Ex Parte Katz et al

Board of Patent Appeals and Interferences

Dec 30, 2009

10319328 (B.P.A.I. Dec. 30, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte DAVID P. KATZ,
JAMES R. KOMOROWSKI, and DANIELLE GREENBERG
____________

Appeal 2009-006343
Application 10/319,328
Technology Center 1600
____________

Decided: December 30, 2009
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Before DEMETRA J. MILLS, LORA M. GREEN, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal from the Examiner’s final rejection of
claims 21-30 and 61-70. Jurisdiction for this appeal is under 35 U.S.C.
§ 6(b). We affirm.

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STATEMENT OF THE CASE
The claims are directed to a pharmaceutically effective dose of a
conjugated fatty acid or fatty alcohol, and a chromium complex for
improving insulin sensitivity in a subject. The conjugate and chromium
complex are in a ratio of at least 1:5.
Claims 21-30 and 61-70 are pending and stand rejected by the
Examiner as follows:
Claims 21-30 and 61-70 under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement (Ans. 5); and
Claims 21-30 and 61-70 under 35 U.S.C. § 103(a) as obvious in view
of Paul (U.S. Patent 5,292,538, issued Mar. 8, 1994), Seidel (U.S. Patent
6,342,619 B2, issued Jan. 29, 2002), and de la Harpe (U.S. Patent
5,980,905, issued Nov. 9, 1999) (Ans. 6).
Claim 21 is representative and reads as follows:
21. A method of improving insulin sensitivity in a subject in
need thereof comprising administering to said subject a
pharmaceutically effective dose of a conjugated fatty acid or
conjugated fatty alcohol in conjunction with at least one
chromium complex selected from the group consisting of
chromium picolinate, chromium nicotinate, chromic
tripicolinate, chromic polynicotinate, chromium chloride,
chromium histidinate, and chromium yeasts, wherein the ratio
of the conjugated fatty acid or conjugated fatty alcohol to the
chromium complex is at least 1:5.

FINDINGS OF FACT
Chromium
1. Chromium was known to be involved in diabetes prior to the application
filing date (Spec. 4: ¶ 12).
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2. The Specification teaches that dietary supplementation with chromium in
normal individuals was reported “to lead to improvements in glucose
tolerance, serum lipid concentrations, including high-density lipoprotein
cholesterol, insulin and insulin binding . . . with improvements of risk
factors associated with adult-onset (type 2) diabetes” (Spec. 3: ¶ 9).
3. Chromium was also known as an insulin cofactor, potentiating insulin’s
physiological functions (Spec. 3: ¶ 10).
4. The Specification discloses a patent which described dietary chromium
complexes, such as chromium picolinates, that were absorbed by the
intestine (Spec. 4: ¶ 11).
5. A patent is also described in the Specification which administered
chromium tripicolinate for the treatment of adult-onset diabetes
(Spec. 4: ¶ 12).
Conjugated fatty acid/alcohol and chromium
6. According to the Specification, the invention provides a method of
treating type 1 diabetes in a subject comprising administering effective doses
of a conjugated fatty acid or fatty alcohol in conjunction with at least one
chromium complex (Spec. 7: ¶ 24; see also Spec. 9-10: ¶ 30).
7. “In another aspect of the invention, the chromium complex and
conjugated fatty acid or conjugated fatty alcohol are in a ratio of between
1:666 to about 1:200 (w/w).” (Spec. 6: ¶ 22). This ratio is equivalent to
200:1 to 666:1 of conjugated fatty acid/alcohol to chromium complex.1

1 The ratios are restated in this form because the claim expresses the ratio as
“conjugated fatty acid or conjugated fatty alcohol to the chromium
complex.”
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8. “Preferably, the ratio of the chromium complex to the chelating agent [is]
from about 10:1 to about 1:10, more preferably from about 5:1 to about 1:5
(w/w).” (Spec. 11-12: ¶ 38.) This ratio is equivalent to 1:10 to 10:1 and 1:5
to 5:1, respectively, of conjugated fatty acid/alcohol to chromium complex.
9. In Example 1, a subject is administered 300 micrograms chromium
picolinate (CP) to 1 gm conjugated linoleic acid (CLA) twice a day; or
0.0003 g CP:1 gm CLA (Spec. 16-17: ¶ 53). This ratio is equal to 10,000:3
CLA (conjugated fatty acid) to CP (chromium complex).
10. In Example 2, a subject is administered 500 micrograms chromium
nicotinate to 500 mg CLA; or 0.0005 g chromium complex:0.5 g CLA
(Spec. 16-17: ¶ 53). This ratio is equivalent to 0.5/0.0005 or 0.1/.0001 or
1,000:1 CLA (conjugated fatty acid) to (CP) chromium complex.
11. The Specification discloses that the effective dose of the conjugated
fatty acid/alcohol can be between 75 mg and 10 g, including 75 mg, 100,
mg, 250 mg, 500 mg, 750 mg, 1000 mg, 2 g, 5 g, 7 g, and 10 g (Spec. 11:
¶ 34). The Specification states the conjugated fatty acid/alcohol can have as
few as 4, 5, 6, 7 carbon atoms or as many as 16, but preferably not more than
32, 30, 28, or 26 carbon atoms (Spec. 8: ¶ 28).
12. The Specification discloses that the effective dose of the chromium
complex can be between about 50 and 10,000 micrograms per day of
chromium (Spec. 15: ¶ 50).
13. Original claim 21 was to a method of improving insulin sensitivity in a
subject comprising administering a pharmaceutically effective dose of a
conjugated fatty acid or alcohol in conjunction with at least one chromium
complex selected from a list of specifically recited complexes (Spec. 18).
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Results
14. The Specification teaches:
A primary basis of the present invention is the novel and
unexpected discovery that compositions comprising an
effective dose of a chromium complex in combination with a
conjugated fatty acid or conjugated fatty alcohol produce a
synergistic effect on glucose uptake in a subject in need thereof.
(Spec. 7: ¶ 26.)
15. Figs. 1-3 show experiments with a chromium complex (chromium
picolinate, “CP”) and a conjugated fatty acid (linoleic acid, “CLA”) on
glucose uptake by cultured human muscle skeletal cells (Spec. 9-10: ¶ ¶ 30-
32).
16. The ratio of CP to CLA used was: 5/0.1, 5/1, and 5/10 (Spec. Figs. 2
and 3); or 0.1/5, 1/5, and 10/5 CLA to CP.
17. CLA alone had no effect on glucose uptake under basal (without insulin)
and stimulated (with insulin) conditions (Spec. 10: ¶ 30; Fig. 1).
18. Administration CLA and CP were stated to “significantly” increase
glucose under both basal and stimulated conditions (Spec. 10: ¶ 31; Fig. 2).
19. “CP and CLA under basal conditions was shown to have a greater effect
than insulin alone.” (Spec. 10: ¶ 31; Fig. 2).
20. Fig. 3 is stated to show “that CLA plus a chromium complex [CP]
synergistically aid in the percent increase in the uptake of glucose in human
skeletal muscle culture.” (Spec. 10: ¶ 32).

WRITTEN DESCRIPTION REJECTION
Statement of the Issue
Original claim 21 was to a method of improving insulin sensitivity in
a subject comprising administering “a pharmaceutically effective dose of a
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conjugated fatty acid or conjugated fatty alcohol in conjunction with at least
one chromium complex.” During prosecution, Claim 21 was amended to
recite that “the ratio of the conjugated fatty acid or conjugated fatty alcohol
to the chromium complex is at least 1:5.” The Examiner contends that the
added numerical limitation is not described in the Specification and rejected
the claim under 35 U.S.C. § 112, first paragraph, for lack of written
description. Appellants contend that the Examiner erred in this
determination and seek review of the rejection in this appeal.

Principles of Law
To satisfy the written description requirement, the inventor “must also
convey with reasonable clarity to those skilled in the art that, as of the filing
date sought, he or she was in possession of the invention.” Vas-Cath Inc. v.
Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). In describing the
claimed invention, there is no requirement that the wording be identical to
that used in the specification as long as there is sufficient disclosure to show
one of skill in the art that the inventor “invented what is claimed.” Union
Oil Co. of California v. Atlantic Richfield Co., 208 F.3d 989, 997 (Fed. Cir.
2000). Thus, so long as a person “of ordinary skill in the art would have
understood the inventor to have been in possession of the claimed invention
at the time of filing, even if every nuance of the claims is not explicitly
described in the specification, then the adequate written description
requirement is met.” In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996).
“[H]ow the specification accomplishes this is not material.” In re Wertheim,
541 F.2d 257, 262 (C.C.P.A. 1976).

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Analysis
When a claim is amended during its prosecution, the Examiner must
determine whether the claimed invention, as amended, is described in the
Specification as required by the written description requirement of 35 U.S.C.
§ 112, first paragraph. The purpose of § 112, first paragraph, in these
circumstances is to ensure that the inventor is not claiming an invention that
he did not invent. The wording in the amended claim does not have to be
identical to the words in the Specification. But the Specification must
convey that the inventor had “possession” of the later claimed invention with
all its limitations.
In this case, Appellants had originally claimed effective doses of a
conjugated fatty acid or conjugated fatty alcohol in conjunction with a
chromium complex, but later amended the claim to recite that the two
components be in the specific ratio of “at least 1:5.” The Examiner found
that the Specification did not expressly recite the limitation of “at least 1:5,”
and, therefore, reviewed the written description of the Specification for other
descriptive support. The Examiner found that the Specification described a
number of different ratios between a conjugated fatty acid/alcohol and a
chromium complex, but did not consider these sufficient to support the new
numerical limitation. The Examiner concluded:
[A]lthough Appellants described several ratios which fall with
the breadth of the [“]at least 1:5[”], they have not disclosed a
representative number of ratios within this breadth in order to
indicate that Appellants contemplated a large breadth of
potential amounts.
(Ans. 17.)
The Examiner clearly articulated her reasons for the rejection,
provided thorough fact-finding to support it, and skillfully framed the issue
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for review. We agree with the facts as found by the Examiner, but not the
legal test for written description which was applied to these facts. By
focusing on whether Appellants had “disclosed a representative number of
ratios” within the claimed range of “at least 1:5,” the Examiner was led
astray from the underlying factual issue of whether Appellants had
possession of the claimed invention at the time of filing. In re Alton,
76 F.3d at 1175. While the disclosure of a representative number of
examples may be useful in determining whether a later-filed invention is
described in the Specification, such a test is merely an expedient, but does
not limit the written description inquiry or define the § 112, first paragraph,
standard (“[H]ow the specification accomplishes [the written description of
the invention] is not material.” In re Wertheim, 541 F.2d at 262).
In this case, the Specification contained broad disclosure that its
invention was administering effective doses of a conjugated fatty acid or
fatty alcohol in conjunction with at least one chromium complex (FF6 and
13). Various ratios of the two components are disclosed in the Specification,
including the ratio of 1:5 – the lower endpoint which is now claimed – and a
ratio as high as 10,000:3 (FF7-10, 16). Broad ranges of actual amounts of
the conjugate and chromium complex to be administered are also described
in the Specification (FF11-12).
The Specification states that a “primary basis” of its invention was
“the novel and unexpected discovery” that compositions of effective doses
of a chromium complex and a conjugated fatty acid/fatty alcohol “produce a
synergistic effect on glucose uptake in a subject in need thereof.” (FF14; see
FF18-20.) Therefore, the Specification explicitly conveys that the invention
involved synergy between the two recited components. Consistently, the
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claimed was amended to recite the lower limit of 1:5, a ratio acknowledged
by the Examiner as producing a synergistic result (Ans. 19). Therefore, the
ordinary skilled worker would have understood that synergy was a guidepost
to the invention, rather than a particular upper ratio between the conjugate
and chromium complex.
Taken together, the broad disclosure in the Specification would have
reasonably conveyed to the person of ordinary skill in the art at the time of
filing that the inventors had possessed a “pharmaceutically effective dose” in
excess of the ratios actually disclosed in the Specification.

Conclusion of Law & Summary
In sum, we agree with Appellants that the Examiner erred in
determining that claimed invention reciting that “the ratio of the conjugated
fatty acid or conjugated fatty alcohol to the chromium complex” of “at least
1:5” is not described in the Specification. The rejection of claims 21-30 and
61-70 is reversed.

OBVIOUSNESS REJECTION
Statement of the Issue
Appellants did not challenge the Examiner’s prima facie case of
obviousness. Instead, they argued that the Examiner’s case was rebutted by
a showing of unexpected results. The Examiner acknowledged that
Appellants established unexpected results for certain combinations of a
conjugate and chromium complex, but not for the full scope of the claim.
Therefore, the issue in this rejection is whether the Examiner erred in
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determining that Appellants’ showing of unexpected results was not
commensurate with the full breadth of the claim.
Principles of Law
“In order to establish unexpected results for a claimed invention,
objective evidence of non-obviousness must be commensurate in scope with
the claims which the evidence is offered to support.” In re Clemens,
622 F.2d 1029, 1035 (C.C.P.A. 1980). As explained in Clemens:
[T]he scope of the temperature limitation in claims 1-7 and 9-10
is very broad.
The probative value of appellants’ evidence, on the other
hand, is quite narrow. Appellants’ evidence comes solely from
comparative tests conducted at 110°C and 130°C.
This is not a case in which the probative value of a
narrow range of data can be reasonably extended to prove the
unobviousness of a broader claimed range. Cf. In re Kollman,
595 F.2d 48, 56, 201 USPQ 193, 199 (CCPA 1979), where it
was held that the unobviousness of a broader claimed range was
proven by a narrower range of data, when one having ordinary
skill in the art could ascertain a trend in the exemplified data
which would allow him to reasonably extend the probative
value thereof. . . . There is therefore no basis in this data for
predicting the relative performance of VBC- and CME-based
resins at temperatures at which the latter would be expected to
perform well.
(Clemens, 622 F. 2d at 1036.)
Analysis
The Examiner acknowledged that the results shown in Figs. 1-3 of the
Specification established unexpected results for a specific combination of a
chromium complex with a conjugated linoleic acid (Ans. 22). However, the
Examiner found:
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Appellants have only demonstrated a synergistic result with
regard to CLA and no other conjugated fatty acid/alcohol. The
showing of CLA in combination with chromium picolinate in
having a synergistic result is not extrapolated to all other
conjugated fatty acids and all other conjugated fatty acids
because conjugated fatty acids have different structures and are
expected to have different functions (this is true also for
conjugated fatty alcohols) and further because Appellants have
not provided any indication that a representative sample of
species of conjugated fatty acids/alcohols would work similarly
to CLA.
(Ans. 20.)
The Examiner’s position is well-reasoned. “In order to establish
unexpected results for a claimed invention, objective evidence of non-
obviousness must be commensurate in scope with the claims which the
evidence is offered to support.” In re Clemens, 622 F.2d at 1035. For the
data to be probative for the full scope of what is claimed, it must be
established that “one having ordinary skill in the art could ascertain a trend
in the exemplified data which would allow him to reasonably extend” it to
the broader invention which is claimed. Clemens, 622 F.2d at 1036. In this
case, the Examiner found that the claimed genus of conjugated fatty
acids/alcohol structures included structures which differed from CLA, the
only fatty acid conjugate which produced synergy when combined with a
chromium complex (Ans. 20). Persons of ordinary skill in the art would not
have reasonably expected that the activity of CLA would predict the activity
of all other fatty acid conjugates having different chemical structures. As
noted by the Examiner, Appellants did not provide rebuttal evidence or
arguments as to why other species of conjugates, with different chemical
structures, would have been expected to produce the same results obtained
with CLA (id.).
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Conclusion of Law & Summary
The Examiner did not err in determining that Appellants’ showing of
unexpected results was not commensurate with the full breadth of the claim.
The rejection of claim 21 is affirmed. Claims 22-30 and 61-70 fall with
claim 21 because separate reasons for their patentability were not provided.
37 C.F.R. § 41.37(c)(1)(vii).

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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