Ex Parte Bunick et al

Patent Trial and Appeal Board

Nov 3, 2016

11691839 (P.T.A.B. Nov. 3, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111691,839 03/27/2007
27777 7590 11/07/2016
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
FIRST NAMED INVENTOR
Frank J. Bunick
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
MCP5124USNP 6368
EXAMINER
ROSENTHAL, ANDREWS
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
11/07/2016 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):
jnjuspatent@corus.jnj.com
lhowd@its.jnj.com
pairjnj@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FRANK J. BUNICK and JEN-CHI CHEN
Appeal2015-004093
Application 11/691,839
Technology Center 1600
Before MELANIE L. McCOLLUM, JEFFREY N. FREDMAN, and
KRISTI L. R. SA WERT, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving a process for
preparing a dosage form. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
"The present invention relates to coating for pharmaceutical dosage
forms wherein the coatings form at least a continuous shell portion having a
first composition and at least one discontinuous shell portion that is
1 Appellants identify the Real Party in Interest as McNeil-PPC, Inc., a
wholly owned subsidiary of Johnson & Johnson (see Br. 2, Appellants' Brief
lacks page numbers. We number the pages sequentially starting with the
"Appeal Brief' header page).
Appeal2015-004093
Application 11/691,839
compositionally different and located within the continuous shell portion"
(Spec. 1 :3---6).
The Claims
Claims 24--26, 33-35, and 40-43 are on appeal. Claim 24 is
representative and reads as follows:
24. A process for preparing a dosage form, comprising:
a) forming a compressed core containing at least one
pharmaceutical active ingredient in a compression tableting
machine; and
b) coating the compressed core with a coating
composition comprising a dispersion of:
gelatin, and
alginate,
wherein the solids content of the alginate is controlled so
as to provide a desired appearance, wherein if the alginate has a
solids content greater than the solids content of gelatin, a
coating having raised particle regions is formed and if the
alginate has a solids content less than the solids content of the
gelatin, a coating having depressed particle regions is formed.
The Issue
The Examiner rejected claims 24--26, 33-35, and 40-43 under 35
U.S.C. § 103(a) as obvious over Sowden,2 Dong,3 MacQueen,4 and
Tonnesen5 (Final Act. 4--12).
2 Sowden et al., US 2003/0219484 Al, published Nov. 27, 2003
("Sowden").
3 Dong et al., Alginate/ gelatin blend films and their properties for drug
controlled release, 280 J. Membrane Sci. 37-44 (2006) ("Dong").
4 MacQueen et al., US 6,399,670 Bl, issued June 4, 2002 ("MacQueen").
5 Tonnesen et al., Alginate in Drug Delivery Systems, 28 Drug Dev. and
Industrial Pharmacy 621---630 (2002) ("Tonnesen").
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Application 11/691,839
The Examiner finds Sowden teaches "an immediate release dosage
form comprising a solid core and a shell surrounding the core ... by
injecting flowable material into a molding chamber" (Ans. 5). The
Examiner finds Sowden teaches suitable gelling polymers include alginate
and gelatin and Sowden has an embodiment where "the flowable material is
taught as comprising gelatin as the gelling polymer" (Ans. 5---6).
The Examiner acknowledges that "Sowden does not teach a
combination of gelatin and alginate as the coating material." (Id.).
The Examiner finds that "Dong teaches film compositions comprising
mixtures of alginate and gelatin ... and Dong teaches that it is well known
that blending gelatin can be done to improve the performance of the polymer
material, thus providing motivation for blending gelatin with alginate" (Ans.
6).
The Examiner finds that "due to the insolubility issue of these
particles, the resulting texture of a tablet coated with this insoluble alginate
particle matrix would comprise depressions and/ or raised areas according to
how much alginate is used" (Ans. 9).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Sowden, Dong, MacQueen,
and Tonnesen render the process of claims 24--26 obvious?
Findings of Fact
1. Sowden teaches "a dosage form providing immediate release of
an active ingredient. The dosage form comprises a solid core and a shell
surrounding the core" (Sowden i-f 2).
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Application 11/691,839
2. Sowden teaches the "core may [be] prepared by any suitable
method, including for example compression or molding" (Sowden i-f 35) and
that the "core typically comprises active ingredient" (Sowden i-f 108).
3. Sowden teaches the "shell is applied to the core by spraying,
dipping, enrobing, or molding ... Optionally, the shell or readily soluble
shell portion of the present invention may further comprise one or more
thickeners, and various adjuvants and/or excipients" (Sowden i-f 211 ).
4. Sowden teaches that "[ e ]xamples of such thickeners include but
are not limited to hydrocolloids ... Examples of suitable hydrocolloids (also
referred to herein as gelling polymers) such as alginates ... Additional
suitable thickening hydrocolloids include low-moisture polymer solutions
such as mixtures of gelatin and other hydrocolloids" (Sowden i-fi-1222-223).
5. Dong teaches "the alginate/gelatin film was potentially useful
in drug delivery systems" (Dong, abstract).
6. Dong teaches "blending is effective and convenient method to
improve the performance of polymer materials. In the present study, we
prepared alginate/ gelatin blend films" (Dong 38, col. 1 ).
7. Dong teaches "that blending is effective in improving the
mechanical properties of the drug loaded films" (Dong 41, col. 1 ).
8. Tonnesen teaches "[a]lginates have a wide application as rate-
controlling excipients in drug delivery systems, as a matrix for
biomolecules, and as an excipient in pharmaceutical preparations for local
administration" (Tonnesen 628, col. 2).
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Application 11/691,839
9. MacQueen teaches the "macroscopic texture may have any
design, shape, or pattern on the surface of the coating" (MacQueen 9:37-
38).
10. The Specification teaches:
The raised regions are a result of a greater percentage of water
evaporating from the portion with lower percent solids than
from the portion with a higher percent solids upon drying. In
another embodiment, polymeric particles for the discontinuous
have a solids content less than the solids content of the
continuous film-forming polymer, which are combined with
one another to form a dispersion that can be used to provide a
shell portion over a core having depressed particle regions.
(Spec. 10: 16-22).
Principles of Law
Where, as here, the claimed and prior art products ... are
produced by identical or substantially identical processes, the
PTO can require an applicant to prove that the prior art products
do not necessarily or inherently possess the characteristics of
his claimed product. ... Whether the rejection is based on
'inherency' under 35 U.S.C. § 102, on 'prima facie
obviousness' under 35 U.S.C. § 103, jointly or alternatively, the
burden of proof is the same, and its fairness is evidenced by the
PTO' s inability to manufacture products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations and footnotes
omitted).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 4--12; FF 1-10) and agree that
the claims would have been obvious over Sowden, Dong, Tonnesen, and
Mac Queen.
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Appellants contend that
if one were to combine Sowden et al., Dong et al., MacQueen et
al., and/or Tonnesen et al. as proposed, the result would be a
process for preparing a film wherein a core is dispersed
throughout the film, wherein the film comprises gelatin and
alginate. As discussed above, the film of Dong et al. is not the
same as a coating. This does not describe Applicants invention.
Applicants respectfully submit that neither Sowden et al.,
Dong et al., MacQueen et al., Tonnesen et al. nor any
combination thereof, disclose or suggest the novel feature
recited in Claim 24, wherein the solids content of the alginate is
controlled so as to provide a desired appearance, wherein if the
alginate has a solids content greater than the solids content of
gelatin, a coating having raised particle regions is formed and if
the alginate has a solids content less than the solids content of
the gelatin, a coating having depressed particle regions is
formed.
(Br. 5---6)
We do not find this argument persuasive. The ordinary artisan
forming Sowden' s coating---comprising thickeners made up of "mixtures of
gelatin and other hydrocolloids"-would have further relied on Sowden's
teaching that alginate is such an "other hydrocolloid" (FF 3--4) to form a
coating comprising gelatin and alginate. Dong further motivates this
combination by teaching that the hydrocolloid mixture of alginate and
gelatin results in improved mechanical properties (FF 7).
Once the artisan formed the coating with alginate and gelatin as
suggested by Sowden and Dong, that coating would necessarily have
comprised a solids content with greater or lesser amounts of alginate and
gelatin, inherently yielding a "texture of a tablet coated with this insoluble
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Application 11/691,839
alginate particle matrix [that] would comprise depressions and/ or raised
areas according to how much alginate is used" (Ans. 8). That is, the ratio of
these hydrocolloids would be controlled by whatever ratio would have been
selected by the routine artisan. The Specification itself indicates that the
ratio itself inherently results in either raised or depressed portions (FF 10).
Therefore, the Examiner reasonably cites In re Spada, 911 F .2d 705,
709 (Fed. Cir. 1990), for the proposition that the obvious coating of Sowden
and Dong would thus necessarily result in a controlled ratio of gelatin to
alginate, with the appearance based on this ratio representing an inherent
property of the obvious resultant coating.
Appellants' also contend that "[ c ]laims 25 and 26 also include the
noteworthy feature wherein the solids content of the alginate is controlled so
as to provide a desired appearance" (Br. 6). We find this argument
unpersuasive for the same reasons as given for claim 24 because the desired
appearance simply represents an inherent property of the alginate/gelatin
ratio, and no particular appearance is required by the claims.
Conclusion of Law
The evidence of record support the Examiner's conclusion that
Sowden, Dong, MacQueen, and Tonnesen render the process of claims 24--
26 obvious.
SUMMARY
In summary, we affirm the rejection of claims 24--26 under 35 U.S.C.
§ 103(a) as obvious over Sowden, Dong, MacQueen, and Tonnesen. Claims
33-35 and 40-43 fall with claim 24--26.
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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
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