Ex Parte Alfano et al

Patent Trial and Appeal Board

Jun 21, 2017

12684739 (P.T.A.B. Jun. 21, 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.
12/684,739 01/08/2010 Robert R. Alfano 3060722 5882
44331 7590
Barclay Damon, LLP
Barclay Damon Tower
125 East Jefferson Street
Syracuse, NY 13202
06/23/2017 EXAMINER
SMITH, RUTH S
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
06/23/2017 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):
RochesterIP @ hblaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT R. ALFANO, CHENG-HUI LIU,
WUBAO WANG, and VIDYASAGAR SRIRAMOJU
Appeal 2016-002618
Application 12/684,7391
Technology Center 3700
Before ULRIKE W. JENKS, RACHEL H. TOWNSEND, and
DAVID COTTA, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of detecting the risk of vulnerable plaque, which have been rejected as
failing to comply with the written description and enablement requirements,
as well as being indefinite, and/or as being obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse the Examiner’s rejection of the claims. However, we
provide a new ground of rejection of the claims on appeal under 35 U.S.C.
§ 101 pursuant to our authority under 37 C.F.R. § 41.50(b).
1 Appellants identify the Real Party in Interest as inventor, Robert R. Alfano.
(Appeal Br. 1.)
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Application 12/684,739
STATEMENT OF THE CASE
Atherosclerotic plaque builds up inside the arterial walls. (Spec. 1.)
“[T]he detection of atherosclerotic plaque is important for the diagnosis,
treatment, and prognosis of atherosclerosis and other cardiovascular
disease.” {Id.) Appellants’ Specification notes that
[n]ot all plaque presents the same risk for sudden major cardiac
events such [an] unstable angina, myocardial infarction, and
sudden cardiac death. It has been found that vulnerable plaque
(VP), which is a soft lipid pool covered by a thin fibrous cap,
provides an increased risk of thrombosis and rapid stenosis
progression.
{Id.) “[Vulnerable plaques] often have a thin fibrous cap, which is generally
less than 100 pm or less than 65 pm, and are a more specific precursor of
plaque rupture due to tissue stress.” {Id.) Appellants’ invention is directed
to a method for detecting vulnerable plaque using Raman spectroscopy. {Id.
at 2.)
Claims 3, 6, 7, 10-12, 27, 29, 30, and 37 are on appeal.2 Claim 29 is
representative and reads as follows:
29. A method of detecting the risk of vulnerable plaque
comprising:
a) irradiating a cardiovascular tissue sample with
monochromatic light,
b) detecting reference or background Raman signal
scattering lRef from the cardiovascular tissue sample at one or
more background frequencies primarily representing
cardiovascular tissue;
2 Claims 22, 23, 26, 28, and 31-35 are also pending but are withdrawn from
consideration. (Appeal Br. 2.) Claims 1, 2, 4, 5, 8, 9, 13-21, 24, 25, and 36
have been canceled. {Id.)
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c) detecting Raman signal scattering I at at least at one
decision point at about 1435 cm'1, about 2850 cm'1 or about
2892 cm'1,
d) processing Raman signal I to obtain spectroscopic
information to establish a level of vulnerable plaque, and
e) determining a thickness d of a plaque tissue cap layer
by measuring attenuation of the spectroscopic information at
one of about 1435 cm'1, about 2850 cm'1 or about 2892 cm'1,
from the following exponential decay relationship:
I=I0e'ad
wherein a is an attenuation coefficient of the plaque tissue cap
layer at 633 nm and I0 is the Raman intensity of fat without a
cap layer.
(Appeal Br. 20-21.)
The following grounds of rejection by the Examiner are before us on
review:
1. Claims 3, 6, 7, 10-12, 27, 29, 30, and 37 are rejected under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the written
description requirement.
2. Claims 3, 6, 7, 10-12, 27, 29, 30, and 37 are rejected under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the enablement
requirement.
3. Claims 3, 6, 7, 10-12, 27, 29, 30, and 37 are rejected under 35 U.S.C.
§ 112, second paragraph, as being indefinite for failing to particularly
point out and distinctly claim the subject matter which the applicant
regards as the invention.
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4. Claims 3, 6, 7, 10-12, 27, 29, 30, and 37 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Ling,3 Scepanovic,4 and Puppels.5
DISCUSSION
I.
1. Written Description
The Examiner finds that “[t]he [Specification, as originally filed, fails
to disclose that the thickness of the cap layer is determined by measuring
attenuation of the spectroscopic information using a first order exponential
decay function.” (Final Action 3; Ans. 2) According to the Examiner, the
Specification discloses plotting intensity changes versus thickness of cap and
determining that the “plotted data fits the model” but not that “the function is
initially used to determine the thickness.” {Id.)
[T]he Examiner agrees that the use of the formula as set forth in
the claims could be recognized by one skilled in the art as a
possible alternative for use in the determination of thickness,
[but] the fact that such is not specifically disclosed renders the
inclusion of such in the claims as new matter.
(Ans. 5.)
We disagree with the Examiner’s conclusion that because the
Specification does not “specifically disclose” the use of the function
“initially ... to determine the thickness,” the claims are not adequately
supported by the Specification as originally filed.
[T]he patent specification is written for a person of skill in the
art, and such a person comes to the patent with the knowledge
3 Ling et al., US 2009/0231578 Al, published Sept. 17, 2009.
4 Scepanovic et al., US 2007/0167836 Al, published July 19, 2007.
5 Puppels et al., US 2006/0139633 Al, published June 29, 2006.
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of what has come before. Placed in that context, it is
unnecessary to spell out every detail of the invention in the
specification [to satisfy the written description requirement];
only enough must be included to convince a person of skill in
the art that the inventor possessed the invention ....
LizardTech, Inc. v. Earth Resource Mapping, PTY, Inc., 424 F.3d 1336,
1345 (Fed. Cir. 2005) (internal citation omitted). Moreover, examples are
not necessary to support the adequacy of a written description. Falkner v.
Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006). “In other words, the test for
sufficiency is whether the disclosure of the application relied upon
reasonably conveys to those skilled in the art that the inventor had
possession of the claimed subject matter as of the filing date.” Ariad
Pharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en
banc).
Appellants explain that “the application shows that experimental data
is fitted with a curve and the curve is expressly disclosed as an equation for
that fitted curve.” (Reply Br. 2; Appeal Br. 7) Appellants explain that “once
the data is plotted and a curve is best fitted with the exponential decay
function they clearly become equivalent approaches or methods and either
one or both can be used to obtain the desired results.” (Appeal Br. 7.)
Accordingly, Appellants note,
one skilled in the art of data acquisition would immediately
understand and appreciate that, to the extent that a plot can be
properly fitted with a curve defined by an equation the equation
becomes an alternative to analysis and is especially useful for
establishing an infinite number of points along the curve,
including providing solutions between measured data points
along the plot.
(Appeal Br. 6; Reply Br. 2-3.) Appellants point out that
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any person skilled in the art reading the application as a whole
and being given the mathematical expression resulting from the
curve fitting would immediately understand that the same
information regarding the thickness of the cap layer can be
determined either from the plotted curved data or from the fitted
curve expressed mathematically or expressed by the
mathematically fitted curve.
(Reply Br. 3; see also Appeal Br. 6.)
In light of the foregoing, we find that regardless of whether the
Specification expressly provides an example of use of the function initially
to determine thickness, the disclosure that the exponential decay function
data fits a curve reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter, i.e., using the
exponential decay function to determine a thickness of a plaque tissue cap
layer, as of the filing date.
In light of the foregoing, we reverse the Examiner’s rejection under
35 U.S.C. § 112, first paragraph, written description requirement.
2. Enablement
The Examiner finds that it is “unclear as to how a detectable/usable
Raman signal can be obtained without subtracting background frequency
signals.” (Final Action 3; Ans. 2-3.) The Examiner contends that
“[s]ubtraction of a background signal is a necessary requirement in Raman
signal processing in order to obtain a usable signal.” (Ans. 3.)
We disagree with the Examiner that the claims are not enabled by the
Specification.
The enablement requirement “is satisfied if, given what they already
know, the specification teaches those [of ordinary skill] in the art enough
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that they can make and use the invention without ‘undue experimentation.’”
Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1334 (Fed. Cir.
2003).
While it is not clear what “background signal” the Examiner refers to,
to the extent the Examiner refers to some basic step that must be taken to
obtain a detectable/usable Raman signal, the Examiner’s rejection appears to
make it clear that such is well known to one of ordinary skill in the art. And
in that regard, we note “a patent disclosure need not enable information
within the knowledge of an ordinarily skilled artisan. Thus, a patentee
preferably omits from the disclosure any routine technology that is well
known at the time of application.” Chiron Corp. v. Genentech Inc., 363 F.3d
1247, 1254 (Fed. Cir. 2004).
Moreover, to the extent the Examiner is referring to some other
background signal we note, as Appellants explain, that the Specification
teaches subtraction of background spectra with reference to figure 4.
(Appeal Br. 8-9.) In addition, the determination of the thickness of the
plaque layer is described by using determination from “On Raman lipid
resonance and Off Raman peaks” (Reply Br. 6), i.e., background signal at
1350 or 2750 being an Off Raman peak with regard to adipose lipid and
1435 cm'1, 2850 cm'1, and 2892 cm'1 being On Raman peaks with respect to
adipose lipid. That is at 1435 cm'1, 2850 cm'1, and 2892 cm'1 there are
strong bands (four times stronger than that of other modes) for Raman
vibration from adipose lipids provided that overlying tissue is thin, and
overlying tissue does not have Raman bands in these regions but does at
1350 and 2750, bands that adipose lipid does not have Raman peaks. (See
Spec. 18 (describing Figure 1 and measured Raman spectra), Spec. 14
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(describing that aortic tissue produces Raman scatter at 1350 cm'1 and 2750
cm'1, not at 1435 cm'1, 2850 cm'1, and 2892 cm'1), and Figure 1.)
In particular, the Specification explains that
[t]he Raman vibration modes from the lipids for determining
the presence of VP include the strong bands at 1435 cm'1, 2850
cm'1, and 2892 cm'1. . . under a thin tissue layer. The overlying
tissue layer does not have Raman bands in these regions but
acts to attenuate the intensity of the Raman signal from the
underlying lipid layer.
{Id. at 5; see also id. at 6 (“the main characteristic fingerprint Raman
vibration modes of adipose tissue at 1435 cm'1, 2850 cm'1, and 2892 cm'1
have an intensity approximately four times stronger than that of the other
modes”), id. at 9 (“1435 cm'1, 2850 cm'1, and/or 2892 cm'1, which are
characteristic scattering bands of aortic fatty tissue”).) The Specification
further explains that “[f]or aorta or sections thereof having a thick tissue
layer, the excitation and emission signals at the three Raman lipid modes are
absorbed by the tissue and the lipid bands are not seen.” {Id. at 8.) The
Specification further explains that, in view of the foregoing information, it
was determined that the intensity changes versus thickness of tissue layer fits
a first order exponential decay function: I=I0e'ad, where d is the thickness of
layer in film and a is the attenuation coefficient at 633nm. {Id. at 19.)
In view of these facts, the Specification explains that “[ajttenuation
due to tissue cap layer thickness can be distinguished from the thickness of
the VP layer by calculating a ratio or subtracting background signal at, for
example 1350 cm'1 (for the 1435 band) or 2750 cm'1 (for the 2850 cm'1, or
2892 cm'1 bands.” {Id. at 14 and 18-19; see also Figure 2.)
Consequently, Appellants’ Specification enables the claimed method,
which requires “detecting reference or background Raman signal scattering
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iRef from the cardiovascular tissue sample at one or more background
frequencies primarily representing cardiovascular tissue” and “processing
Raman signal I [from at least at about 1435 cm'1, about 2850 cm'1 or about
2892 cm'1] to obtain spectroscopic information to establish a level of
vulnerable plaque.”
In light of the foregoing, we reverse the Examiner’s rejection based on
the enablement provision of 35 U.S.C. § 112, first paragraph.
3. Definiteness
With regard to indefiniteness, the Examiner finds:
i. Claim 29 “fails to set forth a connection between the step of
detecting reference/background signals and the remaining
steps in the claim.”
ii. Claims 29 and 37 are “unclear as to whether the step of
determining a thickness uses the same wavenumber used in
the step of detecting Raman scattering at a decision point.”
iii. Claim 29 “fails to positively set forth a step of detecting the
risk of vulnerable plaque as set forth in the preamble” and
thus is incomplete.
iv. Claim 7 “is unclear as to whether the detection is directed to
a background frequency or the decision points.”
(Final Action 4; Ans. 3.)
We disagree with the Examiner’s legal conclusion as to each of the
rejections i)-iv) enumerated above.
35 U.S.C. § 112, second paragraph requires a claim to “particularly
point[] out and distinctly claim[] the subject matter which the applicant
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regards as his invention.” As the Supreme Court explained, this statute
“require[s] that a . . . claim[], viewed in light of the specification and
prosecution history, inform those skilled in the art about the scope of the
invention with reasonable certainty.” Nautilus, Inc. v. Biosig Instruments,
Inc., 134 S. Ct. 2120, 2129 (2014). A claim fails to meet the statutory
requirement when it contains words or phrases whose meaning is unclear—
claims are “not [read] in a vacuum, but always in light of the teachings of
the prior art and of the particular application disclosure as it would be
interpreted by one possessing the ordinary level of skill in the pertinent art.”
In re Moore, 439 F.2d 1232, 1235 (CCPA 1971).
In our reversal of the Examiner’s enablement rejection (see above 2)
we have already addressed the Examiner’s assertion in point i) above that
claim 29 “fails to set forth a connection between the step of detecting
reference/background signals and the remaining steps in the claim.” As we
stated there, the background detection is incorporated into and is a part of
step d) “processing Raman signal I to obtain spectroscopic information to
establish a level of vulnerable plaque,” which is then used in the method of
determining the thickness d of a plaque with the recited first order
exponential decay function.
Regarding the alleged lack of clarity of claims 29 and 37 and
“whether the step of determining a thickness uses the same wavenumber
used in the step of detecting Raman scattering at a decision point,” we note
that when the claims are read in light of the Specification, one of ordinary
skill in the art would know that the only way the method works is when the
same wavenumber used in the step of detecting Raman scattering at a
decision point is used in determining a thickness.
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Regarding the Examiner’s alleged indefiniteness of claim 29 because
it “fails to positively set forth a step of detecting the risk of vulnerable
plaque as set forth in the preamble,” we note that “breadth is not to be
equated with indefiniteness.” In re Miller, 441 F.2d 689, 693 (CCPA 1971).
That the positive method steps recited in the claim do not tie back in to the
preamble is a question of claim breadth not indefiniteness. See, e.g., Bristol-
Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir.
2001) (finding that the preamble language, stating that method was “for
reducing hematologic toxicity,” did not further limit the method claims
because “[t]he steps of the . . . method are performed in the same way
regardless whether or not the patient experiences a reduction in hematologic
toxicity, and the language of the claim itself strongly suggests the
independence of the preamble from the body of the claim”); Eaton Corp. v.
Rockwell Inti Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003) (“When
limitations in the body of the claim rely upon and derive antecedent basis
from the preamble, then the preamble may act as a necessary component of
the claimed invention.”).
As to claim 7, in light of our discussion above as to enablement, we
note that when the claims are read in light of the Specification, one of
ordinary skill in the art would know that at 1435 cm'1, the detection is
directed to decision points as to adipose tissue signals not background
cardiovascular tissue, as cardiovascular tissue does not emit a signal at 1435
cm'1. (See Spec. 14 and Figure 1.)
For the foregoing reasons, we find that the Examiner has not provided
persuasive reasoning to support his conclusion that claims 29, 37, and 7 are
indefinite.
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4. Obviousness
The Examiner finds that Ling discloses using “Raman spectroscopy to
detect lesions such as vulnerable plaque” where the “wavenumber range
used is in the range of 2600-3200 cm'1 and 200-2000 cm'1” but does not
disclose using the frequencies set forth in the claims or determining the
thickness of the fibrous cap. (Final Action 5.) The Examiner finds that
Scepanovic discloses “using spectroscopy to determine the thickness of the
fibrous cap which is used in the diagnosis of vulnerable plaque.” (Id.) The
Examiner further finds that Puppels teaches
a method of Raman spectroscopy including determining the
thickness of the fibrous cap [0086], and that various spectral
regions can be used [0033] and that the specific parameters
used are adapted to the tissue sample under investigation using
portions of the spectra known to be present in the plaque
[0085],
(Id.) The Examiner also finds Puppels employs “correction of measured
spectra for background signal contributions.” (Id.) The Examiner notes that
Appellants admit that it was “known that vulnerable plaque exists where the
fibrous cap is thin, generally less than 100 pm” and that it would, therefore,
have been obvious to have “used the spectroscopic information to determine
a thickness of the fibrous cap and used the thickness measurement to
determine the presence of vulnerable plaque.” (Id.) According to the
Examiner, modifying Ling to perform such an analysis “involves the use of a
known measurement (spectra) to determine a desired physiological
parameter (fibrous cap thickness).” (Ans. 6.) The Examiner contends that
even though “Scepanovic . . . fails to provide details on the use of Raman
spectroscopy to determine thickness of the fibrous cap,” the fact that it
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teaches such can be done in combination with Puppels teachings (id. at 7)
would have made it “obvious to one skilled in the art to have selected the
wavenumbers . . . [recited in the claims] since it has been held that
discovering an optimum value of a result effective variable involves only
routine skill in the art.” (Final Action 5; see also Ans. 6). The Examiner
also contends that it would have been obvious to have employed, in that
method, subtraction of detected background signals “from the spectra to
obtain a more accurate and usable signal.” (Id.) Regarding the specific
formula recited, the Examiner contends that “[i]n the absence of any
showing of criticality or unexpected result, the formula used to calculate the
thickness from the measured spectra would have been an obvious design
choice of known equivalents in the art.” (Final Action 5.)
We disagree with the Examiner’s conclusion of obviousness because,
as Appellants explain, none of the prior art recognized that Raman
Spectroscopy alone could be used to determine the thickness of the
cardiovascular tissue layer covering a lipid pool. Not a single reference
cited by the Examiner recognizes that there are different wavelengths that
can be used to measure cardiovascular tissue but not lipid pools, that
attenuation of the Raman signal from lipid pools at specific wavelengths is a
result of fibrous cap thickness, and that there is a first order exponential
function that can be used to provide a measure of fibrous cap thickness
based on this attenuation.
Scepanovic does not disclose a method of determining the thickness
of the fibrous cap using Raman Spectroscopy. Rather, Scepanovic teaches
using “IFS spectra at 308 and 340 nm excitation ... to parameterize fibrous
cap thickness” and that the ratio of fit coefficients C308/C340 can be used to
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identify thin fibrous cap. (Scepanovic TJ 58.) Ling also does not teach that
Raman Spectroscopy measurements can be used to determine the thickness
of the fibrous cap. Rather, Ling teaches that lipid rich lesions, such as
vulnerable plaques, can be located with Raman spectra because such plaques
“have characteristic Raman spectra within the high wavenumber region, i.e.,
approximately 2,600 to 3,200 cm'1” (Ling 71, 37). Ling teaches that
calcification can be evaluated using the range of approximately 800 to 1200
cm'1. (Id. T( 37.) In light of the foregoing, Ling also teaches that, in addition
to locating the lipid-rich lesions, those lesions can be characterized as being
calcified or not. (Id. 71.)
Moreover, as Appellants note (Appeal Br. 12), while Puppels
mentions fibrous cap thickness, it does not provide any teaching of
determining that thickness using Raman Spectroscopy. Example 5 of
Puppels sets forth “Steps to Arrive at a Tissue Analysis.” (Puppels 131-
36.) It is explained that Raman Spectroscopy can be used to assess the
weight percentages of specific compounds or groups of compounds in the
tissue composition and that this information can also be used “to type the
tissue and determine its clinical diagnostic class.” (Id. 135; see also id.
138-139, 18, 24, and Figures 2 and 8.) Thus, Puppels does not shed any
light on how one of ordinary skill in the art could use only Raman
Spectroscopy to assess fibrous cap thickness.
There is nothing in the prior art that would suggest that in light of
Scepanovic’s disclosure of using a different spectroscopic measure to
determine fibrous cap thickness that one could instead use Raman
Spectroscopy to do this as well. The art does not teach that there are
different wavelengths that can be used to measure cardiovascular tissue but
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not lipid and that attenuation of the Raman signal at the lipid specific
wavelengths is a result of fibrous cap thickness. Consequently, the art does
not provide any indication that these measures can establish the presence of
vulnerable plaque. Nor could the art teach or suggest that in light of the
foregoing there is a particular first order exponential function that relates the
foregoing information to a measure of fibrous cap thickness.
For the foregoing reasons, the Examiner has not established a prima
facie case of obviousness of claims 29 or 37. We reverse the Examiner’s
obviousness rejection of the claims.
II
35 U.S.C. §101
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 Ass ’n for Molecular Pathology v.
Myriad Genetics, Inc., 133 S. Ct. 2107, 2116 (2013)). “Phenomena of
nature, though just discovered, mental processes, and abstract intellectual
concepts are not patentable, as they are the basic tools of scientific and
technological work.” Mayo Collaborative Servs. v. Prometheus Labs, Inc.,
566 U.S. 66, 71 (2012) (quoting Gottschalkv. Benson, 409 U.S. 63, 67
(1972)).
Our reviewing court, based on the Supreme Court’s § 101
jurisprudence, has held a prenatal diagnostic method patent ineligible despite
the fact that the claims recite concrete steps, Ariosa Diagnostics, Inc. v.
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Sequenom, Inc., 788 F.3d 1371, 1374, 1376-78 (Fed. Cir. 2015) (noting that
patent ineligible claim 25, directed to “[a] method for performing a prenatal
diagnosis” including obtaining a certain fraction from a blood sample,
amplifying certain nucleic acid from the fraction and performing analysis on
it to detect paternally inherited fetal nucleic acid, was generally “directed to
detecting the presence of a naturally occurring thing or a natural
phenomenon”). The Supreme Court has held a treatment method
(optimizing therapeutic efficacy) ineligible, which method includes such
concrete steps as administering a particular drug, noting that limiting the
treatment method to a particular environment cannot be used to circumvent
“the ‘prohibition against patenting abstract ideas [or natural phenomena].’”
Mayo, 566 U.S. at 78 (citation omitted).
In Mayo, the patentee had discovered the relationship between the
level of a particular metabolite in a patient’s blood and whether a patient
could and should safely be administered additional medication. Id. at 74.
The Court found that the method steps amounted to little more than a broad
command to “apply the law [of nature].” Id. at 78. Focusing on the
“determining” step, the Court explained that “methods for determining
metabolite levels were well known in the art” and that “scientists routinely
measured metabolites as part of their investigations into the relationships
between metabolite levels and efficacy and toxicity of [the drug].” Id. at 79.
Because the additional steps did little more than instruct the practitioners to
apply the natural law in routine and conventional ways, the claim was
deemed patent ineligible. Id. at 79-80.
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Abstract Idea
In analyzing patent-eligibility questions under 35 U.S.C. § 101, the
Supreme Court instructs us to “first determine whether the claims at issue
are directed to a patent-ineligible concept.” Alice, 134 S. Ct. at 2355. If the
initial threshold is met, we then move to a second step and “consider the
elements of each claim both individually and ‘as an ordered combination’ to
determine whether the additional elements ‘transform the nature of the
claim’ into a patent-eligible application.” Id. (quoting Mayo, 566 U.S. at 78-
79).
“The Supreme Court has not ‘delimit[ed] the precise contours of the
‘abstract ideas’ category.’” Content Extraction & Transmission LLC v.
Wells Fargo Bank, Natl Ass n, 776 F.3d 1343, 1347 (Fed. Cir. 2014)
(alteration in original) (quoting Alice, 134 S. Ct. at 2357). Our reviewing
Court has held “information as such is an intangible” and thus, has “treated
collecting information, including when limited to particular content (which
does not change its character as information), as within the realm of abstract
ideas.” Elec. Power Grp., LLCv. Alstom S.A., 830 F.3d 1350, 1353 (Fed.
Cir. 2016) (collecting cases). Likewise, it has “treated analyzing
information by steps people go through in their minds, or by mathematical
algorithms, without more, as essentially mental processes within the
abstract-idea category.” Id. at 1354 (collecting cases). And, it has
“recognized that merely presenting the results of abstract processes of
collecting and analyzing information, without more (such as identifying a
particular tool for presentation), is abstract as an ancillary part of such
collection and analysis.” Id. (collecting cases).
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Independent claim 29 is directed to a method of detecting the risk of
vulnerable plaque by detecting Raman signal scattering from certain samples
and at certain decision points and processing that data. In other words, the
method is directed to collecting information and analyzing it and does
nothing to change the character of information as information. The same is
true for independent claim 37. Our reviewing court has held claims similar
in nature to be patent-ineligible under § 101. PerkinElmer Inc. v. Interna
Ltd., 496 F. App’x 65, 70 (Fed. Cir. 2012) (non-precedential) (considering
claims directed to “[a] method of determining whether a pregnant woman is
at an increased risk of having a fetus with Down’s syndrome” including
steps of assaying a sample for and measuring a screening marker and
determining the risk based on a comparison to known statistical measures).
The Court noted: “That an increased risk of fetal Down’s syndrome
produces certain analytical results is a natural process, an eternal truth that
‘exists in principle apart from any human action.’” Id. at 70 (quoting Mayo,
566 U.S. at 77). The Court also noted: “The claims . . . recite the mental
process of comparing data to determine a risk level: data are gathered in the
first trimester of pregnancy; data are gathered in the second trimester of
pregnancy; those data are compared to known statistical information. No
action beyond the comparison is required.” Id.
Similarly, here the risk of vulnerable plaque exists apart from any
human action regardless of the fact that it produces certain Raman spectral
analytical results. It is, thus, a natural process. In addition, the algorithm
used to analyze the data (claims 29 and 37), without more, is a mental
process within the abstract-idea category. Elec. Power Grp., LLC, 830 F.3d
at 1354. The dependent claims, which do little more that direct additional
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data gathering, specify certain decision points, or further define the data
processing steps to be used, do not change the character of the claims as
being within the abstract-idea category. Thus, we find the claims on appeal
to recite abstract ideas and natural laws.
Consideration of the claim limitations individually and as a whole
We turn next to the second step under Alice to decide whether the
claims add enough to the statements of ineligible subject matter to direct the
claims, not to the ineligible concepts themselves, but to applications of those
concepts. We find that the recited method steps, individually and as a
combined whole, do not confer patent-eligibility.
In PerkinElmer, the Court noted that “[pjurely ‘conventional or
obvious’ ‘presolution activity’ is normally not sufficient to transform an
ineligible law of nature into a patent-eligible application of such a law.”
PerkinElmer, 496 F. App’x at 71 (quoting Mayo, 566 U.S. at 79). In a more
recent case, our reviewing Court noted that even “a claim for a new abstract
idea is still an abstract idea. The search for a § 101 inventive concept is thus
distinct from demonstrating § 102 novelty.” Synopsys, Inc. v. Mentor
Graphics Corp., 839 F.3d 1138, 1151 (Fed. Cir. 2016). As the Court
explained in PerkinElmer, “physical data-gathering steps, which may cover
patent-eligible subject matter [but which merely derive data for use in the
algorithm], are insufficient to make claims reciting abstract ideas patent-
eligible applications of the ineligible concepts.” PerkinElmer, 496 F. App’x
at 72. Steps that simply recite the use of conventional techniques or
activities also cannot save claims directed to patent ineligible abstract ideas.
Genetic Techs. Ltd. v. MerialLLC, 818 F.3d 1369, 1376 (Fed. Cir. 2016).
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In Genetic Technologies, our reviewing Court found claims to a
“method for detection of at least one coding region allele of a multi-allelic
genetic locus” patent ineligible where “Applicant has not invented a new
way to analyze genetic loci. Rather Applicant has found that when prior art
techniques are applied to the non-coding sequences, the result can be more
informative than analysis of the coding regions.” Id. at 1377-78. There the
Court explained that “the novelty of looking to non-coding DNA to detect a
coding region allele of interest resides in the novelty of the newly discovered
natural law of linkage disequilibrium between coding and non-coding
regions and adds little more than a restatement of the natural law itself.” Id.
at 1379-80.
Similarly here, using Raman Spectroscopy to determine the presence
of vulnerable plaque was conventional, as Ling and Puppels make clear.
The algorithm recited for use in claims 29 and 37 are mental process steps.
Appellants have found that using prior art techniques, a mathematical
relationship exists by which one can determine vulnerable plaque;
Appellants have not invented any new physical techniques. Similar to
Genetic Technologies, the novelty of looking at a specific Raman spectra
decision point that will reflect fatty tissue measurement and not
cardiovascular tissue, and of looking at a different decision point that will
reflect cardiovascular tissue and not fatty tissue, resides in the newly
discovered natural law of the relationship between those measures and the
determination of the thickness of a plaque tissue cap layer. The method steps
thus add little more than a restatement of the natural law itself.
For the foregoing reasons, we find that the steps of the claims on
appeal when considered individually and as a whole do not provide
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sufficient inventive concept to render the claims on appeal patent eligible.
Consequently, we enter a new ground of rejection of claims 3, 6, 7, 10-12,
27, 29, 30, and 37 under 35 U.S.C. § 101 as being directed to patent-
ineligible subject matter. 37 C.F.R. § 41.50 (b).
SUMMARY
We reverse the rejection of claims 3, 6, 7, 10-12, 27, 29, 30, and 37
under 35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
We reverse the rejection of claims 3, 6, 7, 10-12, 27, 29, 30, and 37
under 35 U.S.C. § 112, first paragraph, as failing to comply with the
enablement requirement.
We reverse the rejection of claims 3, 6, 7, 10-12, 27, 29, 30, and 37
under 35 U.S.C. § 112, second paragraph, as being indefinite for failing to
particularly point out and distinctly claim the subject matter which the
applicant regards as the invention.
We reverse the rejection of claims 3, 6, 7, 10-12, 27, 29, 30, and 37
under 35 U.S.C. § 103(a) as unpatentable over Ling, Scepanovic, and
Puppels.
We enter a new ground of rejection of claims 3, 6, 7, 10-12, 27, 29,
30, and 37 under 35 U.S.C. § 101 as being directed to patent-ineligible
subject matter.
37 C.F.R. § 41.50(b)
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b), which provides that “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
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37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. . . .
REVERSED: 37 C.F.R, § 41,501b)
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