DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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 the Claims
Claims 1-3, 6-11, and 13-22 are under examination.
Specification
2. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. (See page 24, line 4). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// , www. or other browser-executable code. See MPEP § 608.01.
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 7 and 16 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 claim 7 depends from cancelled claim 4. Since claim 4 is cancelled, the metes and bounds of the instant claim is unclear.
Instant claim 16 depends from cancelled claim 12. Since claim 12 is cancelled, the metes and bounds of the instant claim is unclear.
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.
Claims 1-3, 6-11, and 13-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 1-3, 6-11, and 13-22 are directed to method and system of determining the replication rate of a bacterial organism. 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 mapping DNA sequence reads to a reference sequence database, identifying a plurality of bacterial organisms, measuring the read coverage at the genomic locations of phylogenetic marker genes, fitting a linear function for each of the bacterial organisms, obtaining the slope of the linear function, estimating the an expected read coverage at the origin of replication, estimating an expected read coverage at the terminus of replication, interpreting each of the bacterial organism a replication rate. These steps are mental steps or mathematical steps. Dependent claims 3, 6-11, 15-19 and 22 recite additional mental or mathematical steps or the data used in the judicial exception. The courts have found mathematical algorithms to be drawn to the judicial exception of an abstract idea (In re Grams, 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)). 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 recites the steps of collecting a microbiome sample, extracting bacterial DNA, and performing PCR. However, these steps are extra solution data gathering steps. Extra solution data gathering steps are not sufficient to integrate the judicial exception into a practical application. The instant claims also recite The instant claims also recite a system, a sample collection module, DNA extraction module, a PCR amplification module, sequencer, memory, processor, and non-transitory machine-readable information storage medium. However, the instant claims do not recite structural limitations of these elements. Thus, the instant claims do not recite a particular machine that integrates 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 collecting a microbiome sample, extracting bacterial DNA, and performing PCR. However, these elements are well-understood, routine, and conventional activity in the life sciences (MPEP §2106(d) (II)). The elements of a system, a sample collection module, DNA extraction module, a PCR amplification module, sequencer, memory, processor, and non-transitory machine-readable information storage medium. However, these element are well-understood, conventional, and routine devices (MPEP §2106(d) (II); Specification, pages 37-39). Reciting such well-understood, routine, and conventional elements 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 abstract idea into a non-abstract idea. (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 a generic device for implementing the judicial exception. Thus, the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
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.
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, Olivia Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JERRY LIN/ Primary Examiner, Art Unit 1685
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