DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
2. Applicant’s election without traverse of Species B, claim 45, in the reply filed on October 28, 2025 is acknowledged.
Status of the Claims
Claims 30-38 and 40-52 are under examination.
Claim Rejections - 35 USC § 112
3. 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 51 and 52 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.
Instant claims 51 and 52 are drawn to a system and a computer readable medium that is executed by a computer system. In both claims, step c requires the system or computer readable medium to using at least one laboratory assay to generate molecular profiling data for the cancerous cells. It is unclear how the system or the computer readable medium are to perform wet laboratory steps. Clarification via clearer claim language is required.
Claim Rejections - 35 USC § 101
4. 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.
5. Claims 30-38 and 40-52 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 30-38 and 40-52 are directed to method of storing data in a database. As described in Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 573 U.S._, 134 S. Cr. 2347, 110 U.S.P.Q.2d 1976 (2014), a two-step analysis is required in considering the patent eligibility of the claimed subject matter. The first step requires determining if the claimed subject matter is directed to a judicial exception. The instant claims require the steps of storing a set of applications, obtaining clinical trial data, storing the clinical trial data in a database, storing molecular profiling data in a database, organizing a subset of data in the first database to generate structured data that is configured for searching, selecting an application specific subset of data from the second database, and storing the application specific subset of data in a structure configured for accessing by the application. However, these steps are drawn to mental processes. Mental processes are a judicial exception. Dependent claims 31-34, 40-43, and 46 recite additional mental steps, the sources of data, or the types of data to be used in the judicial exception. Thus, the instant claims are drawn to a judicial exception.
This judicial exception is not integrated into a practical application. The instant claims do not recite an element that reflects an improvement in the functioning of a computer or other technology, an element that applies the judicial exception to effect a particular treatment, an element that implements the judicial exception with a particular machine, or an element that effects a transformation of a particular article to a different state or thing. The instant claims recite the elements of databases, user interface, host server, processor, memory, computer system, and computer readable storage medium. However, the claims do not recite any structural limitations of these elements, and do not recite a particular machine. Instant claims 35-38, 44-45, and 47-50 recite different assays. However, these assays are performed as extra solutional activity to gather data for the judicial exception. Thus, the instant claims do not integrate the judicial exception into a practical application.
The second part of the analysis requires determining if the claims include additional elements that are sufficient to amount to significantly more than the judicial exception. The instant claims recite the additional elements of databases, user interface, host server, processor, memory, computer system, and computer readable storage medium. These additional element are well-known, conventional, and routine elements of a computer system (Specification, pages 128-134). The assays of claims 35-38, 44-45, and 47-50 are also well-unknown, conventional and routine data gathering steps (Specification, pages 134-135). Reciting such well-understood, routine, and conventional data gathering steps do not transform a judicial exception into patent eligible subject matter. In addition, the recitation of the specific types of data, to be used in the judicial exception does not transform the judicial exception into patent eligible subject matter. (See buySAFE, Inc. v Google, Inc. 765 F.3d 1350, 112 U.S.P.Q.2d 1093 (Fed.Cir.2014)). Furthermore, the elements taken as a combination are also well-understood, routine, and conventional, since the elements are merely specifying the types of data for a data gathering step and reciting a general purpose computer for performing the claimed method. Thus, the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
6. Claim 52 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter.
Instant claim 52 is drawn to a computer readable medium. However, a computer readable medium encompasses carrier waves. Carrier waves are non-statutory per se. Thus, the instant claim is drawn to non-statutory subject matter.
Examiner’s Note:
7. The closest prior art is Kornblith et al. (US 2004/0086888 A1). Kornblith et al. teaches a method that data structure that combines genetic data (molecular profiling) with the source of the tissue sample and clinical data (paragraph [0024]). However, Kornblith et al. does not teach storing a set of applications, selecting an application specific subset of data, and storing the application specific subset of data in a data structure for accessing by the application.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JERRY LIN whose telephone number is (571)272-2561. The examiner can normally be reached T-F 7am-5pm.
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/JERRY LIN/Primary Examiner, Art Unit 1685