Ex Parte Connolly

Board of Patent Appeals and Interferences

Feb 26, 2010

11110122 (B.P.A.I. Feb. 26, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte KAREN W. SHANNON, PAUL K. WOLBER,
GLENDA C. DELENSTARR, PETER G. WEBB,
and ROBERT H. KINCAID
__________

Appeal 2009-008571
Application 11/110,122
Technology Center 1600
__________

Decided: February 26, 2010
__________

Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and STEPHEN
WALSH, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
Appeal 2009-008571
Application 11/110,122

2
STATEMENT OF CASE
Claims 1, 2 and 4 are representative and read as follows:
1. A therapeutic composition comprising a mixture of ingredients
including thiamin (vitamin B1), riboflavin (Vitamin B2), niacin (vitamin
B3), pantothenic Acid (vitamin B5), pyridoxine (vitamin B6), Vitamin B7,
pteroylmonoglutamic acid (vitamin B10), cyanocobalamine (vitamin B12),
Inositol, para-aminobenzoic acid, choline, potassium, magnesium, and
conjugated linoleic acid.

2. The therapeutic composition of Claim 1 and further comprising
about 270-330 mg thiamin (vitamin B1), about 216-264 mg riboflavin
(vitamin B2), about 216-264 mg niacin (vitamin B3), about 216-264 mg
pantothenic acid (vitamin B5), about 216-264 mg pyridoxine (vitamin B6),
about 0.6-1.4 mg (vitamin B7), about 216-264 mg pteroylmonoglutamic acid
(vitamin B10), about 216-264 mg cyanocobalamine (vitamin B12), about
216-264 mg inositol (vitamin B8 biotin), about 54-66 mg para-aminobenzoic
acid (vitamin B11 PABA), about 216-264 mg choline, about 180-220 mg
potassium, about 180-220 mg magnesium and about 630-770 mg conjugated
linoleic acid.

4. An orally delivered composition for preloading nutrients, prior to
metabolizing of alcohol by the liver of a person, having thiamin (vitamin
B1), riboflavin (Vitamin B2), niacin (vitamin B3), pantothenic acid (vitamin
B5), pyridoxine (vitamin B6), pteroylmonoglutamic acid (vitamin B10),
Inositol, and choline, wherein the improvement comprises:

about 0.6-1.4 mg biotin (vitamin B7);
about 216-264 mg pteroylmonoglutamic acid (vitamin B10);
about 54-66 mg para-aminobenzoic acid (vitamin B11);
about 216-264 mg cyanocobalamine (vitamin B12);
about 180-220 mg potassium;
about 180-220 mg magnesium; and,
about 630-770 mg conjugated linoleic acid.

Appeal 2009-008571
Application 11/110,122

3
Cited References
Hageman et al. (Hageman) US 6,548,483 B2 Apr. 15, 2003
Meredith US 2005/0008656 A1 Jan. 13, 2005

Grounds of Rejection
Claims 1-2 and 4 stand rejected under 35 U.S.C. § 103 over Meredith
in view of Hageman.
Appellants provide separate argument for claims 1, 2, and 4 and
therefore we address each claim separately.

FINDINGS OF FACT
1. The Examiner finds that:
Meredith, on page 15, Example 8 and claims on pages
15-17, teaches compositions useful for reducing inflammation
comprising:

• 75-300mg of thiamin (B-1) *this amount
encompasses and overlap with Applicants amount set
forth in claim 2.

• 75 to 300mg of riboflavin (B-2) *this amount
encompasses and overlap with Applicants amount set
forth in claim 2.

• 75 to 300mg of niacin (B-3) *this amount
encompasses and overlap with Applicants amount set
forth in claim 2.

• 75 to 300mg of pantothenic acid (B-5) *this amount
encompasses and overlap with Applicants amount set
forth in claim 2.

Appeal 2009-008571
Application 11/110,122

4
• 75 to 300mg of pyridoxine (B-6) *this amount
encompasses and overlap with Applicants amount set
forth in claim 2.
• 75 to 300ug of d-biotin (B7)

• 200 to 800ug of cyanocobalamine (B-12)

• 75 to 300mg of inositol *this amount encompasses
and overlap with Applicants amount set forth in claim
2.

• 575 to 2300 ug of para-aminobenozic acid (PABA)

• 75 to 300mg of choline *this amount encompasses
and overlap with Applicants amount set forth in claim
2.

(Ans. 3-4).

2. Meredith teaches that the composition can be orally administered (pg. 4,
para. [0054]).
3. Meredith teaches that magnesium and potassium can be also employed in
the composition among with PABA and biotin (pg. 6, para. [0113]).
4. Meredith teaches that the effective dosages of composition will depend
upon a variety of factors known in the art, such as the body mass of the
individual to whom the composition is administered and the dosages that can
be optimized (pg. 3, para. [0044] and pg. 4, para. [0045]).
5. Meredith teaches that there are no toxic levels of biotin that are known
due to the fact that the excess of biotin is easily being lost in the urine and
feces (pg. 11, under Biotin, para. [0226]).
6. Meredith teaches that body builders and athletes consuming raw eggs
should be careful of not running into a biotin shortage, since raw eggs
Appeal 2009-008571
Application 11/110,122

5
contain avidin, which binds with the biotin making it impossible to absorb
by the body (pg. 11, para. [0223]).
7. Meredith teaches that long-term use of antibiotics may also decrease the
availability of biotin (id.).
8. Meredith lacks conjugated linoleic acid, pteroylmonoglutamic acid
(vitamin B10) and their amounts, and the amounts of cyanocobalamine
(vitamin B12), d-biotin (B7) and PABA in a single pill (Ans. 4).
9. Hageman teaches an oral tablet (pill) composition for treating
inflammation comprising pteroylmonoglutamic acid (vitamin B10) and
conjugated linoleic acid (Ans. 4).
10. The Examiner finds that it would have been obvious to one of ordinary
skill in the art to modify the composition taught by Meredith and to combine
it with the active agents such as pteroylmonoglutamic acid (vitamin B10)
and conjugated linoleic acid taught by Hageman in a single formulation.
This is because Hageman teaches that these active agents are useful and
effective for the treatment of inflammation (Ans. 4-5).
11. The Examiner finds that one would have been motivated to combine
pteroylmonoglutamic acid (vitamin B10) and conjugated linoleic acid to
Meredith’s composition in order to achieve at least an additive effect in
treating inflammation condition (Ans. 5).
12. The Examiner finds that the motivation for combining the components
flows from their individually known common utility (Ans. 5).
13. The Examiner finds that the amounts of active agents (cyanocobalamine
(vitamin B12), d-biotin (B7), and PABA) to be used, the pharmaceutical
forms, e.g., tablets, etc., are all deemed obvious since they are all within the
knowledge of the skilled pharmacologist, and that Hageman teaches that the
Appeal 2009-008571
Application 11/110,122

6
composition is useful for treating inflammatory conditions which can be
formulated in tablet form (Ans. 5).
14. The Examiner finds that one of ordinary skill in the art would optimize
the amounts of cyanocobalamine (vitamin B12), d-biotin (B7), and PABA
according to the severity of the inflammation condition in a patient to be
treated in order to achieve optimize dosage for the individual patients being
treated (Ans. 5).

ISSUE
The Examiner argues that it would have been obvious to one of
ordinary skill in the art to modify the composition taught by Meredith and
combine with the active agents such as pteroylmonoglutamic acid (vitamin
B10) and conjugated linoleic acid taught by Hageman in a single
formulation because Hageman teaches that these active agents are useful and
effective for the treatment of inflammation.
Appellants contend that Meredith does not teach a remedy for a
hangover, and that the lower limits of biotin, PABA, and B12 claimed are
well above the levels of the Meredith reference.
The issue is: Have Appellants demonstrated error in the Examiner’s
obviousness rejection? Has the Examiner provided evidence in the prior art
of the claimed levels of biotin, PABA, and B12?

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
Appeal 2009-008571
Application 11/110,122

7
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
Moreover, “obviousness requires a suggestion of all limitations in a
claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir.
2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
When evaluating claims for obviousness, “the prior art as a whole
must be considered. The teachings are to be viewed as they would have
been viewed by one of ordinary skill.” In re Hedges, 783 F.2d 1038, 1041
(Fed. Cir. 1986). Thus, “‘[i]t is impermissible within the framework of
section 103 to pick and choose from any one reference only so much of it as
will support a given position, to the exclusion of other parts necessary to the
full appreciation of what such reference fairly suggests to one of ordinary
skill in the art.’” Id. (quoting In re Wesslau, 353 F.2d 238, 241 (CCPA
1965)).
Determining the optimum values of result effective variables is
ordinarily within the skill of the art. See In re Boesch, 617 F.2d 272, 276
(CCPA 1980). In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here
general conditions of a claim are disclosed in the prior art, it is not inventive
to discover the optimum or workable ranges by routine experimentation.").
Appeal 2009-008571
Application 11/110,122

8
“[T]here must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.” In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006).

ANALYSIS

Claim 1
The Examiner argues that it would have been obvious to one of
ordinary skill in the art to modify the composition taught by Meredith and to
combine it with the active agents such as pteroylmonoglutamic acid (vitamin
B10) and conjugated linoleic acid taught by Hageman in a single
formulation because Hageman teaches that these active agents are useful and
effective for the treatment of inflammation.
Appellants contend that Meredith does not teach a remedy for a
hangover, and that the lower limits of biotin, PABA, and B12 are well above
the levels of the Meredith reference (Br. 9).
We essentially agree with the Examiner’s fact finding, statement of
the rejection with respect to claim 1, and response to Appellants’ arguments
as set forth in the Answer. We provide the following additional comment.
It is not found persuasive that the lower limits of biotin, PABA, and
B12 claimed are well above the levels of the Meredith reference, because
claim 1 does not specify specific amounts of these ingredients. Both the
compositions of Meredith and Hageman are useful for the treatment of
inflammation and thus we agree that the Examiner has provided sufficient
evidence to support a prima facie case of obviousness for the subject matter
of claim 1.
Appeal 2009-008571
Application 11/110,122

9
We note that claim 1 is not limited to a hangover treatment method,
and thus Appellants’ argument that Meredith does not teach a remedy for a
hangover is not convincing. Also, the composition of claim 1 is recited in
“comprising” language, which does not exclude the presence of any of the
other ingredients disclosed by Meredith or Hageman. The rejection of
claim 1 is affirmed.

Claims 2 and 4
Appellants contend that Meredith does not teach a remedy for a
hangover, and that the lower limits of biotin, PABA, and B12 claimed are
well above the levels of the Meredith reference (Br. 9).
Meredith, paragraph [0233] discloses that the recommended dosage of
B12 is 3 µg per day and indicates that certain populations, including the
elderly and alcohol consumers, require more, but does not disclose how
much more. The Examiner indicates that Meredith paragraph [044] further
indicates that the effective dosage depends upon a variety of factors
including body weight (Ans. 6). Hageman discloses B12 in the range of 0.2
to 4000 µg (4 mg) (Table 1, column 12).
However, claims 2 and 4 require about 216-264 mg cyanocobalamine
(vitamin B12). We do not find that the Examiner has provided sufficient
evidence in the prior art of the claimed amount of B12 in claims 2 and 4.
While the Examiner indicates that those of ordinary skill in the art would
adjust the dosage of Meredith for body weight, we do not find that the
Examiner has explain how the significantly higher amounts of B12 claimed
can be accounted for by body weight differences. Thus, we do not find that
Appeal 2009-008571
Application 11/110,122

10
the Examiner has provided articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness of claims 2
and 4.
For this reason, we are constrained to reverse the rejection of claims 2
and 4 in view of the evidence before us.

CONCLUSION OF LAW
Appellants have not demonstrated error in the Examiner’s
obviousness rejection with respect to claim 1. The rejection is affirmed.
The rejection of claims 2 and 4 are reversed.
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-IN-PART

clj

PAUL M. DENK
STE. 170
763 S. NEW BALLAS ROAD
ST. LOUIS, MO 63141