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 Group I in the reply filed on 2/9/2026 is acknowledged.
Claims 1-5, 7-11 are pending. Claim 6 has been cancelled.
Claims 9-11 are withdrawn as drawn to a nonelected invention.
An action on the merits for claims 1-5 and 7-8 is set forth below.
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.
Claim 1, 7 and 8 recite the language of “configured to”. As such claims 1-5 and 7-8 are indefinite.
Claim 1 and 7 recites “a reagent configured to detect methylation” which invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification does not teach a specific structure, rather, in paragraph 60 the specification states “reagent is a reagent necessary for the bisulfite treatment described above, a primer, a probe, a methylation-sensitive restriction enzyme or the like”. This limitation is not a specific an clear structure. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim 8 recites “a determination unit configured to determine” which invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification does not teach a specific structure, rather, in paragraph 37 the specification states “the determination unit may detect whether a subject has oral cancer by combining methylation data”. Therefore there is not recitation of a specific structure material or acts for performing. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 1-5 and 7-8 are 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature and abstract ideas without significantly more. The claim(s) recite(s) reagents which are products of nature and a determination unit which is considered an abstract idea. 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 fragments of naturally occurring genes or reagents or the abstract idea of data.
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).
The claim(s) recite(s) a kit comprising reagents. The claimed invention is directed to naturally occurring fragments of a naturally occurring nucleic acids or reagents that comprise enzymes of nature. This judicial exception is not integrated into a practical application because it conveys the same genetic information as the gene itself. 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 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.” Further claim 8 requires a determination unit, which is taught by the specification to be "methylation data" (para 37) and as such recites mental information.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because simply placing a product of nature into a generic container such as a kit, does not add a meaningful limitation as it is merely a nominal or token extra solution component of the claim and is nothing more than an attempt to generally link the product of nature to a particular technological environment.
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) 1-5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Widschwendter et al. (US Patent Application Number 2019/0323090 October 24, 2019).
With regard to claims 1 and 7, the specification states “reagent is a reagent necessary for the bisulfite treatment described above, a primer, a probe, a methylation-sensitive restriction enzyme or the like” (paragraph 60). Widschwendter et al. teaches an enzyme used in bisulphite methylation conversion (para 66 and 101). The limitations of the genes and the subject do not appear to limit the structure of the reagent claimed.
With regard to claim 2-3, the claim appears to limit the structure of the genes, however, this recitation does not alter the reagent claimed.
With regard to claims 4-5, the recitation limits the intended use of the reagent. As the reagent of Widschwendter et al. would be capable of the intended use the structure as provided would be encompassed by the teaching of Widschwendter et al..
Claim(s) 1-5 and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ribeiro et al. (Cell Oncol 2016 Vol 39 p. 573).
With regard to claims 1 and 7, the specification states “reagent is a reagent necessary for the bisulfite treatment described above, a primer, a probe, a methylation-sensitive restriction enzyme or the like” (paragraph 60). Ribeiro et al. teaches primers and probes for the promoter region of KLLN, CASP8, CHFR, GSTP1 (p. 576 and 577).
With regard to claim 2-3, the claim appears to limit the structure of the genes, however, this recitation does not alter the reagent claimed.
With regard to claims 4-5, the recitation limits the intended use of the reagent. As the reagent of Ribeiro et al. would be capable of the intended use the structure as provided would be encompassed by the teaching of Ribeiro et al.
With regard to claim 8, Ribeiro et al. teaches a determination unit as Ribeiro et al. teaches methylation data for the recited genes (Figure 5 and p. 577).
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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