Ex Parte RAU et al

Patent Trial and Appeal Board

Oct 17, 2017

13867308 (P.T.A.B. Oct. 17, 2017)

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 10/18/
The Kelber Law Group
1875 Eye Street, N.W., Fifth Floor
Washington, DC 20006
EXAMINER
KARPINSKI, LUKE E
ART UNIT PAPER NUMBER
1616
MAIL DATE DELIVERY MODE
10/18/2017 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 ALLEN RAU, DONALD STADOLNIK,
MELVIN CORCINO, and FREDDY ACOSTA1
Appeal 2016-001380
Application 13/867,308
Technology Center 1600
Before DONALD E. ADAMS, DEMETRA J. MILLS, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a tablet exhibiting reduced friability. Claims 1—7 are on
appeal as rejected under 35 U.S.C. § 112, first paragraph, and § 103(a);
claims 9 and 10 are withdrawn from consideration.2 We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as “Tower Laboratories, Ltd.”
App. Br. 2.
2 Oral argument was heard October 12, 2017, where Appellants’ counsel
indicated that claims 9 and 10 should be considered withdrawn from
consideration.
Appeal 2016-001380
Application 13/867,308
STATEMENT OF THE CASE
The Specification states:
the term friability describes a tablet’s propensity to
crumble. When a tablet formulation displays high friability, it
crumbles easily. This is not a good thing. Highly friable tablets
are difficult to convey during production and are hard to package
and transport. Consumers, reasonably, expect their tablet
products to be unbroken and whole.
This invention is based on the inclusion of lower
molecular weight polyethylene glycol (low MW PEG) in tablet
formulations. These PEGs are liquid at room temperature
(melting points below about 35°C). They have average
molecular weights of about 200 to 800. We have discovered that
low molecular weight PEG has the surprising benefit of
dramatically improving the friability of tablet formulations.
Spec. H1—2.
Claim 1 is the sole independent claim, is representative, and is
reproduced below:
1. A tablet exhibiting reduced friability, comprising an active
agent, an excipient compatible with said active agent, and an
agent to reduce friability, wherein said agent to reduce friability
is present in amounts of about 0.1 % — about 5.0 % by weight of
the tablet, said friability reducing agent comprises a compound
which exhibits a solubility in room temperature water of at least
eighty percent (80%) (w/w%), wherein said friability reducing
agent is comprised of at least three percent (3%) by weight -OH
moieties and wherein said tablet comprising said friability
reducing agent exhibits a hardness of at least eighty percent
(80%) of the hardness exhibited by said tablet prepared in the
absence of said friability reducing agent.
App. Br. 17 (Claims App’x).
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Appeal 2016-001380
Application 13/867,308
The following rejections are on appeal:3
Claims 1—7 stand rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the enablement requirement. Final Action 2—3.
Claims 1—7 stand rejected under 35 U.S.C. § 103(a) over Flamed.4 Id.
at 6.
DISCUSSION
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the claims and prior art, and conclusions set out in the Final
Office Action and Answer. Only those arguments presented by Appellants
in the Briefs have been considered in this Decision. Arguments not
presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv).
Enablement
“The enablement requirement is met if the description enables any
mode of making and using the invention.” Johns Hopkins Univ. v. Cellpro
Inc., 152 F.3d 1342, 1361 (Fed. Cir. 1998) (quoting Engel Indus., Inc. v.
Lockformer Co., 946 F.2d 1528, 1533 (Fed. Cir. 1991)). However,
“[sjection 112 requires that the patent specification enable those skilled in
the art to make and use the full scope of the claimed invention without
undue experimentation. . . . [S]ee also In re Goodman, 11 F.3d 1046, 1050
(Fed. Cir. 1993) (‘[T]he specification must teach those of skill in the art how
to make and how to use the invention as broadly as it is claimed.’).”
3 A rejection under 35 U.S.C. § 112, second paragraph, for indefmiteness is
withdrawn. Ans. 2. And, as noted above at n.2, claims 9 and 10 are
withdrawn from consideration.
4 US 2008/0031947 A1 (published Feb. 7, 2008) (“Hamed”).
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Application 13/867,308
Invitrogen Corp. v. Clontech Labs. Inc., 429 F.3d 1052, 1070-71 (Fed. Cir.
2005) (internal quotes omitted).
Factors to be considered in determining whether a disclosure
would require undue experimentation... include (1) the quantity
of experimentation necessary, (2) the amount of direction or
guidance presented, (3) the presence or absence of working
examples, (4) the nature of the invention, (5) the state of the prior
art, (6) the relative skill of those in the art, (7) the predictability
or unpredictability of the art, and (8) the breadth of the claims.”
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). We note,
[e]ven if some of the claimed combinations were inoperative, the
claims are not necessarily invalid. “It is not a function of the
claims to specifically exclude ... possible inoperative substances
. . .” In re Dinh-Nguyn, 492 F.2d 856, 858-59 (CCPA 1974).. . .
Of course, if the number of inoperative combinations becomes
significant, and in effect forces one of ordinary skill in the art to
experiment unduly in order to practice the claimed invention, the
claims might indeed be invalid.
Atlas Powder Co. v. E.I. Du Pont De Nemours & Co., 750 F.2d 1569, 1576
(Fed. Cir. 1984) (citations omitted).
The Examiner determined that, while the Specification may be
enabling for a range of embodiments within the scope of the claims, i.e., the
use of PEG 400 at 0.1-0.6% /wt., it did not support the entire scope of the
invention as defined by claim 1. See Final Action 2—3. In analyzing the
claims and disclosure under the Wands factors, part of the Examiner’s
reasoning was that there are specifically identified and claimed
embodiments, i.e., “polyethylene glycol of about 200-1,000, polypropylene
glycol of about 250-1,000, methoxypolyethylene glycol of about 350-1,000,
polysorbate, glycerin and mixtures thereof’ at claim 3, which define a
certain scope of the dependent and independent claims, but the Specification
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Application 13/867,308
describes embodiments using the same materials and concentrations as
claimed that were not acceptable or failed to meet the hardness limitation of
claim 1. Id. at 3^4. For example, the Examiner identifies that the
Specification describes an embodiment with 5% PEG 400 as not meeting the
“80% hardness limitation” and providing a formulation where a tablet could
not be pressed, an embodiment where 1.0% PEG 400 also did “not meet the
80% hardness limitation,” and an embodiment where polysorbate 80 (at
0.6% by wt.) also did “not meet the 80% hardness limitation as claimed.”
Id. at 4.
Appellants argue that the embodiments disclosed in the Specification
as failing to meet the specific requirements of claim 1 are only at the
“extremes of the recited ranges,” and that such failures “could not have been
predicted.” App. Br. 11. Appellants argue that any experimentation
required to practice the invention would not be undue and cite the
Declaration of Rau, which indicates the Specification is “replete with
examples and results” as a guide, as support therefore. Id. at 11—12. We do
not find Appellants’ arguments persuasive.
Claim 1 is written to cover any friability reducing agent with the
solubility, -OH moieties, and hardness qualities recited, and this agent is
recited to be present in amounts of about 0.1% to about 5.0% /wt. The
dependent claims, e.g., 3, 4, and 5, narrow the scope of such agents to PEG
200-1000, PPG 250-1000, MPEG 350-1000, polysorbate, glycerine, and
mixtures thereof. The Specification is explicit that 5% PEG 400, which is
within the claim scope, will not work, at least because the hardness of the
tablet is unacceptable and also because the inventors could not even make a
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Application 13/867,308
tablet with it. Spec. Tflf 9, 24, 36 (Table 8). Also, the Specification indicates
that Polysorbate 80, when included in a tablet at 0.6% / wt, which is within
the claim scope, also fails the hardness test. Spec. 127 (Table 4). Further,
PEG 1000 and PPG 700, also within the claim scope, were identified in the
Specification as only “somewhat” improving friability. Spec. 128 (Table 5).
Also, a tablet with 1.0% PEG 400, again within the claim scope, achieved a
hardness of 3.7 kp, which amounts to only 69% of the hardness (5.4 kp) of a
tablet without PEG 400, while claim 1 requires 80%. Spec. 36 (Table 8).
These represent failures not limited to the extreme limits of the claimed
ranges, which are expressly identified in the Specification and which create
uncertainty about the claimed subject matter. Based on the Specification,
while there are some embodiments within the scope of the claims that are
described as working, there is no way to know how to reliably produce
embodiments across the entire scope of the claims. Moreover, Appellants’
Declaration evidence states that testing each possible weight percentage of
each agent is “an impossible task.” Rau Declaration 110.
Based on the facts identified above and in view of the above-cited
precedent, we conclude the Specification does not provide the guidance
necessary to enable the practice of the invention within the scope of the
claims without undue experimentation. We affirm the enablement rejection.
Obviousness
“[Wjhen a patent claims a structure already known in the prior art that
is altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result.” KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007), citing United States v.
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Application 13/867,308
Adams, 383 U.S. 39, 50-51 (1966). “The combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.” Id.
We find that, under the above-cited precedent, the Examiner has
established that claim 1 would have been obvious over Hamed. The
Examiner provides a detailed and well-reasoned explanation as to how
Hamed teaches and suggests the claimed subject matter. Final Action 6—8.
We will not restate all the Examiner’s findings, but accept them as our own.
We note, Hamad teaches a tablet with an active pharmaceutical
ingredient and excipients. Hamed 17. Hamed teaches including PEG 400
in such a tablet in an amount ranging from about 0% to about 5% /wt. Id.
1 60. Moreover, Hamad also teaches including Tween®, which is
Polysorbate 80, in an amount ranging from about 0.5% to about 5% /wt. Id.
1 69. Hamed also discloses an exemplary embodiment identified as batch
“009-07/1,” which includes 35% phenylephrine as an active ingredient and
0.21% PEG 400, among other ingredients. Id. 196 (Table). The hardness of
this exemplary batch including PEG 400 was indicated to be 26.2 N. Id.
1101 (Table). Comparing this to batch 457-06 (where PEG 400 is absent),
which had a hardness of 32.8 N, the batch including PEG 400 in the claimed
amount had a hardness of 79.87%, or -80%, of the batch not including that
friability reducing agent. Id.
Further, we agree that there would have been motivation to select the
claimed components, in the claimed amounts, from the cited prior art, at
least because the Hamed reference teaches and suggests it, which would
have been reasonably expected to succeed because the references says it was
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Application 13/867,308
successful. Appellants have not produced evidence showing, or persuasively
argued, that the Examiner’s determinations are incorrect.
Appellants contend there would have been no motivation to use an
agent of the type claimed. App. Br. 14. Appellants contend the data of
Hamed relied upon by the Examiner showed PEG 400 did not provide the
80% hardness limitation of the claims (citing Rau Declaration 112). Id.
These are not persuasive arguments, at least for the reasons discussed above.
As identified above, Hamed discloses an embodiment within the
scope of claim 1. No modifications would have been necessary. We affirm
the obviousness rejection.
SUMMARY
The enablement rejection of claims 1—7 under 35 U.S.C. § 112, first
paragraph, is affirmed
The obviousness rejection of claims 1—7 under 35 U.S.C. § 103(a) is
affirmed.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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