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 ALK, APC, BRAF, BRCA1, BRCA2, EGFR, IDH1, KIT, KRAS, MYC, MYCN, NRAS, PDGFRA, PIK3CA in the reply filed on 10/28/2025 is acknowledged. It is noted that the claim list the term “PGFRA”, however, it appears that the gene should be “PDGFRA” and as such this gene is used in the art provided below.
CLiams 1-8 are pending.
An action on the merits is provided below.
Claim Objections
Claims 1-8 are objected to because of the following informalities: Claims 1 and 8 appear to encompass the same steps and preamble. As such should claim 1 be allowed, claim 8 would be objected to as encompassing the same steps and preamble. Claims 2-7 are objected to as being dependent on claim 1. Appropriate correction is required.
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 1-8 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.
Claims 1-8 are indefinite over the phrase “clinically actionable target information” in claim 1 and 8. The term is not defined in the specification. The specification asserts that the clinically actionable target maybe particular genes (para 32). The term is not an art recognized term. It is not clear the metes and bounds of the term. It is not clear if the information is intended to be the expression, presence or absence, particular levels, or any other information. As such the metes and bounds of the claims are unclear.
Claim 5 is indefinite. The claim is drawn to “PGFRA” which is found in paragraphs 11, 32. However, this acronym for a gene is not known in the prior art. Rather, the art provides for PDGFA. This gene name is recited in the response to restriction. As such it is not clear the metes and bounds of the term “PGFRA” as it is not clear which gene is represented by the nomenclature.
Claim 7 is indefinite. The phrase "that is" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 are rejected under 35 U.S.C. 101 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a natural phenomenon, and/or an abstract idea without significantly more. The judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons that follow.
Note that the unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012).
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 Int’l, 134 S. Ct. 2347, 2354 (2014).
Applicant’s attention is directed to the USPTO January 7, 2019 Revised Patent Subject Matter Eligibility Guidance (i.e., “PEG”) available at URL:
<https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf>.
Regarding Step 1 of the PEG, the claims are directed to the statutory category of a process.
Regarding Step 2A, prong one, the claims recite the judicial exception of a natural phenomenon. The claims recite relationship between predicting cancer recurrence and information of sequencing information. As in Mayo Collaborative Services v. Prometheus, the recited relationship is a natural phenomenon that exists apart from any human action.
The claims also recite the judicial exception of an abstract idea and particularly mental processes. In particular the step of “analyzing”, which would encompass a step of looking at data. Further, the step of “generating” a panel of information (data) and comparing that information is considered abstract steps of providing data and comparing. Note that the Courts have held that steps that can be performed by a human using mental processes or basic critical thinking, or intangible verbal communication are types of activities that represent abstract ideas.
Regarding abstract mental processes, Applicant’s attention is directed to the Association for Molecular Pathology (AMP) and ACLU v. USPTO and Myriad Genetics (Fed. Cir. 2012)) wherein it is stated at 56-57:
Having determined that steps ii-iv are abstract ideas, we move to the second step of Alice and ask whether the particular mechanism for the detection renders the claims patent-eligible. For this step, Alice dictates that we ask whether the remaining elements, either in isolation or combination with the other non-patent-ineligible elements, are sufficient to “‘transform the nature of the claim’ into a patent-eligible application.” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297). There must be a further inventive concept to take the claim into the realm of patent-eligibility. Id. at 2355. In particular these steps merely produce a score.
Thus, the claims recite and are directed to the patent-ineligible concepts of abstract processes and a natural phenomenon.
Regarding Step 2A, prong two, having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application.
Herein, the claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). The steps of obtaining, is not method considered an integration as rather, it is using any routine and conventional hybridization methods. Further, the dependent steps merely limit the types of samples/genes detected but do not limit the steps themselves to integrate the method and the judicial exception.
Regarding Step 2B, the next question is whether the remaining elements/steps – i.e., the non-patent-ineligible elements/steps - either in isolation or combination, amount to significantly more than the judicial exception.
Herein, the claims as a whole are not considered to recite any additional steps or elements that amount to significantly more than routine and conventional activity and do not add something “significantly more” so as to render the claims patent-eligible. The additionally recited steps are routine in the prior art.
The claims are using a known method of NGS. Further, DeLaVega (US Patent Application 20190050530 Feb 14, 2019) system for cancer recurrence (para 78). DeLaVega obtaining genomic variant information and genomic sequences (clinically actionable target information) from tissue samples (para 31). DeLaVega comparing these to sequence information from blood from the individual (para 31).
For the reasons set forth above, when the claims are considered as a whole, the claims are not considered to recite something significantly more than a judicial exception and thereby 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 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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DeLaVega (US Patent Application 20190050530 Feb 14, 2019).
With regard to claims 1 and 8, DeLaVega teaches system for cancer recurrence (para 78). DeLaVega obtaining genomic variant information and genomic sequences (clinically actionable target information) from tissue samples (para 31). DeLaVega comparing these to sequence information from blood from the individual (para 31).
With regard to claim 2, DeLaVega teaches a method of using formalin fixed paraffine embedded tissue (para 150).
With regard to claim 3, DeLaVega teaches that the sequencing can be at least 20 nucleotides (para 104).
With regard to claim 4, DeLaVega teaches a method of using cell free samples (para 83).
With regard to claim 5, DeLaVega teaches a method of detecting ALK, APC, BRAF, BRCA1, BRCA2, EGFR, IDH1, KIT, KRAS, MYC, MYCN, NRAS, PDGFRA, PIK3CA (para 212).
With regard to claim 6, DeLaVega teaches a method of detecting variants in an exon (para 236).
With regard to claim 7, DeLaVega teaches a method in which multiple molecules are detected (para 218-235).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682