Ex Parte Ashdown

Patent Trials and Appeals Board

Mar 29, 2019

14063104 - (D) (P.T.A.B. Mar. 29, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/063,104 10/25/2013 Martin Leonard Ashdown
22442 7590 04/02/2019
Sheridan Ross PC
1560 Broadway
Suite 1200
Denver, CO 80202
UNITED ST A TES OF AMERICA
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
8651-2-2 9942
EXAMINER
HALVORSON, MARK
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
04/02/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
e-docket@sheridanross.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARTIN LEONARD ASHDOWN
Appeal2018-000527
Application 14/063,104 1
Technology Center 1600
Before TA WEN CHANG, DEVON ZASTROW NEWMAN, and
DAVID COTTA, Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of detecting the dynamics of immune system cycling in a patient having a
cancer. The Examiner rejected the claims on appeal under 35 U.S.C. § 101
as directed to patent ineligible subject matter, under 35 U.S.C. § 103(a) as
obvious, and under 35 U.S.C. § 112 as indefinite.
1 According to Appellants, the real party in interest is Biotempus Pty Ltd.
App. Br. 3.
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STATEMENT OF THE CASE
The Specification discloses that "[ n ]umerous diseases have been
linked to the production of regulator cells." Spec. 1. The Specification
states that "[t]he present inventor has surprisingly found that the immune
system is cycling during disease states characterized by the presence of
regulator cells." Id. at 3. According to the Specification, "[t]his cycling
occurs on a regular basis of approximately 14 to 15 days in humans." Id.
Appellant's alleged invention "relates to the observation that the immune
system is cycling in these diseases" and, [b ]ased on these observations, ...
provides methods for treating diseases such as cancer and a HIV infection."
Id. at 1. Appellant's invention also "relates to methods of determining when
a therapy to treat a disease characterized by the production of regulator cells
should be administered to a patient." Id.
Claims 45--49, 51-55, 57, and 58 are on appeal. Claim 45 is
illustrative and reads as follows:
45. A method of detecting the dynamics of immune system
cycling in a patient having a cancer, comprising:
a. selecting a patient who has not received a cancer
treatment for at least about 14 days,
b. obtaining multiple samples from the patient before
the patient receives any cancer treatment at a frequency of at
least one sample every three days, and
c. detecting the dynamics of immune system cycling
in the patient by assaying each of the multiple samples for the
level of one or more immune system marker(s).
App. Br. 33 (Claims App.). During prosecution, in response to a
requirement to elect a species, Appellant elected c-reactive protein ("CRP")
as the claimed immune system marker. Ans. 2-3. We limit our discussion
and consideration to the elected species, and take no position respecting the
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patentability of the broader generic claims, including the remaining, non-
elected species. See Ex parte Ohs aka, 2 USPQ2d 1460, 1461 (BP AI Mar.
31,1987).
The claims stand rejected as follows.
Claims 45--49, 51-55, 57, and 58 were rejected under 35 U.S.C. § 101
as directed to patent ineligible subject matter.
Claims 45--49, 51-55, 57, and 58 were rejected under 35 U.S.C.
§ 103 (a) as obvious over the combination of Broom 2 and Cohen. 3
Claims 45--49, 51-55, 57, and 58 were rejected under 35 U.S.C.
§ I03(a) as obvious over the combination of Kaminska4 and Cohen.
Claims 46 and 47 were rejected under 35 U.S.C. § 112 as indefinite
for failing to particularly point out and distinctly claim the subject matter
which the inventor regards as the invention. 5
CLAIM CONSTRUCTION
We begin by construing the claims. During prosecution before the
PTO, claim terms are given their broadest reasonable interpretation
consistent with the specification, reading claim language in light of the
2 Broom et al., INTERLEUKIN 2 THERAPY IN CANCER: IDENTIFICATION OF
RESPONDERS, 66 Br. J. Cancer 1185-1187 (1992) ("Broom").
3 Cohen et al., US Patent Publication No. 2004/0022787 Al, published Feb.
5, 2004 ("Cohen").
4 Kaminska et al., CRP, TNFA, IL-IRA, IL-6, IL-8, AND IL-10 IN BLOOD
SERUM OF COLORECTAL CANCER PATIENTS, 6 Pathology Oncology Research
3 8--41 ( 2 000) ("Kaminska").
5 After consideration of Appellant's arguments, the Examiner withdrew the
pending rejection of claims 45, 48, 49, 51-55, 57, and 58 under 35 U.S.C.
§ 112 as indefinite for failing to particularly point out and distinctly claim
the subject matter which the inventor regards as the invention. Ans. 30.
Accordingly, the rejection of those claims is no longer part of this appeal.
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specification as it would be interpreted by one of ordinary skill in the art. In
re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
Claim 45 requires "obtaining multiple samples from the patient before
the patient receives any cancer treatment at a frequency of at least one
sample every three days." This language presents the question: does this
limitation establish a minimum sampling frequency, such that the claim can
be met by e.g., obtaining samples more frequently than once every three
days, or does it instead establish a minimum interval between sampling, such
that at least one of the multiple samples must be obtained three days after
another sample was obtained? We find that the limitation establishes a
minimum sampling frequency that can be met by obtaining multiple samples
within a three day period.
Our construction is supported by the teaching in the Specification that
it is important to monitor the patient as frequently as possible. The
Specification states:
Furthermore, it is preferred that the patient is monitored
as frequently as possible to ensure immune system cycling
within a given patient is suitably characterized. Naturally this
will ensure that the agent is administered at the appropriate time
and that any small variations in, for example, effector/regulator
cell numbers or activity, or markers thereof, is not
misinterpreted. Preferably, the patient is monitored at least
every 3 days, more preferably at least every 2 days, and most
preferably at least every day. Monitoring may occur more
frequently, for instance every 12 hours, when the cycling is
reaching a stage where it is likely that the timing would be
appropriate to administer the agent.
Spec. 7. This passage suggests that monitoring "at least every 3 days" is a
minimum sampling frequency and that the limitation can be met by
obtaining samples more frequently. This interpretation is consistent with
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dependent claims 51-53, each of which narrows claim 45 by specifying a
more frequent sampling frequency. For example, claim 53, the narrowest of
these claims, requires that "the step of assaying6 comprises assaying at least
one sample every twelve hours." This suggests that the broader limitation
"at least one sample every three days" can be met by sampling more
frequently- e.g., by sampling every twelve hours.
We acknowledge that the Specification also teaches that patients need
to be monitored for an extended period of time in order to properly assess
their immune system cycle. See e.g., Spec. 6 ("As result, it will most likely
be desirable to monitor the patient for a sufficient length of time to ensure
that the dynamics of the immune system cycling within a particular patient is
understood."). However, given the Specification's teachings regarding the
importance of frequent sampling, and the fact that dependent claims 51-5 3
narrow claim 45 by requiring more frequent sampling, we find that the
limitation "at least one sample every three days" is best understood as a
minimum sampling frequency.
Claim 45 also requires "detecting the dynamics of immune system
cycling in the patient." The Examiner interpreted this phrase to mean
"analyzing multiple samples for the level of CRP for determining the
dynamics of the immune system cycling, based on the multiple assayed
levels of CRP." Ans. 2-3. This interpretation is consistent with Appellant's
6 Claims 51-53 narrow the "assaying" step recited in claim 45, however, in
context, it appears that these claims were intended to instead narrow the
"obtaining" step because the import of the limitation is how frequently
samples are obtained rather than how frequently assays on the samples as
performed. For purposes of this opinion, we treat claims 51-53 as
narrowing the "obtaining" step.
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position at oral argument (Tr. 7 6:7-7:6) and with the Appellant's position
with respect to the Examiner's indefiniteness rejection that "some amount of
calculation is inherent to 'detecting dynamics' as recited in step (c)." App.
Br. 32. It is also consistent with the way the claimed method is described in
the Specification. See, e.g., Spec. 3 ("The present inventor has surprisingly
found that the immune system is cycling during disease states characterized
by the presence of regulator cells .... Knowledge of this cycle can be used
to treat diseases where it is known that the emergence of regulator cells is
detrimental to the patient."). Accordingly, we construe the phrase "detecting
the dynamics of immune system cycling" to require analyzing samples to
determine the length of the patient's immune system cycle.
OBVIOUSNESS OVER BROOM AND COHEN
Claims 45, 51-55, 57, and 58
Appellant argues claims 45, 51-55, 57, and 58 together. We
designate claim 45 as representative.
In finding claim 45 obvious over the combination of Broom and
Cohen, the Examiner found that Broom disclosed "measuring CRP levels in
blood during IL-2 treatment of patients with metastatic colorectal cancer."
Ans. 16. The Examiner then found that Cohen disclosed "measuring for
baseline levels of CRP in autoimmune patients prior to treatment." Id. at 16.
Based on the combination of Broom and Cohen, the Examiner concluded
that it would have been obvious to "combine Broom's method of measuring
CRP levels during treatment of cancer patients with Cohen's method for
establishing baseline levels of CRP prior to treatment." Id. Citing to a
medical dictionary, the Examiner noted that a baseline is "a set of data
7 Transcript from March 5, 2019 Oral Hearing ("Tr.").
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collected at the beginning of a study or before intervention has occurred,"
and reasoned that establishing a baseline would thus "require assaying
multiple samples from the patient." Id. at 20.
We agree with the Examiner's conclusion that claim 45 would have
been obvious over the cited art. We address Appellant's arguments below.
Appellant argues that "[ w ]hilst it may have been common place to
take multiple samples to account for variance between samples at the same
time point, the Examiner has provided no evidence to show that establishing
a baseline before a treatment involved multiple samples taken over different
time periods." App. Br. 12. We are not persuaded.
The Examiner has provided evidence establishing that taking a
baseline would require obtaining multiple samples. Ans. 20 ( citing medical
dictionary for the proposition that a baseline is a set of data collected at the
beginning of a study or before intervention has occurred). Appellant does
not argue or identify persuasive evidence to the contrary. While Appellant
may be correct that the evidence does not support baseline samples "taken
over different time periods," the claims do not require this. Rather, taking
multiple samples substantially contemporaneously- as would be done to
establish a baseline - meets the limitation requiring obtaining "at least one
sample every three days."
Appellant argues that there is no motivation to combine Broom, which
discloses using CRP levels to identify patients that respond to cancer
treatments, with Cohen which teaches measuring levels of CRP as a baseline
for treatment of an immune disease. 8 Reply Br. 10. Appellant explains that
8 Appellant does not argue that Cohen is non-analogous art. Reply. Br. 10.
Accordingly, it is not clear what significance Appellant attaches to the fact
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"because neither reference contains a recognition of the cycling of immune
system in a cancer patient," there would be no "reason to make more
frequent CRP measurements in a cancer patient who has not received
treatment for a period of time." Id. Put another way Appellant contends
that, without the knowledge of immune system cycling, which did not exist
until the inventors discovered it, the ordinary artisan would not have been
motivated to make more frequent CRP measurements. Reply Br. 10. We
are not persuaded because, as discussed above, the Examiner has provided
evidence suggesting that establishing a baseline would require obtaining
multiple samples.
Appellant argues that "detecting the dynamics of immune system
cycling" is a "positively recited claim step" and that the Examiner erred in
failing to give it patentable weight. App. Br. 23. Appellant argues that "it
appears that the Examiner ... confus[ ed] patent eligibility analysis under
§ 101 with that of obviousness under§ 103." Id. We are not persuaded
because, as discussed above, we interpret this limitation to require analyzing
samples to determine the length of a patient's immune system cycle.
Perceiving or calculating the length of the cycle is a mental step and, as
such, is not accorded patentable weight in an obviousness analysis. Praxair
Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd., 890 F.3d 1024,
1033 (Fed. Cir. 2018) (rejecting argument that consideration of whether
that Cohen relates to an immune disease rather than cancer. In this regard,
we find that Cohen's teaching regarding establishing a baseline for CRP
prior to treatment for an immune disease would reasonably have suggested
establishing a baseline for CRP prior to treatment for cancer. In addition, we
note that Broom also discloses measuring CRP prior to treatment. See e.g.,
Broom 1185 ("One of the non-responding patients, (GR), had a low CRP
level prior to the start of therapy ... ").
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claims were directed to mental steps applied only in evaluating patent
eligibility, not obviousness, explaining, "[b ]ecause claim limitations directed
to mental steps may attempt to capture informational content, they may be
considered printed matter lacking patentable weight in an obviousness
analysis."). A limitation that recites a mental step will be accorded
patentable weight only if the limitation has a "functional relationahip to the
rest of the claim." Id. at 103 5 ("By interrelating the claimed information ...
with the concrete step of discontinuing treatment because of the information,
... the printed matter ... has a functionally relationship to the rest of the
claim and ... patentable weight."). Appellant does not identify, and we do
not find, such a functional relationship between the mental step at issue and
the remaining claim limitations.
Appellant argues that Broom does not disclose the step of "selecting a
cancer patient who has not received a cancer treatment for at least about 14
days." App. Br. 20-21. However, Appellant concedes that Broom discloses
measuring CRP levels in cancer patients immediately prior to treatment - at
which point, they have not received a cancer treatment for at least 14 days.
Moreover, Appellant does not dispute that Cohen discloses measuring CRP
levels as a baseline. Id. at 21. See In re Keller, 642 F.2d 413, 426 (CCPA
1981) (citation omitted) ("[O]ne cannot show non-obviousness by attacking
references individually where, as here, the rejections are based on
combinations of references.").
Appellant argues that Cohen does not disclose the steps of "selecting a
cancer patient who has not received a cancer treatment for at least about 14
days" because Cohen "makes no mention of cancer." App. Br. 21.
Appellant also argues that Cohen does not disclose "obtaining multiple
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samples from the patient before the patient receives any cancer treatment."
Id. Appellant's argument that Cohen does not disclose treating cancer is not
persuasive because the Examiner relies on Broom rather than Cohen for this
purpose. See In re Keller, 642 F.2d at 426. Appellant's argument that
Cohen does not disclose obtaining multiple samples is not persuasive
because, as Appellant concedes, Cohen discloses measuring levels of CRP
as a baseline. As discussed above, the current record supports that
establishing a baseline involves obtaining multiple samples. See supra. 7.
Appellant argues that "[t]here is simply no logical reason to modify
how Broom established a baseline, let alone examine CRP levels in a cancer
patient who has not received a cancer treatment for at least about 14 days by
obtaining multiple samples at the claimed frequency." App. Br. 22.
Appellant explains that "[ o ]btaining multiple samples at a high frequency
comes with increased costs in terms of time, money, inconvenience and
more blood draws, and Broom in no way suggests that their determination of
baseline needs to, or even could be, improved." Id. We are not persuaded
because, as discussed above, we interpret claim 45 to encompass taking
multiple samples substantially contemporaneously. While Appellant's
argument might have merit if the multiple samples were required to be taken
repeatedly over an extended period of time, we are not persuaded that the
marginal additional cost and time required to obtain multiple substantially
contemporaneous samples rather than a single sample would have
discouraged the ordinary artisan from obtaining multiple samples, particular
in light of the definition of "baseline."
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Accordingly, we affirm the Examiner's rejection of claim 45 as
obvious over the combination of Broom and Cohen. Because they were not
argued separately, claims 48, 49, 51-55, 57, and 58 fall with claim 45.
Claims 46 and 47
Claim 46 depends from claim 45 and additionally requires "predicting
subsequent cycling of the one or more immune system marker( s) based on
the calculations of step ( c ). " Claim 4 7 depends from claim 46 and
additionally requires "determining or predicting a peak in the cycling of the
one or more immune system marker(s)." Appellant argues that because
immune system cycling was not known, the combination of Broom and
Cohen does not "make[] obvious the steps of 'predicting subsequent cycling'
or 'determining or predicting a peak in the cycling."' App. Br. 25. We are
not persuaded because both of these limitations are mental steps and, as
discussed above, not entitled to patentable weight. Praxair, 890 F.3d at
1033. Accordingly, we affirm the Examiner's rejection of claims 46 and 47.
OBVIOUSNESS OVER KAMINSKA AND COHEN
Claims 45, 51-55, 57, and 58
Appellant argues claims 45, 51-55, 57, and 58 together. We
designate claim 45 as representative.
In finding claim 45 obvious over the combination of Kaminska and
Cohen, the Examiner found that Kaminska disclosed "measuring CRP levels
in blood following surgery in colorectal cancer patients." Ans. 24; see also
Kaminska 38, right column ("Blood serum cytokines ... and CRP were
assessed in ... patients with ... colorectal cancer ... before treatment and
1, 10 and 42 days after surgery" involving "locally radical excision of the
colorectal tumour."). The Examiner then found that Cohen disclosed
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"measuring for baseline levels of CRP in autoimmune patients prior to
treatment." Id. Based on the combination of Kaminska and Cohen, the
Examiner concluded that it would have been obvious to "combine
Kaminska' s method of measuring CRP levels during treatment of cancer
patients with Cohen's method for establishing baseline levels of CRP prior
to treatment." Id.
As is evident from the discussion above, the portion of Kaminska's
disclosure relied upon by the Examiner in rejecting claim 45 as obvious over
Kaminska and Cohen is similar to the portion of Broom relied upon by the
Examiner in rejecting claim 45 as obvious over Broom and Cohen. The two
rejections parallel one another. We agree with the Examiner's conclusion
that claim 45 would have been obvious over the cited art and find that claim
45 would have been obvious over the combination of Kaminska and Cohen,
for the same reasons it would have been obvious over the combination of
Broom and Cohen. We provide the following discussion of Appellant's
arguments with respect to Kaminska for emphasis.
Appellant argues that Kaminska does not disclose the step of
"selecting a cancer patient who has not received a cancer treatment for at
least about 14 days" and "obtaining multiple samples from the patient before
the patient receives any cancer treatment." App. Br. 27. However,
Appellant concedes that Kaminska discloses measuring CRP levels in cancer
patients immediately prior to treatment - at which point, they have not
received a cancer treatment for at least 14 days. Id. Moreover, Appellant
does not dispute that Cohen discloses measuring CRP levels as a baseline.
Id. at 28. See In re Keller, 642 F.2d 413,426 (CCPA 1981) (citation
omitted) ("[O]ne cannot show non-obviousness by attacking references
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individually where, as here, the rejections are based on combinations of
references.").
Appellant argues that Cohen does not disclose the steps of "selecting a
cancer patient who has not received a cancer treatment for at least about 14
days" because Cohen "makes no mention of cancer." App. Br. 28.
Appellant also argues that Cohen does not disclose "obtaining multiple
samples from the patient before the patient receives any cancer treatment."
Id. Appellant's argument that Cohen does not disclose treating cancer is not
persuasive because the Examiner relies on Kaminska rather than Cohen for
this purpose. See In re Keller, 642 F.2d at 426. Appellant's argument that
Cohen does not disclose obtaining multiple samples is not persuasive
because, as Appellant concedes, Cohen discloses measuring levels of CRP
as a baseline. As discussed above, the current record supports that
establishing a baseline involves obtaining multiple samples. See supra. 7.
Appellant argues that "once again the Examiner disregards step ( c)
directed at 'detecting the dynamics of the immune system' ... limit[ing] the
discussion of obviousness to only those steps that he considers 'active'
steps." App. Br. 28. As discussed above, we find that the Examiner was
correct in declining to give the mental step "detecting the dynamics ... "
patentable weight. See, Praxair, 890 F.3d at 1033. A limitation that recites
a mental step will be accorded patentable weight only if the limitation has a
"functional relationship" to the rest of the claim Id. at 1035. Appellant does
not identify, and we do not find, such a functional relationship between the
mental step at issue and the remaining claim limitations.
Appellant argues that
[a]s discussed before, when all steps are included in the analysis
and the claimed invention is considered as a whole, it is clear
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that neither Kaminska, nor Cohen discloses or suggests all
elements of claim 45, and there is no motivation ... to modify
their teachings to arrive at the invention of claim 45.
App. Br. 29. We understand the statement "as discussed before" in this
argument to refer back to Appellant's arguments with respect to Broom. We
are not persuaded for the reasons discussed above.
Claims 46 and 47
Claim 46 depends from claim 45 and additionally requires "predicting
subsequent cycling of the one or more immune system marker( s) based on
the calculations of step ( c ). " Claim 4 7 depends from claim 46 and
additionally requires "determining or predicting a peak in the cycling of the
one or more immune system marker(s)." Appellant argues that because
immune system cycling was not known, the combination of Kaminska and
Cohen does not "make[] obvious the steps of 'predicting subsequent cycling'
or 'determining or predicting a peak in the cycling."' App. Br. 29. We are
not persuaded because both of these limitations are mental steps and, as
discussed above, not entitled to patentable weight. Praxair, 890 F.3d at
1033. Accordingly, we affirm the Examiner's rejection of claims 46 and 47.
PATENT ELIGIBLE SUBJECT MATTER
Appellant agues claims 45--49, 51-55, 57, and 58 together. We
designate claim 45 as representative.
An invention is patent-eligible if it claims a "new and useful process,
machine, manufacture, or composition of matter." 35 U.S.C. § 101.
However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: "[l]aws of nature, natural phenomena, and abstract
ideas" are not patentable. E.g., Alice Corp. v. CLS Bank Int 'l, 573 U.S. 208,
216 (2014).
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In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court's two-step framework, described in Mayo
and Alice. Id. at 217-18 ( citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with that framework,
we first determine what concept the claim is "directed to." See Alice, 573
U.S. at 219 ("On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk."); see also Bilski v. Kappas, 561 U.S. 593, 611 (2010) ("Claims 1 and 4
in petitioners' application explain the basic concept of hedging, or protecting
against risk.").
Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219-20; Bilski, 561 U.S. at 611 );
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594--95 (1978)); and
mental processes (Gottschalkv. Benson, 409 U.S. 63, 69 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as "molding rubber products" (Diamond v. Diehr, 450 U.S. 175, 192
(1981) ); "tanning, dyeing, making water-proof cloth, vulcanizing India
rubber, smelting ores" (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S.
252, 267---68 (1853))); and manufacturing flour (Benson, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Supreme Court held that "[a] claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
mathematical formula." Diehr, 450 U.S. at 176; see also id. at 191 ("We
view respondents' claims as nothing more than a process for molding rubber
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products and not as an attempt to patent a mathematical formula."). Having
said that, the Supreme Court also indicated that a claim "seeking patent
protection for that formula in the abstract ... is not accorded the protection
of our patent laws, ... and this principle cannot be circumvented by
attempting to limit the use of the formula to a particular technological
environment." Id. (citing Benson and Flook); see, e.g., id. at 187 ("It is now
commonplace that an application of a law of nature or mathematical formula
to a known structure or process may well be deserving of patent
protection.").
If the claim is "directed to" an abstract idea, we tum to the second
step of the Alice and Mayo framework, where "we must examine the
elements of the claim to determine whether it contains an 'inventive
concept' sufficient to 'transform' the claimed abstract idea into a patent-
eligible application." Alice, 573 U.S. at 221 ( quotation marks omitted). "A
claim that recites an abstract idea must include 'additional features' to
ensure 'that the [claim] is more than a drafting effort designed to
monopolize the [abstract idea]."' Id. ( quoting Mayo, 566 U.S. at 77).
"[M]erely requir[ing] generic computer implementation[] fail[ s] to transform
that abstract idea into a patent-eligible invention." Id.
The PTO recently published revised guidance on the application of
§ 101. USPTO's January 7, 2019, Memorandum, 2019 Revised Patent
Subject Matter Eligibility Guidance ("Memorandum"). Under that
guidance, we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract
ideas (i.e., mathematical concepts, certain methods of organizing
human activity such as a fundamental economic practice, or mental
processes); and
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(2) additional elements that integrate the judicial exception into a
practical application (see MPEP § 2106.05(a}-(c), (e}-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that
exception into a practical application, do we then look to whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not
"well-understood, routine, conventional" in the field (see MPEP
§ 2106.05(d)); or
( 4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of
generality, to the judicial exception.
See Memorandum.
Following the Guidance, we begin by considering whether claim 45
recites a judicial exception. In rejecting claim 45 as directed to patent
ineligible subject matter, the Examiner found that the claim was focused on
a natural principle, "the cycling of immune system markers in a patient
having cancer." Ans. 3. The Examiner also found that the method step of
"detecting the dynamics of immune system cycling in the patient" was an
abstract idea. We agree with the Examiner that claim 45 recites a judicial
exception.
Consistent with Mayo, the Guidance expressly identifies mental
processes - i.e. "concepts performed in the human mind (including an
observation, evaluation, judgment, opinion)" - as judicial exceptions. See,
Memorandum; Mayo, 566 U.S. at 71 (citation omitted) ("'[M]ental
processes[] and abstract intellectual concepts are not patentable, as they are
the basic tools of scientific and technological work'").
Claim 45 recites a method of "detecting the dynamics of immune
system cycling in a patient." This phrase appears both in the preamble and
in method step ( c ). As discussed above, we construe the phrase "detecting
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the dynamics of immune system cycling" to require analyzing samples to
determine the patient's immune system cycle. This is a step that can be
performed mentally. It requires nothing more than thinking about and/or
observing the data obtained from assays. Accordingly, we conclude that the
claims recite concepts performed in the human mind, which is one of the
mental processes identified in the Guidance, and thus an abstract idea.
Additionally, claim 45 step ( c ), "detecting the dynamics of immune system
cycling in the patient by assaying each of the multiple samples for the level
of [CRP]" recites a natural law, i.e., the natural correlation between changes
in CRP level and immune system cycling.
Appellant argues that "'detecting the dynamics of immune system
cycling in the patient' cannot be considered an abstract idea" because it "is
not something that can be done merely by thought and is not merely
manipulation of information." App. Br. 10-11. Instead, according to
Appellant, "it requires testing for and quantification of molecules that are
present in biological samples over time." Id. at 11.
We do not dispute that in order to detect the dynamics of immune
system cycling one needs first to obtain data to analyze. However, in this
case, the focus of the claims is on the method of detecting the dynamics of
immune system cycling - the analysis - rather than on the data gathering
steps that precede the analysis. See Athena Diagnostics, Inc. v. Mayo
Collaborative Services LLC, 915 F.3d 743 (Fed. Cir. 2019) (finding that
method for diagnosing neutrotransmission or developmental disorders was
directed to a judicial exception notwithstanding steps requiring contacting
bodily fluid with labeled muscle-specific tyrosine kinase ("MuSK") and
immunoprecipitating an antibody/MuSK complex from the bodily fluid);
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Genetic Technologies Ltd. v. Merial LLC, 818 F.3d 1369, 1372 (Fed. Cir.
2016) ( finding that method for detection of at least one coding region allele
was directed to a judicial exception notwithstanding steps requiring
amplifying genomic DNA); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788
F.3d 1371 (Fed. Cir. 2015) (finding that method for preforming a prenatal
diagnosis on a maternal blood sample was directed to a judicial exception
not withstanding steps requiring obtaining a blood sample and amplifying
paternally inherited nucleic acid from the sample).
Appellant argues that the claims are analogous to Example 29 of the
May 2016 Interim Guidance on Patent Subject Matter Eligibility ("Interim
Guidelines"). Claims 1 and 2 of Example 29 are reproduced below:
1. A method of detecting mL-1 in a patient, said method
compnsmg:
a. obtaining a plasma sample from a human patient;
and
b. detecting whether JUL-I is present in the plasma
sample by contacting the plasma sample with an anti-JUL- I
antibody and detecting binding between JUL- I and the
antibody.
2. A method of diagnosing julitis in a patient, said method
compnsmg:
a. obtaining a plasma sample from a human patient;
b. detecting whether mL-1 is present in the plasma
sample by contacting the plasma sample with an anti-JUL- I
antibody and detecting binding between JUL- I and the
antibody; and
c. diagnosing the patient with julitis when the
presence of JUL- I in the plasma sample is detected.
Interim Guidelines at 10. Appellant argues that, under the Interim
Guidelines, claim 1 was patent eligible because it does not "recite or
describe any recognized uudicial] exception" while claim 2 was "ineligible
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because it recited the natural law in the Example, namely, 'a correlation or
relationship between the presence of JUL- I in a patient's plasma and the
presence ofjulitis in the patient."' App. Br. 11-12. Appellant argues that
claim 45, like claim 1 of Example 29, is patent eligible because it does not
recite a judicial exception. Id. Appellant explains that "the recited steps in
claim 45 of selecting a defined patient population, obtaining samples at a
defined frequency and assaying for the level of markers in claim 45 are not
themselves a natural principle." Id. at 12-13. We are not persuaded.
While we agree with Appellant that the steps of obtaining samples and
assaying for the level of biological markers are not directed to a judicial
exception, claim 45 also requires "detecting the dynamics of immune system
cycling in the patient." As discussed above, this step requires more than just
assaying samples, it also requires that the samples be analyzed to determine
the patient's immune system cycle. Claim 45 is thus distinguishable from
claim 1 of Example 29 because it does recite patent ineligible subject matter.
Having determined that claim 45 recites a judicial exception, the
Guidance directs us to next consider whether the claims integrate the judicial
exception into a practical application. Summarizing the relevant case law,
the Guidance notes that courts have generally not considered an "additional
element [that] adds insignificant extra-solution activity," like "mere data
gathering," to integrate a judicial exception into a practical application. See
Memorandum ( citing Mayo as teaching that the "additional element of
measuring metabolites of a drug administered to a patient was insignificant
extra-solution activity, which was insufficient to confer patent eligibility").
Appellant argues that claim 45 is directed to "a specific application,
namely detecting the dynamics of the immune cycle in a patient having a
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cancer, in which a particular patient population is selected ... a defined
sampling protocol is followed ... and the samples are assayed." App. Br.
16. We are not persuaded that these limitations integrate the judicial
exception into a practical application.
Here, in addition to the recited judicial exception, the claim includes
limitations identifying the patient from whom samples are to be taken,
specifying a minimum frequency with which samples are taken, and
requiring that those samples be assayed for the level of CRP. These steps
merely generate data that is analyzed in the step corresponding to the
judicial exception. We agree with the Examiner that these steps are the type
of well-understood activities that "a scientist would have relied upon to
achieve the goals of the invention." Ans. 12. They represent insignificant
extra-solution activity that is not sufficient to confer patentability on the
recited judicial exception. See, Athena, 915 F .3d at 7 54 ("[ A ]pp lying
standard techniques in a standard way to observe a natural law does not
provide an inventive concept"). 9
Appellant argues that it was not routine or conventional to obtain
multiple samples for a patient prior to cancer treatment. App. Br. 16.
Appellant explains that "[ o ]btaining multiple samples at a high frequency
comes with increased costs in terms of time, money, inconvenience and
more blood draws, and practitioners did not routinely obtain samples from a
cancer patient as per the claimed method." Id.
9 Our opinion does not address whether taking samples over an extended
time period before instituting cancer treatment amounts to insignificant extra
solution activity because, as discussed above, we understand the claims to
encompass taking multiple samples substantially contemporaneously to
establish a baseline.
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We are not persuaded because, as discussed above, the evidence
supports that it was known to establish a baseline CRP level. The evidence
also supports that a baseline would involve obtaining multiple samples.
While it may be the case that obtaining multiple samples over an extended
time period was unconventional, the claims encompass the conventional
technique of obtaining multiple substantially contemporaneous samples to
establish a baseline CRP level.
Appellants argue that selecting a patient who has not received cancer
treatment ensures that "the immune system cycling within the patient is not
obfuscated by effects of administration of prior cancer treatment to the
patient." Id. We are not persuaded. While we do not dispute the necessity
of obtaining samples from an untreated patient in order to accurately analyze
immune system cycling, simply specifying that the samples be obtained
from an untreated patient does not confer patentability on the claimed
method.
Appellant argues that the "element of detecting the dynamics of
immune system cycling by assaying each of the multiple samples for the
level of one or more immune system marker( s) was unknown in the art at the
time." Id. We are not persuaded because assaying samples is routine extra
solution activity and because the step of "detecting the dynamics ... " is,
itself, the judicial exception.
Having determined that the judicial exception - the mental step of
detecting the dynamics of immune system cycling - is not "integrated into a
practical application," the Guidance directs us to "evaluate the additional
elements individually and in combination ... to determine whether they
provide an inventive concept (i.e., whether the additional elements amount
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to significantly more than the exception itself)." Here, we find that
remaining additional elements do not amount to significantly more than the
exception itself because they simply append well understood, routine, and
conventional activities to the recited judicial exception.
Appellant argues that none of the cited references "show that the
claim elements are routine and conventional." App. Br. 17. As support for
this argument, Appellant points to the fact that the Examiner does not assert
that the claims are anticipated. Id. Appellant further argues that the
Examiner has failed to provide evidence that it was routine to obtain "at least
one sample every three days" from a cancer patient who has not received
cancer treatment for at least 14 days. Supp. Br. 2-3 ( citing Berkheimer v.
HP Inc., 881 F.3d 1360 (Fed. Cir. 2018)). We are not persuaded.
The Examiner has provided evidence that measuring CRP levels was
routine in the art and also that it was known to measure baseline levels of
CRP. The Examiner explains:
The active method steps of the claims are readily recognized in
the art as routine. For instance, Kaminska et al (Pathol Oncol
Res, 2000, 6:38-41, cited previously) discloses measuring CRP
levels in blood following surgery in colorectal cancer patients.
(Figure 2). Broom et al (Br J Cancer, 1992, 66:1185-1187)
discloses measuring CRP levels in blood during IL-2 treatment
of patients with metastatic colorectal cancer. (Figure 1 ). Child
et al (Cancer, 1980, 45:318-326, IDS, cited previously)
discloses measuring CRP levels in blood during treatment of
patients with Hodgkin's lymphoma. (Figure 1). Wu et al (US
5,358,852, issued Oct 25, 1994, cited previously) disclose
measuring levels of CRP in various disease conditions and
states that monitoring disease activity by measuring the
concentration level of CRP has become a much used practice.
(column 1, lines 13-23, column 2, lines 2-38). Cohen et al (US
Patent Application Publication 2004/0022787, published 5 Feb
2004, filed 18 April 2003) disclose measuring for baseline
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levels of CRP in autoimmune patients prior to treatment. (Table
1 ).
Ans. 5. The claim limitations at issue need not all be found in the same
reference to support a finding that they were routine and conventional; the
law does not require anticipation to support such a finding. In addition, for
the reasons discussed above, we find that obtaining a CRP baseline satisfies
the limitation requiring obtaining "at least one sample every three days."
The Examiner's evidence that it was known to measure CRP levels and to
obtain a CRP baseline prior to treatment is thus sufficient to show that the
limitations at issue were routine and conventional. For this reason, we are
not persuaded that the Examiner's evidence was insufficient under
Berkheimer. 10
Appellant argues that claim 45 does not "tie up" the subject matter of
the judicial exception because the claims recite a "specific sampling protocol
(multiple samples taken from the patient before the patient receives any
cancer treatment at a frequency of at least one sample every three days) for a
specific population of patients ( a patient who has not received a cancer
treatment for at least about 14 days)." App. Br. 17. We are not persuaded
because even accepting Appellant's argument that monopolization of
excepted subject matter is not a concern in this case, "the absence of
complete preemption does not demonstrate patent eligibility." Ariosa, 788
F.3d at 1379.
10 Our opinion does not address whether obtaining samples over an extended
time period before instituting cancer treatment was routine and conventional
because, as discussed above, we understand the claims to encompass taking
multiple samples contemporaneously to establish a baseline.
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Accordingly, we affirm the Examiner's rejection of claim 45 as
directed to patent ineligible subject matter. Because they were not argued
separately, claims 46-49, 51-55, 57, and 58 fall with claim 45.
INDEFINITENESS
Claims 46 depends from claim 45 and additionally requires
"predicting subsequent cycling of the one or more immune system marker( s)
based on the calculations of step (c)." Claim 47 depends from claim 46.
The Examiner rejected claim 46 as indefinite on the ground that the
"calculations" recited in claim 46 lack antecedent basis.
Appellant argues that "some amount of calculation is inherent to
'detecting dynamics' as recited in step ( c) and therefore this term has
sufficient antecedent basis in claim 45." App. Br. 32. We are not persuaded
because Appellant has not identified persuasive evidence or argument that
calculations would be inherent in the analysis involved in "detecting the
dynamics of immune system cycling." See id. at 31-32. While detecting the
dynamics may involve some degree of calculation, we agree with the
Examiner that "detecting the dynamics of immune system cycling could be
[also] done by visually looking at the unmanipulated data or by visually
looking at the data that had been plotted on a graph." Ans. 29. These steps
would not inherently involve a calculating step.
According, we affirm the Examiner's rejection of claims 46 and 47 as
indefinite.
SUMMARY
In summary, we affirm the Examiner's rejection of claims 45--49, 51-
55, 57, and 58 under 35 U.S.C. § 103(a) as obvious over the combination of
Broom and Cohen.
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We affirm Examiner's rejection of claims 45--49, 51-55, 57, and 58
under 35 U.S.C. § 103(a) as obvious over the combination of Kaminska and
Cohen.
We affirm the Examiner's rejection of claims 45--49, 51-55, 57, and
58 under 35 U.S.C. § 101 as directed to patent ineligible subject matter.
We affirm the Examiner's rejection of claims 46 and 47 under 35
U.S.C. § 112 as indefinite for failing to particularly point out and distinctly
claimed the subject matter which the inventor regards as the invention.
No period for taking any subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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