Ex Parte ROSENBERGER et al

Patent Trial and Appeal Board

Mar 15, 2019

14283014 (P.T.A.B. Mar. 15, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/283,014 05/20/2014
25225 7590 03/19/2019
MORRISON & FOERSTER LLP
12531 HIGH BLUFF DRIVE
SUITE 100
SAN DIEGO, CA 92130-2040
FIRST NAMED INVENTOR
Carrie M. ROSENBERGER
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.
655652003910 2429
EXAMINER
KINSEY WHITE, NICOLE ERIN
ART UNIT PAPER NUMBER
1648
NOTIFICATION DATE DELIVERY MODE
03/19/2019 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):
PatentDocket@mofo.com
EOfficeSD@mofo.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CARRIE M. ROSENBERGER and
ALAN ADEREM 1
Appeal2017-007722
Application 14/283,014
Technology Center 1600
Before TA WEN CHANG, DEVON ZASTROW NEWMAN, and
DAVID COTTA, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method to modulate the antiviral response or immune system of a subject,
which have been rejected as indefinite. We have jurisdiction under 35
U.S.C. § 6(b ).
We REVERSE.
STATEMENT OF THE CASE
The Specification states that MicroRNAs (miRNAs ), "a
phylogenetically conserved class of post-transcriptional regulators," are
1 Appellants identify the Real Party in Interest as Institute for Systems
Biology. (Appeal Br. 1.)
Appeal2017-007722
Application 14/283,014
"small (20-25 nucleotide) non-coding RNAs [that] bind to target mRNAs by
base-pairing to effect mRNA degradation or translational repression."
(Spec. ,r 5.) The Specification states that miRNAs are "excellent candidates
for finely tuning immune responses." (Id.) In particular, according to the
Specification, antiviral responses are diminished in response to miR-144.
(Id. ,r 11.) Further according to the Specification, because miR-144's
mechanism of action involves "proteins ... involved in the immune
response generally," "methods to modulate the levels or activity of miR-144
are useful in a wider context than viral defense since immune responses are
important in respect to any infection, with respect to inflammation, and with
respect to autoimmune diseases." (Id. ,r 11.)
Claims 8, 9, 22, and 23 are on appeal. 2 Claims 8 and 22 are
illustrative and reproduced below with key limitations emphasized:
8. A method to modulate the antiviral response of a
subject infected by virus and in need of such modulation which
method comprises
(a) determining that the level of immune response of the
subject to the viral infection is not adequate and increasing the
level of antiviral response by decreasing the level or activity of
miR-144 in said subject or
(b) determining that the response of the subject to viral
infection is too intense and decreasing the level of antiviral
response by increasing the level or activity of miR-144 in said
subject.
2 Claims 12, 13, and 24--28 were withdrawn from consideration because of
species election. ( Appeal Br. 1.) Appellants submit that if the Board
reverses the rejection of independent claims 8 and 22, claims 12, 13, and 24--
28 should be rejoined and deemed allowable as well. (Appeal Br. 5; Reply
Br. 4.) Because claims 12, 13, and 24--28 are not on appeal, we decline to
consider these claims and leave matters relating to their further prosecution
for the Examiner's consideration.
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22. A method to modulate the immune system of a
subject infected with bacteria, fungi or protozoa and in need of
said modulation which comprises either
(a) determining that the level of immune response of the
subject to the infection is too low and increasing the level of
immune activity by decreasing the level or activity of miR-144
in said subject or
(b) determining that the level of immune response of the
subject to the infection is too high and decreasing immune
activity by increasing the level or activity of miR-144 in said
subject.
(Appeal Br. 6, 7 (Claims App.) (emphases added).)
The Examiner rejects claims 8, 9, 22, and 23 under 35 U.S.C. § 112(b)
or 35 U.S.C. § 112 (pre-AIA), second paragraph, as being indefinite. (Ans.
2.)
DISCUSSION
Issue
The Examiner finds that the phrases "not adequate" and "too intense"
in independent claim 8 and "too low" and "too high" in independent claim
22 are "relative phrases [that] render the claims indefinite." (Ans. 2.) More
particularly, the Examiner finds that a skilled artisan would not have been
reasonably apprised of the scope of the invention because "[these] phrases
are not defined by the claim" and "the specification does not provide a
standard for ascertaining the requisite degree of intensity or adequacy." (Id.
at 2-3.)
Appellants contend that relative phrases are not per se indefinite.
Appellants contend that
[i]t is clear from the description in the specification that the
claims are directed to increasing or decreasing the amount or
activity of miR-144 according to the activity of this micro RNA
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as described in the specification if one wished to enhance the
effectiveness of the immune system in fighting a viral, or other
microbial infection or to overcome the overresponse of the
immune system to such infection as illustrated by, for example,
inflammation as mentioned in paragraph 31. Determining
whether either of these is desirable merely indicates whether the
levels of miR-144 should be increased or decreased.
(Appeal Br. 2.) Appellants contend that a skilled artisan would have
understood when "the immune system has to be regulated to either enhance
its effect or diminish it." (Id. at 4.)
The issue with respect to this rejection is whether the Examiner erred
in concluding that the phrases "not adequate" and "too intense" in claim 8,
and the phrases "too high" and "too low" in claim 22, are indefinite.
Analysis
As our reviewing court has explained,
[ w ]hile a claim employing a "term[ ] of degree" may be definite
"where it provide[ s] enough certainty to one of skill in the art
when read in the context of the invention," a term of degree that
is "purely subjective" and depends "on the unpredictable
vagaries of any one person's opinion" is indefinite.
Intellectual Ventures I LLC v. T-Mobile USA, Inc., 902 F.3d 1372, 1381
(Fed. Cir. 2018). The question before us is thus whether a skilled artisan,
upon reading the application's Specification, would have had enough
certainty as to whether a subject's level of immune response to a viral
infection is "not adequate " "too intense " "too low " or "too high " or
' ' ' '
whether these terms are "purely subjective."
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Application 14/283,014
On balance, we find Appellants have the better argument. The
Specification states:
There are many instances wherein it is desirable to
upregulate the antiviral response mounted by a host. Of course,
subjects exposed to or harboring viral infection are suitable
subjects. It appears particularly advantageous to do so very early
in, or prior to, infection as the ability of the intervention to inhibit
replication of the virus provides a sufficient handicap to the
infective agent that the immune system is better able to deal with
it and this enhancement may prevent or ameliorate symptoms.
On the other hand, too robust a response to viral infection may
lead to undesirable effects such as inflammation, which would
indicate the desirability of downregulating the response system.
Similarly, there are instances wherein the immune system
is beneficially strengthened, as in response to a variety of
infective agents, not just viruses, but also bacteria, protozoa or
fungi. On the other hand, an excessive immune response may
result in undesired side effects such as inflammation, and
autoimmune diseases would also be benefited by damping down
the activity of the immune system.
(Spec. ,r,r 33-34.) Likewise, the Specification states:
As noted above, the reason for treating a subject to
modulate miR-144 levels or activity is variable. An individual
subject whose antiviral response system is so intense as to cause
side effects would benefit from a decrease in the level of this
antiviral response, and thus from an enhanced level or activity of
miR-144. On the other hand, a subject whose response to viral
infection is too feeble would benefit from a reduction in levels of
this microRNA. Similarly, an individual whose immune system
is not adequately dealing with infection would benefit from a
decreased miR-144 level or activity and the opposite would be
true of an individual having an autoimmune disease, such as
lupus, or an overreaction to infection.
(Id. ,I 41.)
We conclude that a skilled artisan would have understood, in light of
these passages from the Specification, that claim limitations relating to the
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level of immune response being "not adequate," "too intense," "too low," or
"too high" should be determined based on whether the level of immune
response is medically beneficial to or desirable for the subject. Thus, in
contrast to the phrases at issue in Datamize, LLC v. Plumtree Software, Inc.,
417 F.3d 1342 (Fed. Cir. 2005) and Interval Licensing LLC v. AOL, Inc.,
766 F.3d 1364 (Fed. Cir. 2014), the claim terms at issue are not "purely
subjective," but are rooted in medically measurable criteria such as, e.g., the
ability of the subject to fight an infection. See Son ix Tech. Co., Ltd. v.
Publications Int'!, Ltd., 844 F.3d 1370 (Fed. Cir. 2017) (explaining that the
claim term "visually negligible" is not "'purely subjective' in the same
manner as 'aesthetically pleasing' in Datamize and 'in an unobtrusive
manner that does not distract a user' in Interval Licensing," because the
latter "were subjective in the sense that they turned on a person's taste or
opinion," whereas "whether something is 'visually negligible' or whether it
interferes with a user's perception ... involves what can be seen by the
normal human eye," which "provides an objective baseline through which to
interpret the claims") (citation omitted); see also Datamize, 417 F.3d 1342,
Interval Licensing, 766 F.3d 1364. Neither does the record contain any
evidence that what level of immune response would be considered medically
beneficial to or desirable for a subject varies so significantly among skilled
artisans that reliance on it as a standard renders the claims indefinite. Sonix
Tech., 84 F.3d at 1379; see also Source Search Technologies, LLC v.
LendingTree, LLC, 588 F.3d 1063, 1076-1077 (rejecting party's argument
that claim term is indefinite because "a skilled artisan will understand the
markets and the system enough to determine what is a 'standard"' item).
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The Examiner asserts that the disclosure in the Specification is
insufficient to render the claims definite, because the Specification
does not define what appellant contemplates for "not
adequate", "too intense", "too low" and "too high" nor does [it]
provide any standard such that one of ordinary skill in the art can
ascertain the requisite degree of intensity ("too intense" or "not
adequate") of the immune response or the level of the immune
response ("too low" or "too high"). The phrase "so intense as to
cause side effects" does not define the level of intensity or what
is considered a side effect. The phrases "not adequate", "too
intense", "too low" and "too high" are not defined by the claims
or by the specification such that one of ordinary skill in the art
would know how intense is "too intense", how low is "too low",
how high is "too high" or what type or level of immune response
is considered "not adequate". Accordingly, one of ordinary skill
in the art would not know the metes and bounds of the claims.
(Ans. 4.)
We acknowledge the Examiner's concern. However, as the
Specification points out, the reasons for treating a subject to modulate his or
her antiviral response are "variable." (Spec. ,r 41.) We are not persuaded
that definiteness requires the patent to enumerate every situation in which
such modulation might be desirable. Cf Source Search Technologies, 58
F.3d at 1076 (patent does not need to list "every possible good or service" in
order for "goods or services" limitation to be definite). Neither are we
persuaded that definiteness requires the patent to specify the appropriate
level of immune response with the degree of precision the Examiner appears
to require. As our reviewing court has explained,
[ t ]he amount of detail required to be included in claims depends
on the particular invention and the prior art, and is not to be
viewed in the abstract but in conjunction with whether the
specification is in compliance with the first paragraph of section
112: "If the claims, read in the light of the specifications,
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reasonably apprise those skilled in the art both of the utilization
and scope of the invention, and if the language is as precise as
the subject matter pennits, the courts can demand no more."
Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 624
(Fed. Cir. 1985).
Accordingly, because we agree with Appellants that a skilled artisan
would understand, with reasonable certainty, what it means for a subject's
immune response to be "not adequate " "too intense " "too low " or "too
' ' '
high," we reverse the Examiner's rejection of claims 8, 9, 22, and 23 as
indefinite.
SUMMARY
For the reasons above, we reverse the Examiner's decision rejecting
claims 8, 9, 22, and 23.
REVERSED
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