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 .
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 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.
Restriction election
In response to a requirement for restriction dated 04/16/2025, applicant elects AX8 in claim 2 as a target gene, AGPAT2 in claim 3 as a suboptimal gene, and BMP7-SH2D6 in claim 4 as a digenic combination without traverse per applicant response dated 07/29/2025.
Claim Status
Claims 1-10 are pending.
Claims 1-10 are rejected.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to App. No. CHINA 202410133356.6, filed 01/31/2024. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 01/29/2025 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS document is included with this Office Action.
Drawings
The Drawings submitted 01/29/2025 are accepted.
Specification
The disclosure is objected to for the following informalities. It is noted that for purposes of the instant Office Action, any reference to the specification pertains to the clean copy of the substitute specification as originally filed on 01/29/2025.
Hyperlinks
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Non-limiting examples include paragraphs [0040]. Applicant will note that this is exemplary and other instances may exist. It is requested that all instances be corrected.
Appropriate correction for all objections to the specification is required.
Claim Interpretation
35 U.S.C. 112(f)
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 prediction system”, “an acquisition unit“, “an extraction unit, and “a prediction unit“ in claim 8.
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.
The three-prong test: (A) “unit” is a substitute for “means” that is a generic placeholder; (B)unit is modified by the functional language “for”; (C) unit is modified by prediction, which does not provide sufficient structure for performing the step of predicting MRKH syndrome. The specification discloses the acquisition unit [0014 and 0050] but does not disclose adequate structure to perform the claimed function. See below regarding issues under 112(a) and 112(b) arising from this claim interpretation.
The three-prong test: (A) “unit” is a substitute for “means” that is a generic placeholder; (B)unit is modified by the functional language “configured to”; (C) unit is modified by acquisition, which does not provide sufficient structure for performing the step of acquire gene expression data of a sample to be tested. The specification discloses the acquisition unit [0014 and 0050-0051] but does not disclose adequate structure to perform the claimed function. See below regarding issues under 112(a) and 112(b) arising from this claim interpretation.
The three-prong test: (A) “unit” is a substitute for “means” that is a generic placeholder; (B)unit is modified by the functional language “configured to”; (C) unit is modified by extraction, which does not provide sufficient structure for performing the step of extract expression data of target genes from the gene expression data. The specification discloses the acquisition unit [0014 and 0050.] but does not disclose adequate structure to perform the claimed function. See below regarding issues under 112(a) and 112(b) arising from this claim interpretation.
The three-prong test: (A) “unit” is a substitute for “means” that is a generic placeholder; (B)unit is modified by the functional language “configured to”; (C) unit is modified by prediction, which does not provide sufficient structure for performing the steps of perform classification prediction based on the expression data of the target genes to obtain a classification result about whether the sample to be tested suffers from MRKH, obtain a classification result that the sample to be detected suffers from MRKH if expression level of any one or more of the target genes is high, and obtain a classification result that the sample to be tested does not suffer from MRKH if the expression level of any one or more of the target genes is low. The specification discloses the acquisition unit [0014 and 0050.] but does not disclose adequate structure to perform the claimed function. See below regarding issues under 112(a) and 112(b) arising from this claim interpretation.
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
35 U.S.C. 112(a)
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.
Claim(s) 1-10 is/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 1 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)), the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation”. These factors include: (a) the quantity of experimentation necessary; (b) the amount of direction or guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the relative skill of those in the art; (g) the predictability of the art; and (h) the breadth of the claims.
In considering the factors for the instant claims:
(a) In order to practice the claimed invention, one of skill in the art must be able to predict MRKH syndrome based on the gene expression levels of AGPAT2 and/or PAN2. For the reasons discussed below, there would be an unpredictable amount of experimentation required to practice the claimed invention.
(b) The specification provides guidance for predict MRKH syndrome based on the gene expression levels of AGPAT2 and/or PAN2 [0005-0006]. The specification provides guidance on genes that have high expression levels that could be indicative of MRKH syndrome [0007]. The specification does not provide guidance that the expression levels of AGPAT2 and/or PAN2 alone is enough to be predicative for the MRKH. Also, there is not a digenic combination of these two genes that is shown to be sufficient.
(c) The specification does not provide working examples of the expression levels of AGPAT2 and/or PAN2 predicting MRKH.
(d) The invention is drawn to predicting MRKH syndrome based on the gene expression levels of AGPAT2 and/or PAN2.
(e) The state of the art of gene expression levels of AGPAT2, can be represented by Agarwal et al."Congenital generalized lipodystrophy: significance of triglyceride biosynthetic pathways." Trends in Endocrinology & Metabolism 14.5 (2003). The reference makes clear that high AGPAT2 mRNA expression is linked to various isoforms of enzymes involved in triglyceride biosynthetic pathway such as: visceral adipose tissue, liver and heart; moderate in pancreas, lung, skeletal muscle, kidney, spleen and bone marrow; and low in thymus, brain and placenta.
The state of the art of gene expression levels of PAN2, can be represented by Reuter, M.S., Zech, M., Hempel, M. et al. Biallelic PAN2 variants in individuals with a syndromic neurodevelopmental disorder and multiple congenital anomalies. Eur J Hum Genet 30, 611–618 (2022). The reference makes clear that PAN2 encodes a subunit of a deadenylation complex with important functions in mRNA stability and post-transcriptional regulation of gene expression. A homozygous frameshift deletion in PAN2 was reported in a single affected individual with developmental delay and multiple congenital anomalies. Five additional individuals from three unrelated families with homozygous predicted loss-of-function variants in PAN2. The affected individuals presented with significant overlap in their clinical features, including mild-moderate intellectual disability, hypotonia, sensorineural hearing loss, EEG abnormalities, congenital heart defects (tetralogy of Fallot, septal defects, dilated aortic root), urinary tract malformations, ophthalmological anomalies, short stature with other skeletal anomalies, and craniofacial features including flat occiput, ptosis, long philtrum, and short neck.
The state of the art of gene expression levels for predicting MRKH, can be represented by Chen, Na, et al. "Perturbations of genes essential for Müllerian duct and Wölffian duct development in Mayer-Rokitansky-Küster-Hauser syndrome." The American Journal of Human Genetics 108.2 (2021): 337-345. The reference makes clear that Knock-out of genes expressed in the Mullerian duct (MD) or the Wolffian duct (WD) such as Lhx1,5 Pax8,6 Wnt9b,7 and Tbx68 lead to MRKHS-like phenotypes in mice. In addition, knock-out of abdominal B homeobox genes (Hoxa9, Hoxa10, Hoxa11, Hoxa13), which are expressed along the anterior-posterior axis in a segmental pattern, can also disrupt the development of the corresponding part of the Mullerian duct, Wolffian duct, and the spine. Chen further discloses despite numerous candidate genes and pathways, only WNT4 (MIM: 603490) has been well established to be associated with a clinically distinct subtype of MRKHS characterized by Mullerian aplasia with hyperandrogenism (MIM: 158330). Chen also discloses that in summary candidate variants in genes associated with MD/WD development were identified in MRKHS. Of them, PAX8 represents the most significant gene underlying the etiology of 7/ 592 (1.2%) individuals and is associated with a syndromic condition characterized by CH and MRKHS (CH-MRKHS). Other candidate genes such as BMP4 and BMP7 still warrant further genetic and functional studies.
There is no direction as to how relate AGPAT2 and/or PAN2 are involved in the prediction of MRKH.
(f) The skill of those in the art of molecular biology and bioinformatics is high as evidenced by Chen above.
(g) The art is unpredictable because the prior art of Agarwal and Rueter, makes clear that there are many other mutations that can be predicted from the gene expression levels of AGPAT2 and/or PAN2.
(h) The claims are broad because they are drawn to drawn to predicting MRKH syndrome based on the gene expression levels of AGPAT2 and/or PAN2. However, the instant specification does not provide specific guidance to practice the claimed invention OR these embodiments. As such, the skilled practitioner would turn to the prior art for such guidance. However, the prior art demonstrates a multitude of diseases involved with the AGPAT@ and/or PAN2 genes. Finally, said practitioner would turn to trial and error experimentation to determine how to predicting MRKH syndrome based on the gene expression levels of AGPAT2 and/or PAN2, which represents undue experimentation. Claim(s) 2-10 is/are rejected for the same reason because they depend from claim 1, and does not resolve the enablement issue in those claims.
Claim 8 and those dependent therefrom is/are rejected because, as outlined above under 35 USC 112(f), the disclosure does not contain adequate structure for “a prediction system”, “an acquisition unit“, “an extraction unit, and “a prediction unit“ to perform the claimed functions. The specification mentions “an acquisition unit“, “an extraction unit, and “a prediction unit“ without any structure as how to perform the claimed limitations. Therefore, there is insufficient disclosure as to necessary structure, steps explained in prose, or any mathematical expression necessary to carry out the above recited function.
With respect to the above limitations, adequate written description for specific programming to carry out said functions in computer-related inventions requires disclosure of the algorithm by which to perform said function. Without the algorithm disclosed, it is unclear as to the exact structure that performs said function (see Finisar Corp. v. DirecTV Group Inc., 86 USPQ2d 1609, 1623 (Fed. Cir. 2008); Halliburton Energy Services v. M-I LLC 514 F.3d 1244, 1256 n.7 (Fed. Cir. 2008)). This raises issues under 112(a) because without the respective algorithms disclosed, one is not apprised of the inventor or joint inventor having possession of the claimed invention.
35 U.S.C. 112(b)
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.
Claim 8 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 8 and those dependent therefrom limitation “a prediction system” , “an acquisition unit“, “an extraction unit, and “a prediction unit“ 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. (i) the disclosure is devoid of any structure that performs the function in the claim. 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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 organizes judicial exception analysis into Steps 1, 2A (Prongs One and Two) and 2B as follows below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
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 (Prong Two); and
Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1
With respect to Step 1: yes, the claims are directed to method, device, and system i.e., a process, machine, or manufacture within the above 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. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
The claims also recite a law of nature or a natural phenomenon. The MPEP at 2106.04(b) further explains that laws of nature and natural phenomena include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature.
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims are found to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas) as well as a law of nature or a natural phenomenon are as follows:
Independent claim 1:
performing classification prediction based on the expression data of the target gene to obtain a classification result about whether the sample to be tested suffers from MRKH; if expression level of any one or more of the target genes is high, obtaining a classification result that the sample to be tested suffers from MRKH; and if the expression level of any one or more of the target genes is low, obtaining a classification result that the sample to be tested does not suffer from MRKH
decomposing an ultra- rare variant in the genome sequencing data into gene units by using a weighting system, and performing burden test on the MRKH patient and healthy people to obtain a target gene expressed significantly in whole exome and an expression level of the target gene;
modeling based on the expression level of the target gene as well as the clinical characteristics to obtain a prediction model.
Dependent claim 5:
predicting the classification result of high or low risk of suffering from MRKH according to the score; if the genome mutation burden score is high, obtaining a classification result that the sample to be tested has a high risk of suffering from MRKH; and if the genome mutation burden score is low, obtaining a classification result that the sample to be tested has low risk of suffering from MRKH
screening out rare variants in the target genes by using a mutation effect prediction tool, endowing weight values respectively according to harmful degrees of the rare variants to gene function,
comprehensively weighting to calculate the genome mutation burden score of the sample to be tested;
screening out a rare variant in each gene by using the mutation effect prediction tool,
endowing weight values respectively according to the harmful degree of each rare variant to the gene function,
comprehensively weighting to calculate the genome mutation burden score of the sample to be tested.
Dependent claim 7:
extracting gene expression data of the significant gene after removing a whole exome signal of the target gene from the gene expression data of the significant gene to obtain a first suboptimal gene related to MRKH, wherein the first suboptimal gene comprises: MT1F
modeling based on expression levels of the target gene and the first suboptimal gene as well as the clinical characteristics to obtain a prediction model
extracting MRKH-related digenic combinations from the genome sequencing data, and screening from the MRKH-related digenic combinations to obtain a first digenic combination;
determining a second digenic combination from the digenic combinations with the target gene;
modeling based on expression levels of the target gene and the digenic combination as well as the clinical characteristics to obtain a prediction model
performing hierarchical clustering on gene expression patterns of the transcriptome sequencing data to obtain at least one co-expressed gene cluster;
screening from the co-expressed gene cluster to obtain a gene that does not reach the significance of the whole exome but is clustered into a same gene module as the whole exome signal,
recording the gene as a second suboptimal gene, wherein the second suboptimal gene comprises BMP7, and AGPAT2;
decomposing an ultra-rare variant in the co-expressed gene cluster into genes by using a weighting system,
summing a maximum weight burden score of each gene after decomposition to calculate a genome mutation burden score,
fitting the genome mutation burden scores to obtain a fitting result; and modeling based on expression levels of the target gene and the suboptimal gene, as well as the fitting result and the clinical characteristics to obtain a prediction model.
modeling based on the expression level of the target gene as well as the clinical characteristics to obtain a prediction model.
Dependent claims 2-4 recite further steps that limit the judicial exceptions in independent claim 1 and, as such, also are directed to those abstract ideas. For example, claims 2-4 further limit the target gene of claim 1.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined to each cover performance either in the mind and/or by mathematical operation because the method only requires a user to manually classify, decompose, predict, model, screed, calculate, extract, cluster, record, sum, and fit. Without further detail as to the methodology involved in “performing classification prediction”, “decomposing an ultra- rare variant”, “modeling”, “predicting the classification result”, “screening out rare variants”, “weighting to calculate the genome mutation burden score”, “extracting gene expression data”, “modeling based on expression levels”, “hierarchical clustering on gene expression patterns”, “screening”, “recording the gene as a second suboptimal g”, “decomposing an ultra-rare variant”, “summing a maximum weight burden score”, and “fitting the genome mutation burden scores”, under the BRI, one may simply, for example, use pen and paper to predict MRKH syndrome.
Therefore, claim 1 and those claims dependent therefrom recite an abstract idea and a law of nature/natural phenomenon [Step 2A, Prong 1: YES; See MPEP § 2106.04].
Step 2A, Prong Two
Because the claims do recite judicial exceptions, direction under Step 2A, Prong Two, provides that the claims must be examined further to determine whether they integrate the judicial exceptions into a practical application (MPEP 2106.04(d)). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the judicial exceptions are integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exceptions, the claim is said to fail to integrate the judicial exceptions into a practical application (MPEP 2106.04(d).III).
Additional elements, Step 2A, Prong Two
With respect to the instant recitations, the claims recite the following additional elements:
Independent claim 1:
acquiring a gene expression data of a sample to be tested
Dependent claim 5:
acquiring a genome mutation burden score of the sample to be tested
Dependent claim 7:
acquiring gene expression data of significant genes in metanephric cells of human and mouse at different embryonic stages
acquiring transcriptome sequencing data of a sample from a training set
Considerations under Step 2A, Prong Two
With respect to Step 2A, Prong Two, the additional elements of the claims do not integrate the judicial exceptions into a practical application for the following reasons. Those steps directed to data gathering, such as “acquire” and “acquiring”, perform functions of collecting the data needed to carry out the judicial exceptions. Data gathering and outputting do not impose any meaningful limitation on the judicial exceptions, or on how the judicial exceptions are performed. Data gathering and outputting steps are not sufficient to integrate judicial exceptions into a practical application (MPEP 2106.05(g)).
Further steps directed to additional non-abstract elements of “a prediction system”, “device”, and “readable storage medium” do not describe any specific computational steps by which the “computer parts” perform or carry out the judicial exceptions, nor do they 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 that 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 (MPEP 2106.05.A i-vi)
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).
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 data gathering 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 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 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 specification also notes that computer processors and systems, as example, are commercially available or widely used at [0072-0074]. The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than the judicial exceptions (see MPEP 2106.05(b)I-III).
Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself [Step 2B: NO; See MPEP § 2106.05].
Therefore, the instant claims are not drawn to eligible subject matter as they are directed to one or more judicial exceptions without significantly more. For additional guidance, applicant is directed generally to the MPEP § 2106.
2. With respect to claim 8, the claimed invention is further directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because they only recite a system with units. Therefore, the claims read on 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") when claimed as a product without any structural recitations MPEP 2106.03.
Conclusion
No claims are allowed.
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/D.M.B./Examiner, Art Unit 1685
/Soren Harward/Primary Examiner, TC 1600