Valter Longo et al.

Patent Trials and Appeals Board

Feb 12, 2021

2020003172 (P.T.A.B. Feb. 12, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
12/910,508 10/22/2010 Valter D. Longo USC 0108 PUSP 8295
22045 7590 02/12/2021
Brooks Kushman
1000 Town Center
22nd Floor
Southfield, MI 48075
EXAMINER
EBRAHIM, NABILA G
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
02/12/2021 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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docketing@brookskushman.com
kdilucia@brookskushman.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte VALTER D. LONGO and CHANGHAN LEE
________________

Appeal 2020-003172
Application 12/910,508
Technology Center 1600
________________

Before JASON V. MORGAN, DEBORAH KATZ, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

MORGAN, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 27–30, 33, and 35–45. Claims 1–26, 31,
32, and 34 are canceled. Final Act. 2. We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.

1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant
identifies the real party in interest as University of Southern California.
Appeal Br. 2.
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SUMMARY OF THE DISCLOSURE
Appellant’s claimed subject matter relates to “nutritional methods and
formulations that are capable of reducing cancer growth without causing
chronic weight loss in patients, protecting normal cells, tissues and organs
from chemotherapy and/[or] radiation therapy, and sensitizing cancer cells
against low, normal and high-dose chemotherapy.” Abstract.
REPRESENTATIVE CLAIM
(disputed limitations emphasized and bracketing added)
27. A therapeutic meal package for providing meals to a cancer
patient that retards cancer growth and enhances efficacy of
chemotherapy drugs, the therapeutic meal package comprising:
[1] a first meal component portioned into meals, the first meal
component providing the cancer patient 700 to 1200 kcal/day
with at least 50% of the kilocalories derived from fat, the first
meal component providing meals for a first predetermined
period of time from about 1 to 5 days;
[2] a second meal component portioned into meals, the second
meal component providing the cancer patient with at most 500
kcal/day, the second meal component providing meals for a
second predetermined period of time from about 2 to 7 days;
and
[3] a replenishing composition comprising essential amino
acids and other non-essential amino acids, essential fatty acids,
minerals, vitamins and vegetable extracts for a third
predetermined period of time following the second
predetermined period of time.
Appeal Br. (Claims Appendix 1).
REFERENCES
The Examiner relies on the following prior art:
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Name Reference Date
Zemel et al. (“Zemel”) US 2007/0286886 A1 Dec. 13, 2007
David M. Klurfeld et al., Inhibition of chemically induced mammary and
colon tumor promotion by caloric restriction in rats fed increased dietary
fat 47 Cancer Res. 2759–62 (June 1, 1987) (“Klurfeld”)
Tim Byers et al., American Cancer Society guidelines on nutrition and
physical activity for cancer prevention: Reducing the risk of cancer with
healthy food choices and physical activity, 52(2) CA Cancer J. Clin. 92–
119 (Mar.–Apr. 2002) (“Byers”)
Peter Fürst and Peter Stehle, What are the essential elements needed for
the determination of amino acid requirements in humans? Volume 134,
Issue 6 J. Nutrition, pp. 1558S–65S (June 2004) (“Fürst”)
Noboru Mizushima et al., Autophagy fights disease through cellular self-
digestion 451 Nature 1069–75 (Feb. 28, 2008) (“Mizushima”)
Lizzia Raffaghello et al., Starvation-dependent differential stress
resistance protects normal but not cancer cells against high-dose
chemotherapy 105(24) Proc. Nat’l Acad. Sci. USA 8215–20 (June 17,
2008) (“Raffaghello”)
Hisham M Mehanna et al., Refeeding syndrome: what it is, and how to
prevent and treat it 336(7659) BMJ 1495–98 (June 28, 2008)
(“Mehanna”)
REJECTIONS
The Examiner rejects claims 27, 28, 33, and 40–452 under 35 U.S.C.
§ 103(a) as obvious over Klurfeld, Mizushima, Raffaghello, Zemel, and
Mehanna. Final Act. 2–7.

2 The Examiner omits claims 40–45 in the statement of the rejection (Final
Act. 2), but addresses them in the body of the rejection (id. at 4). Thus, this
omission is merely a non-substantive typographical error.
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The Examiner rejects claims 29, 30, and 35–39 under 35 U.S.C.
§ 103(a) as obvious over Klurfeld, Mizushima, Raffaghello, Zemel,
Mehanna3, Byers, and Fürst. Final Act. 7–8.
ANALYSIS
In rejecting claim 27 as obvious, the Examiner cites to Klurfeld’s
teaching regarding use of a high-fat, low-calorie diet in inhibiting chemically
induced mammary and colon tumor promotion, along with Klurfeld’s
suggestion of determining whether caloric restriction is effective at higher
fat levels. Final Act. 3–4 (citing, e.g., Klurfeld 2759, 2761). The Examiner
cites to Mizushima’s teaching regarding the effects of autophagy (i.e., self-
digestion in response to starvation) in suppressing tumors and enhancing
chemotherapy. Id. at 5 (citing Mizushima 1072–73). The Examiner cites to
Raffaghello’s teachings regarding short-term starvation’s effect of protecting
normal cells, but not cancer cells, against high-dose chemotherapy. Id. at 6
(citing Raffaghello 8127). And the Examiner cites to Zemel’s restriction of
caloric intake to 300–1,000 kcals per day, with 500 kcals being preferable,
and to Zemel’s suggestion of the use of such a diet as part of the treatment
for certain cancers. Id. at 6 (citing Zemel ¶¶ 60, 72). The Examiner
concludes that it would have been obvious to an artisan of ordinary skill to
combine these teachings and suggestions together in the manner of recitation
[1], “a first meal component portioned into meals . . . providing the cancer

3 Although these claims depend from independent claim 27, the Examiner
omits Mehanna from the statement of the rejection. Final Act. 7. The
Examiner, however, notes in the body of the rejection that Mehanna and the
other references “are relied on for the reasons set forth” with respect to claim
27. Therefore, this omission is merely a non-substantive clerical error.
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patient 700 to 1200 kcal/day with at least 50% of the kilocalories derived
from fat,” and recitation [2], “a second meal component . . . providing the
cancer patient with at most 500 kcal/day.” Id. at 3–6.
Appellant argues the Examiner erred because “Klurfeld’s restricted
diet includes less than 50 percent calories from fat.” Appeal Br. 5.
Specifically, Appellant argues “the number of calories from fat in . . .
Klurfeld’s restricted diet is only about 34 percent.” Id. at 5–6. In response,
the Examiner cites to extrinsic evidence4 as the basis for finding that because
researchers fed rats 54 percent of their calories in fat to show that fat in rats’
diets did not promote tumors, Klurfeld “tripled the amount of the fat used in
the restricted composition in [Klurfeld] table 1.” Ans. 8. Appellant
challenges the Examiner’s reliance on this extrinsic evidence because “there
is no certainty that this article is referring to the specific scientific paper[,]
Klurfeld[,] relied [on] by the Examiner[].” Reply Br. 3.
We agree with Appellant that Klurfeld does not explicitly teach
tripling the amount of fat used in the restricted composition of Klurfeld table
1. Rather, Klurfeld shows that fat (in the form of corn oil) was more than
tripled in terms of composition from the unrestricted diet (4.0) to the
restricted diet (13.1). Klurfeld Table 1. Nonetheless, the Examiner’s finding
show that Klurfeld suggests the claimed reliance on fat for “at least 50% of
the kilocalories” in the first meal component of recitation [1].
Specifically, the Examiner correctly finds that “Klurfeld teaches that it
is important from a nutritional standpoint to determine if caloric restriction is
effective at even higher fat levels than those used” in Klurfeld. Final Act. 4

4 Jean Carper, The calorie-cancer connection, The Washington Post (Apr.
25, 1989) (cited in Notice of References Cited (Sept. 9, 2016); Ans. 8).
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(citing Klurfeld 2761). We agree with the Examiner that this emphasis on
higher fat levels would have “suggested increasing the fat amount in the
composition.” Ans. 8. Specifically, this teaching in Klurfeld is evidence that
the fat content of a meal composition was recognized as a results-effective
variable. In re Antonie, 559 F.2d 618, 620 (CCPA 1977). Thus, given this
suggestion of increasing the fat amount, determining the efficacy of the
claimed reliance on fat for at least 50% of the kilocalories of a meal
component would have involved routine experimentation, not invention. In
re Aller, 220 F.2d 454, 458 (CCPA 1955). Therefore, we agree with the
Examiner that Klurfled suggests the fat composition of the first meal
component of recitation [1].
Appellant also argues the Examiner erred by failing “to provide any
reason or benefit for combining the high-fat diet of Klurfeld with the low-
calorie diet of Mizushima, Raf[f]aghello, and Zemel” Appeal Br. 4. But as
the Examiner’s findings show, “Klurfeld teaches inhibiting cancers by
caloric restriction in rats fed increased dietary fat.” Final Act. 3 (emphasis
added). The Examiner concludes, however,
that a person having ordinary skill in the art would have been
motivated to synergize the effect of caloric-restriction and high
fat diet taught by Klurfeld by adding an extra period of
starvation as disclosed by Mizushima to the therapeutic
regimen for treating cancer since both Klurfeld and the
combination of Mizushima, Raf[f]aghello and Zemel are
directed [sic] to autophagy are all in the same field of treating
cancers. It would be within the purview of an artisan using
routine experimentation to adjust the two periods of treatment
accordingly to ensure a safe efficient therapy for the patients. It
would have also been obvious to a person having ordinary skill
in the art to follow the amount of calories taught by Zemel in
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starving a patient to induce the apoptosis taught by Mizushima
in the low caloric meals instructed by Klurfeld.
Ans. 5–6. Appellant does not rebut the Examiner’s basis for concluding that
it would have been obvious to combine the teachings and suggestions of
Klurfeld, Mizushima, Raffaghello, and Zemel in the manner of recitations
[1] and [2].
In rejecting claim 27 as obvious, the Examiner relies on Mehanna
treatment of for patients at risk of Refeeding syndrome with vitamins and
minerals to suggest recitation [3], “a replenishing composition comprising
essential amino acids and other non-essential amino acids, essential fatty
acids, minerals, vitamins and vegetable extracts.” Final Act. 6–7 (citing
Mehanna 1495). Appellant contends the Examiner erred because “the
refeeding protocol of Mehanna does not involve the replenishing
component” of recitation [3]. Appeal Br. 6. Appellant argues the Examiner
“convolutes components that may be present in refeeding with the elements
of the claimed replenishing composition.” Id. at 7 (emphasis added); Reply
Br. 3–4.
Appellant’s arguments are not persuasive because, as the Examiner
correctly finds, it would have been obvious to an artisan of ordinary skill to
have the subcomponents of a refeeding or replenishing component contain
subcomponents “that are convenient to the body as well-known in the art
and even well known to the public, such as protein, carbohydrates, fats,
fibers, vitamins and minerals.” Ans. 10. Appellant contends recitation [3]
“calls for a particular combination” of subcomponents. Reply Br. 4. But we
are unable to discern anything in the combination of subcomponents of
recitation [3] that would have been non-obvious to an artisan of ordinary
skill following the management guidelines detailed in Mehanna as to the
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types of nutrients to provide after a period of starvation, particularly given
the widespread public availability of knowledge such as the use of vegetable
components to provide nutrients. See Mehanna 1495; Ans. 9–11. Therefore,
we agree with the Examiner that Mehanna suggests the replenishing
component of recitation [3].
For these reasons, we sustain the Examiner’s obviousness rejection
under 35 U.S.C. § 103(a) of claim 27, and the Examiner’s obviousness
rejections under 35 U.S.C. § 103(a) of claims 28, 33, and 35–45, which
Appellant does not argue separately. Appeal Br. 7; Reply Br. 4.
CONCLUSION
Claims
Rejected 35 U.S.C. § Referencess Affirmed Reversed
27, 28, 33,
40–45
103(a) Klurfeld,
Mizushima,
Raffaghello,
Zemel, Mehanna
27, 28,
33, 40–45

29, 30, 35–39 103(a) Klurfeld,
Mizushima,
Raffaghello,
Zemel, Mehanna,
Byers, Fürst
29, 30,
35–39

Overall
Outcome
27–30,
33, 35–45

TIME PERIOD FOR RESPONSE
No time period for taking subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
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AFFIRMED