Ex Parte Van Duyne et al

Patent Trial and Appeal Board

Oct 15, 2018

13303815 (P.T.A.B. Oct. 15, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
13/303,815
123818 7590
Casimir Jones, S.C.
2275 Deming Way
Suite 310
FILING DATE
11/23/2011
10/17/2018
Middleton, WI 53562
FIRST NAMED INVENTOR
Richard P. Van Duyne
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.
NWEST-31668/US-2/0RD 1089
EXAMINER
FARDANESH, MARJAN
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
10/17/2018 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):
docketing@casimirjones.com
pto .correspondence@casimirjones.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RICHARD P. VANDUYNE, MATTHEW R. GLUCKSBERG,
JOSEPH T. WALSH JR., JONATHAN M. YUEN, and NILAM C. SHAH 1
Appeal2017-009873
Application 13/303 ,815
Technology Center 3700
Before ERIC B. GRIMES, JOHN G. NEW, and TIMOTHY G. MAJORS,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants identify Northwestern University as the real party-in-interest. App.
Br. 3.
Appeal2017-009873
Application 13/303,815
SUMMARY
Appellants file this appeal under 35 U.S.C. § I34(a) from the Examiner's
Final Rejection of claims 1-20 as unpatentable under 35 U.S.C. § 101 as being
directed to nonstatutory subject matter.
Claims 1-20 also stand rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over the combination of Van Duyne et al. (US 2009/0118605 Al,
May 7, 2009) ("Van Duyne") and Mahadevan-Jansen et al. (US 2010/0145200 Al,
June 10, 2010) ("Mahadevan-Jansen").
Claims 1-20 stand further rejected as unpatentable under 35 U.S.C. § I03(a)
as being obvious over the combination of Van Duyne et al. (US 2009/0118605 Al,
May 7, 2009) ("Van Duyne") and Morris et al. (US 2009/0219523 Al, Sept. 3,
2009) ("Morris").
Claims 1-20 also stand rejected as unpatentable under the nonstatutory
doctrine of obviousness-type double patenting over claims 1, 2, and 4 of US
8,592,226 B2 (Nov. 26, 2013) ("the '226 patent") and Morris.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to systems and methods employing a
surface-enhanced Raman biosensor and sensing devices for collecting spatially
offset Raman spectra from the biosensor. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
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1. A method for quantification of an analyte in vivo,
compnsmg:
a) acquiring, through the skin of a subject, a spatially offset
Raman spectrum from a biosensor implanted under the skin of said
subject, wherein said biosensor comprises a plurality of nanospheres
and a metal film over said nanospheres; and
b) quantifying the concentration of an analyte in said subject
based on said spatially offset Raman spectrum.
App. Br. 14.
ISSUES AND ANALYSES
A. Rejection of claims 1-20 under 35 U.S.C. § 101
Issue
Appellants argue that the Examiner erred in concluding that the claims are
unpatentable as being drawn to a judicially-created exception to 35 U.S.C. § 101,
viz., an abstract idea. App. Br. 12.
Analysis
The Examiner concludes that Appellants' claims 1-20 are directed to the
abstract idea of quantifying the concentration of an analyte based on spatially
offset Raman spectrum. Final Act. 3. The Examiner also finds that the claims do
not include additional elements that are sufficient to amount to significantly more
than the judicial exception, because the additional elements, such as biosensor and
processor, are recited at a high level of generality, and provide conventional data
collection elements and/or computer components performing functions that do not
add meaningful limits to practicing the abstract idea. Id. The Examiner concludes
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that the claims are directed to an abstract idea because, although not drawn to the
same subject matter, these claim limitations are similar to mathematical concepts
and operations for manipulating and/or relating data, organizing information
through correlations, and/or collecting and comparing known data, and thus
constitute an abstract idea. Id.
Appellants argue that limitation reciting: "acquiring, through the skin of a
subject, a spatially offset Raman spectrum from a biosensor implanted under the
skin of said subject, wherein said biosensor comprises a plurality of nanospheres
and a metal film over said nanospheres" is a concrete (i.e., not abstract) step which
represents significantly more than the quantifying step alone. App. Br. 12.
Appellants assert that claim 2 further clarifies the concrete nature of the acquiring
step by reciting "wherein said acquiring step comprises the steps of: ( 1)
illuminating said biosensor at least one first spot with light; (2) collecting Raman
scattering light from said biosensor at a [sic] at least one second spot [[spots]] in
response to illumination by said light, wherein each second spot is apart from the at
least one first spot so as to define a source-detection (S-D) offset distance."
Appellants contend that the acquiring step is not merely an abstract idea, but a
concrete step that must be performed. Id.
Appellants argue further that the claimed use of an implanted biosensor with
the detection of spatially offset Raman spectrum had not been performed prior to
the work conducted during development of the presently claimed invention. App.
Br. 13. According to Appellants, it was accepted in the field that Surface-
enhanced Raman spectroscopy ("SERS") and spatially offset
Raman spectroscopy ("SORS") were incompatible, and that tools (mathematical or
otherwise) were not available at the time of the invention to demonstrate otherwise.
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Id. (citing Declaration of Richard P. Van Duyne2, March 14, 2016 (the "Van
Duyne Declaration") ,r,r 4, 8). Appellants argue that the recited "acquiring" step
utilizes a procedure that was not routine or conventional at the time of the
invention; rather, the combination of SERS and SORS into a single method had
never been performed prior to the present work, as is evident from the absence in
the Examiner's search of any reference that teaches or suggests such a technique.
Id.
The Examiner responds that the abstract idea of the claim consists of
quantifying the concentration of an analyte based on a spatially offset Raman
spectrum. Ans. 15. The Examiner finds that Appellants' Specification indicates
SERS and SORS components and functions are well-understood, routine and
conventional activity and, therefore, do not add significantly more to the abstract
idea recited in the claims. Id.
We are not persuaded by the Examiner's reasoning. We agree with
Appellants that the claims are directed to a method, i.e., a "process" and therefore
fall into one of the broad statutory categories of patent-eligible subject matter
under 35 U.S.C. § 101. We consequently next tum to determine whether this
process is patent eligible or comes under one of the nonstatutory exceptions to
Section 101.
In performing such a patentability analysis under 35 U.S.C. § 101, we follow
the framework set forth by the Supreme Court in Mayo Collaborative Serves. v.
2 Dr. Richard P. Van Duyne, one of the named inventors of the instant application,
is Charles E. and Emma H. Morrison Professor of Chemistry at Northwestern
University, the author of over 300 peer-reviewed publications, and the discoverer
of Surface-enhanced Raman Spectroscopy ("SERS"). Van Duyne Declaration
,r 2. We find Dr. Van Duyne sufficiently qualified to render an expert opinion in
this appeal.
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Prometheus Labs. Inc., 566 U.S. 66 (2012). As a first step, we determine whether
the claims at issue are directed to a patent-ineligible concept, i.e., a law of nature, a
phenomenon of nature, or an abstract idea. Mayo, 566 U.S. at 70-71. If the claims
are so directed, we next consider the elements of each claim both individually and
"as an ordered combination" to determine whether additional elements "transform
the nature of the claim" into a patent-eligible application. Id. at 78-79; see also
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1375 (Fed. Cir. 2015).
Specifically, the Supreme Court considered this second step as determining
whether the claims recite an element or combination of elements that is "sufficient
to ensure that the patent in practice amounts to significantly more than a patent
upon the [ineligible concept] itself." Mayo, 566 U.S. at 72-73.
We agree with the Examiner that the limitation reciting: "quantifying the
concentration of an analyte in said subject based on said spatially offset Raman
spectrum" recites an abstract idea - a quantification of an analyte based upon an
observed spectrum. However, all inventions at some level embody, use, reflect,
rest upon, or apply laws of nature, natural phenomena, or abstract ideas. Mayo,
5 66 U.S. at 71. We, therefore tum to the remaining limitations to determine
whether they add significantly more to the abstract idea itself. Id. at 72-73.
We conclude that they do. Claim 1 recites: "acquiring, through the skin of a
subject, a spatially offset Raman spectrum from a biosensor implanted under the
skin of said subject, wherein said biosensor comprises a plurality of nanospheres
and a metal film over said nanospheres." As Appellants explain, combining the
SERS technique taught by Van Duyne (for measuring the Raman spectrum shift
from a subdermal biosensor) and the SORS method, as taught by Mahadevan-
Jansen and Morris (for measuring the shift in a spatially offset Raman spectrum),
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was not thought to be practicable by persons of skill in the art prior to the filing of
Appellants' application. As Dr. Van Duyne explains:
Prior to the work described in the present application, it was believed
that this increased angular distribution of the Raman signal in SERS
would have been incompatible with the SORS technique. Mathematical
models describing the combination of SERS and SORS were not
available at that time (nor are they available today), so there was no
way to predict their compatibility. Our grant application to help support
the work described in the present application was actually turned down
for this exact reason. Those deemed by a funding agency to be experts
in the field did not believe that the scattering geometry produced by
SERS would be compatible with SORS. Those in the field actually
predicted that SERS and SORS could not be successfully combined and
were therefore unwilling to provide support for such research.
Van Duyne Deel. ,r 8. The inventive concept recited in Appellants' claims,
therefore, is the combination of the SERS and SORS methods, which was thought
impracticable at the time of invention, to measure the level of an analyte in an
individual by determining the shift in the spatially offset Raman spectrum from a
subdermally-implanted biosensor. We are not persuaded by the Examiner's
finding that this is "well-understood, routine and conventional activity" or simple
data collection, such as taking a blood sample or isolating a gene. To the contrary,
Appellants claim a new technique hitherto considered unfeasible by persons of
high skill in the art (i.e., funding agency grant reviewers, who are "deemed ... to
be experts in the field," Van Duyne Declaration ,r 8).
We consequently conclude that Appellants' claims recite significantly more
than merely the recitation of an abstract idea coupled with routine, well-understood
data collection activity, but rather comprises an inventive concept that adds
significantly more than just the abstract idea itself. We consequently reverse the
Examiner's rejection on this ground.
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B. Rejection of claims 1-20 under 35 U.S.C. § 103(a)
Appellants argue both rejections under Section 103(a) together, contending
that the claims are not obvious over the combination of either Van Duyne and
Mahadevan-Jansen or, alternatively Van Duyne and Morris. App. Br. 8.
Appellants argue that, contrary to the Examiner's conclusion, a person of ordinary
skill in the art would have had no reasonable expectation of success in combining
the teachings of Van Duyne and Mahadevan-Jansen or Morris. Id. at 9.
Analysis
The Examiner finds that that Van Duyne teaches that the SERS technique is
a process whereby the Raman scattering signal is increased when a Raman-active
molecule is spatially confined within range of the electromagnetic fields generated
upon excitation of the localized surface plasmon resonance of nanostructured noble
metal surfaces. Ans. 13. The Examiner finds that SERS retains all of the
advantages of normal Raman spectroscopy while achieving significantly stronger
signal intensity. Id. ( citing Van Duyne ,r 49).
However, the Examiner finds, Van Duyne fails to explicitly disclose
obtaining spatially offset measurements in order to obtain tissue depth sensitive
information. Ans. 13. The Examiner finds that Mahadevan-Jansen teaches that the
collection fiber is translationally movable along a straight line so that it is capable
of collecting the Raman scattering light at various source-detector offsets. Id. at
13-14 (citing Mahadevan-Jansen Fig. 2). The Examiner concludes that it would
have been obvious to a person of ordinary skill in the art to have modified the
method and system of Van Duyne by utilizing spatially offset Raman spectroscopy
( obtaining measurements at various source-detector offsets), with a reasonable
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expectation of success, because an ordinary artisan would have recognized routine
and conventional methods for obtaining spatially offset Raman spectra, as taught
by Mahadevan-Jansen and suggested by Van Duyne. Id. at 14.
As an initial matter, Appellants argue that the Examiner has misunderstood
the claim terms "Raman shift" and "spatially offset" and has incorrectly equated
the terms. App. Br. 8. Appellants point to the Examiner's findings that: "Van
Duyne et al. fails to disclose acquiring spatially offset Raman spectra," but that
"light detected from a sample illuminated with a Raman spectrometer is
necessarily 'Raman-shifted' (i.e., spatially offset)." Id. (quoting Final Act. 6, 7).
According to Appellants, equating the Raman shift utilized in all forms of Raman
spectroscopy with the spatial offset that is specific to spatially-offset Raman
spectroscopy ("SORS") is a fundamental mischaracterization of these concepts.
Id. at 8-9. Appellants point again to the Van Duyne Declaration, in which Dr. Van
Duyne attests:
The Office Action incorrectly equates the meanings of the terms of
"Raman-shifted" and "spatially-offset." The Examiner appears to
allege that because the Van Duyne et al. reference described the
detection of Raman-shifted light, the reference necessarily describes
the detection of spatially-offset light. This is not the case, and
necessarily stems from a mischaracterization of one or both of these
terms. Raman shift refers to a change in the energy in monochromatic
light upon interaction with molecular vibrations, phonons or other
excitations in a system. This energy shift provides information about
the vibrational modes in the system. Spatially-offset Raman
spectroscopy (SORS) refers to the collection of a Raman spectrum from
a location that is spatially offset from the point of laser excitation.
Acquiring a Raman spectrum does not necessarily entail collection of a
spatially-offset Raman spectrum, unless specifically noted. Even
though the light collected in the Van Duyne reference is "Raman-
shifted" it was not "spatially offset." Any statement to the contrary is
untrue.
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Id. at 9 ( quoting Van Duyne Deel. ,r 5). Appellants contend that the Raman shift
that is present in the methods described in Van Duyne et al. is not an inherent
teaching or suggestion of spatial offset or SORS and that Van Duyne does not
suggest spatial offset. Id.
Appellants argue further that there is nothing about the combination of
SERS and SORS that would have been obvious or predictable, based on the
understanding of an ordinary artisan at the time of the invention. App. Br. 10.
In the Van Duyne Declaration, Dr. Van Duyne states that:
As one who was working in the relevant fields at the time of the
development of the presently claimed technology, I can attest to the fact
that the successful combination of elements of these SERS and SORS
into a single method for quantification of an analyte beneath the surface
of a subject's skin was not predictable. In fact, I am not aware of any
mathematical demonstration of the compatibility of these two
techniques at the time of the invention, making it impossible to simulate
experiments combining SERS and SORS, or to make educated
predictions about the outcomes and/or success of such methods. In the
absence of a mathematical description of the SERS and SORS together,
predictions about the results of such a technique could not have been
made; therefore, the success of the claimed methods was not predictable
at the time of the present invention.
Id. (quoting Van Duyne Deel. ,r 4). Appellants also point to Dr. Van Duyne's
statement, quoted in Section A, supra, that, at the time of the filing of Appellants'
application, persons of high skill in the art did not consider the combination of
SERS and SORS practicable with any reasonable expectation of success. Id.
( quoting Van Duyne Deel. ,r 8 ("Those in the field actually predicted that SERS
and SORS could not be successfully combined and were therefore unwilling to
provide support for such research")).
Appellants assert that, contrary to the Examiner's findings, the changes in
the means and manner of generating, reflecting, and collecting Raman signals have
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complex consequences that are not easily predicted in the absence of mathematical
descriptions of the techniques, which were not available at the time of the
invention. App. Br. 11 ( citing Van Duyne Deel. ,r,r 4, 8). Consequently,
Appellants argue, a person of ordinary skill in the art would have had no
reasonable expectation of success in combining the teachings of Van Duyne and
Mahadevan-Jansen, or Van Duyne and Morris, to arrive at Appellants' claimed
invention. Id.
The Examiner responds that that it would have been obvious to a person of
ordinary skill in the art at the time of the instant invention to have modified the
method and system of Van Duyne by utilizing spatially offset Raman
spectroscopy, with a reasonable expectation of success, because such an artisan
would have recognized routine and conventional methods for obtaining spatially
offset Raman spectra, as taught by Mahadevan-Jansen and suggested by Van
Duyne. Ans. 12-13. Specifically, the Examiner concludes that a person of
ordinary skill in the art would have reasonably expected this modification could
have been made with predictable results, since both references teach the use of
Raman spectral data and analysis, and that the rationale to combine the references
would have been no more than the predictable use of prior art elements according
to their established functions. Id. at 13 (citing KSR Int 'l Co. v. Teleflex Inc., 550
U.S.398,417(2007D.
We are not persuaded by the Examiner's reasoning. As an initial matter, in
view of the Examiner's Answer to Appellants' arguments, we are not persuaded
that the Examiner has erroneously confused and equated the claim terms "Raman
shift" and "spatially offset," as Appellants argue. Nevertheless, we are not
persuaded that the Examiner has met the burden of establishing a prima facie case
of obviousness.
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Van Duyne is directed to surface-enhanced Raman biosensors for detection
of in vivo and ex vivo analytes and is silent with respect to spatially offset Raman
spectroscopy ("SORS"), which Mahadevan-Jansen teaches: "comprises the steps of
acquiring a plurality of spatially offset Raman spectra from the surgical site of
interest, identifying tissue signatures from the plurality of spatially offset Raman
spectra." Mahadevan-Jansen Abstr. Mahadevan-Jansen does not teach the use of
either SERS or SORS for the detection of analytes, but rather teaches the use of
SORS: "for surgical margin evaluation during breast conserving therapy and
discriminating two layers of soft tissues." Mahadevan-Jansen ,r 4. Although both
Van Duyne and Mahadevan-Jansen are directed to using Raman spectroscopy as a
diagnostic technique, the references employ different methodologies of measuring
Raman spectrum shifts (i.e., surface-enhanced spectroscopy versus spatially-offset
spectroscopy) for different purposes. More importantly, we are not persuaded by
the Examiner's reasoning that a person of ordinary skill in the art would have been
motivated to combine the teachings of the references with a reasonable expectation
of success.
We find the Van Duyne Declaration to be important with respect to this
issue in our analysis. Dr. Van Duyne attests, from personal experience, that: "the
successful combination of elements of these SERS and SORS into a single method
for quantification of an analyte beneath the surface of a subject's skin was not
predictable." Van Duyne Deel. ,r 4. Dr. Van Duyne further states that he was not
aware: "of any mathematical demonstration of the compatibility of these two
techniques at the time of the invention, making it impossible to simulate
experiments combining SERS and SORS, or to make educated predictions about
the outcomes and/or success of such methods." Id.
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Dr. Van Duyne further states that he was not alone in believing that the
SERS and SORS methodologies could not be combined with any reasonable
expectation of success:
Our grant application to help support the work described in the present
application was actually turned down for this exact reason. Those
deemed by a funding agency to be experts in the field did not believe
that the scattering geometry produced by SERS would be compatible
with SORS. Those in the field actually predicted that SERS and SORS
could not be successfully combined and were therefore unwilling to
provide support for such research.
Van Duyne Deel. ,r 8. The reason for the skepticism was:
The SERS technique produces a much broader angular signal
distribution than conventional Raman spectroscopy techniques. This
means that the reflected Raman signal is scattered over a much larger
area when using SERS than when employing conventional Raman
techniques. Prior to the work described in the present application, it was
believed that this increased angular distribution of the Raman signal in
SERS would have been incompatible with the SORS technique.
Mathematical models describing the combination of SERS and SORS
were not available at that time (nor are they available today), so there
was no way to predict their compatibility.
Id. We find Dr. Van Duyne's testimony persuasive that, at the time of Appellants'
filing of the instant application, it would not have been considered as practicable in
the art to combine the SERS technique taught by Van Duyne and the SERS
technique of Mahadevan-Jansen with a reasonable expectation of success.
Furthermore, Appellants' Specification discloses that:
The solution provided by embodiments of the present invention
removes the window and directly collect the SERS spectra
transcutaneously. However, introducing the skin into the optical
detection system presents a new set of challenges that have been
overcome by the present invention. The large refractive index change
between skin and air immediately produces light intensity losses due to
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back reflections. Within the skin layers, light is further attenuated due
to multiple scattering and absorption events. These can be caused by
lipids in cell walls, which scatter, blood, which absorbs, and proteins
such as keratin and melanin which can both scatter and absorb light.
These difficulties are further compounded when illuminating and
collecting from a subcutaneous sample since both the input laser
excitation light must pass through the skin and the output Raman
scattered light must pass back out through the skin to reach the detector.
The present invention addresses these issues with the use of spatially
offset Raman spectroscopy (SORS).
In SORS, Raman scattered light is collected from regions offset
from the point of laser excitation at the sample. In contrast, for normal
Raman spectroscopy the excitation and collection points are coincident
so that the surface of the sample gives the greatest contribution to the
Raman spectrum. When spectra are collected some distance away from
the excitation point, spectral features originating from underlying
layers give greater contribution than the surface. Combining the
sensitivity of SERS with the depth resolution of SORS yields a
powerful new tool for biomedical sensing.
Spec. 11-12 (internal references omitted). These disclosures of Appellants'
Specification support Appellants' argument that the combination of SERS and
SORS was a novel and innovative technique that was neither taught nor suggested
by the cited prior art.
The Examiner has not effectively rebutted Appellants' arguments that the
Examiner failed to establish a prima facie case of obviousness. We consequently
reverse the Examiner's rejections of claims 1-20 upon this ground. Furthermore,
Appellants and the Examiner rely upon the same arguments with respect to the
Examiner's rejection of claims 1-20 on the ground of obviousness-type double
patenting. The '226 patent, like Van Duyne, is directed to biosensors employing
SERS methods. '226 patent Abstr. For the same reasons explained supra, we
similarly reverse the Examiner's rejection of the claims upon that ground.
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DECISION
The Examiner's rejection of claims 1-20 as unpatentable under 35 U.S.C.
§ 101 is reversed.
The Examiner's rejection of claims 1-20 as unpatentable under 35 U.S.C.
§ 103(a) is reversed.
The Examiner's rejection of claims 1-20 as unpatentable under the
nonstatutory doctrine of obviousness-type double patenting is reversed.
REVERSED
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