Ex parte Ebert et al.

Board of Patent Appeals and Interferences

Aug 25, 1998

07725222 (B.P.A.I. Aug. 25, 1998)

Application for patent filed June 26, 1991. According to appellants, the1
application is a continuation of Application 07/638,944, filed January 9, 1991, now
abandoned; which is a continuation of Application 07/512,639, filed April 20, 1990, now
U.S. Patent No. 5,064,654; which is a continuation of Application 07/296,910, filed
January 11, 1989, now abandoned; which is a continuation of Application 07/133,681, filed
December 16, 1987, 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publication in a law journal and (2) is not binding precedent of the Board.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. 35
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte CHARLES EBERT,
GERARD C. MAZZENGA,
JOHN H. OTTE, and
BRET BERNER
__________
Appeal No. 94-2894
Application 07/725,2221
__________
ON BRIEF
__________
Before WINTERS and WILLIAM F. SMITH, Administrative Patent Judges, and
McKELVEY, Senior Administrative Patent Judge.
WILLIAM F. SMITH, Administrative Patent Judge.
Appeal No. 94-2894
Application 07/725,222
2
Appeal No. 94-2894
Application 07/725,222
3
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of claims 2, 5
through 7, and 9 through 15, all the claims remaining in the application.
Claims 10, 15, and 7 are illustrative of the subject matter on appeal and read as
follows:
10. A dosage form for transdermally administering a pharmaceutically active agent
which dosage form comprises
a) an impermeable backing,
b) a rate-controlling membrane of polyurethane or ethylene-vinyl acetate of greater
than 20% vinyl acetate and from 0.5 to 10.0 mils thick,
c) a silicone-based or acrylic-based pressure sensitive adhesive on said rate
controlling membrane distal from said backing,
d) a reservoir formed by a and b,
e) an aqueous pharmaceutically acceptable lower alkanol reservoir composition
having a volume fraction of said lower alkanol of from 0.39 to 0.9 calculated based on said
alkanol and water only, and
f) said pharmaceutically active agent.
15. A transdermal drug delivery system comprising
(I) an occlusive, impermeable polymeric backing layer;
(ii) a drug depot on one side thereof;
(iii) a removable, occlusive covering layer over said drug depot; and
(iv) an adhesive means by which said delivery system, absent said
removable covering layer may be affixed to an intended patient;
Appeal No. 94-2894
Application 07/725,222
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said drug depot containing a drug formulation comprising a transdermally
administrable pharmaceutically acceptable pharmaceutically active agent or a precursor
thereof, water and lower alkanol;
said active agent or precursor thereof being present in a pharmaceutically effective
amount;
said lower alkanol and said water being present in a volume:volume ratio of from
30:70 up to less than 95:5 such that said lower alkanol, water and drug are delivered to a
patient's skin, which patient has applied said system absent said removable covering layer
to said patient's skin, in amounts that said drug is delivered in a transdermally
administrable efficacious amount, said water has an activity at said patient's skin of about
0.4 to about 0.95 and said lower alkanol, at said patient's skin, has an activity of 0.3 to
about 0.9, and
wherein, once applied to said patient's skin, said lower alkanol has a flux from said
system to said skin of at least 1500 mcg/cm /hr and through said skin of at least 15002
mcg/cm /hr.2
7. The system of claim 15 wherein said water and said lower alkanol are delivered
to said patient's skin so as to result in an ethanol activity of at least 0.5.
The examiner does not rely upon prior art references in rejecting the claims on
appeal. Rather, claims 2, 5 through 7, and 9 through 15 are rejected under 35 U.S.C. §
101 as claiming the same invention as that of claims 1 through 11 of U.S. Patent No.
5,064,654 ('654 patent). In addition, claims 2, 5 through 7, and 9 through 15 stand rejected
under 35 U.S.C. § 112, first and second paragraphs, as being nonenabled and indefinite.
We reverse each of these rejections. In addition, we make new grounds of rejection under
37 CFR § 1.196(b) and statements under 37 CFR § 1.196(c).
Appeal No. 94-2894
Application 07/725,222
5
Double Patenting Rejection
This rejection is clearly erroneous. In relevant part, the claims on appeal require the
presence of a "lower alkanol" while the claims of the '654 patent require the presence of
"ethanol." The examiner's position as stated at page 2 of the Answer is "The instant
claims are rejected under 35 USC § 101 based on Applicant's own specification wherein
the only alkanol disclosed is ethanol."
It is difficult to discern why at this point in time an examiner would make such a
rejection. The facts presented in this application are very similar to those presented in In
re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970). In Vogel at 441, 164 USPQ at
622, the court stated:
A good test, and probably the only objective test, for "same invention," is
whether one of the claims could be literally infringed without literally infringing
the other. If it could be, the claims do not define identically the same
invention.
Here, the present claims would be infringed by a device which uses methanol where such
a methanol containing device would not infringe the claims of the ‘654 patent. Similar to
the facts in Vogel, where the court determined that claims requiring pork are not identical
to claims requiring meat, the claims in this application which require lower alkanol are not
identical to the claims in the '654 patent which require ethanol.
The double patenting rejection is reversed.
Appeal No. 94-2894
Application 07/725,222
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Rejections Under 35 U.S.C. § 112, First and Second Paragraphs
The examiner considers the term "lower alkanol" as used in the claims on appeal to
be indefinite and not enabled. The only reason given in support of the examiner's position
is that the only lower alkanol exemplified in the specification of this application is ethanol. It
appears to be the examiner's position that the claims on appeal must be limited to the
presence of ethanol.
In regard to the rejection made under the first paragraph of this section of the
statute, the examiner states at page 3 of the Examiner's Answer that "the claims are not
commensurate in scope with that which is disclosed." This determination is clearly
erroneous. The specification of this application clearly and unambiguously "discloses" that
the present invention involves the use of lower alkanols. See, e.g., the paragraph bridging
pages 4-5 of the specification. Suffice it to say that the examiner has failed to articulate
any reason why one skilled in the art would not be able to make and use the claimed
invention set forth in the claims on appeal.
Turning to the rejection as it is premised under the second paragraph of this section
of the statute, the examiner's position as set forth at page 3 of the Examiner's Answer is
that "lower" is a relative term. The short answer to the examiner's position is, So what? It
has long been held that the use of relative terms in a patent claim does not per se give rise
to a rejection under 35 U.S.C. § 112, second paragraph. In re Mattison, 509 F.2d 563,
Appeal No. 94-2894
Application 07/725,222
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564-65, 184 USPQ 484, 486 (CCPA 1975). Again, it will suffice for us to point out that the
examiner has failed to present a reasoned, fact supported explanation why one skilled in
the art would not be able to reasonably ascertain the metes and bounds of the term "lower
alkanol."
The rejections under 35 U.S.C. § 112, first and second paragraphs, are reversed.
New Grounds of Rejection Under 37 CFR § 1.196(b)
Under the provisions of 37 CFR § 1.196(b), we make the following new grounds of
rejection.
1. Obviousness-type double patenting.
Claims 2, 5 through 7, and 9 through 15 are rejected under the judicially created
doctrine of obviousness-type double patenting on the basis of the claims of the '654
patent.
The claims of the '654 patent correspond to those pending in this application with
the exception that the patented claims are limited to the presence of ethanol while the
claims pending in this application require the presence of lower alkanols. Since ethanol is
a lower alkanol, it should be beyond dispute that the claims in this application are an
obvious variation of the claims of the '654 patent.
Appeal No. 94-2894
Application 07/725,222
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We note that appellants understood that an obviousness-type double patenting
issue was raised when these claims were presented in immediate parent application
07/638,944 in that a terminal disclaimer was submitted with that application. However,
terminal disclaimers do not carry forward to subsequent continuing applications. As the
record in this application now stands, an appropriate terminal disclaimer is not of record.
But see, the statement under 37 CFR § 1.196(c) set forth below.
2. Claim 7.
Claim 7 is rejected under 35 U.S.C. § 112, second paragraph, as being indefinite.
While claim 7 refers to the lower alkanol required by claim 15, the result required in
claim 7 is measured in terms of ethanol activity, not lower alkanol activity. Thus, claim 7 is
indefinite on its face.
Appellants recognized this and attempted to amend claim 7 to obviate this error in
an amendment filed with the Appeal Brief filed March 29, 1993. That amendment was not
entered by the examiner. Thus, as of this date, the examiner has not allowed appellants to
correct this error. Again, see the statement under 37 CFR § 1.196(c) below.
Statements Under 37 CFR § 1.196(c)
Under the provisions of this rule, we make the following two statements. First, if
appellants file an appropriate terminal disclaimer in the time period set forth below, the
Appeal No. 94-2894
Application 07/725,222
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obviousness-type double patenting rejection would be obviated. Second, if the
amendment to claim 7 filed March 29, 1993, is now approved for entry by the examiner, the
new ground of rejection we have made of claim 7 under 35 U.S.C. § 112, second
paragraph, would be obviated.
Time Period for Response
This opinion 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 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 (§ 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 application 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. . . .
Appeal No. 94-2894
Application 07/725,222
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37 CFR § 1.196(c) provides:
Should the decision of the Board of Patent Appeals and Interferences
include an explicit statement that a claim may be allowed in amended form,
appellant shall have the right to amend in conformity with such statement
which shall be binding upon the examiner in the absence of new references
or grounds of rejection.
A statement pursuant to 37 CFR § 1.196(c) has been made in this decision. A time
period in which appellants may file an amendment for the purpose stated in
§ 1.196(c) is hereby set to expire TWO MONTHS FROM THE DATE OF THIS DECISION.
No time period for taking subsequent action in connection with this appeal may be
extended under 37 CFR § 1.136(a).
REVERSED - 37 CFR § 1.196(b) & (c)
Sherman D. Winters )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
William F. Smith ) APPEALS AND
Administrative Patent Judge ) INTERFERENCES
)
)
)
Appeal No. 94-2894
Application 07/725,222
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Fred E. McKelvey, Senior )
Administrative Patent Judge )
Michael W. Glynn
Novartis Corporation
Patent Department
59 Route 10
East Hanover, NJ 07936-1080