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 .
DETAILED ACTION
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
Claims 1-11, 32, 34-35 and 37-42 are pending and examined on merits in this office action.
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 1-11, 32, 34 and 37-38 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.
The claims are directed to method of detection of colorectal pre-cancerous adenomas (APA) in a subject and the method comprises only measuring at least IGFBP2 and one or more of certain biomarker. The claims do not require any comparison of standard levels of the biomarkers and do not require expression any of the biomarkers over a threshold value, nor does the claims require any type of expression profile. Thus, it is unclear as to how are only the measurement of one or more biomarker provides detection of colorectal pre-cancerous adenomas without any comparison with a reference value. Moreover, as claimed detection of decreased expression or level of negative expression, would also be considered detection of the APA.
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.
Claim 1-11, 32, 34-35 and 37-42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. an abstract idea) without significantly more.
Step 1: The instantly claimed invention is directed to a method for detection of colorectal pre-cancerous adenomas (APA) comprising determining a panel of biomarkers in a sample obtained from the subject. The claim thus recites series of steps and, therefore, the instantly claimed invention falls into one of the four statutory categories. (Step 1: YES).
ELIGIBILITY STEP 2A; WHETHER A CALIM IS DIRECTED TO A JUDICIAL EXCEPTION. First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Step 2A Prong 1
Claim 1 recites the following steps which fall under the mathematical concepts and/or mental processes groupings of abstract ideas and law of nature or natural phenomena:
Claim 1 is drawn to a method of detection of colorectal pre-cancerous adenomas (APA) from measuring a level of a panel of biomarkers and determining a measurement for a panel of biomarkers.
First, these limitations are abstract ideas of mental processes for the following reasons. In particular, the steps of determining the level of a panel of biomarker from the measurement level can be practically performed in the practitioner’s mind. Therefore, these limitations recite a mental process.
Second, the claims are drawn to detection of colorectal pre-cancerous adenomas (APA) from the plurality of biomarker measurements associating/correlating of the measured biomarkers with a disease (colorectal pre-cancerous adenomas). The claim thereby recites laws of nature/ natural phenomena. The natural relationship to which the claims are directed (i.e., the naturally occurring correlation between the APA and proteomic markers in a biological sample) exists in principle apart from any human action. Similar concepts have been held by the courts to constitute laws of nature/ natural phenomena, as in the identification of a correlation between the presence of a marker in a bodily sample (such as blood or plasma) and cardiovascular disease risk in Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017); see also Univ. of Utah Research Found. v. Ambry Genetics Corp., 774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and In re Grams, 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)).
Dependent claims 2-11, 37 and 38 further recite limitations directed to the law of nature and natural phenomena, as the claims recite the proteomic markers, naturally produced samples such as biological sample (such as blood, plasma, serum), and the naturally occurring APA associated with said proteomic markers.
Dependent claims 35 and 39 further recite limitations for the abstract ideas. The claim recites measuring the concentration and/or performing statistical analysis. Imputing value into a logistic regression algorithm, comparing values and obtaining a disease likelihood score. The claims recite a calculation to generate a statistical probability from mathematical calculation and thus falls into a “mathematical concepts” grouping of abstract ideas. (Step 2A, Prong 1: YES).
Step 2A: Prong 2:
The Step 2A, Prong 2 analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the judicial exception. A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Besides the abstract ideas and law of nature/natural phenomena, claims 1-11, 35 and 37-38 do not recite any additional elements. However, claims 32 and 34 recite that the measurement of the biomarker comprises contacting with detectable binding agents wherein the binding agent is an antibody. Claims 40 and 42 recite additional step of providing recommendation for definite diagnosis and referral for surgical polyp removal.
When so evaluated, The additional elements in claims 32 and 34 of performing immunoassays with antibodies and claimed detectable labels to obtain the proteomic measurements do not integrate the judicial exception into a practical application because these steps constitute as insignificant extra solution activity of data gathering. These additional elements only interact with the judicial exception by providing data to be processed by the judicial exception.
The additional elements in claims 40 and 42 of recommendation for definite diagnosis by colonoscopy or sigmoidoscopy and referral for surgical polyp removal does not integrate the judicial exceptions into a practical application because this step constitutes as mere instructions to apply the exception (see MPEP 2106.05(f)). These additional elements of conducting further testing, recommendation of colonoscopy and referral for surgical polyp removal, constitute as mere instructions to apply the exception because of the generality of the application of the judicial exception. Further, these additional elements are not integrated into a practical application because treating or conducting further testing do not interact with the judicial exception in a manner which requires the output of the classifier to limit the treatment or further testing (i.e., how is the quantitative or qualitative result used in the step of treating or further testing). Even if these limitations indicate specific treatments, it does not provide any information as to how the said markers producing the proteomic data set and analyzing the data set would conclude administering the therapeutic agent. What is that connection between analyzing a data set to administering the therapeutic agent for lung cancer? In fact, these limitations are recited at such a high level of generality. Therefore, the administering step does not apply or use the judicial exception in a meaningful way.
Thus, none of the additional elements recited in the claims would integrate a judicial exception into a practical application, and the claims are directed the judicial exceptions (Step 2A, Prong 2: NO).
Step 2B:
In the second step it is determined whether the claimed subject matter includes additional elements that amount to significantly more than the judicial exception. See MPEP 2106.05. The claims do not include any additional steps appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception.
With respect to the instant claims, the courts have found that receiving and outputting data are well-understood, routine, and conventional functions of a computer when claimed in a merely generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network), Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015), and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93, as discussed in MPEP 2106.05(d)(II)(i)).
As such, the claims (claims 35 and 39) simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (MPEP2106.05(d)). The data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
The additional limitations in claim 1, 32 and 34 are extracting colorectal pre-cancerous adenomas (APA) associated proteomic markers, selective binding to form detectable complexes and detecting the detectable complexes. The dependent claims further reciting additional elements of contacting with detectable binding agents, measuring concentration from the bound detectable complex, recommending for colonoscopy and referring for polyp removal (claims 32, 34, 39, 40 and 42).
The additional elements are well-understood, routine, and conventional. This position is supported by Blume et al et al. (WO 2014/085826A3). Blume teaches detecting the presence or absence of an adenoma or polyp of the colon in a subject, wherein said subject has no symptoms or family history of adenoma or polyps of the colon, said method comprising the steps of: (a) obtaining a biological sample from said subject; (b) performing an analysis of the biological sample for the presence and amount of one or more proteins and/or peptides; (c) comparing the presence and amount of one or more proteins and/or peptides from said biological sample to a control reference value; and (d) correlating the presence and amount of one or more proteins and/or peptides with the subject's adenoma, cancer, or polyp status (para [0007]). Blume teaches detection of one or combination of plurality of biomarkers for the detection (para [013]-[015] and claim 11). Blume teaches immunoassay detection of biomarkers utilizing antibody as specific binding agent to the biomarkers using various types of immunoassays and using detectable labels (para [0105-0113]). Blume teaches data analysis with includes reference biomarker and biomarkers for comparison (para [241]) and also analysis includes logistic regression algorithm (para [078]-[082]; [090]). Blume teaches that tthe present disclosure provides new biomarkers for medical diagnosis of colon polyp and colorectal cancer which may help physicians to guide patient to undergo colonoscopy (para [068-074]).
Therefore, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself. (Step 2B: NO)
Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. For additional guidance, applicant is directed generally to applicant is directed generally to the MPEP § 2106.
Conclusion
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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