Ex Parte CHANDRAN et al

Patent Trial and Appeal Board

Feb 25, 2019

13890173 (P.T.A.B. Feb. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/890, 173 05/08/2013
23387 7590 02/27/2019
IP Practice Group
Harter Secrest & Emery LLP
1600 Bausch & Lomb Place
Rochester, NY 14604-2711
FIRST NAMED INVENTOR
Sajeev CHANDRAN
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.
99336.000087 1123
EXAMINER
LEE, ANDREW P
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
02/27/2019 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):
patent@hselaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SAJEEVE CHANDRAN, SHIRISHKUMAR KULKARNI,
PRA VIN MEGHRAJJI BHUTADA, ASHISH ASHOKRAO DESHMUKH,
DOUGLAS BAKAN, MITCHELL WORTZMAN
Appeal2018-004437
Application 13/890, 173
Technology Center 1600
Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and
MICHAEL A. VALEK, Administrative Patent Judges.
VALEK, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants 1 appeal from the
Examiner's rejection of claims 1-15 and 17-20 as obvious. 2 We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 Appellants identify the real party in interest as Medicis Pharmaceutical
Corporation. App. Br. 1. Herein we refer to the Final Office Action dated
October 19, 2015 ("Final Act."), Office Action dated April 7, 2014 ("Non-
final Act."), Appeal Brief filed July 21, 2016 ("App. Br."), Examiner's
Answer, mailed January 24, 2018 ("Ans."), and Reply Brief filed March 21,
2018 ("Reply").
2 Claim 16 was canceled. App. Br. 3.
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Application 13/890, 173
STATEMENT OF THE CASE
Claims 1-15 and 17-20 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. The only independent claims are claims 1
and 12. They read as follows:
1. A method for treating acne, rosacea, or a combination
thereof comprising
administering to a patient in need thereof a controlled
release doxycycline pharmaceutical dosage form comprising an
amount of immediate release doxycycline, wherein said
controlled release doxycycline pharmaceutical dosage form has
a mean Cmax that is at least about 70% that of an immediate
release doxycycline dosage form of equivalent strength and has
an AUC that is at least about 85% of an immediate release
doxycycline dosage form of equivalent strength.
12. A method for treating acne, rosacea, or a combination
thereof comprising
administering to a patient in need thereof a controlled
release doxycycline dosage form comprising an amount of
immediate release doxycycline, wherein said doxycycline dosage
form has a tmax that is at least about 1.15 times greater than the tmax
of an immediate release doxycycline dosage form of equivalent
strength.
App. Br. Appendix 1-3. Claims 2-11 depend from claim 1 and recite
narrower thresholds for the Cmax and AUC ratios in claim 1. Claims 13-15
depend from claim 12 and recite narrower thresholds for the T max ratio in
claim 12. Appellants do not argue claims 2-11 and 13-15 separately so
those claims stand or fall with their respective independent claim. 3 7 C.F .R.
§ 4I.37(c)(l)(iv).
Claims 1 7-20 depend from claim 1 or 12 and add the additional
requirement that the immediate release doxycycline is contained in an
immediate release doxycycline "overcoat" ( claims 17 and 19) or "layer"
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( claims 18 and 20). Id. at 3--4.
Appellants seek review of Examiner's rejection of claims 1-15 and
17-20 under 35 U.S.C. § 103 as unpatentable over Desjardins3 and
Prinderre. 4 App. Br. 2-8.
The issue is: Does the preponderance of evidence of record support
Examiner's conclusion that the cited prior art renders obvious the claimed
methods of treatment involving the administration of controlled release
doxycycline dosage forms?
Findings of Fact
FFJ. Desjardins teaches a controlled release oral dosage form for the
delivery of a "pH-dependent solubility drug" such as doxycycline or
minocycline to treat a variety of conditions including acne. Desjardins ,r 51,
claims 1-3 and 63, see also ,r 79 ("The dosage forms of the present
invention can be used in the treatment of acne"). Desjardins' dosage form
comprises a release layer containing the active pharmaceutical ingredient
(API) and an organic acid, such as sorbic acid, to reduce the dissolution rate
of the API under low pH conditions in the stomach and to enhance
dissolution under higher pH conditions in the intestine. Id. ,r,r 21, 41, 63, 94.
In addition to the acid-containing release layer, Desjardins teaches that its
dosage form preferably includes a "floating layer" with a density less than
water. Id. ,r 53. The floating layer extends the time the dosage form remains
in the stomach where absorption is optimal. Id. ,r,r 3, 112.
3 Alain Desjardins et al., US 2008/0318910 Al, published Dec. 25, 2008
("Desjardins").
4 Pascal Prinderre et al., US 2012/0021009 Al, published Jan. 26, 2012
("Prinderre").
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FF2. Desjardins teaches that its dosage form "releases no more than 60% of
the total amount of drug" within the first hour and the remaining amount
"over a period of time of about 5 to about 8 hours subsequent to the first
hour." Id. ,r 18, claim 1; see also id. Fig. 3 (showing release within first
hour). In example 1, Desjardins describes a controlled release bilayer tablet
comprising a release layer containing minocycline and sorbic acid and a
floating layer. Id. ,r 118, Table 1. Under low pH conditions, the "sorbic acid
acts as a barrier to the dissolution of highly soluble minocycline," whereas it
"enhances the solubilisation" at higher pH. Id. ,r 124. Table 2 provides in
vivo plasmatic concentration and ratio data comparing this controlled release
bilayer tablet embodiment to an immediate release minocycline product. Id.
,r 126. The data show the ratio of the controlled release to the immediate
release form's Cmax and AUC. Id.
FF3. Prinderre describes "oral solid gastro-retentive forms" that "are
retained in the stomach or upper gastrointestinal tract for a controlled
delivery of a drug," including doxycycline. Prinderre, Abstract; ,r 36.
Prinderre teaches that the API may be contained in an "outer layer
surrounding a core" and that the outer layer may be in "an immediate release
form." Id. ,I,I 50-51. Prinderre does not disclose Cmax, AUC or Tmax values
for any such dosage form.
Analysis
Examiner finds that "Desjardins teaches a controlled release dosage
form of doxycycline that releases no more than 60% of the doxycycline
within the first hour and the remaining amount [is released in] the
subsequent 5 to 10 hours" for treating acne. Ans. 3; Final Act. 3--4.
According to Examiner, Desjardins teaches "an overlapping range for
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release profile parameters," including those parameters disclosed for the
extended release minocycline tablet in Example 1. Ans. 4; Non-Final Act.
2-3. 5 Examiner states that it would be obvious to add an immediate release
doxycycline outer layer as taught in Prinderre to Desjardins. Id.
Appellants contend that Examiner has misinterpreted these references
in several respects. Specifically, Appellants argue that: (1) Desjardins does
not teach a doxycycline dosage form for the treatment of acne; (2) Prinderre
does not teach doxycycline formulated in the outer layer for the controlled
release of doxycycline; and (3) Desjardins does not teach any overlapping
range for the claimed release parameters of doxycycline. App. Br. 4--5.
Appellants additionally contend that one of ordinary skill in the art would
have had no reason to combine the references because Desjardins and
Prinderre "disclose alternate, distinct methods of achieving controlled
release oral dosage forms" and no reasonable expectation of success because
neither reference discloses in vivo data for a doxycycline dosage form. App.
Br. 6-8; Reply 6.
The claims on appeal fall into three groups: (1) the Cmaxl AUC claims
(claims 1-11); (2) the Tmax claims (claims 12-15); and (3) the topcoat/layer
claims ( claims 17-20). Because the differences between the claims in these
groups are relevant to our analysis, we address each claim grouping in tum.
5 While the final action does not specifically refer to Desjardins Example 1,
Appellants acknowledge that Examiner "more specifically relied on
Example 1" in prior actions and have discussed such in their appeal briefs.
App. Br. 6; Reply 5-6. Accordingly, Appellants "have had a fair
opportunity" to respond to the "thrust of the rejection" including as it relates
to Example 1. See In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011).
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1. Claims 1-11
We are unpersuaded by Appellants' arguments that Examiner erred in
rejecting claims 1-11 as obvious over the cited art. As explained above,
Desjardins teaches the administration of a controlled release doxycycline
dosage form to treat acne. See FFI. Desjardins teaches that some amount of
that drug, but "no more than 60%," is released immediately in the first hour
from an acid-mediated, extended release layer. FF2.
Claims 1-11 do not require the immediately-released doxycycline be
in a distinct immediate release layer. Rather, it is dependent claims 1 7 and
18 that specify an additional requirement that the "amount of immediate
release doxycycline" in claim 1 be "contained in an immediate release
doxycycline overcoat" or "layer." Because claims 1-11 contain no such
requirement, Appellants cannot distinguish those claims on this basis. See,
e.g., In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993) (rejecting
appellant's nonobviousness argument as based on limitation not expressly
recited in claim, stating "limitations are not to be read into the claims from
the specification"); In re Helgason, 136 F.2d 260, 263 (CCPA 1943)
(limitations not in the claims need not be considered in determining
patentability). For this reason, Appellants' arguments regarding whether
Prinderre teaches an immediate release doxycycline outer layer and the
rationale to combine such a layer with Desjardins are of no moment because
Desjardins' extended release profile already meets this limitation without the
need to incorporate the teachings of Prinderre.
We also agree with Examiner's determination that Desjardins teaches
overlapping ranges for the claimed Cmax and AUC ratios. Specifically, the
data in Table 2 show that the ratios of the Cmax and AUC values for the
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controlled release form in Example 1 overlap with the ranges for those ratios
in claims 1-11. See Desjardins ,r 126, Table 2. While the drug in Example 1
is minocycline, one of ordinary skill in the art would understand Desjardins,
in the absence of evidence to the contrary, to teach that its bilayer
controlled-release tablet achieves a similar pharmacokinetic profile for
doxycycline and the other "pH-dependent solubility drugs" it describes.
Desjardins ,r 51. Appellants contend that the release profile is "entirely
speculative" in the absence of doxycycline-specific in vivo data, but
"[ o ]bviousness does not require absolute predictability of success ... all that
is required is a reasonable expectation of success." In re Drage, 695 F.3d
1334, 1338 (Fed. Cir. 2012) (quoting In re Kubin, 561 F.3d 1351, 1360 (Fed.
Cir. 2009)). Because Desjardins discloses values that closely overlap with
the claimed ranges, we agree that Examiner established a prima facie case of
obviousness for claims 1-11. See, e.g., In re Peterson, 315 F.3d 1325, 1329
(Fed. Cir. 2003) ("[W]e and our predecessor court have consistently held
that even a slight overlap in range establishes a prima facie case of
obviousness."). Appellants have not identified sufficient evidence to rebut
that prima facie case. Accordingly, we affirm the rejection of claims 1-11.
2. Claims 12-15
In contrast to the overlapping Cmax and AUC ratios recited in claims
1-11, Examiner has not adequately explained how the cited prior art teaches
the Tmax ratio required by claims 12-15. According to Examiner, Desjardins
discloses an overlapping range of release parameters that establishes a prima
facie case of obviousness. Ans. 5. But Examiner has not explained how
Desjardins' teaching of a controlled release form "that releases no more than
60% of the doxycycline within the first hour and the remaining amount [ is
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released in] the subsequent 5 to 10 hours" relates to claim 12' s requirement
of that the tmax be at least 1.15 times greater than an immediate release
doxycycline dosage form of equivalent strength. Id. Moreover, the data in
Desjardins Example 1 appears to show that the T max for the controlled
release form is less, not greater, than that of the immediate release form. See
Desjardins ,r 126 (reporting a Tmax of 7.08 hours for Example 1 as compared
to 13.95 hours for the immediate release reference). Accordingly, we do not
perceive the allegedly overlapping range on which Examiner based the
rejection and for that reason conclude that a prima facie case of obviousness
has not been established for claims 12-15.
3. Claims 17-20
Claims 17-20 require the administration of a controlled release
dosage form containing either an immediate release doxcycyline "topcoat"
or "layer." Examiner's rejection relies on Prinderre's teaching of a drug-
containing "outer layer" for these limitations. Final Act. 3--4.
Appellants argue that Examiner failed to provide adequate reasoning
to explain why one of ordinary skill in the art would have modified
Desjardins' dosage form to include the outer layer taught in Prinderre.
Specifically, Appellants contend that the references "disclose alternate,
distinct mechanisms for achieving controlled release oral dosage forms."
App. Br. 6. In addition, Appellants point to the lack of data for doxycycline
or any API in Prinderre, arguing that one of ordinary skill would not
reasonably expect that the addition of an immediate release outer layer
would achieve the claimed release profile, particularly given the
unpredictability of the pharmaceutical arts. App. Br. 7.
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On this record, we agree with Appellants that Examiner has not
articulated a sufficient rationale for combining Prinderre' s immediate release
doxycycline outer layer with Desjardins. As explained above, Desjardins
teaches a dosage form with an organic acid in the release layer to reduce the
dissolution rate of the drug at low pH. See FFl and FF2. That dosage form
achieves release ratios that overlap with the ranges in claims 1-11. FF2.
Examiner has not explained why one of ordinary skill in the art would
reasonably expect to achieve a similar release profile if Desjardins' dosage
form were modified to include an immediate release outer layer either in
addition, or as an alternative, to the acid-containing release layer. This is
particularly so because Desjardins suggests that the release profile observed
for Example 1 results from the presence of sorbic acid in the release layer
and that "[ t ]his is a considerable advantage over the prior art minocycline
dosage forms, which quickly release the drug at low pH." Id. ,r 123.
According to Examiner, it would have been obvious to optimize the release
profile to achieve the claimed profile because Desjardins teaches a dosage
form with such a profile for the treatment of acne. Ans. 5. But Examiner
has not explained why one of ordinary skill would reasonably expect that
Prinderre' s alternate approach of an immediate release outer layer would
achieve a profile similar to that of Desjardins' acid-mediated bilayer tablet.
For these reasons, we conclude that Examiner did not establish a prima facie
case that claims 17-20 would have been obvious over Desjardins and
Prinderre. 6
6 Because claims 19 and 20 depend from claim 12, the analysis in section 2
regarding the Tmax ratio in claim 12 also applies to claims 19 and 20.
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SUMMARY
We affinn the rejection of claims 1-11 under 35 U.S.C. § 103 over
Desjardins and Prinderre.
We reverse the rejection of claims 12-15 and 17-20 under 35 U.S.C.
§ 103 over Desjardins and Prinderre.
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-IN-PART
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