Ex Parte Morgan

Patent Trial and Appeal Board

Sep 27, 2012

11866573 (P.T.A.B. Sep. 27, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/866,573 10/03/2007 Clyde E. Morgan 35085-CIP 7391
23589 7590 09/27/2012
Hovey Williams LLP
10801 Mastin Blvd., Suite 1000
Overland Park, KS 66210
EXAMINER
BUCKLEY, AUDREA
ART UNIT PAPER NUMBER
1617
MAIL DATE DELIVERY MODE
09/27/2012 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte CLYDE E. MORGAN
__________

Appeal 2011-010368
Application 11/866,573
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and JEFFREY N. FREDMAN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
therapeutic composition. The Examiner has rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The Specification discloses “improved electrical producing creams ...
which are useful in the treatment of a variety of conditions that are
ameliorated by increased cell metabolism, circulation, and nerve function”
(Spec. 1:11-14). The Specification discloses “electrical producing creams
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having improved metabolic activity through small electrical charges (in mV)
in contact with dendrite channels” (id. at 2:8-9).
Claims 1-11 are on appeal. Claims 1 and 10, the only independent
claims, are representative and read as follows:
1. An electrical producing cream comprising from about 0.005%-
15% by weight potassium, and a source of oxygen sufficient to provide at
least about 0.005% by weight oxygen, said percentages based upon the total
weight of the electrical producing cream taken as 100% by weight, said
cream having a peak metabolic activity of at least about 30 mV.

10. An electrical producing cream comprising:
an active ingredient selected from the group consisting of analgesics,
anesthetics, antipruritics, antihistamines, and counterirritants;
potassium; and
a source of oxygen, said electrical producing cream having a peak
metabolic activity of at least about 30 mV.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 1-3, 7, and 9 in view of Danner,1 Oge,2 and Kühne;3 and
• Claims 4-6, 8, 10, and 11 in view of Danner, Oge, Kühne, and
Shiroyama.4
I.
Issue
The Examiner has rejected claims 1-3, 7, and 9 as obvious in view of
Danner, Oge, and Kühne. The Examiner finds that Danner discloses
therapeutic “formulations … [that] rely on the presence of 0.002% and 0.5%

1 Danner et al., US 5,855,922, Jan. 5, 1999.
2 Oge et al., US 5,955,067, Sept. 21, 1999.
3 Kühne et al., US 4,507,285, Mar. 26, 1985.
4 Shiroyama et al., US 6,328,982 B1, Dec. 11, 2001.
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by weight of metal chlorite, a source of oxygen associated with skin
restoration and healing.… [P]otassium chlorite is one of the metal chlorites.”
(Answer 4.) The Examiner calculates that Danner’s composition comprises
“the approximate maximum presence of 0.001 to 0.25% oxygen from the
metal chlorite” (id.). The Examiner finds that Danner does “not specifically
teach a cream formulation of the active agents … [or] the advantages of the
potassium” (id. at 5).
The Examiner finds that Oge discloses the “advantages of potassium
in topical, skin-treating cream compositions” (id.) and that Oge’s
formulations “can be a cream, an emulsion, a suspension, or a gel, preferably
containing 1-30% potassium by weight” (id.). The Examiner concludes that
“it would have been prima facie obvious to one of ordinary skill in the art …
to combine the teachings of Danner et al. and Oge et al. in order to combine
the known benefits of potassium in a topically applied cream composition
with the known benefits of a topical formulation utilizing an oxygen source”
(id.). The Examiner reasons that the “composition obtained upon
combination of Danner and Oge is identical to the instantly claimed …
formulation, [and] this composition necessarily would have peak metabolic
activity of at least about 30 mV” (id. at 6).
Appellant contends that the cited references would not have made the
claimed electrical producing creams prima facie obvious to one having
ordinary skill in the art (Appeal Br. 22-23). Appellant also contends that he
has provided evidence of unexpected results that overcomes any prima facie
case of obviousness (id. at 15-22).
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The issues presented are: Does the evidence of record support the
Examiner’s conclusion that the electrical producing creams of claims 1-3, 7
and 9 would have been prima facie obvious in view of Danner and Oge?
If so, has Appellant provided evidence of unexpected results that
successfully rebuts the prima facie case of obviousness?
Findings of Fact
1. We adopt the Examiner’s findings regarding the scope and content
of the prior art (Answer 4-6).
2. Appellant has provided a declaration under 37 C.F.R. § 1.132
(Declaration of Clyde Morgan, filed Feb. 24, 2010, Exhibit B in the
Evidence Appendix attached to the Appeal Brief).
3. Dr. Morgan declares that “[c]ompositions from each of the Oge et
al. and Danner et al. patents were prepared according to the teachings of
each reference.… Compositions containing menthol, camphor, or capsicum
from Shiroyama et al. were also tested.” (Morgan Declaration 1-2, ¶ 3.)
4. Dr. Morgan declares that each composition was made by mixing
the active ingredient from the compositions with a non-reactive aqueous gel
base (id. at 2, ¶ 3).
5. Dr. Morgan declares that Danner discloses sodium and potassium
chlorite as suitable alkali metal chlorites (id. at 2, ¶ 3A).
6. Dr. Morgan declares that he “called several sources but was unable
to obtain potassium chlorite and was informed by a representative of Cole-
Parmer® that it is not stable enough to exist in pure form under ambient
conditions. The same source informed [him] that potassium chlorate would
be a suitable substitute.” (Id. at 2-3, ¶ 3A.)
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7. Dr. Morgan declares that compositions of sodium chlorite and
potassium chlorate were used to formulate the Danner compositions, within
the concentration ranges disclosed in Danner (id. at 3, ¶ 3A).
8. Dr. Morgan declares that Oge “discloses that the composition may
contain 1-30% potassium (such as potassium chloride), so compositions
were formulated using potassium chloride within this range (id. at 3, ¶ 3B).
9. Dr. Morgan declares that compositions containing camphor,
menthol, or capsicum were used to represent the Shiroyama compositions
(id. at 3, ¶ 3C).
10. Dr. Morgan declares that a composition according to the
invention was prepared that contained the following active ingredients:
0.03% sodium chlorite, 0.09% potassium, 3.1% camphor, and 3.0% menthol
(id. at 3-4, ¶ 4).
11. Dr. Morgan declares that a “thin layer of each composition was
sandwiched between two electrodes. A voltage reading was taken upon start-
up and continued every minute for the duration of the test” (id. at 4, ¶ 5).
12. Dr. Morgan declares that the results are shown in the table
attached to the Appeal Brief as Exhibit A in the Evidence Appendix (id. at 4,
¶ 6).
13. Exhibit A shows that the Danner compositions each produced a
peak metabolic activity between 0.20 and 1.30 mV (Exhibit A, second
through sixth columns).
14. Exhibit A shows that the Oge compositions each produced a peak
metabolic activity between 0.20 and 0.90 mV (Exhibit A, seventh through
ninth columns).
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15. Exhibit A shows that the Shiroyama compositions each produced
a peak metabolic activity between 0.10 and 0.90 mV (Exhibit A, tenth
through fifteenth columns).
16. Exhibit A shows that the inventive composition produced, on
average, a peak metabolic activity of 140.85 mV (Exhibit A, far right
column).5
17. Dr. Morgan declares that the test results show that “the inventive
composition has significantly different metabolic activity from the
compositions in the cited references” (Morgan Declaration 4, ¶ 6).
18. Dr. Morgan declares that “the inventive composition represents a
significant and unexpected improvement in the state of the art that could not
have been foreseen or predicted based upon the proposed combination of”
Danner, Oge and Shiroyama (id. at 5, ¶ 6).
Analysis
We adopt the Examiner’s findings regarding the scope and content of
the prior art (Answer 4-6) and agree with her conclusion that the electrical
producing creams of claims 1-3, 7, and 9 would have been prima facie
obvious in view of the cited references. Appellant presents arguments
disputing the prima facie case of obviousness, but we do not find it
necessary to address these arguments since, as discussed below, we conclude
that the evidence of unexpected results has successfully rebutted the prima
facie case of obviousness.

5 Dr. Morgan declares that the inventive composition was tested twice to
obtain an average (Morgan Declaration 4, ¶ 5).
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Appellant argues that “the recited peak metabolic activity was an
unexpected property achieved by the claimed composition” (Appeal Br. 13),
and that the data show “an unexpected synergy of the claimed composition
that could not have been predicted based upon the teachings of the cited
references” (id.). Appellant argues that Morgan Declaration provides
evidence that none of the Danner and Oge compositions “came close to
reaching a peak metabolic activity of at least about 30 mV over the 48-
minute testing period. The highest (i.e., peak) metabolic activity reading for
any of the prior art compositions was 1.3 mV, which was reached by the 1%
sodium chlorite Danner composition” (id. at 15-16) and the “peak metabolic
activity for Oge was only 0.90 mV.” (Id. at 16.)
We agree with Appellant that the evidence of unexpected results
presented in the Morgan Declaration is sufficient to rebut the prima case of
obviousness of claims 1-3, 7, and 9 in view of Danner and Oge. As
Appellant points out, the peak metabolic activity of the compositions
corresponding to the prior art never exceeded 1.30 mV, which is far below
the 30 mV recited in claim 1 as well as the 140.85 mV found for the
composition corresponding to the claims.
The Examiner argues that Appellant’s evidence does not overcome
the prima facie case of obviousness because the “relationship between
electrical potential and ‘metabolic activity’ is unclear. Absent a definition in
the specification, the term ‘metabolic activity’ refers to chemical reactions
that take place inside biologically living cells.” (Answer 8-9.) However, the
claims define “metabolic activity,” as used therein, as a property measured
in mV. The Specification describes how to measure the metabolic activity
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of a compound (Spec. 10: 14-19), and the Morgan Declaration states that
metabolic activity of the claimed compositions has practical significance in
improved pain relief, among other things (Morgan Decl. 5, ¶ 6). The
Examiner has not provided a persuasive basis for dismissing the evidence of
unexpected results based on the nonstandard use of the phrase “metabolic
activity.”
The Examiner further asserts that the data provided in the Morgan
Declaration was not “a proper comparison of the cited references with the
pending inventive formulation” (Answer 10) because “no definition of the
composition based on the … Danner (primary) reference is presented for
comparison with the inventive composition” (id.). The Examiner also
argues that the Declaration states that the inventive composition’s
components are shown in Table 12 but “the concentration of sodium
chlorite actually measured was unknown (see table footnote)” (id.).
We disagree with the Examiner’s criticisms of Appellant’s data. First,
the Morgan Declaration at paragraph 3 makes clear which compositions
based on Danner were tested. Second, although we agree with the Examiner
that the Morgan Declaration is somewhat ambiguous on whether the
inventive composition contained 0.03% sodium chlorite or 0.03% of a
mixture that comprised sodium chlorite, the Declaration makes clear that the
composition contained, at most, 0.03% sodium chlorite. The Examiner has
not provided a persuasive basis for concluding that an amount of sodium
chlorite less than 0.03% would have been expected to show the results
achieved with the inventive composition.
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The Examiner further asserts that the data in the Morgan Declaration
are not commensurate in scope with the claimed invention (Answer 10-11)
because only a single inventive composition with “a single concentration of
potassium and a single concentration of sodium chlorite is employed” (id. at
10).
The Examiner’s reasoning is not persuasive. While the Morgan
Declaration provides data for only one composition encompassed by claim
1, the Examiner has not provided any persuasive reasoning, based on
evidence or technical reasoning, to show that other compositions
encompassed by the claim would be expected to show significantly different
properties. Specifically, the Examiner has provided no persuasive basis for
concluding that the peak metabolic activity of other compositions
encompassed by the claims would not be significantly greater than those of
the prior art compositions. See In re Kao, 639 F.3d 1057, 1068 (Fed. Cir.
2011) (“If an applicant demonstrates that an embodiment has an unexpected
result and provides an adequate basis to support the conclusion that other
embodiments falling within the claim will behave in the same manner, this
will generally establish that the evidence is commensurate with [the] scope
of the claims.”).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
electrical producing creams of claims 1-3, 7, and 9 would have been prima
facie obvious in view of Danner and Oge. However, Appellant has provided
evidence of unexpected results that successfully rebuts the prima facie case
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of obviousness. We therefore reverse the obviousness rejection in view of
Danner and Oge.
II.
The Examiner has rejected claims 4-6, 8, 10, and 11 under 35 U.S.C.
§ 103(a) as obvious in view of Danner, Oge, Kühne, and Shiroyama.
The Examiner relies on Danner, Oge, and Kühne as discussed above.
The Examiner finds that Shiroyama discloses “additives to topical
compositions which impart a desirable cool feeling when used in cosmetics,
toiletries, bath agents, and pharmaceutical compositions” (Answer 7). The
Examiner finds that Shiroyama discloses that “menthol and camphor are
among the active agents which are analgesics and counterirritants” (id.).
The Examiner concludes that it “would have been prima facie obvious to
one of ordinary skill in the art … to impart the desirable sensations taught by
Shiroyama into the topical healing compositions taught by Danner and Oge”
by incorporating additives such as camphor and menthol (id. at 8).
We agree with the Examiner’s conclusion that the electrical producing
creams of claims 4-6, 8, 10, and 11 would have been prima facie obvious in
view of the cited references. However, for the reasons discussed above, we
conclude that Appellant’s evidence of unexpected results successfully rebuts
the prima facie case of obviousness. We therefore reverse the rejection of
claims 4-6, 8, 10, and 11 as being obvious in view of Danner, Oge, Kühne,
and Shiroyama.
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SUMMARY
We reverse the rejection of claims 1-11 under 35 U.S.C. § 103(a).

REVERSED

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