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 II, claims 6-8, and species rs73375428 in the reply filed on 06/16/2026 is acknowledged.
Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/16/2026.
Claims 6-8 are under examination with respect to rs73375428.
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 6-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception, a law of nature without significantly more.
The claims recite a composition for predicting likihood of brain amyloid-beta deposition, the composition containing an agent capable of detecting an APOE e4 genotype at least one SNPE genotype including rs73375428. The claims are drawn to a composition of matter and encompasses a natural phenomenon. The claims are drawn to a composition that comprises primer, probes, antisense oligonucleotide that bind to APOE e4 genotype or rs73375428. Because the claims are drawn to agents that comprise primers, probes and oligonucleotides the claims comprise nucleic acid sequences to known naturally occurring nucleic acids of APOE e4 and rs73375428 and therefore the claims encompass a law of nature. Nucleic acid molecules that are identical to fragments of naturally occurring nucleic acids are naturally occurring sequences. The specification does not define agent or primer, probe or antisense. There is no recitation within the claims that indicate that the composition claimed have any structural or functional characteristics that differ from the naturally occurring nucleic acids.
This judicial exception is not integrated into a practical application because the claims recite agents, primers and probes that are naturally occurring sequences and the agent, primer and probe detect naturally occurring sequences. The recitation of agent, primer or probe is nothing more than an attempt to generally link the product of nature to a technological environment and is a nominal extra solution component of the claim and does not structurally change the nucleic acids sequence. Many cited prior art references in this record demonstrate the agent, primer, probe and oligonucleotides are naturally occurring sequences.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims as a whole are not considered to recite any additional elements that amount to significantly more than the naturally occurring nucleotide sequences. Besides the nucleic acids, the claims recite a composition in the preamble with an intended use. Additional claims recite a kit comprising the composition. The recitation of a kit or composition does not structurally change the recited agent, and the agent has been given its broadest reasonable interpretation to include nucleic acids. At the time the invention was made, a kit was well-established, routine and conventional. Additionally, where a composition such as a kit is recited at such a high level of generality it does not meaningfully limit the claim. Thus, the claims as a whole does not amount to significantly more than each “product of nature” by itself and the claims do not qualify as eligible subject matter.
Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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. Claim 8 recites a kit comprising the composition of claim 6. Claim 8 does not require any other limitations other than the composition of claim 6. The recitation of kit does not encompass any additional elements. The kit comprising the composition of claim 6 does not further limit claim 6 as it requires all the elements of claim 6 with no additional elements. 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
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 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reeves (US 6399364).
Reeve et al teach compositions comprising all possible "N mer" oligonucleotides or subsets thereof "where N is preferably from 5 to 10, particularly 8 or 9" (see, e.g., col. 2, lines 62-67; claims 11 and 12; quotation from col 2, lines 63-65). Reeve et al teach that each of the 5 to 10 N-mers is labeled with a detectable moiety that is a detected by fluorescence, and particularly detectable moieties that are fluorophores (see, e.g., col. 2, lines 62-67; col. 3, lines 18-21; col. 10, line 1). Given that Reeve teaches compositions comprising all possible 5-10mers, it is a property of at least one of the nucleic acids in the composition that it comprises an agent and probe that will specifically bind to a nucleotide sequence comprising the APOE e4 genotype or rs73375428.
Regarding the preamble of the claims, as noted in the MPEP 2111.02, if “the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention' s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997). In Pitney Bowes Inc. v. Hewlett-Packard Co., 182F.3d 1298, 1305, 51 USPQ2d 1161, 1166 (Fed Cir. 1999) the court held that if the body of the claim sets forth the complete invention, and the preamble is not necessary to give “life, meaning and vitality” to the claim, “then the preamble is of no significance to claim construction because it cannot be said to constitute or explain a claim limitation.” In the present situation, the claim language of “for predicting likelihood of brain amyloid-beta deposition” is a statement of purpose and intended result and does not materially affect the structural properties of the composition. Thereby, the intended use of the composition does not materially distinguish the claimed composition over the prior art.
Further, it is noted that the claims recite the open claim language of “comprising” and thereby the recited compositions may include any number of nucleic acid probes in addition to the first and second nucleic acid probes. The recitation of “kit” in claim 8 is not defined in the specification and is given its broadest reasonable interpretation to include a plurality of articles grouped together, wherein the plurality of articles is a composition comprising an agent capable of detecting an APO e4 genotype and rs73775428, which is disclosed by Reeve.
Claims 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hexanucleotide Mix of Boehringer Mannheim (1997).
The Boehringer Mannheim provides a kit comprising a hexanucleotide mix that
is a mixture of hexamer nucleotides of all possible sequences for random-primed DNA labeling. The hexanucleotide mixture is provided as a kit that comprises primers, PCR reagents, and instructions. This kit is considered to comprise probes or primers for determining and binding APOE e4 and rs733754285 because the random primers could be used to amplify and specifically bind to APOE e4 and rs73375428, for example. Thus, the kit provided by Boehringer Mannheim meets the limitation of the claims. It is further noted that the recitation of “predicting likelihood of brain amyloid-beta deposition” is an intended use for the claim which does not appear to impart any structural limitation on the claim. The kit taught by Boehringer Mannheim could be used for this purpose.
Claims 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nauck (Clin Chem, 2000, vol 46, pp 722-724).
Nauck teaches genomic DNA and Ape mutation detection kit in a composition (see pg. 723, 1st column). The genomic DNA disclosed by Nauck comprises rs73375428. Nauck discloses primers for amplification of APOE mutations, as such the composition comprising a genomic DNA and primers for APOE e4 comprises a composition containing an agent capable of detecting APOE e4 and rs73375428, including a primer set that specifically binds to a sequence comprising APOE e4 and a kit comprising primers. It is noted that the recitation of rs73375428 encompasses either allele and encompasses only the allele at this location, it does not comprise additional sequence, as such any of the primers of the APOE detection kit can detect either allele at position rs73375428 and alternatively the genomic DNA comprises either allele at position rs73375428.
Claims 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (Alheimzer’s Research and Therapy, 2021, 13:117, pp 1-11, cited on IDS).
Kim teaches using Illumina Asian Screening array beadhchip for SNP markers (see genotyping and imputation). Kim teaches the array was used for screening genotypes, including rs7337548 and SPOE variants (see pg. 9, 2nd column). Therefore the array comprises agents and probes for detecting APOE e4 and rs7337548. The array further is a kit that comprises agents for detecting APOE e4 and rs7337548.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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/SARAE L BAUSCH/ Primary Examiner, Art Unit 1699
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