, for example, the disclosure of an invention involving a "predictable" factor such as a mechanical or electrical element. See Fisher, 427 F.2d at 839, 166 USPQ at 24. In view of such legal precedence, the aspect of having to work for so many years just to provide the starting materials for minute fraction of the scope of the claimed invention is deemed to constitute both an unreasonable length of time and undue experimentation. Conclusions: Herein, although the level of skill in the art is high, given the lack of disclosure in the specification and in the prior art and the unpredictability of the art, it would require undue experimentation for one of skill in the art to make and use the invention as broadly claimed. The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim s 1- 3 and 5- 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim s 1 , 3 , and 5-20 are rejected for the recitation “ who has a level of NEAT1” in claim 1, as lacking antecedent basis. I t is unclear whether “a level of NEAT1 ” recited in the selecting step is the same as the “ the tumor expression level” which is compared in the previous step . For the purposes of compact prosecution, the examiner interprets the limitation to mean that the level of NEAT1 in the selecting step is the same as the level in the comparing step (i.e. the tumor expression level) . Regarding Claims 1 , 3, and 5-20 , it is not clear how the recited preamble is intended to breathe life and meaning into the claim. The preamble of the claim recites a method of selecting a treatment for and treating a subject who has a tumor, yet the method steps in the claim only require selecting an immunotherapy treatment for a subject who has a level of NEAT1 above the reference level and administering the immunotherapy treatment to the subject. The claims broadly encompass methods where NEAT1 is NOT above the reference level. In this embodiment of the claims, no selecting and treating occurs as is required by the preamble of the claims. Regarding Claim 2 , it is not clear how the recited preamble is intended to breathe life and meaning into the claim. The preamble of the claim recites a method for determining if a subject who has a tumor is likely to benefit from an immunotherapy treatment, yet the method only requires active process steps of “obtaining” a sample, “determining” an expression level, and “comparing . ” Thus , it is not clear if applicant intends to cover only a method of “obtaining” a sample, “determining” an expression level, and “comparing , ” OR if the method is intended to somehow require more to accomplish the goal set forth in the preamble. If it is the later, then it appears that the claims are incomplete, as they fail to provide any active steps that clearly accomplish the goal set forth by the preamble of the claims. Regarding the recitation of “wherein the tumor expression level of NEAT1 and/or HNRNPH1 in comparison to the reference expression level of NEAT1 and/or HNRNPH1 indicates whether the subject is likely to benefit from treatment with immunotherapy”, Applicants are reminded that claim scope is not limited by claim language such as wherein clauses which suggests or makes optional but does not require steps to be performed. Claims 10-15 and 20 are rejected because they further comprise “administering an additional treatment . ” This recitation is confusing since the step of treating in claim 1 is conditional and does not necessarily occur. Claims 11, 12, 14, and 15 are rejected because they recite that the additional treatment is a “second immune checkpoint inhibitor . ” This recitation is confusing because the claims do not recite administering a first immune checkpoint inhibitor. Clarification is requested. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19 recites that the subject which is “a mammal” as recited in claim 18 is “a human or non-human veterinary subject.” This limitation in claim 19 does not further restrict the scope of the claim on which it depends, since any mammal from which samples are obtained and treatments are administered may be considered to be either a human or a non-human veterinary subject. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1- 3 and 5-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more . The claims have been evaluated using the 2019 Revised Patent Subject Matter Eligibility Guidance (see Federal Register Vol. 84, No. 4, Monday, January 7, 2019). Step 1 : The claims are directed to the statutory category of a process. Step 2A, prong one : Evaluate Whether the Claim Recites a Judicial Exception The instant claims recite a law of nature. The claims recite a correlation between the expression level of NEAT1 genes and patient response to tumor immunotherapy. This type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo . The instant claims recite abstract ideas. The claims recite a step of “comparing” the expression level of NEAT1 generally, with no recited reference level for comparison. Neither the specification nor the claims set forth a limiting definition for “comparing” and the claims do not set forth how this step is accomplished. The “comparing” step broadly encompasses mental processes. For example, one may “compare” the expression levels by looking at data and thinking about whether the expression level is higher than a reference level. Mental processes, which are concepts performed in the human mind (including observation, evaluation, judgement, and opinions) are considered to be abstract ideas. The claims recite a step of ”selecting” an immunotherapy treatment for a subject who has a level of NEAT1 above a reference level. Neither the specification nor the claims set forth criteria for selection of any particular immunotherapy and the claims do not set forth how this step is accomplished. The broadest reasonable interpretation of the “selection” step is that it may be accomplished by a mental process. For example, one may “select” the treatment by thinking about the subject whose expression level of NEAT1 is relatively high and deciding which treatment to administer. Mental processes, which are concepts performed in the human mind (including observation, evaluation, judgement, and opinions) are considered to be abstract ideas. Claim 2 recites “determining” if a subject is likely to benefit from an immunotherapy treatment. The claim is considered to encompass “determining,” even though there are no active process steps of “determining.” Neither the specification nor the claims set forth criteria for “determining” and the claims do not set forth how this step is accomplished. The broadest reasonable interpretation of the “determination” step is that it may be accomplished by a mental process. For example, one may “determine” likelihood of benefit by thinking about the subject’s expression levels and expression signature relative to the reference level. Mental processes, which are concepts performed in the human mind (including observation, evaluation, judgement, and opinions) are considered to be abstract ideas. Step 2A, prong two : Evaluate Whether the Judicial Exception Is Integrated Into a Practical Application The claims do NOT recite additional steps or elements that integrate the recited judicial exception(s) into a practical application of the exception(s). For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application: An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or a technological field; An additional element that applies or used a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim; An additional element effects a transformation or reduction of a particular article to a different state or thing; An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. In addition to the judicial exceptions, the claims recite a step of “obtaining” a sample comprising a plurality of cells from a tumor of the subject. This step is not considered to integrate the judicial exceptions into a practical application because it merely adds insignificant extra-solution activity (data gathering) to the judicial exceptions. In addition to the judicial exceptions, the claims recite a step of “determining” a tumor expression level of NEAT1 in the sample. This step is not considered to integrate the judicial exceptions into a practical application because it merely adds insignificant extra-solution activity (data gathering) to the judicial exceptions. In addition to the judicial exceptions, Claim 1 recites “selecting an immunotherapy treatment for a subject who has a level of NEAT1 above the reference level” and “administering the immunotherapy treatment to the subject.” Here, the selecting and administering steps are conditional and only occur when the subject is found to have a level of NEAT1 above a reference level. The claims broadly encompass situations where the subject is found to NOT have NEAT1 above the reference level. In those situations, the immunotherapy treatment would not be selected and administered. As the selecting and administering steps need not occur, Claim 1 does not recite any steps or elements that integrate the judicial exception so as to practically apply the judicial exception. Claims 10, 14, and 20 recite step(s) of administering additional treatment(s).These administration steps are not particular, i.e., specifically identified so that they do not encompass all application of the judicial exceptions. These steps are merely instruction to apply the exception in generic ways. Thus, the administration steps do not integrate the mental analysis step into a practical application. Claim 11 recites that the additional treatment is selected from a second immune checkpoint inhibitor, a resection, a chemotherapy, and radiation. Claim 12 limits the second immune checkpoint inhibitor to not an inhibitor of PD-1 or PD-L1, while Claim 13 requires that the second immune checkpoint inhibitor is selected from inhibitors of CTLA-4, Lag3, or Tim3. Claim 15 limits the second additional treatment to CAR T therapy. These claims recite particular treatments. However, claim 1 recites “selecting an immunotherapy treatment for a subject who has a level of NEAT1 above the reference level” and claim 10 recites “administering an additional treatment.” Here, the administering step is not specifically linked to the relative expression level of NEAT1. Since the administering step does not have more than a nominal or insignificant relationship to the judicial exception, these claims do not integrate the mental analysis step into a practical application. Step 2B : Evaluate Whether the Claim Provides and Inventive Concept In addition to the judicial exceptions, the claims recite step s of “obtaining” a sample comprising a plurality of cells from the tumor of the subject , “determining” a tumor expression level of NEAT1 in the sample , and “administering” the immunotherapy treatment to the subject . Th ese step s do not amount to significantly more because they simply append well-understood, routine, and conventional activities previously known in the art, specified at a high level of generality, to the judicial exceptions. The se step s are recited a high level of generality. Determining the expression levels of NEAT1 , obtaining a sample comprising a plurality of cells from a tumor , and/or administering a treatment merely instruct a scientist to use any known technique for measuring expression levels , obtaining a tumor cell sample , and administering a therapy . The claim does not require the use of any particular non-conventional reagents or equipment or methodology. When recited at this high level of generality, there is no meaningful limitation that distinguishes this step from well-understood, routine, and conventional activities engaged in by scientists prior to applicant’s invention and at the time the application was filed. Additionally, the teachings in the specification demonstrate the well-understood, routine, and conventional nature of additional elements because it teaches that the additional elements are well-known or commercially available. For example, the specification teaches the following: Further, it is noted that the courts have recognized the following laboratory techniques as well-understood, routine, and conventional activity in the life science arts when they are claimed in a merely generic manner (e.g. at a high level of generality) or as insignificant extra-solution activity. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017); Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015); Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017); Immunizing a patient against a disease, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011); Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546; Freezing and thawing cells, Rapid Litig. Mgmt. 827 F.3d at 1051, 119 USPQ2d at 1375; Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014) For the reasons set forth above the claims are not directed to patent eligible 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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent. (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States. Claims 1-3, 7 -11, 13, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Jerby et al. (published April 11, 2019; International Publication No. WO 2019/070755). Regarding claims 1 -3 , Jerby teaches a method of selecting a treatment for and treating a subject who has a tumor , the method compris ing : obtaining a sample comprising a plurality of cells from the tumor of the subject (pg. 425, claim 20) ; determining a tumor expression level of nuclear paraspeckle assembly transcript 1 ( NEAT1 ) in the subject (p g. 422, claim 9 ); comparing the tumor expression level of NEAT1 to a reference expression level of NEAT1 (par. 176); selecting an immunotherapy treatment for a subject with a particular gene expression level ( pg. 425, claim 20 ) ; and administering the immunotherapy treatment to the subject ( pg. 425, claim 20 ) . Jerby does not explicitly teach that the treatment is selected and administered to a subject who has a level of NEAT1 above the reference level or which indicates whether a likelihood of response or benefit from an immunotherapy treatment . However, Jerby does teach detecting a biomarker signature which can be composed of NEAT1 alone, and which is upregulated in tumors with T cell infiltration ( pg. 422, claim 9 ). Jerby teaches that if a gene signature is detected ( including the exclusion-down gene signature characterized by upregulated NEAT1 ) , treatment comprises administering an immunotherapy ( pg. 425, claim 20). Additionally, Jerby teaches that immune cell infiltration indicates that a subject is likely to respond to immunotherapy (par. 6 ; par. 402 ). Therefore, the limitation s are considered to be anticipated. Regarding claims 7- 9 , Jerby teaches administration of an immune checkpoint inhibitor (par. 13), where the immune checkpoint inhibitor targets PD-1 (par. 15) and is an antibody (par. 340 ). Regarding claim 10, Jerby teaches administering an additional treatment ( par. 340 ). Regarding claims 11 and 13, Jerby teaches that the additional treatment is a second immune checkpoint inhibitor which targets CTLA-4, Lag3, or Tim3 (pg. 425, claim 25 ; par. 340 ). In this case, the “immunotherapy treatment” and the “additional treatment” are any two of the inhibitors used in phased combination therapy . Regarding claims 16 and 17, Jerby teaches that the sample is from a glioblastoma or carcinoma or melanoma (par. 307) Regarding claims 18 and 19, Jerby teaches that the s ubject is a mammal or a human (par. 282). Regarding claim 20, Jerby teaches a second additional treatment (pg. 425, claim 25; par. 340). In this case, the “second additional therapy” would be CDK4/6 inhibitor used in phased combination therapy. 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 ( 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made. This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a). Claims 5 and 6 are rejected under 35 U.S.C. 10 3 as unpatentable over Jerby et al. (published April 11, 2019; International Publication No. WO 2019/070755) , as applied to claim 1 above, and in view of Gao et al. (published March 13, 2020; Front Oncol. 2020 Mar 13;10:310). Jerby teaches the limitations of claim 1, as discussed above. Regarding claims 5 and 6, Jerby does not explicitly teach that the sample used in the method of treating is a fresh tumor sample or a fixed tumor sample. Gao teaches the use of fresh and fixed tumor samples in targeted cancer therapy (Introduction). It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to combine the teachings of Jerby and Gao. One would have been motivated to do so in order to better preserve DNA for analysis or make use of convenient and commonly used clinical samples (pg. 2, col. 2). Claims 12, 14, and 15 are rejected under 35 U.S.C. 10 3 as unpatentable over Jerby et al. (published April 11, 2019; International Publication No. WO 2019/070755) , as applied to claims 1, 10, a