Ex Parte Shuba

Patent Trial and Appeal Board

Jul 16, 2018

13761206 (P.T.A.B. Jul. 16, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/761,206 02/07/2013
67649 7590 07/17/2018
Y AROSLA V M. SHUBA
SHOT A RUST A VELI STREET, 40
APT. 16
KYIV, 01023
UKRAINE
FIRST NAMED INVENTOR
Yaroslav M. Shuba
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.
Shuba03 1130
EXAMINER
SAMALA, JAGADISHW AR RAO
ART UNIT PAPER NUMBER
1618
MAIL DATE DELIVERY MODE
07/17/2018 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 Y AROSLA V M. SHUB A 1
Appeal2017-007835
Application 13/7 61,206
Technology Center 1600
Before ERIC B. GRIMES, JOHN E. SCHNEIDER, and DAVID COTT A,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to method
for in vivo control of light-sensitive bioactive molecules, which have been
rejected as indefinite, anticipated, and lacking adequate written description
in the Specification. We have jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
1 Appellant states that "[t]he present Application is owned by
inventor/applicant Yaroslav M. Shuba." Br. 3.
Appeal2017-007835
Application 13/761,206
STATEMENT OF THE CASE
Appellant's Specification discloses a
method for delivering visible light stimuli to any part inside the
body of higher animals including humans with the purpose of
activating light-sensitive bioactive compounds or
photosensitive recombinant proteins ... based on systemic
infusion or local injection of scintillator-based nanoparticles.
N anoparticle core is made from scintillator material. ...
Focused irradiation of the site with the highly penetrable X-rays
will cause nanoparticles to emit visible light which will activate
light-sensitive bioactive molecule(s) within this site causing
sought therapeutic effect.
Spec. 2 4.
Claims 3-5 are on appeal. Claim 3 is the only independent claim and
reads as follows:
3. A method for non-invasive remote in vivo control of
light-sensitive bioactive molecules with the purpose of research
and therapy, comprising:
creating a nanoparticle with biocompatible protective coating and the
core part consisting of scintillator material that absorbs highly
penetrable X-ray and in response emits visible light of certain
wavelength;
wherein the surface of said nanoparticle bears targeting agent
enabling recognition of desired target cells within the area of
interest inside the body and interaction with them;
creating a separate light-sensitive bioactive molecule from a class of
caged compounds or photoactivated recombinant proteins which
remains biologically inert unless it absorbs the quantum of visible
light of the same wavelength as emitted by the core scintillator
material of said nanoparticle;
2 Amended Specification, filed Dec. 6, 2015.
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Application 13/761,206
wherein said light-sensitive bioactive molecule after absorbing
visible light converts into active form capable of exerting
sought biologic or therapeutic effect on target cells within the
area of interest inside the body;
administering of said light-sensitive bioactive molecule to target cells
inside the body by direct injection into the area of interest, via
bloodstream or using gene transfer technologies;
administering of said nanoparticle to target cells inside the body by
direct injection into the area of interest or via bloodstream;
wherein relative timing and administering regimens of said
nanoparticle and of said light-sensitive bioactive molecule
ensure simultaneous presence of both around the target cells
within the area of interest inside the body.
The claims stand rejected as follows:
Claims 3-5 under 35 U.S.C. § 112, second paragraph, as indefinite
(Ans. 2);
Claims 3-5 under 35 U.S.C. § 112, first paragraph, for lack of
adequate written description (Ans. 2; Final Action3 2);
Claims 3-5 under 35 U.S.C. § I02(b) as anticipated by Chen4 (Ans. 2;
Final Action 8);
I
The Examiner has rejected claims 3-5 as indefinite. Ans. 2.
Appellant disputes this conclusion. Br. 10-13.
3 Office Action mailed March 1, 2016.
4 Chen et al., US 2007/0218049 Al, published Sept. 20, 2007. In the Final
Action, the Examiner cites US 2007 /0218029 but that appears to be a
typographical error. Appellant understood the rejection to be based on US
2007/0218049 Al. Br. 13.
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Application 13/761,206
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case ofunpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
In the Non-Final Action, 5 the Examiner rejected original claims 1 and
2 as indefinite. Non-Final Action 6. In response, Appellant canceled claims
1 and 2 and introduced claims 3-5. Amendment filed Dec. 6, 2015. In the
Final Action, the Examiner rejected claims 3-5 under 35 U.S.C. § 112, first
paragraph, and 35 U.S.C. § 102(b), but not under 35 U.S.C. § 112, second
paragraph.
In the Answer, the Examiner states that"[ c ]laims 3-5 are rejected
under 35 U.S.C. 112(b) or U.S.C. 112 (pre-AIA), second paragraph, as being
indefinite for failing to particularly point out and distinctly claim the subject
matter which the inventor or a joint inventor, or for pre-AIA the applicant
regards as the invention." Ans. 2. However, the record includes no
explanation of what the Examiner believes to be indefinite about the
currently pending claims. We therefore reverse the rejection under 35
U.S.C. § 112, second paragraph. See In re Jung, 637 F.3d 1356, 1362 (Fed.
Cir. 2011) ("[T]he PTO carries its procedural burden of establishing a prima
facie case when its rejection satisfies 35 U.S.C. § 132, in 'notify[ing] the
applicant ... [by] stating the reasons for [its] rejection, or objection or
requirement, together with such information and references as may be useful
5 Office Action mailed Sept. 25, 2015.
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Application 13/761,206
in judging of the propriety of continuing the prosecution of [the]
application."').
II
The Examiner has rejected claims 3-5 for lack of adequate written
description. The Examiner finds that the
[ c ]laims are drawn to a light-sensitive bioactive molecule; a
biocompatible nanoparticle, wherein a core of said nanoparticle
consists of scintillator material that absorbs highly penetrable
X-ray. However, the claims are devoid of any structural
elements that correlate to the function which is to be achieved
with the claimed light-sensitive bioactive molecule that absorbs
penetrable X-ray properties.
Final Action 3.
Id.
The Examiner also finds that
[ t ]he specification as originally filed does not provide support
that Applicant had possession of the invention as generically
claimed .... [ A Jpplicant has not provided an adequate
description as to the physical and chemical structures of the
light-sensitive bioactive molecules that are necessary to
observation of delivered nanoparticles to target cells inside the
body.
Appellant argues that "said scintillator nanoparticles and light-
sensitive bioactive molecules already exist, and one just has to select the
types of them to be used for specific purpose of research or therapy,
synthesize them according to the known and described procedures, or even
simply buy them from the large array of commercially available" ones. Br.
7. Appellant also argues that the Specification
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Id.
provide[ s] the examples of chemical formulas of scintillator
materials, as including, but not limited to, doped rare earth and
alkaline earth halides, LaF3:Ce3+, LuF3:Ce3+, CaF2:Mn2+,
CaF2:Eu2+, BaFBr:Eu2+, and semiconductors, ZnO, ZnS and
Ti02 ... , of light-sensitive bioactive molecules from the class
of caged compounds, as caged forms of ions, neurotransmitters,
nucleotides, nucleosides, inositols, bioactive amines, peptides,
lipophilic and water soluble pharmacological agents .... and of
photoactivated recombinant membrane proteins, as including,
but not limited to rhodopsin, ChR2, halorhodopsin and their
new genetically engineered isoforms.
We agree with Appellant that the Examiner has not shown that the
Specification fails to describe the claimed invention. The Examiner
"bears the initial burden ... of presenting a prima facie case of
unpatentability." In re Oetiker, 977 F.2d 1443, 1445, 24
USPQ2d 1443, 1444 (Fed. Cir. 1992). Insofar as the written
description requirement is concerned, that burden is discharged
by "presenting evidence or reasons why persons skilled in the
art would not recognize in the disclosure a description of the
invention defined by the claims." ... If ... the specification
contains a description of the claimed invention, albeit not in
ipsis verb is (in the identical words), then the examiner ... , in
order to meet the burden of proof, must provide reasons why
one of ordinary skill in the art would not consider the
description sufficient.
In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996).
Here, Appellant amended the Specification to recite specific types of
scintillator-based nanoparticles and to state that
[ c ]urrently, a huge number of caged forms of various classes of
biologically active molecules (ions, neurotransmitters,
nucleotides, nucleosides, inositols, peptides) have been
designed and made, many of which are commercially available
(Ellis-Davies (2007) Nat. Methods 4, 619-628). The
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technologies of organic chemistry for caging essentially any
biomolecule or second messenger have now been developed so,
the synthesis of caged form of any new molecule or
pharmacological agent with required biological or therapeutic
activity is technically feasible.
Spec. 6-7. The Examiner did not object to the amendments under 35 U.S.C.
§ 132 as adding new matter. See Final Action 2 ("Receipt is acknowledged
of Applicant's Amendments and Arguments filed on 12/06/2015.")
Thus, we assess the written description of the invention based on the
Specification as amended December 6, 2015, not based on "[t]he
specification as originally filed." Final Action 3.
The Examiner finds that "the claims are devoid of any structural
elements that correlate to the function which is to be achieved with the
claimed light-sensitive bioactive molecule that absorbs penetrable X-ray
properties." Id. Claim 3, however, recites "a nanoparticle with ... [a] core
part consisting of scintillator material that absorbs highly penetrable X-ray"
and "a separate light-sensitive bioactive molecule from a class of caged
compounds or photoactivated recombinant proteins." Br. 15 (Claims App.
( emphasis added)). The claimed method does not require a light-sensitive
bioactive molecule that absorbs X-rays.
The Specification, as amended, states that the claimed
method comprises using of a scintillator-based nanoparticle 10
which core part consists of phosphor/scintillator material that
absorbs quanta of highly penetrable X-ray 41 and in response
emits quanta of visible light 43 of certain wavelength. In
particular, the range of scintillator materials can include, but is
not limited to, doped rare earth and alkaline earth halides,
LaF3:Ce3+, LuF3:Ce3+, CaF2:Mn2+, CaF2:Eu2+, BaFBr:Eu2+, and
semiconductors, ZnO, ZnS and Ti02.
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Amended Spec. 6. The Specification also states that
a huge number of caged forms of various classes of biologically
active molecules (ions, neurotransmitters, nucleotides,
nucleosides, inositols, peptides) have been designed and made,
many of which are commercially available (Ellis-Davies (2007)
Nat. Methods 4, 619-628). The technologies of organic
chemistry for caging essentially any biomolecule or second
messenger have now been developed so, the synthesis of caged
form of any new molecule or pharmacological agent with
required biological or therapeutic activity is technically
feasible.
Id. at 7.
Finally, the Specification states that
identification and cloning of numerous bioluminescent and
light-sensitive proteins from various organisms such as,
aequorin from luminescent jellyfish, luciferases from bacteria
and fireflies, green fluorescent protein (GFP) from jellyfish or
sea pansy, channelrhodopsins from green algae, halorhodopsin
from halobacteria, etc. gave rise to the whole new avenue of
optogenetics (Deisseroth (2011) Nat. Methods 8, 26-29). By
inserting recombinant genes for these proteins alone or in
combinations with other genes optogenetics allows
visualization of various structures and processes as well as
controlling cells' behavior in desired direction.
Id. at 2.
The Examiner stated that "Appellant has attempted to amend
specification to present new limitations not previously present in original
specification. Examiner has not entered the amendment as they would
constitute new matter issue in the specification." Ans. 3.
However, although the Examiner denied entry to Appellant's
amendments that were filed after the Final Office Action (mailed March 1,
2016), the Examiner but did not object to Appellant's amendments to the
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Application 13/761,206
Specification that were filed December 6, 2015. The Specification,
therefore, was amended to reflect those amendments.
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability." In
re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). "[T]he test for sufficiency
[ of written description] 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. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).
Here, the Examiner has not shown that those of ordinary skill in the
art would not have recognized that Appellant had possession of the claimed
method as of the filing date of the instant application. We therefore reverse
the rejection under 35 U.S.C. § 112, first paragraph.
III
The Examiner has rejected claims 3-5 as anticipated by Chen. The
Examiner finds that Chen discloses
a method for treating tumors in animals including humans by
photo-dynamic therapy comprising the step of: administering an
effective amount of luminescent nanoparticles consisting of
scintillation luminescence to a target site, administering a photo
effective amount of a photosensitizer molecules (fullerenes) to
the target site, and applying radiation to the target site, by
providing excitation source.
Final Action 8. With regard to the light-sensitive bioactive molecule
required by the claims, the Examiner finds that
Chen discloses photosensitizers such as porphyrins and their
derivatives. This porphyrin molecules reads on light-sensitive
caged compounds of instant claims, (since the porphyrins are
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heterocyclic macrocycle organic compounds and are cleaved
from the nanoparticles in the same way by excitation with
radiation beams such as X-rays, light is generated from the
nanoparticles and activates the photosensitizers for desired
activity).
Ans. 4.
Appellant argues, among other things, that Chen's disclosure "relates
to the class of chemical agents known as photosensitizers and to the
destructive effects thereof on cells via generation of ROS [reactive oxygen
species]," while the "present invention deals with completely different
classes of light-sensitive bioactive molecules, namely, caged compounds and
photoactivated proteins." Br. 13. Appellant also argues that Chen
"disclose[ s] composite nanoparticles wherein photosensitizing agents are
attached to luminescent nanoparticles. On the contrary, in the present
invention scintillator-based nanoparticles and light-sensitive bioactive
molecules are used as separate entities." Id.
We agree with Appellant that the Examiner has not shown that Chen
discloses the method defined by the claims on appeal. Specifically, claim 3
requires "a nanoparticle with biocompatible protective coating and the core
part consisting of scintillator material that absorbs highly penetrable X-
ray[ s ]" and "a separate light-sensitive bioactive molecule from a class of
caged compounds or photoactivated recombinant proteins." Br. 13 (Claims
App.)
Chen discloses "a method for photodynamic therapy ... [that]
includes the steps of (1) providing at least one luminescent nanoparticle; (2)
providing at least one photosensitizer that is functionally associated with the
at least one luminescent nanoparticle; and (3) providing an excitation
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Application 13/761,206
source." Chen ,r 18. The photosensitizer can be, e.g., a porphyrin. Id. ,r 21.
Chen states that, "[u]pon excitation by ionizing radiation such as X-rays,
light is generated from the nanoparticles and activates the photosensitizers to
produce singlet oxygen for PDT [photodynamic therapy]." Id. ,r 49.
Claim 3 requires a nanoparticle and "a separate light-sensitive
bioactive molecule from a class of caged compounds or photoactivated
recombinant proteins." The Examiner concludes that "porphyrin molecules
reads on light-sensitive caged compounds of instant claims, (since the
porphyrins are heterocyclic macrocycle organic compounds and are cleaved
from the nanoparticles in the same way by excitation with radiation beams
such as X-rays, light is generated from the nanoparticles and activates the
photosensitizers for desired activity)." Ans. 4.
We agree with Appellant that this reasoning does not support the
rejection. First, the Examiner states that, in Chen, the porphyrin photo-
sensitizer is "cleaved from the nanoparticles" by X-ray radiation (Ans. 4),
but claim 3 requires the bioactive molecule to be separate from the
nanoparticle. The Examiner has not shown that Chen discloses this
limitation.
In addition, the Specification describes "caged compounds" as
follows: "a huge number of caged forms of various classes of biologically
active molecules (ions, neurotransmitters, nucleotides, nucleosides, inositols,
peptides) have been designed and made, many of which are commercially
available." Spec. 7. In describing Figure 2, the Specification states that
[n]anoparticle 10 absorbs X-ray and in response emits visible
light 43 with the wavelengths, which must coincide with the
wavelength for uncaging of caged compound 30 to cause
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dissociation of its bioactive constituent 31 from photo labile
protecting group 32 .... Free bioactive constituent of caged
compound 31 ... in tum produce[s] desired biological effect on
target cells.
Id. at 9.
Thus, the Specification describes caged compounds as having a
bioactive constituent and a photolabile protecting group, where absorption of
visible light causes dissociation of the two components and frees the
bioactive constituent to produce its biological effect. The Examiner has not
provided evidence or persuasive technical reasoning to show that the
broadest reasonable interpretation of "caged compounds," read in light of the
Specification and as understood by those of ordinary skill in the art, includes
the porphyrins disclosed by Chen.
We therefore reverse the rejection of claims 3-5 as anticipated by
Chen.
SUMMARY
We reverse all of the rejections on appeal.
REVERSED
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