Ex Parte Daneshvari

Patent Trial and Appeal Board

Feb 14, 2018

14391543 (P.T.A.B. Feb. 14, 2018)

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.
14/391,543 10/09/2014 Dana Daneshvari 212501-0002-US-517889 1024
123223 7590 02/16/2018
Drinker Biddle & Reath LLP (WM)
222 Delaware Avenue, Ste. 1410
Wilmington, DE 19801-1621
EXAMINER
SONG, JIANFENG
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
02/16/2018 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):
IPDocketWM @ dbr.com
penelope. mongelluzzo @ dbr. com
DB RIPDocket @ dbr. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DANA DANESHVARI1
Appeal 2016-008746
Application 14/391,543
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, 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 wet granulation process comprising contacting a
material to be granulated with a granulating liquid comprising Arabic gum.
The Examiner’s rejection of claims 20, 22, 25—28, and 40-43 under 35
U.S.C. § 103 is appealed. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellant identifies the Real Party in Interest as “ALPINA LAUDANUM
INSTITUTE OF PHYTOPHARMACEUTICAL SCIENCES AG
(IMPETUS IP LTD.).” Br. 2 (Appellant’s brief numbers every page as “3”;
therefore, we cite herein to Appellant’s brief by counting its pages
consecutively)
Appeal 2016-008746
Application 14/391,543
STATEMENT OF THE CASE
The Specification states, “[t]he present invention relates to a wet
granulation process for producing granulate material comprising Arabic
gum.” Spec. 1:13—14. The Specification states, “Arabic gum, also known as
gum Arabic, acacia gum, chaar gund, char goond, or meska, is a natural gum
made of hardened sap taken from acacia trees.” Id. at 1:18—19.
Claim 20, reproduced below, is the sole independent claim and is
representative:
20. A wet granulation process comprising contacting a
material to be granulated with a granulating liquid,
wherein the granulating liquid comprises Arabic gum and the
concentration of Arabic gum in the granulating liquid is from
about 5% to about 40% (w/v) and
wherein the material to be granulated is Arabic gum or one or
more metal salts where the metal is selected from the group
consisting of potassium, sodium, lithium, calcium, magnesium,
zinc, selenium, and iron, and wherein the counter ion of the metal
salt is an organic counter ion selected from the group consisting
of acetate, alginate, ascorbate, aspartate, amygdalate, benzoate,
borogluconate, carbasalate, citrate, cyclamate, dinatriumtetra-
lactate, dobesilate, ferro-phospholactate, folinate, formate,
fumarate, glubionate, glucoheptonate, gluconate, glutamate,
glycerophosphate, iopodate, ketoglutarate, lactate, lacto-
gluconate, laevulinate, malate, methionate, orotate, oxalate,
pangamate, pantothenate, phospholactate, phatalate, picrate,
pidolate, propionate, resinate, saccharate (glucarate), saccharin,
sorbate, and succinate.
Br. 22 (Claims App’x) (paragraph formatting added for clarity).
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Application 14/391,543
The following rejection is appealed:
Claims 20, 22, 25—28, and 40-43 stand rejected under 35 U.S.C.
§ 103(a) over Lang,2 Chawla,3 Cherukuri,4 and Adusumilli.5 Final Action 4.
DISCUSSION
Only those arguments made by Appellant in the Appeal Brief (no
Reply Brief was submitted) have been considered in this Decision.
Arguments not so presented in the Brief are waived. See 37 C.F.R.
§ 41.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ 2d 1473
(BPAI 2010) (informative) (“Any bases for asserting error, whether factual
or legal, that are not raised in the principal brief are waived.”).
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
An applicant may rebut a prima facie case of obviousness by
providing a “showing of facts supporting the opposite
conclusion.” Such a showing dissipates the prima facie holding
and requires the examiner to “consider all of the evidence anew.”
In re Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984); In re
Rinehart, 531 F.2d 1048, 1052 (CCPA 1976).
In re Kumar, 418 F.3d 1361, 1368 (Fed. Cir. 2005).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
2 US 7,807,125 B2 (issued Oct. 5, 2010) (“Lang”).
3 WO 2005/011666 A1 (pub. Feb. 10, 2005) (“Chawla”).
4 US 2009/0311317 A1 (pub. Dec. 17, 2009) (“Cherukuri”).
5 US 2005/0202084 A1 (pub. Sept. 15, 2005) (“Adusumilli”).
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KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[T]he analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” Id. at
418. “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 1325, 1329 (Fed. Cir. 2003). “[T]he discovery of an
optimum value of a variable in a known process is normally obvious.”
Exceptions to this rule include (1) the results of optimizing a variable were
unexpectedly good and (2) the parameter optimized was not recognized in
the prior art as one that would affect the results. In re Antonie, 559 F.2d
618, 620 (CCPA 1977).
In analyzing patentability in view of the prior art, “a reference is not
limited to the disclosure of specific working examples.” In re Mills, 470
F.2d 649, 651 (CCPA 1972)). “[A] prior art publication cited by an
Examiner is presumptively enabling barring any showing to the contrary by
a patent applicant.” In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed.
Cir. 2012).
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
Action and Answer. See Final Action 4—19 and Answer 3—25. The
Examiner determined that Lang, directed to compactable granulated
pharmaceutical formulations with calcium and sodium salts, Arabic gum,
and binder components, and their manufacture, taught general methods of
granulation using a granulating liquid. See Final Action 5, 8, 10—18; Answer
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Application 14/391,543
3—4, 7, 9-11, 13-15, 17, 20-21, 23-25; and Lang Abstract, 2:15-20, 4:6-8,
4:65—67, 5:61—6:2, 6:56—64, 7:7—8:23. The Examiner also determined that
Chawla, directed to granulated pharmaceutical formulations with calcium
salts, 3%-80% (e.g., at least 20% or at least 50%) Arabic gum, and binder
components, and their manufacture, taught that in wet granulation the
granulating liquid can include dissolved binder component. See Final
Action 4—5, 8—10, 15—18; Answer 3—4, 7—8, 16—17, 20—24; and Chawla
Abstract, H 12, 21, 33, 34. The Examiner also determined that Cherukuri,
directed to granulated pharmaceutical formulations including a binder
component, and their manufacture, taught that in wet granulation a non-
aqueous solution or dispersion of binder component at 1 %—25%, which can
be Arabic gum, can be used as a granulation liquid. See Final Action 4, 6,
8—9, 11, 17—18; Answer 3, 5, 7—8, 10, 17—24; and Cherukuri H 46, 51—55,
58. The Examiner also determined that Adusumilli, directed to granulated
pharmaceutical formulations with calcium salts (e.g., calcium citrate and
calcium lactate) and binding components and their manufacture, taught wet
granulation using a granulation solution containing dissolved binder. See
Final Action 4, 7—8, 14; Answer 3, 5—7, 19-25; and Adusumilli Abstract,
11 5, 45—47. Both Chawla and Cherukuri described amounts of Arabic gum
which overlap or are encompassed by the claimed amounts.
The Examiner determined that there would have been motivation to
combine and a reasonable expectation of success in combining the cited
references’ disclosures to achieve a wet granulation process comprising
contacting a calcium salt (e.g., Ca-lactate) to be granulated with a
granulating liquid including the binder component Arabic gum at 5%-40%
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Application 14/391,543
because such a combination amounts to mere substitution of known
equivalent components in a predictable fashion and that any narrowing of
the ranges for amounts of Arabic gum would be routine optimization
because the prior art taught these amounts were results effective and
optimizable variables. Final Action 8—10.
Having considered the evidence before us, we conclude the
Examiner’s determinations that the combination of the references’ teachings
would have rendered claim 20, and also claims 22, 40, and 43, obvious are
reasonable. Appellant has not persuasively established any error in the
Examiner’s determinations. We address Appellant’s arguments below.
To the extent Appellant argues the references individually, we do not
find such arguments persuasive because the rejection is over a combination
of prior art. “Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references. [The references] must be read, not in isolation,
but for what [they] fairly teach [] in combination with the prior art as a
whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellant argues the Examiner’s combination of prior art required
picking and choosing from the disclosed parameters without proper
motivation as to a particular selection; Appellant urges this amounts to a
hindsight reconstruction of the claimed invention. Br. 9—10. These
arguments are not persuasive. We agree with the Examiner’s determination
that the prior art references teach and suggest the components and steps
claimed and that, without resort to hindsight reasoning, it would have been
obvious to combine the art as determined by the Examiner. The picking and
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choosing would not be unreasonable; the number of options is not so
extreme and the references urge use of the components claimed, in the
claimed amounts, for the same purposes.
Appellant attacks Lang’s disclosure as directed to calcium carbonate
as the component to be granulated and acknowledges that, while Lang
teaches sodium chloride as a salt, it does not teach the claimed counter ion of
the metal salt (e.g., lactate, citrate, acetate). Br. 10—11. Appellant argues
Lang teaches “many different optional hydrocolloids” and acacia gum is
taught to be one that is “particularly useful.” Id. at 11—12. Appellant argues
that, because the examples set forth in Lang do not include Arabic gum,
there were many different gums generally disclosed, and because Lang
indicates a preference for acacia gum not Arabic gum, the claims are
patentable over Lang.
These arguments are not persuasive. As noted above, the rejection is
over a combination of references, not just Lang (the Examiner provided
express reason for modifying Lang to reach the limitations in the claim and
Appellant has not persuasively identified error in this reasoning); therefore,
attacking Lang individually is not persuasive. Also, while it is noted that
Lang is focused on calcium carbonate, Lang teaches that other metal salts,
such as calcium sulfate and ferrous sulfate and sodium chloride can be used
in the formulation and, while Lang does not specify counter ions, other
references do—Adusumilli specifically identifies calcium citrate and
calcium lactate. It is immaterial whether or not Lang includes specific
components in its examples because a reference’s teachings are not limited
to its examples and, contrary to Appellant’s argument that Lang expresses a
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preference for acacia gum over Arabic gum, Appellant’s Specification is
explicit that these are synonymous terms for Arabic gum. See Spec 1:18—19
(“Arabic gum, also known as . . . acacia gum”).
Appellant argues Chawla is directed to and requires gabapentin in its
granulated pharmaceutical formulation, but gabapentin is not required in
Appellant’s claimed process. Br. 12—13. Appellant further argues that,
while Chawla discloses Arabic gum, Chawla does not disclose Arabic gum
can be in the granulating liquid and in the material to be granulated, and that
Chawla’s examples do not include Arabic gum. Id. at 13.
These arguments are not persuasive. Again, attacking Chawla
individually is not persuasive because the rejection is over a combination of
art. The Examiner provided reasons for modifying Chawla, which Appellant
has not persuasively shown to be error. Further, even if Chawla does not
disclose Arabic gum in the granulation liquid, it teaches its inclusion in the
granulation target material in the claimed amounts and other cited references
teach to include it in the claimed amounts in the granulation liquid. That
Chawla’s examples do not include Arabic gum is not determinative because
is reference is not limited to its working examples. Mills, 470 F.2d at 651.
Appellant argues Cherukuri, like the other references, teaches several
choices for binders, one being Arabic gum, but provides no reason to select
it from the group. Br. 14—15. Appellant argues Cherukuri teaches the
granulating medium is water and does not suggest the amount of gum to be
included in the water medium. Id. at 16.
These arguments are not persuasive. Again, attacking Cherukuri
individually is not persuasive because the rejection is over a combination of
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Application 14/391,543
art, which the Examiner provided reasons to combine. Each of Cherukuri’s
disclosed binders for use in its ultimate formulation and for use as an agent
in the granulating liquid of its manufacturing process is obvious in view of
the reference’s disclosure, Arabic gum being one such listed component,
thus establishing its suitability for the granulating process. Appellant’s
argument that Cherukuri does not teach how much binder, e.g., Arabic gum,
to include in the granulating solvent is inaccurate because Cherukuri teaches
amounts which overlap with the claimed range of 5—40%, namely, “[t]he
amount of this ‘binder’ may range from about 1% to about 25%” and teaches
that Arabic gum is a binder agent. Cherukuri || 53, 55 (“the granulating
solvent (whether aqueous or non-aqueous) may contain an excipient that
serves as a binder. . . . The amount of this ‘binder’ may range from 1% to
about 25%.”).
Appellant argues Adusumilli discloses a pharmaceutical composition
with alginic acid or salt thereof and a water-soluble carbonate, which is not
required in the claimed invention. Br. 16. While Appellant concedes
Adusumilli discloses including Arabic gum in its composition, Appellant
argues it is not included in the examples of the reference. Id.
These arguments are not persuasive. The fact that Adusumilli might
include components not expressly recited in Appellant’s claims is not
determinative; Appellant’s claims are “comprising” claims and can include
other steps or materials, including any additional materials suggested by the
prior art. Again, that Adusumilli does not include Arabic gum in an example
is not determinative in view of the reference’s teachings as a whole.
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Appellant concludes with an argument that the cited references are
directed to different things and are not related and, so, would not have been
combined by the skilled artisan. This argument is not persuasive. The
references are each directed to producing a pharmaceutical formulation by
granulation, they disclose similar components (e.g., calcium salts and Arabic
gum binder), and they disclose similar manufacturing methods (e.g., wet
granulation). These references are all in the same field of endeavor and
pertinent to the same problem of wet granulation with which the
Specification is concerned. In re Clay, 966 F.2d 656, 658—59 (Fed. Cir.
1992). It would have been reasonable for the skilled artisan to consult each
of the cited references to develop a similar granulated pharmaceutical
formulation or granulation manufacturing process because they are in the
same endeavor as the claimed subject matter.
As for claim 22, which recites “the material to be granulated
comprises Arabic gum, in an amount of at least 20% (w/w),” and claim 40,
which recites “wherein the material to be granulated comprises Arabic gum,
in an amount of at least 50% (w/w),” these Arabic gum amounts overlap
with the ranges disclosed by Chawla of Arabic gum as a polysaccharide
component in the amount of about 3% to about 80%. In “cases involving
overlapping ranges, [courts] have consistently held that even a slight overlap
in range establishes a prima facie case of obviousness.” In re Peterson, 315
F.3d at 1329. Appellant’s arguments are not persuasive as the prior art
combination teaches and suggests Arabic gum can be in the granulating
liquid and in the material to be granulated.
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As to claim 43, which recites “the material to be granulated does not
include carbonate,” Appellant argues Lang and Adusumilli each requires
carbonite and teaches away from this claim element. Br. 20. This argument
is not persuasive. There is no requirement that the methods of either Lang or
Adusumilli be incorporated whole-cloth into an ultimate method taught and
suggested by the combined prior art. The prior art combination teaches and
suggests compositions that include carbonate and also compositions that do
not; either and both would have been obvious. There is no teaching in either
reference that discourages, discredits, or criticizes exclusion of carbonate
and disclosed examples and preferred embodiments do not constitute a
teaching away from a broader disclosure or non-preferred embodiments. In
re Susi, 440 F.2d 442, 446 n.3 (CCPA 1971).
SUMMARY
The obviousness rejection is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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