Ex Parte Cilurzo et al

Patent Trial and Appeal Board

May 25, 2016

10577408 (P.T.A.B. May. 25, 2016)

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.
10/577,408 04/25/2006 Francesco Cilurzo 207,565 1408
7590 05/26/2016
Jay S. Cinamon
Abelman, Frayne & Schwab
666 Third Avenue
10th Floor
New York, NY 10017
EXAMINER
COHEN, MICHAEL P
ART UNIT PAPER NUMBER
1612
MAIL DATE DELIVERY MODE
05/26/2016 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 FRANCESCO CILURZO,
PAOLA MINGHETTI, and LUISA MONTANARI1
__________

Appeal 2014-002181
Application 10/577,408
Technology Center 1600
__________

Before ERIC B. GRIMES, MELANIE L. McCOLLUM, and
JACQUELINE T. HARLOW, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a self-
supporting film and to a process for its preparation. The Examiner has
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 Appellants identify the real party in interest as Pharmafilm S.R.L. (Br. 3).
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STATEMENT OF THE CASE
Claims 1–5, 12–14, 16, 17, and 21–24 are on appeal (Br. 7).2 The
claims subject to each rejection have not been argued separately and
therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(iv). Claims 1, 2, 14,
and 21 are representative and are set forth in the Claims Appendix to
Appellants’ Brief (id. at 30–31). Claim 1 reads as follows:
1. Self-supporting films consisting essentially of:
a) between 40 and 80% by weight of a filmogenic substance
consisting of a maltodextrin,
b) between 15 and 55% by weight of a plasticiser,
c) between 0.05% and 30% by weight of an active ingredient for food
or pharmaceutical use, on the total weight of said films,
wherein said films are free from hydrocolloids.
Claims 1, 4, 5, 12, 13, 16, and 17 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Barkalow et al. (US 2004/0096569 A1, published
May 20, 2004) in view of Chen et al. (US 2003/0068378 A1, published
Apr. 10, 2003) (Ans. 3).
Claims 2 and 3 stand rejected under 35 U.S.C. § 103(a) as obvious
over Barkalow in view of Chen and Zyck et al. (US 2003/0054039 A1,
published Mar. 20, 2003) (Ans. 6).
Claim 14 stands rejected under 35 U.S.C. § 103(a) as obvious over
Barkalow in view of Chen and Falkenhausen et al. (WO 02/02085 A2,
published Jan. 10, 2002 (US 2004/0028732 A1 published Feb. 12, 2004,
being “provided as a translation guide”)) (Ans. 7).

2 Claims 6–11, 18–20, 25, and 26 are also pending but have been withdrawn
from consideration (Final OA 1).
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Claims 21–24 stand rejected under 35 U.S.C. § 103(a) as obvious over
Barkalow in view of Chen, Falkenhausen, and Kasper et al. (US 4,222,973,
issued Sep. 16, 1980) (Ans. 8).
Claims 1, 4, 5, 12, 13, 16, and 17 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Chen (Ans. 10).
Claims 2 and 3 stand rejected under 35 U.S.C. § 103(a) as obvious
over Chen in view of Zyck (Ans. 12).
Claim 14 stands rejected under 35 U.S.C. § 103(a) as obvious over
Chen in view of Falkenhausen (Ans. 13).
I
The Examiner relies on Barkalow for teaching “edible thin films and
methods of making and using same” (Ans. 3). The Examiner finds that
Barkalow teaches:
The edible film product consist[s] of a film former such as starch
hydrolyzed products including maltodextrin in amounts from 5%
to about 60%; the film comprises a plasticizer such as
polyethylene glycol, propylene glycol, sorbitol and glycerin and
other polyols in amounts of from 0 to 20% . . . . The product
includes medicaments such as pharmaceutical agents.
(Id.) However, the Examiner finds that Barkalow does “not teach a specific
embodiment comprised of 40-80% maltodextrin, 15-55% of a plasticizer and
0.05-30% of an active agent” (id. at 4).
The Examiner relies on Chen for teaching “a mucosal surface coating
forming film containing a water soluble hydrocolloid which includes an
effective dose of an active agent” (id.). The Examiner finds that Chen
teaches:
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[T]he hydrocolloid includes a polymer consisting of a natural
polymer such as a polysaccharide; in addition, the film further
includes a plasticizer; and may further include an active agent
such as a therapeutic agent or a dietary supplement . . . . Active
agents include analgesics, anti-Parkinson’s medication, anti-
histamines, anti-hypertensives, anti-inflammatories, anti-
migraines, antiemetics, antipsychotics, anti-asthmatics and
nutritional supplements . . . . The percentage of ingredients
incorporated into the film includes a plasticizer at 0.5 to 20% and
active agents from 0.01-75%.
(Id. at 4–5.) The Examiner concludes:
At the time of the invention, it would have been obvious to
modify the composition of Barkalow et al. to be comprised of the
pharmaceutical agents, such as antiemetics, of Chen et al. in
amounts of 0.01% to 75% since they are taught to be deliverable
from edible films comprised of substantially the same
components in those amounts.
(Id. at 5.)
Findings of Fact
1. Barkalow discloses an “edible thin film product compris[ing] a
film former”; that “[a]ny suitable watersoluble, film-former can be used”;
that “[s]uitable film-formers include but are not limited to watersoluble non-
starch polysaccharides such as . . . algins . . . ; native starches . . . ; modified
starches . . . ; starch hydrolyzed products such as maltodextrin; protein . . . ;
polymers . . . alone or in any combination”; and that “the concentration of
the film-forming agent constitutes between 5% to about 60% by dry weight
. . . of the final film composition” (Barkalow ¶¶ 24 & 87).
2. Barkalow also discloses that, “[i]n an embodiment, the edible
thin film product comprises a plasticizer,” that “softeners . . . are also known
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as plasticizers,” and that “the softener can constitute 0% to about 20% by
dry weight of the film” (id. ¶¶ 26 & 89).
3. In addition, Barkalow discloses that, “[i]n an embodiment, the
edible thin film product includes a medicament chosen from the group
consisting of . . . pharmaceutical agents, nutraceutical agents, vitamins,
mineral, other like medicaments or combinations thereof” (id. ¶ 27).
4. Barkalow also discloses that a “variety of other suitable
ingredients can be added to the edible thin film” (id. ¶ 91).
5. In particular, Barkalow discloses:
A variety of flavoring agents can . . . be added to the rolled edible
thin films. . . . The flavor can be enhanced and distributed evenly
throughout the product by emulsification. Any suitable amount
and type of natural and/or synthetic food-grade emulsifier can be
used. For example, the emulsifier can include lecithin, enzyme-
modified lecithin, food-grade non-ionic emulsifiers, such as fatty
acids (C10-C18), mono and diacyl glycerides, ox bile extract,
polyglycerol esters, polyethylene sorbitan esters, propylene
glycol, sorbitan monopalmitate, sorbitan tristerate, other like
emulsifiers or combinations thereof.
(Id. ¶¶ 94–95 (emphasis added).)
6. Barkalow’s Examples 7 and 19 include maltodextrin and
alginate (id. ¶ 106).
7. Chen discloses a “dosage unit includ[ing] a water-soluble
hydrocolloid, mucosal surface-coat[-]forming film, such film including an
effective dose of an active agent” (Chen ¶ 11).
8. Chen also discloses: “Active agents . . . include therapeutic
agents, nutritional supplements and hygiene aids. The therapeutic agents are
exemplified by . . . anti-nasuants[sic]/antiemetics.” (Id. ¶ 42.)
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9. In addition, Chen discloses:
In addition to hydrocolloids and the active agents, the films may
contain any or all of the following ingredients: emulsifying
agents, . . . plasticizers . . . . In a preferred embodiment, the
percentage dry weight concentration of at least single ingredients
incorporated in a film in each of the following categories is as
follows: emulsifying agent (0.1%-10%), plasticizer (0.5-20%),
active agents (0.01-75%) . . . .
(Id. ¶ 61).
Analysis
Barkalow suggests a film containing a) between 5 and 60% by dry
weight maltodextrin, b) between 0 and 20% by dry weight of a plasticizer,
and c) an active ingredient for food or pharmaceutical use (Findings of Fact
(FF) 1–3). Chen discloses a film containing 0.01–75% by dry weight active
agents (FF 9). In view of Chen, we agree with the Examiner that it would
have been prima facie obvious to include between 0.05 and 30% by weight
active ingredient in Barkalow’s composition (Ans. 5–6).
Appellants argue that Barkalow fails to disclose the “specific
embodiment comprised of 40-80% maltodextrin, 15-55% plasticiser and
0.05-30% of an active agent” (Br. 11). However, Appellants do not
adequately explain why the combination fails to suggest this.
Appellants also argue that Barkalow fails to disclose “films free from
hydrocolloids” (id.). In particular, Appellants argue:
[E]ven if maltodextrin can be used alone as a film former (see
[0087]), . . . Barkalow et al. do not envisage the exclusion of
hydrocolloids, since [a] “variety of other suitable ingredients can
be added to the edible thin film” (see [0091]), e.g. “any suitable
amount and type of natural and/or synthetic food-grade
emulsifier can be used.” (see [0095]). It should be reminded that
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hydrocolloids act as emulsifiers (see pp. 7-8 of Annex A[3] . . . ).
For example, alginates are well known hydrocolloids as well as
emulsifiers (see e.g. Annex A, p. 8, propylene glycol alginate).
Examples 7, 11 and 19 of Barkalow et al. involve maltodextrin
and alginate: in these cases, if maltodextrin is read to be the only
film former, it follows that the exemplified films include
hydrocolloids as emulsifiers.
(Id.) We are not persuaded.
As noted by Appellants, Barkalow’s Examples 7 and 19 include
alginate, as well as maltodextrin (FF 6).4 Barkalow discloses including
algins as film-formers (FF 1). In addition, Annex A indicates that alginate is
a hydrocolloid (Annex A 7–8). However, even if every example in
Barkalow includes at least one hydrocolloid film-former, we agree with the
Examiner that it would have been prima facie obvious to include
maltodextrin as the only film-former, particularly in view of the disclosure
in Barkalow that the film-formers may be used “alone or in any
combination” (FF 1).
As also noted by Appellants, Barkalow discloses that a “variety of
other suitable ingredients can be added to the edible thin film” (FF 4). In
particular, Barkalow discloses that “[a]ny suitable amount and type of
natural and/or synthetic food-grade emulsifier can be used” (FF 5). In

3 Timothy J. Foster, Hydrocolloids Structure and Properties: The building
blocks for structure, Unilever Vlaardingen, The University of Nottingham
(March 29–31, 2010).
4 Appellants also state the Barkalow’s Example 11 includes an alginate
(Br. 11). It is not clear to us that this example includes an alginate
(Barkalow ¶ 106). However, it does include carrageenan (id.), which is also
identified in Annex A as a hydrocolloid (Annex A 7–8).
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addition, Annex A indicates that propylene glycol alginate is an emulsifier
(Annex A 8). However, even if we assume that the alginate in Examples 7
and 19 is an emulsifier, Barkalow discloses that emulsifiers are optional
ingredients (FF 5). In addition, Appellants have not shown that it would not
have been obvious to select an emulsifier that it not a hydrocolloid. In
particular, Appellants have not provided any evidence indicating that the
emulsifiers that are specifically identified as such in Barkalow (see FF 5) are
hydrocolloids. Thus, Appellants have not persuaded us that a film that is
free of hydrocolloids would not have been obvious in view of Barkalow.
We acknowledge Appellants’ argument that Chen discloses a film that
contains a hydrocolloid and “that references have to be considered as a
whole in making an obviousness rejection” (Br. 16–17). However, even if
Chen’s films always contain a hydrocolloid as this term is used in the
present Specification, Appellants have not shown that Chen teaches away
from a film that is free from hydrocolloids, as suggested in Barkalow.
“[T]he question is whether there is something in the prior art as a whole to
suggest the desirability, and thus the obviousness, of making the
combination, not whether there is something in the prior art as a whole to
suggest that the combination is the most desirable combination available.”
In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (citation omitted).
In addition, Appellants argue that Barkalow fails to disclose “self-
supporting films” (Br. 10). In particular, Appellants argue:
Barkalow et al. nowhere refer to this feature, conversely teaching
as essential and necessary the “container including a body that
defines an interior for housing the edible thin film” (see [0010],
and claim 1), where the “container has substantially the same
cross-sectional shape as the edible thin film” (see [0011]). Thus,
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at a minimum, the skilled person understands that the edible
films of Barkalow et al. need the support of the container, or, in
other words, said films are not self-supporting.
(Id. at 10–11.) We are not persuaded.
As discussed above, we conclude that the Examiner has set forth a
prima facie case that Barkalow and Chen suggest films containing
a) between 40 and 80% by weight of a maltodextrin, b) between 15 and 55%
by weight of a plasticizer, and c) between 0.05 and 30% by weight of an
active ingredient for food or pharmaceutical use, wherein the films are free
from hydrocolloids. Appellants’ Specification suggests that these
components would provide a self-supporting film (see Spec. 2: 5–10). Thus,
Appellants’ argument does not persuade us that films having these
components would not be self-supporting.
Appellants also argue:
[T]he inventors of the current invention firstly discovered an
unrecognized problem [that films containing hydrocolloids do
not provide a clean mouth sensation] and secondly found that
films according to Claim 1, not only unexpectedly overcome all
the known problems related to rapid dissolution, clean mouth
feel, clean flavour and ease of manufacture, but at the same time
surprisingly overcome the problem of the unclean mouth
sensation raised by the presence of hydrocolloids.
(Br. 14–15.) We are not persuaded.
In In re Omeprazole Patent Litig., 536 F.3d 1361, 1379–1381 (Fed.
Cir. 2008), the Federal Circuit found “no error in the [district] court’s
findings of fact and conclusions of law on the question of obviousness,”
noting that, in concluding that it would not have been obvious to include the
claimed subcoating in the prior art tablet, the district court “observed that the
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[applied prior art] does not disclose or suggest a negative interaction
between the drug core and the enteric coating.” However, as discussed
above, in the present case, we conclude that Barkalow teaches using
maltodextrin as the film-former, together with a plasticizer and an active
ingredient for food or pharmaceutical use, and, therefore, suggests films that
are free from hydrocolloids (FF 1–3). Barkalow also suggests the claimed
amounts of maltodextrin and plasticizer (FF 1–2). The Examiner is relying
on Chen to suggest the claimed amount of active ingredient and is not
relying on the alleged unrecognized problem to provide a reason to modify
the prior art. In addition, Appellants have not provided sufficient evidence
that the present invention provides unexpectedly superior results as
compared to the closest prior art.
Conclusion
The evidence supports the Examiner’s conclusion that Barkalow and
Chen suggest the product of representative claim 1. We therefore affirm the
obviousness rejection of claim 1 over Barkalow and Chen. Claims 4, 5, 12,
13, 16, and 17 fall with claim 1.
II
The Examiner rejects representative claims 2, 14, and 21 over
Barkalow and Chen in view of Zyck, Falkenhausen, or Falkenhausen and
Kasper, respectively (Ans. 6–8). Appellants traverse these rejections based
on the dependency of claims 2, 14, and 21 from claim 1 and the failure of
Zyck, Falkenhausen, and/or Kasper to “fill the gap between the presently
claimed invention and the teachings of Barkalow et al. and Chen et al.”
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(Br. 19–21). We are not persuaded by these arguments for the reasons
discussed above.
Conclusion
The evidence supports the Examiner’s conclusion that Barkalow,
Chen, and Zyck suggest the product of claim 2; that Barkalow, Chen, and
Falkenhausen suggest the product of claim 14; and that Barkalow, Chen,
Falkenhausen, and Kasper suggest the process of claim 21. We therefore
affirm the obviousness rejections of claims 2, 14, and 21 over Barkalow and
Chen in view of Zyck, Falkenhausen, and/or Kasper. Claims 3 and 22–24
fall with claims 2 and 21, respectively.
III
In rejecting claim 1 over Chen alone, the Examiner acknowledges that
Chen does “not teach a specific embodiment comprised of 40-80%
maltodextrin, 15-55% of a plasticizer and 0.05-30% of an active agent”
(Ans. 10). However, the Examiner concludes that “it would have [been]
obvious to have selected various combinations of various disclosed
ingredients maltodextrin, plasticizer, i.e. polyethylene glycol or propylene
glycol, and active agent, i.e. an antiemetic, to arrive [at the claimed]
compositions” (id. at 11).
Findings of Fact
10. As noted above, Chen discloses a “dosage unit includ[ing] a
water-soluble hydrocolloid, mucosal surface-coat[-]forming film” (Chen
¶ 11).
11. Chen also discloses:
In embodiments of the invention, a hydrocolloid concentration in
the range of 5-99% of the dry weight of the films is provided,
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more particularly greater than 10%. These films have dry tack
and wet tack properties that improve ease of handling and use.
The low dry tack properties of the film provide for a physically
attractive and easily handled film that is neither fragile nor sticky
and can be easily removed from packaging and placed on a
mucosal surface. The wet tack properties of the film provide the
advantage of stickiness of the moistened film such that when the
film is placed on the mucosa, it remains attached at that site until
it dissolves. In contrast, if the wet tack is too low, the film can
move in the mouth and may be swallowed before dissolving and
possibly give rise to choking.
(Id. ¶ 58.)
12. In addition, Chen discloses:
In embodiments of the invention, the hydrocolloid may be a
water soluble non-gelling (at room temperature) natural
polysaccharide or derivatives including pectin and derivatives,
guar gum arabic, tragacanth gum, xanthan gum, gellan sodium
salt, propyleneglycol alginate, starches (amylose, amylopectin),
modified starches, hydroxyethyl starch, pullulan, carboxymethyl
starch, gum ghatti, okra gum, karaya gum, dextrans, dextrins and
maltodextrins, konjac, acemannan from aloe, locust bean gum,
tara gum, quince seed gum, fenugreek seed gum, scleroglucan,
gum arabic, psyllium seed gum, tamarind gum, oat gum, quince
seed gum, carrageenans, scleraglucan, succinoglucan, larch
arabinogalactan, flaxseed gum, chondroitin sulfates, hyaluronic
acid, curdlan, chitosan, deacetylated konjac, and rhizobium gum.
(Id. ¶ 59 (emphasis added).)
13. Chen also discloses that “[e]mulsifying agents include
solubilizers and wetting agents and are exemplified by polyvinyl alcohol,
sorbitan esters, cyclodextrins, benzyl benzoate, glyceryl monostearate,
polyoxyethylene alkyl ethers, polyoxyethylene stearates, poloxamer,
polyoxyethylene castor oil derivatives, hydrogenated vegetable oils, bile
salts, polysorbates and ethanol” (id. ¶ 41).
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Analysis
Chen suggests films containing a) between 5 and 99% by weight of a
“hydrocolloid,” b) between 0.5 and 20% by weight of a plasticizer, and
c) between 0.01 and 75% by weight of an active ingredient for food or
pharmaceutical use (FF 7–11). In addition, Chen discloses that “the
hydrocolloid may be a water soluble non-gelling (at room temperature)
natural polysaccharide or derivatives including . . . maltodextrins” (FF 12).
We conclude that the Examiner has set forth a prima facie case that it would
have been obvious to select maltodextrin as the “hydrocolloid” and to select
the amounts recited in claim 1 (Ans. 10–11).
Appellants argue, however, that “maltodextrin is not a hydrocolloid”
(Br. 24 (emphasis omitted)). In response to Appellants’ argument,
the Examiner agrees that the inclusion of maltodextrin as a
hydrocolloid in the disclosure of Chen et al. seems to be
misplaced, [but] is interpreting maltodextrin’s inclusion as a
useful film forming agent as an admission by Chen et al. that, at
the least, maltodextrin can be used as an equivalent to the
hydrocolloids in the production of the edible films of Chen et al.
(Ans. 20–21.) We conclude that Appellants have not adequately explained
why the Examiner’s position is in error.
In particular, Appellants argue that “maltodextrin does not gel on
contact with saliva, thus, if hypothetically used as the sole film-former in the
films of Chen et al., as per the Examiner’s interpretation, the resulting films
would have never shown the desired wet tack properties on the mucosa
observed when very [sic] hydrocolloids are used” (Br. 26). In addition,
Appellants argue that, “if Chen et al. dosage unit was modified to exclude
hydrocolloids, the modification would render said dosage unit unsatisfactory
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and inoperable for their intended purpose of overcoming the problems
caused by ‘the mobility of the dosage unit within the mouth[]’” (id. at 27
(quoting Chen ¶ 24)). However, Appellants have not provided sufficient
evidence to support these positions.
In addition, we are not persuaded by the additional arguments raised
by Appellants for the same reasons we are not persuaded by these arguments
in the context of the rejection over Barkalow and Chen.
Conclusion
The evidence supports the Examiner’s conclusion that Chen suggests
the product of representative claim 1. We therefore affirm the obviousness
rejection of claim 1 over Chen. Claims 4, 5, 12, 13, 16, and 17 fall with
claim 1.
IV
The Examiner rejects claim 2 over Chen in view of Zyck and rejects
claim 14 over Chen in view of Falkenhausen (Ans. 12–13). Appellants
traverse these rejections based on the dependency of claims 2 and 14 from
claim 1 and the failure of Zyck and Falkenhausen to “fill the gap between
the presently claimed invention and the teaching of” Chen (Br. 28–29). We
are not persuaded by these arguments for the reasons discussed above.
Appellants also argue that “the Office failed to provide some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness” (id. at 28). However, we detect no error in the
reasoning provided in the Examiner’s Answer (Ans. 12–13).
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Conclusion
The evidence supports the Examiner’s conclusion that Chen and Zyck
suggest the product of claim 2 and that Chen and Falkenhausen suggest the
product of claim 14. We therefore affirm the obviousness rejections of
claims 2 and 14 over Chen in view of Zyck and Falkenhausen, respectively.
Claim 3 falls with claim 2.
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