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 .
Status of Claims
Claims 1-20 are currently pending and examined on the merits.
Specification
The disclosure is objected to because of the following informalities: The specification is silent to the definition of “EPHT”, and the examiner interprets this as “Expressed Phenotypic Health Traits”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“…a means for identifying a plurality of influenced biochemical pathways…” (clm. 17, ln. 1);
“… a means for identifying an activity that affects at least one of the influenced biochemical pathways…” (clm. 17, ln. 2);
“…a means for recommending the activity for the individual…” (clm. 17, ln. 2-3);
“… a means for identifying an expressed phenotypical health trait…” (clm. 18, ln. 1);
“…a means for identifying a second gene…” (clm. 20, ln. 1);
“…a means for determining that the second gene also influences a second phenotypical health trait…” (clm. 20, ln. 1-2); and
“…a means for not recommending a second activity…” (clm. 20, ln. 2-3)
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
In cases involving a special purpose computer-implemented means-plus-function limitation, the Federal Circuit has consistently required that the structure be more than simply a general-purpose computer or microprocessor and that the specification must disclose an algorithm for performing the claimed function. See, e.g., Noah Systems Inc. v. Intuit Inc., 675 F.3d 1302, 1312, 102 USPQ2d 1410, 1417 (Fed. Cir. 2012); Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239.
On paragraphs 0006 and 0010, the applicant describes aspects of the claimed system as including a “means for identifying…”, “…a means for indicating a genetic makeup of the individual”, “…a means for recommending…” (para. 0006), “…a means for determining…” (para. 0010); however, the applicant’s specification does not disclose a specific physical processor or computer to execute these means.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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 17-20 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.
Claim 17 recites a system comprised of various means:
“a means for identifying” a plurality of biochemical pathways that influence a plurality of phenotypical health traits
“a means for indicating” a genetic makeup of the individual
“a means for identifying” an activity affecting at least one of the influenced biochemical pathways and,
“a means for recommending” the activity to enhance gene expression tied to influencing a phenotypical health trait among a set of given traits.
The claims do not disclose a particular structure, material, or acts to perform the aforementioned means. The applicant merely repeats the inclusion of a “means” in the disclosure of the specification without a structure associated with said means. The applicant discloses information about genetic testing on paragraphs 0043 and 0044 of the specification, noting that phenotypic health traits (PHTs) may be inferred via “an indirect means such as a questionnaire or interview”, but these acts are not related to, do not reference, nor do they directly encapsulate any of the means disclosed in the claims. The inclusion of “such as” does not explicitly disclose genetic testing as the “means for…” disclosed in the claims. The applicant also discloses in paragraphs 0040-0043 that a pathway database, a health trait database, and an activity database can be produced by reviewing research publications and entering their findings into “the appropriate database”. The specification does not disclose definitions of the explicit type of or components of said databases, nor does the specification disclose active steps linking genetic testing to the aforementioned databases. In paragraph 0044, the specification discloses that “… questionnaires may also be automatically analyzed to infer PHTs”, but does not disclose active steps to do said analysis. In paragraphs 0045-0054, and in reference to Fig. 1 and Fig. 2. the applicant discloses that “A DNA test result can be obtained via genetic testing of the individual. Such testing is often performed by professional genetic testing laboratories. The DNA test result can include a number of gene indicators that indicate the individual's genetics. Pathway and genetic analysis can use the DNA test results and a pathways database to calculate biochemical pathway scores…”, but there is no disclosure of active steps to derive said calculation of biochemical pathway scores. Paragraph 0062 of the specification denotes the association of gene correlations to the calculation of pathway scores, stating “The values for the gene correlations…can be assigned based on the scientific and research literature reporting the effects of the genes on the biochemical pathways…The gene correlations can be numerical values with larger numbers indicating greater correlation (e.g., the gene more strongly influences the pathway) between a gene and a biochemical pathway…”, but the specification does not state an equation explicitly denoted as claimed in the invention.
Furthermore, the specification discloses on paragraph 0045 “biochemical pathway scores”, which the specification discloses can be used in concert with the aforementioned health trait database to “calculate phenotypical health trait scores”. However, the specification is silent to how these biochemical pathway scores are explicitly calculated; on paragraph 0062 of the specification and on Fig. 8, the applicant does disclose biochemical pathway score initialization via a provided an example. Although this example discloses summations of gene correlations and pathway scores, the specification is silent to, nor does it claim or disclose, an explicit formula or series of active steps to define said score or gene correlations.
Additionally, Although paragraph 0063 of the specification (in reference to Fig. 9) does disclose a process to “receive the identified EPHTs of an individual,” which are also disclosed to “…be determined from a questionnaire, a remote interview, an in-person interview, an in-person examination, a telemedicine examination, etc…” the specification does not explicitly disclose active steps linking the various methods of data collection listed (questionnaire, etc.) to the derivation of EPHT, does these methods explicit relate to the means disclosed in claim 17.
Therefore, both the claims and specification are silent as to the definition of the means disclosed in claim 17.
Claim 18 recites:
“a means for identifying an expressed phenotypical health trait of the individual, wherein the activity is recommended to enhance the expressed phenotypical health trait.”
As previously stated, the specification is silent to active steps detailing the means for identifying an expressed phenotypical health trait. The specification merely restates the claim. Paragraph 0046 of the specification discloses “health trait and activity analysis” that may produce a recommendation but does not disclose active steps of said analysis. Therefore, both the claims and specification are silent as to the definition of the means disclosed in claim 18.
Claim 20 recites:
“The system of claim 17 further including: a means for identifying a second gene that influences the phenotypical health trait; a means for determining that the second gene also influences a second phenotypical health trait; and a means for not recommending a second activity wherein expression of the gene and of the second gene is enhanced by the second activity.
As previously stated, the specification is silent to active steps detailing the means for identifying a second gene that influences the phenotypical health trait; a means for determining that the second gene also influences a second phenotypical health trait; and a means for not recommending a second activity wherein expression of the gene and of the second gene is enhanced by the second activity. In paragraph 0067-0068 of the specification, the applicant discloses a description of a side effect scoring function, but the specification and the figures referenced (Fig. 5-6; Fig. 8, Fig.10-12) is silent as to specific functions or acts defining the results of score calculations. The specification states on para. 0067 “… the scoring function can be the side effect score (calculated in FIG. 12). In another example, the scoring function can be the activity score of the candidate activity (calculated in FIG. 11) minus the side effect score. The selected candidate activity can be recommended to the individual,” however, these scores are not precluded by specific and explicit functions detailed in the specification or claims. Additionally, although the specification does disclose a side effect scoring function (“…activity score minus side effect score…”), the specification is silent as to the functions generating each individual component for the variables within the scoring function, nor are they well-understood, routine and conventional activity in the art. Therefore, both the claims and specification are silent as to the definition of the means disclosed in claim 20.
Original, amended, or new claims are each given their broadest reasonable interpretation in light of, and consistent with the written description of the invention. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or how the result is to be achieved.
As set forth in MPEP 2161, 2181 and 2185, the claims must be supported by adequate written description of the step-by-step directions, algorithms, or structures to carry out the claimed steps. Functional claim limitations may be adequately described if: (1) The written description adequately links or associates adequately described particular structure, material, or acts to perform the function recited; or (2) it is clear based on the facts of the application that one skilled in the art would have known what specific structure, material, or acts disclosed in the specification perform the specialized function. See Aristocrat Techs. Australia PTY Ltd. v. Int’l Game Tech., 521 F.3d 1328, 1336-37, 86 USPQ2d 1235, 1242 (Fed. Cir. 2008). As stated previously, as the applicant does not disclose the composition or makeup of said modules in the claims or specification, the written description does not adequately link or associate adequately described particular structure, material, or acts to perform the function recited, nor it is clear based on the facts of the application that one skilled in the art would have known what specific structure, material, or acts disclosed in the specification perform the specialized function. Additionally, in the specification within paragraphs 0033-0039 and 0080-0090, the applicant simply reiterates the function of the modules without disclosing corresponding structure, material or act that performs the entire claimed function.
Merely restating a function associated with a means-plus-function limitation is insufficient to provide the corresponding structure for definiteness. See, e.g., Noah, 675 F.3d at 1317, 102 USPQ2d at 1419; Blackboard, 574 F.3d at 1384, 91 USPQ2d at 1491; Aristocrat, 521 F.3d at 1334, 86 USPQ2d at 1239. It follows therefore that such a mere restatement of function in the specification without more description of the means that accomplish the function would also likely fail to provide adequate written description under section 112(a) or pre-AIA section 112, first paragraph (MPEP 2181). The applicant can overcome this insufficiency by disclosing a structure, material or act that performs the entire claimed function in the claim or specification.
Claim 19 does not provide any particular structure, material, or acts to perform the aforementioned means of claim 17.
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 17-20 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.
The following terms are a relative term which render the claim indefinite:
“…a means for identifying …” (clm. 17, ln. 1);
“… a means for identifying …” (clm. 17, ln. 2);
“…a means for recommending …” (clm. 17, ln. 2-3);
“… a means for identifying …” (clm. 18, ln. 1);
“…a means for identifying …” (clm. 20, ln. 1);
“…a means for determining …” (clm. 20, ln. 1-2); and
“…a means for not recommending …” (clm. 20, ln. 2-3)
The terms are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 19 does not provide any definition for the mean terms recited in claim 17.
Claim limitation “a means for” 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 disclosure is devoid of any structure that performs the function in the claim, and no association between the structure and the function can be found in the specification. Therefore, the claims are 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of mental steps, mathematic concepts, organizing human activity, or a natural law without significantly more.
Step 2A, Prong 1
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea/law of nature/natural phenomenon:
Claim 1 and 11 recite, “…a pathway database indicating a plurality of gene correlations between a plurality of genes and a plurality of biochemical pathways…” (lines 1-2), which is a mental step, i.e. can be performed with pen and paper (see MPEP 2106.04), is a claim directed to products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") (see MPEP 2106.03), is a claim directed to conveying a message or meaning to a human reader independent of the intended computer system, and/or the computer-readable medium merely serves as a support for information or data, i.e. no functional relationship exists between printed matter and associated substrate (see MPEP 2111.05), and is a claim directed to a law of nature, natural phenomena, or product of nature, i.e. gene sequences (see MPEP 2106.04).
“…maintaining an activity database…” (line 2), mental step; software per se; natural law
“…using the pathway database and the gene indicators to identify a plurality of influenced biochemical pathways…” (line 4); mental step; software per se; natural law
“…using the activity database to identify an activity…” (line 4-5; line 6); mental step; software per se; natural law
“…recommending the activity to the individual…” (line 5; line 6); mental step; natural law
Claim 2 recites, “… identifying an expressed phenotypical health trait …” (line 1), mental step; natural law
Claim 10 recites, “…identifying a second gene …” (line 1); mental step & “…determining that the second gene also influences a second phenotypical health trait…” (line 1-2); mental step; natural law
The claims recite an abstract idea of analyzing human genes and biochemical pathways (See MPEP 2106.07(a)).
These recitations are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas.
While claims 11-20 recite performing some aspects of the analysis using a “system”, there are no additional limitations that indicate that this model requires anything other than carrying out the recited mental process or mathematical concept in a generic computer environment. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then if falls within the “Mental processes” grouping of abstract ideas. As such, claim(s) 1-10 recite(s) an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 1: YES).
Step 2A, Prong 2
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology or applies or uses the recited judicial exception to affect a particular treatment for a condition. Rather, the instant claims recite additional elements that amount to mere instructions to implement the abstract idea in a generic computing environment or mere instructions to apply the recited judicial exception via a generic treatment. Specifically, the claims recite the following additional elements:
Claim 11 recites “…a memory; and a processor communicatively coupled to the memory…” (line 3)
There are no limitations that indicate that the claimed analysis engine or the formats of the provided data require anything other than generic computing systems. As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. As such, claims 1-10 is/are directed to an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 2: NO).
Step 2B
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment. The instant claims recite the following additional elements:
Claim 1 and 11 recite “… receiving a DNA test result…” (line 3; line 4)
Regarding claims 1-20, The steps of obtaining sequencing data and performing sample collection do not integrate the abstract idea into a practical application and constitutes an insignificant extra-solution activity (i.e., data gathering and presentation), which does not impose a meaningful limit on the abstract idea. As discussed above, there are no additional limitations to indicate that the claimed analysis engine requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims.
Furthermore, the additional elements recited in the claims amount to well-understood, routine and conventional activity, as evidenced by the GTEx Consortium (GTEx Consortium. Genetic effects on gene expression across human tissues. Nature 550, 204–213 (2017)), Decombel et al. (EP3488369B1), Chen et al. (US20200381083A1), and Nova et al. (US20210166794A1).
The GTEx Consortium reflects a database of collected gene expression data across over 44 human tissue types, with characterizations of local genetic variation and inter-chromosomal effects tied to and in the context of human disease. The GTEx Consortium therefore necessarily contains methods of receiving a DNA test result that includes a plurality of gene indicators that indicate a genetic makeup of an individual, and is often used and cited during gene pathway enrichment and characterization studies, as denoted in a commentary from the eGTEX Project (eGTEx Project. Enhancing GTEx by bridging the gaps between genotype, gene expression, and disease. Nat Genet 49, 1664–1670 (2017)) and shown in a study from Bellenguez, et al. on the genetic etiology of Alzheimer’s disease (Bellenguez, C., Küçükali, F., Jansen, I.E. et al. New insights into the genetic etiology of Alzheimer’s disease and related dementias. Nat Genet 54, 412–436 (2022)).
Decombel et al. reflects a computer implemented method of determining a health and wellness plan. On Figure 1, 101a Decombel et al. discloses a Genetic Data collection element, which is DNA collection including but is not limited to, a saliva sample home collection kit and instructions. Decombel et al. therefore recites receiving a DNA test result that includes a plurality of gene indicators that indicate a genetic makeup of an individual.
Chen reflects a method of estimating predisposition for disease based on classification of artificial image objects created from omics data. Chen recites on claim 1 a method of obtaining a first set of genetic variants from a first subject, which includes receiving a DNA test result that includes a plurality of gene indicators that indicate a genetic makeup of an individual.
Nova reflects a genetics based health management apparatus. On Figure 2, a DNA sample from a user is received at the input port, converted into a digital genome dataset. Nova also discloses on paragraph 0072 of their specification a method to receive input from a genetic scanner apparatus, the input including details about a plurality of genetic markers. Therefore, Nova’s apparatus includes receiving a DNA test result that includes a plurality of gene indicators that indicate a genetic makeup of an individual.
The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 1-20 is/are not patent eligible.
Claim Rejections - 35 USC § 102
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) 1-3 and 5-20 is/are rejected under 35 U.S.C. 102(b) as being anticipated by Decombel et al. (EP3488369B1).
Regarding claims 1, 11, and 17, Decombel et al. discloses a computer implemented method and system of determining an optimum wellness regime that:
Accesses a databank of defined and categorized genetic and environmental information collected from a user, identifies physiological, behavioral or biological traits associated with states of a user, identifies one or more genetic variants (polymorphisms, INDELS, gene copy number variants) of the user relevant to one or more traits, and relates them via a weighted “trait score”, a quantitative physiological or biological readout for one or more traits of a user based on genetic and environmental data (clm. 1 (method), clm. 8 (system); para. 0105-107 [Data Collection; DNA test 101b], Fig. 1 [103, Databank], [104, Refined Databank], [105, Trait Scoring Algorithm, [105a, Trait Scores]]; in reference to: maintaining an activity database indicating a plurality of activity correlations between a plurality of human activities and a plurality of biochemical pathway effects; receiving a DNA test result that includes a plurality of gene indicators that indicate a genetic makeup of an individua; using the pathway database and the gene indicators to identify a plurality of influenced biochemical pathways of the individual)
Determines a trait profile for the use from the trait scores, wherein the trait profile is calculated from the hierarchical, synergistic, additive, subtractive or antagonistic interaction of the trait scores, said trait profile characterizing the user's likely biological, behavioral or physiological response to a wellness regime, and takes the trait profile into account to design a wellness regime optimized to the user’s wellness goals (clm. 1 (method), clm. 8 (system); in reference to: using the activity database to identify an activity that affects at least one of the influenced biochemical pathways; and recommending the activity to the individual to enhance expression of a gene that influences a phenotypical health trait that is one of the phenotypical health traits.)
Decombel et al. also teaches on paragraph 0045 of the specification that “…different wellness regimes (health, nutritional and/or fitness programs) can be matched to users goals or needs. Typical goals or needs may include fat loss, muscle building, endurance training, cardiovascular improvement, rehabilitation from illness/disease, disease prevention, although many others can be envisaged.” (Spec, para. 0044; in reference to: maintaining an activity database indicating a plurality of activity correlations between a plurality of human activities and a plurality of biochemical pathway effects; using the activity database to identify an activity that affects at least one of the influenced biochemical pathways; and recommending the activity to the individual to enhance expression of a gene that influences a phenotypical health trait that is one of the phenotypical health traits).
Of note, the instant application discloses several means which the examiner interprets based on what one skilled in the art (Decombel et al. in this case) would consider as appropriate means:
“A means for identifying a plurality of influenced biochemical pathways of an individual…”, which is interpreted as a DNA test result obtained via genetic testing of an individual as disclosed on paragraph 0045 of Decombel et al. ’s specification.
“…based on a means for indicating a genetic makeup of the individual,” which is interpreted as a DNA test result obtained via genetic testing of an individual as disclosed on paragraph 0054 of Decombel et al. ’s specification.
“…a means for identifying an activity that affects at least one of the influenced biochemical pathways;” which is interpreted as trait scoring, as described on paragraph 0113, Fig. 1, 105, and 105a of the specification.
“…a means for recommending the activity for the individual to enhance expression of a gene that influences a phenotypical health trait that is one of the phenotypical health traits,” which is interpreted as a diet and fitness recommendation package known as a wellness regime, as described on paragraph 0004 of Decombel et al. ’s specification and trait bands that provide a series of bandings or categories trait scores align on based on user biological data, as described on paragraph 0119 of Decombel et al. ’s specification.
Decombel et al. ’s method of determining an optimum wellness regime and recommending activities based on the determined method teaches on all the limitations of claim 1 and is done so computationally; therefore, Decombel et al. anticipates claim 1.
Regarding claims 2, 13, and 18 Decombel et al. discloses a trait profile which is calculated from the hierarchical, synergistic, additive, subtractive or antagonistic interaction of the trait scores said trait profile characterizing the user's likely biological, behavioral or physiological response to a wellness regime; the trait profile or health-related traits wherein may necessarily be enhancing and are necessarily phenotypic (additive, synergistic) (clm. 1, f). Decombel et al. also discloses a wellness regime optimized to the user with recommendations, inclusive of these enhancing health-related phenotypic traits (clm. 1, f, e; in reference to: identifying an expressed phenotypical health trait of the individual, wherein the activity is recommended to enhance the expressed phenotypical health trait).
Of note, the instant application discloses several means which the examiner interprets based on what one skilled in the art (Decombel et al. in this case) would consider as appropriate means:
“a means for identifying an expressed phenotypical health trait of the individual, wherein the activity is recommended to enhance the expressed phenotypical health trait.…”, which is interpreted as a DNA test as described on paragraph 0054 of Decombel et al. ’s specification, trait bands that 1) provide a series of bandings or categories trait scores aligned with user biological data, as described on paragraph 0119 of Decombel et al. ’s specification and 2) compartmentalize genes to determine which gene phenotype is expressed, as disclosed on paragraph 0124 of the specification, and a diet and fitness recommendation package known as a wellness regime, as described on paragraph 0004 of Decombel et al. ’s specification.
Decombel et al. ’s method of calculating and recommending enhancing and synergistic traits teaches on all the limitations of claim 2; therefore, Decombel et al. anticipates claim 2.
Regarding claim 3 and 12, Decombel et al. discloses in the specification and on Figure 1, 101a (Genetic Data Collection), 102 (Environmental Data), and 102a (environmental data collection), in which multiple methods of inputting environmental data into the system which may include, but are not limited to, health monitoring applications or devices, questionnaires and professional health data (Spec para. 0089; Fig. 1 102a; in reference to: The method of claim 2 wherein the expressed phenotypical health trait is selected based on an online questionnaire). Decombel et al. ’s teaching of using an online questionnaire teaches on all the limitations of claim 3; therefore, Decombel et al. anticipates claim 3.
Regarding claim 5, Decombel et al. discloses in the specification a databank of diet plans in Fig. 109b, and discloses that “As an additional example, a recommendation may be provided to the user regarding the total amount of protein that should make up the user’s diet. This may be provided as a % of food intake, kcal intake, or a goal intake of protein in grams. The recommendation may be given to the user in bands, ranging from very low to very high.” The recommendations are tailored to the user and a part of the greater trait analysis and therefore consider enhancement of phenotypical health traits (Spec, 0135; Fig. 1, 109b; in reference to: The method of claim 1 wherein the activity is eating a food that enhances the phenotypical health trait via the at least one of the influenced biochemical pathways.). Decombel et al. ’s teaching of a tailored diet plan address all the limitations of claim 5. Decombel et al. anticipates claim 5.
Regarding claim 6, Decombel et al. discloses in the specification an omission of a recommendation: “Due to the contribution of the data element 'diet', then the system can determine a sensible recommendation on how to do this based on their diet i.e. if they are vegetarian, a recommendation isn't made to eat more fish. “(Spec, para 0134; in reference to: The method of claim 1 wherein the activity is avoiding a food that promotes the phenotypical health trait via the at least one of the influenced biochemical pathways.) Decombel et al. ’s disclosure of the possibility of not recommending a food (fish) and the involvement of the omission of said recommendation in Decombel et al. ’s analysis engine anticipates claim 6.
Regarding claim 7, Decombel et al. discloses on paragraph 0137 of the specification that a dietary supplement can be recommended in relation to the weight of various user-specific phenotypic traits: “For example, a recommendation on whether to supplement the user's diet with vitamin B12 that is dependent on the trait describing folate metabolism and the environmental factor diet is likely to be heavily weighted to diet. It can be appreciated that other weightings may be appropriate for other recommendation.” (Spec, para. 0137; in reference to: The method of claim 1 wherein the activity is taking a dietary supplement that suppresses the phenotypical health trait via the at least one of the influenced biochemical pathways.) Decombel et al. ’s methods could recommend a dietary supplement that suppresses a phenotypical health trait in the interest of pursuing the optimum wellness regime; therefore, Decombel et al. anticipates claim 7.
Regarding claim 8 and 19, Decombel et al. discloses a system which may identify one genetic factor and/or environmental factor that are relevant to multiple traits, and the weighting assigned to these factors vary for different traits (clm. 3, clm. 8; in reference to: The method of claim 1 wherein the gene is one of a plurality of genes that govern a biochemical pathway associated with the phenotypical health trait.). Decombel et al. also discloses on paragraph 0011 of the specification an example of testosterone genes which may be used to establish a trait score. Decombel et al. ’s disclosure of genetic testing and the genes examined therein in the context of phenotypical health trait and scoring anticipates claim 8.
In regard to claim 9, 15, and 16, Decombel et al. discloses in the specification an example use-case of their system—analyzing several genes associated with testosterone and developing a trait score (Spec, para. 0011). Claim 1 of Decombel et al. ’s method also states “identifying one or more genetic variants of the user that are relevant to one or more of the traits…” (clm. 1) Furthermore, Decombel et al. discloses examples of how their system could provide conditional recommendations based upon a user’s profile that could enhance or suppress activities of traits or biochemical pathways. Decombel et al. teaches “For example, if calories are >2500, which may reflect an increased endurance activity level, the system can determine and advise the user to hold protein at a maximum ratio of 30% in terms of macronutrient ratio, and to increase carbohydrate ratio respectively. In another example, if the output of 'amount of carbohydrate' in diet is 'reduce' and the output of 'amount of fat' in diet is 'reduce' the consequence on total macronutrient ratio is a significantly increased 'amount of protein' in diet.” (Spec, para. 0165, 0166; in reference to: ...wherein the activity does not enhance expression of the second gene; …the activity is selected instead of a second activity because expression of the second gene is enhanced by the second activity.) In this manner, Decombel et al. teaches advising a user of activities that influence traits (which include genetic facets and gene expression) that influence biological pathways. Decombel et al. ’s teaching of analyzing multiple traits and conditional activity recommendations which may enhance or decrease gene expression anticipates claims 9, 15, and 16.
Regarding claims 10 and 20, Decombel et al. discloses in the specification on paragraph 0119 that calculated trait scores give readouts according to biological systems from a user, which are a representative trait profile for that user’s biological system. Decombel et al. discloses trait scores can be binned into trait bands, which can be used to categorize and align, compare, and contrast trait scores. Decombel et al. teaches that “…trait scores may be deemed or aligned to be very high, high, medium, low or very low for a particular trait. Such bands provide an indication of the relative expression of the trait. Directionality, namely whether a trait contributes or prevents/acts-against an outcome can also be taken into account.” (Fig. 1, 105a [Trait scores]; 106a [Biological system Characterization]; Spec, para. 0119; in reference to: The method of claim 1 further including: identifying a second gene that influences the phenotypical health trait; and determining that the second gene also influences a second phenotypical health trait, wherein the activity is selected instead of a second activity that enhances expression of the gene and the second gene.; The system of claim 11 wherein: a second gene is identified that influences the phenotypical health trait and influences a second phenotypical health trait; and
the activity does not enhance expression of the second gene.). Additionally, Decombel et al. discloses in the specification an omission of a recommendation: “Due to the contribution of the data element 'diet', then the system can determine a sensible recommendation on how to do this based on their diet i.e. if they are vegetarian, a recommendation isn't made to eat more fish. “(Spec, para 0134; in reference to: a means for not recommending a second activity wherein expression of the gene and of the second gene is enhanced by the second activity.)
Furthermore, the instant application discloses several means which the examiner interprets based on what one skilled in the art (Decombel et al. in this case) would consider as appropriate means:
“…a means for identifying a second gene that influences the phenotypical health trait …”, and “…a means for determining that the second gene also influences a second phenotypical health trait…” which are interpreted as a DNA test as described on paragraph 0054 of Decombel et al. ’s specification and trait bands that 1) provide a series of bandings or categories trait scores aligned with user biological data, as described on paragraph 0119 of Decombel et al. ’s specification and 2) compartmentalize genes to determine which gene phenotype is expressed, as disclosed on paragraph 0124 of the specification.
“…a means for not recommending a second activity wherein expression of the gene and of the second gene is enhanced by the second activity…”, which is interpreted as applying the context of data element (comprised of user-specific genetic factors, environmental factors and wellness goals) to trait scores in order to make user-defined recommendations, as disclosed on paragraphs 0016, 0017, and 0134 of Decombel et al. ’s specification.
Decombel et al. ’s teaching of agonistic/antagonistic traits and conditional recommendations address the limitations of claims 10 and 20; Decombel et al. anticipates claims 10 and 20.
Regarding claim 14, Decombel et al. discloses examples of how their system could provide conditional recommendations based upon a user’s profile that could enhance or suppress activities of traits or biochemical pathways. Decombel et al. teaches “For example, if calories are >2500, which may reflect an increased endurance activity level, the system can determine and advise the user to hold protein at a maximum ratio of 30% in terms of macronutrient ratio, and to increase carbohydrate ratio respectively. In another example, if the output of 'amount of carbohydrate' in diet is 'reduce' and the output of 'amount of fat' in diet is 'reduce' the consequence on total macronutrient ratio is a significantly increased 'amount of protein' in diet.” (Spec, para. 0165, 0166; in reference to: The system of claim 11 wherein the phenotypical health trait is suppressed by the activity via the at least one of the influenced biochemical pathways.) Decombel et al. ’s system of adaptive, tailored recommendations teach on all the limitations of claim 14; Decombel et al. anticipates claim 14.
Claim Rejections - 35 USC § 103
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Decombel et al. (EP3488369B1) as applied to claims 1-3 and 5-20 above, in view of Raymond Anthony Joao (US20250391561A1).
Claim 4 is directed to identifying an expressed phenotypical health trait based using a telepresence interview.
Decombel et al. is directed to collecting genetic and environmental data from a user via questionnaires.
Decombel et al. does not teach identifying an expressed phenotypical health trait based using a telepresence interview.
JOAO is directed to using a computer to conduct a tele-health visit involving a video call between a user communication device a healthcare provider communication device.
In regards to claim 4, Decombel et al. discloses a method to collect genetic and environmental data from a user via questionnaires (Spec para. 0054 (DNA); 0089; Fig. 1 102a; in reference to: the expressed phenotypical health trait is identified…). Decombel et al. does not teach identifying an expressed phenotypical health trait based on using a telepresence interview.
JOAO teaches using a computer to conduct a tele-health visit involving a video call between a user communication device a healthcare provider communication device (clm. 1; “providing or facilitating, with or using the central processing computer, a tele-health visit involving a video call”, in reference to: health trait is identified using a telepresence interview)
In KSR Int 'l v. Teleflex, the Supreme Court, in rejecting the rigid application of the teaching, suggestion, and motivation test by the Federal Circuit, indicated that “The principles underlying [earlier] cases are instructive when the question is whether a patent claiming the combination of elements of prior art is obvious. When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR Int'l v. Teleflex lnc., 127 S. Ct. 1727, 1740 (2007).
Applying the KSR standard to Decombel et al. and JOAO., the examiner concludes that the combination of the user-related genetic and environmental data collection according to Decombel et al. with the telehealth video call as disclosed by JOAO represents a combination of known elements which yield the predictable result of a telehealth-video-call-backed user data collection method. The use of the telehealth video call method as disclosed by JOAO in this combination would have further served to achieve the predictable result of a telehealth-video-call-backed user data collection method because both Decombel et al. and JOAO disclose methods to collect user genomic data via a query.
One of ordinary skill in the art of medical information gathering would have been motivated to combine Decombel et al. ’s questionnaire method with JOAO’s telehealth video call method because JOAO’s device (a computer capable of facilitating tele-health video interviewing) differs from Decombel et al. ’s questionnaire method, the claimed elements (computational or tele-health video interviewing methods or general video communication) are known in the art surrounding healthcare interviewing, and Decombel et al. ’s art relies on gathering user genomic data. Furthermore, JOAO discloses on paragraph 0162 of the specification, “Any healthcare professional, hospital, clinic, pharmacy, treatment center, treatment facility, and/or any other provider of services, healthcare or otherwise, which is described herein can also be referred to herein as a “provider”, and the term “provider” is inclusive of “doctor” as stated on paragraph 0147 of JOAO’s specification. Therefore, JOAO’s method is adapted to facilitate patient-doctor interactions via video that elicit utilize user-genetic data later be collected and utilized. One skilled in the art could have combined Decombel et al. and JOAO’s methods as claimed with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the invention.
One of ordinary skill in the art of sequence analysis before the effective filing date of the claimed invention would have had a reasonable expectation of success because the teachings of Decombel et al. and JOAO disclose computationally-based healthcare-related data collection. Decombel et al. discloses environmental data collection methods which “may include, but are not limited to, health monitoring applications or devices, questionnaires and professional health data…” (Spec para. 0089; Fig 102a.) Combining Decombel et al. ’s method with JOAO’s tele-health visit method would have been expected to have provided more accessible avenues to collect doctor-or-health-professional-vetted, detailed user genetic data and metadata, improving the convenience of data collection and enhancing the volume and significance of data collected. Therefore, the invention would have been prima facie obvious to one of skill in the art at the time of filing of the application, absent evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN T STUBBS whose telephone number is (571)272-0340. The examiner can normally be reached M-F 8-5 EST.
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, Larry Riggs can be reached at 571-270-3062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.T.S./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686