from the United States Patent and Trademark Office, Patent
Trial and Appeal Board in Nos. 95/002, 396, 95/002, 405,
V. PADMANABHAN, Winthrop & Weinstine, PA, Minneapolis,
MN, argued for appellant. Also represented by Sri Sankaran,
Erin Dungan, Brett Klein.
D. Giarratana, McCarter & English, LLP, Hartford, CT,
argued for appellee. Also represented by Eric E. Grondahl,
Charles D. Ray.
Prost, Chief Judge, Bryson and HUGHES, Circuit Judges.
Bryson, Circuit Judge.
Gel Technologies, Inc., appeals from three inter
partes reexamination decisions of the Patent Trial and
Appeal Board. The Board's decisions invalidated numerous
claims in each of three related Soft Gel patents for
obviousness. We affirm.
Gel is the named assignee of U.S. Patent Nos. 8, 124, 072
("the '072 patent"), 8, 105, 583 ("the
'583 patent"), and 8, 147, 826 ("the '826
patent"). The '583 patent issued from a
continuation-in-part, and '826 patent issued from a
continuation, of the '072 patent. The '072 patent
issued on February 28, 2012; the '583 patent issued on
January 31, 2012; and the '826 patent issued on April 3,
specifications of the three patents describe a method for
dissolving a substance commonly referred to as CoQ10 in
solvents known as monoterpenes. '072 patent, col. 2, 11.
46-48. The patented inventions include a
composition, a soft gelatin capsule, and a method of making
such a soft gelatin capsule, each involving a solution of
CoQ10 dissolved in a monoterpene.
also known as ubiquinone, is a coenzyme, i.e., a chemical
compound that is required for the biological activity of
certain proteins. '072 patent, col. 1, 11. 16-25. It
"affects the function of almost all cells in the body,
making it essential for the health of all human tissues and
organs." Id., col. 1, 11. 39-41.
is necessary for certain metabolic processes and for the
production of cellular energy; it has a secondary role as an
antioxidant. '072 patent, col. 1, 11. 18-24, 37-38. It is
particularly important in "the cells that are the most
metabolically active: heart, immune system, gingiva, and
gastric mucosa." Id., col. 1, 11. 22-24, 41-43.
In clinical trials, CoQ10 has been shown to be effective in
regulating blood pressure and cholesterol levels, improving
cardiovascular health, and "thwarting various diseases
such as certain types of cancers." Id., col. 1,
11. 44-49; see also id., col. 7, 11. 11-21 (noting
that CoQ10 has been used in the treatment of cardiovascular
conditions, periodontal diseases, mitochondrial-related
diseases and disorders, and neurological disorders).
CoQ10 is synthesized by the body, the body may require more
than it can synthesize or obtain through normal dietary
intake. '072 patent, col. 1, 11. 26-28. Oral
supplementation can compensate for a CoQ10 deficiency.
Id., col. 1, 11. 29-31.
CoQ10 is "sparingly soluble in hydro-philic solvents
such as water." '072 patent, col. 1, 11. 51-52.
According to the Soft Gel patents, at the time of the
inventions most solvents that were used to administer CoQ10
in liquid form could dissolve, at most, only about 5 to 10
percent of the CoQ10. Id., col. 1, 11. 64-67;
id., col. 2, 11. 59-61. For that reason, CoQ10 was
generally administered in solid form, such as in a tablet or
powder. Id., col. 1, U. 52-53; id., col. 2,
11. 63-64. CoQ10 could also be administered as a suspension,
in which the CoQ10 is partially dissolved in a solvent.
Id., col. 1, 11. 52-53; id., col. 3, 11.
21-23. But those delivery methods limited the bioavailability
of the CoQ10, as only a small fraction of the CoQ10 would
enter the bloodstream. Id., col. 1, 11. 53-55;
id., col. 3, 11. 23-24. The Soft Gel patents state
that there was "a need in the art for an improved
methodology to deliver increased amount[s] of bioavailable
CoQ-10 to an individual in need thereof." Id.,
col. 1, 11. 56-58.
patents describe the discovery of monoterpenes as a solvent
for CoQ10. '072 patent, col. 1, 11. 62-64; id.,
col. 2, 11. 46-48; see also id., col. 3, 11. 24-26.
Monoterpenes are a class of compounds that have a ten-carbon
skeleton and consist of "two isoprene units connected in
a head-to-end manner." Id., col. 3, 11. 31-34.
"Suitable examples of monoterpenes include, but are not
limited to, limonene, . . . carvone, . . . and derivatives
thereof." Id., col. 3, 11. 49-53; see also
id., col. 3, 11. 59-63 (listing, "[i]n particular,
" a number of "suitable limonene
aqueous solvents, monoterpenes can dissolve significant
amounts of CoQ10. "Generally, about 30 to about 45% of
the CoQ-10 (by weight [relative to that of the monoterpene])
is solubilized [dissolved] in the monoterpene." '072
patent, col. 2, 11. 11-12; see also, e.g., id., col.
2, line 65, through col. 3, line 11 (noting that up to about
60% by weight of CoQ10 may be dissolved in monoterpene, and
describing other "aspects" of the invention in
which the weight of solubilized CoQ10 relative to monoterpene
is "about 0.1 percent ... to about 45 percent, "
"about 5 to about 50 percent, " "about 15 to
about 40 percent, " and "about 20 to about 35
percent"). The solution of CoQ10 dissolved in
monoterpene may then be formulated as a caplet or soft
gelatin capsule containing the solution. Id., col.
3, line 64, through col. 4, line 1. Formulations of that
solution of CoQ10 dissolved in a monoterpene "provid[e]
increased bioavailability in delivery, " id.,
col. 1, 11. 10-12, because "the solvated [dissolved]
coenzyme can more easily pass into cells[, ] . . . delivering
increased amounts of the coenzyme into an individual's
physiological makeup, " '583 patent, col. 7, 11.
claims of the Soft Gel patents focus on solutions of CoQ10
and a monoterpene called limonene. Limonene is a compound
that can have one of two different three-dimensional physical
structures, labeled d-limonene and 1-limonene. The claims of
the three Soft Gel patents were amended to cover only
solutions of CoQ10 and d-limonene.
of each patent is representative for purposes of ...