Ex Parte Johnson et al

Board of Patent Appeals and Interferences

Dec 30, 2009

10392422 (B.P.A.I. Dec. 30, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte ERIC SCOTT JOHNSON, ELIZABETH ANN CRANE,
JAMES ROBERT SCHWARTZ, CARL HINZ MARGRAF III, GREGORY
V. TORMOS, and DAVID THOMAS WARNKE
____________

Appeal 2009-006686
Application 10/392,422
Technology Center 1600
____________

Decided: December 30, 2009
____________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal by the Patent Applicants from the
Patent Examiner’s rejection of claims 1, 3-6, 8-10, 15, 16, 18, 19, and 47-50
under 35 U.S.C. § 112, first paragraph. The Board’s jurisdiction for this
appeal is under 35 U.S.C. §§ 6(b) and 134. We reverse.
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STATEMENT OF THE CASE
The claims are to a personal care composition comprising a zinc-
containing material (“ZCM”). According to the Specification, zinc was
known to be especially important to skin health and had been used in anti-
dandruff and skin care applications (Spec. 1-2).
Claims 1, 3-6, 8-10, 15, 16, 18, 19, and 47-50 stand rejected by the
Examiner under 35 U.S.C. § 112, first paragraph, as lacking a written
description and failing to enable the full scope of the claims. Claim 1 is
representative and reads as follows:
1. A composition comprising:

a. an effective amount of a zinc containing material having an aqueous
solubility within the composition of less than about 25% by weight at 25°C;

b. from about 5% to about 50% by weight of a detersive surfactant
wherein the detersive surfactant is selected from the group consisting of
anionic, cationic, amphoteric or zwitterionic surfactants and mixtures
thereof;

c. a component selected from the group consisting of sodium
bicarbonate, sources of carbonate anions and mixtures thereof; and

d. from about 40% to about 95% by weight water;
wherein the pH of the composition is greater than about 7 and further
wherein the zinc containing material has a relative zinc lability of greater
than about 15%.

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FINDINGS OF FACT
Claim 1
1. Claim 1 is to a composition having the following components and
properties:
2. a. a zinc containing material “having an aqueous solubility within the
composition of less than about 25% by weight at 25°C”;
3. b. “from about 5% to about 50% by weight of a detersive surfactant,”
which is “selected the group consisting of anionic, cationic, amphoteric or
zwitterionic surfactants and mixtures thereof”;
4. c. sodium bicarbonate, sources of carbonate anions, and mixtures
thereof;
5. d. “from about 40% to about 95% by weight water.”
6. The pH of the composition is recited to be greater than about 7.
7. The zinc containing material is recited to have “a relative zinc lability of
greater than about 15%.”
Specification
8. A zinc containing material is defined beginning on page 4 of the
Specification as a material “comprising zinc bound covalently, and/or
ionically, or physically by a host material.” (Spec. 4:28-30.) Numerous
examples of zinc containing materials are disclosed (id. at 5:6 to 6:33).
9. In the “Summary,” it is stated that the “invention is directed to a
composition comprising an effective amount of a zinc containing material
having an aqueous solubility within the composition of less than about 25%
by weight, at 25°C” (Spec. 2:5-7), the same language recited in claim 1,
component a. (F2).
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10. The Specification identifies certain zinc salts that become insoluble
above a pH of 7 (Spec. 7:1-5).
Solubility
11. The Specification provides a “Definition of ZCM Solubility”: “A zinc
containing material with a solubility of less than 25% will have a measurable
% soluble zinc value below a threshold value determined by the weight
percent and molecular weight of the zinc compound.” (Spec. 7:6-8.) An
equation to determine the “theoretical threshold value” is disclosed and
accompanied by examples in which the value is calculated (id. at 7:8-12).
12. Persons of ordinary skill in the art would have understood that “ZCM
solubility” as defined on page 7 of the Specification (F11) refers to the zinc
material’s “aqueous solubility” disclosed in the Specification (F9) and
claimed (F2) because the same terminology is used (“solubility”, albeit the
Specification definition on page 7 does not state “aqueous solubility”) and
the same upper limit of 25% appears in both (compare claim “25%, by
weight” with Specification at 7:7 & 11, and the header on column 4 of the
Table at 7:10-15).
13. The Specification contains a graph (Figure 1) which “demonstrates the
relationship between pH and percent (%) soluble zinc.” (Spec. 34:15-16.)
“An acid level study is demonstrated wherein solubility and pH are
measured in a composition. As the pH goes below 7.5, the % soluble zinc
measured in a composition begins to rise.” (Id. at 34:16-18.)
Lability
14. “Zinc lability,” the property recited in claim 1 (F7) is defined in the
Specification as “a measure of the chemical availability of zinc ion.” (Spec.
35:21.) It is stated that soluble zinc that does not complex with other species
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in solution has a relative zinc lability of 100%. (Id. at 35:21-23.) “The use
of partially soluble forms of zinc salts and/or incorporation in a matrix with
potential complexants generally lowers the zinc lability substantially below
the defined 100% maximum.” (Id. at 35:23-25.)
15. The Specification discloses a chemical test to measure zinc lability
(Spec. 35:26 to 36:25.)
16. The Specification teaches that a ZCM with a low intrinsic lability, such
as ZnO, “can be improved substantially by incorporating a protective
material such as sodium bicarbonate, a source of carbonate anions and
mixtures thereof” (Spec. 36:19-25).
Examples
17. Examples 1, 6, 8-10, and 25 of the Specification are to shampoos which
have zinc lability and zinc solubility values that meet the corresponding
claim limitations (Spec. 40 & 42).
18. The pH of the shampoo of examples 1, 6, 8-10, and 25 is not disclosed.
19. The Specification states that pH adjusting agents may be used (Spec. 47:
15-18.)
20. The combination of original claims 1, 2, and 7 is drawn to the same
subject matter which is now claimed as claim 1 in this appeal (App. Br. 5-6).
WRITTEN DESCRIPTION REJECTION
Statement of the issue
The Examiner contends that claimed invention requires two features
that are “empirical and unpredictable”: “aqueous solubility within the
composition of less than 25% by weight” and “relative zinc lability of
greater than about 15%.” (Ans. 4.) According to the Examiner:
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The two features are individually divergent in that the
first feature requires less zinc in solution, whereas the second
feature requires more zinc in solution. Together, the two
features combine to require finding a balance – the composition
has to be formulated such that the zinc [containing material] in
the composition is not too soluble (first feature [“less than
about 25% by weight”]) and not too insoluble (second feature
[“relative zinc lability of greater than about 15%]
(Ans. 4.)
The Examiner asserts that the Specification does not describe how to
obtain a composition with both claimed features and therefore has not
adequately described the claimed composition (id. at 6-8). The Examiner
finds that the Specification discloses examples which meet the claimed
solubility and lability requirements, but does not disclose their pH (id. at 9).
Because the claim requires the composition to have a pH greater than about
7, the Examiner concludes that the Specification does not describe examples
within the scope of the claimed invention (id.)
Appellants contend that the Examiner erred in rejecting the claims for
lack of written description.
Principles of Law
“Whether an applicant has complied with the written description
requirement is a finding of fact, to be analyzed from the perspective of one
of ordinary skill in the art as of the date of the filing of the application.” In
re Alonso, 545 F.3d 1015, 1019 (Fed. Cir. 2008).
“To satisfy the written description requirement in the case of a
chemical or biotechnological genus, more than a statement of the genus is
normally required. One must show that one has possession, as described in
the application, of sufficient species to show that he or she invented and
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disclosed the totality of the genus.” Carnegie Mellon University v.
Hoffmann-La Roche Inc., 541 F.3d 1115, 1126 (2008).
The following claim was at issue in Union Oil Co. of California v.
Atlantic Richfield Co., 208 F.3d 989, 992 (Fed. Cir. 2000) (“Unocal”):
117. [An unleaded gasoline fuel suitable for combustion in an
automotive engine, said fuel having a Reid Vapor pressure no
greater than 7.0 psi, and a 50% D-86 distillation point no
greater than 200 degrees F., and a 90% D-86 distillation point
no greater than 300 degrees F., and a paraffin content greater
than 85 volume percent, and an olefin content less than 4
volume percent] wherein the maximum 10% distillation point is
158 degrees F (70 degrees C.).

[It was asserted] that the specification does not describe
the exact chemical component of each combination that falls
within the range claims of the ‘393 patent. However, neither the
Patent Act nor the case law of this court requires such detailed
disclosure. . . . Rather, the Patent Act and this court’s case law
require only sufficient description to show one of skill in the
refining art that the inventor possessed the claimed invention at
the time of filing.
Drs. Jessup and Croudace described their invention in
terms of ranges. That form of description does not offend
Section 112, Para. 1. In fact, this invention lends itself to
description in terms of ranges and variance of those ranges to
achieve particular properties of the gasoline products. The
inquiry for adequate written description simply does not depend
on a particular claim format, but rather on whether the patent's
description would show those of ordinary skill in the petroleum
refining art that the inventors possessed the claimed invention
at the time of filing.
Unocal, 208 F.3d at 997.
Although we held in Unocal that a “descri[ption] of the exact
chemical component of each combination that falls within the
range claims of the … patent” is not necessary to comply with
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§112, we explained that the patentee is nonetheless required to
provide sufficient description to show one of skill in the art that
the inventor possessed the claimed invention at the time of
filing. Unocal, 208 F.3d at 997. Evidence was adduced in that
case that artisans skilled in petroleum refining were aware of
the properties of raw petroleum sources and knew how to mix
streams of such sources to achieve a final product with desired
characteristics. Accordingly, we held that the written
description requirement was satisfied in that case by specifying
the ranges of properties of the claimed gasolines, reflecting the
way that oil refiners actually formulate gasoline, such that one
skilled in the art could recognize what was being claimed. Id. at
992.
University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927 (Fed. Cir.
2004).
In our judgment, a patent applicant is entitled to a reasonable
degree of latitude in complying with the second paragraph of 35
U.S.C. Section 112 and the examiner may not dictate the literal
terms of the claims for the stated purpose of facilitating a search
of the prior art. Stated another way, a patent applicant must
comply with 35 U.S.C. Section 112, second paragraph, but just
how the applicant does so, within reason, is within applicant's
discretion.
Ex parte Tanksley, 37 USPQ2d 1382, 1386 (BPAI 1994).

Analysis
Claim 1 is to composition with four specific chemical components:
zinc containing material, detersive surfactant, carbonate, and water (F2-5).
The claim does not specify the type or amount of zinc containing material
present in the composition, but rather requires the material to have two
properties:
1) “an aqueous solubility within the composition of less than about
25% by weight at 25°C” and
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2) “a relative zinc lability of greater than about 15%.”
The Examiner’s key concern in rejecting the claim for lack of written
description is that these properties are “unpredictable” and necessitate
empirical testing to determine whether a composition falls within the scope
of the claim. The Examiner was also concerned that specifying the ZCM
must not be “too” soluble (less than 25%), yet not be “too” insoluble (greater
than 15%), was contradictory.
Appellants are entitled to claim their invention as they deem
appropriate as long as the claims conform to 35 U.S.C. § 112, second
paragraph, by “particularly pointing out and distinctly claiming the subject
matter which the applicant regards as his invention.” See Ex parte
Tanksley, 37 USPQ2d at 1386. In this case, it is apparent that the inventors
regarded their invention as having specific “aqueous solubility” and “zinc
lability” requirements. These terms represent physical properties that are
explicitly defined in the Specification (F11 & 14), apprising persons of
ordinary skill in the art of their meaning. It is not a per se violation of the
written description requirement of § 112, first paragraph, to describe a
claimed invention, inter alia, by its physical properties.
The Examiner complained that “aqueous solubility” as recited in
claim 1 was not defined in the Specification (Ans. 5). We do not agree. One
of ordinary skill in the art would have understood that the aqueous solubility
property referred to in the Specification on page 4 (F9) and recited in the
claims is the same as “ZCM solubility” defined on page 7. Both use the
same vocabulary and have the same upper limit of 25% (F12). It would be
evident from reading the Specification that the solubility of the zinc
containing material is a key limitation of the invention – as evidenced from
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its appearance in the invention “Summary” (F9) and the original claims
(F20) – and that therefore ZCM solubility” is interchangeable with “aqueous
solubility.”
The Specification also dispels any apparent contradiction between the
solubility and lability properties by disclosing compositions, which the
Examiner acknowledged, meet both claim limitations (F17). The disclosure
is not defective because the pH of the examples was not disclosed. The
Specification discloses that pH adjusting agents can be added (F19) and
describes the relationship between pH and zinc solubility (F13).
In a chemical or biotechnological genus, it is said to be “normally”
required that more than a statement of the genus is need to comply with the
written description requirement of § 112, first paragraph. Carnegie Mellon,
541 F.3d at 1126. Apparently for this reason, the Examiner found the claims
to lack written description support because none of the Specification
examples having the claimed solubility and lability values were described to
have a pH of “greater than about 7” as recited in claim 1.
In our opinion, the line of cases represented by Carnegie Mellon does
not strictly apply here. Unlike the chemicals (plasmids) in Carnegie Mellon,
the chemicals recited in the instant claims were known. Appellants do not
claim to have invented a new compound genus. There is no requirement to
describe what was already known in the art. See Capon v. Eshhar, 418 F.3d,
1349, 1357-1358 (Fed. Cir. 2005); Falko-Gunter Falkner v. Inglis, 448 F.3d
1357, 1367 (Fed. Cir. 2006).
The Unocal case is more relevant since that case involved a claim to a
combination of known components, as does the composition at issue in this
rejection. Unocal, 208 F.3d at 992. In Unocal, the court rejected an attack
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on claims to a gasoline fuel comprising several known components as
lacking written descriptive support. The components were recited to be
present in certain ranges and the fuel to have specific physical properties
(e.g., “maximum 10% distillation point is 158 degrees F”). Id. The court
concluded that, to satisfy the written description requirement, it was not
necessary to describe the exact chemical component needed to achieve the
claimed physical properties of the fuel because the skilled worker knew how
to obtain a final product with the desired characteristics. Unocal, 208 F.3d
at 992, 997; Rochester, 358 F.3d at 927.
The Unocal claim is similar to the claim at issue in this appeal. As in
Unocal, the instantly claimed composition is characterized by both
component ranges and physical properties. The Specification provides
guidance as to what components could be incorporated into the composition
to achieve the claimed physical properties (F8, 10) and describes how
persons of ordinary skill in the art would determine whether the properties
are met (F11, 14). The Examiner has not established that, based on these
disclosures, persons of ordinary skill would not have recognized what is
actually being claimed. Therefore, we conclude that the written description
requirement was satisfied.
The Examiner also asserted that zinc lability is a “made-up feature”
used by Appellants’ to avoid prior art, “not by dint of invention but by use of
creative claim draftsmanship.” (Ans. 4). The Examiner’s complaint is not
legitimate. If there was sound reason to believe that the claimed
composition was anticipated or obvious in view of prior art, the Examiner
had recourse to shift the burden to Appellants to prove otherwise. In re Best,
562 F.2d 1252, 1255 (CCPA 1977).
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[T]he examiner may not dictate the literal terms of the claims
for the stated purpose of facilitating a search of the prior art.
Stated another way, a patent applicant must comply with 35
U.S.C. Section 112, second paragraph, but just how the
applicant does so, within reason, is within applicant’s
discretion.
Ex parte Tanksley, 37 USPQ2d at 1386.

ENABLEMENT REJECTION
Statement of the issue
The Examiner contends that it would require undue experimentation
to practice the full scope of claim 1. The Examiner summed up the ground
of rejection as follows:
with the exception of specific examples provided in the
specification[ ], the skilled person in this art would not have
been able to formulate additional compositions comprising a
ZCM such as zinc oxide (negligible solubility in water) in the
presence of water up to 95 wt% and the claim-recited
surfactants, having a pH of greater than about 7 and a relative
zinc lability of greater than about 15% without undue
experimentation.
(Ans. 13.)
The Examiner contends that it was unpredictable as to what zinc
containing materials would meet the claimed solubility and lability
requirements, that Appellants have no data with respect to compositions that
meet the pH limitation, and that given the breadth of the claims, the
“quantity of experiment necessary for one skilled in the art to arrive at the
instant invention is extraordinary.” (Ans. 16)
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Appellants contend that the Examiner erred in concluding that the
claimed invention is not enabled. They assert that only routine screening is
necessary to determine compositions within the scope of the claim.

Principles of Law
“[T]o be enabling, the specification . . . must teach those skilled in the
art how to make and use the full scope of the claimed invention without
‘undue experimentation.’” In re Wright, 999 F.2d 1557, 1561 (Fed. Cir.
1993).
“That some experimentation may be required is not fatal; the issue is
whether the amount of experimentation required is ‘undue.’” In re Vaeck,
947 F.2d 488, 495 (Fed. Cir. 1991) (emphasis in original). Some
experimentation, even a considerable amount, is not “undue” if, for example,
the specification provides a reasonable amount of guidance as to the
direction in which the experimentation should proceed. In re Wands, 858
F.2d 731, 737 (Fed. Cir. 1988).
Analysis
The Examiner did not provide sufficient evidence to establish that it
would require “undue experimentation” to make and use the full scope of the
claimed subject matter. The Specification describes numerous examples of
compounds that could be used to make the claimed composition (F8 & 17;
App. Br. 8-11). To make the compositions, the skilled worker would have
needed only to select the claimed components in the claimed ranges, using
the guidance in the Specification (F8 & 17; App. Br. 8-11), and then to
determine whether the solubility and lability limitations are met. The
Specification describes how the latter are measured (F11 & 15), enabling the
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skilled worker to routinely determine which compositions meet the
limitations and which do not. While such experimentation might be tedious
and time-consuming, there is no evidence that it could not have been
accomplished routinely by the skilled worker.
As to the unpredictability of zinc solubility, the Specification, in fact,
shows the relationship between pH and zinc solubility (F13). The
Specification identifies numerous zinc containing materials, and warned
which would become insoluble at about pH 7 (F8 & 10). The Specification
also explains that adding carbonate improves solubility of low lability zinc
compounds (F16). While this was exemplified with ZnO, the Examiner did
not provide any scientific basis on which to doubt that carbonate would not
work with other zinc compounds as claimed.
As to the lack of examples of a composition having the claimed pH
values, the Examiner has not explained why it would require “undue”
experimentation to adjust the pH of the final solution and determine whether
the composition fell within the scope of the claim.
The Examiner states that the Specification does not teach what is
“needed in the composition to deliver the claimed empirical features.” (Ans.
14.) The Examiner erred. The claims explicitly recite the components and
amounts of the components. While the specific zinc containing material is
not recited in the claims, the Specification describes examples and explicitly
teaches how to determine which, when combined with detergent, carbonate,
and water, would meet the claimed properties.

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SUMMARY
The rejections of claims 1, 3-6, 8-10, 15, 16, 18, 19, and 47-50 stand
rejected by the Examiner under 35 U.S.C. § 112, first paragraph, are
reversed.

REVERSED.

dm

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