Ex Parte Matson

Patent Trial and Appeal Board

Dec 18, 2017

14515399 (P.T.A.B. Dec. 18, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/515,399 10/15/2014 Wayne R. Matson IXC 12.01 DIV2 5513
27667 7590
HAYES SOLOWAY P.C.
4640 E. Skyline Drive
TUCSON, AZ 85718
EXAMINER
BORGEEST, CHRISTINA M
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
12/20/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WAYNE R. MATSON
Appeal 2017-005028
Application M/515,3991
Technology Center 1600
Before DEBORAH KATZ, ULRIKE W. JENKS, and
ELIZABETH A. LaVIER, Administrative Patent Judges.
LaVIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant seeks review of the
Examiner’s rejection of claims 50 and 57. We have jurisdiction under 35
U.S.C. § 6(b). For the reasons set forth below, we AFFIRM.
BACKGROUND
The Specification relates to the use of indole-3-proprionic acid as a
biomarker for diagnosing health conditions. See Spec. 1. This compound is
produced by certain microorganisms that reside in the guts of mammals. See
id. From the gut, the majority of indole-3-proprionic acid enters the blood
plasma, but residual levels can be detected in fecal samples. See id. at 2.
1 Appellant states the real party in interest is Ixcela, Inc. Appeal Br. 2.
Appeal 2017-005028
Application 14/515,399
Indole-3-proprionic acid can cross the blood-brain barrier. See id.
Decreased levels of this compound may be found in individuals suffering
from certain neurodegenerative diseases, stroke, and heart disease. See id. at
4.
Claim 50 is illustrative:
A method for monitoring changes in a health state of an
individual having a gut microbiome, the method comprising
providing a sample of fecal material of the individual in a
stabilizing solution;
extracting a plurality of metabolites from the fecal material of
the individual into a solution of acidified acetonitrile wherein
one of the plurality of metabolites extracted is indole-3-
propionic acid;
subjecting the extracted plurality of metabolites to survey
LCEC or LCEC/MS[2] parallel techniques to create a sample
profile, wherein the profile includes a measurement of indole-3-
propionic acid and at least one additional metabolite, wherein
the additional metabolite is a precursor or a product of
metabolism of the gut microbiome; and
determining ratios of the measurement of indole-3-propionic
acid and the measurement of the additional metabolite in the
profile and comparing the ratios to the profile of a second
sample from said individual to identify change in the aggregate
composition of the gut microbiome of the individual or
comparing the ratios to a data base to determine a category of
the individual.
Appeal Br. 14—15 (Claims Appendix).
2 As the Examiner notes (see Ans. 2), these abbreviations are not defined in
the Specification. The Examiner finds that “LCEC appears to stand for liquid
chromatography-electrochemistry” and that “MS” is used here as an
abbreviation for “[m]ass spectrometry (or mass spectroscopy).” Id. Appellant
does not dispute these interpretations.
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Application 14/515,399
REJECTION MAINTAINED ON APPEAL
Claims 50 and 57 stand rejected under 35U.S.C. § 101 as directed to
patent-ineligible subject matter. Ans. 3.
DISCUSSION
Section 101, which provides that a patent may be obtained for the
invention of “any new and useful process, machine, manufacture, or
composition of matter, or any new and useful improvement thereof,” is
limited implicitly insofar as “[ljaws of nature, natural phenomena, and
abstract ideas are not patentable.” Alice Corp. Pty. Ltd. v. CLS Banklnt’l,
134 S. Ct. 2347, 2354 (2014) (quoting Assn for Molecular Pathology v.
Myriad Genetics, Inc., 133 S. Ct. 2107, 2116 (2013)). The Supreme Court
has established a two-step framework for this analysis, wherein a claim does
not satisfy § 101 if
(1) it is “directed to” a patent-ineligible concept, i.e., a law of
nature, natural phenomenon, or abstract idea, and (2), if so, the
particular elements of the claim, considered “both individually
and ‘as an ordered combination,” do not add enough to
“transform the nature of the claim into a patent-eligible
application.”
Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016)
(quoting Alice, 134 S. Ct. at 2355).
The Examiner finds that claim 50 “is directed to a judicial exception
(i.e., a law of nature, a natural phenomenon, or an abstract idea) without
significantly more.” Ans. 3. Specifically, the Examiner finds that the ratio­
determining “comparing” and “identifying]” steps of claim 50 “are
generally recited and encompass merely looking at and evaluating data,”
noting that “comparing also encompasses a mental evaluation” Id. at 5.
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Application 14/515,399
Further, the Examiner finds that the “providing,” “extracting,” and
“subjecting” steps are routine and conventional (see id. at 5—6) and that the
claim as a whole is “recited at a high degree of generality” and “does not
contribute to significantly more than the judicial exceptions” (id. at 6).
Appellant argues that the rejection is not consistent with the USPTO’s
2014 Interim Eligibility Guidance3 and the Life Sciences Examples4 issued
concurrently with the May 2016 Subject Matter Eligibility Update.5 See
Appeal Br. 10—12. Appellant also attempts to distinguish claim 50 from the
patent-ineligible claims in Ariosa Diagnostics v. Sequenom, Inc., 788 F.3d
1371 (Fed. Cir. 2015) (see Appeal Br. 13) and to analogize claim 50 to the
patent-eligible claims in Rapid Litigation Management Ltd. v. CellzDirect,
Inc., 827 F.3d 1042 (Fed. Cir. 2016) (see Reply Br. 6—7). Appellant
maintains that claim 50 is patentable because it “use[s] a conventional
process in an unconventional manner.” Id. at 12; see also Reply Br. 7—8.
Appellant explains:
As distinguished from conventional stool sample testing,
Appellant extracts metabolites including indole-3-propionic
acid from the stool samples. This is quite different from
conventional stool analysis tests which test stool for identified
diseases of the digestive tract, liver and pancreas, screen for
colon cancer by checking for blood, parasites, bacterial
organisms, etc. or for poor absorption of nutrients. Stool
3 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 Fed. Reg.
74618 (Dec. 16, 2014).
4 Subject Matter Eligibility Examples: Life Sciences (May 4, 2016), available
at https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf.
5 Memo: Formulating a Subject Matter Eligibility Rejection and Evaluating
the Applicant’s Response to a Subject Matter Eligibility Rejection (May 4,
2016), available at https://www.uspto.gov/sites/default/files/documents/ieg-
may-2016-memo.pdf.
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Appeal 2017-005028
Application 14/515,399
samples also arc tested for certain DNA markers, for example,
for screening for colorectal cancer. However, prior to the
present invention, stools were not tested for indole-3-propionic
acid, and prior art did not look at the ratio of indol[e]-3-
propionic acid and other metabolites in the gut microbiome.
Appeal Br. 12.
We are unpersuaded by Appellant’s arguments. The independent
claim at issue in Rapid Litigation, for example, was “directed to a new and
useful laboratory technique for preserving hepatocytes,” based on but not
limited to the inventors’ discovery that hepatocytes could “survive multiple
freeze-thaw cycles.” 827 F.3d at 1048. As the court noted, the inventors in
Rapid Litigation “employed their natural discovery to create a new and
improved way of preserving hepatocyte cells for later use.” Id. Here,
however, we agree with the Examiner that “it is not clear how the recited
techniques are unconventional.” Ans. 9. Indeed, the Examiner finds that
“methods of acidified acetonitrile extraction followed by analysis by liquid
chromatography-electrochemical detection/mass spectrometry were common
methods used in the art for extracting metabolites from feces” (Ans. 13), and
that “it was known that indolic compounds form in the large intestine and
could be measured in fecal matter, including indole-3-propionic acid” {id. at
12—13). Further, “[t]he relationship between the metabolic ratios and the
health or disease state exist in nature, regardless of whether they are
measured.” Id. at 5.
As to the Life Sciences Examples, Appellant points specifically to
claim 4 of Example 29, a hypothetical method of diagnosing and treating
“Julitis,” which included a step of using a particular monoclonal antibody to
detect a specific protein. See Appeal Br. 10-12. However, the hypothetical
background information provided for the Julitis examples states that the
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Application 14/515,399
claimed detection step (of using the particular monoclonal antibody to detect
human proteins) was not conventional. See Ans. 8. Thus, the
unconventional “detecting” step of hypothetical claim 4 in the Julitis
example rescued its patent eligibility6 because the claim as a whole
“amounts to significantly more than” the abstract idea or law of nature
embedded in the claim. Life Sciences Examples 14 (Example 29).
Accordingly, the hypothetical Julitis claim 4 is distinguishable from
the present claim 50 for the same reasons as the Rapid Litigation claim, i.e.,
both employ unconventional process step(s) to make use of a newly
discovered naturally-occurring phenomenon or correlation, whereas claim
6 In other words, the answer to the Step 2B question in the 2014 Interim
Eligibility Guidance, i.e., “Does the claim recite additional elements that
amount to significantly more than the judicial exception?” is “yes” for
hypothetical claim 4 of the Julitis example. Appellant asserts that claim 50 is
not directed to an abstract idea, law of nature, or other judicial exception to
patent eligibility (see Reply Br. 5—7), and thus is patent eligible under Step
2 A of the 2014 Interim Eligibility Guidance, but this is simply not the case.
As explained above, the Examiner finds, and we agree, that the “comparing”
and “identifying]” steps of claim 50 “are generally recited and encompass
merely looking at and evaluating data,” and further finds that “comparing also
encompasses a mental evaluation” Ans. 5. To be sure, as Appellant notes,
claim 50 does not expressly recite a “correlation” step. Reply Br. 5.
Nonetheless, the Examiner’s point stands that the “comparing” and
“identifying” steps are mental steps, which amount to abstract ideas. See, e.g.,
Genetic Techs. Ltd. v. MenialL.L.C., 818 F.3d 1369, 1379—80 (Fed. Cir. 2016)
(“We thus hold that the simple mental process step of “detecting] the allele”
in claim 1, either alone or in combination with the physical steps described
above, does not supply sufficient inventive concept to make the claim patent-
eligible under § 101.”); Life Sciences Examples 12 (“[U]sing mental steps or
basic critical thinking . . . are types of activities that have been found by the
courts to represent abstract ideas.”).
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Application 14/515,399
50 uses only routine steps. Cf. Ariosa, 788 F.3d at 1377 (“For process
claims that encompass natural phenomenon, the process steps are the
additional features that must be new and useful.”). As the Examiner puts it:
In other words, even if prior to the present invention, stools
were not routinely tested for indole-3-propionic acid, the
methods recited in the claim, namely liquid chromatography-
electrochemical detection and mass spectrometry, were
techniques that would have been thought of by the artisan for
extracting metabolites from fecal samples given the relevant
information.
Ans. 12.
For these reasons and those of record, we affirm the Examiner’s
rejection under § 101 of claim 50. Appellant argues claim 57 together with
claim 50. See Appeal Br. 12—13. It falls with claim 50. See 37 C.F.R.
§ 41.37(c)(l)(iv).
CONCLUSION
The rejection of claims 50 and 57 is affirmed. No time period for
taking any subsequent action in connection with this appeal may be extended
under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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