Ex Parte Greenhaff et al

Patent Trial and Appeal Board

Oct 27, 2016

10549384 (P.T.A.B. Oct. 27, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
10/549,384 11103/2005 Paul Leonard Greenhaff
20350 7590 10/31/2016
KILPATRICK TOWNSEND & STOCKTON LLP
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ATTORNEY DOCKET NO. CONFIRMATION NO.
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EXAMINER
KRISHNAN, GANAPATHY
ART UNIT PAPER NUMBER
1673
NOTIFICATION DATE DELIVERY MODE
10/31/2016 ELECTRONIC
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.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAUL LEONARD GREENHAFF and
DUMITRU CONSTANTIN-TEODOSIU1
Appeal2015-006392
Application 10/549,384
Technology Center 1600
Before RY ANH. FLAX, TIMOTHY G. MAJORS, and DAVID COTTA
Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
of promoting camitine accumulation in a subject's skeletal muscle, which
have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
"[C]amitine is essential in muscle metabolism and function ... [and]
the muscle store of camitine is important for energy production in muscle.
1 Appellants identify the Real Parties in Interest as The University of
Nottingham and Lonza Sales, Ltd. (App. Br. 3.)
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Application 10/549,384
If the store of camitine declines, the function of the muscle can be
impaired." (Spec. 1:7-10.) Appellants' "invention relates to camitine
retention in biological tissue. More particularly, but not exclusively, the
invention relates to compositions and methods of increasing camitine
retention in the animal and/or human body." (Id. at 1 :3-5.)
Claims 160 and 166-198 are on appeal. Claim 166 is representative
and reads as follows:
166. A method for promoting camitine accumulation in skeletal
muscle of a subject in need thereof comprising increasing the
serum insulin concentration to greater than 50 mU/L in the
subject and orally administering L-camitine to the subject,
wherein the amount of L-camitine is 0.25g to 3g.
(App. Br. 16 (Claims App'x).)
The claims stand rejected as follows:
I. Claims 166-168, 183-186, 188, 189, and 196-198 under
35 U.S.C. § 103(a) over Cavazza,2 Boyns,3 and Georges4
("Rejection I").
2 Cavazza, US 4,320, 145, issued Mar. 16, 1982 ("Cavazza").
3 Boyns et al., Oral Glucose Tolerance and Related Factors in a Normal
Population Sample, 1 BRIT. MED. J. 595-98 (1969) ("Boyns").
4 Georges et al., Carnitine Transport into Muscular Cells. Inhibition of
Transport and Cell Growth by Mildronate, 59 BIOCHEM. PHARMACOL.
1357---63 (2000) ("Georges").
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Application 10/549,384
II. Claims 160, 169-182, and 187-195 under 35 U.S.C. § 103(a)
over Cavazza, Kamarei, 5 Boyns, Van Loon, 6 Georges, and
Brantman 7 ("Rejection II").
DISCUSSION
Because the same issues are dispositive for both Rejection I and
Rejection II, we address the rejections together. As indicated above, we
select claim 166 as representative. 37 C.F.R. § 41.37(c)(l)(iv).
For both Rejections I and II, the Examiner relies on the teachings of
Cavazza, Boyns, and Georges. 8 (Ans. 3-5, 7-8.) The Examiner finds that
"Cavazza teaches the administration of two 5% glucose solutions wherein
one of them has L-camitine admixed in it in an amount of 40mg/Kg to a
subject." (Id. at 4.) According to the Examiner, "Cavazza [] does not
expressly teach the amount in grams of glucose in his compositions and that
the administration of glucose ... in his example causes increase in [the]
insulin level to greater than 50mU/L as in claim 166." (Id.) 9
5 Kamarei, US 5,985,339, issued Nov. 16, 1999 ("Kamarei").
6 Van Loon et al., Plasma insulin responses after ingestion of different
amino acid or protein mixtures with carbohydrate, 72 AM. J. CLIN. NUTR.
96-105 (2000) ("Van Loon").
7 Brantman, US 4,687,782, issued Aug. 18, 1987 ("Brantman").
8 Rejection II further cites teachings of Kamarei, Van Loon, and Brantman.
9 The Examiner notes, however, that "in two instances a higher insulin level
has been observed" (Ans. 4 (citing Cavazza Table 3.) We understand the
"two instances" to be the two subjects (among ten) whose insulins levels
were "61. 7" and "88.6" at the end of infusion of a 5% glucose solution+ L-
camitine. (Cavazza col. 8 (Table 3).)
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Application 10/549,384
The Examiner finds that Boyns and Georges disclose the elements not
taught by Cavazza. The Examiner finds Boyns teaches "insulin levels
increase to about 75mU/mL after administration of 50g of glucose" and
Georges teaches "camitine is transported to the skeletal muscles and is found
to be about fifty times higher in skeletal muscles." (Id. (emphasis omitted).)
The Examiner concludes that "one of ordinary skill in the art would []
expect camitine accumulation to be promoted in the human skeletal muscle
by increasing the insulin concentration to greater than 50mU/L in a subject .
. . since the method of Cavazza performs the same function." (Id. at 4--5.)
According to the Examiner, "analogous compositions comprising camitine,
glucose, amino acids and proteins are taught in the art and proteins and
amino acids are also known to increase insulin levels and increase in insulin
levels parallels the increase in sugar concentration." (Id. at 6.)
The Examiner also concludes that "it is obvious to combine prior art
elements and improve the method of the prior art to yield predictable results
by making and administering compositions comprising the components in
the claimed methods by increasing the concentration of insulin to greater
than 50 mU/L." (Id.) According to the Examiner, "[m]ethod improvement
is the motivation" and "additional motivation is provided by Cavazza [] in
that such a composition also has the effect of increased tissue utilization of
the sugar (replenishment of [the] body's energy reserves) and decreased
levels of glucose in the peripheral blood." (Id.)
Appellants argue that Cavazza does not teach all the elements of
method claim 166, and that the secondary prior art references do not remedy
Cavazza's deficiencies. (App. Br. 11.) Appellants argue, inter alia, that
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Application 10/549,384
"Cavassa does not disclose or suggest oral administration of L-camitine and
an agent that increases blood plasma or serum insulin concentration." (Id.)
According to Appellants, "Cavazza goes to great lengths to emphasize that
the described formulations are intended for parenteral administration only ..
. [and] [n]o evidence has been provided by the Examiner to support the
argument that Cavazza can be read to teach oral administration of the
described formulations." (Id. at 11-12; see also Reply Br. 1-2.)
On the present record, Appellants have the better position. As
Appellants persuasively argue, Cavazza relates exclusively to parenteral
administration (particularly intravenous (IV) infusion) of glucose solutions.
(See Cavazza passim.) For example, claim 1 of Cavazza recites "[a]
parenterally administrable pharmaceutical composition useful for nourishing
patients who cannot be fed via the enteral [i.e., oral] route .... " (Id. at col.
7, 11. 54--56 (emphasis added).)
Indeed, the formulations disclosed in Cavazza are designed to address
unique problems arising with IV administration of glucose - adequately
nourishing the patient who cannot be fed orally while preventing high blood-
sugar levels and excessive secretion of insulin that would otherwise occur
when administering IV solutions with high glucose concentrations. (See id.
at Abstract and col. 1, 11. 5----67.) By combining L-camitine with glucose in
an IV solution, Cavazza teaches "[i]ncreased tissue utilization of glucose
and, therefore, reduced glycaemia and decreased glucose level in the
peripheral blood ... [and] [d]isappearance of excessive insulin secretion
which would occur in the absence of L-camitine when administering an
equal amount of glucose." (Id. at col. 3, 11. 44--52.)
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The Examiner does not identify any specific disclosure in Cavazza
teaching or suggesting oral administration of Cavazza' s formulations.
Instead, the Examiner states that Cavazza's disclosure that the composition
"is also for patients who need to receive nutrition via parenteral route for a
few days only, as in case of patients who have been subjected to minor
abdominal operations such as appendectomy or cholecystectomy" "indicates
that ... for subjects who have had such operations his composition need not
be administered via the parenteral route." (Final Act. 12.) The Examiner
thus states that Cavazza' s composition "can be administered to such patients
via other routes including the oral route after a few days." (Id. at 12-13; see
also Ans. 13.)
The Examiner's reasoning and reading of Cavazza is not persuasive.
The disclosure of Cavazza cited by the Examiner, in its full context, reveals
a picture different from that painted by the Examiner:
[T]he invention relates to a glucose solution for nutrition by drip
phleboclysis of any type of patient who may require, over a more
or less long period, to be fed via the parenteral route. Such a
solution is, therefore, suitable for the nutrition of patients who
need to receive nutrition via the parenteral route for a few days
only, as in the case of patients who have been subjected to minor
abdominal operations such as appendectomy or
cholecystectomy, and for patients who cannot receive food via
the enteral route for several weeks, as in the case of patients who
have been subjected to extended resections of the intestinum
tenue, esophageal perforations, etc.
During the postoperative period, there arises, among other
problems, the problem of providing the patient with a supply of
energy in a utilizable form. The patient, for more or less long
periods, according to severity and extension of the surgical
operation, is unable to absorb via the enteral route the saccharide,
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protein and lipid substrates which provide sources of utilizable
energy.
The patient must, therefore, be fed via the parenteral
route, generally by intravenous administration.
(Cavazza, col. 1, 11. 8-29 (emphasis added); see also App. Br. 12-13.)
Nothing in this disclosure teaches or suggests oral administration, either
before or after parenteral administration. Quite the opposite, this disclosure
- and the remainder of Cavazza's teachings- confirms that Cavazza
relates to parenteral administration alone.
Absent hindsight gleaned from Appellants' disclosure, we are not
persuaded the skilled artisan would have understood Cavazza as teaching or
suggesting oral administration of a solution of glucose and L-camitine. The
Examiner has not identified other persuasive evidence or reasoning to make
up for this deficiency in Cavazza. We thus conclude the Examiner has not
met the burden to show that claim 166 or Appellants' other method claims
would have been prima facie obvious.
Having found that the Examiner did not establish a prima facie case of
obviousness, we decline to address Appellants' evidence of alleged
unexpected results.
SUMMARY
We reverse the rejection of claims 166-168, 183-186, 188, 189, and
196-198 under 35 U.S.C. § 103(a) over Cavazza, Boyns, and Georges.
We reverse the rejection of claims 160, 169-182, and 187-195 under
35 U.S.C. § 103(a) over Cavazza, Kamarei, Boyns, Van Loon, Georges, and
Brantmann.
REVERSED
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