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 the invention of Group 1 (claim 1-7, 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, in the reply filed on 08/28/2025 is acknowledged.
Claim Objections
Claim 3 objected to because of the following informalities: the claim recites “determined from a DNA sample from said subject by buccal swab” where the phrase “determined from a DNA sample from said subject taken by buccal swab” is likely intended. Appropriate correction is required.
Claim 8-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/28/2025.
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.
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 1-7 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.
Claims 1-7 are unclear over recitation of the limitation “comparing the reference recommended daily intake of said nutrient to the personalised recommended daily intake of said nutrient based on the individual's genetic risk score per nutrient for at least one of a plurality of nutrients”, as recited in step (iv) of claim 1, from which claims 2-7 depend. The limitation is unclear over recitation of the phrase “the reference recommended daily intake of said nutrient” because there is no antecedent basis for any “reference recommended daily intake”. The phrase is additionally unclear where step (iii) encompasses more than one nutrient (i.e.: recitation of “at least one of a plurality of nutrients”), as so it is unclear if this aspect of the methods encompasses more than one nutrient, or is intended to be limited to one nutrient. The limitation is additionally unclear because any recommended daily intake of a nutrient may be different depending on the reference subject (e.g.: dependent upon age or sex), and thus a “reference recommended daily intake” is a relative value that is not particularly defined in the scope of the claims.
The phrase is further unclear over the phrase “to the personalized recommended daily intake of said nutrient based on the individual's genetic risk score per nutrient for at least one of a plurality of nutrients”, because there is no antecedent basis for any “personalized recommended daily intake”, nor is there any step of using a risk score to establish a personalized recommended daily intake of a nutrient. Step (iii) of claim 1 is directed to “calculating the individual's genetic risk score per”, but such a calculation is not a step of providing a “personalized recommended daily intake”.
Claim 4 is unclear over recitation of the limitation “wherein the at least one of a plurality of nutrients are selected from the group comprising vitamins and/or minerals”. The use of the open transitional term “comprising” in the recited Markush style group of alternative elements make the claim unclear. See MPEP 2173.05(h): A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. The phrase is additionally unclear over recitation of the alternative members of the “group” (i.e.: vitamins and/or minerals), because where the limitation encompasses only one of the elements, it is not clear that the single element is itself a group.
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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas (e.g.: mental processes, mathematical calculations) and a natural phenomenon without significantly more.
The claim(s) recite(s) methods of determining a recommended daily intake of nutrients, and include “comparing” genotypes (claim 1, step (ii)) and recommended daily intakes (claim 1 (step (iv)), as well as “calculating” as risk score (claim 1, step (iii)). The claims are thus directed to the comparing of collected information, which is and abstract idea that is a mental process (e.g.: MPEP 2106.04(a)(2)(III)(A)); it is the observation and evaluation of information to reach a judgment or conclusion. Where the evaluation of data to reach a conclusion is based in the asserted correlation between gene content and nutrient utilization/intake requirements, such an association is accepted part of how a biological organism functions (i.e.: genotype:phenotype relationships), and as such this element of the claim is a natural phenomenon (e.g.: MPEP 2106.04(b)(I)). The claims additionally recite a step of calculating a score, which is a mathematical calculation (see MPEP 2106.04(a)(2)(I)(C)).
This judicial exception is not integrated into a practical application because there are no practical steps related to the determination of a recommended daily intake for the subject. There are no additional steps of the claims that are directed to applying or using the judicial exception(s) noted above (e.g.: MPEP 2106.04(d)(I)). The claims end with “providing” a recommendation to the subject (step (v) of claim 1), but providing a recommendation is not a practical application of the judicial exceptions; this broadly recited step of providing results is properly considered to be insignificant extra solution activity (see for example MPEP 2106.05(g). Merely presenting the results of a process otherwise unpatentable under section 101 is insufficient to establish eligibility under the statute. See FairWarning IP, LLC v. Iatric Sys., Inc., (Fed. Cir. Oct. 11, 2016) (claim unpatentable despite recitation of the step: "providing notification if [an] event has occurred"). The courts have affirmed that merely collecting data, extracting information from the data and/or storing data are not patent-eligible (see, For example, Content Extraction and Transmission LLC v. Wells Fargo Bank., N.A. 776 F.3d 1343, 112 USPQ2d 1354 (Fed. Cir. 2014) and Electric Power Group LLC v Alstom S.A. CAFC 2015-1778).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims only broadly recite steps of determining a genotype in a sample. However, such steps were well understood, routine and convention in the prior art (e.g.: MPEP 2106.05(d)). For example, the instant specification indicates that the required genotypes were detected in the European 1000 Genome population (page 33 of the specification), and teaches that “SNPs associated with vitamin D level in genome-wide association study (GWAS) literature were extracted from the GWAS catalog (https://www.ebi.ac.uk/gwas/)”. And determination of genotypes, from previously collected data as well as determination via genome-wide genotyping steps, in subjects in the context of nutrient levels was known in the prior art and is taught by Wang et al 2010 (e.g.: see Supplemental Methods).
Claim Rejections - 35 USC § 112 – Written Description
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection of claims for lack of an adequate written in the specification as originally filed is relevant the generic breadth of the structures (i.e.: SNP genotypes) determined in the claims, in combination with the required functionality (i.e.: relevant to a score indicative of recommended intake of any nutrient).
Where the claims generically encompass the detection of any alleles of any SNPs, it is noted that the claims encompass a large breadth of possible structures. A map of the human genome from 2010 (from The 1000 Genomes Project Consortium publication) teaches over 15 million SNPs in the human genome, though it is noted that the claims are not limited to human subjects.
The claims encompass the association of any detected SNP with a score relevant to daily intake of any nutrient (e.g.: any vitamin or mineral).
But the specification teaches only the analysis of genome wide association study (GWAS) data related to vitamin D levels in humans, and that analysis provides only 16 SNPs (Table 1 of the specification) that are used in generating score related to vitamin D levels). Thus there is a large gap between the subject matter encompassed by the claims, and the breadth of the claimed subject matter. Where the specification discloses only limited structures related to human polymorphisms, such a disclosure is not itself a description of other members of the genus by structure, or physical and/or chemical characteristics. Common structural attributes of the species in the genus are not described. The skilled artisan is then left with the teachings of the related art to bridge the gap between the generic breadth encompassed by the claims, and the limited specific teachings of the specification. But while there may be teachings in the prior art with regard to some SNPs being associated with some nutrient levels, such particular teachings also do not establish some defining structures or characteristic of nutrient-related polymorphisms. The association between any SNP and any nutrient level is not apparent a priori based on the SNP structure; the association only comes a posteriori from an analysis of SNP allele and phenotypes. There is no correlation between naturally occurring allelic structures in the genome (as broadly encompassed by the claims) and the function required in the claims. Neither the state of the art, nor the disclosure of the particular SNPs of the specification, provides the skilled artisan with the knowledge to pick from the broadly encompassed genus of SNPs (i.e.: any single nucleotide polymorphism) those particular species of alleles that satisfy the functional limitations of the claims (i.e.: indicative of nutrient requirements). This is relevant where the general unpredictability in genotype:phenotype association studies is recognized in the related art (Lucentini (2004)).
The nature of alleles is that they are variant structures, and in the present state of the art, the structure of one allele does not provide guidance to the existence or structure of other alleles. In other words, the existence and structure of other alleles are not predictable from the particular species disclosed in the specification.
Relevant to the rejection it is noted that the specification also teaches the general methodology for generation a risk score based on known SNP:phenotype associations. However, possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
This finding is also emphasized in Ex Parte Kubin (No. 2007-0819, Bd. Pat. App. & Int. May 31, 2007), wherein it is stated that:
“Although there is often significant overlap” between the enablement and written description requirements, “they are nonetheless independent of each other.” University of Rochester, 358 F.3d at 921, 69 USPQ2d at 1891. An “invention may be enabled even though it has not been described.” Id. Such is the situation here. While we conclude one skilled in the art would have been able to make and use the full scope of claim 73 through routine experimentation, we find Appellants did not describe the invention of claim 73 sufficiently to show they had possession of the claimed genus of nucleic acids. See, e.g., Noelle v. Lederman, 355 F.3d 1343, 1348, 69 USPQ2d 1508, 1513 (Fed. Cir. 2004) (“invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed”).
Thereby, a showing of how to potentially identify polymorphisms or alleles that might be used in the claimed methods is not sufficient to establish that Applicants were in possession of the invention as broadly claimed.
Based on this analysis, one of skill in the art would conclude that applicant was not in possession of the claimed genus because a description of only several members of this genus is not representative of the species in the genus and is insufficient to support the claim.
Claim Rejections - 35 USC § 103
The claims are previously rejected in this Office Action under 35 USC 112(a) for lack of an adequate written description. Here it is noted that while the art teaches particular examples of specific SNP alleles associated with particular nutritional requirements, the particular teachings of the prior art are not sufficient to establish that the prior art provides a description of the full scope of the claimed subject matter. Where the prior art renders obvious a particular embodiment of the claims, the rejection under 35 USC 103 is appropriate.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blander et al (US PG Pub 2018/0261329) in view of McMichael et al (2009).
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).
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 use of a buccal sample (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 Blander 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).
Double Patenting
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 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). Although the claims at issue are not identical, they are not patentably distinct from each other because 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.
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 McMichael et al (2009).
The teachings of the conflicting claims 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 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.
Conclusion
No claim is allowed.
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
Prosecution Insights