ALLEN RAU et al.

Patent Trials and Appeals Board

Apr 7, 2021

2020005456 (P.T.A.B. Apr. 7, 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.
13/867,308 04/22/2013 ALLEN RAU PHYZ-0025-UT1 5366
80308 7590 04/07/2021
The Kelber Law Group
6701 Democracy Blvd
Suite 300
Bethesda, MD 20817
EXAMINER
LOVE, TREVOR M
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
04/07/2021 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):
steve@kelberlawgroup.com
susan@kelberlawgroup.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ALLEN RAU, DONALD STADOLIK,
MELVIN CORCINO, and FREDDY ACOSTA
____________

Appeal 2020-005456
Application 13/867,308
Technology Center 1600
____________

Before DONALD E. ADAMS, RYAN H. FLAX, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

FLAX, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision under 35 U.S.C. § 134(a) involving claims directed
to a denture cleanser.1 Claims 11–18 are on appeal as rejected under
35 U.S.C. § 103. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.2

1 “Appellant” herein refers to the “applicant” as defined by 37 C.F.R. § 1.42.
Appellant identifies the Real Party-in-Interest as “Tower Laboratories LTD.”
Appeal Br. 2.
2 Oral argument was heard from Appellant on March 23, 2021. A transcript
of the hearing (“Hr’g Tr.) will be made a part of the record.
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RELATED MATTERS
Appellant indicates that “[t]here are no other prior or pending appeals,
interferences or judicial proceedings that may be related to, directly affect,
be directly affected by, or have some bearing on the Board’s decision.”
Appeal Br. 3. We note this is not the first appeal to the Board in this
application, but that a decision affirming a final rejection of the claims was
entered by the Board in Appeal No. 2016-001380. We also note that the
claims on appeal here differ from those in the prior appeal.
STATEMENT OF THE CASE
Independent claim 11 is representative and is reproduced below:
11. A denture cleanser in the form of a compressed tablet
exhibiting reduced friability, wherein said denture cleanser
comprises
a bleach,
an excipient compatible with said bleach, and
an agent to reduce friability, wherein said agent to reduce
friability is PEG-400 present in amounts of about 0.1% - 0.6%
by weight of the tablet,
said compressed tablet exhibits a hardness of at least 4.7
kp and
wherein said compressed tablet comprising said PEG-400
exhibits a hardness of at least eighty percent (80%) of the
hardness exhibited by said compressed tablet prepared in the
absence of said PEG-400.
Appeal Br. 49 (Claims Appendix; formatting added).
The Specification states that “friability describes a tablet’s propensity
to crumble. When a tablet formulation displays high friability, it crumbles
easily[,] [h]ighly friable tablets are difficult to convey during production and
are hard to package and transport,” and “[c]onsumers, reasonably, expect
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their tablet products to be unbroken and whole.” Spec. ¶ 1. The
Specification also states that the “[h]ardness of a tablet is impacted by a
wide variety of factors, one of which is the character of the central or active
agent of the tablet, as well as the excipients included therewith.” Id. ¶ 12.
The Specification further states:
We have discovered that low molecular polyethylene
glycols can dramatically improve the friability of tablet
formulations when incorporated at surprisingly low levels. In
particular, polyethylene glycols in the range of about PEG 200[3]
to about PEG 1000 give superior performance and improvement
in friability, without a significant loss in hardness or other
properties, when formulating tablets in otherwise customary
fashion.
Id.
The following rejection is appealed:
Claims 11–18 stand rejected under 35 U.S.C. § 103 over Welsh.4 See
Final Action 3–7; see also Answer 3–4 (explaining that the obviousness
rejection is over Welsh alone).
DISCUSSION
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Regarding obviousness, “[t]he combination of familiar elements
according to known methods is likely to be obvious when it does no more

3 “PEG” refers to polyethylene glycol and the number associated with
“PEG” refers to its molecular weight. Spec. ¶ 2.
4 US 3,518,343 (issued June 30, 1970) (“Welsh”).
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than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
416 (2007).
Where claimed subject matter has been rejected as obvious in
view of a combination of prior art references, a proper analysis
under § 103 requires, inter alia, consideration of two factors: (1)
whether the prior art would have suggested to those of ordinary
skill in the art that they should make the claimed composition or
device, or carry out the claimed process; and (2) whether the
prior art would also have revealed that in so making or carrying
out, those of ordinary skill would have had a reasonable
expectation of success. Both the suggestion and the reasonable
expectation of success must be founded in the prior art, not in the
applicant’s disclosure.
In re Vaeck, 947 F.2d 488, 493 (Fed. Cir. 1991) (citation omitted). “Even
when obviousness is based on a single prior art reference, there must be a
showing of a suggestion or motivation to modify the teachings of that
reference.” In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). “‘[M]erely
throw[ing] metaphorical darts at a board’ in hopes of arriving at a successful
result, [where] ‘the prior art gave either no indication of which parameters
were critical or no direction as to which of many possible choices is likely to
be successful,’” impermissibly involves “‘hindsight claims of obviousness.’”
In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent
Litigation, 676 F.3d 1063, 1070–71 (Fed. Cir. 2012) (quoting In re Kubin,
561 F.3d 1351, 1359 (Fed. Cir. 2009) and In re O'Farrell, 853 F.2d 894, 903
(Fed. Cir. 1988)).
We review the Examiner’s determinations and Appellant’s arguments
in view of these standards of law.
The Examiner determines that Welsh teaches all the claimed tablet
components, without directly exemplifying them together in a single tablet
and, further, does not directly indicate that PEG-400 is used in the tablet
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formulation. Final Action 3–4. The Examiner determines that Welsh
teaches forming tablets with lubricants, including PEG of a molecular
weight range of 250–2000, and using it at a concentration of at least 0.5%,
which are ranges covering those recited for the claimed component. Id. at 3
(citing Welsh, 2:60–68, 3:6–9, claim 1). The Examiner also determines that
Welsh teaches tablets having a hardness of 6.4–10.7 (kg), which also
includes the claimed hardness. Id. (citing Welsh, Table 1).
Appellant presents a voluminous body of arguments spanning 74
pages of briefing and including two inventor declarations and two other new
exhibits as evidence. See Appeal Br.; Reply Br.; Declaration of Allen Rau
dated Mar. 13, 2019 (Rau 1); Declaration of Allen Rau dated Apr. 17, 2019
(Rau 2). Appellant, generally, argues that Welsh is a confusing, internally
scientifically conflicting reference that lacks the teachings necessary to have
instructed the skilled artisan to combine its disclosed tablet components in a
way so as to have arrived at the claimed invention, that evidence of
unexpected results in the Specification rebuts any prima facie case for
obviousness, and that there is evidence of commercial success in the
invention regarding Appellant’s ability to market a commercial tablet
product at all.5 See generally Appeal Br.; Reply Br. As explained below,
we are persuaded by Appellant’s first argument.

5 On this record, Examiner does not dispute Rau’s definition of the skilled
artisan as:
[S]omeone of ordinary skill in the art in the field of tableting of
chemical formulations would typically hold an undergraduate
degree in chemistry, chemical engineering or similar educational
experience. That person would also have at least 2 – 3 years of
field experience in the preparation of formulations that are
tableted, and the problems encountered in preparing such tablets.
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Appellant argues that:
The target of [Welsh], and the reason for its casual (if
inexplicable) reference to[,] but no exemplification of PEG 250
- 2000, is the creation of an alternate form of “lubricant,” which
is identified as either “fumaric acid or particles of a liquid
lubricant coated with a water-soluble, oil insoluble film forming
substance.” Welsh. Col. 1, ll. 64-67.
Appeal Br. 18. Appellant argues that “the solid-state lubricant of Welsh
‘consists of particles of a lubricating oil coated with an oil insoluble, water
soluble film-forming substance.’ Welsh, Col. 2., 11. 59-61.” Id. Appellant
further argues that Welsh
is not directed to tablets comprising PEG-400 at all; it is directed
to tablets comprising coated particles of some uncertain nature
that may be provided a core of some amount of a synthetic oil
. . . . That is not a teaching to provide a tablet compounded of
0.1 – 0.6% PEG-400 as claimed herein.
Id. at 20. Appellant summarizes this, stating “the ‘lubricant’ of Welsh is a
coated particle, NOT a polyethylene glycol.”
We agree with Appellant that there is a lack of clarity in Welsh’s
disclosure of PEG as a component of a tablet formulation, and also conclude
that any determination that the claimed PEG-400 component at the claimed
concentration is taught by the prior art and may affect tablet hardness and
friability is premised on impermissible hindsight, relying upon the teachings
of the application on appeal.

They would be familiar with the issues of poor friability
presented by those tablets - the tendency of the edges of the
tablets to crumble and the tablets to lose coherency over time or
when shipped or handled.
Rau Declaration 1, ¶ 3. We apply this definition herein.
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According to Welsh, its tablets include a “coated particulate lubricant”
that “consists of particles of a lubricating oil coated with an oil-insoluble,
water soluble film-forming substance.” Welsh 2:59–61. Welsh identifies a
variety of vegetable oils, animal oils, mineral oil, and PEG-250 to PEG-
2000, as potentially being the lubricating oil part of this coated particulate
lubricant, and identifies a variety of, e.g., gums, celluloses, proteinaceous
materials, and polymeric materials, as the potential film-former part. Id.
2:69–3:71. Welsh states that the coated particle lubricant can be about 0.5%
to about 50% of the total weight of the tablet; however, contrary to the
Examiner’s assertions, this concentration does not relate solely to PEG, but
would be the combination of the lubricating oil and film-former in whatever
form they take after their combination. Id. at 2:63–68; see also id. at 3:71–
4:8 (disclosing the process of making the coated particle lubricant).
Welsh never discusses PEG again, but the reference does discuss how
the coated particle component is formed, e.g., by combining 1-9 parts film-
former and 1 part lubricating oil in an oil-in-water emulsion,6 spraying this
emulsion into moving air, and collecting the dried, coated particles. Id. at
3:72–4:7. Although Welsh indicates the starting materials, the ultimate
composition of these particles is not specified. Welsh does disclose several
examples of tablets, each including a vegetable oil as the oil component of
the coated particles. Welsh also discloses measurements of tablet hardness
of 3–4 kg, 6.4 kg, 8.7 kg, and 10.7 kg, which appears to evolve over time
after tableting, for a tablet having refined vegetable oil as the lubricating oil

6 Appellant’s Specification evidences that PEG-200, PEG-400, and PEG-600
are fully soluble in water; thus, it is not clear how such materials would be
used to make an oil-in-water emulsion. Spec. ¶ 28 (Table 5).
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component of the coated oil particles, which were included at 1.4% by
weight of the tablet. Id. at 6:46–70, 9:48–10:28 (Example VII, Table 1).
Welsh does not teach the hardness (nor friability) of any tablet composed of
PEG.
Welsh makes no suggestion that its coated particles or their
lubricating oil components have any relationship to the tablet’s hardness.
Moreover, Welsh does not mention friability as a concern when formulating
a tablet or a characteristic dependent upon any components. These
omissions by the reference are important in view of the claimed invention,
which recites that PEG-400 is used as a tablet friability reducer and that
including this component in a tablet formulation results in “a hardness of at
least 4.7 kp and wherein said compressed tablet comprising said PEG-400
exhibits a hardness of at least eighty percent (80%) of the hardness exhibited
by said compressed tablet prepared in the absence of said PEG-400.”
Appeal Br. 49.
Welsh does not teach that PEG (or any lubricant) has any relationship
to tablet hardness or friability. Appellant cites its Specification as
explaining that the claimed PEG-400 falls within a critical molecular weight
range, and that the claimed PEG-400 concentration, i.e., 0.1–0.6% by weight
of the tablet, is also a critical range, which together thread a proverbial
needle when including PEG in a tablet so that the tablet can be formed
without being overly friable, but still retain suitable hardness. See Appeal
Br. 23–33 (citing, e.g., Spec. ¶¶ 18, (Table 1), 22, 25 (Table 3).
Appellant’s Specification evidences that, when other tablet
components are kept constant, tablets with PEG-400 concentrations of 0.1–
1.0% (by tablet weight) exhibit good friability and maintain hardness, but
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using less PEG-400 results is “unacceptable” friability and using more
PEG-400 results in “unacceptable” hardness (or lack thereof). Spec. ¶¶ 23–
24 (Table 2). Furthermore, the Specification evidences that tablets having
PEG at molecular weights of 200–1000 exhibited good friability and
maintained hardness, but that not including PEG resulted in worse friability
and that the use of higher molecular weight PEG resulted in unacceptable
hardness and friability. Id. ¶ 25 (Table 3).
“[A] patentable invention may lie in the discovery of the source of a
problem even though the remedy may be obvious once the source of the
problem is identified. This is part of the ‘subject matter as a whole’ which
should always be considered in determining the obviousness of an invention
under 35 U.S.C. § 103.” In re Sponnoble, 405 F.2d 578, 585 (CCPA 1969)
(the inventor discovered the cause of moisture transmission through a plug,
there was no teaching in the prior art to suggest the necessity of the claimed
plug material). Here, the named inventors of the claimed invention
recognized that, when using PEG in a tablet, friability and hardness can vary
to unacceptable levels unless the excipient is used in a specific range of
molecular weights and in a specific range of concentrations.7 Welsh does
not suggest this specific relationship or recognize the general relationship
between its lubricants and friability and hardness. This fact supports the
non-obviousness of the claims.
“The law is replete with cases in which the difference between the
claimed invention and the prior art is some range or other variable within the

7 Appellant’s evidence indicates that PEG-400 is a, somewhat, necessary
component in one of its commercial products, which embodies the appealed
claims. Rau Declaration 1, ¶ 17.
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claims. These cases have consistently held that in such a situation, the
applicant must show that the particular range is critical, generally by
showing that the claimed range achieves unexpected results relative to the
prior art range.” In re Woodruff, 919 F. 2d 1575, 1578 (Fed. Cir. 1990)
(citations omitted, emphasis in original). Here, although Welsh may
arguably disclose a range of PEG molecular weights and potentially disclose
a range of concentrations of such PEG overlapping the claimed ranges, as
discussed above, Appellant has identified evidence that the claimed ranges
are critical to the hardness and friability of the tablet in which the PEG is
used. As noted above, the prior art of record does not make such an
association and, thus, provides no teaching that would have directed the
skilled artisan to the claimed range. This also supports the non-obviousness
of the claims.
Finally, Appellant provides evidence that the skilled artisan would not
have been led to optimize or modify Welsh’s disclosed molecular weight
and concentration of PEG to arrive at the invention with any reasonable
expectation of success because the reference is internally inconsistent as to
the use of PEG and its properties (e.g., Welsh calls for a synthetic oil, PEG
is not one; Welsh calls for an oil-in-water emulsion, PEG-400 is soluble in
water; Welsh does not identify the end-composition resulting from its
process for forming coated particulate lubricant). Appellant also provides
evidence that much of the potential range of PEG’s molecular weight and
concentration taught by Welsh would result in tablets having unacceptable
friability and hardness characteristics. See Spec. ¶¶ 23–25 (Tables 2, 3).
“While absolute certainty is not necessary to establish a reasonable
expectation of success, there can be little better evidence negating an
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expectation of success than actual reports of failure.” Boehringer Ingelheim
Vetmedica, Inc. v. Schering–Plough Corp., 320 F.3d 1339, 1354 (Fed. Cir.
2003). Appellant’s evidence in the Specification (¶¶ 23–25) illustrates
several failures when using PEG outside the claimed range, but within the
potential ranges taught by Welsh. Appellant’s evidence supports that there
would have been unreasonable uncertainty regarding Welsh’s teaching of
using PEG. This also supports the non-obviousness of the claims.
For the reasons set forth above, we are persuaded by Appellant’s
arguments for the non-obviousness of the claims. Therefore, we reverse the
Examiner’s obviousness rejection.
DECISION SUMMARY
In summary:
Claim(s)
Rejected 35 U.S.C. § References/Basis Affirmed Reversed
11–18 103 Welsh 11–18

REVERSED