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 .
This Office Action is in reply to Applicants’ correspondence of 03/09/2025.
Applicants’ remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any new grounds of rejection presented in this Office Action are necessitated by Applicants’ amendments. Any rejections or objections not reiterated herein have been withdrawn in light of the amendments to the claims or as discussed in this Office Action.
This Action is made FINAL.
Please Note: The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
In the reply filed on 08/28/2025 Applicants elected, without traverse, the invention of Group 1 (claims drawn to methods comprising SNP profile comparison), and the particular SNP that is rs116970203 (mapped gene PDE3B) listed fifth in Table 1 of the specification.
Claim 8-15 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as set forth on page 2 of the Office Action of 12/08/2025.
Withdrawn Claim Objections
The objection to claim 3, as set forth on page 2 of the Office Action of 12/08/2025, is withdrawn in light of the amendments to the claims.
Withdrawn Claim Rejections - 35 USC § 112 - Indefiniteness
The rejections of claims under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as set forth on pages 2-4 of the Office Action of 12/08/2025, are withdrawn in light of the amendments to the claims.
Withdrawn Claim Rejections - 35 USC § 101
The rejections of claims under 35 U.S.C. 101 as set forth on pages 4-6 of the Office Action of 12/08/2025, is withdrawn in light of the amendments to the claims.
Withdrawn Claim Rejections - 35 USC § 112 – Written Description
The rejections of claims under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as set forth on pages 6-9 of the Office Action of 12/08/2025, is withdrawn in light of the amendments to the claims.
Withdrawn Claim Rejections - 35 USC § 103
The rejection of claims under 35 U.S.C. 103 made over Blander et al (US PG Pub 2018/0261329) in view of McMichael et al (2009), as set forth on pages 10-12, is s withdrawn in light of the amendments to the claims.
New Claim Rejections - 35 USC § 103
Necessitated by Claim Amendments
Claim(s) 1, 2, 4-7, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blander et al (US PG Pub 2018/0261329) in view of Manousaki et al (2020) and Newcombe et al (2019).
Relevant to the methods of the instantly rejected claims, Blander et al teaches methods of providing personalized recommendations related to health for a subject based of genetic information (Abstract). Relevant to claim 1, Blander et al provides for determining a SNP profile in a subject, comparing the subject’s profile to a reference profile of a subject with a known nutrient phenotype, calculating genetic risk scores, comparing the nutrient requirements of the subject as based on the subject’s genetic profile to the nutrient requirements of the reference subject, and providing a recommendation of nutrient intake to the subject (see for example paras 0052-0055).
Relevant to claim 2 and 4-7, Blader et al provides for genetic determinants of high, low, or average levels of various nutrient related biomarkers (e.g.: paras 0052, 0063, 0078) (relevant to claim 2), and teaches that GT genotype for the SNP rs2282679 may inform the user that the long-term response to high-dose vitamin D supplementation may be 9% less efficient, and in such cases, the user may be encouraged to take more vitamin D supplementation (e.g.: para 0073) (relevant to claims 4-6). The reference further teaches that nutrition information can include, e.g., the amount of supplementary nutrition in the food taken by the subject (e.g.: para 0057) (relevant to claim 7).
Relevant to claim 17, Blander et al teaches that nutritional requirements for any individual may be influenced by, and based on, non-genetic factors such as gender and age (e.g.: pare 0049) as well as BMI and ethnicity (e.g.: para 0057).
Relevant to claim 18, Blander et al teaches that determining nutritional requirements of a subject as compared to a reference allows the personalization of the recommended supplementation (e.g.: Fig 1; para 0068).
Blander et al teaches that genetic data may come from labs (e.g.: para 0053), but does not specifically exemplify the determination of genotypes in a sample from the subject (relevant to step (i) of claim 1), or the calculation of a polygenic risk score constructed from a number of weighted SNPs derived from a GWAS where the SNPs are approximately independent. However, the detection alleles content at a plurality if genomic positions associated with nutritional requirements, and the calculation of polygenic risk scores using independent markers were each known in the prior art.
Relevant to the rejected claims, Manousaki et al teaches a genome wide association study (GWAS) to identify alleles of a plurality of SNPs that are associated with vitamin D levels in human subjects, and teaches that understanding the etiology of low vitamin D levels could have important public health implications by prioritizing individuals who would benefit from supplementation. Manousaki et al teaches the analysis of SNP content determined from DNA from blood samples (e.g.: Supplemental Methods - Genotype QC and Imputation in UK Biobank) (relevant to step (i) of claim 1).
Further relevant to the rejected claims, Newcombe et al teaches methods for constructing genome‐wide polygenic risk scores from GWAS data. Newcombe teaches methods that include determining allele effect sizes as weights from a training population (e.g.: p.733 - 2.1 - Inference of multivariate polygenic weights from univariate summary data; Figure 1 legend) and the pruning of SNPs that are in LD to ensure that SNPs used in a polygenic risk score are independent (e.g.: p.735 - Cross‐validation in the Welcome Trust Case Control Consortium).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have performed the genotype-based and nutrient intake recommendation methods of Blander et al using polygenic risk scores calculated using the methods of Newcombe et al and using SNPs associated with vitamin D levels (as taught by Manousaki et al). The skilled artisan would have been motivated to use the polygenic risk score calculation methods of Newcombe et al based on the expressed teachings of Newcombe et al that such methods have improved accuracy in associating genotype with phenotypes, and that such methods are offer robust predictive performance. The skilled artisan would have a reasonable expectation of success based on the expressed teachings of Manousaki et al that a plurality of SNPs are demonstrated to have alleles associated with vitamin D levels as determined by GWAS. With regard to step (vii) of claim 1, it would be obvious to in fact administer a supplementation to a subject determined to be in need of supplementation because the skilled artisan would understand that administering the recommended treatment would be needed to actually provide the physiological benefit that is determined to be need by a subject based on the genetic content of the subject.
Response to Remarks
Applicants haver traversed the rejection of claims made under 35 USC 103 as set forth in the previous Office Action. Applicants have argued (p.11-12 of the Remarks of 03/09/2026) that the amended claims require calculation of a polygenic risk score using SNPs genotyped in a GWAS and selected to be approximately independent. The argument has been considered but is not persuasive in light of the newly applied prior art (Manousaki et al (2020) and Newcombe et al (2019)) cited in the rejection.
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Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blander et al (US PG Pub 2018/0261329) in view of Manousaki et al (2020) and Newcombe et al (2019), as applied to claims 1, 2, 4-7, 17 and 18 above, and further in view of McMichael et al (2009).
Blander et al in view of Manousaki et al and Newcombe et al renders obvious methods of determining a recommended daily intake of nutrients, and administering a supplement based on that recommendation, including calculation of a polygenic risk score using SNPs selected to be approximately independent..
Blander et al in view of Manousaki et al and Newcombe et al does not specifically teach a buccal swab as a source, of DNA for determining a SNP genotype profile, but such methods were known in the prior art.
McMichael et al teaches the high throughput detection of SNPs using DNA obtained from human subjects with the Catch-All buccal swab and Isohelix buccal DNA extraction kit (p.233 - High-Throughput Application).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have performed the methods rendered obvious by Blander et al in view of Manousaki et al and Newcombe et al using a buccal sample as a source of DNA from a subject as taught by McMichael et al. The skilled artisan would have been motivated to use the methods of McMichael et al, and would have had a reasonable expectation of success in using the methods of McMichael et al, based on the expressed teachings of McMichael et al that such methods provide a convenient and reliable method for collection of genetic material, which is inexpensive, noninvasive, and meets the quantitative and qualitative requirements for SNP analysis on an automated platform (p.234 – Discussion).
Double Patenting
Modified as Necessitated by Claim Amendments
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4-7, 17 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/711,189 (reference application), in view of Manousaki et al (2020) and Newcombe et al (2019).
The claims of the conflicting application are directed to the classifying subjects using polygenic risk scores calculated from SNP genotypes and predetermined risk scores associated with daily dose nutrition requirements, and identifying a recommendation to the classified subject.
The claims of conflicting application do not set forth the calculation of a polygenic risk score constructed from a number of weighted SNPs derived from a GWAS where the SNPs are approximately independent. However, the detection alleles content at a plurality if genomic positions associated with nutritional requirements, and the calculation of polygenic risk scores using independent markers were each known in the prior art and are taught by Manousaki et al and Newcombe et al, the teachings of each of the references has been detailed previously in this Office Action.
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have performed the genotype-based and nutrient intake recommendation methods of the conflicting claims using polygenic risk scores calculated using the methods of Newcombe et al and using SNPs associated with vitamin D levels (as taught by Manousaki et al). The skilled artisan would have been motivated to use the polygenic risk score calculation methods of Newcombe et al based on the expressed teachings of Newcombe et al that such methods have improved accuracy in associating genotype with phenotypes, and that such methods are offer robust predictive performance. The skilled artisan would have a reasonable expectation of success based on the expressed teachings of Manousaki et al that a plurality of SNPs are demonstrated to have alleles associated with vitamin D levels as determined by GWAS. With regard to step (vii) of claim 1, it would be obvious to in fact administer a supplementation to a subject determined to be in need of supplementation because the skilled artisan would understand that administering the recommended treatment would be needed to actually provide the physiological benefit that is determined to be need by a subject based on the genetic content of the subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of copending Application No. 18/711,189 in view of Manousaki et al (2020) and Newcombe et al (2019), as applied to claims 1, 2, 4-7, 17 and 18 above, and further in view of McMichael et al (2009).
The teachings of the conflicting claims in view of Manousaki et al and Newcombe et al are detailed in the rejection above.
The conflicting claims do not specifically recite use of a buccal sample (relevant to instantly rejected claim 3). However, the detection of SNP content in buccal samples from subjects was known in the prior art and is taught by McMichael et al.
McMichael et al teaches the high throughput detection of SNPs using DNA obtained from human subjects with the Catch-All buccal swab and Isohelix buccal DNA extraction kit (p.233 - High-Throughput Application).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have performed the genotype-based and nutrient intake recommendation methods of the conflicting claims of copending Application No. 18/711,189 in view of Manousaki et al and Newcombe et al with SNP allele information collected by the methods of McMichael et al. The skilled artisan would have been motivated to use the methods of McMichael et al, and would have had a reasonable expectation of success in using the methods of McMichael et al, based on the expressed teachings of McMichael et al that such methods provide a convenient and reliable method for collection of genetic material, which is inexpensive, noninvasive, and meets the quantitative and qualitative requirements for SNP analysis on an automated platform (p.234 – Discussion).
This is a provisional nonstatutory double patenting rejection.
Response to Remarks
Applicants have acknowledged (p.12-13 of the Remarks of 03/09/2026) the rejection of claims for issues related to double patenting.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN THOMAS KAPUSHOC whose telephone number is (571)272-3312. The examiner can normally be reached M-F, 8am-5pm.
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
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