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 .
Claims 1-7 are the current claims hereby under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 (and all claims dependent therefrom) comprise the steps of collecting circRNAs and screening RBP an gene wherein the steps broadly read on electronically carrying out the steps or performing the laboratory steps required to achieve the results of each of the steps. The specification appears to only read on electronically carrying out the steps. Therefore, with regards to the steps reading on performing the required laboratory steps to achieve the results of said steps, the claims do not appear to have written description. As such, only support for the steps being electronically performed appears found.
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 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 (and all dependent claims therefrom) comprises a step of collecting differentially-expressed circular RNAs (CircRNAs) from gastric cancer cell-derived exosomes and gastric cancer tissues; and screening an RNA binding protein (RBP) gene that is differentially expressed in gastric cancer tissues and targetedly binded with the differentially-expressed circRNAs, which has been deemed as vague and indefinite. It is unclear as to how the collected differentially-expressed circRNAs from gastric cancer cell-derived exosomes are used throughout the following steps. The following step appears to only screen RBP genes differentially expressed in the gastric cancer tissues, but then seeming applies the screening of the differentially expressed RBP genes that are targetedly binded with the differentially-expressed circ RNAs, which can be found in the exosomes or the gastric tissues. Therefore it is unclear as to how exactly the screening step is being carried out. Additionally, the step only requires screening an RNA binding protein (RBP) gene. How is the RNA binding (RBP) gene selected for screening? The step states that it is differentially expressed in the gastric cancer tissues and targetdly binded with the differentially-expressed circRNAs. However, it is unclear as to what thresholds are required for the screening and what the result of screening for “an RBP binding (RBP) gene” is as seemingly only a single gene could satisfy the screening. Clarification via clearer claim wording is required.
Claim 1 (and all dependent claims therefrom) further comprise a step of obtaining a prognostic RBP gene. The step appears to be carried out by using a criterion of a p value < 0.05 for obtaining the differentially expressed RBP gene. However, the step further states “and according to the differentially -expressed RBP gene and a proportional hazards (Cox) regression model.” It is unclear as to how these other two components are used in combination with the p value in the step of obtaining a prognostic RBA gene. It is further unclear as to how exactly the Cox regression model is designed to assist in screening differentially expressed data to obtain a prognostic RBP gene. Clarification via clearer claim wording is required.
Claim 1 (and all dependent claims therefrom) further comprise the step of calculating a Risk score of each sample of the gastric cancer tissues according to an expression level of the prognostic RBP gene and a regression coefficient corresponding to the prognostic RBP gene, which has been deemed as vague and indefinite. It is unclear as to how exactly a risk score is being calculated based on the two parameters that are recited as being used in the calculation. It is further unclear as to how the regression coefficient is determined prior to being used in the calculation of the risk score. Clarification via clearer claim wording is required.
Claim 1 (and all dependent claims therefrom) further comprise a step calculating a median value for each sample of the gastric cancer tissues and classifying each sample of the gastric cancer tissues into a high-risk group and a low-risk group according to the median value, which has been deemed as vague and indefinite. It is unclear what exactly is being used for calculating a median value. Is it only the risk score that is used for calculating a median value. The step recites that “based on the risk score of each sample” but that does not establish exactly what is being used in the calculation of median values as the term “based on” is broad. It is unclear if only risk scores are used in the calculation or other parameter values are being incorporated into the calculation. Moreover, it is unclear as to how the delineation between the two groups (a high risk and low risk) are established based on median values. Finally, it is unclear as to what “risk” exactly refers with regards to the samples. Clarification via clearer claim wording is required.
Claim 1 (and all dependent claims therefrom) is directed to a method of constructing a risk prediction model for a prognosis of gastric cancer. The method comprises the steps of collecting circRNAs, screening an RNA binding protein gene, obtaining a prognostic RBP gene using screening criterion, calculating a risk score of samples, calculating median values “based on the risk score” and classifying each sample as a high risk or low risk group. It is unclear as to how many different samples and from how many different patients are required and from how many different stages of gastric cancer are required in order to arrive at a resulting risk prediction model for a prognosis. Each of the steps do not require any definitive amounts of samples or numbers of different patients at different stages to be sampled for arriving at final step of classifying the samples as a high risk or low risk group. Additionally, the steps of collecting and screening appear to read on both electronically obtaining datasets or carrying out laboratory steps to obtain the required data. However, the specification appears to only describe electronically obtaining the required data. With regards to electronically carrying out the steps, there are no hardware limitations recited in the steps for carrying them out. Clarification via clearer claim wording is required.
Examiner’s Comment
In light of the claim rejections for indefiniteness under 35 U.S.C. 112 2nd paragraph, as set forth above, the Examiner was not able to perform a meaningful search of the prior art. Applicant is reminded that prior art rejections under 35 U.S.C. 102 and/or 35 U.S.C. 103 may be applied in the next Office action in light of applicant's amendments, and that the next Office action can properly be made "Final" if these rejections are necessitated by amendment. See MPEP 706.07.
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 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to a method of constructing a risk prediction model for a prognosis of gastric cancer without significantly more. The claims are being analyzed within the context of being digitally performed.
Analysis of independent claims 1:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a method, which describes one or more of the four statutory categories of patentable subject matter, i.e., a process/machine. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 recites an abstract idea. In particular, the claim recites the following:
a. collecting circRNA data;
b. screening an RBO gene data using specific criteria, such as a p value < 0.05 and a cox regression model;
c. calculating a risk score;
d. calculating a median value; and
e. classifying each sample based on the median value.
These elements recited in claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper and/or they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations.
Steps a-e involve the mental and/or mathematical step of obtaining data, using mathematics to filter it, and based on the result of the mathematics classifying it, which can be performed mentally or using pen and paper.
The identified abstract steps, recited at the high level of generality, do not suggest an undue level of complexity for a person with ordinary skill in the art to be practically performed in the human mind with the aid of pen and paper.
Prong Two: Claim 1 does not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. There are no additional steps identified that are recited outside of the identified JE. As such, all the steps are interpreted as being directed to the JE itself. As such, there are no steps that integrate the JE into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. e.g., all the recited steps appear to be directed to the abstract idea.
In view of the above, there are no additional elements that integrate the exception into a practical application or amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
Analysis of other independent claims 2-7:
Claims 2-7 has the same analysis as each of the dependent claims appear to be extended limitations of the identified JE itself.
Currently the claims do not recite any hardware for performing the recited steps. However, in anticipation of an amendment directed towards a computer and/or processor carrying instructions for performing the recited steps, the integrated limitations would likely have the same analysis as above, but with the addition of the method being carried out on a program stored on a computer. Patenting abstract ideas cannot be circumvented by attempting to limit the use [the idea] to a particular technological environment. In this event, the computer and/or program/product would amount to mere instruction to implement an abstract idea. The anticipated hardware recited by system claims would not offer a meaningful limitation beyond generally linking “the use of the method to a particular technological environment,’ that is, implementation via computers.” see Alice Corp v. CLS Bank Int’l 573 U.S. (2014).
Conclusion
No claim is allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Sims, whose telephone number is (571)-272-7540.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Jonathan Moffat can be reached via telephone (571)-272-4390.
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the Central PTO Fax Center. The faxing of such papers must conform with the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central PTO Fax Center number is (571)-273-8300.
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/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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