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 .
DETAILED ACTION
Status of Claims
Claims 1-5 are pending. Claims 1-4 are the subject of this NON-FINAL Office Action. This is the first office action on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-4) and the gene species of GOT2 in the reply filed on 04/24/2026 is acknowledged. Claim 5 is withdrawn.
Claim Interpretations
The claims are littered with intended uses that fail to distinguish the claimed composition/product over the prior art products. For example, in claims 1 and 3, the preambles merely state intended uses of the generic “gene testing reagent.” The preamble of claim 1 states “kit for judging sensitivity of a patient to liver cancer drug Sorafenib”; claim 3 states “kit for predicting long-term prognosis of a liver cancer patient.” This fails to distinguish the “gene testing reagent” in the body of the claim from prior art “gene testing reagent.” See MPEP § 2111.02.
Similarly, “the gene testing reagent is a reagent for measuring expression levels of [a gene]” merely recites an intended use of the “gene testing reagent,” not its actual structure and/or composition. Thus, the “gene testing reagent” is anything capable of being used in any assay to measure gene expression levels (e.g. water, MgCl2, polymerase, primer, probe, miRNA, aptamer, buffer, etc.).
Duplicate Claim Warning
Claims 3-4 are substantial duplicates of claims 1-2. The only difference between claims 1 and 3 are the preambles. The claims do not differ in the body of the claims. Thus, claims 1 and 3 do not substantially differ in scope because the preambles fail to further limit the body of the claims. See MPEP § 2111.02.
Applicant is advised that should claims 1-2 be found allowable, claims 3-4 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejection - 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 a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Specifically, the claims are directed to natural sequences and other natural products (e.g. water), without significantly more.
First, under Step 1, the claims are directed to a “gene testing reagent,” which is broadly interpreted in light of the specification as any generic thing capable of being used in any assay to measure gene expression levels (e.g. water, MgCl2, polymerase, primer, probe, miRNA, aptamer, buffer, etc.). Thus, the claims are directed to products.
Under step 2A, the claimed “gene testing reagent” (e.g. oligo) is clearly a natural sequence such as a primer, probe or other oligo with natural gene sequences. See MPEP § 2106.04(b)(II).
As to steps 2A-2B, none of the claims recite additional elements that render the natural sequences markedly different from a product of nature. Claims 2 and 4 merely recite primer or probe, but these are all structures that carry a mere natural sequence without any other non-natural component. See MPEP § 2106.04(c). Thus, nothing in the claims recites additional components that render the product claims markedly different from a natural sequence, or natural product such as water.
Thus, the claims fail to pass muster under Section 101.
Claim Rejection - 35 USC § 112 – Written Description
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-4 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the full scope of the claimed invention.
The eight-page specification fails to demonstrate possession of any “gene testing reagent.” In fact, the specification only discloses one generic example of a primer or probe. No other examples are provided. Moreover, this single primer/probe example is so abstract and generic that Applicants never provide detail as to what kind of primers or probe, where on the genes they are located, much less any design requirements, or assays. This is because the bare eight-page specification is directed to the wish or plan to develop an assay that might be able to determine HCC Sorafenib responsiveness using publicly available database mining. Applicants have not actually developed any assays.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.”’ Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353–54 (Fed. Cir. 2010) (en banc). Whether the disclosure of a patent satisfies the written description requirement is a question of fact. See id. at 1351. The test for sufficiency of the written description support is “whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date sought.” Id. This “possession” test “requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. Possession shown by evidence “outside of the specification is not enough,” and “a description that merely renders the invention obvious does not satisfy the requirement.” Id. at 1352. Instead, it is the specification itself that must demonstrate possession. Id.
Where, as here, a genus is claimed using functional language to define a desired result, “the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” Id. at 1349; AbbVie Deutschland GmbH v. Janssen Biotech, Inc., 759 F.3d 1285, 1299 (Fed. Cir. 2014). A “sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad Pharms., 598 F.3d at 1350. Such correlations may be established “by the inventor as described in the specification,” or they may be “known in the art at the time of the filing date.” See AbbVie, 759 F.3d at 1301. And any claimed functions of the various generic terms and phrases that “merely draw[s] a fence around the outer limits of a purported genus [and] is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” See Ariad, 598 F.3d at 1350.
Here, the specification simply never explains in any detail whatsoever what is a “gene testing reagent.” The specification merely repeats the claim language that it is “for measuring [genes],” and mention generic primer or probe. However, the specification completely fails to describe any species. In light of this complete dearth of species and detail, the “gene testing reagent” is not described in any detail that approaches anywhere near “full, clear, concise, and exact terms.”
Claim Rejections - 35 USC § 112- Indefiniteness
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.
Claim 1-4 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 pre-AIA the applicant regards as the invention.
The metes and bounds of “gene testing reagent” are unclear because the specification completely fails to provide any boundaries to this phrase. A single example of primer or probe is provided in the eight-page specification. That’s all. Does this generic phrase include water, buffers, aptamers, miRNA, antibodies, barcode oligos, sequencing adaptors? The list of vastly different possible species is endless. In light of the ambiguity as to the meaning of this generic functional phrase, and a complete lack of a definition in the specification, the metes and bounds are entirely unclear.
Giving “gene testing reagent” it’s only possible clear meaning from the specification (primer or probe), it is not clear from claims 1 and 3 whether the single “gene testing reagent” is intended to measure expression of all genes listed; less than all genes; or only one. These claims recite a kit “comprising a gene testing reagent . . . for measuring expression levels of an LDHA gene, an STC2 gene . . . and an SLC2A2 gene.” This use of “and” introduces the confusion. As a factual matter, a single “gene testing reagent” (such as a primer or probe) can generally only be used to measure one gene due to lack of homology between different genes. Moreover, a “gene testing reagent” (such as a primer or probe) that measures one gene with low homology to another gene would not be expected to specifically measure the other gene.
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 –
(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 WANG (US 20200032345).
As to claims 1-4, WANG teaches kits with primer or probe to GOT2 (Abstract, paras. 0002, 0006, 0197, 0278, 0280). It is also noted that the intended use of the primer or probe is to detect gene expression of GOT2 in order to determine whether an HCC patient should receive TACE, or proceed to Sorafenib (paras. 0306-10).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aaron Priest whose telephone number is (571)270-1095. The examiner can normally be reached 8am-6pm.
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/AARON A PRIEST/Primary Examiner, Art Unit 1681
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