Ex Parte Peyman

Patent Trial and Appeal Board

Dec 20, 2017

14160174 (P.T.A.B. Dec. 20, 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.
075200.46 4526
EXAMINER
POPA, ILEANA
ART UNIT PAPER NUMBER
1633
MAIL DATE DELIVERY MODE
14/160,174 01/21/2014 Gholam A. Peyman
13010 7590 12/21/2017
The Law Office of Patrick F. 0"Reilly III, LLC
1509 Lafayette Drive
Columbus, OH 43220-3869
12/21/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
-UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GHOLAM A. PEYMAN1
Appeal 2017-010738
Application 14/160,174
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellant states that the real party-in-interest is the named inventor,
Gholam A. Peyman. App. Br. 2.
Appeal 2017-010738
Application 14/160,174
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Non-Final Rejection of claims 1, 2, 4, 5, 9, 11—17, 19, and 22—
28. Specifically, claims 1, 2, 5, 9, 11, and 13—16 stand rejected as
unpatentable under 35 U.S.C. § 103(a) as being obvious over the
combination of Olson et al (US 2011/0270153 Al, November 3, 2011)
(“Olson”), Klapoetke et al. (US 2014/0324134 Al, October 30, 2014)
(“Klapoetke”), J. Zhang et al., Integrated Device for Optical Stimulation and
Spatiotemporal Electrical Recording of Neural Activity in Light-Sensitized
Brain Tissue, 6(5) J. Neural. Eng. 1—24 (2009) (“Zhang”), and D.K. James
et al., Graphene: Powder, Flakes, Ribbons, and Sheets, 46 Accts. Chem.
Res., 2307-18 (2012) (“James”).
Claims 1, 2, 5, 9, 11—16, 19, 22, 23, and 25—28 stand rejected as
unpatentable under 35 U.S.C. § 103(a) as being obvious over the
combination of Olson, Klapoetke, Zhang, James, and P. Li et al., A Wireless
Power Interface for Rechargeable Battery Operated Neural Recording
Implants, Proc. 28th IEEE EMBS Ann. Int’l Conf. 6253-56 (2006)
(“Li”).
Claims 1, 2, 5, 9, 11—17, 19, and 22—28 stand rejected as unpatentable
rejected under 35 U.S.C. § 103(a) as being obvious over the combination of
Olson, Klapoetke, Zhang, James, Li, and M. Mogi et al., Brain-Derived
Growth Factor and Nerve Growth Factor Concentrations are Decreased in
the Substantia Nigra in Parkinson’s Disease, 270 Neurosci. Lett., 45—48
(1999) (“Mogi”).
Claims 1, 2, 4, 5, 9, 11, and 13—16 stand rejected as unpatentable
under 35 U.S.C. § 103(a) as being obvious over the combination of Olson,
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Application 14/160,174
Klapoetke, Zhang, Janies, and J.D. Heiss et al., Image-Guided Convection-
Enhanced Delivery of Muscimol to the Primate Brain, 112 J. Neurosurg.,
1-13 (2010).
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
NATURE OF THE CLAIMED INVENTION
Appellant’s invention is directed to methods and compositions to
controllably regulate cells at a target site. A quantum dot-targeting agent
and ion channel gene complex is administered and the complex is stimulated
using an implanted fiber optic system. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A method to enhance functional recovery of a cell in a
patient in need thereof, the method comprising:
administering to a patient in need thereof, in or with a
biocompatible fluid, a plurality of nanoparticles selected from
the group consisting of graphene quantum dots, graphene-oxide
quantum dots, graphene-zinc oxide quantum dots, quantum dots
with at least one (poly)ethylene glycol (PEGylated) quantum dot,
graphene nanotubes, carbon nanotubes, and combinations
thereof, where the nanoparticles are coated with a biocompatible
molecule for cell uptake, contain an antibody that targets the
nanoparticles to a cell, and a gene selected from the group
consisting of a rhodopsin gene, a channelrhodopsin gene, a
halorhodopsin gene, and combinations thereof, one or more of
the nanoparticles functioning as a carrier of the gene to the cell,
and are injected with a biocompatible fluid for, without reliance
on a viral vector, building a light activated rhodopsin channel in
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a membrane of a cell having a defective or absent gene selected
from the group consisting of a rhodopsin gene, a
channelrhodopsin gene, a halorhodopsin gene, and combinations
thereof so that the cell can be stimulated by an external or
internal light transmitted by
a fiber optic device comprising a fiber optic tip containing
a light source, the fiber optic device further comprising an
electrical sensor including a plurality of graphene ribbons spaced
apart on a surf ace of the fiber optic tip,
and
a controller to receive and generate electrical signals
resulting from the altered cellular electrical property at the site,
the controller being operatively connected to the plurality of
graphene ribbons of the electrical sensor, the controller receiving
feedback from the plurality of graphene ribbons of the electrical
sensor, and
providing the signals to a processor to monitor and/or
controllably alter the light activated nanoparticles and the
rhodopsin membrane channel using the controller.
App. Br. 17.
ISSUES AND ANALYSES
We do not agree with, and decline to adopt, the Examiner’s findings
of fact and prima facie conclusions that the appealed claims are obvious
over the cited prior art. We address the dispositive arguments raised by
Appellant below.
A. Claims E 2, 5, 9, 11, and 13—16
Issue
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Appellant argues the Examiner erred because the combined cited prior
art neither teaches nor suggests the limitation of claim 1 reciting: “one or
more of the nanoparticles functioning] as a carrier of the gene to the cell.”
App. Br. 6.
Analysis
The Examiner finds, inter alia, that Olson teaches a method
comprising injecting quantum dots (“QDs”) directly into damaged neural
tissue and activating the QDs with electromagnetic radiation to electrically
stimulate the neurons via the electrical energy discharged by the activated
QDs. Final Act. 3^4 (citing Olson H 11—17, 38, 55—58). The Examiner
finds that teaches that QDs comprise biocompatible PEG-lipids and coupling
QDs with antibodies for targeting cells at the desired site. Id. at 4 (citing
Olson 144; claims 1,5,11, and 14—16). However, the Examiner finds
Olson neither teaches nor suggests an expression plasmid encoding
rhodopsin. Id.
The Examiner finds that Klapoetke teaches a method of treating a
disease, such as Parkinson’s disease, by modifying the membrane potential
of cells by administering an expression plasmid encoding channelrhodopsin
to subjects and activating the expressed rhodopsin by light. Final Act. 4
(citing Klapoetke 119-11, 64, 87, 100, 118, 119, 127, 135-137, 170). The
Examiner concludes that it would have been obvious to skill in a person of
ordinary skill the art to associate the expression plasmid of Klapoetke with
the QDs of Olson to achieve the predictable result of obtaining a
composition suitable to treat Parkinson’s disease. Id. (citing In re
Kerkhoven, 626 F.2d 846, 850 (C.C.P.A. 1980)).
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Appellant argues that the references fail to teach the limitation of
claim 1 reciting: “one or more nanoparticles functioning as a carrier of the
gene to the cell.” App. Br. 6. Appellant asserts that the Olson reference
does not teach gene therapy at all, but, rather, Olson is instead directed to
cell stimulation using quantum dots. Id. (citing Olson Abstr.). Appellant
argues that the Examiner therefore cites to Klapoetke to remedy the alleged
deficiencies of Olson. Id. (citing Final Act. 4). However, Appellant
contends that, even assuming arguendo that one of ordinary skill in the art
would combine the teachings of Klapoetke with those of Olson (the which
contention Appellant rejects), a person of ordinary skill in the art would
nevertheless fail to arrive at the claimed invention because Klapoetke
teaches the use of a viral or expression plasmid as a carrier for the genes,
and not the nanoparticles specified by claim 1. Id. As such, Appellant
argues, because Klapoetke teaches a different type of carrier for the
described genes, and is silent with respect to quantum dots, a person of
ordinary skill in the art would not be led to use the specific types of
nanoparticles required by claim 1 as gene carriers. Id.
Moreover, Appellant argues, the Examiner relies upon Zhang and
James only for features related to the claimed fiber optic device, and
therefore these references fail to remedy the alleged deficiencies of Olson
and Klapoetke with respect to the disputed limitations. Id. (citing Final Act.
5-6).
The Examiner responds that the rejection is based is based, in part, on
combining the QDs taught by Olson with a channelrhodopsin-expressing
plasmid, as taught by Klapoetke into a single composition by coupling the
plasmid to the QDs; two compositions both being useful for the same
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purpose (e.g., the treatment of Parkinson’s disease). Ans. 10. The Examiner
points out that Appellant does not argue that a person of ordinary skill in the
art would not have been capable of combining the teachings of the
references. Id. The Examiner finds that, by coupling the channelrhodopsin
expression plasmid with the QDs, one of skill in the art would have been
able to use the QDs as a carrier for the expression plasmid and, therefore,
also for the channelrhodopsin gene encoded by the expression plasmid, as
required by the instant claim 1. Id. The Examiner emphasizes that that
Appellant’s claims on appeal do not exclude an embodiment in which the
channelrhodopsin gene is part of a plasmid. Id. at 10-11.
We are not persuaded that the Examiner has established a prima facie
case of obviousness with respect to this limitation of the claim. Olson is
directed to: “methods for stimulating cells using quantum dots.” Olson
Abstr. Specifically, Olson teaches that:
[S]uch methods include placing a composition comprising
a quantum dot within a location sufficient to cause the neural cell
function to be stimulated by electrical energy produced by the
quantum dot; and irradiating the composition with
electromagnetic radiation comprising a wavelength that is
absorbed by the quantum dot and is reemitted as an electrical
energy that sufficiently stimulates the neural cell function to treat
the clinical condition.
Olson || 11—13. Furthermore, Olson teaches that its quantum dots can have
a:
coating, formed of, for example, PEG lipids or other suitable
material; and biofimctional material, formed of, for example,
biotin, streptavadin, adhesion proteins, vitamins, organic an
inorganic compounds, carbohydrates, aptamers, amino acids,
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lipids, hyaluronic acid, or other suitable proteins. Such proteins
would include, but not limited to, individual amino acids, small
peptides, antibodies including human, animal, humanized,
monoclonal, and chimeric antibodies used to target various cells
and cellular structures, as well as the various classes of
antibodies such as IgG, IgM, IgA, IgM, and IgD. The quantum
dots could further be conjugated with one another in various
combinations, as well as with the proteins, peptides, and amino-
acids, and other compounds listed above.
Olson 144. However, Olson contains no teaching or suggestion concerning
conjugating an expressible nucleic acid or gene, either alone or in
conjugation with a viral vector, to a quantum dot, or the quantum dot
“functioning as a carrier of the gene to the cell,” as required by claim 1.
Klapoetke “relates to isolated light-activated ion channel polypeptides
[e.g., channelrhodopsin] and methods for their preparation and use. The
invention also includes isolated nucleic acid sequences that encode light-
driven ion channels of the invention as well as vectors and [] constructs that
comprise such nucleic acid sequences.” Klapoetke 1 6. Klapoetke teaches:
Some embodiments of the invention include ... a vector that
contains the gene for the light-activated ion channel polypeptide.
As used herein, the term “vector” refers to a nucleic acid
molecule capable of transporting between different genetic
environments another nucleic acid to which it has been
operatively linked. The term “vector” also refers to a virus or
organism that is capable of transporting the nucleic acid
molecule. One type of vector is an episome, i.e., a nucleic acid
molecule capable of extra-chromosomal replication. Some useful
vectors are those capable of autonomous replication and/or
expression of nucleic acids to which they are linked. Vectors
capable of directing the expression of genes to which they are
operatively linked are referred to herein as “expression vectors”.
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Other useful vectors, include, but are not limited to viruses such
as lentiviruses, retroviruses, adenoviruses, and phages.
Klapoetke 86—87. Klapoetke thus teaches delivery of genes encoding
channelrhodopsin via various viral vectors, but the Examiner points to no
teaching or suggestion, nor can we discern one, concerning the employment
of quantum dots or other semiconductor nanoparticles as a means for
directly delivering such genes to cells. Simply put, there is no nexus
between the teachings of Olson and Klapoetke that would lead a person of
ordinary skill in the art to understand that quantum dots can be used as a
carrier of a gene encoding channelrhodopsin for delivery to a cell, as
expressly recited in the claim.
The remaining references, Zhang and James are not cited by the
Examiner as being directed to this limitation, and we therefore reverse the
Examiner’s rejection of the claim 1. Moreover, because claims 2, 4, 5, 9, 11,
and 13—17 depend, directly or indirectly, from claim 1, we similarly reverse
the Examiner’s rejection of those claims.
B. Claims 19 and 22—28
Issue
Appellant argues that the Examiner erred in finding the combined
cited prior art teaches or suggests the limitation reciting: “the electrical
sensor of the fiber optic device including a plurality of graphene ribbons
spaced apart on a surface of at least a portion of the fiber optic, the plurality
of graphene ribbons of the electrical sensor terminating at different distances
from a tip of the fiber optic at the site” and “using the plurality of graphene
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ribbons as transistors for providing feedback to the [fiber optic device]
controller.” App. Br. 9.2
Analysis
The Examiner finds Zhang teaches that a dual-function optrode can
supply electromagnetic radiation capable of controlled light delivery to
neurons and recording electrical signals. Final Act. 5. The Examiner finds
Zhang teaches the optrode comprises a fiber optic having a tip associated
with a metallic layer coupled to a wire serving as electrical conduit (i.e., a
sensor). Id. The Examiner further finds that Zhang teaches that an LED
could be used as the light source to activate rhodopsin. Id. (citing Zhang 2,
10—11, Fig. 1). The Examiner concludes that a person of ordinary skill in
the art would have found obvious to modify the methods of Olson and
2 We note that claim 1 similarly recites:
[A] fiber optic device comprising a fiber optic tip containing a
light source, the fiber optic device further comprising an
electrical sensor including a plurality of graphene ribbons spaced
apart on a surf ace of the fiber optic tip, and a controller to receive
and generate electrical signals resulting from the altered cellular
electrical property at the site, the controller being operatively
connected to the plurality of graphene ribbons of the electrical
sensor, the controller receiving feedback from the plurality of
graphene ribbons of the electrical sensor, and providing the
signals to a processor to monitor and/or controllably alter the
light activated nanoparticles and the rhodopsin membrane
channel using the controller.
Our reasoning explained herein with respect to claims 19 and 22—28,
therefore, applies similarly to claim 1 and its dependents.
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Klapoetke further implanting a device comprising a dual optrode connected
to a programmable stimulator adapted to control the light exposure time
and/or intensity from an LED source to achieve the predictable result of
activating the complex of QDs and channelrhodopsins according to the
evolution of symptoms. Id.
The Examiner further finds that graphene ribbons were known in the
prior art as being electrically conductive. Final Act. 5 (citing James Abstr.).
The Examiner concludes that it would have been obvious to a person of
ordinary skill in the art, at the effective filing date of the invention, to
modify the method taught by the combination of the cited prior art by using
a plurality of graphene ribbons as sensors for their optrode located at
different distance from the tip and further operably connecting the graphene
ribbons to the controller to achieve the predictable result of obtaining dual
function optrode capable of controlled light delivery to neurons and
recording electrical signals. Id. at 5—6.
We are not persuaded by the Examiner’s findings and conclusions.
Zhang teaches:
The single optrode is a tapered glass optical fiber with a sub­
micron-sized aperture at its tip formed by gold metallization
cladding.... A magnet wire (Alpha Wire Company) was attached
to the metalized part of the optrode by means of silver epoxy
(H20E; Epoxy Technology) and served as the electrical conduit
to external recording electronics. With the exception of the final
50 pm of the tapered tip, the metalized part of the fiber was
insulated using a UV-curable epoxy (Norland Optical Adhesive
74).
Zhang 3; see also Fig. 1. Furthermore, Zhang expressly teaches that the
exposed gold cladding at the tip of the optrode is used for recording
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extracellular neuronal activity: specifically, in the example cited by Zhang,
for recording the activity of retinal cells:
An optrode, mounted on a 3D micromanipulator, was inserted
into the retina until spikes were detected. The extracellular
potential from the optrode (i.e., recorded by its conductive
cladding), with reference to a[n] Ag/AgCl wire in the bath, was
preamplified (1000 gain, 1—10 kHz bandpass; Low Noise
Preamplifer Iso-DAM8, World Precision Instruments). Raw data
(10 kHz sampling rate) were then acquired using Lab view
(National Instruments™). All the spikes were thresholded at -
300 gV (250 Hz-4.8 kHz) and overlaid in a 2 ms window using
Matlab. The spike rasters were obtained using a Matlab program
as well.
Zhang 5; see also Fig. 3. In the other examples cited in Zhang, the optrode
is used to provide a light source in the stimulation of locally patch-clamped
channelrhodopsin (ChR2)-expressing pyramidal cells and as part of a
multielectrode array. Zhang 7—8. Zhang offers no teaching or suggestion
about using the conducting elements (i.e., the gold cladding and the attached
magnet wire) of the optrode as “transistors for providing feedback to the
[fiber optic device] controller,” as recited in claim 19. Furthermore, the
exposed conducting element, the gold cladding at the exposed tip of the
electrode, is circumferential around the optical aperture tip and does not
constitute, as required by the claim, “electrical sensor[s] terminating at
different distances from a tip of the fiber optic at the site.” Zhang 3, Fig. 1.
Rather, the gold acts as a low-impedance recording electrode for measuring
local neural action potential activity. Zhang Fig. 3.
James is directed to graphene ribbons, and teaches that they can be
used as electrodes. See James Abstr. But James offers no teaching or
suggestion that a “plurality of graphene ribbons of the electrical sensor
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terminate] at different distances from a tip of the fiber optic at the site” are
“connected] ... a controller” and act to “sens[e] an electrical signal using
the plurality of graphene ribbons as transistors for providing feedback to the
controller.” The Examiner suggests that it would have been obvious to a
person of ordinary skill in the art to substitute the wire of Zhang with the
graphene ribbons of James (see Ans. 13) but this is not persuasive evidence
of obviousness because, as we have explained, the magnet wire of Zhang is
used to connect the gold cladding recording electrode of the optrode to the
recording elements and is not acting as a transistor for the feedback control
of the fiber optic light source controller of the optrode.
In summary, we are not persuaded by the Examiner’s findings that the
combination of Zhang, James, and the other cited prior art teach or suggest
the disputed limitations. We consequently reverse the Examiner’s rejection
of the claims.
DECISION
The Examiner’s rejection of claims 1, 2, 4, 5, 9, 11—17, 19, and 22—28
as unpatentable under 35 U.S.C. § 103(a) is reversed.
REVERSED
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