Pharmafilm S.r.l.

Patent Trials and Appeals Board

Feb 25, 2021

2020003336 (P.T.A.B. Feb. 25, 2021)

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.
15/423,887 02/03/2017 Francesco Cilurzo SS122-1214-CIP 1432
122515 7590 02/25/2021
Silvia Salvadori, P.C.
Silvia Salvadori
485 Central Park West Unit 5C
New York, NY 10025
EXAMINER
LIU, TRACY
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
02/25/2021 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):
eofficeaction@appcoll.com
silvia30121@me.com
silvia@salvadorilaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FRANCESCO CILURZO, MAURIZIO DI GRIGOLI,
PAOLA MINGHETTI, and STEFANIA PAGANI
Appeal 2020-003336
Application 15/423,887
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1−14. (See Non-Final Action 1.) We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the term “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as
PHARMAFILM S.R.L. (Appeal Br. 3.)
Appeal 2020-003336
Application 15/423,887
2
STATEMENT OF THE CASE
The claims are directed to an orodispersible films having quick
dissolution times for therapeutic and food use. Claim 1, reproduced below,
is illustrative of the claimed subject matter:
1. An orodispersible self-supporting film free from hydrocolloids
comprising:
a) a film-forming substance consisting of a maltodextrin
in an amount between 40 and 80% by weight;
b) one or more plasticizer in a total amount comprised
between 15 and 55% by weight;
c) one or more surfactant system in an amount comprised
between 0.5 and 6% by weight;
d) an active ingredient for food or therapeutic use in an
amount between 0.05 and 30% by weight,
said orodispersible self-supporting film free from
hydrocolloids further containing [e] a homopolymer or a
copolymer of vinyl acetate in a quantity comprised between 1
and 20% by weight, where the percentages are calculated on the
total weight of said film.
(Appeal Br. 21 (Claims Appendix) (emphasis and bracketing added).)
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Zerbe et al. US 7,132,113 B2 Nov. 7, 2006
Cilurzo et al. US 2009/0017085 A1 Jan. 15, 2009
Farshi et al. WO 2011/048563 A2 Apr. 28, 2011
Myers et al. US 2012/0107402 A1 May 3, 2012

Appeal 2020-003336
Application 15/423,887
3
REJECTIONS
Claim(s) Rejected Ground Reference(s)/Basis
1–3, 7–13 35 U.S.C. § 103(a) Cilurzo, Zerbe, Farshi
4–6, 14 35 U.S.C. § 103(a) Cilurzo, Zerbe, Farshi,
Myers
1–14 Non-statutory Double
Patenting
14/430,255
1–14 Non-statutory Double
Patenting
15/218,7442, Zerbe,
Farshi

OPINION
I. Obviousness
Appellant argues the claims and the rejections together. We therefore
address the Examiner’s rejection with respect to representative claim 1.
The Examiner finds that Cilurzo discloses a rapidly dissolving self-
supporting film for food or pharmaceutical use that includes elements (a),
which is a modified starch, (b), and (d) as claimed and in the claimed
percentages. (Non-Final Action 3 (citing Cilurzo abstract, ¶35), 6.)
The Examiner finds that Zerbe discloses a rapidly disintegrating
flavored film that is a matrix that includes a hydroxypropyl cellulose and
modified starch and also includes a small amount of surfactant by weight
(e.g., 1.8%), such as polyoxyethylene sorbitan fatty acid esters to increase
the wettability of the film. (Non-Final Action 4 (citing Zerbe 3:45–48,
7:22); id. at 5 (under “Response to Arguments”).)
The Examiner finds that Farshi discloses a fast
dissolving/disintegrating oral tablet that includes a taste masking layer to

2 US Application 15/218,744 is now US Patent 10,426,725 B2, issued Oct.
1, 2019. Consequently, we find the rejection for obviousness-type double
patenting based on this reference is no longer provisional.
Appeal 2020-003336
Application 15/423,887
4
mask a bitter or irritating drug where the taste masking layer includes a
coating agent, such as polyvinyl acetate. (Id. at 4 (citing Farshi ¶¶ 36, 37).)
The Examiner further finds that one of ordinary skill in the art would have
understood that an added benefit of the addition of polyvinyl acetate would
have been achieving a higher tensile strength film of the maltodextrin film
than would be extant with maltodextrin alone. (Id. at 6–7 (citing
Anastasiou3 (as evidence that it was known that high molecular weight
polyvinyl acetate has high tensile strength) and Singh4 (as evidence that
maltodextrin is ductile).)
The Examiner concludes that it would have been obvious to include a
surfactant such as polyoxyethylene sorbitan fatty acid ester, component [c]
of the claimed composition, as disclosed in Zerbe into the rapidly dissolving
film dosage form disclosed by Cilurzo to increase the wettability of the film.
(Id. at 4, 5.) According to the Examiner, Zerbe “do[es] not disclose wherein
the surfactants must be used with hydroxypropyl cellulose.” (Id. at 5.) The
Examiner also concludes that because Cilurzo may include a
pharmaceutically active ingredient that may be bitter, it would have been
obvious to include a coating agent such as polyvinyl acetate, which is
component [e] of the claimed composition, as disclosed in Farshi to help
mask the bitter taste. (Id. at 5.)
We agree with the Examiner’s conclusion of obviousness.
Appellant argues that it would not have been obvious to include the
wettability agent of Zerbe in the composition of Cilurzo because Zerbe

3 US 2013/0122072 A1, published May 16, 2013.
4 Harmanpreet Singh et al., Optimization and Evaluation of Desloratadine
Oral Strip: An Innovation in Paediatric Medication, 2003 The Scientific
World Journal, 1–9, 5 (2013).
Appeal 2020-003336
Application 15/423,887
5
teaches a rapidly dissolving film that includes, as an essential component, a
hydrocolloid, namely hydroxypropyl cellulose, in combination with a
modified starch, such as maltodextrin. (Appeal Br. 8.) According to
Appellant “[o]ne of ordinary skill in the art would have never combined the
teaching of Zerbe referring to films having a matrix containing
hydrocolloids with the teaching of Cilurzo which refers to films having a
matrix free of hydrocolloids.” (Id.) According to Appellant, “in doing so
the Examiner [is improperly] picking and choosing elements from the prior
art to reconstruct the presently claimed invention.” (Id. at 10.) We do not
find Appellant’s argument persuasive because, as Zerbe teaches, the use of
wettability enhancing agents is well-known in the art of water-soluble films
for oral administration. In particular, Zerbe states:
Water-soluble films for oral administration of therapeutic
agents are well known in the art. It is also known in the art to
use such films for administering a breath freshening agent, e.g.,
menthol. The known films for administering breath freshening
agents and/or active pharmaceutical agents are generally
comprised of at least one water-soluble polymer suitable for
human consumption and at least one compound that enhances
the wettability of the water-soluble polymer, typically selected
from polyalcohols, surfactants and plasticizers.
(Zerbe 1:16–26 (emphases added).) Maltodextrin is a short chain polymer
that is water-soluble. Thus, although the invention of Zerbe is focused on a
hydrocolloid based edible film, we disagree with Appellant that Zerbe as a
prior art reference “is confined” to teaching “the use of surfactants to
increase wettability of films consisting of a matrix containing hydrocolloids.
(Appeal Br. 8.) “Patents are part of the literature of the art and are relevant
for all they contain.” In re Young, 927 F.2d 588, 591 (Fed. Cir. 1991). And
as highlighted above, Zerbe teaches that surfactants are commonly used in
Appeal 2020-003336
Application 15/423,887
6
films that include a water-soluble polymer to enhance wettability. We agree
with the Examiner that “Zerbe does not disclose wherein the surfactants can
only increase wettability for films comprising hydroxypropyl cellulose and
modified starch.” (Ans. 5.)
The test of obviousness is “whether the teachings of the prior art,
taken as a whole, would have made obvious the claimed invention.” In re
Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991). Cilurzo teaches an edible film
that includes maltodextrin but excludes hydrocolloids because
“hydrocolloids tend to gel on contact with saliva” and such films “do not
provide a clean mouth sensation.” (Cilurzo ¶¶ 4–6.) Cilurzo teaches that
maltodextrin combined with a plasticizer can be used to prepare a filmogenic
substance that can dissolve rapidly despite not containing a hydrocolloid.
(Id. ¶¶ 8–14.) Zerbe teaches an edible film with a hydrocolloid and a
modified starch which forms a film that has rapid disintegration properties as
well as improved water dissolution kinetics over prior art edible films, and
yet, indicates that “[i]n certain applications, it may be desirable to increase
the wettability of the film by adding surfactants.” (Zerbe 2:53–64, 3:45–63.)
In light of the foregoing, we agree with the Examiner that one of
ordinary skill in the art would reasonably have been able to glean from the
teachings of Cilurzo and Zerbe that one could achieve increased wettability
of a maltodextrin only film with the addition of a surfactant such as
polyoxyethylene sorbitan fatty acid esters, and that “[i]n certain
applications,” such is “desirable” and has “proven very beneficial in many
cases.” (Zerbe 3:45–46, 58–59.) Thus, we agree with the Examiner, that
one of ordinary skill in the art would have found it obvious to add a known
wetting agent, i.e., surfactant, such as polysorbate 80 to the film taught by
Cilurzo for the purpose of increasing the wettability of that film and would
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Application 15/423,887
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have been motivated to include such an ingredient even though Cilurzo
teaches a film that can dissolve rapidly despite not containing a hydrocolloid
given Zerbe’s teaching that even with rapid disintegration properties and
water dissolution kinetics being improved over prior art edible films, it still
may be “desirable to increase the wettability of the film by adding
surfactants.” (Zerbe 2:53–64, 3:45–63.)
Appellant further argues that the Examiner’s rejection is in error
because Farshi, which is concerned with pharmaceutical tablets, is
completely silent with regard to using PVA in orodispersible self-supporting
films as nanofillers. (Appeal Br. 9.) Appellant points out that Farshi uses
PVA as a taste masking layer and the “presently claimed invention is not
directed to a composition including a taste-masking element.” (Id. at 9, 11.)
Moreover, argues Appellant, “Farshi is completely silent with regard to PVA
maintaining suitable mechanical properties of a film matrix consisting of
maltodextrins when exposed to air so as to avoid brittleness of the film
matrix.” (Id.) We do not find Appellant’s arguments persuasive.
First, regarding the claimed vinyl acetate. The claim language
requires simply that the orodispersible self-supporting film that is free from
hydrocolloids “further contain[] a homopolymer or a copolymer of vinyl
acetate” in a particular percentage range by weight of the total weight of the
film. There is no requirement that this material be a “nanofiller.”
Second, it is not necessary that references be combined or modified
for the same reasons as Appellant arrived at the invention. The reason or
motivation to modify the reference may often suggest what the inventor has
done, but for a different purpose or to solve a different problem. In re
Lintner, 458 F.2d 1013, 1016 (CCPA 1972); In re Dillon, 919 F.2d 688, 693
(Fed. Cir. 1990); see also Ans. 6. We agree with the Examiner that Cilurzo
Appeal 2020-003336
Application 15/423,887
8
teaches “the film comprises an active principle for pharmaceutical use.”
(Non-Final Action 4–5; Cilurzo Abstr.) We also agree with the Examiner
that “orally administered pharmaceutical actives may be bitter, [and]
polyvinyl acetate helps mask the bitter taste in pharmaceutical actives as
taught by Farshi et al.” (Non-Final Action 4–5; Farshi ¶ 37.) Appellant
does not contest this either. Consequently, we agree with the Examiner that
it would have been prima facie obvious to include PVA in the orodispersible
self-supporting film composition of Cilurzo as modified by Zerbe to mask a
bitter taste of an active pharmaceutical agent. And, in so concluding, we
disagree that the Examiner is relying on impermissible hindsight. “Any
judgment on obviousness is in a sense necessarily a reconstruction based
upon hindsight reasoning, but so long as it takes into account only
knowledge which was within the level of ordinary skill at the time the
claimed invention was made and does not include knowledge gleaned only
from applicant’s disclosure, such a reconstruction is proper.” In re
McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). The desirability for
including a task-masking element (Appeal Br. 11) derives from the
combination of Cilurzo and Farshi’s teachings just discussed.
Third, that Farshi is concerned with a tablet and not an orodispersible
film is not sufficient to find non-obvious. Both Farshi and Cilurzo, as well
as the claimed invention, concern orally disintegrating dosage forms and are
therefore in the same field of endeavor. Consequently we find the art to be
analogous even if not directly concerned with the particular problem with
which the inventors here were involved. In re Bigio, 381 F.3d 1320, 1325–
27 (Fed. Cir. 2004) (affirming PTO finding toothbrush art analogous to the
applicant’s hair brush invention); Scientific Plastic Prods., Inc. v. Biotage
AB, 766 F.3d 1355, 1360–61 (Fed. Cir. 2014) (affirming PTO finding
Appeal 2020-003336
Application 15/423,887
9
references directed to resealable closures for beverage containers that
provide fluid tight seals to be reasonably pertinent to the problem of
providing fluid tight seals of a low pressure liquid chromatographic cartridge
while preserving access to the contents of that cartridge).
Appellant additionally argues that it has “previously submitted, the
orodispersible films of the claimed invention have unexpected and surprising
improved mechanical properties[, E modulus, Tensile strength, Elongation at
break, after exposure to air,] in comparison to films not containing
polyvinylpyrrolidone vinyl acetate (PVP-VA) or PVA.” (Appeal Br. 10;
Reply Br. 7–9.) We are not persuaded. “The evidence presented to rebut a
prima facie case of obviousness must be commensurate in scope with the
claims to which it pertains.” In re Dill, 604 F.2d 1356, 1361 (CCPA 1979).
Appellant’s claim 1 requires a specific film-forming compound but it does
not required a specific plasticizer or surfactant system, and recites only a
category of component [e], i.e. a homopolymer or a copolymer of vinyl
acetate. The recited range for component [e] is 1–20%. Appellant’s
examples provided in the two referenced declarations5 alleged to provide
evidence of unexpected results use glycerin as a plasticizer and the
surfactant system was either Peceol and Tween 80 or just Span 80, and the
component [e] was either polyvinyl acetate (PVA) or polyvinylpyrrolidone-
vinyl acetate (PVA/VA). (See Cilurzo Declaration Table 3; Cupone
Declaration Tables 1, 4.) Furthermore, the component [e] that was tested

5 Declaration of Cilurzo dated May 20, 2019 (Cilurzo Declaration) filed in
the present prosecution with the response of May 21, 2019 (see Ans.12);
Declaration of Irma Elisa Cupone dated May 17, 2019 (Cupone Declaration)
filed in the prosecution of the parent application US 14/430,255, and filed in
the present prosecution with the response of May 21, 2019 (see Ans. 9).
Appeal 2020-003336
Application 15/423,887
10
was only in the range of 0–10% and Appellant’s results show that at 10%
under certain conditions tensile strength and elastic modulus decreased as
compared to 2–8% when TWEEN 80 was one of the surfactants with PVA
but not with PVP/VA (See Cilurzo Declaration Table 2, 3, 4, 5, 6). In
addition, when Span 80 was the included surfactant and PVP/VA was
component [e] the testing only provides results with 3% and 5% of PVP/VA
in combination with only 3% of Span 80 (Id. Table 4, 7, 8.) Appellant did
not provide any explanation as to why the limited testing is commensurate in
scope with the breadth of components b, c, and e of the claim. That is,
Appellant has not provided sufficient data “to ascertain a trend in the
exemplified data which would allow [one having ordinary skill in the art] to
reasonably extend the probative value thereof.” In re Kollman, 595 F.2d 48,
56 (Fed. Cir. 1979).
In light of the foregoing, we affirm the Examiner’s rejection of claims
1–3 and 7–13 as being obvious from Cilurzo, Zerbe, and Farshi.
Appellant argues that the Examiner’s rejection adding Myers does not
“change the conclusions that even if, arguendo, Cilurzo, Zerbe and Farshi
would be combined, still their combination would not have rendered obvious
the present invention to one skilled in the art.” (Appeal Br. 17.) That
argument is insufficient to be considered a separate argument, and we affirm
the Examiner’s rejection of 4–6 and 14 as being obvious from Cilurzo,
Zerbe, Farshi, and Myers.

II. Nonstatutory Double Patenting
A. Rejection involving US Patent 10,426,725, Zerbe, and Farshi
The Examiner’s rejection here is similar to that discussed in section I,
above. Here, rather than Cilurzo teaching a film free from hydrocolloids
Appeal 2020-003336
Application 15/423,887
11
that comprises maltodextrin, a plasticizer, and an active ingredient, the
Examiner finds that the co-pending claims in Application 15/218,744 teach
such a film. (Non-Final Action 12.) The Examiner relies on Zerbe and
Farshi for the same reasons discussed in section I, above. Appellant’s
arguments are the same as presented above. (See Appeal Br. 18–20.) We
affirm the Examiner’s conclusion of obviousness-type double patenting for
the same reasons just discussed in section I.

B. Rejection involving Application 14/430,255
Appellant does not contest the Examiner’s provisional rejection of
claims 1–14 for non-statutory double patenting, nor has Appellant indicated
that it has filed a terminal disclaimer. Accordingly, we presume that
Appellant acquiesces to this provisional rejection and thus summarily affirm
it for the reasons advanced by the Examiner. See MPEP § 1205.02 (“If a
ground of rejection stated by the examiner is not addressed in the appellant’s
brief, appellant has waived any challenge to that ground of rejection and the
Board may summarily sustain it, unless the examiner subsequently withdrew
the rejection in the examiner’s answer.”); see also 37 C.F.R. § 41.41(b)(2)
(“Any argument raised in the reply brief which was not raised in the appeal
brief, or is not responsive to an argument raised in the examiner’s answer,
including any designated new ground of rejection, will not be considered by
the Board for purposes of the present appeal, unless good cause is shown.”).
Appeal 2020-003336
Application 15/423,887
12
DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–3, 7–13 103(a) Cilurzo, Zerbe,
Farshi
1–3, 7–13
4–6, 14 103(a) Cilurzo, Zerbe,
Farshi, Myers
4–6, 14
1–14 Non-Statutory
Double Patenting:
15/218,744, Zerbe,
and Farshi
1–14
1–14 Non-Statutory
Double Patenting:
14/430,255
1–14
Overall
Outcome
1–14

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED