DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant claims foreign priority to KR10-2019-0096589 filed 08/08/2019. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/14/2022 is acknowledged. A signed copy of the corresponding 1449 form has been included with this Office action.
Specification
The disclosure is objected to because of the following informalities: [Table 10] is blurry and therefore illegible. 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.
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 limitations use 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. This is a statement under claim interpretation, and is not a rejection. Such claim limitations are:
In claims 1-13, the generic placeholder is “disease/phenotypic/comprehensive unit,” and the specialized function is “obtaining risk.”
Because this/these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
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 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 1-13 are rejected under 35 USC 112(b) or 112 (second paragraph) as they fail to particularly point out and distinctly claim the subject matter which applicant regards as his invention.
As set forth above, claim limitations identified above invoke 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.
Claims 1-13 fail to particularly point out and distinctly claim the algorithms, structures, or step-by-step instructions for performing the specialized function of “obtaining risk.” The specification does not provide a limiting definition of “obtaining risk,” nor does it provide the necessary and sufficient steps which must be performed on disease, phenotypic, or comprehensive “unit.” It is unclear whether any manner of obtaining risk would lead to a dataset which could then be used to predict a risk of disease, or whether certain specific steps must be performed. One of skill would not be apprised as to what particular functions Applicant applies to achieve the desired result. While the claims are read in light of the specification, limitations from the specification cannot be read into the claims.
MPEP 2181.II.B: “For a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite under 35 U.S.C. 112(b) (b). See Net MoneyIN, Inc. v. Verisign. Inc., 545 F.3d 1359, 1367 (Fed. Cir. 2008).” Additionally, “To claim a means for performing a specific computer-implemented function and then to disclose only a general-purpose computer as the structure designed to perform that function amounts to pure functional claiming. Aristocrat, 521 F.3d 1328 at 1333, 86 USPQ2d at 1239.” Finally, “Mere reference to a general-purpose computer with appropriate programming without providing an explanation of the appropriate programming, or simply reciting "software" without providing detail about the means to accomplish a specific software function, would not be an adequate disclosure of the corresponding structure to satisfy the requirements of 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Aristocrat, 521 F.3d at 1334, 86 USPQ2d at 1239...”
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.
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 1-13 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed 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. For computer-implemented inventions, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps or procedures taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed to achieve the desired results. See MPEP §§ 2163.02 and 2181, subsection IV. 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.”
Claims 1-13 recite “obtaining risk” based on the genetic marker, however, the necessary and sufficient calculations, algorithms, or steps for specifically performing the specialized functions of the claims are not clearly provided by the disclosure. While the specification provides tables and equations related to one or more processes or calculations, there is not a clear basis linking specific algorithmic processes to specific steps within the entire scope of the claim, and an issue exists as to whether the disclosure is adequate to perform the entire claimed function. On page 9, lines 3-17 of the instant specification, information regarding storing the genetic marker information associated with disease occurrence and phenotype is discussed. However, there is no clear linkage between this disclosure and the specialized function of “obtaining risk” based on genetic markers. As such, the claims lack adequate written description.
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 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim Analysis:
In accordance with MPEP § 2106, claims found to recite statutory subject matter 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).
Framework with which to Evaluate Subject Matter Eligibility:
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter;
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea;
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application; and
Step 2B: If the claims do not integrate the judicial exceptions, do the claims provide an inventive concept?
Framework Analysis on the Instant Claims:
Step 1:
With respect to Step 1: claims 1-13 are directed to a system, i.e., a process, machine, or manufacture within the above 35 U.S.C. 101 categories [Step 1: YES; See MPEP § 2106.03]
Step 2A, Prong One:
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas [see MPEP § 2106.04(a)(2)]. Under the Step 2A, Prong One evaluation, the claims found to recite abstract ideas that fall into the grouping of laws of nature (a natural phenomenon or product of nature) and mathematical concepts (in particular mathematical relationships and formulas) are as follows:
Independent claims 1 and 7, and 13:
Laws of nature:
obtain a phenotypic genetic risk for a phenotype based on the genetic marker
obtain a comprehensive genetic risk for the disease
Mathematical concepts:
to obtain a disease genetic risk
to obtain a phenotypic genetic risk
to obtain a comprehensive genetic risk
Claims 2-6 and 8-12 recite further steps that limit the judicial exceptions in independent claims 1, 8, and 15 and, as such, are also directed to those abstract ideas. For example, claims 4 and 10 further limit the parameters of claim 1 and 7 by specifying the predefined effective size by state of the phenotype.
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. The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI). When read in light of and consistent with the specification, the claims are determined to be directed to mental processes that in the simplest embodiments are not too complex to practically perform in the human mind. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind. The instant claims must therefore be examined further to determine whether they integrate the abstract idea into a practical application. [Step 2A, Prong 1: YES; See MPEP § 2106.04].Step 2A, Prong Two:
In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP § 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP § 2106.04(d)(I)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP § 2106.04(d)(III)). With respect to Step 2A, Prong Two, there are no additional elements beyond the abstract idea.
Further steps directed to additional non-abstract elements of data analysis should describe any specific computational steps by which the “computer program product or system,” perform or carry out the judicial exceptions, or provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the judicial exceptions. Hence, these are mere instructions to apply the judicial exceptions using a computer, and therefore the claim does not integrate the judicial exceptions into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc.… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer (MPEP 2106.05(f)). Thus, none of the claims recite additional elements which would integrate a judicial exception into a practical application, and the claims are directed to one or more judicial exceptions [Step 2A, Prong 2: NO; See MPEP § 2106.04(d)].
Step 2B
According to analysis so far, the additional elements described above do not provide
significantly more than the judicial exception. A determination of whether additional elements provide significantly more also rests on whether the additional elements or a combination of elements represents other than what is well-understood, routine, and conventional.
Conventionality is a question of fact and may be evidenced as: a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s) (WURC).
With respect to the instant claims, the courts have found that receiving and outputting data are well-understood, routine, and conventional functions of a computer when claimed in a merely generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at
1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information),
buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014)
(computer receives and sends information over a network), Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015), and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93, as discussed in MPEP 2106.05(d)(II)(i)).
As such, the claims simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (MPEP2106.05(d)). The “obtaining” steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
With respect to claims 1, 7, and 13 and those claims dependent therefrom, the computer-related elements or the general-purpose computer do not rise to the level of significantly more than the judicial exception. The claims state nothing more than a generic computer which performs the functions that constitute the judicial exceptions. Hence, these are mere instructions to apply the judicial exceptions when using a computer, which the courts have found to not provide significantly more when recited in a claim with a judicial exception (see MPEP 2106.06(A)).
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; See MPEP § 2106.05].
As such, claims 1-13 are not patent eligible.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4, 5, 7, 8, 10, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KR 2019/0077997, hereinafter Clinomics (as cited in the IDS filed 04/14/2022).
Regarding claims 1, 7, and 13, Clinomics teaches: A device for predicting a risk of a disease combined with a genetic risk for an associated phenotype, the device comprising: a disease risk obtaining unit configured to obtain a disease genetic risk for the disease based on genetic marker information associated with the disease occurrence and information on a genotype of a user (Claim 1: A genetic risk prediction device, comprising: an acquisition unit that acquires genetic marker information for a disease from an external organization server and user genotype information from a user terminal; a detection unit that compares the genetic marker information and the user genotype information to detect the number of users who have risk factors for a disease, detects a frequency value of the risk factors within a group, and detects an effective size of a genotype combination using the effective size for the risk factors and the number of users who have risk factors; and a calculation unit that calculates a genetic risk.); a phenotypic risk obtaining unit configured to obtain a phenotypic genetic risk for a phenotype based on the genetic marker information on the phenotype associated with the disease occurrence and the information on the genotype of the user (Claim 5: In the fourth paragraph, the calculation unit calculates the genetic risk considering the increasing and decreasing influences on the phenotype using the mathematical formula ∑Winc*Rinc -∑Wdec*Rdec, wherein Winc is the effective size for the risk factor of the genetic marker having the increasing influence, Wdec is the effective size for the risk factor of the genetic marker having the decreasing influence, Rinc is the number of the user's increasing influence risk factors, and Rdec is the number of the user's decreasing influence risk factors, a genetic risk prediction device); and a comprehensive risk obtaining unit configured to obtain a comprehensive genetic risk for the disease based on the disease genetic risk obtained by the disease risk obtaining unit and the phenotypic genetic risk obtained by the phenotypic risk obtaining unit (Claim 4: A genetic risk prediction device wherein the detection unit distinguishes the genetic marker information obtained from the acquisition unit into genetic markers having an increasing influence and genetic markers having a decreasing influence, and compares the distinguished genetic markers having an increasing influence and genetic markers having a decreasing influence with user genotype information to detect the number of users having an increasing influence risk factor and the number of users having a decreasing influence risk factor. A genetic risk prediction device).
Regarding claims 2 and 8, Clinomics teaches The device of claims 1 and 7, wherein the comprehensive risk obtaining unit obtains the comprehensive genetic risk based on the disease genetic risk and the phenotypic genetic risk by using a ratio of genetic factors affecting the disease occurrence (Claim 8: A genetic risk prediction device where the acquisition unit acquires the ratio of genetic factors and environmental factors for a disease from an external organization server, acquires the user's clinical survey information from a user terminal, and the detection unit detects the increased risk by environmental factor using the clinical survey information acquired from the acquisition unit).
Regarding claims 4 and 10, Clinomics teaches the device of claims 1 and 7, wherein the phenotypic risk obtaining unit obtains the phenotypic genetic risk based on the genetic marker information on the phenotype and the information on the genotype of the user by using a predefined effective size by state of the phenotype (Claim 2: A genetic risk prediction device where, calculation unit in claim 1 calculates the genetic risk considering the allele frequency within the group using the mathematical formula ∑Wi*Fi*Ri, wherein W represents the effective size for the risk factor, F represents the weight value, R represents the number of risk factors the user has, and the weight value represents a value converted from the risk factor frequency value within the group by the detection unit, and when the risk factor frequency value within the group is 0.5 or less, the weight value is equal to the risk factor frequency value within the group, and when the risk factor frequency value within the group is greater than 0.5, the weight value is a value obtained by subtracting the risk factor frequency value within the group from 1. Claim 5: In the fourth paragraph, the calculation unit calculates the genetic risk considering the increasing and decreasing influences on the phenotype using the mathematical formula ∑Winc*Rinc -∑Wdec*Rdec, wherein Winc is the effective size for the risk factor of the genetic marker having the increasing influence, Wdec is the effective size for the risk factor of the genetic marker having the decreasing influence, Rinc is the number of the user's increasing influence risk factors, and Rdec is the number of the user's decreasing influence risk factors, a genetic risk prediction device.).
Regarding claims 5 and 11, Clinomics teaches The device of claim 4 and 10, wherein the phenotypic risk obtaining unit obtains a genetic risk based on the genetic marker information on the phenotype and the information on the genotype of the user, converts the obtained genetic risk to a relative value as compared with the genetic risks for the phenotypes of other users in an affiliated group of the user, obtains the state of the phenotype based on the genetic risk converted to the relative value, and determines an effective size corresponding to the obtained state as the phenotypic genetic risk (Claim 6: the calculation unit can also calculate the genetic risk considering the increasing and decreasing influence on the phenotype using the mathematical formula [ ∏Winc*Rinc / ∏Wdec*Rdec ], where Winc represents the effective size for the risk factor of the genetic marker having the increasing influence, Wdec represents the effective size for the risk factor of the genetic marker having the decreasing influence, Rinc represents the number of the user's increasing influence risk factors, and Rdec represents the number of the user's decreasing influence risk factors).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over KR 2019/0077997 (Clinomics) as applied to Claims 1, 2, 4, 5, 7, 8, 10, 11, and 13 above, in view of KR 2017/0134203 A, hereinafter Medizen Humancare (cited in the IDS filed 04/14/2022).
The claims are directed to methods of predicting a risk of disease with a genetic risk for a phenotype associated with the disease by obtaining a disease, phenotypic, and a combined genetic risk for a disease based on genetic marker information.
Regarding claims 3 and 9, Clinomics teaches the device of claim 1 and 7 above. Clinomics further teaches wherein the disease risk obtaining unit converts the obtained disease genetic risk to a relative value as compared with disease genetic risks of other users in an affiliated group of the user, the phenotypic risk obtaining unit converts the obtained phenotypic genetic risk to a relative value as compared with phenotypic genetic risks of other users in the affiliated group of the user (Claim 2: A genetic risk prediction device where, calculation unit in claim 1 calculates the genetic risk considering the allele frequency within the group using the mathematical formula ∑Wi*Fi*Ri, wherein W represents the effective size for the risk factor, F represents the weight value, R represents the number of risk factors the user has, and the weight value represents a value converted from the risk factor frequency value within the group by the detection unit, and when the risk factor frequency value within the group is 0.5 or less, the weight value is equal to the risk factor frequency value within the group, and when the risk factor frequency value within the group is greater than 0.5, the weight value is a value obtained by subtracting the risk factor frequency value within the group from 1).
Clinomics does not teach obtaining the comprehensive genetic risk.
Medizen Humancare teaches: and the comprehensive risk obtaining unit obtains the comprehensive genetic risk based on the disease genetic risk converted to the relative value and the phenotypic genetic risk converted to the relative value and converts the obtained comprehensive genetic risk to a relative value as compared with comprehensive genetic risks of other users in the affiliated group of the user (Para [0047] - [0056]: 1. Confirmation of the heritability of the target disease: Research is conducted by predicting the extent to which genetic factors influence the target disease, selecting research methods based on heritability, and the success probability of association studies. Therefore, the prevalence/incidence rate of the target disease is also investigated. 2. Selection of the research subject phenotype (trait): Investigate whether the biochemical phenotype that is important for the development of the disease was selected as the criterion for dividing the patient group. 4. Confirming the ethnicity of the research subjects: When including multiple ethnicities with different genetic backgrounds, it is very likely that the frequency of different genotypes by ethnicity is due to racial differences rather than an association with the disease. Therefore, it is meaningful to confirm whether the study is on a heterogeneous or homogeneous ethnic group. 5. Confirm the collection of genetic samples, clinical information, phenotypic and environmental information of the research subject: It is necessary to confirm whether accurate clinical information has been collected and the disease subtypes have been classified due to the type of sample, DNA extraction method, genetic complexity and phenotypic complexity, and whether various types of environmental factors have been collected and applied to the analysis as most diseases are complex).
Case for prima facie obviousness:
Clinomics discloses an apparatus and method for predicting disease and phenotypic risk by providing a weight for each marker to a group to be predicted with respect to genetic risk and predicting the genetic risk for various diseases and phenotypic genetic markers for various races and ethnicities. Medizen Humancare, in the same field, relates to a system to analyze a disease-related genome using an SNP where it inspects a genome to predict a disease and drug reaction.
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 of obviousness to Clinomics in view of Medizen Humancare represents combining prior art elements according to known methods to yield predictable results. For one having skill in the art, the additional features in claims 3 and 9 could easily be derived by means of design changes to the feature of Clinomics of calculating a genetic risk score in accordance with an allele frequency in a population by means of a mathematical formula, wherein a risk allele frequency value in the population is used as a weight value (see claim 2) with the feature of Medizen Humancare of calculating a relative risk score in accordance with the genotype of a subject by means of a relative risk score of a population for each genotype, and deriving a result of correlation with a disease by means of the subject’s genome sample, clinical information, phenotypes, environmental information and the like (see paragraphs [0047]-[0057] and claim 1),
Both Clinomics and Medizen Humancare are directed to predicting disease risk. This combination would have been expected to yield the predictable result of a more comprehensive prediction of disease risk by integrating genotypic and phenotypic risk. Therefore, the invention would have been prima facie obvious to one of skill in the art before the effective filing date of the application, absent evidence to the contrary.
Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over KR 2019/0077997 (Clinomics) as applied to claims 1, 2, 4, 5, 7, 8, 10, 11, and 13, in view of US 2019/0087540 A1, hereinafter Syntekabio (cited in the IDS filed 04/14/2022.)Clinomics in view of Medizen Humancare is applied to claims 3 and 9 above.
Clinomics teaches the device of claims 1 and 7. Clinomics does not teach obtaining a genetic risk for each phenotype. Syntekabio teaches: wherein when there is the plurality of phenotypes associated with the disease occurrence, the phenotypic risk obtaining unit obtains a genetic risk for each of the plurality of phenotypes and obtains the phenotypic genetic risk based on the obtained plurality of genetic risks (Claim 1: ... multi-gene information database is configured to include a single gene information database storing genotype information for each phenotype....the search control unit derives a disease cause relationship map (Πx) by calculating an arithmetic formula calculated by logistic regression analysis to derive a disease cause prediction result; A genotyping analysis system using genetic variation information of an individual's whole genome, characterized by parameters based on the genotypes of single genes or genotypes of multiple genes by phenotype included in the analysis data).
Case for prima facie obviousness:
Syntekabio discloses method for analyzing and providing genotype information from a personal genome by comparing input genome information with multiple genome database constructed by the genome project.
Applying the KSR standard of obviousness to Clinomics in view of Syntekabio represents combining prior art elements according to known methods to yield predictable results. For one having skill in the art, the additional features in claims 6 and 12 could easily be derived by means of design changes to the feature of Syntekabio of using the genotypes of multiple genes for each phenotype as parameters when deriving a prediction result for the cause of a disease by analyzing personal genetic information (see claim 1). Both Clinomics and Syntekabio are directed to analyzing genetic markers and genotype data. This combination would have been expected to yield the predictable result of a more comprehensive prediction of disease risk by integrating genotypic and phenotypic risk. Therefore, the invention would have been prima facie obvious to one of skill in the art before the effective filing date of the application, absent evidence to the contrary.
Conclusion
Claims 1-13 are rejected.
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/K.R.K./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686