Jeffery Jon. Seyer et al.

Patent Trials and Appeals Board

Sep 26, 2019

12819760 - (D) (P.T.A.B. Sep. 26, 2019)

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.
12/819,760 06/21/2010 Jeffery Jon Seyer PC63491A 1794
25291 7590 09/26/2019
Pfizer Inc.
Attn:Legal Patent Department, Chief IP Counsel
235 East 42nd Street
NEW YORK, NY 10017
EXAMINER
BROWE, DAVID
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
09/26/2019 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):
~IPGSMadisonDocketing@pfizer.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JEFFERY JON SEYER, AMY LEE CONDER,
ANGELA PEARCE TAYLOR, and BONNY RENÉ SHAW1
____________

Appeal 2018-000122
Application 12/819,7602
Technology Center 1600
____________

Before RICHARD M. LEBOVITZ, TAWEN CHANG, and
RYAN H. FLAX, Administrative Patent Judges.

PER CURIAM

DECISION ON APPEAL
The claims in this appeal are directed to a pharmaceutical composition
comprising sodium ibuprofen dihydrate and mannitol. The Examiner
rejected the claims under 35 U.S.C. § 103 as obvious. Pursuant to 35 U.S.C.
§ 134, Appellants appeal the Examiner’s determination that the claims are
unpatentable. We have jurisdiction for the appeal under 35 U.S.C. § 6(b).
The Examiner’s decision is affirmed.

1 The Appeal Brief (“Br.” entered July 1, 2017) lists Wyeth, LLC, as the
Real Party in Interest. Br. 3.
2 “The ’760 Application.”
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STATEMENT OF THE CASE
“Solid dosage forms of ibuprofen are well known.” Spec. 1:25.
According to the Specification, however, “poor tablet compression, stability
and disintegration remain critical formulation issues.” Id. at 1:25–27.
Further according to the Specification, the present invention is advantageous
because
it allows for the formation of [sodium ibuprofen]
tablet/caplet cores having a maximum daily sodium
content for a patient of less than 140 mg/day . . . and
further provides . . . cores and corresponding coated . . .
cores exhibiting improved physical stability, high
tablet/caplet hardness· and high . . . core strength, coupled
and balanced with excellent dissolution and bioavailability
characteristics.
Id. at 1:9–19.
Claims 1–4 and 9–12 stand rejected by the Examiner under 35 U.S.C.
§ 103(a) as obvious in view of Gruber et al. (U.S. Patent Application Pub.
No. 2008/0020042 A1, published Jan. 24, 2008) (“Gruber”). Ans. 3; Final
Act. 3.
Claims 1 and 4 are representative and are reproduced below
(indentations added for emphasis):
1. A pharmaceutical composition for commercial
manufacture and use in pain relief and/or fever reduction in
humans comprising a core, said core comprising sodium
ibuprofen dihydrate, mannitol, and at least one lubricant;
wherein the sodium content of said pharmaceutical
composition is below 140 mg per 1200 mg of free ibuprofen;
wherein the disintegration time of said core is no greater
than 5.48 minutes;
wherein the friability measurement of a batch of said core
is no greater than 0.55%; and
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wherein the pharmaceutical composition has a hardness
greater than 80 N.

4. A pharmaceutical composition for commercial
manufacture and use in pain relief and/or fever reduction in
humans comprising a coated core, said core containing sodium
ibuprofen dihydrate, mannitol,
at least one disintegrant comprising microcrystalline
cellulose in an amount greater than 0.1 %, and at least one
lubricant;
said coated core having a sodium content of less than 23
mg;
wherein the disintegration time of said core is no greater
than 5.48 minutes;
wherein the friability measurement of a batch of said core
is no greater than 0.55%; and
wherein the pharmaceutical composition has a hardness
greater than 80 N.

REJECTION
The Examiner found that Gruber discloses a core comprising sodium
ibuprofen dihydrate and mannitol, which are also recited in claims 1, 3, and
4.3 Final Act. 3. The Examiner also found that Gruber teaches that its core
may comprise calcium carbonate or tricalcium phosphate, which are
disintegrants, and microcrystalline cellulose and sodium dodecylsulfate,
which are lubricants. Id. at 3–4. The Examiner further found that Gruber
teaches compositions having a hardness and disintegration time within the
scope of the claims. Id. at 4.

3 Claim 3 is similar to claims 1 and 4, reproduced above, except that the
sodium content is described as the “composition having a ratio of sodium
ibuprofen dihydrate to total sodium content of about 11:1 by weight.” Br.
16–17 (Claims App.).
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The Examiner found that Gruber does not “explicitly disclose that the
pharmaceutical composition has a ratio of sodium ibuprofen to total sodium
of about 11:1,” as required by claim 3, or “a friability of no greater than
0.55%,” as required by all the claims. Id. Nevertheless, the Examiner
concluded that “[i]t would have been prima facie obvious for one of
ordinary skill in the art at the time of the present invention to employ the
teachings of Gruber . . . to devise Applicant’s presently claimed
pharmaceutical composition.” Id. at 5.
With respect to the claimed sodium content, the Examiner noted that
“the weight ratio of sodium ibuprofen dihydrate as a whole to sodium in
‘sodium ibuprofen dihydrate’ itself is . . . about 11:1” and found that “it is
common knowledge that the long established trend since at least the late
1960s is to provide ‘low sodium’ or ‘reduced sodium’ products for human
consumption to minimize the generally perceived hazards associated with
too much sodium intake, and to boost potassium intake.” Id. The Examiner
further found that Gruber also discloses utilizing alkali bicarbonates. Id.
The Examiner determined that it would have been obvious to one of
ordinary skill “to employ sodium ibuprofen dihydrate with an alkaline
bicarbonate agent, wherein the alkali is not sodium (e.g. is calcium or
potassium)” to minimize sodium intake and, thereby, meet the claimed
sodium content. Id.
With respect to the friability limitation, the Examiner found that,
because Gruber suggests compositions having “the same requisite
constituent elements in the same amounts” as the claimed compositions, the
properties of the compositions must also be the same and “it follows that the
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pertinent Gruber composition will have a corresponding friability, if actually
measured, of no greater than 0.55%.” Id. at 6.
DISCUSSION
Appellants do not separately argue the claims. We therefore limit our
analysis to claims 1, 3, and 4 as representative. Unless otherwise noted, we
adopt the Examiner’s findings of fact and reasoning regarding the
Examiner’s rejection of claims 1, 3, and 4 under pre-AIA 35 U.S.C. § 103(a)
(Final Act. 3–10; Ans. 3–16) and agree that these claims are obvious over
Gruber. Only those arguments timely made by Appellants in the Appeal
Brief (no Reply Brief was submitted) have been considered; arguments not
so presented in the Brief are waived. See 37 C.F.R. § 41.37(c)(1)(iv)
(2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010)
(informative) (“Any bases for asserting error, whether factual or legal, that
are not raised in the principal brief are waived.”). We highlight the
following findings of fact for emphasis.
Findings of Fact
1. Gruber teaches an ibuprofen tablet comprising a tablet core and,
if desired, a coat, wherein
the tablet core, based on the weight of the tablet core,
consists of 50 to 100% by weight sodium ibuprofen
hydrate and 50 to 0% by weight auxiliary material
component and contains no lubricant and no disintegrant,
and wherein the sodium ibuprofen hydrate has a water
content of 8 to 16% by weight, preferably 11 to 16% by
weight, possesses a sufficient hardness, is comparably
small and leads to a particularly rapid increase in blood
level and thereby to an accelerated onset of analgesic
effect.
Gruber Abstract; see also id. ¶ 36–40.
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2. Gruber teaches that the tablets of its invention can contain for
example “about 128 mg to 1024 mg of sodium ibuprofen hydrate
(corresponding to 100 mg to 801 mg ibuprofen), in which dosages in the
range of about 256 mg to 768 mg, in particular about 256 mg to 512 mg, are
generally preferred.” Id. ¶ 50.
3. Gruber teaches that “the ability of sodium ibuprofen to be
tabletized heavily depends on its water content and, contrary to current
opinion, it is possible to produce tablets with sufficient hardness and short
disintegration times, that contain comparatively little or no auxiliary
material.” Id. ¶ 18.
4. Gruber teaches that
[i]t is quite common, that the sodium ibuprofen dehydrate
[sic] is delivered from the manufacturer with a water
content not corresponding to the dihydrate, as the water of
crystallization is easily lost upon drying at 40–50° C. and
the substance easily changes into the monohydrate form
by drying. This fact illustrates the importance of a precise
control of the water content, and it may also explain why
the dependence of the ability to be tabletized on the water
content has not been discovered in the art.
Id. ¶ 25. Gruber teaches that “[a]ttention should . . . be paid during production
to ensure that the water content of the sodium ibuprofen hydrate lies in the
[suggested] ranges.” Id. ¶ 52.
5. Gruber teaches that, “[a]ccording to a preferred embodiment,
the tablet core can essentially consist of sodium ibuprofen hydrate and be
essentially free of auxiliary materials, i.e. it can contain preferably less than
0.1% by weight or especially preferably no auxiliary materials.” Id. ¶ 37.
Gruber teaches, however, that in this embodiment “the water content of the
sodium ibuprofen hydrate should be preferably about 11 to 16% by weight, a
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water content of about 12.5 to 15% by weight, in particular about 13 to 14%
by weight, being especially preferred.” Id.
6. Gruber teaches that the elimination of lubricant and disintegrant
and the reduction or elimination of further auxiliary materials in the tablet
formulation of its invention is to “enable[] a significant decrease of the tablet
weight and size.” Id. ¶ 31.
7. Gruber suggests that where the water content of the sodium
ibuprofen hydrate is lower, “a comparatively high auxiliary material
proportion is in general indicated.” Id. ¶ 49; see also id. ¶ 26.
8. Gruber teaches that its tablet “do not contain significant
quantities (i.e., less than 0.1% by weight) of lubricant in the tablet core, and
. . . are advantageously completely free of inner lubricants.” Id. ¶ 28.
9. Gruber teaches that its tablets “expediently do not contain
significant quantities (i.e. less than 0.1% by weight) of disintegrants . . . such
as . . . microcrystalline cellulose . . . and advantageously they are completely
free of such materials.” Id. ¶ 29.
10. Gruber teaches that “[t]he distintegration times of the tablets of
this invention are generally significantly below 10 minutes, typically in the
range from about 2 to 7 minutes.” Id. ¶ 30.
11. Gruber teaches that its tablets should have a tablet hardness
(measured by means of a Schleuniger Hardness Tester) of preferably at least
about 30 N, especially preferably at least about 40 N.” Id. ¶ 37; see also id.
at Table 1 (providing examples of tablets having hardness values greater
than 80 N (examples 12, 26, 29, 34, 42, 43, and 47–49)).
12. Gruber teaches that “[p]referably suitable as the auxiliary
material component in the tablet core are fillers and/or basic auxiliary
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materials. Furthermore, if desired, the tablet core can contain a low quantity
of surfactant.” Id. ¶ 41.
13. Gruber teaches that examples of preferably suitable basic
auxiliary materials include calcium carbonate and tricalcium phosphate. Id.
¶ 42. Gruber teaches that “the proportion of the basic auxiliary materials in
the tablet core may, if present, preferably be about 5 to 30% by weight, in
particular about 6 to 25% by weight, based on the weight of the tablet core.”
Id. ¶ 43.
14. Gruber teaches mannitol as an example of a preferably suitable
filler for its tablets. Id. ¶ 44. Gruber teaches that “[t]he proportion of the
filler in the tablet core can, if present, preferably amount to about 1 to 25%
by weight, in particular about 3 to 20% by weight and typically about 5 to
15% by weight, based on the weight of the tablet core.” Id. ¶ 45.
15. Although Gruber teaches that “[t]he addition of a surfactant is
. . . generally not required,” Gruber also teaches that, “[i]f desired, the tablet
mixture can also contain a surfactant such as sodium dodecylsulfate as
auxiliary material” in an amount “in general not over about 2% by weight
and . . . typically . . . 0.1 to 2% by weight, for example about 1% by weight,
based on the weight of the tablet core.” Id. ¶ 48.
16. The Examiner finds, and Appellants have not disputed, that
sodium dodecylsulfate is also known as sodium lauryl sulfate. Final Act. 4.
17. Gruber teaches examples of compositions comprising 53.0%
sodium ibuprofen hydrate, 12.7% water, 20.0% povidone K25, 5.0%
mannitol, and 22.0% NaHCO3 (Examples 47 and 48), which Gruber teaches
as having tablet hardness of 115 and 105 N respectively and disintegration
time of 7.2 and 7.8 minutes respectively. Id. at Table 1. Gruber also teaches
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that its examples 9–20, 22, 23, 26–36, 41, 44, 45 and 47–50 showed “good
to very good tablet properties (hardness, disintegration time, friability, look
of the tablet surface), in particular those of the Examples 12, 15–20, 22, 23,
29, 34, 47 and 48 resulting in practically perfect tablets.” Id. ¶ 69.
18. The Specification teaches that microcrystalline cellulose (MCC)
and sodium lauryl sulfate are lubricants. Spec. 6:29.
19. The Specification teaches that disintegrants may comprise
“microcrystalline cellulose (MCC) plus one or more of . . . metal carbonate
. . . , or calcium phosphate.” Id. at 6:33–7:5.
20. The Specification teaches that, by law, a warning must appear
on the label of over the counter drug products intended for oral ingestion “if
the amount of sodium present in the labeled maximum daily dose of the
product is more than 140 milligrams.” Id. at 7:17–25.
Appellants contend that the Examiner improperly failed to consider
the Declaration of Expert Jeffery Jon Seyer under 37 C.F.R. § 1.132 (“Seyer
Declaration”), filed on October 16, 2014. Br. 8–9. Appellants contend that
the Examiner has not established that Gruber suggests a sodium ibuprofen
dihydrate core having the claimed friability. Id. at 10. Appellants contend
that Gruber teaches away from compositions with disintegrants and
lubricants. Id. at 13. Finally, Appellants contend that a skilled artisan would
not have had reason to combine the various disclosures of Gruber with a
reasonable expectation of arriving at the claimed invention. Id. at 11, 13–14.
We address these arguments below.

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When considered together with the evidence of obviousness, the Seyer
Declaration does not show the claims to be non-obvious

Appellants contend that the Examiner did not provide a substantive
response to the Seyer Declaration. Br. 9. Appellants state that the Seyer
Declaration “provided Applicants’ rebuttal evidence to the Examiner’s
reading of Gruber and of the Examiner's finding of obviousness.” Br. 8.
Appellants state that the Seyer Declaration shows “the technological
challenges experienced by the Applicants and their developmental efforts
which led to the invention.” Id. The Declaration also provides
“experimental test data,” which Appellants contend demonstrate
“manufacturing and stability problems with prior art tablets as represented”
by Gruber and further shows “how the tablets prepared in accordance with
the present invention showed superior results” and “was commercially
successful in the marketplace.” Id. at 8–9.

The Examiner Properly Considered the Seyer Declaration
As discussed by the Examiner (Ans. 6–7), the Declaration was
addressed in the Office Action mailed January 26, 2015. Thus, we are not
persuaded by Appellants’ contention that the Examiner failed to provide a
substantive response to the Seyer Declaration.

Gruber addressed the problem of formulating sodium ibuprofen
Dr. Seyer identified problems with formulating sodium ibuprofen and
sodium ibuprofen dihydrate, stating that, because of these problems, efforts
at developing a commercially viable formulation were discontinued. Seyer
Decl. ¶¶ 8–13. Dr. Seyer stated that sodium ibuprofen dihydrate “presents a
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known challenge as it is difficult to granulate and has markedly poor
compression properties.” Id. ¶ 8. See also id. ¶ 11 (stating that “[s]odium
ibuprofen is a poorly compressible material that is difficult to work with”).
Gruber similarly mentions difficulties with formulating sodium
ibuprofen. Gruber ¶ 15. However, Gruber explained how these difficulties
could be addressed using sodium ibuprofen hydrate:
Surprisingly it was found that the ability of sodium
ibuprofen to be tabletized heavily depends on its water
content and, contrary to current opinion, it is possible to
produce tablets with sufficient hardness and short
disintegration times, that contain comparatively little or no
auxiliary material, if a sodium ibuprofen hydrate is used
with a water content of 8 to 16% by weight, preferably 11
to 16% by weight and the water content is precisely
controlled.
Gruber ¶ 18.
While Dr. Seyer identifies problems with formulating sodium
ibuprofen, he omitted the fact that Gruber acknowledged this difficulty and
disclosed using sodium ibuprofen hydrate to address it. All the rejected
claims require sodium ibuprofen hydrate, the form of sodium ibuprofen that
Gruber expressly teaches has “useful compression and disintegration
properties.” Gruber ¶ 18. Dr. Seyer states that sodium ibuprofen “is a
poorly compressible material” (Seyer Decl. ¶ 11), but Gruber recognized this
problem and solved it using sodium ibuprofen hydrate. Dr. Seyer’s
discussion about the difficulties of compressing sodium ibuprofen is,
therefore, unpersuasive because he and his co-inventors utilized the same
solution described in the prior art by Gruber.
Likewise, Dr. Seyer’s discussion about the difficulties of working
with sodium ibuprofen dihydrate is not persuasive because it does not
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address Gruber’s suggestion that manufacturing issues with sodium
ibuprofen dihydrate may be due to loss of water content due to drying, and
that by controlling water content and thereby reducing the need for auxiliary
materials a significant decrease of tablet size and weight may be achieved.
FF3, FF4, FF6.

Use of MCC in claimed invention is obvious
Dr. Seyer stated that his team was aware of publications suggesting
sodium ibuprofen combinations that did not include MCC “because that
material was thought to result in poorly compressible combinations . . . and
could also potentially retard dissolution.” Seyer Decl. ¶ 10. Dr. Seyer states
that “researchers such as Peter Gruber have taught against using MCC is
[sic, in] Sodium Ibuprofen formulations.” Id. ¶ 13. We address Gruber’s
disclosure below.
Gruber first explains that lubricants are not necessary to make its
tablets comprising sodium ibuprofen hydrate, and may even make the tablet
worse:
In fact it was found that addition of classic lubricants such as
magnesium stearate even increases the danger that the final
mixture sticks to the surface of the punch. Moreover, the
customary lubricants are hydrophobic and would decrease the
compressibility and the disintegration properties. Therefore,
the tablet formulations of this invention expediently do not
contain significant quantities (i.e. less than 0.1 % by weight) of
lubricant in the tablet core, and they are advantageously
completely free of inner lubricants.
Gruber ¶ 28.
Gruber further explains that “it turned out as a consequence of the
absence of inner lubricants, that it is also no longer required to add a
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disintegrant to the tablet mix,” allowing the proportion of auxiliary materials
to “be further reduced or even completely eliminated.” Gruber ¶ 29. MCC
is a disintegrant. Gruber teaches:
The water solubility of the sodium ibuprofen hydrate is actually
so great, that the disintegration of the tablet cannot be improved
through the addition of customary disintegrants or combinations
of fillers such as microcrystalline cellulose with disintegrants.
Therefore, the tablet formulations of this invention expediently
do not contain significant quantities (i.e. less than 0.1 % by
weight) of disintegrants or fillers with disintegrant properties,
such as crosslinked polyvinylpyrrolidones, magnesium
aluminium silicates, microcrystalline cellulose, starches,
sodium carboxymethylcellulose starches etc., and
advantageously they are completely free of such materials.
Id. (emphasis added.)
Thus, the basis for Gruber’s reason for teaching that MCC is not
necessary in its tablets is because the water solubility of sodium ibuprofen
hydrate is “so great” that additional disintegrants, such as MCC, are not
needed.
On the other hand, Gruber teaches that insignificant quantities of less
than 0.1% of a disintegrant may be present. Gruber ¶ 29 (reproduced
above). Claim 4 recites a pharmaceutical composition comprising “at least
one disintegrant comprising microcrystalline cellulose in an amount greater
than 0.1%.” While the two ranges do not overlap, they “are so close that
prima facie one skilled in the art would have expected them to have the
same properties,” shifting the burden to the applicant to show they are
different and thus should not be considered obvious from the prior art
composition. Titanium Metals Corp. v. Banner, 778 F.2d 775, 783 (Fed.
Cir. 1985); see also In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)
(“We have . . . held that a prima facie case of obviousness exists when the
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claimed range and the prior art range do not overlap but are close enough
such that one skilled in the art would have expected them to have the same
properties.”). Appellants have not met this burden.
Moreover, as the Examiner points out, the broadest reasonable
interpretation of the claim limitation “at least one disintegrant comprising
MCC in an amount greater than 0.1%” is that the total amount of
disintegrants in the composition, including MCC, be greater than 0.1% –
i.e., the amount of MCC by itself need not be greater than 0.1%. Final Act.
7. As the Examiner also points out, Gruber teaches that its compositions
may comprise other ingredients, e.g., calcium carbonate, and the
Specification teaches that the disintegrants of the invention may comprise
MCC plus a metal carbonate. Id.; see also FF13, FF19. Given that Gruber
teaches that its composition may include less than 0.1% MCC and also
suggest inclusion of a metal carbonate such as calcium carbonate, Gruber
suggests at least one disintegrant comprising MCC in an amount greater than
0.1%.
We, therefore, agree with the Examiner’s finding that disintegrant
limitation in claim 4 is met by Gruber’s disclosures.
With regard to Dr. Seyer’s arguments about MCC having negative
properties and Gruber teaching away from its use (Seyer Decl. ¶ 13), Gruber
teaches that Examples 24 and 25 show that “tablet formulations, which
additionally contain microcrystalline cellulose, talc and, if applicable, the
disintegrant material Kollidon CL, are worse than comparable examples
without these additions.” Gruber ¶ 71. Gruber specifically states that “tablet
hardness is not improved through these additions, and the disintegration time
is about 9 minutes.” Id. However, Gruber does not solely attribute this
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result to MCC because talc is also present, and even if Gruber did, the
amount of MCC in these tablets is 10.5% (Gruber 7, Table 1), which is more
than 100-fold more than the claimed lower limit of above 0.1%. Appellants
have not established that a skilled artisan would, based on such result with
10.5% MCC and talc, predict that values as low as about 0.1% MCC would
have the same worsening effect.
Neither Gruber nor the Seyer Declaration suggests that the prior art
unequivocally teaches away from using MCC. Gruber teaches prior art in its
background section which used MCC in ibuprofen formulations. Gruber ¶¶
10, 12. Dr. Seyer acknowledged in his Declaration that MCC is “commonly
used as a binder/filler in tablet formations” and “[i]ncluding MCC often
results in hard, durable tablets suitable for large scale commercial
manufacture.” Seyer Decl. ¶ 13. Therefore, Dr. Seyer admits that MCC was
known to be beneficial in tablets, consistent with Gruber’s disclosure,
providing an additional reason to have included it in a tablet.

Use of mannitol in claimed invention is obvious
Dr. Seyer also states that “mannitol in a formulation usually results in
a low hardness, friable tablet that breaks apart easily when chewing.” Seyer
Decl. ¶ 12. However, Gruber teaches three formulations comprising sodium
ibuprofen dihydrate and mannitol with hardness values of 76 N, 115 N, and
105 N, respectively (Examples 45, 47, and 48 in Table 1 of Gruber ¶ 66), the
latter two of which meet the claimed hardness limitation of 80N. Thus, Dr.
Seyer’s statement about mannitol leading to “low hardness” is not supported
by the evidence before us.
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Furthermore, Gruber discloses that mannitol is a preferred filler (Final
Act. 10; FF14) and states that such fillers “improve the compressibility” of
the tablet (Gruber ¶ 44), providing an express reason to have incorporated it
in a tablet.

Seyer Declaration does not evidence secondary considerations
commensurate with the scope of the claims
Dr. Seyer described in his Declaration testing the combination of
mannitol and MCC, and each of these ingredients by itself. Seyer Decl.
¶ 16. In paragraphs 17 and 18 of his Declaration, he describes “how [the
inventors] ho[m]ed in [on their] best formulation of using combinations of
mannitol with MCC to achieve excellent manufacturing characteristics
despite MCC being discounted by other established experts such as Peter
Gruber.” Seyer Decl. ¶ 15.
To begin, as noted by the Examiner, the results achieved in the Seyer
Declaration are accomplished with specific amounts of mannitol and MCC.
Ans. 7–9; Seyer Decl. ¶¶ 16–17 (Tables 1 & 6). The claims are unlimited as
to specific amounts. Seyer’s experiments also describe placing the mannitol
and MCC in either 1) the granulation or 2) the compression mix prior to
carrying out the compression process. In Table 1, MCC is in the
compression mix and mannitol is in the granulation of Formula 1. In Table
6, MCC is in the compression mix, but the mannitol is in both the
granulation and compression mix. Dr. Seyer describes this “placement” of
MCC and mannitol components as a “new idea.” Seyer Decl. ¶ 17. Dr.
Seyer stated “by carefully choosing the right blend and the placement in the
formula, we were able to formula very good tablets that have not been
achievable by others and that could be easily commercialized.” Id. ¶ 18.2.
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However, the claims are neither limited to how the formulation is
manufactured nor to whether the mannitol and MCC are placed in the
granulation, compression mix, or both. Claim 1 does not even require the
presence of MCC. Thus, to the extent that Dr. Seyer’s experiments are
intended as evidence of secondary considerations,4 they are not
commensurate with the full scope of the claim because, while the claim is
limited to specific hardness, friability, and disintegration characteristics, it is
not limited to the specific amounts of each ingredient or the manufacturing
process utilized to achieve such values. See In re Harris, 409 F.3d 1339,
1344 (Fed. Cir. 2005).
Moreover, Appellants did not establish a nexus between the evidence
and the claimed pharmaceutical composition. “A nexus between the merits
of the claimed invention and the evidence of secondary considerations is
required in order for the evidence to be given substantial weight in an
obviousness decision.” Simmons Fastener Corp. v. Illinois Tool Works, Inc.,
739 F.2d 1573, 1575 (Fed. Cir. 1984); Hearing Components, Inc. v. Shure

4 Factual considerations that underlie the obviousness inquiry include the
scope and content of the prior art, the differences between the prior art and
the claimed invention, the level of ordinary skill in the art, and any relevant
secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17–18
(1966). Relevant secondary considerations include commercial success,
long-felt but unsolved needs, failure of others, praise, and unexpected
results. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007); Institut
Pasteur & Universite Pierre Et Marie Curie v. Focarino, 738 F.3d 1337,
1344 (Fed. Cir. 2013); In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995).
Secondary considerations are “not just a cumulative or confirmatory part of
the obviousness calculus but constitute[] independent evidence of
nonobviousness . . . [and] enable[] the court to avert the trap of hindsight.”
Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358 (Fed. Cir. 2013)
(internal quotation marks and citations omitted).
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Inc., 600 F.3d 1357, 1374 (Fed. Cir. 2010). In this case, the merits of the
invention described in Dr. Seyer’s Declaration is a composition comprising
specific amounts of each of the claimed ingredients made by a specific
manufacturing process, none of which are recited in the claims. Thus, the
recited characteristics and “new idea” relied upon by Appellants were
conferred by specific features that are not recited in the claims. Therefore,
Appellants have not established a nexus between what is actually claimed
and the properties recited in the claims and described in Dr. Seyer’s
Declaration.
Finally, Dr. Seyer stated that the product described in his Declaration
“has been tremendously successful in the U.S. marketplace for a year and a
half with no equivalent products fielded by competitors.” Seyer Decl.
¶ 18.2. However, no evidence of the stated commercial success has been
provided, such as “significant sales in a relevant market.” Ormco Corp. v.
Align Technology, Inc., 463 F.3d 1299, 1311–1312 (Fed. Cir. 2006). Thus,
there is insufficient information to determine whether the product described
in Dr. Seyer’s Declaration was commercially successful.

Comparisons to Gruber’s compositions in Seyer Declaration does not
show claims are non-obvious
Appellants state that “[t]wo of the closest Gruber formulations were
tested to show their inferior quality and characteristics.” Br. 9. Appellants
state that such results “further demonstrat[e] that Gruber’s approach and
disclosure would not have taught one of skill in the art to make the claimed
formulations.” Id. at 10. In particular, the Seyer Declaration states that Dr.
Seyer tested the tablets made according to the formulation in Examples 42
and 47 of Gruber and found that the friability of these tablets were outside
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the claimed amount of “no greater than 0.55%” and that Gruber’s Examples
42 and 47 “would not be . . . commercially viable formula[s].” Seyer Decl.
¶¶ 19.1–19.3.
The evidence is not sufficiently persuasive. As an initial matter,
“[A]ll disclosures of the prior art, including nonpreferred embodiments,
must be considered.” In re Lamberti, 545 F.2d 747, 280 (CCPA 1976).
Thus, the fact that certain examples in Gruber may not meet the friability
limitation of the claims does not show that Gruber’s disclosures fail to
render the claimed composition obvious.
We further note that, while the Seyer Declaration sets out the raw
material formula used to make the tablets of Gruber’s Examples 42 and 47,
the declaration fails to state the water content of the sodium ibuprofen
dihydrate. Seyer Decl. ¶¶ 19.2–19.3. In light of Gruber’s explicit
disclosures regarding the importance of water content in the ability of
sodium ibuprofen to be tabletized and the need to ensure that water content
of the sodium ibuprofen hydrate lies in the suggested ranges, the Seyer
Declaration has not provided sufficient evidence for us to evaluate whether
the tested formulations are, in fact, identical to the formulations of Gruber’s
Examples 42 and 47. FF3, FF4.
In addition, the Seyer Declaration states that Gruber’s formulas were
“compressed . . . using 10.5 mm round tooling so as to compare to the
manufacturing process” in the instant application. Seyer Decl. ¶ 19.2.
Gruber, however, states that its formulations were “compressed on a rotary
press with 16 presses at an average hourly output of 40[,]000-60[,]000
tablets.” Gruber ¶ 65. It is thus unclear whether Dr. Seyer in fact used
identical manufacturing procedure as that described in Gruber. To the extent
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the compression tools were indeed different, Appellants did not establish
that departing from Gruber’s manufacturing process by using the 10.5 mm
rounding tool would have had no effect on the tablet’s subsequent friability
value. Seyer Decl. ¶ 19.3.
Assuming that the formulations tested in the Seyer Declaration are
identical to the formulations of Gruber’s Examples 42 and 47 and made by
the same process, and to the extent the experimental data in Seyer’s
Declaration is intended to show evidence of unexpected results, we are not
persuaded. We have already explained that the experimental data contained
in the Seyer Declaration is not commensurate with the scope of the claims
and have not shown sufficient nexus between the claim limitations and any
expected results. Furthermore, we are not persuaded that the Seyer
Declaration has compared the claimed compositions to the closest prior art.
For example, Gruber’s Example 42 does not comprise either mannitol
(as in claims 1, 3, and 4) or MCC (as in claim 4). Thus, Example 42 is not
the “closest Gruber formulation” because it lacks mannitol, which is
required by all the claims, and MCC, which is required by claim 4. In
contrast, Example 45 of Gruber, which was not tested by Dr. Seyer, appears
closer than Example 42 to the claimed composition because it contains
mannitol. Example 42 is also characterized by Gruber as “sticky,” and is not
among the list of tablets said to have good friability or to be “practically
perfect,” while Example 45 is described as having good to very good tablet
properties (hardness, distintegration time, friability, look of the tablet
surface).” Gruber ¶ 69. Accordingly, one of ordinary skill in the art would
not have expected Example 42 to have good friability, but instead would
have expected it to be inferior.
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We note that Dr. Seyer also did not test Example 48, which has the
same ingredients and amounts as Example 47, but is made by a different
manufacturing process. The Seyer Declaration states that Example 48 was
not tested because it has the same ingredients as Example 47 and lower
hardness. Seyer Decl. n. 1. As Dr. Seyer acknowledges, however,
Examples 48 and 49 are manufactured differently. Id. In particular, the
tablets in Gruber were produced by combining materials A (i.e., auxiliary
material(s) in the granulate) and material B (i.e., tabletization auxiliary
material(s)). Gruber ¶¶ 64, 65. The NaHCO3 is placed in material B in
Example 47 and in material A in Example 48. Gruber ¶ 66 (Table 1). To
the extent Appellants argue that placement of the tablet ingredients in the
granulation and compression mix affected the properties of the resulting
tablet, see, e.g., Seyer Decl. ¶ 18.2, Dr. Seyer has not established that
Example 48, with the NaHCO3 placed in a different auxiliary material than
in Example 47, would have a friability outside the claimed range.
Dr. Seyer’s apparent purpose was to show that Gruber’s formulations
comprising mannitol, and having a hardness within the scope of the claims,
do not meet the claimed friability limitation. Assuming this to be the case,
such a result would still not show that it would not be obvious for a skilled
artisan to arrive at the claimed compositions, for the reasons discussed
above. Moreover, as explained above, Dr. Seyer did not test Examples 48
and 45,5 both of which also contained mannitol, and it is unclear whether the

5 Gruber’s Example 45 has a reported hardness of 76 N, which is slightly
lower than the claimed value of greater than 80 N. Gruber Table 8.
However, as shown in Gruber Figure 1, it is known that tablet hardness may
be increased at least to some extent by increasing the compressive force.
Gruber Fig. 1.
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identical manufacturing process was used. Therefore, Dr. Seyer did not
even persuasively establish that the recited friability was not achieved or
achievable by Gruber with a formulation comprising mannitol.

The Examiner has established a prima facie case of obviousness with
respect to the friability limitation

Appellants contend that the Examiner has not shown that Gruber’s
tablets meet the limitation regarding friability (no greater than 0.55%). Br.
10. Appellants emphasize that Gruber “does not disclose the friability of
any of the disclosed tablets.” Id. We are not persuaded.
As discussed above, Gruber suggests a composition comprising all of
the claimed ingredients, even if it does not provide an example of a
composition comprising all of these ingredients. “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. Whether the
rejection is based on ‘inherency’ under 35 U.S.C. § 102, on ‘prima facie
obviousness’ under 35 U.S.C. § 103, jointly or alternatively, the burden of
proof is the same, and its fairness is evidenced by the PTO’s inability to
manufacture products or to obtain and compare prior art products.” In re
Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations and footnote omitted).
Appellants contend that “[i]t is factually incorrect that Gruber’s
disclosed compositions are the same as those claims being appealed.” Br.
10. Appellants do not explain what is factually incorrect about the
Examiner’s finding in this regard. To the extent that Appellants’ argument
is that none of the examples disclosed in Gruber contain all of the
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ingredients required by the claims, we note that “all disclosures of the prior
art, including nonpreferred embodiments, must be considered.” In re
Lamberti, 545 F.2d 747, 280 (CCPA 1976). Appellants’ focus on only
Gruber’s examples is thus misguided.
Neither are we persuaded by Appellants’ arguments relying on the
Seyer Declaration, i.e., that “representative samples from Gruber showed
much poorer friability measurements.” Br. 10. In addition to the issues we
noted above with respect to the testing described in the Seyer Declaration,
none of the Gruber examples tested in the Seyer Declaration contain all of
the ingredients recited in the claims, even though such a composition is
suggested by Gruber’s disclosures. Thus, the fact that they allegedly showed
“much poorer friability measurements” does not suffice to meet the burden
articulated in In re Best for showing that “the prior art products do not
necessarily or inherently possess the characteristics of [the] claimed
product.”

A skilled artisan would have had reason to manufacture tablets
having the claimed sodium content.

Appellants contend that a skilled artisan would not have had
“motivation to prepare a low-sodium sodium ibuprofen composition.” Br.
11 (emphasis omitted).
We are not persuaded. As explained above, the Examiner found that,
in making a composition suggested by Gruber, a skilled artisan would have
had a reason to utilize an alkaline bicarbonate agent using an alkali other
than sodium, in order to minimize sodium intake. Final Act. 5. Thus, the
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Examiner found that Gruber’s disclosures render the claimed sodium content
prima facie obvious. Id.
Appellants contend that the evidence cited by the Examiner as a
reason to lower the sodium content “only discusses sodium levels in the
context of food and daily consumption and does not suggest reducing the
sodium content of a medicine such as ibuprofen.” Br. 11.
This argument is not persuasive. Based on the molar sodium content
of sodium ibuprofen dihydrate, the Examiner found that the sodium content
recited in the claims is “basically equivalent to stipulating that the sodium
ibuprofen dihydrate is the only element in the composition that contains
sodium.” Final Act. 7–8. Appellants did not dispute this finding. The
Examiner also found that “Gruber’s examples 1–8, 10–12, 14, 21, and 33
disclose compositions in which the sodium ibuprofen dihydrate is the only
element in the composition that contains sodium.” Id. at 8. The Examiner,
therefore, concluded that Gruber contemplated compositions without
additional sodium. Id.
Gruber also discloses using alkali material other than a sodium salt,
such as potassium hydrogen carbonate. Gruber ¶ 42; Final Act. 7. Thus,
even if the Examiner’s reasoning regarding lowering sodium content to
minimize sodium intake were not persuasive, the Examiner established that
Gruber described formulations which lacked additional sodium and
contemplated other carbonate salts.
Finally, while the evidence cited by the Examiner for lowering
sodium intake may have been directed at foods, one of ordinary skill in the
art is “not an automaton,” but is a person of “ordinary creativity” (KSR, 550
U.S. at 421) and would have recognized sodium intake could be reduced
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from any source, including a pharmaceutical. Indeed, this is shown by the
Specification itself, which explains that “by law, a warning must appear on
the label of over the counter drug products intended for oral ingestion “if the
amount of sodium present in the labeled maximum daily dose of the product
is more than 140 milligrams.” FF20.

Gruber does not teach away from the claimed compositions
comprising disintegrants and lubricants

Appellants contend that Gruber teaches away from the inclusion of
lubricants and disintegrants. Br. 13. We are not persuaded.
Claims 1, 3, and 4 all recite “at least one lubricant,” but does not limit
how much (or little) lubricant is present. Gruber discloses that the lubricant
can be present in an amount “less than 0.1% by weight” of its formulations.
Gruber ¶ 28. Moreover, as the Examiner points out, Gruber teaches that its
tablets may contain 0.1 to 2% sodium dodecylsulfate, also known as sodium
lauryl sulfate, which the Specification acknowledges to be a lubricant.
FF15, FF18. Thus, Gruber does not teach away from including the amount
of lubricants required by the claims.
Claim 4, as discussed above, further comprises a disintegrant, which
comprises MCC in an amount greater than 0.1%. Gruber discloses that the
disintegrants can be present in an amount “less than 0.1% by weight” of its
formulations. Gruber ¶ 29. As discussed above, the claimed ranges “are so
close that prima facie one skilled in the art would have expected them to
have the same properties,” shifting the burden to Appellants to show they are
different. Titanium Metals, 778 F.2d at 783; see also In re Peterson, 315
F.3d at 1329. This burden was not met.
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As also discussed above, the broadest reasonable interpretation of the
claim limitation “at least one disintegrant comprising MCC in an amount
greater than 0.1%” is that the total amount of disintegrants in the
composition, including MCC, be greater than 0.1%. The Specification
teaches that the disintegrants of the invention may comprise MCC plus a
metal carbonate. FF19. In addition to teaching that the composition may
contain disintegrants in an amount less than 0.1%, Gruber also teaches that
its compositions may comprise calcium carbonate, which is a metal
carbonate, in an amount of about 6 to 25% by weight. FF13. Accordingly,
Gruber does not teach away from a composition comprising “at least one
disintegrant comprising MCC in an amount greater than 0.1%.”

The Examiner has established a prima facie case that a skilled artisan
would have had reason to combine Gruber’s disclosures to arrive at
the claimed invention, with a reasonable expectation of success

Appellants contend that the Examiner erred in concluding
that one of ordinary skill in the art would have a reasonable
expectation that the resulting tablet would exhibit the optimal
rate of disintegration and maximum hardness, and been
motivated to make the claimed invention, AND would have
been able to make the claimed invention by attempting routine
variations of the cited prior disclosures.
Br. 13. We are not persuaded and address each of these arguments below.

A skilled artisan would have a reasonable expectation of success in
preparing the claimed tablets
As an initial matter, and as already discussed above with respect to the
friability limitation, Gruber suggests a composition having all of the claimed
ingredients in the claimed amounts. Thus, a skilled artisan would have a
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reasonable expectation of success of preparing a tablet having the claimed
ingredients. In light of the substantial similarity between the claimed
composition and the composition suggested by the prior art, the burden is
shifted to Appellants to show that the composition suggested by Gruber
would not necessarily or inherently possess the characteristics (i.e., hardness,
disintegration times, and friability) of the claimed product. In re Best, 562
F.2d at 1255. Appellants have not provided persuasive evidence to satisfy
this burden, and to the extent such properties are inherent, they do not render
the claims non-obvious even if a skilled artisan cannot “reliably predict”
such properties. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“The
discovery of a new property . . . of a previously known composition, even
when that property . . . [is] unobvious from the prior art, can not impart
patentability to claims to the known composition.”).
Furthermore, a skilled artisan would have a reasonable expectation of
being able to prepare a tablet having the claimed rate of disintegration and
hardness by following Gruber’s disclosures, because Gruber explicitly
teaches that its tablets have disintegration times and hardness values that
overlap with the claimed ranges and also teaches that several of its
formulations showed “good to very good tablet properties” including
friability and others of which resulted in “practically perfect tablets.” FF10
(teaching tablets typically having disintegration times from about 2 to 7
minutes); FF11 (teaching that it is especially preferable that tablets have
hardness of at least about 40 N and providing examples of tablets having
hardness values above 80 N); FF17. “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 at 1329–30, and
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Appellants have not provided persuasive evidence why a skilled artisan
would not reasonably expect to be able to prepare a tablet having the
claimed characteristics when Gruber teaches tablets having overlapping
disintegration times and hardness values.

A skilled artisan would be motivated to prepare tablets having the
claimed properties
As already discussed, Gruber teaches sodium ibuprofen dihydrate
tablets having the claimed auxiliary ingredients as optional ingredients.
Thus, Gruber’s explicit disclosures serves as motivation for a skilled artisan
to prepare tablets comprising claimed ingredients. Appellants have not
provided persuasive evidence showing that such a composition would not
necessarily or inherently possess the claimed characteristics relating to
hardness, disintegration times, and friability. In re Best, 562 F.2d at 1255.
A skilled artisan need not have the same reason as Appellants (e.g., to
achieve a certain hardness, disintegration times, and/or friability) to combine
the ingredients in the claimed manner. KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 419-20 (2007).
Moreover, we are not persuaded by Appellants’ apparent argument
that a skilled artisan would not have been motivated to prepare a tablet
having the allegedly optimal hardness and disintegration times. As
evidenced by Gruber, hardness and disintegration times (as well as friability)
are well-known in the prior art as important tablet properties for
optimization. FF17.
Appellants argue that “[t]here is . . . no suggestion of the desirability
of tablets having hardness greater than 80N as Gruber is satisfied with
relatively low hardnesses of about 30N or 40N” and that Gruber “does not
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discuss friability at all.” Br. 14. We are not persuaded. Gruber teaches that
tablet hardness is especially preferred to be at least about 40 N, but suggests
that much higher hardness values are desirable: all of the examples Gruber
describes as “almost perfect” tablets have hardness values significantly
above 40 N. FF11, FF17. Likewise, as already discussed and contrary to
Appellants’ contention, Gruber suggests that friability is an important tablet
property by listing it among the properties considered in evaluating its
examples. FF17.
Finally, we are not persuaded by Appellants’ arguments that, because
“Gruber exemplified numerous possible combinations of excipients, many or
most of which are not within the presently claimed composition,” that “it is
only with the hindsight benefit of [Appellants’] disclosure that one of
ordinary skill could pick and choose [and] discern which specific
pharmaceutical elements could be selected from the prior art to recreate the
claimed invention.” Br. 13–14. While it is true that Gruber discloses many
possible combinations of excipients, not all of which would be within the
claimed composition, the claimed compositions are not non-obvious merely
because Gruber made obvious compositions other than what is claimed.
Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989)
(“[D]isclos[ing] a multitude of effective combinations does not render any
particular formulation less obvious. This is especially true because the
claimed composition is used for the identical purpose taught by the prior
art.”)
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Appellants have not shown that a skilled artisan would not have been
able to arrive at the claimed invention based on Gruber’s disclosures
Appellants contend that, “[a]lthough Gruber discloses a sodium
ibuprofen composition, Gruber does not disclose a composition with
qualities and characteristics as strong as [Appellants’]” and “contains no
suggestion that one could reliably predict tablet properties as claimed. Br.
14.
We note once again that, because Gruber suggests a composition
having all of the claimed ingredients, the burden is shifted to Appellants to
show that the suggested composition would not have the claimed hardness,
disintegration times, and friability. In re Best, 562 F.2d at 1255. We find
Appellants have not met this burden.
Appellants point to the fifty examples in Table 1 of Gruber showing
“various tablets have extremely different hardnesses and disintegration times
(even when prepared using similar recipes) and there is no suggestion of
how to predict the properties of the resultant tablets in view of the varying
manufacturing formulas provided.” Br. 14. Appellants argue that there is no
disclosure in Gruber how to predict the hardness and disintegration times,
and that Gruber “states in para. 0027 that hardness and disintegration time
are nearly independent of the compressive force used during tabletization
despite the lack of a disintegrant. Accordingly, this disclosure does not
provide any teaching of how to prepare or predict tablet properties.” Id.
We are not persuaded. None of the examples in Table 1 of Gruber
contains all of the claimed ingredients in the amounts suggested by Gruber
(e.g., MCC, mannitol, lubricants such as sodium lauryl sulfate, calcium
carbonate). Thus, they do not satisfy Appellants’ In re Best burden for
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showing that the composition rendered obvious by Gruber (i.e., a sodium
ibuprofen dihydrate tablet comprising the claimed ingredients in the amounts
suggested by Gruber) would not necessarily or inherently have the claimed
tablet properties relating to hardness, disintegration times, and friability
when manufactured in the manner taught in Gruber.
We acknowledge Appellants’ argument that Gruber appears to show
that compositions containing the same ingredients in the same amounts (e.g.,
Examples 28, 29, and 30 of Gruber) may have different hardness values,
friability, and disintegration times depending on the manufacturing process.
Br. 14. However, because the claims recite a range of hardness values,
friability, and disintegration, and because examples 28, 29, and 30 are very
different from the compositions comprising the claimed ingredients that are
suggested by Gruber, we find that this evidence does not persuasively show
that the tablets suggested by Gruber containing all of the claimed ingredients
would not necessarily or inherently fall within the claimed ranges of
hardness, friability, and disintegration times, if manufactured in the manner
taught by Gruber.
Indeed, we do not agree with Appellants’ argument that “Gruber does
not disclose a composition with qualities and characteristics as strong as
Applicants’” or that Gruber does not “provide any teaching of how to
prepare or predict tablet properties.” Br. 14. Some of the closer examples in
Gruber to the claimed composition are Examples 45, 47, and 48, because
each of these comprise mannitol. Example 45 has a disintegration time of
4.3 min, which is within the scope of claims 1, 3, and 4, although it has a
hardness of 76 N which falls outside of it. However, it is so close to 80 N, it
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would be reasonably expected to have the same properties. Titanium Metals,
778 F.2d at 783. The friability of this tablet was not tested by Dr. Seyer.
Examples 47 and 48 have hardness values of 115 N and 105 N,
respectively, which are within the claim scope, but have disintegration times
of 7.2 min and 7.8 min, outside the scope of the claims. However, as found
by the Examiner, Figure 1 of Gruber suggests that the hardness and
disintegration times within the scope of the claim could be routinely met by
following Gruber’s guidance. Specifically, Figure 1 of Gruber, which
reveals “the hardness and the disintegration time of a tablet of this invention
in relation to the compressive force used in the tabletization process”
(Gruber ¶ 19), shows a compressive force that results in a tablet having a
disintegration time below 5 and a hardness of 80 N, both values of which
meet the corresponding values of the claim. See Final Act. 9 discussing the
values shown in Figure 1 of Gruber.
Figure 1 is reproduced (grey shading added) below:

Figure 1, reproduced above, shows the compressive force to make a
tablet with a hardness of about 80 N and above and a disintegration time
below about 5 min (grey shading added to emphasize these values). While
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these tablets do not contain mannitol (Gruber ¶ 27), Gruber attributes the
hardness and short disintegration times to the water content of the sodium
ibuprofen. Gruber ¶ 18 (reproduced above). It is true, as discussed by
Appellants, that Gruber states that “hardness and disintegration time of the
tablets of this invention are nearly independent of the compressive force
used during tabletization” (Gruber ¶ 27) (emphasis added), yet Gruber
shows there is a relationship in at least a part of the graph and Figure 1
expressly shows compressive forces that result in properties that meet the
claimed limitations.
With respect to the claimed friability property, while Gruber does not
disclose actual friability values, Gruber discloses that its tablets exhibit good
friability. Gruber ¶ 69; Ans. 9–10. We agree with the Examiner that
“Appellant cannot patent or re-patent a prior art composition merely by
documenting a ‘new’ property of the prior art composition, even if the
property is not expressly disclosed in the prior art.”6 Answer 10. Thus,
because Appellants determined the friability of only one of three examples
in Gruber comprising mannitol and did not test examples said to have good
friability (Gruber ¶ 69), it has not been persuasively established that
Gruber’s examples lack the friability disclosed in the claims.

6 It is well-established by case precedent that merely recognizing something
that was inherent, but not known before, is insufficient to render an old
process again patentable. In re Cruciferous Sprout Litig., 301 F.3d 1343,
1351 (Fed. Cir. 2002); see also In re Woodruff, 919 F.2d 1575, 1578 (Fed.
Cir. 1990); MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365
(Fed. Cir. 1999); In re Omeprazole Patent Litig., 483 F.3d 1364, 1373 (Fed.
Cir. 2007).
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SUMMARY
For the foregoing reasons, the obviousness rejection of claims 1, 3,
and 4 is affirmed. Claims 2 and 9–12 were not argued separately, and fall
with claims 1, 3, and 4. 37 C.F.R. § 41.37(c)(1)(iv).

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)(1)(iv).

AFFIRMED