Ex Parte Fang et al

Patent Trial and Appeal Board

Feb 21, 2017

13862199 (P.T.A.B. Feb. 21, 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.
13/862,199 04/12/2013 Qi Fang 15660-24 (BLS 1080US1) 1859
129259 7590 02/21/2017
BGL/Banner Life Sciences
c/o CPA Global
P.O. Box 52050
Minneapolis, MN 55402
EXAMINER
COUGHLIN, DANIEL F
ART UNIT PAPER NUMBER
1619
MAIL DATE DELIVERY MODE
02/21/2017 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 QI FANG, DON A. ARCHIBALD,
MADHU SUDAN HARIHARAN, and ROGER E. GORDON1
Appeal 2015-005646
Application 13/862,199
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN and
RYAN H. FLAX, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a). The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse and enter a New Grounds of Rejection.
1 Real Party in Interest is Banner Pharmacaps, Inc. App. Br. 3.
Appeal 2015-005656
Application 13/862,199
STATEMENT OF CASE
According to the Specification, the invention is directed to soft elastic
capsules and methods for their manufacture. Spec. 5.
The following claims are representative. Remaining claims are found
in the Appendix to the Brief.
1. An enteric soft elastic capsule, comprising:
a gastric-resistant capsule shell that defines an
encapsulated space comprising a
predetermined volume;
a liquid or semisolid fill comprising a first active
ingredient located within the
encapsulated space; and
a first compressed tablet comprising a volume that is at
least 25% smaller than the encapsulated space and having a
dimension range of 2 mm to 16 mm, being located within the
encapsulated space, unanchored to the capsule shell, and
surrounded by the fill, said tablet comprising a second active
ingredient and being substantially insoluble in the fill.
24. The soft elastic capsule of claim 1, wherein the capsule shell
further comprises a gelling agent.
Grounds of Rejection
1. Claims 1, 5—7, 17, 18, 20, 21, 23, 27, 28, and 30-33 are rejected
pursuant to 35 U.S.C. § 103(a), as being obvious over Duena,2
Altamar3 and Chidambaram.4
2 Duena et al., WO 2012/013331 A2, published February 2, 2012.
3 Altamar et al., WO 2012/017326 A2, published February 09, 2012.
2
Appeal 2015-005646
Application 13/862,199
2. Claims 24 and 26 are rejected pursuant to 35 U.S.C. § 103(a) as
being obvious over Duena in view of Altamar, Chidabaram, and Andersen.4 5
FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Final Action at
pages 2—13.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
The Federal Circuit has held that, where the only difference between
the prior art and the claims was a recitation of relative dimensions of the
claimed device and a device having the claimed relative dimensions would
not perform differently than the prior art device, the claimed device was not
patentably distinct from the prior art device. Gardner v. TEC Systems, Inc.,
725 F.2d 1338, 1344 (Fed. Cir. 1984).
4Chidambaram et al., US 2007/0082046 Al, published April 12, 2007.
5 Andersen et al., US 2010/0266848 Al, published October 21, 2010.
3
Appeal 2015-005646
Application 13/862,199
Rejections 1 and 2
We find that the Examiner has not provided specific evidence or a
cogent rationale to serve as a basis for the capsule and tablet size dimensions
in claim 1 to support a prima facie case of obviousness. In particular, the
Examiner did not provide a specific indication of support in the prior art that
the compressed table and capsule size were known to those of ordinary skill
in the art to be result effective variables.
Rejection 1 is reversed. Rejection 2 is also reversed base upon its
dependency upon Rejection 1.
New Grounds of Rejection
We enter the following New Grounds of Rejection under 37 C.F.R.
§ 41.50(b):
Claims 1, 5—7, 17, 18, 20, 21, 23, 24, 26—28, and 30-33 are rejected
pursuant to 35 U.S.C. § 103(a), as being obvious over Altamar, in view of
Andersen, Chidambaram, and the Oxford Dictionary definition of tablet.
Altamar discloses softgel capsules having incorporated therein
other solid dosage forms, such as pellets, smaller capsules, or smaller
tablets (see Abstract), wherein the capsules contain two drugs that are
not compatible with each other (see, p. 1,11. 12—15; p. 9,11. 19-21),
wherein the capsule is made of gelatin [pending claim 17] (see p. 9,1.
23; p. 14,11. 19-20), wherein one of the drugs is an omega-3 oil (see
p. 16,1. 6) [pending claims 5, 7], wherein the second drug is
acetylsalicylic acid (see p. 16,1. 19) [pending claim 6], and wherein
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Appeal 2015-005646
Application 13/862,199
the internal solid dosage forms comprise a substantial portion of the
internal volume of the softgel capsule (see FIGS. 6, 7). Altamar
discloses (see Abstract), “softgel capsules having incorporated therein
other solid dosage forms selected from the group consisting of pellets,
smaller capsules, smaller tablets, sustained release solid dosage
forms.” Figures 6 and 7 of Altamar show smaller tablets or capsules
within a larger capsule may be of varying size. Altamar discloses (see
p. 3) that softgels generally comprise an outer shell primarily made of
gelatin, a plasticizer, and water, and a fill contained within the shell.
Andersen discloses that it is well known in the art to prepare
gelatin capsules of varying size (p. 3), diameter and volume (p. 11).
In particular, Andersen discloses that
The seamless dry capsules may be of a non-spherical
shape, such as oval; oblong; or cylindrical, in which the
capsules have both a length and a diameter, the length differs
from the diameter of the capsule, and either the length or the
diameter is in the range of 0.5 to 35 mm. Non-spherical, larger
capsules, i.e. capsules with a length or a diameter above about
12 mm, may be particularly useful for oral consumption as non-
spherical shapes may provide benefits such as ease of
swallowing compared to a spherical seamless capsule. Typical
dimensions for such a large capsule are length of from about 12
mm to about 30 to 35 mm and even 40 mm, for example, from
about 15 to about 30-35 mm, from about 18 to about 30-35 mm,
from about 20 to about 30-35 mm, or from about 25 to about
30-35 mm, and a diameter of about 5-12 mm, for example,
about 7-12 mm, about 8-12 mm, or 10-12 mm. The fill weight
for such a large capsule may be about 500-2500 mg, for
example, about 750-2000 mg, about 1000-1500 mg, or 1200-
1400 mg.
Andersen 1123. Andersen also discloses that,
5
Appeal 2015-005646
Application 13/862,199
As a result, the capsules can be pharmaceutical, veterinary,
agricultural or nutraceutical solid dosage forms and can be used in
specialty applications such as paintballs or as a cosmetic product such
as bath oils, etc. Depending on the emulsion used and the components
added, the capsules can be manipulated to control the release of the
active ingredient as desired in its end use, e.g., in vivo the capsules
can be in a form of immediate or delayed release.
Andersen 1103. Thus, the combination of Altamar and Andersen teaches
that capsule size, length, diameter, and volume are result effective variables,
for example sizing for easy swallowing, and that internal tablets or capsule
may be of varying sizes. See In re Boesch, 617 F.2d 272, 275 (CCPA 1980)
(“This accords with the rule that discovery of an optimum value of a result
effective variable in a known process is ordinarily within the skill of the
art.”) One of ordinary skill in the art would have understood that it is also
well known in the art that tablet or capsule size may vary with required
dosage or type of application, e.g., agricultural, cosmetic, or pharmaceutical
use. Andersen 1103.
We find it would have been prima facie obvious at the time of the
invention to fabricate soft gel capsules comprising omega-3 oils as a first
active ingredient, and a solid dosage form comprising a second active
ingredient, wherein the capsule is made of soft gelatin, as well as additional
additives such as plasticizers, as taught by Altamar, wherein the solid dosage
forms comprise acetylsalicylic acid, and occupy a significant portion of the
internal volume of the capsule, as expressly taught by Altamar. It also
would have been prima facie obvious at the time of the invention to vary the
size of the tablet and capsule, as capsule size and dosage are result effective
variables in view Altamar and Andersen.
6
Appeal 2015-005646
Application 13/862,199
It also would have been prima facie obvious at the time of the
invention to modify the capsule shell material of Altamar to comprise from 8
to 20% wt. of a natural film-former, such as pectin, or a synthetic film-
former, such as a methacrylic acid/methacrylic acid methyl ester co-polymer
(EUDRAGIT® LI00), acid-resistant polymer, and from 10 to 50% wt. of a
plasticizer, as taught by Chidambaram in place of the capsule shell material
that requires a subsequent enteric coating of Andersen (| 106). One of skill
in the art would be motivated to do so, with a reasonable expectation of
success, by a desire to combine, but physically separate potentially
incompatible active drug species, such as omega-3 oils and salicylic acid, in
a single dosage form. In addition the express teachings of Chidambaram
disclose the effect that application of enteric coatings to dosage forms, and
the resulting dosage forms, all display problems, such as uneven distribution
of the coating material on the surface of the dosage form. These problems
are even more critical with gelatin capsules due to the delicate and heat
sensitive nature of the capsule material, and may be solved by incorporating
the acid-resistant polymer into the gelatin-based shell material (see
Chidambaram | 8). For these reasons we find Appellants’ claim 1 would
have been obvious over the cited prior art combination.
In addition to the prior art teachings discussed above, with respect to
Appellants’ claims 5—7, Altamar teaches, “administering orally to a mammal
a double soft capsule containing a first substance in a first capsule, which is
enclosed with a second substance, incompatible with the first substance, in a
second larger soft capsule.” Altamar, p. 10.
With respect to Appellants’ claim 18, Chidambaram discloses a well-
known capsule shell is prepared from a mass comprising a film-forming
7
Appeal 2015-005646
Application 13/862,199
polymer, an acid insoluble polymer, an aqueous solvent, and optionally a
plasticizer. Chidambaram 1 86.
Suitable film-forming polymers include gelatin. Chidambaram
Abstract. Suitable acid-insoluble polymers include acrylic-acid/methacrylic
acid copolymers. Chidambaram 127. The acid-insoluble polymer is
present in an amount from about 8% to about 20% by weight of the wet gel
mass. Chidambaram 131. Chidambaram teaches a weight ratio of acid-
insoluble polymer to film-forming polymer is from about 25% to about 50%.
Chidambaram p. 2 (first partial paragraph). Thus, Chidambaram discloses a
capsule shell with a range of film-forming, natural polymers encompassing
the claimed range, according to Appellants’ claim 18. Andersen discloses a
gel forming polymer including pectin. Andersen 1 86.
As to Appellants’ claims 20-24, Andersen discloses capsules
including gel forming polymers of either alginate or pectin (see 1 86), which
are identical to Appellants’ gastric resistant polymers (see Spec. 2).
Andersen discloses that, “[a] typical concentration of gel-forming polymer
in gelling solution ... is about 0.1 wt% to about 10 wt%, preferably about
0.5 wt% to about 7 wt% by total weight of the gelling solution.” Andersen
186.
With respect to Appellants’ claim 24, Andersen discloses capsules
having a wall of gel-forming polymer and a gelling agent, wherein the
gelling agent typically comprises a polyvalent cation (see 1 85), wherein
suitable polyvalent cations include calcium (see 199), and wherein the
gelling agent comprises from about 2% to about 15% wt. of the emulsion
formulation from which the capsule shell material is formed {see 1100).
8
Appeal 2015-005646
Application 13/862,199
Andersen also generally teaches (see 1100) that, “the gelling agent is
present at levels of “25 wt%, or less.”.
Appellants summarized their arguments with respect to the
Examiner’s rejection as follows:
1. The asserted combination of references does not teach or
suggest all the elements of the claims;
2. The asserted combination does not teach the claimed volume
or size elements of the compressed tablet;
3. The asserted combination does not teach any ranges that
could overlap with Appellants’ claims;
4. The asserted combination does not teach any result effective
variables to optimize to arrive at Appellants’ claimed volume
and dimension elements;
5. The asserted combination does not teach or suggest that the
second active ingredient should be insoluble in the liquid or
semisolid fill;
6. The asserted combination teaches away from using a
“compressed tablet;”
7. The asserted combination does not teach any result effective
variables to optimize to arrive at a “compressed tablet;” and
8. The dependent claims are nonobvious because claim 1 is
nonob vious.
App. Br. 20. We address these arguments below with respect to the New
Ground of Rejection entered herein.
9
Appeal 2015-005646
Application 13/862,199
With respect to the above-summarized arguments 1—4 and 6—8, the
cited evidence shows that internal tablet or capsule sizes may vary, and that
the surrounding capsule size may also be varied, and that such dimensions
are result effective variables, e.g., the capsule size is varied to provide easier
swallowing for patients. Altamar, p. 3, 11; Andersen 1123. Based on the
same evidence we understand capsule and tablet size may also vary based on
the type of application and or dosage to be administered.
While Appellants are correct that patent drawings do not define the
precise proportions of the elements and may not be relied on to show
particular sizes if the specification is completely silent on the issue (App. Br.
11), we do not rely on Figs. 6 and 7 of Altamar for precise sizes. Altamar,
Fig. 6, in particular, provides a general disclosure of an example of a ratio of
smaller tablets or capsules within a larger capsule, and evidences that the
tablets or capsules within a larger capsule may be of varying size, with no
particular size restrictions. It is also well settled that, where the only
difference between the prior art and the claims was a recitation of relative
dimensions of the claimed device and a device having the claimed relative
dimensions would not perform differently than the prior art device, the
claimed device was not patentably distinct from the prior art device.
Gardner, 725 F.2d at 1344.
Appellants fail to identity any disclosure in the Specification or
evidence to show criticality of the internal tablet size, or external capsule
size with respect to any unexpected result. Nor have Appellants shown that
the claimed capsule would perform differently than the tablet filled capsule
of Altamar. Thus, Appellants have not shown that the claimed capsule is
10
Appeal 2015-005646
Application 13/862,199
patentably distinct from Altamar’s capsule as modified by Andersen, or vice
versa.
With respect to argument 5 summarized above, regarding compressed
tablets, we agree that the tablet dosage forms disclosed by Altamar are not
characterized as “compressed” tablets. However, one of ordinary skill in the
art would have recognized at the time of the invention that the commonly
accepted method for producing tablets comprising an active pharmaceutical
ingredient, and the excipients of the disclosed dosage forms, would comprise
die compression. See, e.g., Chidambaram 14 ( “granules are compressed
into tablets” and Spec. 14:22—25 (“The tablets as described herein can be
prepared using techniques and procedures known to those of skill in this art);
see, for example, Ansel Introduction to Pharmaceutical Dosage Forms,
Seventh Edition, 1999. The tablets can be made, for example, by direct
compression”). Moreover, the ordinary meaning of the term “tablet” as
used in Altamar is “a small disc or cylinder of a compressed solid substance,
typically a measured amount of a medicine or drug: ‘headache tablets’.”6
Therefore, we conclude that Altamar teaches a compressed tablet inside a
capsule, as claimed.
Nor are we convinced by Appellants’ arguments with respect to
Andersen’s gelling agent. Andersen discloses a range of gelling agent of
25% or less (0 to 25%). Appellants’ recited 2% or less concentration of the
gelling agent by weight of the capsule (claim 26) is encompassed by
Andersen’s disclosed range of capsule gelling agent.
6 Oxford Dictionary definition of “tablet,” available at
https://en.oxforddictionaries.com/defmition/tablet (visited Feb. 16, 2017)
(emphasis added).
11
Appeal 2015-005646
Application 13/862,199
In cases involving overlapping ranges, we and our predecessor
court have consistently held that even a slight overlap in range
establishes a prima facie case of obviousness ....
Selecting a narrow range from within a somewhat broader
range disclosed in a prior art reference is no less obvious than
identifying a range that simply overlaps a disclosed range. In
fact, when, as here, the claimed ranges are completely
encompassed by the prior art, the conclusion is even more
compelling than in cases of mere overlap. The normal desire of
scientists or artisans to improve upon what is already generally
known provides the motivation to determine where in a
disclosed set of percentage ranges is the optimum combination
of percentages.
In re Peterson, 315 F.3d 1325, 1329-1330 (Fed. Cir. 2003).
CONCLUSION OF LAW
The cited references do not support the Examiner’s obviousness
rejections 1 and 2 which are reversed. We enter a new ground of rejection
based upon Altamar, Andersen, Chidambaram, and the Oxford Dictionary
definition of tablet.
TIME PERIOD FOR RESPONSE
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
12
Appeal 2015-005646
Application 13/862,199
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new Evidence relating to the claims so rejected,
or both, and have the matter reconsidered by the examiner, in which
event the prosecution will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same Record. . . .
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
REVERSED and 37 C.F.R, $ 41.50(b)
13
Application/Control No. Applicant(s)/Patent Under Patent
Notice of References Cited 13/862,199
Appeal No.
2015-005646
Examiner Art Unit
1619 Page 1 of 1
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2/16/2017 tablet - definition of tablet in English | Oxford Dictionaries
We use cookies to enhance your experience on our website. By continuing to use our website, you are agreeing to our use of cookies. You can change your
cookie settings at anytime. rind mot':
Homs > British & vVorici English > tablet
Definition of tablet\n English:
NOOhii
1 A flat slab of stone, clay, or wood, used
especially for an inscription.
‘at the corner of the apse is a memorial tablet’
f -i- Mom example sentences ;i :i 4- Synonyms i
1.1 Arc/i/tpcnyre
another term for table (sense 3 of the
noun)
2 British A small disc or cylinder of a
compressed solid substance, typically a
measured amount of a medicine or drug.
‘headache tablets’
; ne Oxford DmUonanes Word of
the Year 2016 is...
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2.1 A small block or bar of soap,
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3 A small portable computer that accepts input
directly on to its screen rather than via a
https://en.oxforddictionaries.com/definition/tablet 1/4
2/16/2017 tablet - definition of tablet in English | Oxford Dictionaries
5 A kind of token giving authority for a train to
proceed over a single-track line.
Which Roald Dahl character are
you?
4 Example sentences :
6 Scottish [mass noun] A traditional sweet made
from sugar, condensed milk, and butter,
resembling fudge but having a hard, grainy
texture.
Origin
Middle English: from Old French tablete, from a
diminutive of Latin tabula (see table).
11 words you perhaps didn't know
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Pronunciation
tablet /'tablit/
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Further reading
https://en.oxforddictionaries.com/definition/tablet 2/4
2/16/2017 tablet - definition of tablet in English | Oxford Dictionaries
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