Ex Parte Taylor et al

Patent Trial and Appeal Board

Sep 26, 2017

12845655 (P.T.A.B. Sep. 26, 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.
12/845,655 07/28/2010 Vanessa Taylor 7946-87496-02 1400
74839 7590
Klarquist Sparkman, LLP
121 SW Salmon St
Suite 1600
Portland, OR 97204
09/28/2017 EXAMINER
FAY, ZOHREH A
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
09/28/2017 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 @klarquist.com
AS CChair @klarquist. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte VANESSA TAYLOR, HUI LI, and RAJINDER SINGH
Appeal 2016-004332
Application 12/845,6551
Technology Center 1600
Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and
DAVID COTTA, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a process of
treating dry eye syndrome. The Examiner rejected the claims for
obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner’s rejection of
claims 1, 8, 9, and 10, under 35 U.S.C. § 103(a) for obviousness over
Argade.2 Ans. 2-4.
1 Appellants state that the real party in interest is “Rigel Pharmaceuticals,
Inc., the Assignee of the present application.” Appeal Br. 2.
2 US 2007/0203161 A1 (published Aug. 30, 2007).
Appeal 2016-004332
Application 12/845,655
Claim 1 is representative and reads as follows (Appeal Br. 11):
1. A method of treating a disease and/or disorder of
the eye, comprising administering to a subject an effective
amount of a compound of formula I and/or II, or a
pharmaceutically acceptable salt form thereof
wherein the disease and/or disorder of the eye is selected from
dry eye syndrome.
In response to a species election requirement, Appellants elected the
compound of formula II as the examined compound, and dry eye syndrome
as the treated disorder to be examined. Amendment and Response to
Restriction/Election of Species Requirement 4 (filed September 19, 2012).
Accordingly, we limit our analysis to the patentability of the elected species
and the extent to which the rejected claims read on them. See Ex parte
Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987).
OBVIOUSNESS
The Examiner’s Prima Facie Case
In rejecting claims 1, 8, 9, and 10 over Argade, the Examiner found
that Argade teaches or suggests administering the compound of formula II
for treating Sjogren’s syndrome. Ans. 3. The Examiner found that Argade
differs from the rejected claims in that the reference does not expressly state
that Sjogren’s syndrome “is a condition which causes dry eye.” Id.
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The Examiner concluded, nonetheless, that an ordinary artisan would
have considered it obvious “to use a compound being used for the treatment
of Sjogren’s syndrome, such as the claimed compounds and use it for the
treatment of dry eye, considering that dry eye is very common among people
having Sjogren’s syndrome as evidenced by the attached Article ‘Sjogren’s
syndrome Wikipedia.’” Ans. 3.
The Examiner reasoned that “Wikipedia makes clear that Sjogren’s
syndrome is a disease in which the body’s white cells destroy the lacrimal
glands that produce tears, which leads to the development of dry eye.
Therefore, the treatment of Sjogren’s syndrome also treats the dry eye
associated with such disorder.” Id. at 3^4.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
Appellants do not persuade us that a preponderance of the evidence
fails to support the Examiner’s conclusion of obviousness as to claim 1.
Appellants initially contend that an ordinary artisan would have
recognized that the term “dry eye syndrome” in claim 1, describing the
disease treated in the claimed process, does not encompass Sjogren’s
syndrome, as evidenced by the classification of those diseases by the World
3
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Application 12/845,655
Health Organization (WHO),3 and Shiboski.4 Appeal Br. 3^4; Reply Br. 4—
6. Appellants contend, moreover, that the Specification expressly
distinguishes between dry eye syndrome and Sjogren’s syndrome. Appeal
Br. 3 (citing Spec. 4). Appellants further contend that dry eye symptoms are
distinguishable from dry eye syndrome. Appeal Br. 4—5.
We are not persuaded.
It is well settled that during examination, the PTO must interpret
terms in a claim using “the broadest reasonable meaning of the words in
their ordinary usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of definitions or
otherwise that may be afforded by the written description contained in the
applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997).
3 Appellants cite the International Classification of Diseases and Related
Health Problems (“ICD”), 8th Revision, and 10th edition, as evidence of the
WHO’s distinct classifications for Sjogren’s syndrome and dry eye
syndrome. Appeal Br. 3^4; Reply Br. 4—6. Appellants, however, do not
identify where in the record copies of those documents may be found.
4 S.C. Shiboski et al., American College of Rheumatology Classification
Criteria for Sjogren’s Syndrome: A Data-Driven, Expert Consensus
Approach in the Sjogren’s International Collaborative Clinical Alliance
Cohort, 64 Arthritis Care & Research 475^487 (2012).
Although Appellants state that the Shiboski reference was submitted
during prosecution (see Appeal Br. 4), Appellants do not identify where in
the record the reference may be found, or when it was submitted. In
reviewing the record, we note that, like the ICD mentioned above, the
Shiboski reference does not appear to be listed in either of the two
information disclosure statements filed by Appellants (filed January 3, 2011
and December 2, 2014), or in the lists of references cited by the Examiner
(entered December 5, 2012 and May 21, 2014).
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Under that standard, “words of the claim are generally given their
ordinary and accustomed meaning, unless it appears from the specification .
. . that they were used differently by the inventor.'1'’ In re Paulsen, 30 F.3d
1475, 1480 (Fed. Cir. 1994) (emphasis added).
In other words, in “the situation in which a patent applicant has
elected to be a lexicographer by providing an explicit definition in the
specification for a claim term . . ., the definition selected by the patent
applicant controls.” Renishaw PLC v. Marposs Societa ’per Azioni, 158
F.3d 1243, 1249 (Fed. Cir. 1998).
In the present case, Appellants’ Specification includes a section
entitled “Definitions” which states that, “[a]s used herein, the following
definitions shall apply unless otherwise indicated.” Spec. 6.
That section of the Specification includes the following paragraph:
“Keratitis sicca” or “keratoconjunctivitis sicca” or “dry
eye syndrome” refers to a dry eye condition associated with
decreased tear production or increased evaporation, and having
various etiologies, such as inflammatory, non-inflammatory,
traumatic, iatrogenic, drug-induced, rosacea-associated, or
idiopathic origins. A particular cause of dry eyes is decreased
production of tears from the tear glands, for example because
of an autoimmune associated condition that impairs the proper
function of the lacrimal glands or meibomian glands.
Id. (emphasis added).
Thus, giving claim 1 its broadest reasonable interpretation consistent
with the controlling definition provided in the Specification, we interpret the
term “dry eye syndrome” as encompassing dry eye conditions that are
associated with decreased tear production, including conditions that have an
inflammatory etiology, such as autoimmune-associated conditions that
impair the proper function of the lacrimal glands.
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As explained in the Background section of the Specification, “[a]
common cause of dry eyes is Sjogren’s syndrome, which is an autoimmune
disorder in which immune cells attack and impair the glands that produce
tears and saliva. The hallmark symptoms of the disorder are dry mouth and
dry eyes.” Spec. 3; see also id. at 2 (“Dry eye syndromes (keratitis sicca)
represent a particularly widespread clinical problem. Dry eye disorders are
generally caused by either evaporative dysfunction or aqueous tear-
deficiency. . . . Aqueous deficiencies are generally caused by either
Sjogren’s syndrome or non-Sjogren’s disorders.”).
Thus, as explained in the Specification, Sjogren’s syndrome is a dry
eye condition which is associated with decreased tear production, and which
is caused by an autoimmune-associated condition that impairs the proper
function of the lacrimal (tear) glands. Because Sjogren’s syndrome is a dry
eye condition that falls within the controlling definition of “dry eye
syndrome” in Appellants’ Specification, Appellants do not persuade us that
the term “dry eye syndrome” fails to encompass Sjogren’s syndrome.
Given the controlling definition of “dry eye syndrome,” moreover, we
agree with the Examiner that claim 1 encompasses treating Sjogren’s
syndrome with the compound of formula II. We also agree with the
Examiner that, based on the current record, Argade teaches or suggests
treating Sjogren’s syndrome with the compound of formula II.
Argade discloses “compounds, prodrugs, and methods of using these
compounds and prodrugs thereof in the treatment of conditions in which
modulation of the JAK [JAnus Kinase] pathway or inhibition of JAK
kinases, particularly JAK3, are therapeutically useful.” Argade 13.
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Argade discloses compounds that are useful for treating JAK-related
disorders in Tables I—XV. See Argade 1183. Appellants do not dispute the
Examiner’s finding (Ans. 3) that the compound of formula II in Appellants’
claim 1 is among the compounds listed in Table 1.
Argade discloses that Sjogren’s syndrome is a JAK-related disorder
treatable using its compounds. Argade 1188.
Given Argade’s disclosure that a compound of formula II is useful for
treating disorders involving the JAK pathway, and given Argade’s
disclosure that Sjogren’s syndrome is a JAK pathway-associated disorder
treatable using its compounds, we agree with the Examiner that an ordinary
artisan had good reason for, and a reasonable expectation of success in,
treating Sjogren’s syndrome by administering an effective amount of the
compound of formula II to a patient suffering from that disorder.
As discussed above, Sjogren’s syndrome is a dry eye condition
encompassed by the term “dry eye syndrome” in claim 1. We, therefore,
also agree with the Examiner that Argade teaches or suggests administering
a compound encompassed by claim 1, to a patient encompassed by claim 1.
Accordingly, we further agree with the Examiner that the process recited in
claim 1 would have been prima facie obvious.
Appellants do not persuade us to the contrary.
Appellants contend that “Argade alone teaches over 500 JAK
inhibitory compounds,” and that, at the time of the invention, an ordinary
artisan was also “presented with thousands of JAK inhibitory compounds
from which to select the two particular compounds claimed by the present
application for treating dry eye syndrome.” Appeal Br. 6. Therefore,
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Appellants contend, the “prior art fails to teach or suggest a smaller subset of
compounds potentially useful for treating dry eye syndrome.” Id. at 6—7.
As an initial matter, Appellants do not advance specific evidence
supporting their assertion that thousands of JAK inhibitory compounds were
known in the art. As our reviewing court has explained, moreover, that the
prior art “discloses a multitude of effective combinations does not render
any particular formulation less obvious. This is especially true because the
claimed composition is used for the identical purpose taught by the prior
art.” Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 807 (Fed. Cir. 1989)
(holding species claim obvious where claim recited one of 1200 possible
combinations of embodiments disclosed by reference and where reference
suggested no preference for claimed embodiment).
Thus, that the compound of formula II might be one of over 500
compounds taught by Argade as being useful for treating JAK-related
disorders does not persuade us that an ordinary artisan lacked a sufficient
reason for selecting that compound to treat a JAK-related disorder, such as
the Sjogren’s syndrome, expressly disclosed as being treatable with those
compounds. As noted above, Sjogren’s syndrome is also disclosed in
Appellants’ Specification as a disorder treatable by Appellants’ claimed
methods, and falls within the express definition of dry eye syndrome, the
condition treated in claim 1. In other words, the claimed compound is being
used for the identical purpose taught by the prior art.
Indeed, taken to its logical extension, Appellants’ interpretation of
their cited case law as requiring in all situations a small number of identified
solutions would mean that a well investigated technical problem having
numerous known solutions could never be obvious under § 103, simply
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because numerous solutions were known. We are not persuaded that such an
interpretation is applicable in the present fact situation.
As to Appellants’ contention that the lead compound analysis
demonstrates that the present facts do not support the Examiner’s prima
facie case (Reply Br. 2-4), Appellants do not explain how or why those
newly presented arguments could not have presented earlier, such that they
are properly submitted for the first time in the Reply Brief. See 37 C.F.R.
§ 41.41(b)(2):
Any argument raised in the reply brief which was not
raised in the appeal brief, or is not responsive to an argument
raised in the examiner’s answer, including any designated new
ground of rejection, will not be considered by the Board for
purposes of the present appeal, unless good cause is shown.
In any event, the lead compound analysis is applied to determine
whether it would have been obvious to modify a particular compound in the
prior art, to yield a compound recited in a claim at issue. See, e.g., Eisai Co.
v. Dr. Reddy's Laboratories, Ltd., 533 F.3d 1353, 1357 (Fed. Cir. 2008)
(“Obviousness based on structural similarity . . . can be proved by
identification of some motivation that would have led one of ordinary skill
in the art to select and then modify a known compound (i.e. a lead
compound) in a particular way to achieve the claimed compound.”)
(emphasis added).
In the present case, as noted above, Appellants do not dispute that
Argade describes expressly claim 1 ’s compound of formula II, without any
need for modification. Accordingly, even if it were proper to consider
Appellants’ newly presented arguments regarding the lead compound
analysis, we would not find those arguments persuasive.
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Appellants also do not persuade us (see Appeal Br. 7—8; Reply Br. 7)
that the clinical trial discussed in the Liew reference5 demonstrates that the
teachings in Argade failed to provide an ordinary artisan with a reasonable
expectation of treating Sjogren’s syndrome, a disorder encompassed by
claim 1, by administering a compound of formula II, as recited in claim 1.
Nor are we persuaded that Liew can be considered to teach away from the
process of claim 1. See Appeal Br. 8.
Section 103(a) specifies that obviousness is determined from the
perspective of an ordinary artisan “at the time the invention was made.” 35
U.S.C. § 103(a).
The present application has a filing date of July 28, 2010, and claims
priority to a provisional application filed July 28, 2009. See Spec. 1. In
contrast, the Liew reference has a publication date of 2012. Liew 1.
Appellants do not explain how or why an ordinary artisan could or
would have been aware of the disclosures in Liew at the time of Appellants’
invention, such that the artisan could or would have taken into consideration
Liew’s disclosures when determining whether Argade’s teachings provided
a reasonable expectation of success in treating Sjogren’s syndrome with the
compound of formula II. Moreover, because Liew’s publication date is
several years after the earliest priority date claimed by Appellants, we are
not persuaded that Appellants explain sufficiently how or why Liew would
have taught away from the process recited in claim 1, given that an ordinary
5 Shiao Hui (Melissa) Liew et al., Tofacitinib (CP—690,550), a Janus Kinase
Inhibitor for Dry Eye Disease[;] Results from a Phase 1/2 Trial,
Ophthalmology 2012 (published online as “Article in Press”; doi:
10.1016/j.ophtha.2012.01.028).
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artisan would not have been aware of the disclosures in Liew at the time of
Appellants’ invention. In addition, aside from the improper publication date,
Appellants have not shown that Liew relates to any compound described in
Argade.
Moreover, as the Examiner contends, Appellants’ assessment of the
teachings in Liew conflict directly with Liew’s ultimate conclusion that
“[t]his phase 1/2 study of tofacitinib demonstrated a trend for improving
both signs and symptoms of dry eye.” Liew 1. Although Appellants
contend that trials of the compound tested by Liew were ultimately
abandoned (Reply Br. 7), Appellants do not advance evidence to support that
contention, nor do Appellants advance evidence suggesting that the alleged
abandonment of such trials was for a reason that would undermine an
ordinary artisan’s reasonable expectation of successfully treating Sjogren’s
syndrome with the compound of formula II.
In sum, for the reasons discussed above, Appellants do not persuade
us that a preponderance of the evidence fails to support the Examiner’s
prima facie case of obviousness as to claim 1. In addition, for the reasons
discussed below, Appellants do not persuade us that they have advanced
subjective evidence of nonobviousness sufficient to outweigh the evidence
of prima facie obviousness.
Appellants contend that data submitted in their response of August 20,
2014, demonstrates that the compound of formula II, when tested in the
Induced Dye Eye Mouse Model of Example 8 of the Specification,
unexpectedly exhibited the capacity:
[T]o successfully treat dry eye syndrome. A person of ordinary
skill in the art would not have predicted that compound II
would be converted to its active metabolite, compound I, in the
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eye. The active metabolite, compound I, then demonstrated
surprising efficacy for treating dry eye syndrome in the mouse
model.
Appeal Br. 9.
We acknowledge, and have reviewed the six pages presented as
“Exhibit 1” with the Amendment and Response to Non-Final Office Action
filed August 20, 2014. We first note, however, that Exhibit 1 is not
presented in the form of a declaration or affidavit, and does not include the
averments required by the relevant rules, and therefore cannot constitute
evidence in this proceeding. See 37 C.F.R. § 1.132 (“[A]ny evidence
submitted to traverse the rejection or objection on a basis not otherwise
provided for must be by way of an oath or declaration under this section.”);
see also 37 C.F.R. § 1.68 (explaining requirements for written declaration,
including (1) warning against willful false statements and (2) requirement of
positively stating that “all statements made of the declarant’s own
knowledge are true and that all statements made on information and belief
are believed to be true”).
Moreover, other than Appellants’ conclusory assertion that the
information shown therein demonstrates unexpected results, and the
assertion that the conditions were those described in Example 8 of the
Specification, the tables and graphs in Exhibit 1 are not accompanied by any
specific explanation as to the underlying experiments and conditions. For
example, the first page of Exhibit 1 contains the heading “JAK3 DED” yet
no explanation is provided in the record as to the meaning of that heading.
Similarly, the second through sixth pages include either score values, or
percent changes, yet no explanation is provided in the record as to what
these values mean.
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Thus, in the absence of a properly submitted affidavit explaining
specifically the experiments underlying the information presented in Exhibit
1, and why those experiments demonstrate that the claimed process yields
unexpected results, we are not persuaded that Appellants have submitted
objective evidence of nonobviousness sufficient to outweigh the evidence of
prima facie obviousness advanced by the Examiner. See In re Geisler, 116
F.3d 1465, 1471 (Fed. Cir. 1997) (argument by counsel is not an adequate
substitute for actual evidence of unexpectedness).
In sum, for the reasons discussed, Appellants do not persuade us that
the Examiner erred in concluding that the process recited in Appellants’
claim 1 would have been prima facie obvious in view of Argade. Because,
for the reasons discussed, Appellants have not advanced objective evidence
of nonobviousness sufficient to outweigh the Examiner’s evidence of prima
facie obviousness, we affirm the Examiner’s rejection of claim 1 over
Argade. Because, as to each of claims 8 and 9, Appellants argued only that
the rejection was deficient “for at least the reasons provided above for claim
1” (Appeal Br. 9), we affirm the Examiner’s rejection as to those claims as
well.
As to claim 10, Appellants contend that “[tjhere also is no teaching or
suggestion in Argade et al. or the Wikipedia article to pair appellants’
claimed compound II with any one of the agents listed in claim 10.” Appeal
Br. 10.
As the Examiner found, however, Argade discloses that its JAK
inhibitory compounds may be combined with “common immunosuppressive
therapies, such as, for example . . . prednisolone . . . .” Argade 1207. As
explained in Appellants’ Specification, for combination with compound II in
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treating ocular disorders such as dry eye syndrome, “the anti-inflammatory
agent may be a . . . corticosteroid (such as prednisolone). . . Spec. 5.
Because Argade discloses that its JAK inhibitory compounds may be
combined with prednisolone, an agent recognized in Appellants’
Specification as an anti-inflammatory medication, Appellants do not
persuade us that Argade fails to teach or suggest the process recited in
Appellants’ claim 10. We, therefore, also affirm the Examiner’s rejection as
to claim 10.
SUMMARY
For the reasons discussed, we affirm the Examiner’s rejection of
claims 1, 8, 9, and 10, under 35 U.S.C. § 103(a) for obviousness over
Argade.
TIME PERIOD
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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