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 .
Specification
The disclosure is objected to because page 47, lines 26-28 of the specification contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The specification in paragraph [0029] line 4 contains a clerical error: "SEQ ID NOS: 2-4 respectively" should read "SEQ ID NOS: 1-4 respectively."
Status of Claims
Claims 1-20 are currently pending and under consideration.
This is the first action on the merits.
Priority
Regarding claim 1 and its dependent claims, the earliest priority is 06/07/2022 because the priority document (PCT/US2022/032423) filed that date is the first to disclose a kit comprising nucleic acids 1.
Claims Interpretation
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP§ 2111.
For the purpose of applying prior art, claim 1 and its dependent claims recite a kit comprising nucleic acid and instructions.
It is noted that the recited instructions in claims 1-7, 10-16 and 19 constitute printed matter that lack functional relationship with the claimed product, and do not limit the scope of the kit. See MPEP 2112.01. MPEP 2111.05 states: "To be given patentable weight, the printed matter and associated product must be in a functional relationship. … where the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864."
For the purpose of applying prior art, claim 1 recites languages describing intended functions of a kit and "at least one nucleic acid" as follows:
a kit "for detecting a cancer from a biological sample obtained from a subject," and "is capable of achieving diagnostic accuracy having an AUC value greater than approximately 0.75 for detecting any one of lung cancer, biliary tract cancer, bladder cancer, colorectal cancer, esophageal cancer, gastric cancer, glioma, liver cancer, ovarian cancer, pancreatic cancer, prostate cancer, or sarcoma";
at least one nucleic acid "capable of specifically recognizing each miRNA in an miRNA biomarker set, thereby allowing an expression profile of the miRNA biomarker set to be obtained from the biological sample. "
These functional languages have been considered but they do not further distinguish the claimed kit from the teachings in prior art. MPEP§ 2111.04 states: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure."
Here, these functional languages do not recite any specific structures in the claimed kit that directly support or relate to these functions. See MPEP § 2111.05. Therefore, the descriptive languages noted above do not distinguish the claimed nucleic acid or kit from any of nucleic acid known in the art. “It is trite to state that the patentability of apparatus claims must be shown in the structure claimed and not merely upon a use, function, or result thereof.” In re Gardiner 171 F.2d 313 (C.C.P.A. 1948) (CCPA 12/07/48).
Claim Rejections - 35 USC § 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 1-20 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A) Claim 1 recites "a 500-miRNA set as listed in Table 1, "which is indefinite.
MPEP 2173.05(s) states:
“Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only 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. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).”
Therefore, according to MPEP, claims should be self-contained and clearly define the invention without relying on external references. This approach ensures clarity and avoids potential ambiguity in interpreting the scope of the claims. In this instant case, claim 1 is indefinite because it refers to miRNAs listed in a table in the specification, without specifically naming the miRNAs in the claim itself. The miRNAs associated with the recited table can be readily incorporated into the claim (e.g., a 500-miRNA set consisting of hsa-miR-5100, hsa-miR-1343-3p, hsa-miR-1290, hsa-miR-4787-3p… ), therefore reference to the specification is improper.
Claims 2-20 are rejected for depending from claim 1 and not remedying the indefiniteness.
B) Regarding claim 9, it recites "wherein the at least one nucleic acid consists of a total of 4 polynucleotides" that hybridize to SEQ ID Nos: 1-4, which modifies the nucleic acid of the claimed kit using both open ("at least one ") and closed claim language ("consists of").
The claim language recites a kit "comprising" (open) "at least one nucleic acid" (open) that "consist of" (closed) a total of four polynucleotides. This combination of open and closed transitional language renders the scop unclear.
Specifically, it is unclear whether the claimed kit excludes additional polynucleotides beyond the recited four, or permits inclusion of additional nucleic acids. Accordingly, the metes and bounds of the claim cannot be determined with reasonable certainty.
For the purpose of compact prosecution and applying prior art under 35 USC§ 102 and 103, the specification has been considered for claim interpretation.
Para. [00029] describes a microRNA biomarker set that "consist of "four miRNAs (i.e. hsa-miR-5100, hsa-miR-1343-3p, hsa-miR-1290, and hsa-miR-4787-3p), "[a]s demonstrated in EXAMPLE 1 below." However, Example 1 describes detecting miRNA expression using a commercial microarray kit ("3DGene® Human miRNA Oligo Chip"), "designed to investigate 2588 miRNA sequences registered in miRBase release 21." ([0145] lines 1-5).
The application's disclosure does not clearly describe any alternative kit comprising only four polynucleotides.
Thus, in light of the specification, the kit comprising "at least one nucleic acid" is interpreted under BRI as not limited to comprising only four polynucleotides. The only described embodiment supporting the claim is a microarray kit that includes additional polynucleotides targeting more than four microRNAs. Accordingly, the scope of the claimed kit is interpreted as encompassing additional polynucleotides beyond the four recited in claim 9.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Independent claim 1 is drawn to a kit comprising at least one nucleic acid with undefined structure.
Following the analysis below the claims are not patent eligible under 35 U.S.C. 101.
Step 1 - Whether the Claim is to a Statutory Category : YES. The claims are drawn to a kit, therefore to one of the of statutory categories.
Step 2A Prong 1 - Whether the Claim Recite an Abstract idea, Law of Nature, or Natural Phenomenon: Yes. The claims recite a kit comprising at least one nucleic acid without specifying any unique, markedly different characteristics compared to what occurs in nature. As stated in MPEP 2106.04(b)(I), laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature.
Nucleic acids are naturally occurring, nature-based products.
The courts have identified that "short, synthetic, single-stranded DNA molecule[s] that bind specifically to … intended targets nucleotide sequence[s]" are products of nature because they claim the same nucleotide sequence as naturally occurring DNA. See University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755, 761, 113 USPQ2d 1241, 1244 (Fed. Cir. 2014). See also MPEP 2106. In this instant case, Applicant does not claim any specific structural feature or characteristics, that could distinguish the claimed nucleic acid from naturally occurring nucleic acid sequences.
In conclusion, the claims recite nature-based products.
Step 2A Prong 2 - Whether the Claim Recite Additional Elements that Integrate the Judicial Exception into a Practical Application: No. The claim as a whole do not integrates the exception into a practical application of that exception.
Claim 1 does not recite any additional element that can transform the claimed nature-based products to something that are markedly different than their naturally occurring counterparts in their natural state.
Although the claim recites instructions for use and functional languages describing the intended use and intended function of the claimed kit, it lacks structural features that directly support for relate to these functional, use languages. Therefore, these descriptive claim languages do not impose any meaningful limit on the judicial exception.
Furthermore, the instructions in claim 1 recite instructions for performing calculation, which constitutes another judicial exception (abstract idea), thus cannot transform the nature of the claim into a patent-eligible subject matter. Also, the courts have identified limitations that merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea do not integrate a judicial exception into a practical application. See MPEP 2106.04.
Step 2B - Whether a Claim Amounts to Significantly More: No.
According to MPEP§ 2106.05, The second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).
In this instant case, the claims, when considered as a whole, do not recite any inventive concept with additional elements that amount to significantly more than the judicial exception. The claims do not appear to add markedly different characteristics that significantly modify the naturally occurring nucleic acid in a manner that is not naturally occurring.
Although the claim recites intended use of the claimed nucleic acid such as "capable of specifically recognizing each miRNA in an miRNA biomarker set," there is no structure in the claim that can directly support or relate to the "specifically recognizing…" functional language.
In the life science art, short nucleic acid fragments such as primers and probes can be designed to comprise complementary sequence to a target nucleic acid, target detection can be achieved via hybridization. But this type of approach is well-understood, routine, conventional activity in the life science arts. See MPEP 2106.05.
Furthermore, even if the claim recites nucleic acid structures that supports the intended function, such as complementary sequence to a target miRNA, the courts have said that for a probe sequence that merely performs its natural function of hybridizing to a complementary strand; in other words, without any structural change to the probe sequence, the resulting hybridization is a natural phenomenon. See, e.g., Roche Molecular Sys., Inc. v. Cepheid, No. 2017-1690, 2018 WL 4868033 (Fed. Cir. Oct. 9, 2018).
The dependent claims do not recite additional elements that amount to significantly more than the judicial exception, as they represent mere general linkage of the judicial exception to the additional elements in the claims (MPEP § 2106.05(h)).
In conclusion, the claims are not patent eligible under 35 U.S.C. 101.
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.
Claims 1-17 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 3D-Gene Human miRNA (3D Gene Human miRNA V21_1.0.0 ; Public on Dec 19, 2015; Toray Industries,Inc ; NCBI GEO platform number GPL21263).
Regarding claims 1, 8, 9 and 17, 3D-Gene Human miRNA anticipates these claims by teaching a microarray assay kit comprising spotted oligonucleotides that hybridize to the following miRNAs:
ID
MicroRNA
MIMAT0022259
hsa-miR-5100
MIMAT0019776
hsa-miR-1343-3p
MIMAT0005880
hsa-miR-1290
MIMAT0019957
hsa-miR-4787-3p
According to the specification (e.g., Table 1), SEQ ID Nos: 1-4 are sequences of hsa-miR-5100; hsa-miR-1343-3p; hsa-miR-1290; hsa-miR-4787-3p. Therefore, the oligonucleotides in the 3D-Gene Human miRNA microarray 2specifically targeting the above miRNAs, meet the limitation for polynucleotides capable of specifically hybridizing to "polynucleotides respectively comprising or consisting of nucleotide sequences of SEQ ID NOS: 1-4."
Regarding claims 2-7, 10-16 and 19-20, they are anticipated by 3D-Gene Human miRNA because they do not recite any structural features applicable to the claimed kit.
MPEP§ 2111.04 states: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure."
Claims 2-7, 10-16 and 19 only recite languages that describe instructions for use, without specifying any structure or composition of the kit. In the absence of physical structure that relate to these instructions, and also in the absence of a clear functional or structural relationship within the kit, these instructions in the claims are printed matters with no patentable weight, see MPEP 2111.05.
Claim 20 recites "wherein the biological sample is a liquid biopsy sample selected from a group consisting of a blood sample, a serum sample, a plasma sample, a urine sample, a saliva sample, and a spatum sample, " which does not further limit the claimed kit because the kit is not required to comprise any biological sample.
Therefore, the descriptive languages in claims 2-7, 10-16 and 19-20 do not distinguish the claimed kit from the prior art.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KIDA (KIDA et al.; US20200140956A1 - Kit, device, and method for detecting ovarian tumor; published
2020-05-07).
Regarding claim 1, KIDA teaches a kit comprising at least one nucleic acid that specifically recognize each miRNA in an miRNA biomarker set ([0038] miR-1343, miR-5100, miR-4787; [0039] “miR-5100 is hsa-miR-5100,” etc ; [0041]-[0042] miR-1290 is hsa-miR-1290).
Regarding claim 8, KIDA teaches hsa-miR-5100, hsa-miR-1343-3p, hsa-miR-1290, and hsa-miR-4787-3p ([0038] miR-1343, miR-5100, miR-4787; [0039] “miR-5100 is hsa-miR-5100,” etc ; [0041]-[0042] miR-1290 is hsa-miR-1290 ).
Regarding claim 9, KIDA teaches a kit “comprising a nucleic acid(s) capable of specifically binding to at least one polynucleotide selected from.. miR-1343, miR-5100, miR-4787” ([0038]) and that “the kit further comprises a nucleic acid(s) capable of specifically binding to at least one polynucleotide selected from … miR-1290 ([0041]).
Regarding claim 17, KIDA teaches molecular array ([0052]).
Regarding claim 18, KIDA teaches at least one set of amplification primers ([0874]; [0886] quantitative RT-PCR; [0909]; [0036]; [0073]).
Regarding claims 2-7, 10-16 and 19-20, they are anticipated by KIDA because they do not recite any structural features applicable to the claimed kit.
MPEP§ 2111.04 states: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure."
Claims 2-7, 10-16 and 19 only recite languages that describe instructions for use, without specifying any structure or composition of the kit. In the absence of physical structure that relate to these instructions, and also in the absence of a clear functional or structural relationship within the kit, these instructions in the claims are printed matters with no patentable weight, see MPEP 2111.05.
Claim 20 recites "wherein the biological sample is a liquid biopsy sample selected from a group consisting of a blood sample, a serum sample, a plasma sample, a urine sample, a saliva sample, and a spatum sample, " which does not further limit the claimed kit because the kit is not required to comprise any biological sample.
Therefore, the descriptive languages in claims 2-7, 10-16 and 19-20 do not distinguish the claimed kit from the prior art.
Conclusion
No claims are allowed.
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/TIAN NMN YU/Examiner , Art Unit 1681 /AARON A PRIEST/Primary Examiner, Art Unit 1681
1 The provisional applications disclose only the analysis of public datasets and do not disclose any kit.
2 For general working principles of microarray based on oligonucleotide hybridization to target miRNAs, see Fig. 3B in Pritchard et al.; MicroRNA profiling: approaches and considerations. Nat Rev Genet. 2012 Apr 18;13(5):358-69. doi: 10.1038/nrg3198. PMID: 22510765; PMCID: PMC4517822.