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 .
Status of Claims
Claims 1-10 has been reviewed and are addressed below.
Response to Arguments/Amendments
With respect to claim amendments filed on 1-2-26 has been entered and are addressed below.
Applicant’s arguments regarding the 101 rejection, applicant argues that the claims have been revised to clarify a practical application that improves upon medical diagnostic technology, in particular determining a target of tumor treatment based upon the output of the degree of malignancy of a tumor. Examiner respectfully disagrees. The amended claims still pertains to certain methods of organizing human activity particularly the managing personal behavior or relationship or interactions between people, per MPEP 2106.04(a)(2) “the sub-groupings encompass both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the "certain methods of organizing human activity" grouping”.
Applicant argues that in light of Ex Parte Desjardins, the instant claim will improve the minimization of side effects to healthy cells. Examiner respectfully disagrees. Evaluating a degree of malignancy of a tumor based upon a computed degree of variation between the transcriptional state of a sample from tumor tissues and a reference sample is a determination step that still falls under certain methods of organizing human activity.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1:
Claims 1-10 are drawn to method and system, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One:
Independent claims 1, 6, recite “receiving gene expression data of a sample obtained from tumor tissue of a subject and gene expression data of reference tissue”, “receiving information on gene set related to at least one gene ontology term”, “extracting first gene expression data for genes belonging to the gene set from among the gene expression data of the sample and second gene expression data for genes belongings to the gene set from among the gene expression data of the reference tissue”, “calculating a degree of variation of the sample based on the reference tissue by calculating entropy for the first gene expression data and the second gene expression data”, “classifying a degree of malignancy of tumor for the sample based on the degree of variation”, “outputting the degree of malignancy of tumor”, “wherein a target of tumor treatment is determined upon the output of the degree of malignancy of tumor”, “wherein the at least one gene ontology term comprises a gene ontology term associated with a cell cycle”, “wherein the degree of variation comprises an index representing a qualified deviation of the sample’s transcriptional state from a normal transcriptional state of the reference tissue”, “wherein the entropy represents non-uniformity of a probability distribution in density matrix defining transcriptional state of the genes belonging to the gene set”.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover mental process. Additionally it can also be interpreted as certain methods of organizing human activity. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
Step 2A Prong Two:
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed (e.g., the “computing device” language is incidental to what it is “configured” to perform). Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
This judicial exception is not integrated into a practical application. That the abstract idea may be performed by specifically “computer terminal”, ‘analysis device”, “device”, “storage device” are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The claims recite the additional element of ”receiving by analysis device”, “receiving information on gene set related to at least one gene ontology term”, which amounts to extra-solution activity concerning mere data gathering. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion
-paragraph 104 recites that the entropy of the transcriptional state, the SP, the LOR, etc. The data processing process or calculations described below was performed using an analysis device (computer device)”.
The claims recite the additional element of ”receiving by analysis device”, “receiving information on gene set related to at least one gene ontology term”, which amounts to extra-solution activity concerning mere data gathering. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2-5, 7-10 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Dependent claims 3 and 9 falls under mathematical concepts.
Conclusion
THIS ACTION IS MADE FINAL. 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 REGINALD R REYES whose telephone number is (571)270-5212. The examiner can normally be reached 8:00-4:30 M-F.
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, Shahid R Merchant can be reached on (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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REGINALD R. REYES
Primary Examiner
Art Unit 3684
/REGINALD R REYES/Primary Examiner, Art Unit 3684