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 .
The claims dated 8/5/2024 are under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 2 and 4, in the reply filed on 2/4/2026 is acknowledged.
Claims 6, 7, 9, 11, 14, 15, 16, 18, 20, 22, 24, 26, 30, 32, 33, 34, 53 and 55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/4/2026.
Priority
The present application is a 371 national stage entry of PCT/US2022/017697 (filed 2/24/2022), which claims benefit of US provisional application 63/153,231 (filed 2/24/2021).
Priority to the 63/153,231 application is recognized.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on a submitted IDS, they have not been considered.
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, 2 and 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions without significantly more.
The claims recite a series of steps and are drawn to a process, one of the four statutory categories.
The claim(s) recite(s):
“selecting a plurality of ancestry-informative SNP markers” (claim 1); and
“calculating a fractional heritage in the genotype of the subject for each of the different heritage populations based on the plurality of ancestry-informative SNP markers” (claim 1).
The step of “selecting” broadly encompasses an abstract idea as it may be performed purely in the human mind. The claims encompasses choosing two SNPs based on three criteria, each of which individually and as whole may be carried out by considering and evaluating a limited amount of information.
The step of “calculating” broadly encompasses an abstract idea in the form of a mathematical equation and because it may be performed purely in the human mind. The claim encompasses using equations to determine a percentage of SNPs derived from two heritages and/or looking at known SNP data to determine the amount of SNPs contributed by two heritages.
This judicial exception is not integrated into a practical application because the step of “measuring a genotype of the subject” is a data gathering step. The above judicial exceptions are not integrated into a practical application because the claims do not involve:
improvements to the functioning of a computer or to any other technology or technical field;
applying or using the judicial exceptions to effect a particular treatment or prophylaxis for a disease or medical condition;
applying the judicial exception with, or by use of, a particular machine; or
effecting a transformation or reduction of a particular article to a different state or thing.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims encompass the use of NGS or a sequencing chip (para. 33 of the instant specification), methods that are well-known and used in a conventional manner.
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 1, 2 and 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites “the SNP markers substantially cover the entirety of the human genome”. It is unclear what is required by the claim for the “SNP markers” to “substantially” cover the human genome. Does the claim require “SNP markers” for each chromosome? Does the claim require the “SNP markers” to be located across 90% of each chromosome? Does the claim require “SNP markers” for a majority of the chromosomes?
Claims 2 and 4 depend from claim 1 and are rejected for the same reason.
Regarding claim 1, the claim is incomplete as the claim does not require “measuring” or “genotyping” any of the selected “ancestry-informative SNP markers”. The genotypes are necessary for carrying out the “calculating” step.
Claims 2 and 4 depend from claim 1 and are rejected for the same reason.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2 and 4 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Gaskin (US 2007/0037182 A1).
Regarding claim 1, Gaskin teaches selecting a “plurality of ancestry-informative SNP markers” (para. 291). The SNPs are selected based on: a genomic frequency of >1%, e.g., 5%, 50% or 100% (para. 291); cover all 23 pairs of chromosomes (para. 34, 79; and Fig. 8); and have different frequencies in different heritage populations (Table 4 and 6).
Gaskin teaches measuring a genotype of a subject (para. 26).
Gaskin teaches a fractional heritage in the genotype of the subject for each of the different heritage populations based on genotypes of the individual (para. 26 and 31) as represented in Figs. 2, 3, 4, 6, 7 and 9.
Regarding claim 2, Gaskin teaches the SNPs have different frequencies in three different heritage populations (para. 31; Table 4 and 6).
Regarding claim 4, Gaskin teaches the between 10 to 50,000 SNPs are included (para. 226, 231, 259, ; Table 4 and 6).
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/JOSEPH G. DAUNER/Primary Examiner, Art Unit 1682
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