Ex Parte Aylor et al

Patent Trial and Appeal Board

Nov 1, 2012

11526410 (P.T.A.B. Nov. 1, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/526,410 09/25/2006 Robert Benson Aylor AYLOR-US2 2874
7590 11/02/2012
ROBERT B. AYLOR
9502 BLUEWING TERRACE
CINCINNATI, OH 45241
EXAMINER
GEMBEH, SHIRLEY V
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
11/02/2012 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ROBERT BENSON AYLOR, LEIGH HEATHER MAKOVER,
and ROBYN AYLOR HAINES
____________

Appeal 2011-004789
Application 11/526,410
Technology Center 1600
____________

Before DONALD E. ADAMS, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
Appellants request reconsideration (rehearing) of the Board's opinion
entered November 1, 2011 (Opinion) affirming the obviousness rejections of
record (Req. Reh’g 1). We have jurisdiction under 35 U.S.C. § 6(b).
On reflection, we note that the rejection of claims 6-9 over the
combination of Bland1 and Thurlimann2 is cumulative to the rejection of
claims 6-20 over the combination of Bland, Thurlimann, Cummins,3 and

1 Bland et al., US 2002/0192310 A1, published December 19, 2002.
2 Thurlimann, US 2003/0158166 A1, published August 21, 2003.
3 Cummins, US 5,017,371, issued May 21, 1991.
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Ramaekers.4 Therefore, in order to simplify the issues on this Appeal, we
vacate the rejection of claims 6-9 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Bland and Thurlimann in favor of the
comprehensive rejection of claims 6-20 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Bland, Thurlimann, Cummins, and
Ramaekers. However, to be complete, this Panel will consider the
contentions Appellants presented in their discussion of the Bland and
Thurlimann combination that relate to the combination of Bland,
Thurlimann, Cummins, and Ramaekers.

Appellants’ claimed invention:
Appellants’ claim 6 is directed to a method of treatment. According
to claim 6, the claimed treatment minimizes the risks associated with a
cancer tumor either by:
1. Minimizing the chances of formation of a cancer tumor, or
2. Suppressing the development of any existing cancer tumor.
The method of claim 6 comprises treating a human, canine, or feline known
to either have:
a. A cancer tumor;
b. An exposure to a carcinogen; or
c. A genetic disposition to form cancer tumors.

4 Ramaekers, US 2003/0077254 A1, published April 24, 2003.
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The method comprises the administration, until there is no more risk of
damage from the cancer tumor, either separately or together, effective
amounts of:
i. Betaine or its functional equivalent, and
ii. Vitamin C or its functional equivalent.
Appellants’ claim 6 defines the effective amounts of each of the betaine and
vitamin C as at least about 5 mg per kg per day of the weight of the human,
canine, or feline.
Appellants’ claim 12 depends from and further limits claim 6 to
require the:
1. Treatment of humans; and
2. Administration of at least 500 mg per day of each of betaine and
Vitamin C.
As seen from the foregoing outline, the method of Appellants’ claims
6 and 12, does not require the treatment of cancer, but instead reads on a
prophylactic administration of betaine and Vitamin C to individuals who
may have (1) been exposed to a carcinogen, which includes “smokers [and]
people exposed to carcinogenic materials … in the workplace” or (2) a
genetic disposition to form cancer tumors (Appellants’ Claims 6 and 12; Cf.
Claim 9; Spec. 1: 33-37).

The combination of art as relied upon by Examiner:
The Opinion states that Appellants’ “[c]laim 12 is representative” and
evaluated the merits of the rejection over the combination of Bland,
Thurlimann, Cummins, and Ramaekers in the context of claim 12 (Opinion
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11-14). The following summarizes the combination of art as relied upon by
Examiner with respect to Appellants’ claim 12.
Appellants do not dispute that Bland suggests the administration of a
composition comprising 60-240 mg of vitamin C and 200-800 mg of betaine
to humans with a family history of breast, uterine, or ovarian cancer (Req.
Reh’g 5; Opinion 7: FF 16, citing id. at 2-4: FF 1-10). Thus, Appellants’
appear to concede that Bland suggests the daily administration of vitamin C
and betaine to humans with a genetic disposition to form cancer tumors as
required by Appellants’ claim 12.
Appellants contend that a typical adult woman weighs either “130
pounds (about 59 kg)’ (App. Br. 5)” or “around 120 pounds or about 54
kilograms” (Opinion 4; Aylor Declaration5: Exhibit D). Thus, Bland’s
composition suggests the administration of betaine to a human in an amount
of 500 mg per day, which, for a 130 pound human, meets the requirement of
claim 12 and the limitation in claim 6 of at least about 5 mg per kg per day
of the weight of the human (500 mg/59 kg = 8.47 mg/kg). Bland, however,
suggests the administration of 240 mg of vitamin C, or 4 mg/kg for a 130
pound human, which is a little short of the amount of vitamin C required by
Appellants’ claims 6 and 12 (see Opinion 4).
Examiner relies on Cummins to make up for the deficiency in the
vitamin C concentration suggested by Bland, as it relates to humans.
Appellants do not dispute that Cummins suggests the administration of
vitamin C at a concentration of 1000 mg to a patient (Req. Rh’g 10; Cf.
Opinion 11-12). Instead, Appellants contend that Cummins suggests “the
use of vitamin C only after the treatment of the cancer has been completed

5 Aylor Declaration, executed June 19, 2010.
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and the cancer is in remission” (id.). Therefore, Appellants contend that
Cummins “does not support the use of vitamin C in the treatment of cancer”
(id. (emphasis added)). However, as discussed above, Appellants’ claimed
invention does not require the treatment of cancer.
Therefore, as it relates to Appellants’ claimed invention, the
combination of Bland and Cummins suggests the daily administration of at
least 500 mg of betaine and Vitamin C, which is at least about 5 mg per kg
per day of the weight of a 130 pound individual, to humans with a family
history of breast, uterine, or ovarian cancer.

Issues presented on Rehearing:
Issue 1: “There is no indication that the Thurlimann active could be
given orally on a daily basis for any reason” (Req. Reh’g 6).
Issue 2: Is Appellants’ claimed invention limited to the treatment of
cancer? If not, does the combination of prior art relied upon by Examiner
support the use of vitamin C for purposes other than the treatment of cancer
(Req. Reh’g 10-12).
Issue 3: The Panel failed to consider Appellants’ separate arguments
of claims 7-20 (Req. Reh’g 2-3).
We take each in turn.
Issue 1:
Appellants’ representative makes a number of unsupported assertions
with regard to the Thurlimann reference (Req Rh’g 6). Specifically, that
Thurlimann fails to indicate that the “active could be given orally on a daily
basis for any reason”; “other ingredients … might affect the behavior of the
fulvestrant”; and “side effects with fulvestrant … is well known” (id.).
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However, when weighed against the preponderance of evidence on this
record, we are not persuaded by Appellants’ unsupported contentions.
As the Opinion explains, “Bland suggests that phytoestrogens and
drugs, such as, tamoxifen ‘have both estrogenic and anti-estrogenic effects’”
and “Thurlimann suggests that a benefit of fulvestrant is that it ‘is
completely free of the partial agonist, estrogen-like activity, associated with
currently available antiestrogens like tamoxifen’” (Opinion 8 (emphasis)).
“Given that Bland suggests that ‘excessive estrogen exposure from both
endogenous and exogenous sources can be a causal factor in the
development of cancer in hormone-dependent tissues, such as, but not
limited to, breast, endometrium, ovary, uterus, and prostate’ …, we find no
error in the Examiner’s conclusion that, at the time the invention was made,
it would have been prima facie obvious to a person of ordinary skill in this
art to substitute the phytoestrogen component of Bland’s composition with
Thurlimann’s fulvestrant to avoid the estrogenic effects of the
phytoestrogen” (id.). Weighing the evidence relied upon by Examiner
against Appellants’ unsupported contentions, we find that the preponderance
of evidence on this record supports Examiner’s conclusion of obviousness.

Issue 2:
As discussed above, Appellants’ claimed invention is not limited to
the treatment of cancer. Accordingly, we are not persuaded by Appellants’
contention that (1) Cummins “does not support the use of vitamin C in the
treatment of cancer”; (2) “[t]here is no evidence that disputes the fact that
the present position of the experts is that antioxidant supplements including
vitamin C should be avoided in the treatment of cancer”; and (3) Freidel’s
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conclusion that “the application of betaine and D-isoascorbic acid as a
cancer treatment is not the answer to the cancer problem” (Req. Reh’g 10-
12; Freidel6 126: 6-7).

Issue 3:
Appellants contend that the Opinion fails to consider the separate
arguments set forth in the “SUMMARY OF CLAIMED SUBECT
MATTER” section of their Brief (Req Rh’g 1-3). Notwithstanding
Appellants failure to follow the requirements of 37 C.F.R. § 41.37 in effect
at the time they filed their Appeal Brief, we will, in this instance, consider
these arguments as reproduced in Appellants’ Request for Rehearing (see
Req. Rh’g 2-3).

Claims 7 and 9:
Appellants’ contend that “there is no suggestion in the art of a need to
disguise the taste of the specific ingredients herein at the levels herein” (Req.
Rh’g. 2). We are not persuaded in view of Examiner’s finding that Bland
suggests disguising the taste of the formulation by the addition of juice (Ans.
6). For the foregoing reasons, we are not persuaded by Appellants’
contention, relating to claim 9, that “there has been no disclosure of a
prophylactic treatment to prevent cancer comprising the specific ingredients
at the specific levels despite the clear need for such a treatment” (Req. Rh’g
3).

6 John Francis Freidel, Dissertation Presented to St. Thomas Institute in
Partial Fulfillment of the Requirements for THE DEGREE OF DOCTOR
OF PHILOSOPHY, Cincinnati, Ohio (1979).
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Claim 8:
Appellants’ claim 8 depends from and further limits claim 6 to the
treatment of breast cancer in humans. Appellants’ contend that claim 8
“requires specific additional treatment for a specific cancer” (Req. Rh’g 2).
We conclude that the Examiner failed to establish an evidentiary basis on
this record to support a conclusion that the combination of Bland, Cummins,
Thurlimann, and Ramaekers suggests the administration of a composition
comprising betaine and vitamin C in an amount of at least about 5 mg per kg
per day of the weight of the human for the treatment of human breast cancer.

Claims 10 and 11:
Claims 10 and 11 depend directly or indirection from and limit claim
6 to, inter alia, the treatment of canines and felines (claim 10) or canines
alone (claim 11). As Appellants point out, while Bland does contemplate
mammals, Bland’s Table 6, from which the specific concentrations of
betaine and vitamin C are derived, relates to a “medical food … nutritional
support of women with symptoms associated with hormone cycles” (Bland
16 ¶ [0171]; Req. Rh’g 5; Cf. Opinion 3-4: FF 10). To the extent that Bland
suggests the administration of this medicinal food to a canine or feline, the
Examiner fails to establish an evidentiary basis on this record to support the
conclusion that Bland suggests that a canine or feline would receive the
same concentration as Bland’s Table 6, which suggests concentration ranges
for betaine and vitamin C for the treatment of humans (see generally Req.
Rh’g 8 (“If one did use … Bland’s composition … the amounts would
necessarily have to be adjusted”)). Therefore, even though Ramaekers
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suggests the administration of a range of vitamin C for the treatment of
feline leukemia and canine malignant tumors that falls within the scope of
Appellants’ claimed invention, Examiner failed to establish, through a
preponderance of evidence on this record that betaine would be administered
to a feline or canine at a concentration required by Appellants’ claimed
invention.
Claims 12-20:
Appellants contend that “[e]ach of [c]laims 12-20 should be
considered separately in view of the basis for rejection in which a previous
disclosure relating to use of vitamin C at normal levels is part of the
rejection” (Req. Rh’g 3).
For the reasons set forth above, we are not persuaded by Appellants’
contentions with regard to claims 12, 14, 16, and 18. In this regard, we note
that claims 14 and 18 are duplicate claims (see Manual of Patent Examining
Practice (MPEP) § 706.03(k)).
The evidence of record supports a similar result for claim 20, wherein
the effective amounts of each of the betaine and vitamin C are at least about
10 mg per kg of the weight of a human. As discussed above, Bland suggests
a composition that comprises 800 mg of betaine. Taken with Cummins’
suggestion of administering 1000 mg of vitamin C the combination suggests
the administration of a combination of betaine and vitamin C at a
concentration of at least about 10 mg per kg of weight of a 130 lb human.
Claims 13, 15, 17, and 19, however, stand on a different footing.
Each of claims 13, 15, 17, and 19 require the administration of at least 1000
mg of betaine per day. Examiner failed to establish an evidentiary basis on
this record to support a conclusion that the combination of Bland, Cummins,
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Thurlimann, and Ramaekers suggests the administration of 1000 mg of
betaine as is required by Appellants’ claims 13, 15, 17, and 19. In this
regard, we note that claims 15 and 19 are duplicate claims (see MPEP
§ 706.03(k)).
SUMMARY
The rejection of claims 6-9 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Bland and Thurlimann is vacated.
The rejection of claims 6, 7, 9, 12, 14, 16, 18, and 20 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Bland, Thurlimann,
Cummins, and Ramaekers is affirmed.
The rejection of claims 8, 10, 11, 13, 15, 17, and 19 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Bland, Thurlimann,
Cummins, and Ramaekers is reversed.

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).

REHEARING GRANTED-IN-PART

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