Usplabs, LLCv.Harcol Research, LLC

Patent Trial and Appeal Board

Nov 15, 2013

08637666 (P.T.A.B. Nov. 15, 2013)

Trials@uspto.gov Paper 12
571-272-7822 Entered: November 15, 2013

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

USPLABS, LLC
Petitioner

v.

HARCOL RESEARCH, LLC
Patent Owner
____________

Case IPR2013-00399
Patent 5,817,364
____________

Before LORA M. GREEN, DEBORAH KATZ, and
CHRISTOPHER L. CRUMBLEY, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

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Patent 5,817,364

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I. BACKGROUND
USPlabs, LLC (“USPlabs”) filed a corrected petition (“Pet.”) requesting
inter partes review of claims 1-7 of U.S. Patent No. 5,817,364 (the “’364 patent”;
Ex. 1001
1
) on July 12, 2013. Paper 6. Patent Owner, Harcol Research, LLC
(“Harcol”), filed a Patent Owner Preliminary Response (“Prelim. Resp.”) on
August 23, 2013. Paper 11. We have jurisdiction under 35 U.S.C. §§ 6(b) and
314.
The standard for instituting an inter partes review is set forth in 35 U.S.C.
§ 314(a), which states:
THRESHOLD. -- The Director may not authorize an inter partes review
to be instituted unless the Director determines that the information
presented in the petition filed under section 311 and any response
filed under section 313 shows that there is a reasonable likelihood that
the petitioner would prevail with respect to at least 1 of the claims
challenged in the petition.

Inter partes review is instituted only if the petition supporting the ground
demonstrates “that there is a reasonable likelihood that at least one of the claims
challenged in the petition is unpatentable.” 37 C.F.R. § 42.108(c).
We conclude that USPlabs has not shown that there is a reasonable
likelihood that it will prevail with respect to at least one of the challenged claims,
and the petition is denied.

1 We note that Harcol filed an exhibit also identified as Exhibit 1001. Exhibits
filed by a patent owner, however, should be filed starting at exhibit number 2001.
37 C.F.R. § 42.63(c). Thus, Harcol should have filed its exhibit as “Ex. 2001.”
References to Ex. 1001 in this Decision are to U.S. Patent 5,817,364.
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A. Related Proceedings
USPlabs indicates that the ’364 patent is the subject of the litigation styled
Harcol Research, LLC v. USPlabs, LLC, et al., Case No: 2:13CV230 (E.D. Tex.).
Pet. 1. USPlabs indicates further that the ’364 patent is also the subject of
additional litigation in the Eastern District of Texas. Id. at 1-2.

B. The ’364 Patent (Ex. 1001)
The ’364 patent is drawn to an energy supply composition that may be used
before, during, or after physical activity. ’364 patent, col. 1, ll. 6-8. The beverage
includes “an effective amount of α-ketoglutaric acid or a water-soluble innocuous
salt thereof together with a nutritionally acceptable water-soluble carrier.” Id. at
col. 3, ll. 52-55. The examples of preparing beverages as set forth in the ’364
patent use α-ketoglutaric acid. Id. at col. 4, ll. 35-60, and col. 6, examples 1 and 2.

C. Representative Claims
USPlabs challenges claims 1-7 of the ’364 patent. Claims 1 and 7 are the
independent claims, and read as follows:
1. A beverage, or a dry composition therefor, providing an energy
source in situations with demand of large and rapid energy
supply to a healthy mammal comprising 0.1 to 2.5 percent of
the wet weight of α-ketoglutaric acid or a water-soluble
innocuous salt thereof together with a nutritionally acceptable
water-soluble carrier.

7. A method of large and rapid energy supply to a healthy
mammal, comprising providing to said animal, a beverage, or a
dry composition therefor, comprising 0.1 to 2.5 percent of the
wet weight of α-ketoglutaric acid or a water-soluble innocuous
salt thereof together with a nutritionally acceptable water-
soluble carrier.
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D. Prior Art Relied Upon
USPlabs relies upon the following prior art references:
Staples (“Staples”), US Pat. No. 4,309,417, issued January 5, 1982
(Ex. 1006).

Kihlberg (“Kihlberg”), WO92/09277, published June 11, 1992
(Ex. 1004).

Mudzhiri (“Mudzhiri”), UK GB 2,198,041 A, published June 8, 1988
(Ex. 1005).

Marconi et al. (“Marconi”), The Effect of an α-Ketoglutarate-
Pyridoxine Complex on Human Maximal Aerobic and Anerobic
Performance, 49(3) EUR. J. APPL. PHYSIOL. 307 (1982) (Ex. 1003).

Glutarase Catalog, published 1989 (Ex. 1008
2
).

2 The Glutarase Catalog is published in the Italian language. Exhibit 1007 is the
catalog in its original language, Exhibit 1008 is the English translation, and Exhibit
1009 is an affidavit attesting to the accuracy of the translation. See Pet. 14.
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E. The Asserted Challenges
USPlabs challenges the patentability of claims of the ’364 patent on the
following grounds. Pet. 5.

Reference(s) Basis Claims challenged
Marconi and Kihlberg § 103 1, 5, and 7
Marconi, Kihlberg, and
Mudzhiri
§ 103 2 and 3
Marconi, Kihlberg, and
Staples
§ 103 4 and 6
Marconi and Glutarase
Catalog
§ 103 1, 5, and 7
Marconi, Mudzhiri, and
GlutaraseCatalog
§ 103 2 and 3
Marconi, Glutarase
Catalog, and Staples
§ 103 4 and 6

II. ANALYSIS
A. Claim Interpretation
In an inter partes review, claim terms in an unexpired patent are given their
broadest reasonable construction in light of the specification of the patent in which
they appear. 37 C.F.R. § 42.100(b). Under the broadest reasonable interpretation
standard, claim terms are given their ordinary and customary meaning as would be
understood by one of ordinary skill in the art at the time of the invention. In re
Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). For purposes of this
decision, we interpret the claim limitation “α-ketoglutaric acid or a water-soluble
innocuous salt thereof.”
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USPlabs contends that the broadest reasonable interpretation of the term “α-
ketoglutaric acid” should encompass both α-ketoglutaric acid, and its anion, α-
ketoglutarate, shown below. Pet. 6-7.

A molecular diagram of α-ketoglutaric acid and α-ketoglutarate, reproduced from
the petition, is depicted above. See Pet. 6.
We disagree. The independent claims recite the limitation “α-ketoglutaric
acid or a water-soluble innocuous salt thereof.” Thus, the term “α-ketoglutaric
acid” is limited to α-ketoglutaric acid, and the term “innocuous salt thereof”
encompasses innocuous salts of α-ketoglutarate. That is, the ordinary artisan
would understand that a water-soluble innocuous salt of α-ketoglutaric acid is α-
ketoglutarate, wherein the hydrogen atoms of the α-ketoglutaric acid are
substituted with an anion, such as a sodium anion. USPlabs’s proffered
interpretation appears to read the limitation “innocuous salt thereof” out of the
independent claims. We, therefore, decline to adopt USPlabs’s proffered
interpretation.

B. Obviousness over Marconi (Ex. 1003) and the Glutarase Catalog
(Ex. 1008)
USPlabs contends that claims 1, 5, and 7 are rendered obvious under 35
U.S.C. § 103 over Marconi as combined with the Glutarase Catalog. See, e.g., Pet.
39-44.
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USPlabs argues that Marconi presents the results of administering a complex
of α–ketoglutarate and pyridoxine (“α–KG complex”), which USPlabs asserts is
merely a combination of α–ketoglutarate and pyridoxine, to individuals undergoing
athletic training. Pet. 12. Marconi, according to USPlabs, teaches that the
administration of the α–KG complex enhances, significantly, the maximal aerobic
power of the subject. Id. at 12-13.
USPlabs relies on the Glutarase Catalog for teaching that glutarase is an
α–ketoglutarate-pyridoxine complex, which is a combination of α–ketoglutarate
and pyridoxine. Id. at 14. USPlabs asserts further that the ordinary artisan would
have combined the Glutarase Catalog with Marconi to arrive at a beverage
containing α–ketoglutaric acid “for administration in situations with demand or
[sic, for] large and rapid energy supply.” Id. at 17.
Harcol responds that Marconi teaches that it is the α–KG complex that has
the positive energy effects, and that those positive effects are not seen with the
administration of α–ketoglutaric acid alone. Prelim. Res. 7-8.
3
Harcol responds
further that the Glutarase Catalog confirms that glutarase, the α–ketoglutarate-
pyridoxine complex used by Marconi, is a combination of α–ketoglutarate and
pyridoxine. Id. at 10. Harcol contends, therefore, that USPlabs has not established
that the challenged claims are unpatentable over the cited art. See, e.g., id. at 13.
We agree with Harcol that USPlabs has not demonstrated a reasonable
likelihood that claims 1, 5, and 7 are unpatentable over Marconi and the Glutarase
Catalog.

3 We note that, while Patent Owner numbered page 1, none of the subsequent pages
were numbered. We, thus, numbered the subsequent pages sequentially from page
1.
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Marconi teaches that the administration of 30 mg/kg of body weight of an
the α–ketoglutarate-pyridoxine complex, which is a stoichiometric ratio of α–
ketoglutarate to pyroxidine of 46.35 to 53.65, to trained, non-athletic individuals,
increases maximal aerobic power by 6%. Marconi, Summary. In addition, the
complex decreases peak blood lactate concentration. Id. According to Marconi,
the increase in maximal aerobic power and decrease in peak blood lactate
concentration is not seen with the separate administration of either component of
the complex. Id. That is, when α–ketoglutarate is administered alone, Marconi
reports that there “does not seem to [be] any positive effects on the maximal flux
of energy along the aerobic pathway.” Id. at 315. Marconi hypothesizes that the
positive effects seen with the complex may be associated with more effective
reabsorption of the complex, as compared to its separate components, at the
mitochondrial level, as well as an enhancement of the oxidative process. Id.
It is not exactly clear from the Petition what reasoning USPlabs is relying
upon to challenge claims 1, 5, and 7 of the ’364 patent, as based on the
combination of Marconi and the Glutarase Catalog. USPlabs may be contending
that the claim term “α-ketoglutaric acid or a water-soluble innocuous salt thereof”
should be interpreted as encompassing the α–ketoglutarate-pyridoxine complex of
Marconi and the Glutarase Catalog. USPlabs, however, does not make that
argument explicitly in the portion of its petition addressing the interpretation of the
term “α-ketoglutaric acid.” See, e.g., Pet. 6-7. Moreover, as noted above, Marconi
teaches that α–ketoglutarate does not have the same effect on the maximal flux of
energy along the aerobic pathway as does the α–ketoglutarate-pyridoxine complex.
Based on that teaching of Marconi, it appears that the α–ketoglutarate-pyridoxine
complex has properties that are distinct from its individual components, and,
therefore, does not support interpreting “α-ketoglutaric acid or a water-soluble
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innocuous salt thereof” as encompassing the α–ketoglutarate-pyridoxine complex
of Marconi. Moreover, USPlabs does not appear to point us to any evidence of
record that would support that interpretation.
USPlabs may be contending also that it would have been obvious to
substitute α-ketoglutaric acid or a water-soluble innocuous salt thereof for the α–
ketoglutarate-pyridoxine complex of Marconi. USPlabs, however, does not
provide a reason to do so, especially in view of the teaching of Marconi that α–
ketoglutarate does not have the same effect on the maximal flux of energy along
the aerobic pathway as does the α–ketoglutarate-pyridoxine complex.
As to the remaining challenges as to claims 2-4 and 6 that are premised on
the underlying combination of Marconi and the Glutarase Catalog, USPlabs does
not explain how the additionally recited references remedy the above deficiencies.
USPlabs, therefore, has not demonstrated a reasonable likelihood that claims 2-4
and 6 are unpatentable over a combination of Marconi and the Glutarase Catalog,
as combined with either Mudzhiri or Staples.

C. Marconi (Ex. 1003) and Kihlberg (Ex. 1004)
USPlabs contends that claims 1, 5, and 7 are rendered obvious under 35
U.S.C. § 103 over Marconi as combined with Kihlberg. See, e.g., Pet. 18-29.
USPlabs relies on Marconi as set forth above. Pet. 12-13. USPlabs
contends that Kihlberg discloses a beverage containing α–ketoglutaric acid that is a
supply of orally administrable nutrients. Id. at 13. According to USPlabs, the
preparation contains a precursor of L-glutamine, wherein the precursor is
preferably α–ketoglutaric acid and salts or derivatives thereof. Id. USPlabs
contends that the ordinary artisan would have combined Marconi with Kihlberg, as
both prior art references deal with oral administration of α–ketoglutarate. Id. at 15.
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Harcol contends, as discussed above, that Marconi teaches that it is the α–
KG complex that has the positive energy effects, and that those positive effects are
not seen with the administration of α–ketoglutaric acid alone. Prelim. Res. 7-8.
For the reasons discussed above, we agree with Harcol that USPlabs has not
demonstrated a reasonable likelihood that claims 1, 5, and 7 are unpatentable over
Marconi and Kihlberg. Moreover, for the same reasons set forth above, USPlabs
has not demonstrated a reasonable likelihood that claims 2-4 and 6 are
unpatentable over a combination of Marconi and Kihlberg, as combined with either
Mudzhiri or Staples.

III. CONCLUSION
For the foregoing reasons, we determine based on the petition and the
preliminary response, that USPlabs has not demonstrated a reasonable likelihood
that it will prevail on its challenges of claims 1-7 of the ’364 patent.

IV. ORDER
It is
ORDERED that the petition is denied as to all challenged claims and no trial
is instituted.

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For Petitioner:
Andrea Reister
Natalie Derzko
Covington & Burling LLP
areister@cov.com
nderzko@cov.com

For Patent Owner:
Steven Lazar
SRL Patents & Licensing
srlpatents@aol.com