Dexcel Pharma Technologies Ltd.

Patent Trials and Appeals Board

Apr 13, 2021

2020001072 (P.T.A.B. Apr. 13, 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.
15/724,502 10/04/2017 Adel PENHASI 15542-15 1232
757 7590 04/13/2021
BGL
P.O. BOX 10395
CHICAGO, IL 60610
EXAMINER
AL-AWADI, DANAH J
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
04/13/2021 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 REQUEST FOR REHEARING

Appellant requests rehearing of the decision entered December 21,
2020 (hereinafter “Decision” or “Dec.”), which affirmed the Examiner’s
rejections of claims 1–3, 12, 14, 16, 18, 20–27, 29, and 33 under 35 U.S.C. §
103(a) as obvious.2 We DENY the requested relief.

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. Appeal Br. 1.
2 The Examiner made two obviousness rejections and a written description
rejection. Appellant does not specify whether it seeks rehearing on one or
both obviousness grounds. However, based on the claim numbers for which
Appellant requested rehearing, we determine that Appellant has not
requested rehearing of the Examiner’s second obviousness rejection – i.e.,
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Application 15/724,502

2
In the Decision, we affirmed the Examiner’s rejection of claims 1–3,
12, 14, 16, 18, 20–27, 29, and 33 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 In its Appeal Brief, Appellant argued all of
the claims together and we found claim 1 to be representative. Appeal Br.
7–21; Dec. 7. Claim 1 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),

the rejection of claims 1 and 30 as obvious over the combination of Lahav,
What is pH, Yu, Friedman, Setty, Important Biological Buffers, and Humar
(US Patent Publication No. 2006/0093680 A1, published May 4, 2006). In
addition, Appellant does not request rehearing of our affirmance of the
Examiner’s rejection of claim 30 under 35 U.S.C. § 112 for failure to
comply with the written description requirement.
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”).
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Application 15/724,502

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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.
Appeal Br. 26.
The Decision included the following summary explaining, in part,
why we found that the claimed composition would have been obvious over
the cited art:
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 ¶ 20.9 In re Kerkhoven, 626

9 Yu discloses “ethanolamine” as one potential alkalizing agent. Yu ¶ 20. We
understand “ethanolamine” to be the same [as] the claimed
“monoethanolamine.” See https://en.wikipedia.org/wiki/Ethanolamine#:
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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 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).
Dec. 10–11.
Appellant argues that “[t]he Board entirely overlooked Appellant’s
arguments” that “none of the cited references, alone or in combination,
teaches a benzimidazole derivative pharmaceutical composition with the pH
of its neutralized enteric coating being about 4.5 to about 6.5.” Req. Reh’g
1–2. We do not find this argument persuasive.
As an initial matter, it is not clear that this argument was properly
raised in Appellant’s Appeal Brief. The full extent of Appellant’s argument
in its Appeal Brief that the cited art does not teach the claimed pH range is

~:text= Ethanolamine%20is%20commonly%20called%20monoethanolamine
,corrosion%20inhibitors%2C%20and%20chemical%20intermediates
(“Ethanolarnine is commonly called monoethanolamine or MEA in order to be
distinguished from diethanolamine (DEA) and triethanolamine (TEA).”).
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one sentence in a paragraph discussing various things that Lahav allegedly
does not disclose. It states: “Lahav et al. is also silent as to . . . a
composition in which the neutralized enteric coating layer has a pH in the
range of from about 4.5 to about 6.5 as measured in 30 ml of distilled water
at 20-25°C as claimed.” Appeal Br. 18. After making this statement, the
Appeal Brief then argues that “[t]he other cited references do not cure the
deficiencies of Lahav.” Id. This argument amounts to little more than
reciting claim elements and asserting that they are not found in the art,
which is insufficient to properly place an issue before the Board. See In re
Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (“[T]he Board [has] reasonably
interpreted Rule 41.37 to require more substantive arguments in an appeal
brief than a mere recitation of the claim elements and a naked assertion that
the corresponding elements were not found in the prior art.”). Manifestly,
we cannot have overlooked an issue that was not properly raised.
Even if this issue were properly raised we would not find Appellant’s
arguments persuasive. Our affirmation of the Examiner’s rejection was
premised on modifying Lahav’s benzimidazole derivative composition to
include a second alkalizing agent. In the Decision, we found that Lahav’s
composition included an enteric coating material that preferably had a pH of
“from about 7 to about 10.” Dec. 10. Appellant’s Rehearing Request does
not discuss this finding or, more specifically, whether a pH of 7 is close
enough to the upper end of the range recited in claim 1 – “about 6.5” – to
meet the claim limitation. See generally Req. Reh’g. Moreover, to the
extent that Lahav’s disclosure of a pH of 7 does not meet the claim
requirement for a pH of “from about 4.5 to about 6.5,” Lahav also discloses,
more broadly, that its composition may have enteric coating with “a pH
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value of at least 6.5.” Lahav ¶ 33. This pH range – “at least 6.5” – overlaps
with the claimed range, creating a prima facie case of obviousness and
shifting the burden to the Appellant to demonstrate the non-obviousness of
the recited range. 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 does not identify persuasive evidence to rebut the prima
facie case of obviousness created by the disclosure of overlapping ranges.
Appellant argues that we erred in finding that the composition
suggested by the cited art would inherently have “a residual amount of less
than 500 parts per million of a second alkalizing agent which is ammonium
hydroxide,” based on the similarity between the method used to prepare
Lahav’s composition and the methods described in the Specification. Req.
Reh’g 2–3. More specifically, Appellant argues that we overlooked that the
method disclosed in the Specification includes two alkalizing agents while
the method disclosed in Lahav uses one alkalizing agent. Id. We disagree.
As explained in the Decision, “both the Specification and Lahav teach
preparing an enteric coating by the same method.” Dec. 14. As support, the
Decision cites “Coating C” disclosed on page 12 of the Specification and
paragraph 101 of Lahav. Id. A comparison of the method disclosed for
“Coating C” and the method disclosed for the coating in paragraph 101 of
Lahav shows that the two methods are almost word-for-word identical. See
Spec. 12; Lahav ¶ 101. As explained in the Decision, this supports the
Examiner’s finding that the two methods would result in the same amount of
residual ammonium hydroxide. Dec. 14–15; see In re Best, 562 F.2d 1252,
1255 (CCPA 1977) (“Where, as here, the claimed and prior art products are
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identical or substantially identical, or are produced by identical or
substantially identical processes, 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.”).
We recognize that Lahav does not employ monoethanolamine, but
neither does Coating C of the Specification. Spec. 12; Lahav ¶ 101.
Appellant argues that absence of monoethanolamine in Lahav is important
because “[i]t is the use of the two alkalizing agents that allows for the
claimed composition having a neutralized enteric coating with the recited . . .
residual amount of ammonium hydroxide in the claimed invention.” Reh’g
Req. 3. This argument is not persuasive because it is not supported by
evidence. See Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir.
1989) (“Attorneys’ argument is no substitute for evidence.”); In re Pearson,
494 F.2d 1399, 1405 (CCPA 1974). It is also difficult to reconcile with the
teaching in the Specification that “strong ammonium solution is used as a
volatile alkalizing agent which is evaporated during the coating process.”
Spec. 11 (identifying no “strong ammonium solution” as being present in the
tablet of Example 1);10 see also Appeal Br. 20 (“Upon drying, the volatile
alkalizing agent evaporates as ammonia gas”). Accordingly, the fact that
Lahav does not use monoethanolamine does not persuade us that its
composition – before it is modified to include a second alkalizing agent –
fails to meet the claimed amount of residual ammonium hydroxide.

10 The tablet of Example 1 includes monoethanolamine. Spec. 11. As
discussed above, we are not directed to persuasive evidence or argument
supporting that it is the presence of monoethanolamine that allows the strong
ammonium solution to evaporate.
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In addition, Appellant does not direct us to persuasive evidence or
provide persuasive argument explaining why modification of Lahav to
include a second alkalizing agent would cause the amount of residual
ammonium hydroxide to increase so as to no longer meet the amount recited
in the claims. Indeed, as discussed above, Appellant argues that the
presence of two alkalizing agents allows the claimed composition to meet
the required amount of residual ammonium hydroxide. Reh’g Req. 3.
Moreover, absent persuasive evidence or argument to the contrary, one
would expect that adding a second alkalizing agent would allow one to
decrease the amount of the first alkalizing agent. Thus, one would expect
that if, contrary to the teaching in the Specification that ammonium
hydroxide evaporates (Spec. 11), some ammonium hydroxide remained in
Lahav’s composition, the amount remaining would decrease if a second
alkalizing agent were added. Accordingly, we are not persuaded that we
erred in crediting the Examiner’s finding that the “volatile alkalizing agent
[ammonium hydroxide] would be present in the claimed amount.” Dec. 14–
15.
Appellant argues that the Decision erred in finding a reason to add
monoethanolamine to Lahav’s method in the fact that ammonium hydroxide
and monoethanolamine were both known to be used as alkalizing agents.
Reh’g Req. 5–6. According to Appellant, “the claimed invention is not
merely a mixing of two known alkalizing agents (ammonium hydroxide and
monoethanolamine) to . . . form a third composition . . . which is to be used
for the very same purpose.” Id. at 6. Rather, Appellant argues, “two
alkalizing agents, one volatile (ammonium hydroxide) and the other less
volatile (monoethanolamine), are used for the first time in an enteric coating
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for a benzimidazole derivative pharmaceutical composition.” Id. Appellant
explains:
The different volatility of these two alkalizing agents and their
impacts on the equilibrium of the chemical reactions
(neutralization) between the alkalizing agents and the enteric
coating allow the claimed invention to yield “a residual amount
of less than 500 parts per million of . . . ammonium hydroxide”
provide a pH of “about 4.5 to about 6.5 as measured in 30 ml of
distilled water at 20–25°C” in the neutralized enteric coating
and consequently a stable benzimidazole composition during
manufacturing, storage and passing through the stomach.
Id. We do not find this argument persuasive.
As discussed in the Decision, “Yu identifies both ammonium
hydroxide and monoethanolamine as alkalizing agents suitable for raising
pH.” Dec. 10 (citing Yu ¶ 20). Ammonium hydroxide and
monoethanolamine are thus both useful for the same purpose – raising pH.
Lahav uses ammonium hydroxide for that purpose. Lahav ¶ 33 (“Preferably,
a pH value in the desired range is obtained by adding an alkaline compound
to an enteric coating material. More preferably, the alkaline compound is
selected from the group consisting of sodium, potassium or ammonium
hydroxide.”). It would have been obvious to use monoethanolamine in
addition to ammonium hydroxide for that purpose. In re Kerkhoven, 626
F.2d 846, 850 (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 which is 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.”).
We recognize that ammonium hydroxide and monoethanolamine have
different volatilities and that the inventors found that using alkalizing agents
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with different volatilities provides benefits beyond just using a single
volatile alkalizing agent. See, e.g., Spec. 21 (teaching that the pH of the
coating solution may become more acidic as the ammonia solution
evaporates but that residual monoethanolamine may continue to raise the pH
of the coating). However, for the reasons discussed in the Decision,
Appellant has not established that unexpected results support the non-
obviousness of the claimed composition. Moreover, notwithstanding their
different volatilities, ammonium hydroxide and monoethanolamine are both
identified in the prior art as alkalizing agents that can be used to raise or
maintain pH. Yu ¶ 20. That the inventors may have had different reasons
for selecting the claimed alkalizing agents, or that they may have recognized
additional benefits in doing so, does not make it any less obvious to use two
known alkalizing agents in place of one to raise pH. See KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 419 (2007) (“In determining whether the subject
matter of a patent claim is obvious, neither the particular motivation nor the
avowed purpose of the patentee controls. What matters is the objective reach
of the claim. If the claim extends to what is obvious, it is invalid under
§ 103.”); see also In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992)
(“[T]he law does not require that the references be combined for the reasons
contemplated by the inventor”); Catalina Mktg. Int’l, Inc. v.
Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002) (“[T]he
patentability of . . . composition claims depends on the claimed structure, not
on the use or purpose of that structure”).
Appellant argues that the use of a second, weaker, alkalizing agent to
Lahav’s method would have been “unnecessary.” Reh’h Req. 4–5. We are
not persuaded because the rational for adding a second alkalizing agent to
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Lahav is grounded not in need, but in the proposition that it would have been
obvious to combine two compositions each of which is taught by the prior
art to be useful for the same purpose. As explained in the Decision
“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.” Dec. 15.
Appellant argues that the Examiner “never provided any reason why
a POSA would have been motivated to combine the cited references without
Freidman [sic].” Reh’g Req. 7.11 We are not persuaded because, as
discussed in the Decision the Board may rely on fewer than all of the
references relied on by the Examiner (Dec. 9–10) and because, as discussed
above and in the Decision, the remaining references support that it would
have been obvious to combine two alkalizing agents known to be useful for
the same purpose.
Appellant argues that “the Examiner did not provide any reason to
select ammonium hydroxide and monoethanolamine from a laundry list of
possible alkalizing agents, and to use them in appropriate amounts that
resulted in the claimed invention.” Reh’g Req. 8. With respect to the
“appropriate amounts” of alkalizing agent, we do not read claim 1 as
requiring any particular amount of alkalizing agent beyond the requirement
for “a residual amount of less than 500 parts per million of a second
alkalizing agent which is ammonium hydroxide.” As to the selection of the

11 We determined that Friedman was not analogous art and thus we did not
rely on Friedman in affirming the Examiner’s obviousness rejections. Dec.
9–10.
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claimed alkalizing agents, the law is clear that “[r]eading a list and selecting
a known compound to meet known requirements is no more ingenious than
selecting the last piece to put into the last opening in a jig-saw puzzle. It is
not invention.” Sinclair & Carrol Co. v. Interchemical Corp., 325 U.S. 327,
335 (1945). We note that Appellant has not identified persuasive evidence
that the selection of alkalizing agents is critical to obtaining a composition
having the claimed properties and, more particularly, that the evidence
supports that the recited pH and amount of residual ammonium hydroxide
were obtained in Lahav’s prior art composition.
In sum, Appellant has not persuaded us that we misapprehended or
overlooked any matter of fact or law in rendering the Decision.
Accordingly, based on the analysis above, we grant Appellant’s request to
the extent that we have reconsidered our Decision. For the reasons
explained above, however, we decline to modify our Decision.

CONCLUSION
Outcome of Decision on Rehearing:
Claim(s) 35 U.S.C
§
Reference(s)/Basis Denied Granted
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

Final Outcome of Appeal after Rehearing:
Claims 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,
1–3, 12, 14,
16, 18, 20–
27, 29, 33

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Setty, Important
Biological Buffers.
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
Nonstatutory
Double Patenting

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

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).

DENIED