Ex Parte Bobrowski

Board of Patent Appeals and Interferences

Mar 31, 2008

10679006 (B.P.A.I. Mar. 31, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte PAUL J. BOBROWSKI
____________________

Appeal 2008-0580
Application 10/679,006
Technology Center 1600
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Decided: March 31, 2008
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Before RICHARD TORCZON, SALLY G. LANE, and JAMES T.
MOORE, Administrative Patent Judges.

MOORE, Administrative Patent Judge.

DECISION ON APPEAL

Appeal 2008-0580
Application 10/679,006

STATEMENT OF CASE
The Appellant appeals under 35 U.S.C. § 134 (2002) from a final
rejection of claims 10, 12-15, and 19-24.1 We have jurisdiction under 35
U.S.C. § 6(b) (2002).
The Appellant’s claims are directed to pharmaceutical preparations for
the treatment of itch, nausea, hyperalgesia and the complications of opioid
agonists. Claims 10 and 13 are the only independent claims in the
application. Claims 10 and 13 read as follows:
10. An extract of plant material from family Euphorbaciae and
species Croton that reduces at least one opioid-induced
complication selected from the group consisting of; [sic]
nausea, emesis, retching and itch, the extract at a concentration
of 1 mg/mL of 50% (v/v) ethanol/water having reduced UV
absorbency of about at least 4.3 between the range of 390 nm
and 430 nm relative to the absorbency within the same range
for unextracted plant material.

13. An extract of plant material from species Croton family
Euphorbaciae that reduces the effect of hyperalgesia, and which
at a concentration of about 1 mg/mL of carrier has a reduced
UV absorbency in the range of 390 nm and 430 nm of at least
4.3 relative to the same concentration of unextracted plant
material in the same carrier.

THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
Persinos US 3,809,749 May 7, 1974

1 Claims 1-9 have been withdrawn from consideration as directed to a non-
elected invention. See Non-final Rejection, Sep. 8, 2005 (restriction
requirement). Claims 11 and 16-18 have been canceled.
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Nilubol US 5,264,638 Nov. 23, 1993
Zaveri US 5,957,437 Sep. 28, 1999
Kashide I JP 52070010 Jun. 10, 1977
Kashide II JP 52144665 Dec. 2, 1977
Kawamori JP 07010777 Jan. 13, 1995
Nagaho JP 410231239 Sep. 2, 1998
Ota EP 0897712 Feb. 24, 1999
Yagi JP 411139952 May 25, 1999
Tsuchizaki JP 12336024 Dec. 5, 2000
Fankhauser US 20020155073 A1 Oct. 24, 2002
The following rejections are before us for review:
1. Claims 10, 12, 13, 15, and 19-24 stand rejected under 35 U.S.C.
§ 102(b) as being anticipated by Persinos.
2. Claims 10, 12, 13, 15, 19-22, and 24 stand rejected under 35 U.S.C.
§ 103(a) over Kashide I (JP52070010), Kashide II (JP52144665),
Kawamori, or Nilubol.
3. Claims 13-15, 19-22, and 24 stand rejected under 35 U.S.C. § 103(a) over
the combination of Tsuchizaki, Ota, Nagano or Yagi with either Zaveri or
Fankhauser.
4. Claims 13-15 and 19-22 stand rejected under 35 U.S.C. § 103(a) over the
combination of Persinos with either Zaveri or Fankhauser.
5. Claims 10, 12, 13, 15, 19-22, and 24 stand rejected under 35 U.S.C. §
103(a) over the combination of Persinos with either Kashide I (JP
52070010), Kashide II (JP 52144665), Kawamori, or Nilubol.
We REVERSE pro forma and enter a new ground of rejection under
35 U.S.C. §112, second paragraph, for independent claims 10 and 13, and
their dependent claims.
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ANALYSIS
The appellant’s claims do not particularly point out and distinctly
claim the subject matter. Because the appealed claims fail to satisfy the
requirements of the second paragraph of 35 U.S.C. § 112, we do not reach
the merits of the Examiner’s rejections under 35 U.S.C. § 102 or § 103 at
this time. To that end, the predecessor of our reviewing court has held that it
is erroneous to analyze claims based on “speculation as to the meaning of
the terms employed and assumptions” as to their scope. In re Steele,
305 F.2d 859, 862, 1300 (CCPA 1962) (“We do not think a rejection under
35 U.S.C. § 103 should be based on such speculations and assumptions.”).
Claims 10 and 13 are newly rejected under 35 U.S.C. § 112, second
paragraph, as failing to particularly point out and distinctly claim the subject
matter which the applicant regards as the invention. (37 C.F.R. § 41.50(b)).
“[T]he definiteness of the language employed must be analyzed – not
in a vacuum, but always in light of the teachings of the prior art and of the
particular application disclosure as it would be interpreted by one possessing
the ordinary skill in the pertinent art.” In re Moore, 439 F.2d 1232, 1235,
1047 (CCPA 1971).
One of ordinary skill, as understood from the art of record, would
have experience formulating topical pharmaceutical compositions (Persinos
1:13-15), such that he or she would be familiar with blending (Id. 2:19-56),
incorporating effective amounts (Id. 3:63 et seq.), and making creams,
lotions, oils, aerosols (Id. 6-7) and testing for efficacy (Id. 8-10).
We now turn to the claims at issue.
Claim 10 reads as follows:
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An extract of plant material from family Euphorbaciae
and species Croton
(1) that reduces at least one opioid-induced complication
selected from the group consisting of; nausea, emesis, retching
and itch,
(2) the extract at a concentration of 1mg/mL of 50% (v/v)
ethanol/water having reduced UV absorbency of about at least
4.3 between the range of 390 nm and 430 nm relative to the
absorbency within the same range for unextracted plant
material.

(Indenting and numbering added).
Claim 13. An extract of plant material from species
Croton family Euphorbaciae
(1) that reduces the effect of hyperalgesia, and which
(2) at a concentration of about 1mg/mL of carrier has a
reduced UV absorbency in the range of 390 nm and 430 nm of
at least 4.3 relative to the same concentration of unextracted
plant material in the same carrier.

(Indenting and numbering added).
Both claim 10 and claim13 recite the term “extract.” In claim 10, the
term first appears in the phrase “[a]n extract of plant material from family
Euphorbaciae and species Croton.” Similarly, in claim 13, the term first
appears in the phrase “[a]n extract of plant material from species Croton
family Euphorbaciae.” We consult the specification for assistance in
defining this term. It is clear from the specification that the application deals
with a solvent extraction process. (See, e.g., Specification 7:15).
Accordingly, we will apply the definition found in The Penguin Dictionary
of Chemistry, Second Edition, 1990, p. 170, which defines “extract” as
follows:
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In solvent extraction a portion of the feed is preferentially
dissolved by the solvent and recovered by distilling off the
solvent. This constitutes the extract.

From this definition, we arrive at a conclusion that the claim term
“extract” means a solvent extracted portion of plant material from Croton.
Next, the claims require us to interpret the term “plant material.” We
do so literally and broadly. This term, as presented, is inclusive of the entire
plant, i.e. leaves, roots, bark, wood, sap, and latex. It also may include
“Sangre de grado,” which the Appellant describes as the “viscous latex
derived from various Croton species plants found primarily in the Amazon
River basin.” (Specification 2:13). The term does not, however, exclude
any portion of the plant.
We now come to the first ambiguity in claim 10. Paragraph (2) recites
“the extract at a concentration of 1mg/mL of 50% (v/v) ethanol/water having
reduced UV absorbency of about at least 4.3 between the range of 390 nm
and 430 nm relative to the absorbency within the same range for unextracted
plant material.” This paragraph is the principal subject of contention
between the Examiner and the Appellant, and the only portion of the claim
that is said to define it over the known and cited prior art. It is not in dispute
that the Sangre de Grado, or Dragon’s Blood, was well-known to reduce
nausea, emesis, retching, and itching.
The Examiner found that the “1mg/mL” phrase has “no patentable
weight” because it is unclear what the amount of the Euphorbaciae is
relative to the claimed composition. (Final Rejection, Jul. 13, 2006, p. 5).
The Appellant is of the viewpoint that the “1 mg/mL” description helps to
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characterize the reduced ultraviolet absorbance of the extract in the specified
range. (Br. 12:18-23).
The Examiner is incorrect in finding that the “1 mg/mL” of claim 10
is not a limitation having weight. It appears to us that the Appellant is
attempting to characterize the extract using a reference to a baseline
material, which would be a limitation to the extract. It is critical to
understand this limitation in order to understand how the claim would be
defined over the prior art, if at all. Amgen Inc. v. Chugai Pharm. Co. Ltd.,
927 F.2d 1200, 1218 (Fed. Cir. 1991) (noting the closeness of the prior art in
doubting the meaning of the claims).
The specification provides some insight into how one of ordinary skill
in the art would interpret and apply this limitation, but not enough to render
the limitation clear and definite.
The specification describes that the first step of an extraction process
involves mixing the “[l]atex, or sap from Croton species” with an organic
solvent in a “1:1 proportion.” (Specification 7:20) Subsequently, the
specification describes the relative absorbency of a “concentration of 1 mg
of extracted latex to 1 mL of water.” (Id. 9:14).
Next, the specification describes the comparative absorbency of the
proanthocyanidin between the “parent latex (SdG)” and the extract “(CGO
110).” (Specification p. 9, “[T]he reduced proanthocyanidin content is
quantifiable spectrophotometrically. Relative absorbance of the extraction
in the visible spectrum was compared to the absorbency peak of the parent
latex (414 nm) in the visible range.”).
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However, claim 10 does not tell one of ordinary skill in the art what
the baseline is. It does not recite “latex.” Indeed, it recites “unextracted
plant material” without any antecedent basis at all (e.g. “the” or “said”).
Such plant material need not even be the same as the extracted plant
material, by the literal language of the claims.
It would not have been apparent to one skilled in the art whether the
unextracted plant material, as broadly claimed, is the latex or sap of Croton,
or some other unextracted portion of the plant material, such as the leaf,
branch, bark, etc. One of ordinary skill in the art could therefore not clearly
determine the baseline measurement. We will not import a limitation from
the specification (plant material is the chosen language, presumably
intentionally broader than “latex”). Without that baseline measurement,
there is no way to know if the property of the extract is any different from
the prior art.
Consequently, the Appellant’s attempt to characterize the test, and
what it is compared against, is so flawed for at least this first reason as to
make it impossible for one skilled in the art to determine the scope of
claim 10.
Additionally, even if the “unextracted plant material” was understood
to be the latex, neither the claim nor the specification describes the amount,
concentration, or method of preparation of this “unextracted plant material”
which is used in the comparison to the “1 mg/mL” of extract.
The second ambiguity in claim 10 relates to its recitation that the
extract at a concentration of 1 mg/mL has a “reduced UV absorbency of
about at least 4.3 between the range of 390 nm and 430 nm….” While the
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specification describes a “4.3 fold reduction in absorbance at 414 nm,” the
claim does not define “4.3.”
This undefined result is particularly problematic because, in the art,
absorbency does not technically have units, although absorbency is usually
described with reference to “Absorbance Units” or “AU.” In any event, one
skilled in the art may consider the recitation of “4.3”, without a description
to the contrary, as an absorbency unit. Even if the 4.3 was understood as a
4.3 fold reduction in absorbance, as described in the specification, the claim
would still be indefinite as it fails to provide sufficient baseline information
such that absorbency values for either of the compared materials could be
meaningfully compared.
Claims 12 depends from claim 10 and is indefinite for the same
reasons as the independent claim, except that claim 12 defines the
absorbency. Claim 12 recites that the UV absorbency of the extract in claim
10 “is about 0.110 Abs Units relative to about 0.515 Abs Units for the
unextracted plant material.” (Br. 18). However, as discussed regarding
claim 10, the claim remains indefinite because it does not provide sufficient
baseline information to allow a skilled artisan to meaningfully compare the
claimed extract with the “unextracted plant material.”
Claims 23 and 24 also depend from claim 10 and are indefinite for the
same reasons discussed for claim 10.
We now turn to independent claim 13, which suffers defects under the
second paragraph of 35 U.S.C. § 112 analogous to those of claim 10. Claim
13 states that the extract “at a concentration of about 1mg/mL of carrier has
a reduced UV absorbency in the range of 390 nm and 430 nm of at least 4.3
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relative to the same concentration of unextracted plant material in the same
carrier.” As discussed above, the Appellant is attempting to characterize the
extract using a reference to a baseline material, which would be a limitation
to the extract. As in claim 10, claim 13 does not inform a skilled artisan
what the baseline is. It is unclear whether the broadly claimed “unextracted
plant material” is the latex or sap of Croton or some other unextracted
portion of the plant material, such as the leaf, branch, bark, etc. One of
ordinary skill in the art is not sufficiently informed so as to clearly determine
the baseline measurement, and hence the scope of the claim.
Moreover, as discussed with claim 10, even if the “unextracted plant
material” was understood to be the latex, neither the claim nor the
specification describes the amount, concentration, or method of preparation
of this “unextracted plant material” which is used in the comparison to the
“1 mg/mL” of extract.
Claims 15 depends from claim 13 and is indefinite for the same
reasons as the independent claim, except that claim 15 defines the
absorbency. Claim 15 recites that the UV absorbency of the extract in
claim 13 “is about 0.010 Abs Units relative to about 0.030 Abs Units for the
unextracted plant material.” (Br. 19). However, as discussed regarding
claim 13, the claim remains indefinite because it does not provide sufficient
baseline information to allow a skilled artisan to meaningfully compare the
claimed extract with the “unextracted plant material.”
Claims 14, 19, and 20-22 also depend from claim 13 and are indefinite
for the same reasons discussed for claim 13.
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It is the applicant’s burden to precisely define the invention. In re
Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997)(citing 35 U.S.C. § 112 ¶ 2,
“The specification shall conclude with one or more claims particularly
pointing out and distinctly claiming the subject matter which the applicant
regards as his invention.”). As written, the Appellant’s independent claims
10 and 13 are indefinite, even in light of the specification. The scope of the
claims are so unclear that we cannot interpret them to resolve the raised
issues regarding the Examiner’s rejections under 35 U.S.C. §102 and §103.
CONCLUSION OF LAW
Accordingly, we reverse the Examiner’s rejections and enter a new
ground of rejection under 35 U.S.C. §112, second paragraph for independent
claims 10 and 13, and their dependent claims.
DECISION
The Rejection of claims 10, 12, 13, 15, and 19-24 under 35 U.S.C.
§ 102(b) is REVERSED.
The Rejection of claims 10, 12, 13-15, 19-22, and 24 under 35 U.S.C.
§ 103(a) are REVERSED.
A new ground of rejection under 35 U.S.C. §112, second paragraph, is
ENTERED for independent claims 10, 12-15, and, 19-24.
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)).
37 C.F.R. § 41.50(b) provides "[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review."
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37 C.F.R. § 41.50(b) also provides that the appellant, 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 the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the proceeding
will be remanded to the examiner. . . .

(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record. . . .

REVERSED
NEW GROUND OF REJECTION (37 C.F.R. §41.50(b))
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MAT

VENABLE, CAMPILLO, LOGAN & MEANEY, P.C.
1938 E. OSBORN RD
PHOENIX AZ 85016-7234

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