Ex parte Rose et al.

Board of Patent Appeals and Interferences

Jul 22, 1998

08309790 (B.P.A.I. Jul. 22, 1998)

Application for patent filed September 21, 1994. According to appellants, the1
application is a continuation-in-part of Application 07/979,804, filed November 20,
1992, 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publication in a law journal and (2) is not binding precedent of the Board.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. 28
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_____________
Ex parte JED E. ROSE
and FREDERIQUE M. BEHM
_____________
Appeal No. 96-3923
Application 08/309,7901
______________
ON BRIEF
_______________
Before MEISTER, STAAB and CRAWFORD, Administrative Patent
Judges.
MEISTER, Administrative Patent Judge.
DECISION ON APPEAL
Jed E. Rose and Frederique M. Behm (the appellants)
appeal from the final rejection of claims 1-28, the only
Appeal No. 96-3923
Application 08/309,790
2
claims present in the application.
We AFFIRM-IN-PART.
The appellants' invention pertains to a method and device
for reducing the incidence of tobacco smoking wherein an
irritant is utilized to simulate respiratory tract sensations
in a user that are substantively similar to those obtained by
inhalation of tobacco smoke. Independent claims 1 and 8 are
further illustrative of the appealed subject matter and copies
thereof may be found in the appendix to the appellants' brief.
The references relied on by the examiner are:
Rose 4,715,387 Dec. 29,
1987
Ray et al. (Ray) 4,800,903 Jan. 31, 1989
Fuller et al. (Fuller), American Physiological Society,
?Bronchoconstrictor response to inhaled capsaicin in humans?,
pages 1080-1084 (1985).
Claims 15-28 stand rejected under 35 U.S.C. § 112, first
paragraph, for failing to (1) provide an adequate written
description of the invention, (2) adequately teach how to make
and use the invention and (3) present a best mode of carrying
out the invention.
Appeal No. 96-3923
Application 08/309,790
The answer contains no "Response to Argument" as expressly required by Manual2
of Patent Examining Procedure (MPEP) § 1208 (6th ed., Rev. 3, Jul. 1997).
3
Claims 15-28 stand rejected under 35 U.S.C. § 112, second
paragraph, for failing to particularly point out and
distinctly claim the subject matter which the appellants
regard as the invention.
Claims 1, 5-8 and 12-14 stand rejected under 35 U.S.C. §
103 as being unpatentable over Fuller in view of Rose.
Claims 1-4 and 8-11 stand rejected under 35 U.S.C. § 103
as being unpatentable over Fuller in view of Ray.
The examiner's rejections are explained on pages 3-6 of
the answer. The arguments of the appellants in support of2
their position are found on pages 8-19 of the brief and pages
1-4 of the reply brief.
OPINION
At the outset, we note the appellants on page 7 of the
brief state that:
1. method claims 1-7 stand or fall together as a
first group;
2. device claims 8-14 stand or fall together as a
Appeal No. 96-3923
Application 08/309,790
4
second group;
3. method claims 15 and 17-22 stand or fall together
as a third group; and
4. device claims 16 and 23-28 stand or fall together
as a fourth group.
Accordingly, group 1 will stand or fall with representative
claim 1; group 2 will stand or fall with representative claim
8; group 3 will stand or fall with representative claim 15;
and group 4
will stand or fall with representative claim 16. See 37 CFR
§ 1.192(c)(7).
We have carefully reviewed the appellants' invention as
described in the specification, the appealed claims, the
examiner's statement of the rejections, the prior art applied
by the examiner and the arguments advanced by the appellants
in the brief and reply brief. As a consequence of this
review, we will reverse the rejections of claims 15-28 under
35 U.S.C. § 112, first and second paragraphs and, with respect
to the rejections under 35 U.S.C. § 103, we will (1) reverse
the rejection of claims 1 and 5-7 based on the combined
Appeal No. 96-3923
Application 08/309,790
The description requirement found in the first paragraph of § 112 is separate3
from the enablement requirement of that provision. See Vas-Cath, Inc. v. Mahurkar, 935
F.2d 1555, 1560-64, 19 USPQ2d 1111, 1114-17 (Fed. Cir. 1991) and In re Barker, 559 F.2d
588, 591, 194 USPQ 470, 472 (CCPA 1977), cert. denied, sub. nom, Barker v. Parker, 434
U.S. 1064 (1978).
5
teachings of Fuller and Rose, (2) affirm the rejection of
claims 8 and 12-14 based on the combined teachings of Fuller
and Rose, (3) reverse the rejection of claims 1-4 based on the
combined teachings of Fuller and Ray and (4) affirm the
rejection of claims 8-11 based on the combined teachings of
Fuller and Ray.
Considering first the rejection of claims 15-28 under 35
U.S.C. § 112, first paragraph, the examiner's rejection
appears to be based on the enablement requirement of that
provision. 3
More specifically, the examiner is of the opinion that the
"whereby" clauses of claims 15 and 16 are
inadequately and insufficiently described
and taught. There is no factual disclosure
to determine when the respiratory tract
sensations created by the irritant are
sufficient to simulate those created by
tobacco smoke to reduce the need of the
user to smoke tobacco, yet insufficient to
Appeal No. 96-3923
Application 08/309,790
6
create a gross bronchoconstrictor response
in the user. The quantity, strength or the
like of the irritant needed to achieve the
desired results of sufficiently simulating
respiratory tract smoking sensations while
not creating gross bronchoconstrictor
response is not disclosed. No comparative
test results have been submitted. [Answer,
page 5.]
Considering first the rejection under 35 U.S.C. § 112,
first paragraph, we note that the test regarding enablement is
whether the disclosure, as filed, is sufficiently complete to
enable one of ordinary skill in the art to make and use the
claimed invention without undue experimentation. See In re
Scarbrough, 500 F.2d 560, 566, 182 USPQ 298, 302 (CCPA 1974)
and In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.
Cir. 1988). Additionally, as the court in In re Gaubert, 524
F.2d 1222, 1226, 187 USPQ 664, 667 (CCPA 1975) set forth in
quoting from Martin v. Johnson, 454 F.2d 746, 751, 172 USPQ
391, 395 (CCPA 1972):
To satisfy §112, the specification disclo-
sure must be sufficiently complete to
enable one of ordinary skill in the art to
make the invention without undue
experimentation, although the need for a
Appeal No. 96-3923
Application 08/309,790
7
minimum amount of experimentation is not
fatal * * *. Enablement is the criterion,
and every detail need not be set forth in
the written specification if the skill in
the art is such that the disclosure enables
one to make the invention. [Citations
omitted.]
The determination of what constitutes undue experimentation in
a given case requires the application of a standard of
reasonableness, having due regard for the nature of the
invention and the state of the art. See Ex parte Forman, 230
USPQ 546, 547 (Bd. Pat. App. & Int. 1986).
Here, with respect to the irritants utilized in the
invention, the appellants’ specification on pages 9 and 10
teaches that (1) oleoresins of black and/or red pepper are
dissolved in a liquid carrier such as ethanol or propylene
glycol "at about .01 to .10 weight percent" and (2)
nonvolatile constituents such as capsaicin are dissolved in a
liquid carrier such as ethanol or propylene glycol "at about
.0002 to .005 weight percent" in order to achieve the results
stated in the specification. Page 5 of the specification of
the parent application stated that the object of the invention
was to "simulate the sensation created by tobacco smoke" and a
Appeal No. 96-3923
Application 08/309,790
See Manual of Patent Examining Procedure (MPEP) § 608.04(b) (6th ed., Rev. 3,4
Jul. 1997): "An amendment which adds additional disclosure filed with a request for a
continuation-in-part application under 37 CFR 1.62 is automatically considered a part of
the original disclosure of the application by virtue of the rule."
8
preliminary amendment (Paper No. 15) filed concurrently with
the instant continuation-in-part application amended page 54
of the specification to state that the sensations created by
the irritant are
sufficient to simulate those created by
tobacco smoke to reduce the need of the
user to smoke tobacco but insufficient to
create a gross bronchoconstrictor response
in the user.
Thus, taken as a whole, the appellants' specification contains
a teaching that the above-noted amounts of irritant set forth
on pages 9 and 10 are sufficient to simulate sensations
created by tobacco smoke but insufficient to create a gross
bronchoconstrictor response in a user. As the court in In re
Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971)
stated
a specification disclosure which contains a
teaching of the manner and process of
making and using the invention in terms
which correspond in scope to those used in
Appeal No. 96-3923
Application 08/309,790
9
describing and defining the subject matter
sought to be patented must be taken as in
compliance with the enabling requirement of
the first paragraph of § 112 unless there
is reason to doubt the objective truth of
the statements contained therein which must
be relied on for enabling support.
Here, the examiner has not provided any reasonable line
of reasoning for doubting the objective truth of the
appellants’ statements concerning the disclosed amounts of
irritant and the results they produce. In this regard, it is
well settled that the examiner has the initial burden of
producing reasons that substantiate a rejection based on lack
of enablement. See Marzocchi, 439 F.2d at 224, 169 USPQ at
370 and In re Strahilevitz, 668 F.2d 1229, 1232, 212 USPQ 561,
563 (CCPA 1982). The examiner, however, has failed to satisfy
this burden. Accordingly, we will not sustain the rejection
of claims 15-28 under 35 U.S.C. § 112, first paragraph.
Turning to the rejection of claims 15-28 under 35 U.S.C.
§ 112, second paragraph, the examiner is of the opinion that
these claims are indefinite because "no quantity, strength or
the like of irritant is recited" (answer, page 6). We do not
agree with the examiner’s position. The legal standard for
Appeal No. 96-3923
Application 08/309,790
10
indefiniteness is whether a claim reasonably apprises those of
skill in the art of its scope. In re Warmerdam, 33 F.3d 1354,
1361, 31 USPQ2d 1754, 1759 (Fed. Cir. 1994). Here, the
examiner has not even alleged that one of ordinary skill in
this art would not be reasonably be apprised of the scope of
these claims. Instead, the examiner’s position is bottomed on
the fact that no particular amount or quantity of irritant has
been set forth. Such a criticism, however, goes to the
breadth of the claim and it is well settled that breadth alone
is not to be equated with indefiniteness. See In re Johnson,
558 F.2d 1008, 1016 n.17, 194 USPQ 187, 194 n.17 (CCPA 1977);
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) and Ex parte Scherberich, 201 USPQ 397, 398 (Bd.
App. 1977). Even though a specific amount or quantity of
irritant has not been set forth, we see no reason why one of
ordinary skill in this art would not be reasonably apprised of
the scope of claims 15-28. This being the case, we will not
sustain the rejection of claims 15-28 under 35 U.S.C.
§ 112, second paragraph.
Appeal No. 96-3923
Application 08/309,790
11
Considering next the rejections under 35 U.S.C. § 103 of
claims 1 and 5-7 based on the combined teachings of Fuller and
Rose and claims 1-4 based on the combined teachings of Fuller
and Ray, each of these claims is directed to a method for
reducing the incidence of tobacco by simulating respiratory
tract sensations in a user substantively similar to those
obtained by inhalation of tobacco smoke. The answer states
that:
Fuller describes an experiment wherein
capsaicin, an extract, or constituent, of
pepper, was inhaled by human subjects (see
page 1080, column 1, first (abstract)
paragraph and column 2, paragraph beginning
"Drug Delivery" in particular). The device
used was a nebulizer. This is the same
method as here claimed. [Page 3.]
Thereafter, the examiner concludes that it would have been
obvious (1) "to have used the aerosol device of Rose in order
to deliver the capsaicin to the human subjects" (answer, page
4) and (2) "to have used the tube of Ray as the nebulizer in
the method of Fuller, substituting capsaicin for nicotine, in
order to deliver the capsaicin to human subjects" (answer,
page 4).
Appeal No. 96-3923
Application 08/309,790
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We cannot agree with the examiner's assertion that the
"method" of Fuller is the "same" as that being claimed in
independent claim 1. Independent claim 1 sets forth:
A method for reducing the incidence of
tobacco smoking by simulating respiratory
tract sensations . . . whereby the
respiratory tract sensations created by
said irritant simulate those created by
tobacco smoke to reduce the need of the
user to smoke tobacco. [Emphasis ours.]
It is thus clear that the method set forth in independent
claim 1 is directed to the process of using an irritant such
as capsaicin to reduce the smoking of tobacco by a user.
While both Fuller's method and the method defined by
independent claim 1 include the steps of repeatedly inhaling
an irritant such capsaicin, Fuller neither teaches nor
suggests the use of this irritant to reduce the need of a user
to smoke tobacco. Instead, Fuller's method is directed to the
measurement of bronchoconstrictor response in humans after an
irritant such as capsaicin has inhaled by a user. Inasmuch as
35 U.S.C. § 100(b) expressly recognizes "a new use of a known
process," the particular use to which the process is directed
Appeal No. 96-3923
Application 08/309,790
13
cannot be ignored as the examiner apparently has done. See,
e.g., In re Zierden, 411 F.2d 1325, 1328, 162 USPQ 102, 104
(CCPA 1969).
The examiner has merely relied on Rose for the teaching
of an aerosol device and on Ray for the teaching of a
dispenser (which dispenses nicotine). In any event, we have
carefully reviewed the teachings of Rose and Ray and find
nothing in the combined disclosures of Fuller and either Rose
or Ray which would fairly suggest the method set forth in
independent claim 1. Therefore, we will not sustain the
rejections under 35 U.S.C.
§ 103 of claims 1 and 5-7 based on the combined teachings of
Fuller and Rose and claims 1-4 based on the combined teachings
of Fuller and Ray.
Considering last the rejections under 35 U.S.C. § 103 of
claims 8 and 12-14 as being unpatentable over Fuller in view
of Rose and claims 8-11 as being unpatentable over Fuller in
view of Ray, we initially note that each of these claims is
directed to a device for reducing the incidence of tobacco by
simulating respiratory tract sensations in a user
Appeal No. 96-3923
Application 08/309,790
14
substantively similar to those obtained by inhalation of
tobacco smoke. Fuller provides a nebulizer (see the last full
paragraph on page 1080) which contains capsaicin (see, e.g.,
the penultimate paragraph on page 1080) and is "adapted" to be
introduced into a user's mouth for inhalation. While the
examiner has additionally relied on the teachings of either
Rose or Ray for the particular type of inhalation device, the
nebulizer of Fuller satisfies the limitations of the
inhalation device as broadly set forth in representative claim
8 and, accordingly, we see no need to resort to the teachings
of either Rose or Ray insofar as the limitations of
representative claim 8 are concerned.
The appellants argue that there is no suggestion in
Fuller to use the inhalation device or nebulizer for the
purpose of having smokers inhale capsaicin so as to reduce
their incidence of smoking tobacco. This is true. We must
point out, however, the particular manner in which a device or
article is used cannot be relied on to distinguish structure
from the prior art. See, e.g., In re Schreiber, 128 F.3d
1473, 1477, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997), In re
Appeal No. 96-3923
Application 08/309,790
15
Spada, 911 F.2d 705, 708, 15 USPQ2d 1655, 1657 (Fed. Cir.
1990), In re Yanush, 477 F.2d 958, 959, 177 USPQ 705, 706
(CCPA 1973) and In re Casey, 370 F.2d 576, 580, 152 USPQ 235,
238 (CCPA 1967). Here, the device of Fuller (i.e., nebulizer)
clearly has the capability of being used in the claimed manner
and whether Fuller's device actually is or might be used to
reduce the need of a user to smoke tobacco depends upon the
performance or nonperformance of a future act of use rather
than a structural distinction in the claims. Stated
differently, the nebulizer of Fuller would not undergo a
metamorphosis to a new device simply because it was used to
reduce the need of a user to smoke tobacco. See In re
Pearson, 494 F.2d 1399, 1403, 181 USPQ 641, 644 (CCPA 1974)
and Ex parte Masham, 2 USPQ2d 1647, 1648 (Bd. Pat. App. & Int.
1987).
In view of the foregoing, we will sustain the rejections
under 35 U.S.C. § 103 of claims 8 and 12-14 as being
Appeal No. 96-3923
Application 08/309,790
16
unpatentable over Fuller in view of Rose and claims 8-11 as
being unpatentable over Fuller in view of Ray.
In summary:
The rejections of claims 15-28 under 35 U.S.C. § 112,
first and second paragraphs, are reversed.
The rejections under 35 U.S.C. § 103 of claims 1 and 5-7
as being unpatentable over Fuller in view of Rose and claims
1-4 as being unpatentable over Fuller in view of Ray are
reversed.
The rejections under 35 U.S.C. § 103 of claims 8 and 12-
14 as being unpatentable over Fuller in view of Rose and
claims 8-11 as being unpatentable over Fuller in view of Ray
are affirmed.
Appeal No. 96-3923
Application 08/309,790
17
No time period for taking any subsequent action in
connection with this appeal may be extended under 37 CFR
§ 1.136(a).
AFFIRMED-IN-PART
)
JAMES M. MEISTER )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
LAWRENCE J. STAAB )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
MURRIEL E. CRAWFORD )
Administrative Patent Judge )
Appeal No. 96-3923
Application 08/309,790
18
Richard J. Jenkins
University Tower, Ste. 1600
3100 Tower Road
Durham, NC 27707