PHARMAFILM S.R.L.

Patent Trials and Appeals Board

Mar 2, 2021

2020003927 (P.T.A.B. Mar. 2, 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.
14/430,255 03/23/2015 Francesco Cilurzo SS122-1214 5778
122515 7590 03/02/2021
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
03/02/2021 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 2020-003927
Application 14/430,255
Technology Center 1600
____________

Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
MICHAEL A. VALEK, Administrative Patent Judges.

VALEK, Administrative Patent Judge.

DECISION ON APPEAL

Appellant submits this appeal under 35 U.S.C. § 134(a) involving
claims to an orodispersible self-supporting film free from hydrocolloids that
have been rejected as obvious under 35 U.S.C. § 103 and provisionally
rejected for obviousness-type double patenting (“ODP”).1 We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Pharmafilm S.R.L. as the real party in
interest. Appeal Br. 3.
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STATEMENT OF THE CASE
According to the Specification, “[o]rdodispersible self supporting
films for releasing active ingredients for therapeutic or food use have been
known for a long time and are available on the market,” but have drawbacks
relating to their “physical stability as they tend to harden over time” as well
as their tendency “to gel in contact with saliva.” Spec. 1. Appellant’s
Specification purports to describe films that overcome these drawbacks. See
Id. at 1–2.
Claims 1 and 3–27 are on appeal and can be found in the Claims
Appendix of the Appeal Brief. Appeal Br. 6–19. Claim 1 is representative
and reads as follows:
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) a plasticizer in an amount comprised between 15 and
55% by weight;
e) one or more surfactants 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
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.
Id. at 20.
The following rejections are before us:
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I. Claims 1, 3, and 6–27 under 35 U.S.C. § 103 as unpatentable over
Cilurzo,2 Ibrahim,3 and Zerbe;4
II. Claims 4 and 5 under 35 U.S.C. § 103 as unpatentable over Cilurzo,
Ibrahim, Zerbe, and Kolter;5
III. Claims 1 and 3–27 as provisionally rejected for ODP over claims 1–
14 of U.S. Application No. 15/423,887 (“’887 Application”); and
IV. Claims 1 and 3–27 as provisionally rejected for ODP over claims 1
and 4–17 of U.S. Application No. 15/218,744 (“’744 Application”) in
view of Zerbe and Farshi.6
Ans. 3–4.
Analysis
I. OBVIOUSNESS REJECTIONS
Examiner’s obviousness rejections are premised on the same
combination of Cilurzo, Ibrahim, and Zerbe as applied to independent claim
1. See Final Act. 5–10. For this reason, we analyze the obviousness
rejections together, focusing on claim 1 as representative. The issue before
us is whether a preponderance of the evidence supports Examiner’s
conclusion that the cited prior art renders the film of claim 1 obvious.
Examiner finds Cilurzo teaches a maltodextrin film that meets most of
the limitations of claim 1, but lacks the recited “homopolymer or a
copolymer of vinyl acetate.” See Final Act. 3–4. For that limitation,
Examiner relies on Ibrahim’s teaching of a film comprising a

2 US 2009/0017085 A1, published Jan. 15, 2009 (“Cilurzo”).
3 US 2005/0281757 A1, published Dec. 22, 2005 (“Ibrahim”).
4 US 7,132,113 B2, issued Nov. 7, 2006 (“Zerbe”).
5 US 2010/0178306 A1, published July 15, 2010 (“Kolter”).
6 WO 2011/048563 A2, published April 28, 2011 (“Farshi”).
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“polyvinylpyrrolidone (PVP) and polyvinyl acetate (PVA)” copolymer (i.e.,
“PVP-VA”). Id. at 4–5. According to Examiner, it would have been
obvious to add PVP-VA to the film of Cilurzo because Ibrahim teaches that
“a composition comprising PVP and PVA is useful in stain removal and
prevention.” Id. at 5; Ans. 5.7
Appellant does not in its Appeal Brief dispute Examiner’s finding that
it would have been obvious to combine Cilurzo and Ibrahim. Instead,
Appellant focuses its argument on what it argues are surprising and
unexpected results arising from the addition of PVA or PVP-VA to a
maltodextrin film as recited in claim 1. See Appeal Br. 7–14. As evidence
of those unexpected results, Appellant relies on the Declaration of Francesco
Cilurzo dated May 20, 2019 (“Cilurzo Declaration”) and the Declaration of
Irma Elisa Cupone dated May 17, 2019 (“Cupone Declaration”). Id.
Appellant contends the data in these declarations show that “it is
possible to avoid brittleness of the film . . . while maintaining suitable
mechanical properties and a quick disintegration time (less than three
minutes) by incorporating in the film a homopolymer or a copolymer of
vinyl acetate,” e.g., PVA or PVP-VA. Appeal Br. 7. According to
Appellant, the declarations show that PVA and PVP-VA act as a
“nanofiller” in the recited films, meaning that the PVA and PVP-VA
particles are dispersed within maltodextrin matrix, as opposed to being

7 Examiner further concludes that it would have been obvious to add a
surfactant, as recited in claim 1, to Cilurzo’s film in view of the teachings in
Zerbe. Final Act. 5–6; see also Ans. 13. We agree that Examiner has
articulated a sufficient rationale for combining Zerbe with Cilurzo and, on
this point, are not persuaded by Appellant’s arguments to the contrary. See
Appeal Br. 15–16.
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solubilized within the polymer matrix to form a homogenous film. Id. at 8–
10. Appellant contends this is surprising and results in an unexpected
improvement in “mechanical properties in comparison to films not
containing” PVA or PVP-VA. Id. at 10. In addition, Appellant points out
that the addition of PVA and PVP-VA to the films tested in the Cupone
Declaration did not affect dissolution time in these experiments. Id. at 11–
14. According to Appellant, this is also surprising because a skilled artisan
considering the teachings in the prior art would have expected the addition
of such polymers to increase dissolution time. Id. at 13–14.
We are persuaded that Appellant’s evidence of unexpected results is
sufficient to overcome the prima facie showing of obviousness. The Cilurzo
Declaration provides data showing that the addition of PVA and PVP-VA in
amounts within the recited ranges recited in claim 1 increased both the
tensile strength and elastic modulus of the film many times over (as
compared to an otherwise identical film lacking PVA or PVP-VA), while
also decreasing the “elongation at break” thereby “allow[ing] the films to be
bended without failure.” Cilurzo Decl. ¶¶ 33–42 (Exs. 4 and 5). The
Cupone Declaration reports data for experiments testing the same
mechanical properties both before and after exposure to air. Cupone Decl.
¶¶ 18–44 (Tables 2–8). According to that data, the claimed films containing
between 2–10% PVA and PVP-VA (i.e., F1–10, F12–13) exhibited better
mechanical properties and could be “handled without failure,” whereas after
only an hour of air exposure control films lacking those polymers (i.e., F0,
F11) could not be tested because they “were very brittle and were subjected
to failures during handling.” Id. ¶¶ 24, 40, and 44. In addition, the Cupone
Declaration reports that the addition of PVA and PVP-VA did not affect
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dissolution and that all of the films tested “disintegrated in less than 1
minute.” Id. ¶¶ 21, 38, and 58.
The Cilurzo Declaration concludes that these favorable properties
result from the discovery PVA and PVP-VA “act, surprisingly and
unexpectedly, as nanofillers, improving the mechanical properties of the
maltodextrin oral dissolving film” without becoming part of the film-
forming material itself. Cilurzo Decl. ¶¶ 7–8, and 43. The Cupone
Declaration supports this conclusion with micrographs showing that in the
recited film PVP-VA particles are dispersed within the maltodextrin matrix.
Cupone Decl. ¶¶ 49–52, Figs. 1 and 2. The Cupone Declaration further
explains that this is different than the use of PVP-VA in Ibrahim where the
PVP-VA is solubilized in and part of the matrix of the film to modulate
dissolution time (id. ¶ 58) and includes a micrograph of a film “prepared
according [to] Ibrahim patent” for comparison. Id. ¶ 51, Fig. 3. Like the
Cilurzo Declaration, the Cupone Declaration describes these results as
surprising. Id. ¶¶ 58–60. In sum, on the record before us, we see no reason
to question the validity of the experiments, data, and conclusions reported in
the Cilurzo and Cupone Declarations. See In re Soni, 54 F.3d 746, 751 (Fed.
Cir. 1995) (“[W]hen an applicant demonstrates substantially improved
results . . . and states that the results were unexpected, this should suffice to
establish unexpected results in the absence of evidence to the contrary.”).
Nevertheless, Examiner asserts these results would have been
expected in light of Anastasiou,8 which teaches that “high molecular weight
polyvinyl acetate has high tensile strength,” and Singh,9 which teaches that

8 US 2013/0122072 A1, published May 16, 2013 (“Anastasiou”).
9 Singh et al., Optimization and Evaluation of Desloratadine Oral Strip: An
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maltodextrin “imparts ductility.” Ans. 7–8. We disagree. Neither
Anastasiou, nor Singh, provide any teaching regarding the effect of adding
PVA to a maltodextrin film, much less one lacking hydrocolloids as recited
in claim 1. Instead, Singh describes films comprising maltodextrin and a
hydrocolloid, i.e., HPMC (Singh, 2) and Anastasiou describes “edible
compositions such as, for example, chewing gum” containing PVA
(Anastasiou ¶ 11). Given these differences, Examiner has not shown that a
skilled artisan would have expected the recited films (which require the
combination of maltodextrin and PVA while expressly excluding
hydrocolloids) to exhibit the improved mechanical properties demonstrated
by the Cilurzo and Cupone Declarations. Moreover, Anastasiou teaches that
high tensile strength PVA is “used in gums to delay the release of sweetners
and other active ingredients.” Anastasiou ¶ 8 (emphasis added). Thus, if
anything, Anastasiou supports Appellant’s argument that a skilled artisan
would not have expected that PVA could be added to improve the film’s
mechanical properties without also increasing dissolution time.
Examiner also points to Zerbe’s teaching that “the concentration of
film-forming agent should be optimized to provide a good balance of rapid
disintegrating properties . . . and good tensile strength.” Ans. 10–11 (citing
Zerbe, 4:21–25). However, that teaching relates to films of the type taught
in Zerbe. Examiner has not sufficiently shown that a skilled artisan would
have expected that a similar optimization could be achieved in a film of the
type recited in claim 1, nor has Examiner shown that a skilled artisan would

Innovation in Paediatric Medication, The Scientific World Journal, Vol.
2013, Article ID 395681, 1–9 (2013) (“Singh”).
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have reasonably expected that the degree of improvement evidenced by the
data in the Cilurzo and Cupone Declarations could be obtained in such films.
For these reasons, Examiner’s rejection of claim 1 is not supported by
a preponderance of the evidence. We therefore reverse that rejection. We
reverse the obviousness rejections of the other claims for the same reasons
we reverse the rejection of claim 1.
II. PROVISIONAL ODP REJECTIONS
Having reversed Examiner’s other rejections, we decline to reach the
provisional ODP rejections. In re Moncla, 95 USPQ2d 1884, 1885 (BPAI
2010) (precedential) (determining that it was premature to address a
provisional ODP rejection where the other rejections had been reversed).
Examiner should process these provisional rejections consistent with MPEP
804(B)(1)(b)(ii).

CONCLUSION
In summary:

Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 6–27 103 Cilurzo, Ibrahim,
Zerbe
1, 3, 6–27
4, 5 103 Cilurzo, Ibrahim,
Zerbe, Kolter
4, 5

1, 3–27 Provisional
Obviousness-type
Double Patenting
(’887 Application)10

10 As explained above, we do not reach the provisional ODP rejections.
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Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3–27 Provisional
Obviousness-type
Double Patenting
(’744 Application)

Overall
Outcome
1, 3–27

REVERSED