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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/09/2026 has been entered.
Applicant’s election of Group II and the species of miR-4443 in the reply filed on 7/24/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13-17 and 20-22 are pending.
It is noted that the elected species of MiR 4443 has been cancelled and as such the next species will be examined.
Claims 1-12 and 18-19 have been cancelled.
The following rejections are newly applied as necessary by amendment.
This action is NONFINAL.
Claim interpretation
The claims are drawn to a kit. The kit requires “reagents necessary to determine in a sample…”. Therefore the claims are interpreted as requiring “reagents”. It is noted that the recited ratios of biomarkers do not necessarily limit the reagents required by the kit.
Withdrawn Rejections
The 35 USC 35 USC 102 rejections made in the previous office action is withdrawn based upon amendments to the claims which modified the species of miRNA.
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 13-17 and 20-22 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.
Claims 13-17 and 20-22 are indefinite over the recitations of “using a technique” and “instructions for performing”. MPEP 2173.05 states a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). In Katz, a claim directed to “[a] system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Katz, 639 F.3d at 1318, 97 USPQ2d at 1749 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited “an input means” and required a user to use the input means was found to be indefinite because it was unclear “whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.”); Ex parteLyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph).
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 13-17 and 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more. The claim(s) recite(s) reagents that can encompass reagents such as miRNAs and water which represent fragments of naturally occurring nucleic acids. This judicial exception is not integrated into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the structures do not include anything other than a component that is found in nature. The recitation samples encompasses fragments of products of nature.
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]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); 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).
The claimed invention is directed to naturally occurring fragments of a naturally occurring nucleic acids as the claims encompass fragments of the samples that are naturally occurring. These molecules are not patent eligible, whether isolated or not, pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics Inc., US (June 13, 2013). The Supreme Court has made clear "separating [DNA] from surrounding genetic material is not an act of invention" Myriad, 133 S. Ct. at 2117. This judicial exception is not integrated into a practical application because they convey the same genetic information as their naturally occurring counterparts. 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 probe or 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 probe hybridizes to its complementary nucleotide sequence. Thus, just as in nature, probes utilize the innate ability of DNA to bind to itself.”
Response to arguments
The reply traverses the rejection. A summary of the arguments is provided below with response to arguments following. The reply asserts that the claim has been amended to demonstrate an integration (p. 2). The reply asserts that the claim provides an improvement over the state of the prior art (p. 2).
This argument has been review but have not been found persuasive.
The structure claims is broad as it only requires reagents that would be capable of determining a ratio. Ratios are mathematical components and therefore do not limit a structure of reagents. It appears that the reagents are based upon compositions that are used in the techniques listed in claim 13. Regents therefore would encompass any of these types of reagents including water, buffer, polymerases, for example. As such the claims broadly encompass components that are not different from those naturally occurring. The recitation of additional steps in the instructions is not considered a modification of the structure as the instructions appear to be considered a written report. Furhtermore the arguetmsn has not provided that the structure claimed is considered an improvement.
Newly Applied 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) 13-17 and 20-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown et al. (US Patent Application 2007/0161004 July 12, 2007)
With regard to claim 13,16-17 Wilson et al. teaches reagents for assaying to determine ratios of miR21, miR 182 (see 318). As such Brown et al teaches “reagents necessary to determine”. With regard to the preamble, this is interpreted as the intended use of the claims. As Brown et al teaches the claimed structure it would be capable of the recited intended use of “necessary to determine”.
The limitation that the kit contains instructions, the inclusion of instructions is not considered to provide a patentable limitation on the claims because the instructions merely represent a statement of intended use in the form of instructions in a kit. See In re Ngai, 367 F.3d 1336, 70 U.S.P.Q.2d 1862 (Fed. Cir. 2004) (holding that an inventor could not patent known kits by simply attaching new set of instructions to that product). The limitation of “with instructions for …” is considered printed instructions and does not limit the required structures. The term “kit” does not provide any structural limitations other than the structures recited.
With regard to claims 14-15 Brown teaches bladder tissues samples (para 362). It is further noted that the sample is not included in the kit, rather only the reagents and as such the samples are not required by the structures of the kit.
With regard to claims 20-22, these claims do not limit the structures of the claimed invention, but rather limit the language recited in the instructions. The limitation that the kit contains instructions, the inclusion of instructions is not considered to provide a patentable limitation on the claims because the instructions merely represent a statement of intended use in the form of instructions in a kit.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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