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 .
Claim Status
Currently, claims 31-35, 39, 51-54 are pending in the instant application. Claim 1-30, 36-38, and 40-50 have been canceled and claims 51-54 have been added. This action is written in response to applicant' s correspondence submitted 12/22/2025. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant' s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is Final.
Claims 31-35, 39, 51-54 is under examination with respect to elected combination of BUB1, CCNA2, CDCA8, CENPL, CTSC, ETV7, EXOSC10, EZH2, GPSM2, HJURP, KIF4A, MOV10, NEK2, NUP210, SKA3, TTK, UNC5CL, and ZNF215; and CGN, KHNYN, GRAMDIC, MYO3A, FN1, ASPHDI, RHBDF1, ABCC8, LANCL2, SLC43A1, ACOX3, PGBD5, MTMR14, SUN1, TXNL4B, BNIP3, CLDN12, GATADI, MSH5, and ZC3H18.
Maintained Rejections
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 31-35, 39, and 51-54 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims recite a law of nature and an abstract idea. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. This rejection was previously presented and has been rewritten to address the amendment to the claims.
The following inquiries are used to determine whether a claim is drawn to patent-eligible subject matter.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? Yes, all of the claims are directed to a process.
Step 2A. Is the claim directed to a law of nature, a natural phenomenon or an abstract idea (judicially recognized exception) and does the claim recite additional elements that integrate the judicial exception into a practical application?
Yes, the claims are directed to law of nature/natural phenomenon. Claim 31 recites a naturally occurring thing or natural phenomenon which is a natural principle: an asserted correlation between expression levels and risk of recurrence of PTC. Claim 31 recites determining a risk of recurrence of a papillary thyroid cancer and a step of determining risk of recurrence of PTC based on expression levels. Claim 39 recites a step of determining high risk or low risk of recurrence of PTC based on expression levels. Claim 51-52 recites determining or classifying the patient has high risk or low risk of PTC based on expression levels. Claim 53-54 recite selecting treatment based on classification of PTC based on expression levels. This conclusion is supported by the recited purposed of the claimed method as set forth in the preamble of claim 31, determining step of claim 31, 39, 51, classifying step of claim 52 and selecting step of claim 53. Claim 31, 39, and 51 requires determining risk of recurrence based on expression levels of genes in a first and second gene set. Claim 52 requires classifying risk of recurrence based on expression levels of genes in a first and second gene set. Claim 53 requires selecting therapy based on risk and expression level of genes in first and second gene set. The recited relationship is a natural phenomenon that exists apart from any human action. This type of correlation is a consequence of natural processes.
The claims also recite the judicial exception of an abstract idea and particularly mental processes and grouping of mathematical concepts. Claim 31 recites the abstract idea of a mental process. Claim 31 recites the step of “determining” if a patient is high risk or low risk. Claim 39 recites determining high risk or low risk of recurrence comprising using a statistical model trained using the expression levels of the first gene set and second gene set. Claim 51 recites the step of “determining” the risk of recurrence of PTC. Claim 52 recites the step of “classifying” the patient as high or low risk PTC and claim 53 recites “selecting” treatment for the patient based on classification. Neither the specification or the claims set forth limiting definition for determining, classifying or selecting and the claims do not set forth how determining, classifying or selecting is accomplished. The broadest reasonable interpretation of the determining, classifying, and selecting is a step that can be accomplished mentally by evaluating data and critical thinking process wherein one mentally reads information in a database or report regarding expression levels then draws a mental conclusion. Such “determining” “classifying” and “selecting” encompasses process that may be performed mentally and this is an abstract idea. The step of using a statical model is encompassed by a mathematical concept.
Having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application. The claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological
environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
As mentioned above, a claim limitation can integrate a judicial exception by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. When evaluating this consideration one must the following:
(i) the particularity or generality of the treatment or prophylaxis limitation;
(ii) whether the limitations have more than a nominal or insignificant relationship to the exception; and
(iii) whether the limitations are merely extra solution activity or field of use.
In addition to the judicial exceptions, claim 32 further limits the sample and claim 33 further limits determining expression level by RT-PCR, cDNA microarray, or RNASeq. Claim 54 further limits the treatment selected however the treatment is not administer the recited treatment only limits the judicial exception of selecting treatment and the treatment is not specific to a population of patients, the claim only recites “based on the classification” which is not specific.
These additional steps/elements are not considered to integrate the judicial exception into a practical application because they merely add insignificant extra-solution activity (data gathering) to the judicial exception.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? No.
Herein the claims as a whole are not considered to recite any additional steps or elements that amount to significantly more than well-understood, routine, and conventional activities in the art and do not add something “significantly more” so as to render the claims patent-eligible. The step of isolating RNA from a sample and determining expression within the isolated RNA merely instructs a scientist to use well established, routine and conventional nucleic acid techniques to gather samples for diagnostic analysis. As address in the instant specification methods of expression analysis are well-known in the art (See para 130). The step of determining RNA expression level in a biological sample constitutes a data gathering step required to apply the law of nature/natural phenomenon. It is acknowledged that the claims name particular genes whose level is to be determined however the claims do not require a particular, non-conventional primer or probe consisting of or comprising a specific nucleotide sequence or any other specific reagent that is used to accomplish such determining such that the claims would recite significantly more than the judicial exception. The targets to be detected are part of the judicial exception and thereby the naming of the targets does not add something “significantly more” to the recited judicial exceptions.
The additional steps and elements are recited at a high degree of generality and are all routine, well understood and conventional in the prior art. The recited steps and elements do not provide inventive concept necessary to render the claims patient eligible. There is no combination of elements in this step that distinguishes it from well-understood, routine and conventional data gathering activity engaged in by scientists prior to applicant’s invention and at the time the application was filed. Many cited prior art references in this record demonstrate that these techniques were conventional at the time of the invention. Probes for determining expression of the gene set are on commercially available microarrays. Affymetrix U133 2.0 microarray comprises probes for the entire gene set claimed. The prior art of Han (Cancer Medicine, 2018, 7(4):1135-1140), Handkiewicz (2016, cited on IDS), and Tarabichi (BJC, 2015, 112, 1665-1674) demonstrate gene expression analysis using U133 2.0 array for thyroid cancer analysis. Dependent claim 34-35, 39, 51-53 further limit the recited judicial exception. Claim 32-33 further describe when the determining steps is carried out and limit the sample type. The dependent claims do not provide significantly more to the claims outside of the judicial exception as they encompass conventional techniques as described in the instant specification as noted above.
Response to Arguments
The response traverses the rejection on pages 9-17 of the response mailed 12/22/2025. The response summarizes judicial exceptions on pages 9-11.
The response asserts the claims are not directed to a naturally occurring thing, natural phenomenon and/or abstract idea. The response asserts the office action has not considered where eh claims as a whole are directed to exclude subject matter. The response asserts the office action ignores the remaining limitation sofa independent claim 31 for step 2A, reciting isolating RNA from a biological sample of a patient and determining a level of expression within the isolated RNA of each of two or more genes or gene products of a first gene signature and determining a level of expression within the isolated RNA of each of two or more gene or gene products of a second gene signature and determining if the patient has a high risk of recurrence of PTC based on the level of expression of the two or more genes of the first gene signature or determining if the patient has a low risk of recurrence of PCT based on the level of expression of the tow or more genes or gene products of the second gene signature. The response asserts that claim 31 is its entirety is not directed to a naturally occurring thing or abstract idea and is directed to a particular method implemented that improves the relevant technology and provides meaningful limitations on how to accomplish the same. The response asserts that a proper analysis of Step 2A prong one and prong two would be to look to whether the claims focus on a specific means or methods the improves the relevant technology or instead directed to a result or effect that itself is the abstract idea and merely invoke generic processes. The response asserts that claim 31 recites a method that includes physical implementation requiring isolating RNA from a sample, determining levels of expression within the isolated RNA of a first gene signature and a second gene signature and based thereon determining high or low risk of recurrence of PTC. This response has been reviewed but not found persuasive. The rejection above addressed the claims as a whole. The rejection above addresses the steps of isolating RNA for a sample and determining level of expression of a first gene signature and a second gene signature is well known, routine and conventional in the art, as taught by Han and the instant specification teaches using previously obtained expression levels to determine risk (see para 34), which demonstrates the step of isolating RNA and determining expression of the claimed gene sets was routine and conventional in the art. The step of isolating RNA and determining expression is not only routine, well-known and conventional in the art but it is a data gathering step necessarily to perform the recited law of nature and abstract idea. Here the claims do invoke generic processes in which the results are used for mental analysis and natural correlations. In keeping with these principles, if the additional elements or steps in the claimed process, “apart from the natural laws themselves,” involve only “well-understood, routine, conventional activity previously engaged in by researchers in the field” at the relevant time, they are insufficient. In the instant case, the application asserted by applicant is the law of nature, the association of the expression of the claimed gene sets with risk of recurrence of PTC and there is no claimed application of this association. With regard to the newly added claims reciting selecting a treatment, this is not a concrete treatment step. The broadest reasonable interpretation of the claim includes critical thinking of the results of expression levels to select a treatment. The step of selecting broadly encompasses a mental analysis of data to determine a treatment, the step does not involve an actual treating step or administering treatment to a patient.
The response asserts the claims do not preempt any method and addresses preemption. The response asserts that claim 31 includes limitations that focus the invention specifically on a specific implementation of isolating RNA, determining a level of expression with the isolated RNA or gene products in the first and second gene signature and determining high risk or low risk of PTC such that the claimed invention would not preempt any prognostic method for PTC. The response asserts that Han describes use of a completely different set of 26 genes to diagnose a patient with thyroid cancer. This response has been reviewed but not found persuasive. Preemption is not a standalone test for determining eligibility (see MPEP, 2106.07(b)). The claims are not limited to a gene set that consists of the elected genes, the claims encompass determining expression of a gene set that comprises the elected gene and further the risk of PTC is “based on “ the level of expression, thus the claim encompasses any additional number of genes and the risk of PTC is loosely related to expression level as the claim recites risk of PTC based on the level of expression. The broadest reasonable interpretation of based on expression encompasses using the information from the expression in some manner for risk however it does not require nor recite how the level of expression is used or what the level of expression is to determined risk, thus the claim is not limited. The claim is not limited to a specific increase or decrease expression level of a specific gene set as the claims encompass comprising language and include any level of expression in which risk is determined. As such no expression level of the recited genes would be included in the risk analysis and therefore Han would encompass the limitations of the claims. Additionally the claims are not directed to any non-conventional or non-routine methods of determining expression of the claimed gene set, as the genes are located on a commercially available nucleic acid microarray platform.
The response asserts the claims cannot be performed in human mind or with pen or paper. The response asserts that when the claim as a whole is considered the claim limitations cannot be done by a human in the mind or by pen and paper. The response asserts the claim does not recite a mental process as the limitation cannot be practically performed in the human mind. The response asserts a human cannot isolate RNA or determine level of expression in their mine or with pen and paper. The response asserts that because isolating RNA and determining level of expression, the claim is against being an abstract idea. This response has been reviewed but not found persuasive. The step of determining risk of PTC and selecting therapy are abstract idea that can be performed in the mind. These steps are recited in the preamble and final step of the claims, as such the claim is directed to an abstract idea. After determining if the claim is directed to a judicial exception, the additional steps recited in the claim are evaluated to determine if these claims are significantly more than judicial exception. As previously addressed the step of isolating RNA and determining expression level of the elected gene sets was routine, conventional and well understood in the art. As such the claim is directed to an abstract idea as the claims recite an abstract idea in the preamble of the claim and the final process step of the claim. These steps can be performed in the mind, while the step of isolate gRNA and determining expression level of the two elected gene sets are not pe4rformed in the mid these steps do not amount to significantly more than the judicial exception as these are routine, conventional, and well understood steps.
The response asserts the claims are directed to significantly more than the judicial exceptions. The response asserts that isolating RNA, using isolated RNA to determining levels of expression of tow or more genes of a first and second gene signature and determining risk of PTC involves an inventive concept over the prior art because the prior art does not determine the level of the first and second gene signatures and determine risk of recurrence. The response further asserts that the claims recite subject matter that improves a technological process by determining expression level within isolated RNA of two or more genes of a first and second gene set and determining risk of PTC based on level of expression. The response asserts this transforms the step into a patent eligible application. The step of determining risk of recurrence is the judicial exception and can not be relied about for significantly more than the judicial exception. As previously addressed commercially available microarrays comprises probes for the elected gene sets as such it was well known, routine and conventional to determine expression of the elected gene sets and isolating RNA. While the claims recite two different gene sets and determining expression levels of these gene sets, the claims are not limited to a specific methodology to determine the expression of the gene sets nor are the claims limited to only the elected genes of the gene sets. Even arguendo the claims were limited to only the elected gene set, the step of determining expression was routine and convention in the art. The claims are directed to judicial exceptions and the additional steps recited within the claims do not amount to significantly more than the judicial exception as each of these steps were well known, routine and conventional in the art. For these reasons and reasons of record this rejection is maintained.
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 31-35, 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Han (Cancer Medicine, 2018, 7(4):1135-1140). This rejection was previously presented and has been rewritten below.
With regard to claim 31, 34 and 35, Han teaches a method of determining expression in isolated RNA from biological samples from subjects. Han teaches datasets comprise thyroid cancer samples and non-tumor samples based on chip platform of Affymetrix Human Genome U133 Array. The samples were isolated and RNA expression was determined by Affymetrix Human Genome U133 Array and RNASeq (see data collection). Han teaches the datasets include GSE33630, which comprised 49 papillary carcinomas from tumor thyroid tissue. The Affymetrix Human Genome U133 2.0 Array (GPL570) comprises probes for BUB1, CCNA2, CDCA8, CENPL, CTSC, ETV7, EXOSC10, EZH2, GPSM2, HJURP, KIF4A, MOV10, NEK2, NUP210, SKA3, TTK, UNC5CL, and ZNF215; and CGN, KHNYN, GRAMDIC, MYO3A, FN1, ASPHDI, RHBDF1, ABCC8, LANCL2, SLC43A1, ACOX3, PGBD5, MTMR14, SUN1, TXNL4B, BNIP3, CLDN12, GATADI, MSH5, and ZC3H18 and thus expression levels of each of the genes would be determined. Additionally because Han teaches datasets that comprise 20 nontumor samples, and TC samples this encompasses a first and second gene set as each sample set will comprise a gene set of expression levels for BUB1, CCNA2, CDCA8, CENPL, CTSC, ETV7, EXOSC10, EZH2, GPSM2, HJURP, KIF4A, MOV10, NEK2, NUP210, SKA3, TTK, UNC5CL, and ZNF215; and CGN, KHNYN, GRAMDIC, MYO3A, FN1, ASPHDI, RHBDF1, ABCC8, LANCL2, SLC43A1, ACOX3, PGBD5, MTMR14, SUN1, TXNL4B, BNIP3, CLDN12, GATADI, MSH5, and ZC3H18.
With regard to claim 32, Han teaches the expression analysis was determined using GSE33630, which comprises data from analysis of 49 papillary thyroid cancer samples that were obtained from thyroid tissue dissection (claim 32) (see characteristics of included datasets).
With regard to claim 33, Han teaches determining expression analysis by microarray analysis and TCGA databases that comprise measuring level of gene expression by RNAseq.
With regard to claim 39, Han teaches a statistical model trained using expression levels (see signature construction) (see fig 2). Han teaches a diagnostic score was developed based on the expression levels. It is noted that Han is silent with respect to recurrence however the claims merely encompass risk of recurrence and individuals with TC have an increased risk of recurrence compared to those patient without TC. Because the claim encompasses only a risk of recurrence and includes high or low risk without any other identifying characteristics, a subject with any thyroid cancer is at risk of recurrence of the same cancer.
Response to Arguments
The response traverses the rejection on page 5-9 of the remarks mailed 12/22/2025. The response asserts Han does not teach each and every limitation as recited by claim 31. The response asserts Han does not describe a first gene signature and a second gene signature as claimed. The response asserts that Han does not teach e determining a level of expression within the isolated RNA of each of two or more genes of a first gene signature and level of expression within the isolated RNA of a second gene signature, wherein the first gene signature comprises BUB1, CCNA2, CDCA8, CENPL, CTSC, ETV7, EXOSC10, EZH2, GPSM2, HJURP, KIF4A, MOV10, NEK2, NUP210, SKA3, TTK, UNC5CL, and ZNF215 and a second gene signature comprises CGN, KHNYN, GRAMDIC, MYO3A, FN1, ASPHDI, RHBDF1, ABCC8, LANCL2, SLC43A1, ACOX3, PGBD5, MTMR14, SUN1, TXNL4B, BNIP3, CLDN12, GATADI, MSH5, and ZC3H18. This response further asserts that each of the gene sets comprise specific genes in each gene signature and Han doesn’t describe, teach or suggest the gene signatures. This response has been thoroughly reviewed but not found persuasive. The claims recite a method a comprising isolating RNA from biological sample from the patient, determining as level of expression within the isolated RNA of each of two or more gene or gene products of a first gene signature comprising BUB1, CCNA2, CDCA8, CENPL, CTSC, ETV7, EXOSC10, EZH2, GPSM2, HJURP, KIF4A, MOV10, NEK2, NUP210, SKA3, TTK, UNC5CL, and ZNF215 and a second gene signature comprising CGN, KHNYN, GRAMDIC, MYO3A, FN1, ASPHDI, RHBDF1, ABCC8, LANCL2, SLC43A1, ACOX3, PGBD5, MTMR14, SUN1, TXNL4B, BNIP3, CLDN12, GATADI, MSH5, and ZC3H18. The recitation of comprising does not limit the first and second gene set to only the elected genes and thus the set can comprise additional genes beyond those recited in the claims. Additionally the claims are a method comprising the steps and therefore can encompass additional steps beyond what is recited within the claim. Because the gene sets are not limited to only the elected genes of each gene set, the use of an array by Han comprises determining a level of expression of a first gene set and a second gene set as Han disclosed using multiple array gene data sets, each of the data sets will comprise the elected gene. The claims further do not require a specific level of expression determined, as such when performing the assay of using the arrays, the expression level of each gene will be determined. The claim does not require a specific level to be determined or a specific value to be measured as such the arrays of Han read on the claims. If the claims were amended to require a specific step of treating each identified risk population this would overcome the rejection of record. Alternatively if the claims were amended to require specific levels of gene expression measured or require specific probe or primer to detect expression this would overcome the rejection of record.
While the response asserts that Han assess 115 genes and paring the gene to identify significant gene pairs associated with disease data the identified signature do not include any of the listed genes for the first gene signature and the second gene signature as claimed. This response has been reviewed and not found persuasive. In the method of Han and in the analysis of assessing 115 genes, the data from the array assays will be evaluated and this encompasses the step of determining an expression level of the claimed elected gene set of the first gene set and second gene set. The claims do not require anything more. The claims do not require identifying a specific expression level of each signature nor limited to only the elected genes. Determining expression including determining no expression, because probes for each of the gens are located on the arrays, the expression levels will be determined, which is all that is required for the claims.
The response asserts the examiner has not provided any correspondence for the first and second gene signature. The response asserts that the 115 genes in Han cannot be located. The response asserts there is no citation provided in the office action to support that the probes of GPL570 include the genes in the first and second gene signature at the time Han was received and published. The response further asserts that the array of probes of GPL570 were not used in Han for determining expression levels and determining if patient has risk of recurrence. The response asserts the probes in Han were used to screen samples for DEGs between tumor and on tumor samples and the most frequent DEGs were selected. It is noted that the claims include determining any expression levels of the elected genes as such even using samples to screen for DEGs encompass determining expression level of the elected genes. Additionally the expression levels of GEO data sets were used in the analysis of Han. The data set of Han use the expression values from isolating RNA from a sample and determining expression level of the claimed gene sets. For example, GSE33630 uses the GLP570 platform by isolated RNA from thyroid samples and provides data for each of the samples. For each sample the GLP570 platform was used to determine expression which includes analysis of expr4ssion levels in the RNA sample. The information of the platform GPL570 has been provided in this response. GLP570 was available on Nov 7, 2003. Additionally Han teaches using the expression data is GSE33630 which includes isolating total RNA from thyroid tissues and determining expression, see GSE33630 extraction protocol. Due to the extremely long document of the manifest for the Affymetrix U133 microarray, the examiner has copied the relevant gene and probe information from the GLP570 platform that comprises Affymetrix U133 microarray and attached as appendix to office action. Attached is identification of the probe for each of the claimed genes from the GLP570 data. Additionally attached is data for GSE33630 of sample GSM/831749 that provides further evidence that each of the elected genes expression level was determined including the genes in each gene set. This additional information provides support for probes on the U133 microarray for the elected genes and any assay that will determine expression level within an isolated RNA, as taught by Han and GSE33630, meets the limitation of claim 31. Because the data of GSE33630 comprises different samples, one sample comprises analysis of a first gene set that includes the elected gene set and another sample comprises analysis of a second gene set that includes the elected gene set for the second gene set. It is noted that the claims are not limited to only a gene set consisting of each of the genes but the claim is comprising as such an entire array analysis reads on the claims. Additionally the claims do not require analysis of only the elected genes of the first gene signature in a sample and analysis of the elected genes of the second gene signature in the same sample but in different assays which is what appears to be the traversal. The recitation of a first and second gene signature does not limit expression analysis of a sample to the first gene set then analysis of a second gene set of the same sample.
The response asserts that Han does not describe determining if the patient has a high risk of recurrence based on the expression level of two or more genes of the first gene signature or determining if the patient has low risk based on the level of expression of the second gene signature. The response further asserts that Han is directed to diagnosing thyroid cancer by using a diagnostic signature based on pairs of genes. The response asserts the claim language recites determining risk of reoccurrence of PTC based on the level of expression of two or more genes of first gene signature or of the second gene signature. The response asserts Han is based on 26 genes in 19 gene pairs. The response asserts that these 26 genes do not include any of the genes of the first or second gene signature. The response addresses claim 34-35 and assert that Han does not teach 5 or more genes in a gene signature. This response has been reviewed but found persuasive. The claims have not been examined to require two or 5 or more genes of the claimed gene signatures but the entire elected combination of each gene signature. With regard to Han not teaching any genes from the gene signature and only teaches 26 genes for diagnosing thyroid cancer, Han was not cited to teach the 26 genes associated with thyroid cancer. Han was cited because Han teaches isolating RNA from a biological sample, determining a level of expression within the isolated RNA of the elected genes of a first gene signature and determining a level of expression of the elected genes of a second gene signature as Han teaches the data sets that use a microarray that comprises the probes of the elected genes and Han teaches analysis of data from expression data that comprises the elected genes of a first gene signature (one sample) and a second gene signature (second sample). The claims do not require anymore more than these process steps and the step of determining a level of expression of the first and second gene signature is comprising language and allows for additional genes to be included in the gene signatures as such analysis of more than one sample will include a first gene signature and second gene signature relative to the first sample and second sample. Neither the claims or specification recite what is required or encompassed by “based on the expression level” for the determining if the patient is high risk or if the patient is low risk, as such any analysis would be encompassed. A subject with any thyroid cancer is at risk of recurrence of cancer and the step of determining of risk of thyroid cancer would be met by Han as the patients would be determined to have a risk of recurrence based on expression of gene set as the claim does not require how the expression determines risk and expression could be transiently related such as taught by Han. Furthermore, the step of determining if the patient is high risk…or determining if the patient is low risk is a necessary result of the determining level of expression. That is once the expression level of the elected genes is known, the risk has been determined. The determining risk does not result in any manipulative different between the prior art meth9od and the claimed method, it merely directs how one thinks about the outcome of the method. Here the sole potential source of novelty would be in determining risk limitation. These limitations add no novelty to the method, which is otherwise anticipated by the prior art because there is no novel and unobvious functional relationship between the descriptive language and the manipulative steps of the claim. Determining risk of recurrence of PTC with no associated further action does not have any further function, it does not transform the process of determining expression levels. Irrespective of what one mentally determines, the actual method, isolating RNA from a biological sample and determining a level of expression with the isolated RNA of the elected genes in each gene set, is the same and determining risk of recurrence adds no additional outcome. For these reasons and reasons of record this rejection is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAE L BAUSCH/ Primary Examiner, Art Unit 1699