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 with traverse of Group I, claims 1-4 (pertaining to restriction requirement dated 9/23/2024) in the reply filed on 2/25/2025 is acknowledged. The traversal and examiner’s response can be found in the action mailed 3/26/2025. This restriction was made final. A second restriction requirement was mailed 3/26/2026 necessitated by the claim amendments (amendment requiring at least 8, instead of all 204 genes recited). On 6/25/2025 and 1/27/2026, applicants elected the invention directed to the combination of genes AXL, DLL3, EGFR, ERBB2, FSHR, MET, MUC1, and TACSTD2 with traverse. The traversal is on the ground(s) that an applicant may claim a reasonable number of species and that the present genus of 204 genes is a finite number and not unreasonable. This is not found persuasive. First it should be noted that the restriction requirement dated 3/26/2025 separated the different combinations of “at least 8” into different groups, not to different species. Lack of unity was explained because each of the combinations of “at least 8” are directed to structurally and functionally different combinations of genes, which lack unity of invention. As to the arguments that 204 genes is a finite number, this is not found persuasive. The claims actually encompass an enormous number of different combinations of any 8 of 204, any 9 of 204, any 10 of 204 genes, etc. Using the binomial coefficient (n choose k formula) for just any 8 of the 204 genes recited, the number of possible combinations of any 8 of the 204 genes is over 6.4 x 1013. There are over 1.4 x 1014 combinations of any 9 genes of the 204 genes listed. This requirement is still deemed proper and is therefore made FINAL.
An action on the merits of claims 1-4, directed to the combination of AXL, DLL3, EGFR, ERBB2, FSHR, MET, MUC1, and TACSTD2 is set forth below. Claims 5-8, 11, 12, and 15-17 are withdrawn from consideration as being directed to non-elected inventions, there being no allowable generic or linking claim.
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more. This 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 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, part II.
The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., , 133 S. Ct. 2107, 2116, (2013).
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 claims were 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 claims were 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)]. In the absence of a step(s) or element(s) that integrate the JE into a practical application, the additional elements/steps have been considered to determine whether they add significantly more to the JE (STEP 2B) [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)]. It was found that the present claims fail to meet the elements required for patent eligibility.
The claims are directed to a genomic assay panel which is interpreted to be directed to nucleic acid sequences and as such are directed to products. Accordingly, the claims are directed to one of the four statutory categories of invention.
The claims recite a genomic assay panel comprising AXL, DLL3, EGFR, ERBB2, FSHR, MET, MUC1, and TACSTD2. These genes are are naturally occurring sequences. As such the claims are directed to a product of nature which is a judicial exception.
This judicial exception is not integrated into a practical application because the nucleic acid molecules encompassed by the claims convey the same genetic information as their naturally occurring counterparts. The Supreme Court has made clear "separating [DNA] from surrounding genetic material is not an act of invention" Myriad, 133 S. Ct. at 2117. In Myriad v. Ambry CAFC 2014-1361,1366, December 17, 2014, the CAFC further (regarding a claim directed to a pair of primers) stated “In fact, the naturally occurring genetic sequences at issue here do not perform a significantly new function. Rather, the naturally occurring material is used to form the first step in a chain reaction—a function that is performed because the primer maintains the exact same nucleotide sequence as the relevant portion of the naturally occurring sequence. One of the primary functions of DNA’s structure in nature is that complementary nucleotide sequences bind to each other. It is this same function that is exploited here—the primer binds to its complementary nucleotide sequence. Thus, just as in nature, primers utilize the innate ability of DNA to bind to itself.”
The dependent claims recite that the panel includes a naturally occurring housekeeping gene, that the panel is an “RNA expression panel”, and that it comprises an “RNA Salah Targeted Expression Panel”. However these recitations are directed to judicial exceptions as well because they simply recite further naturally occurring subject matter. Additionally, these recitations are nothing more than an attempt to generally link the product of nature into a particular technological environment, and furthermore, do not change the structures of the encompassed natural products. The claims do not include any elements that practically apply or add significantly more to the JE’s recited.
Accordingly, the claims are rejected as being directed to non-patentable subject matter.
Claim Rejections - 35 USC § 112
112(b)
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.
Claims 1-4 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The claims recite “a genomic assay panel” comprising AXL, DLL3, EGFR, ERBB2, FSHR, MET, MUC1, and TACSTD2. However the metes and bounds of an “assay panel” are not clear. It is not clear if the claims are directed to a set of gene sequences, a set of gene fragments, nucleic acid probes, etc. Additionally, the structural relationship between the genes in the “panel” are unclear. For example, are the encompassed genes, fragments, probes, etc in a device, a composition, a kit, on the same laboratory bench, in the same room, etc?
Claim 3 recites “wherein the panel comprises an RNA expression panel”, however it isn’t clear if this recitation is meant to be an intended use, or to structurally define the panel. If the latter is the case, the recitation of “RNA expression panel” does not clearly set forth any structural requirements. The same analysis for the recitation of “RNA Salah Targeted Expression Panel” in claim 4.
112(d)
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.
Claims 3 and 4 are rejected under 35 U.S.C. 112(d) 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. The recitations in claims 3 and 4 appear to be directed to intended uses and do not structurally limit the claim from which they depend. 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 § 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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Affymetrix (Affymetrix GeneChip 1.0 ST array system, 2007; pages 1-8).
Affymetrix teaches an array system for RNA expression analysis that comprises probes for expression analysis. This array contains probes for detecting AXL, DLL3, EGFR, ERBB2, FSHR, MET, MUC1, and TACSTD2. Accordingly, the claims are anticipated by the array system taught by Affymetrix.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fodor (Fodor et al; US Patent 6,582,908).
Fodor teaches arrays of all possible 10 mer nucleotide sequences (see claim 5). Therefore, the array necessarily contains fragments of each of AXL, DLL3, EGFR, ERBB2, FSHR, MET, MUC1, and TACSTD2, as well as oligonucleotides that are completely complementary and would therefore hybridize to each of AXL, DLL3, EGFR, ERBB2, FSHR, MET, MUC1, and TACSTD2. The claimed assay “panel” has no particular structure of base composition. Accordingly, the claims are anticipated by Fodor.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner is a hoteling examiner and can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Winston Shen, can be reached on (571) 272-3157. The fax phone number for organization where this application or proceeding is assigned is (571) 273-8300.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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