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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/19/2026 has been entered.
Status of the Claims
The status of the claims as of the response filed 3/19/2026 is as follows: Claim 2 is cancelled, and all previously presented rejections for this claim are considered moot. Claims 1 and 8-10 are currently amended. Claim 3 is as previously presented. Claims 4-7 are original. Claims 11-17 are new. Claims 1 and 3-17 are currently pending in the application and have been considered below.
Note: Applicant is reminded of the requirements of 37 CFR 1.121 as detailed in MPEP 714(II)(C)(B): “All claims being currently amended must be presented with markings to indicate the changes that have been made relative to the immediate prior version. The changes in any amended claim must be shown by strike-through (for deleted matter) or underlining (for added matter).” Examiner notes that at least claim 10 does not comply with this requirement (claim 10 as recited in the immediate prior version of the claims dated 11/7/2025 include the final limitation “administering the recommended second-generation hormone drug to the subject suffering from prostate cancer” which appears to have been removed from the instant claims dated 3/19/2026 but there is no markup of this limitation with a strikethrough, it is merely absent from the claim) and requests that all future amendments properly denote each addition and/or deletion to the claims as required, or a Notice of Non-Compliant Amendment may be mailed.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/19/2026 is in compliance with the provisions of 37 CFR 1.97 and is being considered by the examiner.
Response to Amendment
Drawings
The replacement drawings are accepted and the objection to the drawings is withdrawn.
Rejection Under 35 USC 112(a)
Claim 10 has been amended to remove the unsupported subject matter such that the corresponding 35 USC 112(a) rejection is withdrawn.
Rejection Under 35 USC 101
The claims have been amended but the 35 USC 101 rejections for claims 1 and 3-9 are upheld.
Rejection Under 35 USC 103
The amendments made to the claims introduce limitations that are not fully addressed in the previous office action (e.g. specifying the genes included in each of X1, X2, Y1, and Y2 gene sets), and thus the corresponding 35 USC 103 rejections are withdrawn. However, Examiner will consider the amended claims in light of an updated prior art search and address their patentability with respect to prior art below.
Response to Arguments
Rejection Under 35 USC 101
On pages 12-14 of the response filed 3/19/2026 Applicant argues that the amended independent claims are patent eligible because they include comparison of a physiological signal to gene sets X1, X2, Y1, and Y2 which are not routinely or conventionally used for identifying specific second-generation hormone drugs suitable to treat prostate cancer patients, in a manner analogous to eligible claim 3 of Example 29 which utilized a porcine antibody to detect a human protein for julitis diagnosis in a non-routine and non-conventional manner. Applicant’s arguments are fully considered, but are not persuasive. The comparison of the physiological signal to the four specific gene sets is part of the abstract idea itself, because a human actor could compare indications of these genes in a given patient’s genetic information results to patterns/indications of genes in the four recited gene set lists either mentally or with the aid of pen and paper. In contrast, the use of porcine antibodies to detect whether a specific gene was present in a plasma sample as in Example 29 represented an additional element beyond the abstract idea itself that was unconventional in the art, because it described a specific laboratory procedure that was not routinely performed for human diagnosis. The instant claims do not describe an unconventional assaying procedure analogous to that of Example 29, and instead appear to utilize known assay methods of obtaining genetic information for a patient and then performing abstract comparison and calculation steps on the obtained data to output a recommended treatment. Examiner notes that features of or improvements to the abstract idea itself cannot provide “significantly more” than the abstract idea and do not confer eligibility (see MPEP 2106.05(a): “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” See also 2106.05(a)(II): “it is important to keep in mind that an improvement in the abstract idea itself… is not an improvement in technology.”). Accordingly, the 35 USC 101 rejections are upheld for claims 1 and 3-9.
Claim Objections
Applicant is advised that should claim 8 be found allowable, claim 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 17 is objected to because of the following informalities: it depends on claim 16, which is a system type claim but recites “the method of claim 16.” Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The 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: an input device for receiving ex vivo biological samples obtained from a subject and generating at least one physiological signal (N) of the ex vivo biological samples in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. In the instant case, the input device is described in para. [0025] as “a biochemical instrument well known to persons skilled in the art, including but not limited to: DNA sequencer, next-generation sequencer, biochemical serum analysis system, drug and special protein analyzer, electrolyte analyzer, glycated hemoglobin analyzer or osmotic pressure analyzer.” In accordance with this disclosure, the input device of claim 1 will be interpreted as any kind of biochemical instrument or analyzer that can accept a biological sample and perform any kind of analysis on the sample.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation "the computer device." There is insufficient antecedent basis for this limitation in the claim because parent claim 10 does not introduce a “computer device,” merely a processor. For purposes of examination, Examiner will interpret “the computer device” of claim 15 as “the processor” previously introduced by parent claim 10.
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 and 3-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
In the instant case, claims 1, 3-9, and 16 are directed to a system (i.e. a machine) and claims 10-15 and 17 are directed to a method (i.e. a process). Thus, each of the claims falls within one of the four statutory categories. Nevertheless, the claims fall within the judicial exception of an abstract idea.
Step 2A – Prong 1
Independent claims 1 and 10 recite steps that, under their broadest reasonable interpretations, cover mental processes. Specifically, claim 1 (as representative) recites:
A clinical therapeutic drug prediction and recommendation system for evaluating the efficacy of second-generation hormone drugs in the treatment of prostate cancer, comprising:
an input device for receiving ex vivo biological samples obtained from an untreated subject suffering from prostate cancer and generating at least one physiological signal (N) comprising genetic information of the untreated subject suffering from prostate cancer;
a computer device connected to the input device, wherein the computer device comprising: a processor for receiving the at least one physiological signal (N), wherein the processor further comprises:
an analysis module for executing a calculation method to generate a first score (S1) and a second score (S2) by:
(i) comparing the at least one physiological signal (N) with a first-level gene set (X1) of patients suitable for a first second-generation hormone drug treatment to obtain a comparison value of (N, X1) and comparing the at least one physiological signal (N) with a second-level gene set (X2) of the patients suitable for the first second-generation hormone drug treatment to obtain a comparison value of (N, X2), then applying a first weight value (W1) to the comparison value of (N, X1) and a second weight value (W2) to the comparison value of (N, X2) to obtain a first score (S1) by using a calculation method, and
(ii) comparing the at least one physiological signal (N) with a first-level gene set (Y1) of patients suitable for a second second-generation hormone drug treatment to obtain a comparison value of (N, Y1) and comparing the at least one physiological signal (N) with a second-level gene set (Y2) of the patients suitable for the second second-generation hormone drug treatment to obtain a comparison value of (N, Y2), then applying the first weight value (W1) to the comparison value of (N, Y1) and the second weight value (W2) to the comparison value of (N, Y2) to obtain a second score (S2) by using the calculation method; wherein the gene set X1 comprises the genes of NR4A1, ARHGEF10L, TNNT1, CPAMD8, CYP2S1, PLA2G7, CLEC10A, CD1C, ATF3, FCER1A, PLD4, the gene set X2 comprises the genes of SHROOM1, OSM, CD83, STAB1, UCN, AC106782.1, ANKRD28, CD69, FCHO2, CCR3, CPA3, CCR1 IFNG, OXER1, GAS6, KCNC3, ZNF385A, ELANE, BPI, FAM109A, LCN2, AZU1, DEFA3, MZB1, PCSK6, KLF4, IFI27, SIGLEC1, LGALS2, LRP1, PLXNB2, GATA2, FOSB, ZNF703, HIST1H1C, NUCB2, JUN, C1orf54, CDC42EP1, LILRB4, TUBB2A, CD24, RHOB, ITGB3, TGFBI, AHSP, ZNF358, the gene set Y1 comprises the genes of TMF1, SLC4A1, ASH1L, ARMC2, STXBP5, and the gene set Y2 comprises the genes of SOD2, AQP9, FAM174A, SRSF11, ZBTB11, CDC42EP3, CDK17, NFIL3, GCA, HBG2, HEATR5B, MANF, TTC3, XAF1, APOBEC3A, STRN3, HBQ1, WSB1, TNFAIP3, ZDHHC17, MYSM1, ZMAT1, DDX3Y, CPEB4, ACSL1, FAM156A, ERBIN, WDR44, HBB, SLC39A10, AL132780.3, FPR2, TREM1, RFX2, ATRX, TNIK, PCMTD2, TMEM127, PLCG1, ZBTB38, PHC3, ANKRD28, CXCR2, DYNC1LI2, RNF103, EARS2, RNF19B, TLR8, HELZ2, ZNF518A, SLC38A2, MPZL1, CRLF1, DNAJC25-GNG10, RBL2, G0S2, CREBZF, LEMD3, TRAPPC10, MAP4K5, MGAM, PIK3R4, SCYL2, FAM198B, SDCBP, EIF5, PIGA, TAF1, KRR1, HIF1A, TLR4, GPD2, TCP11L2, PTP4A1, SREK1, ARID4B, KCTD12, TNFAIP8L2, TOB1, HBA2, BIRC3, PIKFYVE, UTRN, CDC14A, FAM76B, SENP7, GPR1 71, NKTR, GOLGA8N, NFKBIZ, GNS, PTGS2, ATXN7, ITGA6, PRF1, TNFRSF10C, RNPC3, KLF9, FAM91A1, PDK4, KIAA1109, ZNF548, HERC1, TRPM7, NAMPT, TNRC6A, YRDC, CXCR3, FCGR3B, PMAIP1, SOCS1, SLC25A36, GTF2I, LAMP2, NUAK2, COMMD3-BMI1, LPINI, MLLT11, B4GALT5, SATB1, MYADM, FGL2, TC2N, CCL3L3, PROK2, RIC1, NPAT, GPATCH2L, CCNG2, GOLGA8A, STX11, MAN2A1, TFRC, UBE4A, UBE2D1, ZDHHC18, MYLIP, MARCKS, CPEB2, ARRDC3, RBM47, PAFAH1B2, MARCH1, SMC5, PTAFR, MORN2, ELL2, GOLGA8B, HBA1, CD83, LCN2, CD69, LTF, TUBB1, CHORDC1, 7-Mar, MCPH1, UGCG, TMEM68, HBM, OSBP2, PDZK11P1, NRGN, SLP1, CLIC3;
a comparison module connected to the analysis module for comparing the first score (S1) and the second score (S2) to obtain a comparison result; and
a recommendation module connected to the comparison module for receiving and analyzing the comparison result, wherein the recommendation module gives an indication to recommend the untreated subject suffering from prostate cancer to take the first second-generation hormone drug when the first score (S1) is higher than the second score (S2), or gives an indication to recommend the untreated subject suffering from prostate cancer to take the second second-generation hormone drug when the first score (S1) is lower than the second score (S2).
But for the recitation of generic computer components like a computer device with a processor implementing various software modules, the italicized functions, when considered as a whole, describe a clinical analysis and recommendation operation that could be achieved via mathematical operations and/or by a human actor (such as a clinician) either mentally or with the aid of pen and paper. For example, a clinician could obtain a measured physiological signal output by a biochemical instrument (e.g. by observing quantified results of a biochemical analysis) and then compare the signal to different sets of specific reference genes known to correlate with patients suitable for different second-generation hormone treatments (e.g. via mathematical similarity or other comparison techniques) and use a calculation method (e.g. an equation) with weighted values to come up with scores representing the patient’s suitability for the different treatments. The clinician could then mentally compare the calculated mathematical scores and recommend a first second-generation hormone treatment if the score for the first treatment is higher, or recommend a second second-generation hormone treatment if the score for the second treatment is higher. Accordingly, claim 1 recites an abstract idea in the form of mathematical concepts and/or a mental process. Claim 10 recites substantially similar subject matter as claim 1 and is found to recite an abstract idea under the same analysis.
Dependent claims 3-9 and 11-17 inherit the limitations that recite an abstract idea from their dependence on claims 1 or 10, and thus these claims also recite an abstract idea under the Step 2A – Prong 1 analysis. In addition, claims 3-9 and 11-17 recite additional limitations that further describe the abstract idea identified in the independent claims. Specifically, claims 3 and 11 specify the types of second-generation hormone drugs, each of which are types of drugs for which a clinician would be capable of evaluating patient suitability in a clinical setting. Claims 4 and 12 note that the calculation method comprises at least one algorithm, which is a series of mathematical steps that a clinician would be capable of following mentally to perform score calculations. Claims 5-6 and 13-14 specify certain types of distance or similarity algorithms, which are known mathematical techniques and thus also abstract. Claims 7 and 15 describe storing the at least one physiological signal, the comparison results and the recommendation indication, which a clinician could achieve mentally (e.g. by remembering these types of information for a patient) or with aid of pen and paper (e.g. by writing down these types of information for a patient). Claims 8-9 and 16-17 describe further details of the calculation method regarding a weight value, which are mathematical concepts that clinician would be capable of incorporating into a mathematical calculation performed mentally or with aid of pen and paper.
However, recitation of an abstract idea is not the end of the analysis. Each of the claims must be analyzed for additional elements that indicate the abstract idea is integrated into a practical application to determine whether the claim is considered to be “directed to” an abstract idea.
Step 2A – Prong 2
The judicial exception is not integrated into a practical application. In particular, independent claim 1 does not include additional elements that integrate the abstract idea into a practical application. The additional elements of claim 1 include an input device for receiving ex vivo biological samples obtained from an untreated subject suffering from prostate cancer and generating at least one physiological signal (N) comprising genetic information of the untreated subject suffering from prostate cancer; a computer device connected to the input device and comprising a processor which further comprises an analysis module, a comparison module, and a recommendation module. Claim 10 similarly includes the additional elements of receiving ex vivo biological samples obtained from an untreated subject suffering from prostate cancer by an input device and obtaining at least one physiological signal (N) comprising genetic information of the untreated subject suffering from prostate cancer and sending the at least one physiological signal to a processor with an analysis module, a comparison module, and a recommendation module. These additional elements, when considered in the context of each claim as a whole, merely provide insignificant extra-solution activity in the form of necessary data gathering (see MPEP 2106.05(g)), and serve to automate/digitize the recited mathematical concepts / mental processes in a manner that amounts to instructions to “apply” the abstract idea using generic computer components (see MPEP 2106.05(f)). For example, the input device is merely invoked as a means to obtain the physiological signal information needed for the main analysis, comparison, and recommendation steps of the invention, such that it amounts to necessary data gathering and does not provide integration into a practical application. Further, the computer device comprising a processor and various modules is recited at a high level of generality and is merely invoked as a tool with which to implement the otherwise-abstract analysis, comparison, and recommendation steps in a digital/electronic environment such that it amounts to mere instructions to apply the exception with computing components. Accordingly, claims 1 and 10 as a whole are each directed to an abstract idea without integration into a practical application.
The judicial exception recited in dependent claims 3-9 and 11-17 is also not integrated into a practical application under a similar analysis as above. The functions of claims 3-6, 8-9, 11-14, and 16-17 are performed with the same additional elements introduced in the independent claims, without introducing any new additional elements of their own, and accordingly also amount to mere instructions to apply the abstract idea using these same additional elements. Claims 7 and 15 introduce the additional element of a storage module of the computer device / processor, which again merely serves to digitize the otherwise-abstract step of storing data such that it occurs in an electronic environment and thus also amounts to instructions to “apply” the abstract idea with generic computing components.
Accordingly, the additional elements of claims 1 and 3-17 do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claims 1 and 3-17 are directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a computer device comprising a processor and various modules for performing the receiving, comparing, obtaining, calculating, analyzing, recommending, storing, etc. steps of the invention amount to mere instructions to apply the exception using generic computer components. As evidence of the generic nature of the above recited additional elements, Examiner notes that Applicant’s specification is silent to the particulars of the computer device, processor, and modules, leaving one of ordinary skill in the art to understand that any known type of computer device with a processor capable of executing software modules may be utilized to implement the invention. The input device is described in para. [0025] as “a biochemical instrument well known to persons skilled in the art, including but not limited to: DNA sequencer, next-generation sequencer, biochemical serum analysis system, drug and special protein analyzer, electrolyte analyzer, glycated hemoglobin analyzer or osmotic pressure analyzer,” showing that this means of obtaining a physiological signal for further analysis is well-understood, routine, and conventional.
Further, the combination of these additional hardware elements is not expanded upon in the specification as a unique arrangement and as such relies on the knowledge of one of ordinary skill in the art to understand the combination of components as a well-known and generic combination for obtaining physiological signal data and automating an abstract idea that could otherwise be performed via mathematical concepts and/or by a human actor either mentally or with the aid of pen and paper. Additionally, the combination of a biochemical instrument to obtain physiological data from a biological sample with a processor-based computer device executing software modules for analysis of the physiological data is a well-understood, routine, and conventional combination, as evidenced by at least Fig. 1, [0231]-[0236], & [0298]-[0301] of Hoffman et al. (US 20230407402 A1); [0022] & [0100]-[0101] of Lee et al. (US 20210327553 A1); and [0105]-[0113] of Luo et al. (US 20170275673 A1). Examiner further notes that receiving or transmitting data over a network (e.g. sharing data between an input device and a computer device), detecting DNA or enzymes in a sample, and analyzing DNA to provide sequence information or detect allelic variants are examples of well-understood, routine, and conventional functions in the computer and laboratory sciences arts, as outlined in MPEP 2106.05(d)(II). Thus, when considered as a whole and in combination, claims 1 and 3-17 are not patent eligible.
Subject Matter Free from Prior Art
The following is a statement of reasons for the indication of subject matter free from prior art:
The prior art of record fails to expressly teach or suggest, either alone or in combination, each and every feature of the independent claims. In particular, the prior art fails to teach comparison of genetic information from an untreated subject suffering from prostate cancer to each of the four specific gene sets X1, X2, Y1, and Y2 as now recited by claims 1 and 10. Upon completion of an updated prior art search, Examiner submits that the closest related art includes:
- Symmans et al. (US 20100311601 A1), showing a system for comparing a given patient’s gene set with at least two gene sets associated with an anticancer treatment to determine a measure of responsiveness to the treatment that can guide treatment recommendations, but failing to explicitly disclose comparison to the specific gene sets and the weighted scoring scheme for the comparison results recited by the claims;
- Koytiger (US 11043305 B1), showing a genetically-based treatment efficacy evaluation and recommendation system that includes comparing gene expression profiles to reference gene expression profiles of multiple candidate treatments via similarity measures so that the similarity measures can be directly compared and used as a basis for recommending a more suitable treatment over a less suitable treatment, but failing to explicitly disclose comparison to the specific gene sets recited by the claims;
- Buzdin et al. (US 20200292515 A1) and Jackson et al. (US 20150363559 A1), showing systems for personalized ranking of predicted efficacies of different drugs based on a patient’s genetic profiles, but failing to explicitly disclose comparison to the specific gene sets and the weighted scoring scheme for the comparison results recited by the claims;
- Sheng (CN 110499364 A) and Skog et al. (US 20140045915 A1), showing genetic assaying systems that test for many of the genes recited by the claims for the purpose of disease identification / prognosis to guide treatment, but failing to explicitly disclose comparison of genetic information to the four specific gene sets recited by the claims and the recited weighted scoring scheme for the comparison results;
- Zhao et al. (Reference U on the accompanying PTO-892), showing use of a 24 gene panel for predicting therapeutic response of patients with prostate cancer, but failing to explicitly disclose comparison to the specific gene sets and the weighted scoring scheme for the comparison results recited by the claims.
Though many aspects of the independent claims are disclosed in the prior art, it would not have been obvious to one of ordinary skill in the art to combine the disparate features into the invention of the instant claims. In particular, it would not have been obvious to select the specific sets of genes for X1, X2, Y1, and Y2 for comparison to genetic information from an untreated subject suffering from prostate cancer. Accordingly, the prior art, either alone or in combination, does not disclose or render obvious all the features of the independent claims and they are found to recite subject matter free from prior art, as are the claims depending therefrom.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A HRANEK whose telephone number is (571)272-1679. The examiner can normally be reached M-F 8:00-4:00 ET.
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/KAREN A HRANEK/ Primary Examiner, Art Unit 3684
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