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 .
The examiner reviewing this application in the USPTO have changed. All new correspondence should be directed to examiner Bailey Buchanan, Art Unit 1682.
Election/Restrictions
Applicant's election with traverse of the claims of the species election in the reply filed on 07/20/2026 is acknowledged. The traversal is on the ground(s) that a requirement is only permissible if there is a patentable different between the species as claimed and there would be a serious burden on the examiner if restriction is not required. This is not found persuasive because this is a national stage application filed under 35 U.S.C. 371. The standard for restriction in such an application is a lack of unity determination, which was set forth in the previous office action
The requirement is still deemed proper and is therefore made FINAL.
A first office action on the merits of claims 1-12, 19, & 22 with the species elections of STAT1 in Tables 1-3 corresponding to a gene involved in the interferon (IFN) alpha or gamma response is set forth herein and claims 13-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
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 applicant regards as his invention.
Claims 1-12, 19, & 22 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.
Regarding claim 1, the claim recites the limitation “the expression level” in line 3 of the claim and there is insufficient antecedent basis for this limitation in the claim. In addition, the recitation of “one or more genes in Tables 1-3” in line 3 of the claim is indefinite. As stated in MPEP 2173.05(s), the claims should be complete to themselves and the reference to a table in the specification renders the claim incomplete. Claims which recited tables are only permitted in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. In addition, the claim recites the limitation “the gene” in lines 4 & 7 of the claim and there is insufficient antecedent basis for this limitation in the claim and it is unclear if “the gene” refers to “one or more genes” recited in line 3 of the claim.
Regarding claim 7, the recitation of “one or more genes in Tables 1-3” in line 2 of the claim is indefinite. As stated in MPEP 2173.05(s), the claims should be complete to themselves and the reference to a table in the specification renders the claim incomplete. Claims which recited tables are only permitted in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. In addition, the claim recites the limitation “the gene” in line 3 of the claim and there is insufficient antecedent basis for this limitation in the claim and it is unclear if “the gene” refers to “one or more genes” recited claim 1, from which claim 7 depends from.
Regarding claim 10, the claim recites the limitation “the gene” in line 2 the claim and there is insufficient antecedent basis for this limitation in the claim and it is unclear if “the gene” refers to “one or more genes” recited in claim 1, from which claim 10 ultimately depends from.
Regarding claim 12, the claim recites the limitation “the gene” in lines 2 & 3 of the claim and there is insufficient antecedent basis for this limitation in the claim and it is unclear if “the gene” refers to “one or more genes” recited in claim 1, from which claim 12 ultimately depends from.
Claims 2-6, 8, 9, 11, & 22 are rejected due to their dependence on claim 1 and claim 19 is rejected due to its dependence on claim 7.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8, 10-12, 19, & 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation/law of nature and an abstract idea without significantly more. This judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106. The unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, 561 U.S. 593, 601 (June 28, 2010) and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014). See also Myriad v Ambry, CAFC 2014-1361, -1366, December 17, 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 71 (2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Dia-mond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. at 601 (2010).
Claims Analysis:
As set forth in MPEP 2106, the claims have been analyzed to determine whether they are directed to one of the four statutory categories (STEP 1).
The instant claims are directed to methods and therefore are directed to one of the four statutory categories of invention.
The claims are then analyzed to determine if they recite a judicial exception (JE) (STEP 2A, prong 1) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)].
The claimed invention recites a method for diagnosing and/or treating cancer in a subject comprising measuring and analyzing the expression level of one or more genes in Tables 1-3 wherein a differential expression level of the one or more genes compared to the corresponding reference level for the gene in the control sample indicates that the subject has cancer. This recitation is a natural correlation between expression level of one or more genes and indication that the subject has cancer. With regard to the natural correlation, as in Mayo, the relationship is itself a natural process that exists apart from any human action. The claimed invention also recites differential expression level of one or more genes compared to the corresponding reference level for the gene in the control sample which is a recitation of an abstract idea because it encompasses conclusions and determinations which can occur entirely within the mind. It is therefore determined that the claims are directed to judicial exceptions.
The claims are then analyzed to determine whether they recite an element or step that integrates the JE into a practical application (STEP 2A, prong 2) [Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018)].
The claims recite steps of measuring and analyzing the expression level of the one or more genes in Tables 1-3 comprising analyzing the expression level of a gene involved in the IFN alpha or gamma response, however this does not integrate the JE into a practical application because it is a mere data gathering step to use the correlation and does not add a meaningful limitation to the method.
Although the claims recite “administering to the subject one or more anticancer agents” to the patient, this step is conditional as it is based on indication that the subject has cancer through measuring and analyzing expression levels of one or more genes. Accordingly, these generally recited elements are considered nothing more than instructions to apply the law of nature because no particular conditions are required by the step of detecting gene expression. As such, the “administering” step is merely a generalized “treat” limitation with no particularity that integrates the judicial exception into a practical application. The Supreme Court does acknowledge that it is possible to transform an unpatentable law of nature, but one must do more than simply state the law of nature while adding the words "apply it.” CLS BankInt’l, 134 S.Ct. at 2358; Prometheus, 132 S. Cl, at 1294.
In the absence of steps or elements that integrate the JE into a practical application, the additional elements/steps are considered to determine whether they add significantly more to the JE either individually or as an ordered combination, to “’transform the nature of the claim’ into a patent eligible application” [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)] (STEP 2B).
In the instant situation, the steps of measuring and analyzing expression level(s) of one or more genes are generally recited and do not provide any particular reagents that might be considered elements that transform the nature of the claims into a patent eligible application because no specific elements/steps are recited. This step is not only a mere data gathering step, but the general recitation of detection of known nucleic acids is well understood, routine, and conventional activity (See MPEP 2106.05(d)(II)). Applicant is reminded that in Mayo, the Court found that “[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Further "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law”. Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’ . . . adding ‘insignificant post-solution activity’” (quoting Diehr, supra, at 191–192)). The Court also summarized their holding by stating “[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Therefore these limitations/steps do not “‘transform the nature of the claim’ into a patent-eligible application.’” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297).
When viewed as an ordered combination, the claimed limitations are directed to nothing more than the determination that a natural correlation/phenomena exists. Any additional element consists of using well understood, routine and conventional activity, and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.
Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-8, 11, 12, 19, & 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dong (Dong et al.; Clinical Cancer Research, Vol. 23, pages 3012-3024, June 2017).
Regarding claim 1, Dong teaches a method of measuring expression levels of genes in KRAS mutated lung adenocarcinoma samples comprising measuring the mRNA expression of STAT1 in a KRAS mutated sample compared to differential STAT1 mRNA expression in a KRAS wildtype sample (control sample) (analyzing the expression level of STAT1 in a biological sample from a subject in conjunction with a corresponding reference level for the gene in a control sample) to diagnose and treat common mutations of lung adenocarcinoma through providing predictive factors and biomarkers in guiding immunotherapy to the subjects indicated to have lung adenocarcinoma (differential expression of one or more genes compared to the corresponding reference level indicates the subject has cancer) (abstract results lines 1-16; abstract conclusions lines 1-4; pg. 3013 column 1 2nd full paragraph lines 1-15; pg. 3013 column 2 3rd full paragraph lines 1-12; pg. 3014 column 1 1st full paragraph lines 1-12; pg. 3015 column 1 1st full paragraph lines 1-13; pg. 3022 column 1 1st full paragraph lines 14-30; pg. 3022 column 2 2nd full paragraph lines 1-8; Figure 2G).
Regarding claims 2-4, Dong teaches the sample is a KRAS mutated lung adenocarcinoma sample (cancer comprises a KRAS mutation in the lung tissue of the subject) (abstract results lines 1-16; abstract conclusions lines 1-4; pg. 3013 column 1 2nd full paragraph lines 1-15; pg. 3014 column 1 1st full paragraph lines 1-12).
Regarding claims 5 & 6, Dong teaches the sample is a KRAS mutated lung adenocarcinoma sample (the cancer is lung adenocarcinoma) (abstract results lines 1-16; abstract conclusions lines 1-4; pg. 3013 column 1 2nd full paragraph lines 1-15; pg. 3014 column 1 1st full paragraph lines 1-12).
Regarding claim 7, Dong teaches a method of measuring expression levels of genes in KRAS mutated lung adenocarcinoma samples comprising measuring the mRNA expression of STAT1 in a KRAS mutated sample compared to differential STAT1 mRNA expression in a KRAS wildtype sample (control sample) (measuring the expression level of STAT1 in a biological sample from a subject and a corresponding reference level for the gene in a control sample) (abstract results lines 1-16; abstract conclusions lines 1-4; pg. 3013 column 1 2nd full paragraph lines 1-15; pg. 3013 column 2 3rd full paragraph lines 1-12; pg. 3014 column 1 1st full paragraph lines 1-12; pg. 3015 column 1 1st full paragraph lines 1-13; pg. 3022 column 1 1st full paragraph lines 14-30; pg. 3022 column 2 2nd full paragraph lines 1-8; Figure 2G).
Regarding claim 8, Dong teaches measuring expression levels of genes in KRAS mutated lung adenocarcinoma samples comprising measuring the mRNA expression of STAT1 to diagnose and treat common mutations of lung adenocarcinoma through providing predictive factors and biomarkers in guiding immunotherapy to the subjects indicated to have lung adenocarcinoma ( after analyzing, administering to the subject one or more anticancer agents) (abstract results lines 1-16; abstract conclusions lines 1-4; pg. 3013 column 1 2nd full paragraph lines 1-15; pg. 3013 column 2 3rd full paragraph lines 1-12; pg. 3014 column 1 1st full paragraph lines 1-12; pg. 3015 column 1 1st full paragraph lines 1-13; pg. 3022 column 1 1st full paragraph lines 14-30; pg. 3022 column 2 2nd full paragraph lines 1-8; Figure 2G).
Regarding claims 11 & 12, Dong teaches a method of measuring expression levels of genes in KRAS mutated lung adenocarcinoma samples comprising measuring the expression level of INF-γ (IFN gamma) in a KRAS mutated sample (analyzing the expression level of a gene involved in the IFN gamma response) compared to differential INF-γ mRNA expression in a KRAS wildtype sample (control sample) (analyzing the expression level of IFN gamma in a biological sample from a subject relative to a corresponding reference level for the gene in a control sample) (abstract results lines 1-16; abstract conclusions lines 1-4; pg. 3013 column 1 2nd full paragraph lines 1-15; pg. 3013 column 2 3rd full paragraph lines 1-12; pg. 3014 column 1 1st full paragraph lines 1-12; pg. 3015 column 1 1st full paragraph lines 1-13; pg. 3022 column 1 1st full paragraph lines 14-30; pg. 3022 column 2 2nd full paragraph lines 1-8; Figure 2G).
Regarding claim 19, Dong teaches measuring the expression level of one or more genes through sequencing and microarray analysis (pg. 3013 column 2 3rd full paragraph lines 1-12).
Regarding claim 22, Dong teaches the sample is a lung adenocarcinoma tissue sample with matched normal tissues (the biological sample is a tissue sample) (pg. 3013 column 1 2nd full paragraph lines 1-15).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 8 & 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dong (Dong et al.; Clinical Cancer Research, Vol. 23, pages 3012-3024, June 2017), in view of Molina-Arcas (Molina-Arcas et al.; Science Translational Medicine, Vol. 11, pages 1-16, September 2019).
The teachings of Dong with respect to claims 1 & 8 are discussed above and incorporated herein.
Regarding claims 8 & 9, Dong does not teach that the anticancer agent is an inhibitor of a KRAS gene (see claim 9).
Molina-Arcas teaches treatment of lung adenocarcinoma with KRAS-G12C, a KRAS mutant specific inhibitory drug (administering to the subject an anticancer agent that is an inhibitor of a KRAS gene) (abstract lines 1-12). Molin-Arcas also teaches that replacing combination therapies for lung adenocarcinoma comprising MEK inhibitor with nutant-specific KRAS-G12C inhibitor (inhibitor of a KRAS gene) is associated with greater efficacy, specificity, and tolerability (abstract lines 1-12).
Dong and Molina-Arcas are considered to be analogous to the claimed invention because they are all in the same field of treatment of lung adenocarcinoma. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of measuring and analyzing expression of STAT1 and treatment of lung adenocarcinoma in Dong to incorporate the treatment with an KRAS gene inhibitor anticancer agent as taught in Molina-Arcas because Molina-Arcas teaches that doing so would provide a treatment option for lung adenocarcinoma with greater efficacy, specificity, and tolerability.
Claim(s) 8 & 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dong (Dong et al.; Clinical Cancer Research, Vol. 23, pages 3012-3024, June 2017), in view of Huang (Huang et al.; Scientific Reports, Vol. 6, pages 1-12, November 2016).
The teachings of Dong with respect to claims 1 & 8 are discussed above and incorporated herein.
Regarding claims 8 & 10, Dong does not teach that the anticancer agent is an inhibitor the gene (STAT1) that is identified to have differential expression level compared to the corresponding level in the control (see claim 10).
Huang teaches a method of analyzing and treating lung adenocarcinoma with a STAT1 inhibitor (anticancer agent is an inhibitor of the gene (STAT1) that is identified to have differential expression compared to the corresponding level in the control) and also teaches that this method of treatment may facilitate design of therapeutic interventions targeting both inflammation and angiogenesis in lung cancer (abstract lines 1-12; pg. 2 1st full paragraph lines 1-6; pg. 2 3rd full paragraph lines 1-4; pg. 7-8 paragraph bridging pg. 7 & 8 lines 1-5; pg. 10 1st full paragraph lines 1-6; Figure 6).
Dong and Huang are considered to be analogous to the claimed invention because they are all in the same field of treatment of lung adenocarcinoma. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of measuring and analyzing expression of STAT1 and treatment of lung adenocarcinoma in Dong to incorporate the treatment with STAT1 gene inhibitor anticancer agent as taught in Huang because Huang teaches that doing so would provide a treatment option for lung adenocarcinoma that can facilitate the design of therapeutic interventions targeting both inflammation and angiogenesis in lung cancer.
Conclusion
Claims 1-12, 19, & 22 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY C BUCHANAN whose telephone number is (703)756-1315. The examiner can normally be reached Monday-Friday 8:00am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston Shen can be reached at (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BAILEY BUCHANAN/Examiner, Art Unit 1682
/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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