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 .
Status of the Claims
Claims 14-18 are cancelled.
Claims 1 and 3-13 are withdrawn.
Claim 2 is under examination.
Election/Restrictions
Applicant’s election without traverse of Group II, drawn to a method for treating non-small cell lung cancer (NSCLC) in a subject, in the reply filed on 27 July 2026 is acknowledged.
Applicant also elected the species of b2 in claim 2 and ERH.
Claims 1 and 3-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 July 2026.
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.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon and an abstract idea) without significantly more. The claim recites treating a patient with docetaxel after assaying a sample from the subject and detecting elevated levels of ERH. This judicial exception is not integrated into a practical application based on the reasoning below:
The unpatentability of laws of nature and abstract ideas was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Diamond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S., (2010) (slip op., at 5). “Phenomena 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).
Additionally, the unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, No. 08-964, 2010 WL 2555192 (June 28, 2010) and in Alice Corp. v. CLS Bank Inti, 134 S. Ct. 2347, 2354 (2014).
The following inquiries are used to determine whether a claim is drawn to patent-eligible subject matter:
Step 1. Is the claim to a process, machine, manufacture, or composition of matter? Yes, the claim is directed to a method.
Step 2A, prong 1. Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? Yes, where the claim recites a treatment decision based on a level of an assayed biomarker, it encompasses a mental comparison of data and the correlation of data and information to reach a conclusion. Further, the treatment decision is based on a law of nature or natural phenomenon because it is based on a level of a biomarker already occurring in the subject.
Step 2A, prong 2. Does the claim recite additional elements that integrate the exception into a practical application? No, the judicial exceptions to which the claims are directed are not integrated into a practical application because the rejected claims do not require any, practical or particular steps related to the determining a biomarker level and administering a treatment.
Step 2B. Does the claim recite additional elements that amount to significantly more than the judicial exception? No, the claims assay a sample and determine an expression level and provide treatment. Additionally, the treatment step is extra solution because docetaxel is a known chemotherapy treatment and a known treatment for NSCLC. (See Manzo et al., Angiogenesis Inhibitors in NSCLC, 2017).
For these reasons, the claim is rejected under USC 35 section 101 as being directed to non-statutory subject matter.
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weng et al. (PNAS, 2012), Freidlaender et al. (Cancer Treat Rev., 2020), and Reck et al. (Lancet Oncol, 2014).
Weng et al. teach that ERH expression is inversely associated with survival of colorectal cancer patients whose tumors harbor KRAS mutations. (abstract). Weng et al. teach that KRAS mutant cells showed less viability on ERH knockdown compared to KRAS WT. (page E3660).
Friedlaender et al. teach that KRAS mutations account for 25% of oncogenic mutations in NSCLC. (abstract). Friedlaender et al. state that there have been conflicting studies regarding treatments and KRAS mutation presence. (page 4). Friedlaender does note that cancers with a KRAS G12V or G13D mutation derived the most benefit from taxanes. (page 4).
Reck et al. teach that docetaxel is a known therapy for non-small-cell lung cancer. (see document in general).
One of ordinary skill in the art would be motivated, based on the above teachings to treat a patient with a known therapy for NSCLC after testing the patient for ERH expression because it is known that ERH is associated with KRAS mutations and KRAS mutations in NSCLC benefit from treatment with taxanes. Therefore, one of ordinary skill in the art would be motivated to test for a gene associated with a known mutation and treat a patient based on that information.
Conclusion
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/MINDY G BROWN/ Patent Examiner, Art Unit 1683
/ANNE M. GUSSOW/ Supervisory Patent Examiner, Art Unit 1683
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