Ex parte Calanchi et al.

Board of Patent Appeals and Interferences

Aug 13, 1998

07972660 (B.P.A.I. Aug. 13, 1998)

Application for patent filed November 6, 1992. 1
According to the appellants, the application is a continuation
of Application No. 07/644,062, filed January 22, 1991, now
abandoned.
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered
today (1) was not written for publication in a law
journal and (2) is not binding precedent of the
Board.
Paper No. 23
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte MASSIMO CALANCHI, MARCO ZEMA, GABRIELE BRUNETTI and
ENZO GIORGETTI
____________
Appeal No. 95-4962
Application No. 07/972,6601
____________
ON BRIEF
____________
Before RONALD H. SMITH, JOHN D. SMITH and PAK, Administrative
Patent Judges.
PAK, Administrative Patent Judge.
DECISION ON APPEAL
Calanchi et al. (appellants) appeal from the examiner’s
final rejection of claims 1 through 3 and 7 through 11, which
are all of the claims pending in the application.
Appeal No. 95-4962
Application No. 07/972,660
2
Claim 1 is representative of the subject matter on appeal
and reads as follows:
1. A targeted drug release formulation for delivery of
drugs to the intestinal tract of the ileum and colon of a
mammal consisting essentially of a plurality of multidose
minitablet units each said unit having a particle size of less
than about
5 mm and consisting essentially of a minitablet core
containing a drug selected from the group consisting of
penicillin G, calcitonin, heparin, ferritin, sucralfate,
mebeverine hydrochlorate, acarbase dimethycone, simethicone
and immunoglobulin surrounded by two membranes consisting
essentially of a pH dependent polymer which is soluble at a pH
greater than about 5.5 and the second of said membranes
consisting essentially of one or more polymers such that said
second membrane is substantially insoluble in but permeable to
gastric fluids, and wherein
a) said formulation is characterized with a
dissolution rate in a simulated gastric
environment such that over a period of 8 hours
substantially all of the drug is released, and
the release is further characterized by the
release of no more than about 10% drug after 3
hours and no more than about 75% drug after 6
hours;
b) said pH dependent polymer is selected from the
group consisting of anionic copolymers based on
methacrylic acid and methacrylic acid methyl
ester, cellulose acetate phthalate,
hydroxpropylmethylcellulose phthalate, polyvinyl
acetate phthalate, shellac,
hydroxpropylmethylcellulose acetate succinate,
carboxymethylcellulose, cellulose acetate
trimellitate, copolymers of maleic acid and
derivatives of phthalic acid; and
c) said substantially insoluble membrane is
selected from the group consisting of copolymers
Appeal No. 95-4962
Application No. 07/972,660
3
formed from acrylic and methacrylic acid esters
with a low content of quaternary ammonium
groups, neutral copolymers based on ethyl
acrylate and methyl methacrylate and having an
average molecular weight of 800,000,
ethylcellulose, polyethylene, polysiloxanes and
mixtures thereof.
Appeal No. 95-4962
Application No. 07/972,660
4
The references relied on by the examiner are:
Ikegami et al. (Ikegami) 4,533,562 Aug.
06, 1985
Mehta 4,800,087 Jan. 24,
1989
Remington’s Pharmaceutical Sciences, Mack Publishing, (1990)
pp. 1306-1307 (hereinafter referred to as “Remington”).
The references relied on by appellants are:
Zeitoun et al. (Zeitoun) 4,432,966 Feb.
21, 1984
Edgreen et al. (Edgreen) 4,503,030 Mar.
05, 1985
The reference of record relied on by the Board is:
Eichel et al. (Eichel) 0239,361 Sep. 30, 1987
(Published European Patent Application)
The appealed claims stand rejected as follows:
(1) Claims 1 through 3 and 7 through 10 under 35 U.S.C.
§ 112, second paragraph, as being indefinite for failing to
particularly point out and distinctly claim the subject matter
which applicants regard as their invention;
(2) Claims 1 through 3 and 7 through 10 under 35 U.S.C.
§ 103 as unpatentable over Mehta in view of Remington; and
(3) Claims 1 through 3 and 7 through 10 under 35 U.S.C.
§ 103 as unpatentable over Ikegami in view of Remington.
Appeal No. 95-4962
Application No. 07/972,660
5
OPINION
We have carefully reviewed the entire record before us,
including all of the arguments advanced by the examiner and
appellants in support of their respective positions. This
review leads us to conclude that the examiner’s rejections are
not well-founded. Accordingly, we will not sustain any of the
foregoing rejections. Our reasons for this determination
follow.
35 U.S.C. § 112, SECOND PARAGRAPH
The examiner has rejected appealed claims 1 through 3 and
7 through 10 under 35 U.S.C. § 112, second paragraph. In this
regard, the examiner alleges that “[t]he term ‘derivatives’
appearing in ‘derivatives of phthalic acid’. . . leads to
speculation what particular compounds are being claimed.”
Although the term in question appears to be broad, we note
that the broadness of claim language should not be equated
with indefiniteness within the meaning of § 112. See In re
Johnson, 558 F.2d 1008, 1016 n.17, 194 USPQ 187, 194 n.17
(CCPA 1977);
Appeal No. 95-4962
Application No. 07/972,660
6
In re Miller, 441 F.2d 689, 693, 169 USPQ 597, 600 (CCPA
1971); In re Gardner, 427 F.2d 786, 788, 166 USPQ 138, 140
(CCPA 1970); Ex parte Scherberich, 201 USPQ 397, 398 (Bd. App.
1977). Also, we find that the examiner’s allegation is
conclusory and is not sufficient to establish a prima facie
case of unpatentability under § 112, second paragraph.
Moreover, the examiner has not rebutted appellants’ position
set forth at pages 6 through 8 of the Brief, which refers to
prior patents to establish that the term “derivatives” is well
accepted in the art. Accordingly, we reverse the examiner’s
decision rejecting claims 1 through 3 and 7 through 10 under
35 U.S.C. § 112, second paragraph.
35 U.S.C. § 103
The examiner has also rejected appealed claims 1 through
3 and 7 through 11 under 35 U.S.C. 103 in view of either Mehta
or Ikegami taken together with Remington. We cannot sustain
these rejections for essentially those reasons set forth at
pages 8 through 14 of the Brief. We only add that the prior
art references relied on by the examiner also do not teach,
7
nor would have suggested, the claimed two membranes capable of
releasing a drug in the claimed rate.
NEW REJECTION UNDER § 1.196(b)
Under the provisions of 37 CFR § 1.196(b), the following
new ground of rejection is entered against claims 1, 3, 7 and
9 through 11.
Claims 1, 3, 7 and 9 through 11 are rejected under 35
U.S.C. § 103 as unpatentable over the disclosure of the
Eichel reference.
The Eichel reference describes a “sustained-release
pharmaceutical preparation comprising an admixture of uncoated
and/or single walled water soluble drug, such as aspirin, and
dual walled coated drug (emphasis supplied).” See abstract.
The dual wall structure has an inner wall microencapsular
control coating and an outer wall enteric coating. Id.; see
also page 3, lines 15-18. “The inner wall microencapsular
control coating is preferably selected from the group
consisting of ethyl cellulose, hydroxy propyl cellulose and
carboxy methyl cellulose.” See page 3, lines 27-28. The
preferred outer wall enteric coating is cellulose acetate
phthalate which dissolves at pH 7.5 as found in the intestine.
See page 3, lines 31-34. “Other enteric coatings may be used
as long as they do not readily dissolve or disperse in the
Appeal No. 95-4962
Application No. 07/972,660
8
gastric juices of the stomach but do dissolve or disperse in
the intestinal fluid of the intestines.” See Page 3, lines
34-36. The other enteric coatings include hydroxy propyl
cellulose phthalate, polyvinyl acetate phthalate, hydroxyethyl
ethyl cellulose phthalate, cellulose acetate
tetrahydrophthalate, shellac “or other film-forming materials
which dissolve or disperse in the intestine but remain intact
in the stomach are possible alternatives. See page 3, lines
36-39 and page 4, lines 48-51. “The dual walled coated drug
has a delayed, gradual, long-term release which takes place in
the intestines. . . .” See abstract. The core drug employed
includes vitamins, minerals, antibiotics and other analgesics.
See page 3, lines 42-43. Any drug can be used so long as it
is reasonably water soluble. See page 3, line 40. It can be
inferred from the teaching of a microcapsule having a core
drug that the particle size of the core drug is less than
about 5 mm as required by the claims. See, e.g., page 6, line
64. Although the Eichel reference does not specifically
mention the claimed property which is defined in terms of
dissolution rates, we find that the Eichel reference provides
the dissolution studies of a dual coated aspirin set forth in
Appeal No. 95-4962
Application No. 07/972,660
9
Tables I and II at pages 5 and 6. These studies indicate that
the dissolution rate is dependent on the amount of polymers
employed. See also the paragraph bridging pages 4 and 5.
Moreover, the desired sustained-release rate of a drug is
dependent on the desired concentration of a drug in a blood
stream, thus avoiding the risk of toxicity associated with a
higher concentration of the drug therein. See page 3, lines
60-65 and page 4, lines 1-9. Accordingly, we conclude that
optimizing the amount of the polymers employed to obtain
desired dissolution rates presumably as claimed would have
been obvious to one of ordinary skill in the art. See In re
Woodruff,
919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed. Cir. 1990);
In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980)
(optimizing a known result-effective variable is well within
the ambit of one of ordinary skill in the art). One of
ordinary skill in the art would have had a reasonable
expectation of avoiding the risk of toxicity associated with a
high concentration of a drug in the blood stream via
controlling the rate of its dissolution.
Appeal No. 95-4962
Application No. 07/972,660
10
This decision contains a new ground of rejection pursuant
to 37 CFR § 1.196(b) (amended effective Dec. 1, 1997, by final
rule notice, 62 Fed. Reg. 53,131, 53,197 (Oct. 10, 1997), 1203
Off. Gaz. Pat. & Trademark Office 63,122 (Oct. 21, 1997)). 37
CFR § 1.196(b)) provides that “[a] new ground of rejection
shall not be considered final for purposes of judicial
review.”
37 CFR § 1.196(b) also provides that the appellants,
WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new
ground of rejection to avoid termination of proceedings (37
CFR § 1.197(c)) as to the rejected claims:
(1) Submit an appropriate amendment of the
claims so rejected or a showing of facts relating to
the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the
applicant will be remanded to the examiner. . . .
(2) Request that the application be reheard
under § 1.197(b) by the Board of Patent Appeals and
Interferences upon the same record. . . .
No time period for taking any subsequent action in
connection with this appeal may be extended under 37 CFR
§ 1.136(a).
REVERSED; 37 CFR § 1.196(b)
Appeal No. 95-4962
Application No. 07/972,660
11
RONALD H. SMITH )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
JOHN D. SMITH ) APPEALS AND
Administrative Patent Judge ) INTERFERENCES
)
)
)
CHUNG K. PAK )
Administrative Patent Judge )
Appeal No. 95-4962
Application No. 07/972,660
12
American Home Products Corporation
Patent Law Department - B #22
One Campus Drive
Parsippany, New Jersey 07054
CKP/jrg

JENINE GILLIS

Appeal No. 95-4962
Serial No.
07/972,660

Judge PAK
Judge RON H. SMITH
Judge JOHN D. SMITH
Typed: 31 Jul 98
Revised: 12 Aug 98
DECISION: REVERSED; 37 CFR §
1.196b

Send Reference(s): Yes No
or Translation(s)
Panel Change: Yes No
3-Person Conf. Yes No
Heard: Yes No
Remanded: Yes No
Index Sheet-2901 Rejection(s): ___________
Acts 2: ____
Palm: ____
Mailed: Updated Monthly Disk: ____
Updated Monthly Report: ___