Ex Parte Brighton et al

Patent Trial and Appeal Board

Jun 17, 2016

13242606 (P.T.A.B. Jun. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/242,606 09/23/2011
23377 7590 06/21/2016
BAKER & HOSTETLER LLP
CIRA CENTRE 12TH FLOOR
2929 ARCH STREET
PHILADELPHIA, PA 19104-2891
FIRST NAMED INVENTOR
Carl T. Brighton
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.
UPN-5595 I M2237 8496
EXAMINER
KETTER, JAMES S
ART UNIT PAPER NUMBER
1636
NOTIFICATION DATE DELIVERY MODE
06/21/2016 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):
eofficemonitor@bakerlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CARL T. BRIGHTON and SOLOMON R. POLLACK1
Appeal2013-009098
Application 13/242,606
Technology Center 1600
Before DONALD E. ADAMS, JEFFERY N. FREDMAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for treating diseased or damaged tissue which have been rejected for
failing to comply with the written description requirement. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
STATEMENT OF THE CASE
The invention is directed to methods for regulating gene expression in
target cells by applying electric or electromagnetic fields to the target cells.
1 Appellants identify the Real Party in Interest as the Trustees of the
University of Pennsylvania. Appeal Br. 1.
Appeal2013-009098
Application 13/242,606
Spec. i-f 2. The method can be used to treat diseased or damaged tissue,
cartilage or bone. Id.
Claims 1-9 are on appeal. Claim 1 is illustrative and reads as follows:
1. A method of treating injured or diseased tissue,
compnsmg:
applying to the injured or diseased tissue an electric or
electromagnetic field that regulates expression of a gene in said
tissue, which regulated expression is therapeutic for the disease
or mJury;
the electric or electromagnetic field having an amplitude
of about 2-40 m VI cm in the injured or diseased tissue; and
the electric or electromagnetic field having a
predetermined duration of time per 24 hour period at a
predetermined duty cycle effective so as to optimize specific
and selective up regulation or down regulation of expression of
said gene in said injured or diseased tissue.
The claims stand rejected as follows:
Claims 1-9 have been rejected under 35 U.S.C. § 112, first paragraph
as failing to comply with the written description requirement
FINDINGS OF FACT
We adopt as our own the Examiner's findings and analysis. The
following findings are included for emphasis and reference convenience.
FF 1. The Examiner finds that the claims encompass up and down
regulation of any gene involved in repair of any tissue. Ans. 7.
FF2. The Examiner finds that "the sequences and functions of genes
(of which there are at least 25,000 in humans alone) are highly variable and
unpredictable, particularly where the art is relatively new." Ans. 17.
FF3. Appellants' Specification provides eight examples of gene
regulation. Spec. i-fi-1 60-84.
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FF4. The Examiner finds that
"[a] small number of genes from one organism (human) all
involved in a similar aspect of physiology (bone and connective
tissue growth and remodeling) would have been insufficient to
place the full scope of the instant claims (any gene from
essentially any organism that can have disease) in the hands of
the skilled practitioner at the time of filing, as there is no way to
reason out or derive the characteristics of the necessary signals
for other genes based on the disclosed parameters, as no
algorithm or rules for such reasoning or derivation were
presented either in the specification or in the prior art."
Ans. 12.
FF5. The Examiner finds that
"[t]he vast number of possible signals defined by the many-
fold range of values for EACH of the four relevant signal
parameters would make the use of the method for non-
exemplified genes essentially trial-and-error. Therefore, despite
the presence of the technique for finding values for these
parameters, said values were NOT KNOWN~ priori, and the
task of finding them even via the disclosed technique \'l/ould
have been tantamount to further invention beyond the actual
disclosure."
Ans. 10. (emphasis in the original)
ISSUE
Whether the Specification's description shows that Appellants were in
possession of the method recited in the claims.
Principles of Law
In evaluating compliance with the written description requirement,
"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
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Application 13/242,606
Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
(citing cases).
When claims are drawn to a genus, "a sufficient description of [the]
genus ... requires the disclosure of either a representative number of species
falling within the scope of the genus or structural features common to the
members of the genus so that one of skill in the art can 'visualize or
recognize' the members of the genus." Id. at 1350 (quoting Regents of the
University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568---69 (Fed.
Cir. 1997) ). Moreover, when claims are drawn to a genus using functional
language to define a desired result, "the specification must demonstrate that
the applicant has made a generic invention that achieves the claimed result
and do so by showing that the applicant has invented species sufficient to
support a claim to the functionally-defined genus." Abb Vie Deutschland
GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1299 (Fed. Cir.
2014) (quotingAriad, 598 F.3d at 1349).
For purposes providing written description of a genus, "merely
drawing a fence around a perceived genus is not a description of the genus.
One needs to show that one has truly invented the genus, i.e., that one has
conceived and described sufficient representative species encompassing the
breadth of the genus. Otherwise, one has only a research plan, leaving it to
others to explore the unknown contours of the claimed genus. Id. at 1300.
"It is not sufficient for the purposes of the written description
requirement of§ 112 that the disclosure, when combined with the
knowledge in the art, would lead one to speculate about the modifications
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Appeal2013-009098
Application 13/242,606
that the inventor might have envisioned but failed to disclose." Lockwood v.
Amer. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997).
Analysis
In our analysis, we shall treat claim 1 as representative of the rejected
claims. The Examiner found that Appellants were not in possession of the
subject matter of Claim 1. Ans. 8. In support of that finding the Examiner
states
"[t ]he claims potentially encompass a virtually infinite set of
possible characteristics of the fields, for the treatment of any
type of injury or disease, but, as set forth above, only a
relatively narrow set of characteristics are actually set forth in
the specification, and incompletely as well. As such, one of
skill in the art would not have recognized that Applicant was in
possession of the full scope of the invention as claimed, and
therefore an adequate written description of said characteristics,
and therefore of the claimed invention, has not been presented."
(Ans. 8.)
The Examiner also points to the unpredictability of the claimed
invention, FF2, the limited number of examples FF3 and the modifications
that one skilled in the art would have to make to perform a method within
the full scope of the claimed invention, FF5, to support the finding that
Appellants have failed to comply with the written description requirement.
Appellants argue that claim 1 is adequately described in their
Specification in that their Specification discloses gives eight different
examples for regulating genes to effect tissue repair and gives guidance as to
optimize regulation of other genes. Appeal Br. 9. Appellants argue that,
with respect to the electric or electromagnetic filed, the only parameters that
are not defined are duty cycle and duration and that Appellants point out that
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Appeal2013-009098
Application 13/242,606
their Specification provides guidance as to how to find these parameters.
Appeal Br. 9-10.
Appellants also argue that the Declaration of Dr. Pienkowski provide
sufficient evidence that one skilled in the art would have read their
Specification and understood that Appellants were in full possession of the
method embraced by claim 1. Appeal Br. 18-19.
We find that the Examiner has the better position. We note at the
outset that claim 1 broadly claims treatment of any tissue disease or injury
by controlling the regulation of any gene in the tissue with an electric of
electromagnetic field. FF 1. While claim 1 specifies the amplitude of the
field, the claim is silent as to the frequency, duration and duty cycle for the
field.
With respect to Appellants' argument that an adequate number of
examples have been provided, we agree with the Examiner that, given the
limited number of examples, Appellants' Specification does not support the
breath of claim 1. Ans. 12. The examples only relate to eight specific
genes and address a specific aspect of physiology (Bone and connective
tissue growth and remodeling). FF4.
The declaration of Dr. Pienkowski supports the Examiner's
conclusion. At paragraph 7 of his declaration, Dr. Pienkowski stated that the
discovery of Drs. Brighton and Pollack is that certain genes may be
regulated by the application of electric or electromagnetic field. Pienkowski
Deel. i-f 7. Thus, Dr. Pienkowski acknowledged that Appellants had only
identified a limited number of genes that could be regulated.
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Application 13/242,606
Appellants also argue that with respect to the parameters not specified
in claim 1, their Specification gives sufficient guidance as to how to derive
those parameters. Appeal Br. 9-10. Appellants argue that the discussion of
dose response curves would lead one skilled in the art to find the appropriate
parameters for a specific tissue. Id. We agree with the Examiner that
merely disclosing how to use the dose response curves does not show
possession of the full scope of Claim 1 but provides a method by which
others can invent beyond Appellants' disclosure. Ans. 16. The written
description requirement is not met when the specification leaves it to others
to define the limits of the invention. AbbVie, 759 F.3d at 1300.
Appellants go on to argue that the Declaration of Dr. Pienkowski
provides sufficient evidence that Appellants' Specification contains an
adequate written disclosure. Appeal Br. 10-11, Reply Br. 3--4. Appellants
argue that the Examiner failed to give the declaration sufficient weight and
that the Examiner failed to rebut the statements in the declaration. Appeal
Br. 18-20. We agree with the Examiner that the declaration is
unpersuasive. Ans. 11. As the Examiner found, "the Declarant overlooks
the problem that for any particular gene, one of skill cannot merely tum to
the specification or the art for the necessary description of the method, but
must labor to provide the most critical and detailed portion of that
description himself or herself employing the disclosed method." Advisory
Action 3.
Moreover, the declaration supports the finding that Appellants'
Specification merely describes a research plan for others to follow and does
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Application 13/242,606
not describe the invention recited in claim 1. In paragraph 9 Dr. Pienkowski
states
If desired, the dose-response technique could be used to
determine if phase and modulation affect the gene expression,
and the description at page 14, lines 6-20, would, in my view,
provide sufficient teachings to enable one skilled in the art to do
so. What the Examiner seems to be missing is the
understanding that the invention pertains to the discovery by
Drs. Brighton and Pollack that gene expression is not uniform
across signal characteristics, such as duration of application and
duty cycle (intervals), and that the resultant electric field will
cause an improved gene expression for a target gene linked to a
disease state, tumor, or injury by varying those signal
characteristics until a suitable differentiation through up-
regulation or down-regulation is achieved. The description
clearly describes this causal relationship and how it may lead to
successful treatment of a disease state, tumor or injury in a
target tissue, whether or not all possible signal characteristics
are varied.
Pienkowski Dec. i-f 9. (emphasis added.)
The declaration speaks of what one skilled in the art could do by
following the teachings of Appellants' Specification, not what has been
done. We agree with the Examiner that "mere possession of the method of
finding the data, with considerable effort and labor it must be emphasized,
would not have been recognized by one of skill as equivalent to possession
of the required information for actual practice of the methods." Advisory
Action 4--5. The Specification itself supports this position, stating that
"[ s ]pecific and selective signals may be applied to each gene systematically
until the proper combination of frequency, amplitude, waveform, duty cycle,
and duration is found that provides the desired effect on gene expression"
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Appeal2013-009098
Application 13/242,606
(Spec. i-f 41 ). Thus, in order to possess a treatment for any particular disease
condition, the skilled artisan must first identify genes of interest whose up or
down regulation will effect healing, with very limited description in the
Specification for these genes, and then must apply an extensive set of
electrical parameters to the newly identified gene to identify signals that
effect gene expression, while preventing gene expression of other,
undesirable genes. This is a research plan, and does not provide descriptive
support sufficient for the scope of claim 1.
With respect to claim 8, Appellants argue that the Examiner has failed
to explain why the specific treatment method recited in the claim lacks
written description support. Appeal Br. 20. Claim 8 is directed to a method
for treating cancerous tissue by down regulating the gene encoding for
metalloproteinase and/or up-regulating the gene for inhibitors of
metalloproteinase. We agree with the Examiner's finding that there is
insufficient written description to support this claim. The Specification
provides data which show the down regulation of the genes for producing
metalloproteinase but is devoid of any teaching concerning the up-regulation
of the genes for inhibitors of metalloproteinases. Ans. 20-21.
Finally, with respect to claim 5, Appellants argue that their
Specification provides sufficient written support as the claim is limited to a
60 kHz sine wave signal. We agree with the Examiner that claim 5 is
unsupported by the written disclosure for the reasons stated for claim 1.
While claim 5 recites specific limitation for two of the field parameters, two
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Application 13/242,606
parameters are left undefined, leaving it to those skilled in the art to discover
the appropriate values for those parameters. Ans. 21.
Conclusion
A preponderance of the evidence of record supports the Examiner's
finding that Appellants' Specification fails to show that Appellants were in
possession of the methods recited in claims 1, 5 and 8. Claims 2--4, 6-7 and
9 were not separately argued and fall with claim 1. 3 7 C.F .R.
§ 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 1-9.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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