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 .
Election/Restrictions
2. Applicant’s election of Species A, claims 11, 14, and 18 in the reply filed on January 5, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10, 15, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Status of the Claims
Claims 1-9, 12-14, 16-18, and 20 are under examination.
Claims 10, 15, and 19 are withdrawn.
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 1-9, 12-13, 16-17 and 20 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 1, 13, and 17 recite “transforming a first portion of the microbiome dataset into a first eigenspectrum” and “transforming at least one additional portion of the microbiome dataset into at least one additional eigenspectrum”. It is unclear what defines a “first portion” and “additional portion”. While dependent claims 11, 14, and 18 provide one embodiment of a first and additional portion, independent claims 1, 13 and 17 are written broadly and encompasses more than the embodiment in claims 11, 14, and 18. Without a clearer definition of a “first portion” and “additional portion”, the metes and bounds of the instant claim are unclear. Dependent claims 2-9, 12, 16, and 20 are also rejected for depending from claim 1, 13, or 17.
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.
4. Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 1-20 are directed to method of characterizing a gut microbiome based on a comparison of a first eigenspectrum and an additional eigenspectrum. 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 transforming a first portion of the microbiome dataset into a first eigenspectrum, transforming at least one additional portion of the microbiome dataset into at least one additional eigenspectrum, characterizing the gut microbiome based on the comparison of the first eigenspectrum and at least one additional eigen spectrum, where the eigenspectrum comprises a plurality of eigenvectors and associated eigenvalues. These steps are drawn to a mathematical algorithm. Dependent claims 2-9, 12, 16, and 20 recite additional mathematical steps, the data to be used in the judicial exception, and the source of data. 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 recite a step of providing a microbiome dataset and a computer device. The instant claims do not recite any structural limitations of the computer device and do not recite a particular machine. In addition, providing a microbiome dataset is an extra solution data gathering step. An extra solution data gathering step is not sufficient to integrate a judicial exception into a practical application. 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 providing a microbiome dataset and a computer device. However, providing a dataset and a computer device is well-understood, conventional and routine (Specification, pages 14-17). 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 or the source 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 identifying the data for the judicial exception and a computer to implement the judicial exception. Thus, the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Examiner’s Note:
5. The closest prior art is by Stein et al. (“Ecological Modeling from Time-Series Inference: Insight into Dynamics and Stability of Intestinal Microbiota” PLOS Computational Biology (December 2013) volume 9, issue 12, pages 1-11). Stein et al. teach a method that determines the dynamics of microbiota and characterize its stability by determining the spectrum (eigenspectrum) of the corresponding Jacobian matrix (page 5, left column). However, Stein et al. does not teach transforming an additional portion of the dataset into an eigenspectrum and comparing the first eigenspectrum to the additional eigenspectrum.
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
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