Ex Parte Jobdevairakkam et al

Patent Trial and Appeal Board

Nov 7, 2018

12423552 (P.T.A.B. Nov. 7, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/423,552 04/14/2009 Christopher N. Jobdevairakkam
24126 7590 11/09/2018
ST. ONGE STEW ARD JOHNSTON & REENS, LLC
986 BEDFORD STREET
STAMFORD, CT 06905-5619
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.
05156-P0013B 8747
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
11/09/2018 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):
patentpto@ssjr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRISTOPHER N. JOBDEV AIRAKKAM and
VIKRAM KATRAGADDA
Appeal2017-002177
Application 12/423,552
Technology Center 1600
Before MICHAEL J. FITZPATRICK, ULRIKE W. JENKS, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FITZPATRICK, Administrative Patent Judge.
DECISION ON APPEAL
Christopher N. Jobdevairakkam and Vikram Katragadda
("Appellants") 1 appeal under 35 U.S.C. § 134(a) from a final decision
rejecting claims 1, 5, 8, 15, 17, 26, 27, 29, and 30. We have jurisdiction
under 35 U.S.C. § 6(b ).
We affirm.
1 The real party in interest is identified as "Navinta, LLC." Appeal Br. 2.
Appeal2017-002177
Application 12/423,552
STATEMENT OF THE CASE
The Specification
According to Appellants, the present invention "relates to a
composition of a rapidly disintegrating buccal dosage form containing the
medicament, such as a drug, at least one non-effervescent base such as an
alkali metal oxide and/ or alkaline earth metal oxide or hydroxide, and a
disintegrant." Spec. i-f2. "The base used in the composition does not
generate any gaseous products upon contact with saliva, and eventually it
regulates the pH gradient useful to deliver the drug to the buccal or
sublingual or oral mucosal membranes at a desired rate of absorption." Id.
Appellants' invention is focused specifically on such compositions in
which the drug is fentanyl. Spec. ,II 7 ("The present invention has disclosed
the use of inorganic bases such as alkali metal and alkaline earth metal
oxides and hydroxides which can convert ionic fentanyl to the unionized
fentanyl."). Prior to their invention, Appellants states that "no prior art
[was] known to compose a rapid disintegration buccal tablet suitable to
deliver fentanyl without using effervescent agents." Id.
The Rejected Claims
Claims 1, 5, 8, 15, 17, 26, 27, 29, and 30 stand rejected. Final Act. 1. 2
Claims 1 and 29 are representative and reproduced below with emphasis
added to limitations Appellants dispute as not taught or suggested by the
asserted prior art.
2 Claims 2--4, 6, 7, 9-14, 16, 18-25, and 28 are cancelled. Appeal Br. 20-
21.
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1. An orally disintegrating tablet composition
compnsmg:
fentanyl,
less than 10% (w/w) citric acid,
at least one disintegrant, and
at least one alkaline earth, bivalent metal oxide or
hydroxide,
wherein said composition is free of an effervescent base,
no gaseous products are generated upon contact with saliva,
and the at least one alkaline earth, bivalent metal oxide or
hydroxide promotes the conversion of the fentanyl from a
substantially ionized form to a substantially unionized form
upon contact with saliva.
29. An orally disintegrating tablet consisting
essentially of:
less than 2% (w/w) fentanyl citrate;
more than 50% (w/w) filler material;
a disintegrant from about 0.1 % to about 12% (w/w);
magnesium oxide or hydroxide;
less than 10% (w/w) acid; and
less than 5% (w/w) lubricant,
wherein the pH of the tablet is from about 6 to about 11,
said tablet is free of an effervescent base, no gaseous products
are generated upon contact with saliva, said less than 2% (w/w)
fentanyl citrate converts from a substantially ionized form to a
substantially unionized form upon contact with saliva, and said
pH of the tablet changes by less than 1 pH unit when dissolved
in 1 to 5 ml of solvent.
Appeal Br. 20-22 ( emphasis added).
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Application 12/423,552
The Appealed Rejection
Claims 1, 5, 8, 15, 17, 26, 27, 29, and 30 stand rejected under
35 U.S.C. § 103 as unpatentable over Moe 3 and Singh4 (Final Act. 2);
Appellants requested oral argument in this appeal, which was heard
October 11, 2018.
DISCUSSION
Moe and Singh both describe fentanyl-containing dosage forms for
oral administration across the oral mucosa. Moe, at [57]; Singh, at [57], ,II2.
The Examiner found that "Moe teaches an effervescent formulation
comprising fentanyl citrate, citric acid, sodium starch glycolate [a
disintegrant], mannitol, and ferric oxide ( e.g. Example 5, i-f237)." Final
Act. 2. The Examiner further found that Moe teaches all of the subject
matter of the claims except that "Moe does not teach magnesium oxide as
the base." Final Act. 3; see also Appeal Br. 20 (claim 1 reciting "at least one
alkaline earth, bivalent metal oxide or hydroxide"), 21 ( claim 29 reciting
"magnesium oxide or hydroxide").
The Examiner relies on Singh as teaching the use of magnesium oxide
as a suitable base for making a buffer system for providing fentanyl in
unionized form. Final Act. 3; Singh ,II5 ("The buffering agents of the buffer
system may be independently selected from the group consisting of sodium
carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate,
potassium citrate, potassium phosphate monobasic, magnesium oxide,
3 US 2005/0142198 Al, published June 30, 2005 ("Moe")
4 US 2005/0042281 Al, published Feb. 24, 2005 ("Singh").
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Application 12/423,552
magnesium carbonate, magnesium bicarbonate, alkaline starch, ascorbic
acid, and mixtures thereof.").
The Examiner concludes that "one of ordinary skill in the art
formulating the ODT [i.e., orally disintegrating tablet] of Moe would find it
obvious to use the magnesium oxide of Singh as the pH adjusting substance
given for the phosphate of Moe given both are recognized as basic buffering
agents. See MPEP 2144.06(II)" (substituting equivalents known for the
purpose). Final Act. 4.
Appellants assert that the Examiner's rejection fails to meet the
following limitations: ( 1) "free of an effervescent base [ such that] no
gaseous products are generated upon contact with saliva" ( claims 1, 5, 8, 15,
17, 26, 27, 29, and 30); (2) "less than 10% (w/w) citric acid" (claims 1, 5, 8,
15, 17, 26, and 27); and (3) "said pH of the tablet changes by less than 1 pH
unit when dissolved in 1 to 5 ml of solvent" ( claims 29 and 30). Appeal
Br. 4--5. However, Appellants include detailed arguments for only the first
two of these three limitations. See Appeal Br. 7-17 (§ iv.B.), 17-19
(§ iv.C.); see also 37 C.F.R. § 4I.37(c)(iv) ("[A]ny arguments or authorities
not included in the appeal brief will be refused consideration by the Board").
''free of an effervescent base [such that] no gaseous
products are generated upon contact with saliva"
Appellants argue that Moe does not teach or suggest a tablet that is
"free of an effervescent base [ such that] no gaseous products are generated
upon contact with saliva." Appeal Br. 7. We disagree.
As pointed out by the Examiner, Moe teaches the following:
It has been discovered that the use of effervescence and/or a pH
adjusting substance, and most preferably both, can provide
significant advantages particularly in terms of the amount of
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fentanyl that is required for dosing. It has also been found that
certain disintegrants and fillers in combination with at least one
effervescent couple and at least one pH adjusting substance can
provide even better, and very unexpected, results.
Moe i-f36; Final Act. 2-3 (citing the same)). This passage teaches: (1) the
use of effervescence together with a pH adjusting substance, (2) the use of
effervescence alone, and (3) the use of a pH adjusting substance alone. Moe
i-f36 ("effervescence and/or a pH adjusting substance").
Appellants label paragraph 36 a "passing reference" and argue that a
person of ordinary skill in the art "reading Moe as a whole would understand
Moe to teach only effervescent compositions." Appeal Br. 7-8 ( emphasis
added). To support this argument, Appellants point to Moe's extensive
description of compositions that employ effervescence. Id. at 8-11. But
such description, no matter how extensive, cannot undo the teaching of
paragraph 36.
A person of ordinary skill in the art, reading Moe as a whole, would
not understand it to teach only effervescent compositions. Rather, he or she
would understand Moe to teach both effervescent and effervescent-free
compositions, with the former being preferred. The Examiner's reliance on
Moe's teaching of the latter was appropriate. See Application of Lamberti,
545 F.2d 747, 750 (CCPA 1976) ("all disclosures of the prior art, including
unpreferred embodiments, must be considered").
"less than 10% (w/w) citric acid"
Appellants argue that Moe does not teach or suggest a tablet
comprising "less than 10% (w/w) citric acid." Appeal Br. 17. We disagree.
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In various examples, Moe teaches tablets that are 15% (w/w) citric
acid. See, e.g., Moe i-f233 (200 mg tablet having 30 mg of citric acid); see
also Appeal Br. 17 ("[T]he examples of Moe disclose 15% w/w citric
acid.").
The Examiner points to a teaching in Moe that multiple acids may be
used in the same tablet (see Moe i-f205) and, thus, concludes that a person "of
ordinary skill in the art would find it obvious to use smaller amounts of
multiple acid sources from the group taught by Moe rather than citric acid as
the entire acid component as demonstrated in the examples." Final Act. 4;
Moe i-f205 (referring to "at least one acid source"), i-f206 (listing various
acids, including citric acid).
Moe paragraph 205 states, in relevant part, the following:
Effervescent couples generally are water- or saliva-activated
materials usually kept in a anhydrous state with little or no
absorbed moisture or in a stable hydrated form. Typically these
involve at least one acid source and at least one source of a
reactive base, usually a carbonate or bicarbonate.
Moe i-f205. Appellants argue (correctly) that the relied-upon teaching of
Moe is in reference to an effervescent tablet. Appeal Br. 17. However, the
claims were rejected for obviousness, not anticipation. We are not
persuaded that a person of ordinary skill in the art would consider Moe's
teaching that multiple acids could be used for the acid component of only an
effervescent tablet, where Moe also teaches non-effervescent tablets that
also include an acid component. See In re Baird, 16 F.3d 380, 383 (Fed. Cir.
1994) ("[A] reference must be considered not only for what it expressly
teaches, but also for what it fairly suggests.") ( quoting In re Burckel, 592
F.2d 1175, 1179 (CCPA 1979).
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Additionally, on the record presented, we do not consider the claimed
range of "less than 10% (w/w) citric acid" to be inventive, given that it was
known in the art to use citric acid for fentanyl tablets and that citric acid's
use in that regard is a result effective variable. For example, the Federal
Circuit has held:
"it is not inventive to discover the optimum or workable ranges
by routine experimentation." In re Aller, 220 F.2d 454, 456, 105
USPQ 233,235 (CCPA 1955). Only if the "results of optimizing
a variable" are "unexpectedly good" can a patent be obtained for
the claimed critical range. In re Antonie, 559 F .2d 618, 620, 195
USPQ 6, 8 (CCPA 1977).
In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997).
As pointed out by the Examiner, the person of ordinary skill in the art
would know that raising or lowering the acid concentration would cause a
predictable decrease or increase in the pH. As additionally pointed out by
the Examiner, the person of ordinary skill in the art would have a reason,
when making fentanyl tablets, to use less acid.
While the specific examples of Moe tend to use 15% citric acid,
the broad disclosure of Moe teaches that "[i]f the ideal conditions
for transmission of a particular drug are basic, the addition of a
sufficient excess of suitably strong acid as part of the
manufacture of an effervescent couple or as a pH adjusting
substance may not be indicated" [i-f208]. Moe also teaches that
"a basic substance is preferred for the delivery of fentanyl"
[i-f209]. Thus, one of ordinary skill in the art would find it
obvious to reduce the amount of acid when delivering fentanyl
in order to provide a more basic environment for the fentanyl, as
taught to be preferred by Moe.
Ans. 4.
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Claim 29
Claim 29 recites "said pH of the tablet changes by less than 1 pH unit
when dissolved in 1 to 5 ml of solvent." Appellants argue, in their Reply,
that "[t]he Examiner has never cited to where in the cited art [this] is
taught." Reply 2. However, in their Appeal Brief, Appellants did not argue
claim 29 separately from claim 1. See, e.g., Appeal Br. 3 ("Claims 1, 5, 8,
15, 17, 26--27, and 29-30 are Patentable Over Moe In View of Singh");
37 C.F.R. § 4I.37(c)(iv) ("Under each heading identifying the ground of
rejection being contested, any claim(s) argued separately or as a subgroup
shall be argued under a separate subheading that identifies the claim( s) by
number."). As such, we need not consider the patentability of claim 29
separately. See id. ("[T]he failure of appellant to separately argue claims
which appellant has grouped together shall constitute a waiver of any
argument that the Board must consider the patentability of any grouped
claim separately.").
In any event, we are not persuaded that this claim language
distinguishes over the combination of the art proposed by the Examiner.
The claim language is "said pH of the tablet changes by less than 1 pH unit
when dissolved in 1 to 5 ml of solvent." Appellants argue this is an inherent
result of a tablet comprised of the specific components that are recited in
claim 29. See Appeal Br. 4 ("The use of magnesium oxide or hydroxide
specifically is important because it allows the pH of the tablets of claims 29
and 30 to change by less than 1 pH when dissolve[ d] in 1 to 5 mL of
solvent."); Reply 3 ("[I]t is advantageous that the pH of the claimed tablets
only changes by 1 unit when in 1 to 5 mL solvent .... Use of the
specifically claimed water insoluble metal oxide and hydroxides enables this
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control."); Transcript 10: 10-11 ("It is a result of the formulation that is
claimed in claim 29").
SUMMARY
For the reasons discussed, we affirm the Examiner's rejection of
claims 1, 5, 8, 15, 17, 26, 27, 29, and 30.
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)(l)(iv).
AFFIRMED
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