Dexcel Pharma Technologies Ltd.

Patent Trials and Appeals Board

Dec 21, 2020

2020001072 (P.T.A.B. Dec. 21, 2020)

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.
15/724,502 10/04/2017 Adel PENHASI 15542-15 1232
757 7590 12/21/2020
BGL
P.O. BOX 10395
CHICAGO, IL 60610
EXAMINER
AL-AWADI, DANAH J
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
12/21/2020 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ADEL PENHASI, AVI AVRAMOFF, MAXIM GOMBERG, and
VALERIE AZOULAY
_____________

Appeal 2020-001072
Application 15/724,5021
Technology Center 1600
____________

Before FRANCISCO C. PRATS, JOHN G. NEW, and DAVID COTTA,
Administrative Patent Judges.

COTTA, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134(a) involving claims to a
stable composition for a benzimidazole derivative. The Examiner rejected
the claims on appeal under 35 U.S.C. § 112 for failure to comply with the
written description requirement, under 35 U.S.C. § 103(a) as obvious, and
on the ground of non-statutory obviousness. 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. According to Appellant, the real party in interest is Dexcel
Pharma Technologies Ltd. App. Br. 1.

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STATEMENT OF THE CASE
The Specification discloses that derivatives of benzimidazole are
“active proton pump inhibitors . . . used conventionally for decreasing
gastric secretion.” Spec. 1. According to the Specification derivatives of
benzimidazole “are known to be susceptible to degradation and
transformation in acid media,” which “increases the difficulty of preparing a
pharmaceutical form designed for oral administration.” Id. Thus,
pharmaceutical compositions including benizimadazole “derivatives should
be protected both during storage and during their passage through the acidic
environment of the stomach.” Id.
Several of the prior art references disclosed in the Specification
address the susceptibility of benizimadazole to acid media using a multilayer
approach with a core comprising a benzimidazole derivative, an intermediate
layer applied to the core, and an enteric layer. Id. at 2–3. Although at least
one prior art reference discloses a benzimidazole derivative composition that
lacks an intermediate layer, it neutralizes the enteric coating with an alkaline
compound, which “usually results in a certain amount of the alkalizing agent
remaining in the final product.” Id. at 3. In addition, the Specification
discloses that “benzimidazole formulations are frequently prepared using
volatile organic solvents, a residual amount of which is also found in the
final product.” Id. at 3–4. These residual solvents “may . . . have a harmful
effect” and thus it is “desirable to keep the levels of such residual solvents as
low as possible for toxicity/safety reasons.” Id. at 4.
The Specification discloses that the inventors overcame the drawbacks
disclosed in the prior art by “providing a benzimidazole formulation which
lacks an intermediate layer and yet which is stable both during storage and
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during the passage through the stomach, and which has low levels of
residual volatile excipients, including but not limited to residual alkalinizing
agents and/or residual solvents.” Id.
Claims 1–3, 12, 14, 18, 20–27, 29, 30, and 33 are on appeal. Claim 1
is representative and reads as follows:
1. A stable composition for a benzimidazole derivative, the
composition comprising:
a substrate and a neutralized enteric coating layer,
wherein said substrate comprises a benzimidazole
derivative, and
at least one excipient selected from the group consisting of
a filler, a disintegrant, a lubricant, and an alkalizing agent, and
wherein said neutralized enteric coating layer consisting
essentially of one or more enteric polymers selected from the
group consisting of cellulose acetate phthalate (CAP),
hydroxypropyl methylcellulose phthalate (HPMCP), polyvinyl
acetate phthalate, cellulose acetate trimellitate, poly(methacrylic
acid, methyl methacrylate (1:1)), poly(methacrylic acid, ethyl
acrylate (1:1)), poly(methacrylic acid, methyl methacrylate
(1:2)), hydroxypropyl methylcellulose acetate succinate
(HPMCAS), sodium alginate, and alginic acid or mixtures
thereof; and
said neutralized enteric coating layer further comprising a
first alkalizing agent which is monoethanolamine, and a residual
amount of less than 500 parts per million of a second alkalizing
agent which is ammonium hydroxide;
wherein the pH of said neutralized enteric coating layer is
in the range of from about 4.5 to about 6.5 as measured in 30 ml
of distilled water at 20–25°C.
App. Br. 26.
The claims stand rejected as follows:
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I. Claim 30 was rejected under 35 U.S.C. § 112 for failure to
comply with the written description requirement.2
II. Claims 1–3, 12, 14, 16, 18, 20–27, 29, and 33 were rejected
under 35 U.S.C. § 103(a) as obvious over the combination of Lahav,3 What
is pH,4 Yu,5 Friedman,6 Setty,7 and Important Biological Buffers.8
III. Claims 1 and 30 were rejected under 35 U.S.C. § 103 as
obvious over the combination of Lahav, What is pH, Yu, Friedman, Setty,
Important Biological Buffers, and Humar.9
IV. Claims 1–3, 12, 14, 16, 18, 20–27, 29, 30, and 33 were rejected
on the ground of non-statutory obviousness type double patenting over
claims 31, 33–39 and 41–62 of US Patent Application No. 14/053611.

2 In the Examiner’s Answer, the Examiner withdrew the rejection of claim 1
under 35 U.S.C. § 112 for failure to comply with the written description
requirement. Ans. 4. The rejection of claim 1 on this basis is thus no longer
a part of this appeal.
3 Lahav et al., US Patent Publication No. 2007/0196485 A1, published Aug.
23, 2007 (“Lahav”).
4 Kohlmann, What is pH, and How is it Measured: A Technical Handbook
for Industry, 2003 (“What is pH”).
5 Yu et al, US Patent Publication No. 2003/0064107 A1, published Apr. 3,
2003 (“Yu”).
6 Friedman et al., US Patent No. 3,634,271, issued Jan 11, 1972
(“Friedman”).
7 Setty et al., US Patent Publication No. 2009/0175935 A1, published July 9,
2009 (“Setty”).
8 Important Biological Buffers,
http://staff/ustc.edu.cn/~liuyz/methods/buffer.htm, Google date: Oct. 25,
2007 (“Important Biological Buffers”).
9 Humar et al., US Patent Publication No. 2006/0093680 A1, published May
4, 2006 (“Humar”).
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REJECTION I
Claim 30 depends from claim 1 and further recites that the
composition “comprises between 0.22wt% to 0.30wt% of
monoethanolamine relative to composition weight.” App. Br. 29. The
Examiner contends that the Specification does not disclose “including
monoethanolamine from 0.22 wt %–0.30 wt % relative to the composition
weight in regards to using any compositional weight.” Ans. 5. Appellant
contends that the claimed percentage of monoethanolamine by weight can be
derived by dividing the amount of monoethanolamine disclosed in Table 2
(Example 3) by the total weight of the tablets disclosed in Example 1. Reply
Br. 2. Thus, according to Appellant, by combining the disclosures from
Table 2 and Example 1, one can derive “seven specific species amounts that
support the claimed range for the monoethanolamine weight percent (0.22
wt.%–0.30 wt.%), two of which constitute the upper and lower boundaries
and five other examples that are within the claimed range.” Id. at 2–3. We
are not persuaded.
Example 3 describes the “determination of residual
monoethanolamine” in tablets that were, according to Appellant, prepared
using the formulation set forth in Example 1. Spec. 13–15; Tr. 8. The
amounts of residual monoethanolamine that were determined to be present
after the tablet had been prepared were, in all cases, less than the amount of
monoethanolamine used to formulate the tablet. Compare Spec. 11
(Example 1, disclosing formulating a tablet with 1.0 mg/tablet of
monoethanolamine) with id. at 15 (Example 3, disclosing residual
monoethanolamine amounts of 0.77, 0.730, 0.681, 0.822, 0.755, 0.908, and
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0.780 mg/tablet). It thus appears that some of the monoethanolamine used
to make the tablets was lost in the tableting process.
In deriving the seven species that Appellant contends support the
claimed range, Appellant uses the total weight of the components used to
formulate the tablet disclosed in Example 1 (the starting weight prior to
tableting) as the denominator and the residual weight of the
monoethanolamine (the post-tableting end weight) as the numerator. Tr. 7.10
There is nothing in the language of claim 30 that suggests that the weights
used to calculate the claimed percentage range encompass weights taken at
different stages of the tableting process. Because Appellant’s calculation
relies on weights from different compositions – the pre-tableting formulation
composition, and the post-tableting formulation composition – the seven
species identified by Appellant do not support the limitation of claim 30
requiring a percentage of monoethanolamine relative to composition weight.
Separate and apart from the problem of whether one can glean from
the combination of Example 1 and Example 3, seven species falling within
the range “between 0.22% to 0.30% of monoethanolamine relative to
composition weight,” in order to satisfy the written description requirement,
there must be some indication that the inventors considered the genus to be
part of their invention. See, Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d
1320, 1328 (Fed. Cir. 2000) (“Because the specification does not clearly
disclose to the skilled artisan that the inventors of the [patent at issue]
considered the Cmax/C24 ratio to be part of their invention, it is immaterial

10 Transcript of Oral Argument presented September 15, 2020 (entered
November 10, 2020)
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what range for the Cmax/C24 ratio can be gleaned from the examples when
read in light of the claims.”).
Here, Appellants do not identify, and we do not find, any teaching in
their Specification that would reasonably convey to the skilled artisan that
the inventors considered the “percentage of monoethanolamine relative to
[the] composition weight” to be a part of their invention. It is thus
immaterial whether the range of 0.22% to 0.30% can be extracted from the
individual examples provided in the Specification. For this additional
reason, we affirm the Examiner’s rejection of claim 30 for failure to comply
with the written description requirement.
REJECTION II
Appellant argues claims 1–3, 12, 14, 18, 20–27, 29, and 33 together.
App. Br. 7–21. We designate claim 1 as representative.
In rejecting claim 1 as obvious, the Examiner found that Lahav
disclosed all of the elements of claim 1 with the exception that it disclosed
using only ammonia hydroxide as a neutralization agent while the claims
require two neutralizing agents – ammonia hydroxide and
monoethanolamine. Final Act. 4–11;11 Ans. 6.
The Examiner found that Friedman taught the use of
monoethanolamine as a neutralizing agent. Final Act. 11. The Examiner
acknowledged that Friedman was not directed to enteric polymers for oral
delivery, but found that the problem solved by Friedman – neutralzing a
polymer – was applicable to Lahav’s polymers. Id.
The Examiner also found that Yu disclosed “reverse enteric coatings”
and taught that is was “desirable to include an alkalizing agent to maintain

11 Office Action mailed December 21, 2018 (“Final Act”).
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the integrity and such agents applicable are capable of raising the pH to
about 5.” Id. According to the Examiner, Yu also discloses using one or
more alkalizing agents, including ammonium hydroxide and ethanolamine,
to raise the pH above 5. Id.
The Examiner further found that Important Biological Buffers taught
that ammonium hydroxide had a pH range of from 8.8–9 and that
ethanolamine has an effective pH range of from 6–12. Id.
Finally, the Examiner found that Setty disclosed neutralizing an
enteric polymer to an “appropriate pH by using alkaline substances such as
ammonium hydroxide and the like.” Id.
Based on the combined teachings of Friedman, Yu, Important
Biological Buffers, and Setty, the Examiner found that “[a]bsent any
evidence of criticality, it would have been prima facie obvious to one of
ordinary skill in the art to include a second alkalizing agent for neutralizing
the enteric coating in the composition of Lahav.” Id. at 12. The Examiner
explained:
One would have been motivated to do so in order to obtain the
desired pH of the enteric coating polymer as evidenced by Yu et
al., combinations of more than one alkalizing agent may be used
to raise the pH of the enteric suspension above 5. One skilled in
the art would know [the] combinations of alkalizing agents to use
to obtain the desired pH range and combinations of such agents
such as monoethanolamine and sodium hydroxide are taught.
Furthermore, the purpose of the alkalizing agents is to neutralize
the acidic enteric polymers. It would have been prima facie
obvious to one of ordinary skill in the art at the time the invention
was made to neutralize the acidic coating with such alkalizing
agents because such agents are recognized as suitable for use to
neutralize the acidic components.
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Id. We agree with the Examiner that the claims would have been obvious
over the combination of Lahav, Yu et al., Important Biological Buffers and
Setty.12 We address Appellant’s arguments below.
Appellant argues that Friedman is not analogous art. App. Br. 8–10.
In determining whether a reference is analogous art we consider “(1)
whether the art is from the same field of endeavor, regardless of the problem
addressed, and (2) if the reference is not within the field of the inventor’s
endeavor, whether the reference still is reasonably pertinent to the particular
problem with which the inventor is involved.” In re Clay, 966 F.2d 656,
658–59, 23 USPQ2d 1058, 1060 (Fed. Cir. 1992).
Here, claim 1 is directed to a pharmaceutical composition. Friedman
is directed to liquid detergent compositions. Accordingly, we agree with
Appellant that Friedman is not directed to the same field of endeavor as the
claimed composition. Similarly, the problem faced by Friedman –
maintaining the fluidity and clarity of liquid detergents after extended
periods of storage – is unrelated to the problems of formulating a
pharmaceutical composition faced by the inventors here. Accordingly, we
agree with Appellant that Friedman is not analogous art.
However, we do not regard Friedman as critical to the Examiner’s
rejection. In affirming a multiple reference rejection under 35 U.S.C. § 103,
the Board may rely on fewer than all of the references relied on by the

12 For the reasons discussed below, we agree with Appellant that Friedman is
not analogous art. However, in affirming a multiple reference rejection
under 35 U.S.C. § 103, the Board may rely on fewer than all of the
references relied on by the Examiner in an obviousness rationale without
designating it as a new ground of rejection. In re Bush, 296 F.2d 491, 496
(CCPA 1961). Here, we do not rely upon Friedman.
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Examiner in an obviousness rationale without designating it as a new ground
of rejection. In re Bush, 296 F.2d 491, 496 (CCPA 1961). Here, we do not
rely upon Friedman.
As the Examiner explained, Lahav discloses all of the elements of
claim 1 with the exception of the use of monoethanolamine as a second
neutralizing agent. Final Act. 4–11; Ans. 6. Lahav teaches preparation of a
solution with the enteric coating material, which preferably has a pH “from
about 7 to about 10.” Lahav ¶ 33. Lahav further teaches that “a pH value
within the pH range is obtained by adding an alkaline compound to an
enteric coating material.” Lahav suggests to add ammonium hydroxide to
achieve the desired pH. Id.
We conclude that it would have been obvious to also use
monoethanolamine as a neutralizing agent in Lahav’s compositions in view
of Yu because Yu identifies both ammonium hydroxide and
monoethanolamine as alkalizing agents suitable for raising pH. Yu ¶ 20.13
In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
(“It is prima facie obvious to combine two compositions each of which is
taught by the prior art to be useful for the same purpose, in order to form a
third composition to be used for the very same purpose . . . . [T]he idea of
combining them flows logically from their having been individually taught
in the prior art.”); In re Susi, 440 F.2d 442, 445 (CCPA 1971) (obviousness

13 Yu discloses “ethanolamine” as one potential alkalizing agent. Yu ¶ 20.
We understand “ethanolamine” to be the same the claimed
“monoethanolamine.” See https://en.wikipedia.org/wiki/Ethanolamine#:
~:text=Ethanolamine%20is%20commonly%20called%20monoethanolamine
,corrosion%20inhibitors%2C%20and%20chemical%20intermediates
(“Ethanolamine is commonly called monoethanolamine or MEA in order to
be distinguished from diethanolamine (DEA) and triethanolamine (TEA).”).
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rejection affirmed where the disclosure of the prior art was “huge, but it
undeniably include[d] at least some of the compounds recited in appellant’s
generic claims and [was] of a class of chemicals to be used for the same
purpose as appellant’s additives”). The teachings of Setty and Important
Biological Buffers further support that it would have been obvious to use
both ammonium hydroxide and monoethanolamine as alkaline agents. See
Setty ¶ 25 (disclosing neutralizing an enteric polymer to an “appropriate pH
by using alkaline substances such as ammonium hydroxide and the like”);
Important Biological Buffers, 1 (disclosing that ammonium hydroxide has a
pH range of from 8.8–9 and that ethanolamine has an effective pH range of
from 6–12).
Appellant argues that the Examiner relied impermissibly on hindsight.
App. Br. 13. We do not find this persuasive because Appellants point to no
evidence that any of the Examiner’s findings were beyond the level of
ordinary skill at the time of the invention or could have been taken only
from Appellants’ Specification. See In re McLaughlin, 443 F.2d 1392, 1395
(CCPA 1971).
Appellants argue that “[i]n addition to failing to provide a legitimate
reason for modifying Lahav et al. in view of Friedman, the Examiner also
fails to provide a reason to modify Lahav et al. in view of the other
references relied on in the rejection.” App. Br. 13; see also, id. 14–17
(arguing that the Examiner failed to explain how each individual reference
would have made it obvious to modify Lahav). We are unconvinced
because the Examiner provides persuasive reasons why it would have been
obvious to modify Lahav in view of the cited references. In the Answer, the
Examiner explained:
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The combination of Friedman Yu et al, Important Biological
Buffers and Setty et al. were used to show that is it is routine in
the art to adjust the pH using alkalizing agents and it would have
been prima facie obvious to further add monoethanolamide to
neutralize the polymer as Friedman discloses combination of
monoethanolamine and sodium hydroxide in order to neutralize
the polymer and sodium hydroxide is one of choice of for use in
Lahav. The Examiner maintains that it would have been prima
facie obvious to one of ordinary skill in the art to include a second
alkalizing agent for neutralizing the enteric coating of Lahav.
One would have been motivated to do so in order to obtain the
desired pH of the enteric coating polymer as evidence by Yu et
al., combinations of more than one alkalizing agent may be used
to raise the pH of the enteric suspension above 5. One skilled in
the art would know what combinations of alkalizing agents to use
to obtain the desired pH range and combinations of such agents
such as monoethanolamine and sodium hydroxide are taught.
The purpose of such alkalizing agents are to neutralize the acidic
enteric polymers.
Ans. 13. We recognize that, in the above quoted passage, the Examiner cites
Friedman as supporting that it was “routine in the art to adjust the pH using
alkalizing agents.” Id. However, the combination of Yu, Important
Biological Buffers and Setty support this position even without Friedman.
Yu ¶ 20, Setty ¶ 25, Important Biological Buffers 1. We also recognize that,
in the above passage, the Examiner cited Friedman as disclosing the use of
“monoethanolamide to neutralize the polymer,” but as discussed above, Yu
also discloses the use of monoethanolamide. Accordingly, we find that the
Examiner provided a persuasive reason to modify Lahav in view of the
“other references” – i.e., the references cited in the rejection other than
Friedman.
Appellant argues that Yu discloses a “reverse enteric polymer
coating” designed to “maintain its integrity in neutral or basic pH.” App.
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Br. 14. Appellant contrasts this with an enteric coating which, according to
Appellant, “is not designed to maintain its integrity in basic pH ranges, but is
rather designed to disintegrate in basic pH ranges.” Id. Appellant thus
argues that the ordinary artisan would “not have been motivated to turn to
Yu for its alleged teaching of alkalizing agents with respect to reverse
enteric coatings.” Id. at 14–15. We do not find this argument persuasive
because, as discussed above, the Examiner relies on Yu for its general
teaching that “it is routine to adjust the pH using alkalizing agents.” Ans.
13. The effect achieved by adjusting pH does not change Yu’s teaching that
the alkalizing agents it identifies are “capable of raising and maintaining the
pH” in a pharmaceutical composition. Yu ¶ 20.
Appellant argues that “Yu would not have motivated a person having
ordinary skill in the art to select monoethanolamine and ammonium
hydroxide as claimed . . . because Yu details a laundry list of alkalizing
agents with no guidance as to their different properties or use except for their
ability to raise the pH.” App. Br. 15. We are not persuaded because Yu
identifies both monethanolamine and ammonium hydroxide as “alkalizing
agents . . . capable of raising and maintaining the pH” of a pharmaceutical
composition. Yu ¶ 20. Absent evidence of unexpected results, the fact that
Yu identifies several other alkalizing agents capable of performing this
function does not render the use of monethanolamine and ammonium
hydroxide any less obvious. Merck & Co. v. Biocraft Laboratories, Inc.,
874 F.2d 804, 807 (Fed. Cir. 1989) (“That the '813 patent discloses a
multitude of effective combinations does not render any particular
formulation less obvious.”); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir.
1985) (affirming obviousness rejection over prior art teachings that
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“hydrated zeolites will work” in detergent formulations, even though “the
inventors selected the zeolites of the claims from among ‘thousands’ of
compounds.”); see also, Perricone v. Medicis Pharm. Corp., 432 F.3d 1368,
1376 (Fed. Cir. 2005) (rejecting the notion that an ingredient “cannot
anticipate because it appears without special emphasis in a longer list”).
Appellant argues that Lahav fails to disclose the limitation requiring
that the enteric coating layer comprise “a first alkalizing agent which is
monoethanolamine, and a residual amount of less than 500 parts per million
of a second alkalizing agent which is ammonium hydroxide.” App. Br. 17.
Appellant further argues that the other cited references “provide no guidance
or teaching of the claimed composition comprising a neutralized enteric
coating layer comprising a first alkalizing agent that is monoethanolamine
and a residual amount of less than about 500 parts per million of a second
alkalizing agent that is ammonium hydroxide.” Id. at 19. These arguments
are not persuasive.
As an initial matter, one cannot show nonobviousness by attacking
references individually when the rejection is based on a combination of
references. In re Keller, 642 F.2d 413, 425 (CCPA 1981). In addition, as
discussed above, we find that the Examiner has provided persuasive reason
to modify Lahav’s composition to include monoethanolamine as a second
alkalizing agent. Finally, with respect to the claimed amount of ammonium
hydroxide, we agree with the Examiner that both the Specification and
Lahav teach preparing an enteric coating by the same method, including
adjusting the pH by adding a 25% ammonia solution. Final Act. 5; Spec. 12
(see particularly “Coating C”); Lahav ¶ 101. Based on the similarity in
methods of preparation, the Examiner further finds that “[a]lthough less than
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500 [ppm] is not explicitly mentioned, the same ammonia solution appears
to be used so it would be expected that the volatile alkalizing agent would be
present in the claimed amount.” Id. at 5–6. As this finding is supported by
the record (Spec. 12; Lahav ¶ 101), and Appellant does not provide
persuasive evidence or argument that this finding is incorrect, we credit the
Examiner’s finding that Lahav discloses the claimed amount of ammonium
hydroxide.
Appellant argues that there are no problems with Lahav’s enteric
coating and thus there is no reason to make any modifications to Lahav.
App. Br. 11–12. We do not find this persuasive because regardless of
whether there were any problems with Lahav’s enteric coating, it would
have been obvious to combine two alkalizing agents known to be useful for
the same purpose – i.e., to raise pH in a pharmaceutical composition. In re
Kerkhoven, 626 F.2d at 850.
Appellant contends that the claimed composition is:
based in part on the unexpected finding that neutralized enteric
coating having a pH range of from about 4.5 to about 6.5 as
measured in 30 ml of distilled water at 20-25°C, provides the
benzimidazole derivative with an appropriate protection during
storage and while passing through the stomach even if the pH
values of the gastric fluid are elevated.
App. Br. 19. Appellant further contends that the claimed composition has
advantageous properties, including that it is stable “both during storage . . .
and during passage through the stomach.” Id. at 20–21.
To the extent Appellant offers these allegedly advantageous properties
as objective indicia of non-obviousness, we do not find them persuasive
because Appellant does not provide evidence that the advantages allegedly
attained were, in fact, unexpected. See, Johnston v. IVAC Corp., 885 F.2d
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1574, 1581 (Fed. Cir. 1989) (“Attorneys’ argument is no substitute for
evidence.”); In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). Nor does
Appellant compare the alleged advantageous properties achieved by the
claimed composition to the closest prior art. In re Baxter Travenol Labs,
952 F.2d 388, 392 (Fed. Cir. 1991) (“when unexpected results are used as
evidence of nonobviousness, the results must be shown to be unexpected
compared with the closest prior art”). Accordingly, even if we credit the
claimed composition as providing advantageous properties, the record before
us does not support reliance on such properties as objective indicia of non-
obviousness.
Accordingly, we affirm the Examiner’s rejection of claim 1. Because
they were not argued separately, claims 2, 3, 12, 14, 16, 18, 20–27, 29, and
33 fall with claim 1.
REJECTION III
Claim 30 depends from claim 1 and further requires that the
composition comprises “between 0.22wt% to 0.30wt% of
monoethanolamine relative to composition weight.” The Examiner
acknowledged that Lahav, modified as discussed above, does not disclose
this additional limitation of claim 30. Final Act. 13. The Examiner found
that Humar supplied this missing limitation, disclosing a coating for a
pharmaceutical composition in which the amount of monoethanolamine
added was 0–10% wt%. Id. Based on this disclosure, the Examiner
concluded that it would have been obvious to “optimize the amount of
alkalizing agents to adjust the desired pH.” Id. We agree with the Examiner
that it would have been obvious to optimize the amount of
monoethanolamine. We address Appellant’s arguments below.
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Appellant argues that “Humar is silent as to the presence of an enteric
pH dependent polymer coating.” App. Br. 21. We do not find this
persuasive because Humar discloses that its coating is “a layer of material
applied directly onto the core which is either an active substance itself or an
active substance with one or more pharmaceutical excipients” which
“affords protection of the active substance and one or more pharmaceutical
excipients, respectively, from environmental influences” and which “enables
release of the active substance in all parts of gastrointestinal tract, regardless
of environmental pH value.” Humar ¶ 83.
Appellant argues that Humar’s disclosure of 0–10% alkalizing agent
does not apply because the percentage recited is the amount of alkalizing
agent relative to the amount of solids in the coating, not the amount of
alkalizing agent relative to the weight of the composition, as recited in the
claims. App. Br. 22. We do not find this argument persuasive because, as
Appellant acknowledges (id.) Humar also discloses a range of 0–50%
alkalizing agent relative to the weight of the composition (Humar ¶ 151).
This range overlaps with that recited in the claims, creating a prima facie
case of obviousness and shifting the burden to the Appellants to demonstrate
non-obviousness. In re Peterson, 315 F.3d 1325, 1329–30 (Fed. Cir. 2003)
(“[T]he existence of overlapping or encompassing ranges shifts the burden
to the applicant to show that his invention would not have been obvious.”).
Here, Appellant points to no persuasive evidence to rebut the prima facie
case of obviousness created by the disclosure of encompassing ranges.
Appellant argues that the range disclosed in Humar is “so broad and
unspecific that it cannot teach or suggest the specific weight percentage of
0.22wt% to 0.30wt% of monoethanolamine as recited in claim 30.” App.
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Br. 22. We are not persuaded that the range disclosed in Humar is too broad
and unspecific to create a prima facie case of obviousness. Cf. Genetics
Institute v. Novatris Vaccines, 655 F.3d 1291, 1306 (Fed. Cir. 2011) (finding
that “the '620 patent's claims would not have been prima facie obvious over
the ’112 patent's claims” where “the ’112 patent contains 68,000 truncated
variants of a protein made up of 2,332 amino acids, and the allegedly
interfering inventions differ in terms of the size of the permitted amino acid
deletions, the location of those deletions, and the degree of allowable amino
acid substitutions”).
Finally, Appellant argues that Humar discloses a “laundry list of
alkalizing agents with no guidance as to their different volatilities or use”
and thus to ordinary artisan, “would not be motivated to the use of a first
alkalizing agent which is monoethanolamine, and a residual amount of less
than 500 parts per million of a second alkalizing agent which is ammonium
hydroxide as claimed.” App. Br. 23. We are not persuaded because, as
discussed above, the alkaline agents disclosed in the art are all useful for the
same purpose. Yu ¶ 20; Humar ¶¶ 93–96; In re Kerkhoven, 626 F.2d at 850.
Accordingly, we affirm the Examiner’s rejection of claim 1 and 30 as
obvious over the combination of Lahav, What is pH, Yu, Friedman, Setty,
Important Biological Buffers, and Humar.

REJECTION IV
The Examiner provisionally rejected claims 1–3, 12, 14, 16, 18, 20–
27, 29, 30, and 33 on the ground of non-statutory obviousness type double
patenting over claims 31, 33–39, and 41–62 of US Patent Application No.
14/053611 (“the ’611 application). Appellant argues that this rejection
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Application 15/724,502

19
“incorrectly relied upon a prior set of claims, not the currently pending
claims of the ’611 application.” Reply Br. 12. We decline to reach this
rejection because the claims now relied are not the same as those originally
considered by the Examiner when the rejection was initially made. See Ex
parte Jerg, Appeal No. 2011-000044, at 5–6 (BPAI Apr. 17, 2012)
(designated informative) (“Panels have the flexibility to reach or not reach
provisional obviousness type double-patenting rejections.”) (citing Ex parte
Moncla, Appeal No. 2009-006448 (BPAI June 22, 2010) (designated
precedential)).
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
30 112 Written description 30
1–3, 12,
14, 16,
18, 20–
27, 29,
33
103(a) Lahav, What is pH, Yu,
Friedman, Setty,
Important Biological
Buffers.
1–3, 12,
14, 16,
18, 20–
27, 29,
33

1, 30 103(a) Lahav, What is pH, Yu,
Friedman, Setty,
Important Biological
Buffers, Humar
1, 30
1–3, 12,
14, 16,
18, 20–
27, 29,
30, 33
Double
patenting
US Patent Application
No. 14/053611

Overall
Outcome
1–3, 12,
14, 16,
18, 20–
27, 29,
30, 33

Appeal 2020-001072
Application 15/724,502

20
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED