DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/02/2026 has been entered.
Applicant's amendments and remarks, filed, 12/19/2025, are acknowledged. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of Claims
Claims 1-7, 10-17, 20 are under examination.
Claims 8, 9, 18, 19 are cancelled.
Priority
This application is a continuation of U.S. Patent Application Serial No. 14/209,703, filed March 13, 2014, which claims the benefit of U.S. Provisional Application Serial No. 61/799,813, filed March 15, 2013.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7, 10-17, 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The United States Patent and Trademark Office published revised guidance on the application of 35 U.S.C. § 101. USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”). Under the Guidance, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (Guidance Step 2A, Prong 1); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)) (Guidance Step 2A, Prong 2).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that are not “well-understood, routine and conventional in the field” (see MPEP § 2106.05(d)); or 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50-57 (January 7, 2019).
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.(Guidance Step 2B). See Guidance, 84 Fed. Reg. at 54-56.
Step 1
This part of the eligibility analysis evaluates whether the claim falls within any statutory category. See MPEP 2106.03. In this case, the claimed invention (claims 1 and 11 being representative) requires performing a series of process steps. As such, the claims fall into one of the four statutory categories. (Step 1: YES).
A. Guidance Step 2A, Prong 1
The Revised Guidance instructs us first to determine whether any judicial exception to patent eligibility is recited in the claim. The Revised Guidance identifies three judicially-excepted groupings identified by the courts as abstract ideas: (1) mathematical concepts, (2) certain methods of organizing human behavior such as fundamental economic practices, and (3) mental processes. In this case, the following claim limitations constitute the abstract idea:
based on a respective variant of the BRCA gene and familial disease data of each individual, classify each individual into one of a plurality of classifications of the BRCA gene, wherein the plurality of classifications include a deleterious variant, a suspected deleterious variant, a variant of uncertain clinical significance (VUS), a genetic variant- favor polymorphism which is likely to be non-pathogenic, and a genetic variant polymorphism;
generate a probability table based on genetic information selected from the set of individuals that have a respective variant of the BRCA gene, the probability table comprising probability data for the set of individuals representing a likelihood that a particular individual carries a respective mutation in the BRCA gene;
determine that the first genetic data classifies the first individual as having a VUS with respect to the BRCA gene;
generate a score for the first individual based on the probability table and the first genetic data indicating the likelihood that the first individual carries a mutation in the BRCA gene;
responsive to determining the first genetic data indicates the first individual as having the VUS classification, reclassify the first individual based on the probability table and the first genetic data;
Mental Processes
Under the broadest reasonable interpretation, the above steps amount to observing and/or analyzing data and making a decision based on said analysis. As such, the above steps can be performed by the human mind and fall within the “mental processes” grouping of abstract idea set forth in the 2019 PEG (Section I, 84 Fed. Reg. at 52). Applicant is also reminded that the amount of sophistication in the data analysis (which may tax the human brain) does not take the analysis outside the realm of mental processes. The Office's eligibility guidance does not set limit on the number of calculations that can or cannot be performed mentally. MPEP § 2106.04(a)(2)III. Accordingly, but for the recitation of a processor, the above steps fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. [Step 2A, Prong 1: YES]
Mathematical Concept
In addition, the steps for generating a probability table and generating a score amount to mathematical calculations (since generating such a table broadly encompasses calculating numerical likelihood scores in order to populate such a table). While no specific equation is being claimed, Applicant is reminded that there is no particular word or set of words that indicates a claim recites a mathematical calculation. See MPEP 2106.04(a)(2). Therefore, when read in light of the specification, the claimed predicting step also encompasses a mathematical concept. [Step 2A, Prong 1: YES].
Natural Correlation
Additionally, the above claims are also directed to a natural correlation for the following reasons. In particular, the instant claims require obtaining genetic sequence data and correlating this information mutations in the BRCA gene (i.e. a particular disease or phenotype). Therefore, the discriminating step further recites a law of nature because it describes the naturally occurring relationship between a subject’s DNA and a particular phenotype. See MPEP 2106.04(b). It is noted that even if a claim does recite a law of nature or natural phenomenon, it may still be eligible. For example, claims reciting a naturally occurring relationship between a patient’s genotype and the risk of QTc prolongation (a law of nature) were held eligible as not “directed to” that relationship because they also recited a step of treating the patient with an amount of a particular medication that was tailored to the patient’s genotype. Vanda Pharms., 887 F.3d at 1134-36, 126 USPQ2d at 1279-81. This particular treatment step applied the natural relationship in a manner that integrated it into a practical application. The court’s analysis in Vanda is equivalent to a finding of eligibility at Step 2A Prong Two (Pathway B).
B. Guidance Step 2A, Prong 2
This part of the eligibility analysis evaluates whether the claim includes any additional steps/elements that integrate the recited judicial exception into a practical application of the exception. In this case, the additional steps/elements that are not part of the abstract idea are as follows:
store a genetic sequencing data for a set of individuals, the genetic sequencing data comprising a variant of a breast cancer (BRCA) gene for each individual of the set of individuals;
receive, via a web-based frontend, first genetic data of a first individual not included in the set of individuals;
provide, via the web-based interface, the reclassification of the first individual, wherein, responsive to reclassifying the first individual, the one or more processors cause an adjustment to a treatment of the first individual in accordance with the reclassification by initiating a clinical intervention comprising at least one of scheduling an imaging procedure, ordering a biopsy, or initiating a physical examination.
With regards to the storing and receiving steps, these steps do not impose any specificity on the type of BRCA genes being used and generally amount to obtaining data for use by the abstract idea. As such, these steps amount to insignificant extra-solution activity and are not indicative of an integration into a practical application. See MPEP 2106.05(g). Similarly, the providing step merely outputs data to an interface (i.e. a display). As such, this step also amounts to insignificant extra-solution activity and is not indicative of an integration into a practical application. See MPEP 2106.05(g).
With regards to the step of “providing” reclassification of the first individual (wherein, responsive to reclassifying the first individual, one or more processors cause an adjustment to treatment…by initiating a clinical intervention comprising scheduling…, ordering a biopsy, or initiating a physical exam), this does not amount to administering a particular treatment. See MPEP 2106.04(d)(2). For example, consider a claim that recites “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype.” This administration step recites a particular dosage and type of medication and it integrates the mental analysis step into a practical application. The Federal Circuit also has rejected the premise that “claims drafted to include treatment steps are automatically patent eligible.” INO Therapeutics LLC v. Praxair Distribution Inc., 782 F. App’x 1001, 1007 (Fed Cir. 2019). In INO Therapeutics, the Federal Circuit held that “[a] closer look at the claim language as a whole confirm[ed] that the focus of the invention [was] not on a new way of actually treating the underlying [medical] condition,” but rather on “screening for a particular adverse condition.” Id. at 1006–07. The court acknowledged that “[a] treatment step of administering a prior art dosage is . . . present.” Id. at 1007. However, the court held that the treatment step “is plainly not the focus of the claimed invention” and “is not innovative.” Id. (“Unlike Vanda, claim 1 does not recite a specific method of treating disease using an improved set of doses in light of this discovery [of an underlying condition]”). Therefore, after careful consideration, this limitation amounts to mere instructions to “apply” the exception in a generic way. MPEP 2106.04(d)(2). Consequently, the claimed invention does not integrate the abstract idea into a “practical application.”
With regards to the processor and “web-based interface” (which is broadly interpreted as a GUI), applicant is reminded that generic computer components such as a computer and database do not satisfy the inventive concept requirement. See MPEP 2106.05(f) and 2106.05(h). In summary, the claim manipulates existing information to generate additional information, which, without more, is not patent eligible. See Digitech Image Techs., LLC v. Elecs. For Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014). Accordingly, the claims as a whole do not integrate the recited judicial exception into a practical application and the claims are directed to the judicial exception. [Step 2A, Prong 2: NO]
C. Guidance Step 2B:
Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. In this case, the claims do not include additional steps and/or elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons:
As discussed above, the non-abstract steps/elements amount to nothing more than insignificant extra-solution activity. Applicant’s own specification teaches that general purpose client-server systems for obtaining, receiving, and displaying information were routine and conventional in the art [see at least page 13, 14]. Moreover, Vallee et al. (Human Mutation, 2012, Vol. 33, No. 1, 22–28) teaches methods for classifying unclassified variants (UV) in the BRCA gene, wherein the method includes using databases for obtaining/storing BRCA genetic sequencing data [pages 25-26]. Accordingly, it is the examiner’s position that the additionally recited steps/elements appending to the judicial exception were well understood, routine, and conventional in the art. See MPEP 2106.05(d)(Part II). Thus, the independent claims as a whole do not amount to significantly more than the exception itself. Therefore, the claim(s) is/are not patent eligible.
Dependent Claims
Dependent claims 2-7, 10, 12-17, 20 have also been considered under the two-part analysis but do not include additional steps/elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons. Regarding claim(s) claims 2-7, 10, 12-17, 20, these claims recite limitations that further limit the abstract idea or the nature of the data being used by the abstract idea. As such, these claims are not patent eligible for reasons set forth above (Step 2A, prong 1). Therefore, based on the two-part analysis, the instantly rejected claims as a whole are not drawn to eligible subject matter as they are directed to an abstract idea (and/or natural correlation) without significantly more.
Response to Arguments
Applicant’s arguments, filed 12/19/2025, have been fully considered but are not persuasive for the following reasons.
Applicant argues that the claims are not directed to an abstract idea because they now recite a concrete clinical intervention comprising at least one of scheduling an imaging procedure, ordering a biopsy, or initiating a physical examination that are real-world, physical actions that directly impact patient care. In response, as discussed above (Step 2A, prong 2), the “wherein” clause (wherein, responsive to reclassifying the first individual, one or more processors cause an adjustment to treatment…by initiating a clinical intervention comprising scheduling…, ordering a biopsy, or initiating a physical exam) does not amount to administering a particular treatment. See MPEP 2106.04(d)(2). For example, consider a claim that recites “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype.” This administration step recites a particular dosage and type of medication and it integrates the mental analysis step into a practical application. In addition, this limitation is also problematic because it is unclear in what way a “processor” causes an adjustment to a treatment as claims (see also rejection under 35 USC 112b, below). Therefore, after careful consideration, this limitation at best amounts to mere instructions to “apply” the exception in a generic way. MPEP 2106.04(d)(2). Consequently, the claimed invention does not integrate the abstract idea into a “practical application.”
Applicant argues that the claims are not directed to a mathematical concept because they do not recite formulas or equations. In response, the steps for generating a “probability table” (comprising data representing likelihood) and generating a “score” based on the probability table amount to mathematical calculations (since generating such a table broadly encompasses calculating numerical likelihood scores in order to populate such a table). While no specific equation is being claimed, Applicant is reminded that there is no particular word or set of words that indicates a claim recites a mathematical calculation. See MPEP 2106.04(a)(2). Accordingly, for reasons discussed above (Step 2A, prong 1), the examiner maintains that the claims are indeed directed to a mathematical concept.
Applicant argues that the claims are not directed to a natural correlation because they go “well beyond” merely recognizing or describing a naturally occurring relationship, e.g. they operationalize complex data through defined statistical methods to produce actionable clinical classifications. In response, the examiner maintains that the claims require obtaining genetic sequence data and correlating this information mutations in the BRCA gene (i.e. a particular disease or phenotype). This relationship recites a law of nature because it describes the naturally occurring relationship between a subject’s DNA and a particular phenotype. See MPEP 2106.04(b). Moreover, the claimed invention results in a transformation of data (not a physical object or substance) and mental processes or mere “manipulation of basic mathematical constructs” have not been deemed a transformation. MPEP 2106.05(c).
Applicant additionally argues that the claimed abstract idea is integrated into a practical application, namely a particular “data engineering-pipeline” that operationalizes genetic and familial information through processor-executed structures, computations, and outputs. In response, to the extent that applicant is arguing that the practical application is administering a particular treatment, this argument is not persuasive for reasons set forth above. On the other hand, if applicant is arguing that the claimed processor structures (tables), computations, and outputs (data) provide an improvement to the technology, this argument is also not persuasive for the following reasons. In response, the “improvements” analysis in Step 2A determines whether the claim pertains to an improvement to the functioning of a computer or to another technology without reference to what is well-understood, routine, conventional activity. As set forth above, the claimed hardware elements (processor, interface) are recited at a high level of generality and can be viewed as nothing more than generic elements for obtaining data for use by the abstract idea. MPEP 2106.05(g). Applicant also does not contend that it invented any of the processor or elements or that there were unknown in the art as of time of the invention. Moreover, to the extent that applicant is asserting that “generating” and “determining” steps provide the abstract idea, applicant is reminded that an improvement in the abstract idea itself is not an improvement in technology. See Trading Techs. Int’l v IBG, 921 F.3d 1084, 1093-94 (Fed. Cir. 2019). The claimed invention’s use of the ineligible concept to which it is directed (i.e. the abstract idea) cannot supply the inventive concept that renders the invention ‘significantly more’ than that ineligible concept.” BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018). Moreover, the courts have instructed that “[t]he different use of a mathematical calculation, even one that yields different or better results, does not render patent eligible subject matter.” Board Of Trustees Of Leland Stanford Junior University, 991 F.3d 1245, 1251 (Fed. Cir. 2021). In summary, the claimed invention is directed to obtaining data, scoring and classifying the data, and outputting the data and does not integrate the abstract idea into a practical application for reasons discussed above.
With regards to Step 2B analysis, Applicant argues that the combination of the additional steps/elements is unconventional. In response, the examiner has provided clear and sufficient reasons as to why the non-abstract steps and additional elements do not amount to significantly more than the judicial exception (Step 2B analysis). In addition, Applicant’s own specification teaches that general purpose client-server systems for obtaining, receiving, and displaying information were routine and conventional in the art [see at least page 13, 14]. Moreover, Vallee et al. (Human Mutation, 2012, Vol. 33, No. 1, 22–28) teaches obtaining/storing BRCA genetic sequencing data [pages 25-26]. Accordingly, it is the examiner’s position that the additionally recited steps/elements appending to the judicial exception were well understood, routine, and conventional in the art. See MPEP 2106.05(d)(Part II). In other words, absent any evidence to the contrary, there is nothing unconventional with regards to how the BRCA data is being stored or displayed.
Applicant additionally argues that the claimed steps are unconventional (providing new and useful results at clinical scale) in view of BASCOM. In response, regarding Bascom, the limitations considered as a whole provided a design scheme of the computer, network, and Internet components, which included a filtering element, that was not conventional and, which implemented the abstract idea of filtering in a way that improved the performance of the computer. In this case, there is no recitation of elements that are not the abstract idea that when considered alone or in combination are unconventional and implement the abstract idea in a way that improves the performance of a computer. Accordingly, the examiner maintains that the claims do not recite any steps/elements that amount to sufficient to amount to significantly more than the judicial exception. For at least these reasons, and absent any evidence to the contrary, the rejection is maintained.
Claim Rejections - 35 USC § 112 – Written Description
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
This rejection is modified in view of applicant’s amendments.
Claims 1-7, 10-17, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”). Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include: A) Partial structure; B) Physical and/or chemical properties; C) Functional characteristics; D) Known or disclosed correlation between structure and function; E) Method of making; and F) Combinations of A-E. See also MPEP 2163 and the 2011 Supplementary Guidelines to analysis under 35 USC 112 (Computer-Implemented Functional Claim Limitations).
Regarding claim(s) 1 and 11, the claimed invention is drawn to a system/method for variant reclassification using probability tables comprising:
store genetic sequencing data for a set of individuals, the genetic sequencing data comprising a variant of a breast cancer (BRCA) gene for each individual of the set of individuals;
based on a respective variant of the BRCA gene and familial disease data of each individual, classify each individual into one of a plurality of classifications of the BRCA gene, wherein the plurality of classifications include a deleterious variant, a suspected deleterious variant, a variant of uncertain clinical significance (VUS), a genetic variant- favor polymorphism which is likely to be non-pathogenic, and a genetic variant polymorphism;
generate a probability table based on genetic information selected from the set of individuals that have a respective variant of the BRCA gene, the probability table comprising probability data for the set of individuals representing a likelihood that a particular individual carries a respective mutation in the BRCA gene;
receive, via a web-based frontend, first genetic data of a first individual not included in the set of individuals;
determine that the first genetic data classifies the first individual as having a variant of uncertain clinical significance (VUS) with respect to the BRCA gene;
responsive to determining the first genetic data indicates the first individual as having the VUS classification, reclassify the first individual based on the probability table and the first genetic data;
provide, via the web-based interface, the reclassification of the first individual, wherein, responsive to reclassifying the first individual, the one or more processors cause an adjustment to a treatment of the first individual in accordance with the reclassification by initiating a clinical intervention comprising at least one of scheduling an imaging procedure, ordering a biopsy, or initiating a physical examination.
Based on a consideration of the above factors, the level of skill and knowledge in the art, and the specification, the instant claims fail to meet the written description requirement for the following reasons:
With regards to the “classify” step, it is unclear in what way the claimed classifying step is achieved, i.e. in what way is the variant data being classified as “a deleterious variant, a suspected deleterious variant, a variant of uncertain clinical significance (VUS), a genetic variant- favor polymorphism which is likely to be non-pathogenic, and a genetic variant polymorphism”. A review of the specification does not describe any algorithms, models, and/or equations that correspond to the claimed function. The specification also does not provide any correlation between the classification groupings and specific quantitative information, properties, or scoring criteria indicating such that the artisan would know how the classification is being performed. The specification states that “As shown in the figure, the score may be used to reclassify the variants 114, 122 into new classifications. For example, the score generated from the probability tables for variant 122 indicates that the variant is more associated with deleterious results than was originally suspected, so the variant 122 is reclassified as a suspected deleterious classification 104. Such reclassification may occur by changing the actual classification of the variant 122 within a series of classifications that are provided by an outside standard, or may occur by leaving the classification in place, but providing additional information for delivery to a healthcare provider so that the provider can identify the patient as needing more intense treatment than someone that who appears with a VUS variant.” [0039 and Figure 1]. However, this does not provide sufficient written description for what is claimed or what scores (or other quantitative information) are being used to classify the data into the various claimed categories.
A review of the prior art teaches that schemes for classifying genetic variants are not trivial. For example, Plon et al. (Human Mutation, 2008, 29(11), pp.1282-1291) teaches well-established systems for classifying variants based on the degree of likelihood of pathogenicity [See entire]. For sequence-based genetic tests, unlike the instant claims, there are three possible results reported to physicians: 1) positive, in which a mutation that clearly disrupts gene function (and therefore is highly likely to cause clinical consequences) is detected; 2) negative, in which no variation in DNA sequence is detected; and 3) uncertain, in which a sequence ‘‘variant of uncertain/unclassified significance’’ (VUS) or ‘‘unclassified variant’’ (UV, UCV) is detected and it is not known whether the variant has any effect on gene function that might confer an increased cancer risk. Unlike the instant claims, Plon teaches determining a probability of pathogenicity based on likelihood ratios or odds ratios that are determined empirically from multiple lines of evidence and also provides an arbitrary point-based system for mismatch repair (MMR) or other repair gene variants [see, e.g. Abstract, pages 1282-85, and Tables 1-3, and Example 1]. Plon additionally notes that there does not appear to be a consistent approach to interpreting and reporting the clinical significance of variants either among genes or among laboratories, and that the potential for confusion among clinicians and patients is considerable and misinterpretation may lead to inappropriate clinical consequences [Abstract]. Therefore, the specification lacks sufficient guidance as to the necessary classification information being used to achieve the claimed function for the full scope of what is being claimed. The specification does not need to spell out every detail of the invention, but the possession requirement demands that the written description show that the inventor actually invented what is claimed.
With regards to the amended “providing” step, it is also unclear in what way said processors “cause an adjustment to a treatment of the first individual in accordance with the reclassification by initiating a clinical intervention comprising at least one of scheduling an imaging procedure, ordering a biopsy, or initiating a physical examination.” A review of the specification does not describe any algorithms or computational techniques that correspond to the claimed function. The specification does teach that “The patient may also be scheduled for additional tests, such as imaging, biopsies, and other tests that would normally be available to a patient who was initially classified at a higher level for the particular disease. Other similar steps may also be taken, in the discretion of the relevant physician, to better care for the patient in view of the additional information that is available as a result of the reclassification process.” [0070]. However, this disclosure suggests that a physician is the one who is initiating the clinical intervention (not a processor). Therefore, the specification lacks sufficient guidance as to the necessary classification information being used to achieve the claimed function for the full scope of what is being claimed.
For the reasons discussed above, the specification does not satisfy the written description requirement with respect to the full scope of what is being claimed. For more information regarding the written description requirement, see MPEP §2161.01- §2163.07(b).
Response to Arguments
Applicant’s arguments, filed 12/19/2025, have been fully considered but are moot in view of the modified rejection set forth above.
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 1-7, 10-17, 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 pre-AIA the applicant regards as the invention. Claims that depend directly or indirectly from claim(s) 1 and 11 is/are also rejected due to said dependency.
Claims 1 and 11 recite “based on a respective variant of the BRCA gene and familial disease data of each individual, classify each individual into one of a plurality of classifications of the BRCA gene…”. Firstly, there is lack of antecedent basis for “familial disease data” as there is no previous step wherein this data is actually being stored or obtained (as is done for the genetic sequencing data). Secondly, it remains unclear in what way individuals are being “classified” into the various classifications (merely “based on” a respective variant of the BRCA gene and familial disease data of each individual). A review of the specification does not describe any algorithms that correspond to the claimed function. Clarification is requested via amendment.
Claims 1 and 11 recite “wherein the plurality of classifications include a deleterious variant, a suspected deleterious variant, a variant of uncertain clinical significance (VUS), a genetic variant- favor polymorphism which is likely to be non-pathogenic, and a genetic variant polymorphism”. It is unclear as to the metes and bounds of the claimed “variants”, which are all generically recited without regards to any specific genetic data or quantitative information. The specification does not provide any limiting definitions, specific properties, or scoring criteria indicating the scope of the claimed classifications, i.e. the result is subjective and imperceptible. Clarification is requested via amendment.
Claims 1 and 11 recite “the one or more processors cause an adjustment to a treatment of the first individual in accordance with the reclassification by initiating a clinical intervention comprising at least one of scheduling an imaging procedure, ordering a biopsy, or initiating a physical examination.” In this case, it is unclear in what way a processor performs the claimed invention of “initiating a clinical intervention”. A review of the specification does not describe any algorithms or computational techniques that correspond to the claimed function. The specification does teach that “The patient may also be scheduled for additional tests, such as imaging, biopsies, and other tests that would normally be available to a patient who was initially classified at a higher level for the particular disease. Other similar steps may also be taken, in the discretion of the relevant physician, to better care for the patient in view of the additional information that is available as a result of the reclassification process.” [0070]. However, this disclosure suggests that a physician is the one who is initiating the clinical intervention (not a processor). Clarification is requested via amendment.
Cited Prior Art
The following prior art made of record and not relied upon is considered pertinent to applicant' s disclosure.
Lindor et al. (Human Mutation, 2012, Volume 33, Issue 1, pp.8-21; Pub. date: Oct. 11, 2011), which teaches a review of a multifactorial probability-based model for classification of BRCA1 and BRCA2 Variants of Uncertain Significance (VUS). Regarding claim(s) 1 and 11, Lindor teaches obtaining genetic sequencing data associated with BRCA
[pages 8-9 and Figure 1]. Lindor teaches a probability model for classifying genetic BRCA1 and BRCA2 alterations as pathogenic, non-pathogenic, or VUS In this case, however, the instant claims do not provide any laboratory analysis of patient samples.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PABLO S WHALEY/Primary Examiner, Art Unit 3619