ETHYPHARM

Patent Trials and Appeals Board

Jan 8, 2021

2020003561 (P.T.A.B. Jan. 8, 2021)

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.
15/104,698 06/15/2016 CATHERINE HERRY ETYR 136 PA / 111396-20 2207
146446 7590 01/08/2021
Dinsmore & Shohl LLP
801 Pennsylvania Avenue, N.W.
Suite 610
Washington, DC 20004
EXAMINER
BROWE, DAVID
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
01/08/2021 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):
abby.feldman@dinsmore.com
dcipdocket@dinsmore.com
kimberly.koen@dinsmore.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CATHERINE HERRY and PAULINE CONTAMIN
Appeal 2020-0035611
Application 15/104,698
Technology Center 1600
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
controlled release baclofen tablet. The Examiner rejected the claims as
obvious under 35 U.S.C. § 103. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as
ETHYPHARM. Appeal Br. 3.
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CLAIMED SUBJECT MATTER
Claims 1, 7, 8, and 13 are on appeal. Ans. 3. Claim 1, the only
independent claim, is illustrative:
1. A matrix-type pharmaceutical tablet administrable by
oral route once to twice per day with controlled release of
baclofen by gastric retention, the tablet comprising:
granules of baclofen and mannitol;
from 3% to 8% by weight superdisintegrant, based on the
total weight of the tablet;
from 4% to 8% by weight gas-generating agent, based on the
total weight of the tablet; and
from 10% to 30% by weight gelling agent, based on the total
weight of the tablet,
wherein:
the superdisintegrant is croscarmellose or crosprovidone;
the gas-generating agent is sodium bicarbonate;
the gelling agent is selected from the group consisting of
xanthan gum, polyethylene oxides, and a mixture of
methylcellulose and hydroxypropylmethylcellulose;
the tablet is a compressed uniform mixture of the granules
and a matrix, the matrix comprising the
superdisintegrant, the gas-generating agent, and the
gelling agent;
the tablet, when subjected to a type II dissolution test in a
fed-mode gastric medium having a pH from 3 to 5 with
paddle stirring at a rotational speed of 100 rpm, rises to
the surface of the fed-mode gastric medium in less than
30 minutes; and
the tablet, when subjected to a type II dissolution test in a
fasting-mode gastric medium having a pH from 1 to 2
with paddle stirring at a rotational speed of 100 rpm, rises
to the surface of the fasting-mode gastric medium in less
than 10 minutes.
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Appeal Br. 24–25 (Claims Appendix).
REFERENCE
The Examiner relies upon the following prior art:
Name Reference Date
Pilgaonkar US 2013/0078290 Al Mar. 28, 2013
REJECTION
Claims Rejected 35 U.S.C. § Reference(s)/Basis
1, 7, 8, 13 103 Pilgaonkar
OPINION
We select claim 1 as representative; the remaining claims stand or fall
with claim 1. 37 C.F.R. § 41.37(c)(1)(iv); see also Appeal Br. 22 (providing
no additional arguments for dependent claims 7, 8, and 13 beyond those
presented for independent claim 1).
The Examiner finds that Pilgaonkar discloses a controlled-release
tablet for once-daily administration comprising baclofen, a matrix
comprising 15–50 wt% of a swelling agent (and specifically a mixture of
methylcellulose and hydroxypropylmethylcellulose), 0.5–25 wt% of a gas-
generating agent (specifically, sodium bicarbonate), and about 8 wt%
crospovidone (a superdisintegrant), where the baclofen can be in granules
with mannitol. Non-Final Act. 4–5 (citing, e.g., Pilgaonkar ¶¶ 14, 15, 23,
24, 39, 42, 47, Example 1, claims 1 and 2). The Examiner finds that it
would have been prima facie obvious for one of ordinary skill in the art to
employ Pilgaonkar’s teachings as outlined above to devise Appellant’s
tablet. Id. at 5. The Examiner finds that although Pilgaonkar does not teach
the claimed float times in the claimed dissolution tests, it sufficiently
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discloses the instantly claimed compositions, which inherently would have
achieved the claimed float times. Id. at 6.
We adopt the Examiner’s findings of fact (e.g. id. at 4–11; Ans. 3–9),
and agree that claim 1 would have been obvious over Pilgaonkar. We find
that Pilgaonkar sufficiently teaches or suggests the claimed tablets, because
it discloses tablets comprising the claimed excipients in overlapping ranges,
as summarized above. “A prima facie case of obviousness typically exists
when the ranges of a claimed composition overlap the ranges disclosed in
the prior art.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Although evidence that claimed ranges are “critical” may constitute
evidence of nonobviousness, In re Geisler, 116 F.3d 1465, 1469–70 (Fed.
Cir. 1997), Appellant has not directed us to persuasive evidence showing
that the claimed ranges achieve unexpected results, as will be further
discussed below.
Appellant argues that “Pilgaonkar does not teach or suggest any single
composition comprising 3% to 8% by weight superdisintegrant, from 4% to
8% by weight gas-generating agent, and from 10% to 30% by weight gelling
agent, as recited in present claim 1.” Appeal Br. 14–15. To the extent
Appellant is arguing that Pilgaonkar does not exemplify a specific tablet that
falls within the claimed genus, we are not persuaded that absence of such an
example makes the claimed subject matter any less obvious to one of
ordinary skill in the art. “[A] reference is not limited to the disclosure of
specific working examples,” but must be considered for all it teaches. In re
Mills, 470 F.2d 649, 651 (CCPA 1972); In re Young, 927 F.2d 588, 591
(Fed. Cir. 1991) (“Patents [and publications] are part of the literature of the
art and are relevant for all they contain.”). Here, as discussed above, we find
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that Pilgaonkar sufficiently teaches or suggests tablets comprising the
claimed excipients in overlapping ranges.
Appellant also argues that Pilgaonkar fails to teach or suggest any
tablet that floats in the claimed time frames, and that the Examiner has not
established that the claimed float times “would necessarily be present” in the
tablets taught in Pilgaonkar. Appeal Br. 15. Appellant relies on the Herry
Declaration2 to demonstrate that “in fact, the claimed float times are not
present.” Id. The Herry Declaration compares tablets prepared according to
Pilgaonkar’s Example 2 (but substituting baclofen in place of pregabalin),
with tablets that fall within the scope of the claims, which were prepared
according to Example 11 in the Specification. Herry Decl. ¶¶ 13, 14, 18.
Both types of tablets were subjected to a type II dissolution test in a fasting-
mode gastric medium as claimed. Id. ¶¶ 21, 23. The average float time for
the tablets prepared according to Pilgaonkar’s Example 2 was over
19 minutes, while the average float time for the tablets prepared according to
the claims and Specification was 30 seconds. Id. ¶¶ 22, 23.
The Herry Declaration does not persuade us that the Examiner erred
in relying on inherency to establish a prima facie case of obviousness. The
tablets described in the Herry Declaration made according to Pilgaonkar’s
Example 2 have amounts of superdisintegrant (crospovidone), gas-
generating agent (sodium bicarbonate), and gelling agent
(hydroxypropylmethylcellulose) that are outside of the claimed ranges.
Herry Decl. ¶ 15. The Examiner, however, relies on Pilgaonkar’s teaching
or suggestion of compositions that fall within the scope of claim 1. See, e.g.,

2 Declaration of Catherine Herry under 37 C.F.R. § 1.132, dated February
18, 2019.
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Non-Final Act. 6. Thus, while the Declaration demonstrates that not all
tablets within the scope of Pilgaonkar’s teachings meet the claimed float
times, Appellant has not demonstrated that tablets within the scope of
Pilgaonkar’s teachings that also fall within the scope of the claims lack the
claimed float times.
Appellant also argues that “[o]bviousness cannot be predicated on
what is not known at the time an invention is made, even if the inherency of
a certain feature is later established.” Appeal Br. 19 (citing In re Rijckaert,
9 F.3d 1531 (Fed. Cir. 1993)). We are not persuaded by this argument. In
Rijckaert, the allegedly inherent property was based on the optimization of
the product, not on a property that was necessarily found in the prior art. See
Rijckaert, 9 F.3d at 1533–34 (“While the condition described may be an
optimal one, it is not ‘inherent’ in [the prior art reference].”). Here, by
contrast, Pilgaonkar sufficiently teaches or suggests tablets having an
amount of gas-generating agent and other claimed excipients that overlap
with the claimed amounts (as discussed above), and teaches that the gas-
generating agent enhances buoyancy. Pilgaonkar ¶ 39. Thus, on this record,
it is reasonable to expect that the tablets taught or suggested by Pilgaonkar
that fall within the scope of claim 1 inherently meet the claimed float times.
“Where . . . the claimed and prior art products are identical or substantially
identical . . . the PTO can require an applicant to prove that the prior art
products do not necessarily or inherently possess the characteristics of his
claimed product.” In re Best, 562 F.2d 1252, 1255 (CCPA 1977)). As
discussed above, Appellant has not directed us to persuasive evidence of
record that such tablets fail to meet the claimed float times.
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Appellant also argues that Pilgaonkar fails to teach “the drastic
shortening of float times” demonstrated by the claimed tablets. Appeal
Br. 14, 18. In particular, Appellant argues that because Pilgaonkar teaches a
“shortest swell time of ‘about 15 minutes,’” it “neither instructs how to
prepare . . . a tablet composition [that performs in the dissolution tests as
claimed] nor suggests that such a composition is possible.” Id. at 15–16
(citing Pilgaonkar ¶ 5). We are not persuaded by Appellant’s arguments,
which confuse float time with “swell time.” Ans. 4. As the Examiner finds,
and Appellant does not dispute, “a ‘swell time’ lower limit of 15 minutes is
not one and the same thing as a ‘float time’ lower limit of 15 minutes.” Id.
Float time and swell time are governed by different mechanisms and
kinetics, and those of ordinary skill in the art generally would have expected
float times to be shorter than swell times. Id. at 5. Further, Pilgaonkar
teaches that the amount of the gas-generating agent is a result-effective
variable that can be optimized to control “float time” or “buoyancy time.”
Id. at 4 (citing Pilgaonkar ¶ 39). Thus, based on Pilgaonkar, a person of
ordinary skill in the art would have known that “the more sodium
bicarbonate, the more buoyant the tablet, and hence the faster the float time.”
Id. at 6.
Citing the Herry Declaration, Appellant argues that “the claimed
tablet unexpectedly differs significantly from the tablet disclosed by
Pilgaonkar” with respect to a significantly shorter float lag time, which
Appellant attributes to “the synergistic interaction of the matrix excipients
(i.e., the gelling agent, the gas-generating agent, and the superdisintegrant).”
Appeal Br. 19, 18. We are not persuaded. As an initial matter, Ms. Herry
does not appear to state that the results reported in her declaration are
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unexpected. According to In re Soni, 54 F.3d 746, 750–51 (Fed. Cir. 1995),
to establish unexpected results, it must be established that the results are
surprising to a person of ordinary skill in the art, or stated to be so by the
patent applicant. Attorney statements are insufficient. See Geisler, 116 F.3d
at 1470–71.
Moreover, Appellant has not demonstrated that the float times
achieved by the claimed tablets are unexpected. “[B]y definition, any
superior property must be unexpected to be considered as evidence of non-
obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir.
2007). Appellant has not provided persuasive evidence that the recited float
time property is due to a synergistic interaction of the gelling agent, gas-
generating agent, and superdisintegrant, rather than just the gas-generating
agent, which Pilgaonkar teaches had the known property of increasing
buoyancy. Instead, we agree with the Examiner that based on the relative
amounts of sodium bicarbonate in the tested tablets, the shorter float time of
the claimed tablet is not unexpected. That is, the tablet prepared according
to Pilgaonkar Example 2 contained less sodium bicarbonate than the tablet
prepared according to the Specification and claim 1 (i.e., 2.9% sodium
bicarbonate versus 5.0% sodium bicarbonate). Herry Decl. ¶¶ 14, 15, 18,
19. “Appellant has merely established that the comparative tablet containing
the lower amount of sodium bicarbonate, i.e. 2.9 wt%, has a significantly
longer float time, which is of course entirely expected in view of
Pilgaonkar’s teachings.” Ans. 8
Finally, Appellant argues that “the Office appears to be improperly
taking official notice” of alleged common knowledge that the amount of
gelling agent and sodium bicarbonate affect float lag times in predictable
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ways. Appeal Br. 20–21. We are not persuaded by this argument, because
the Examiner cites Pilgaonkar to support the common knowledge that the
amount of the gas-generating agent (e.g., sodium bicarbonate) is a results-
effective variable used to optimize buoyancy (float time). Ans. 9 (citing
Pilgaonkar ¶ 39).
CONCLUSION
We affirm the rejection of claims 1, 7, 8, and 13 under 35 U.S.C.
§ 103 as obvious over Pilgaonkar.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 7, 8, 13 103 Pilgaonkar 1, 7, 8, 13
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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED