ACTIGENOMICS SA

Patent Trials and Appeals Board

Jun 28, 2021

2020004702 (P.T.A.B. Jun. 28, 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.
14/785,548 10/19/2015 Marie Françoise BOURGEOIS 15430-000037-US-NP 5028
28997 7590 06/28/2021
Harness Dickey (St. Louis)
7700 Bonhomme, Suite 400
St. Louis, MO 63105
EXAMINER
WESTERBERG, NISSA M
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
06/28/2021 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):
bkamer@hdp.com
stldocket@hdp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARIE FRANCOISE BOURGEOIS, DANIEL CEFAÏ,
WALTER WAHLI, MIREILLE PRINCE-DAVID, and
LISINE TUYISENGE1
Appeal 2020-004702
Application 14/785,548
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
composition for immunity regulation, which have been rejected as patent
ineligible, obvious, and unpatentable on the ground of non-statutory double
patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 Appellant identifies the real party in interest as Actigenomics S.A. Appeal
Br. 1. We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42.
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STATEMENT OF THE CASE
Claims 1, 3, and 5–8 are on appeal. Claim 1, reproduced below, is
illustrative:
1. A composition for immunity regulation and/or stimulation,
per 100g or 100ml, comprising the combination of:
• 10µg to 1000µg of magnesium,
• 10µg to 1000µg of metals selected from zinc and iron
• 7µg to 700µg of at least one plant oil selected from Ribes
nigrum Oleum Acini (blackcurrant seed oil) and Elaeis
guineensis Oleum (palm oil),
• 6µg to 600µg of at least two plant extracts selected
from Thymus vulgaris (thyme), Cicer arietinum (chickpea),
and Ervum lens (lentil),
• 6µg to 600µg of at least one alga chosen among Fucus
vesiculosus (Fucus), Undaria pinnatifida (Wakame),
Palmaria palmata (Dulse), and Porphyra umbilicalis (Nori),
• 7µg to 700µg of at least one mushroom chosen
among Lentinula edodes (Shiitake) and Grifola
frondosa (Maitake),
• 8µg to 800µg of at least one vitamin chosen among
vitamins A, B1, B2, B5, B6, B9, C, E, and PP(B3);
and a pharmaceutically and/or nutritionally acceptable
excipient wherein said composition is a food preparation, a
dietary supplement, a nutraceutical, or a beverage.
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The claims stand rejected as follows:
Claims 1, 3, and 5–8 under 35 U.S.C. § 101 as being directed to a
product of nature without significantly more (Ans. 3);
Claims 1, 3, 5, 6, and 8 under 35 U.S.C. § 103 as obvious in view of
Caenazzo2 and Ebel3 (Ans. 4);
Claim 7 under 35 U.S.C. § 103 as obvious in view of Caenazzo, Ebel,
and Bisen4 (Ans. 7);
Claims 1, 3, 5, 6, and 8 under 35 U.S.C. § 103 as obvious in view of
Wahli5, Deans6, Xu7, and Barre8 (Ans. 8);
Claim 7 under 35 U.S.C. § 103 as obvious in view of Wahli, Deans,
Xu, Barre, and Bisen (Ans. 11);
Claims 1, 3, 5, 6, and 8 for obviousness-type double patenting based
on claims 1–16 of U.S. Patent No. 8,361,517 in view of Deans, Xu, and
Barre (Ans. 12);

2 US 2004/0146545 A1, published July 29, 2004.
3 US 2009/0196921 A1, published Aug. 6, 2009.
4 Lentinus edodes: A Macrofungus with Pharmacological Activities, 17 Curr.
Med. Chem. 2419–2430 (2010).
5 US 2012/0034201 A1, published Feb. 9, 2012.
6 Natural Antioxidants from Thymus Vulgaris (Thyme) Volatile Oil: The
Beneficial Effects upon Mammalian Lipid Metabolism, 332 Acta. Hort. 177–
182 (1993).
7 Comparative Studies on the Antioxidant Activities of Nine Common Food
Legumes Against Copper-induced Human Low-Density Lipoprotein
Oxidation In Vitro, 72 J. Food Sci. S522–S527 (2007).
8 Potential of Evening Primrose, Borage, Black Currant, and Fungal Oils in
Human Health, 45 Ann. Nutr. Metab. 47–57 (2001).

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Claims 1, 3, and 5–8 for obviousness-type double patenting based on
claims 1–16 of U.S. Patent No. 8,361,517 in view of Deans, Xu, Barre, and
Bisen (Ans. 14);
Claims 1, 3,9 5, 6, and 8 for obviousness-type double patenting based
on claims 1–13 of U.S. Patent No. 8,518,459 in view of Deans, Xu, and
Barre (Ans. 14); and
Claims 1, 3,10 5, 6, and 8 for obviousness-type double patenting based
on claims 1–13 of U.S. Patent No. 8,518,459 in view of Deans, Xu, Barre,
and Bisen (Ans. 16).
OPINION
35 U.S.C. § 101
Claims 1, 3, and 5–8 stand rejected as being directed to a product of
nature without significantly more. The Examiner finds that the claims recite
a composition composed of naturally occurring substances and do not include
additional elements that are sufficient to amount to significantly more than
the judicial exception because the composition does not have markedly
different characteristics than the individual components. Ans. 3–4.
Appellant asserts that the claim requires a combination of at least
seven ingredients and this combination has no natural counterpart, even
though the individual components may be naturally occurring (Appeal Br.

9 The Examiner refers to claim 2 but claim 2 has been canceled. We
therefore understand the reference to claim 2 to be a typographical error and,
consistent with the rejections under 35 U.S.C. § 103, we understand claim 3
to be intended.
10 Again, the Examiner refers to claim 2 but claim 2 has been canceled. We
understand the rejection to apply to claim 3 instead.
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6), and that administration of an embodiment of the claimed composition
increases CD4+ T cell counts in immunodeficient patients and prevents loss
of CD4+ T cells in AIDS patients. Id. at 6–7.
We agree with Appellant that the claimed combination of
ingredients—including ingredients derived from at least three different
plants, an alga, and a mushroom—would not have occurred in nature and the
effect on immune deficient patients shows that the claimed composition
provides significantly more than any of its individual components.
The Supreme Court has explained that it has found a patent claim to
be more than a product of nature when it was “‘not to a hitherto unknown
natural phenomenon, but to a nonnaturally occurring manufacture or
composition of matter—a product of human ingenuity . . .’” that was “new
‘with markedly different characteristics from any found in nature.’”
Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576,
590–91 (2013) (quoting Diamond v. Chakrabarty, 447 U.S. 303, 309–10
(1980)).
Appellant argues that it has shown that administration of an
embodiment of the claimed composition increases CD4+ T cell counts in
immunodeficient patients and prevents a loss of such cells in AIDS patients.
Appeal Br. 7. Appellant asserts that there is no evidence of record
suggesting that any of the components of the composition of claim 1 has
such an effect. Id. Appellant contends that, although the Examiner has
provided two references to suggest that at least some of the individual
components stimulate an immune response or enhance immune function,
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neither of these references describes an effect on CD4+ T cells in immune
deficient patients or AIDS patients. Id. at 7–8.
The Examiner responds that the art of record establishes that natural
components of the composition have an effect on the immune system,
although the alteration in the levels of CD4+ T cells is not clearly specified,
and Appellant has not provided evidence that the composition is markedly
different from the natural components. Ans. 18–19. However, “the
examiner bears the initial burden, on review of the prior art or on any other
ground, of presenting a prima facie case of unpatentability.” In re Oetiker,
977 F.2d 1443, 1445 (Fed. Cir. 1992). Here, because the Examiner has not
shown that the individual components of the claimed composition have the
same effect on CD4+ T cell levels observed in immune compromised
patients that is described in the Specification, we conclude that Appellant
has the stronger argument.
We agree that the effects on CD4+ T cells that were documented for
the instantly claimed composition when administered to immune deficient
patients (see Spec. 35–37) amount to “significantly more” than any effects
documented for the individual natural components in the current record. We
reverse the rejection under 35 U.S.C. § 101.
35 U.S.C. § 103 – Caenazzo and Ebel
Claims 1, 3, 5, 6, and 8 stand rejected as being obvious in view of
Caenazzo and Ebel. The Examiner finds that Caenazzo teaches a
composition that differs from the instantly claimed composition only by
lacking maitake or shiitake mushrooms. Ans. 4–5 (citing Example 1 of
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Caenazzo). The Examiner finds that Caenazzo suggests the range of 0.001-
1,000 µg/100 mL for each active substance. Id. at 4.
The Examiner finds that Ebel teaches compositions that enhance the
immune response of a mammal and specifically suggests including shiitake
mushrooms or Grifola frondosa (i.e., maitake) mushrooms in these
compositions. Ans. 5. The Examiner finds that Ebel teaches that “[t]he
amount of the compositions may be dependent on factors such as the health
status of the mammal, age, gender, or other like factors of ordinary
consideration.” Id. (citing Ebel ¶ 225).
The Examiner concludes that it would have been obvious to combine
Ebel’s mushroom extract with Caenazzo’s composition because both are
taught to enhance immune response, and it is obvious to combine two
compositions, each of which is taught by the prior art to be useful for the
same purpose, in order to arrive at a third composition to be used for the
very same purpose. Ans. 6 (citing In re Kerkhoven, 626 F.2d 846, 850
(CCPA 1980) and MPEP 2144.06). The Examiner finds that the amount of
each ingredient would have been adjusted in order to achieve the desired
results based on the total amount of the composition to be administered in a
single dose and the desired administration schedule. Id. 6–7.
We agree with the Examiner. Caenazzo’s Example 1 reads as follows:
Immunity Function
Quantities: active substances dosed at 4 10-8 g
Trace elements: magnesium, iron, zinc
Plants: thymus vulgaris (thyme)
Essential dietary factors: cicer arietinum (split peas), ervum
lens (lentils), ribes nigrum oleum acini (blackcurrant sedd [sic]
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oil), elasis guinensis (palm oil), fucus vesiculosis, undaria
pinatifida, palmaria palmata
Vitamins: A, B1, B2, B5, B6, B9, C, E, F, PP
Form of the product: capsules
Caenazzo ¶¶ 70–75.
Appellant interprets Caenazzo’s “4 10-8 g” to mean 4 x 10-8 g, or
0.04 µg. Appeal Br. 11. The Examiner does not dispute this interpretation.
Appellant argues that this amount is at least 150-fold lower than the lowest
amount of the corresponding component recited in claim 1. Id. We disagree
with Appellant’s conclusion, because the amounts in claim 1 are amounts
per 100 mL or 100 g, whereas Caenazzo’s Example 1 is a quantity to be
included in “capsules,” which would reasonably be expected to be orders of
magnitude smaller than 100 mL or 100 g. In addition, as the Examiner has
pointed out (Ans. 20), Caenazzo suggests using active agents in a
concentration of 10-2–10-9 g per liter, and is not limited to the concentration
recited in Example 1.
Ebel discloses compositions comprising “fungal-derived components
that are known to have beneficial effects with respect to enhancing immune
response to respiratory conditions.” Ebel ¶ 131. Ebel states that a
“particularly useful fungal-derived component can comprise an extract of
edible mushroom,” and lists twenty-two mushroom species as “[u]seful
mushrooms.” Ebel ¶ 132. This list includes both Lentinus edodes (shiitake)
and Grifola frondosa (maitake). Id. Ebel goes on to specify that Lentinus
edodes is particularly useful. Id. Thus, Ebel suggests that shiitake
mushroom is “particularly useful” in its formulations for enhancing immune
response. We find this would have provided sufficient motivation for one of
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ordinary skill in the art to include shiitake mushroom extract in a
composition intended to stimulate or regulate an immune response.
We agree with the Examiner that the composition of claim 1 would
have been obvious to a person of ordinary skill in the art based on Caenazzo
and Ebel. To arrive at the composition of claim 1, the artisan would only be
required to add shiitake or maitake mushrooms, as suggested by Ebel, to the
composition of Caenazzo’s Example 1; and adjust the concentrations of the
components.
[W]here there is a range disclosed in the prior art, and the
claimed invention falls within that range, there is a presumption
of obviousness. But the presumption will be rebutted if it can be
shown: (1) That the prior art taught away from the claimed
invention, In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir. 1997);
or (2) that there are new and unexpected results relative to the
prior art, In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990).
Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed.
Cir. 2004).
In claim 1, the recited ranges for most of the ingredients fall
completely within the ranges taught by Caenazzo (10-9 to 10-2 g per liter;
Caenazzo ¶ 27). In addition, Appellant has not pointed to any teaching away
in the prior art, and has not demonstrated new and unexpected results
relative to the prior art.
With regard to the mushroom component, Ebel teaches that the daily
dosage can range from 0.01 mg to 50 g, and states that the specific
therapeutic amount will vary based on the condition treated, the dosage form
and regimen, and characteristics of the subject. Ebel ¶¶ 30, 136. Ebel thus
identifies the therapeutic amount as a result-effective variable. “[D]iscovery
of an optimum value of a result effective variable in a known process is
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ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276
(CCPA 1980). See also In re Aller, 220 F.2d 454, 456 (CCPA 1955)
(“[W]here the 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.”).
Appellant argues that the combination of Caenazzo and Ebel fails to
disclose a shiitake or maitake mushroom and fails to disclose the claimed
amounts of the components of claim 1. Appeal Br. 11.
With regard to the shiitake or maitake mushroom, this assertion is
factually incorrect because Ebel expressly suggests both Shiitake and
Maitake mushrooms (Ebel ¶¶ 131, 132). With regard to the amounts of the
ingredients contained in the claimed composition, the Examiner persuasively
argues that adjusting the amounts would have been a routine matter based on
factors such as the health, overall condition, age and weight of the subject,
and the desired administration schedule. Ans. 6–7. The Examiner’s
reasoning is supported by Ebel. See Ebel ¶¶ 30, 225.
Appellant argues that Ebel reports immune response enhancing
formulations, which may, but do not necessarily, include a “fungal-derived
component” selected from among yeast, mold, and twenty-two types of
mushrooms. Appeal Br. 12. We are not persuaded, because, as discussed
above, Ebel specified that shiitake mushrooms are particularly useful for
enhancing an immune response (Ebel ¶¶ 131, 132, 136).
Appellant argues that only two of the seventeen examples taught by
Ebel contain mushroom; specifically, 15 mg shiitake extract, which is more
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than twenty-one times the maximum mushroom amount recited in claim 1.
Id.
However, Ebel’s disclosure is not limited to its working examples,
and the Examiner persuasively argues that the amount of each ingredient in
Ebel’s composition would be adjusted to account for the dosing schedule
and for the subject to which the composition will be administered.
Furthermore, Ebel suggests that a superfine particle extract of shiitake
mushroom can be present in its composition in an amount that provides from
about 0.01 mg to about 50 g per day. See Ebel ¶ 136. Therefore, Ebel
suggests quantities other than the 15 mg reduced to practice in its working
examples.
Appellant argues that, according to the rejection,
to arrive at the composition of claim 1 the ordinary artisan
would: select Example 1 of Caenazzo; increase the amount of
each component by at least 150-fold; determine, without
guidance that “immunity function” is an enhanced immunity
function; identify the Ebel compositions that also enhance
immunity function; identify specifically shiitake mushroom
extract as a component that enhances immunity function;
reduce the amount of shiitake mushroom extract from 15 mg to
at most 700 µg (a greater than 21-fold reduction); and include it
in Example 1. This is all done in the absence of any indication
in the art that such a procedure can and should occur.
Appeal Br. 12.
With regard to increasing the amount of each component by at least
150-fold, this is a misunderstanding on the part of Appellant of what was
taught in Caenazzo, as discussed above. The amount in Example 1 of
Caenazzo was a dose delivered in a capsule, not a concentration, and a 150-
fold increase is not required to arrive at the concentrations recited in claim 1.
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With regard to determining that “immunity function” is an enhanced
immunity function, there is no mention in Caenazzo of immune suppression,
and in our view, one of ordinary skill in the art would reasonably interpret
“immunity function” as being intended to support the body’s natural process.
See, e.g., Caenazzo ¶ 39 (“re-establishment of all types of physiological
functions”). Therefore, a skilled artisan would reasonably interpret
“immunity function” to mean enhanced immunity.
With regard to Ebel, it clearly points to shiitake and maitake
mushrooms acting to enhance immunity (see ¶¶ 130–131); therefore, it
would have been obvious for one of ordinary skill in the art to include
shiitake or maitake mushrooms in a composition intended to enhance
immunity.
With regard to the quantity of shiitake or maitake mushroom, the
Examiner points out that prior art is relevant for all that it teaches and the
cited references provide guidance as to the disclosed compositions and
suitable amounts for the various ingredients, in addition to the exemplary
formulations. Ans. 20. We agree with the Examiner that the concentration
of shiitake or maitake mushroom that is recited in claim 1 would have been
obvious based on Ebel’s daily dosage range and its suggestion to determine
the amount based on the health status, age, gender, or “other like factors of
ordinary consideration” (Ebel ¶ 225).
With regard to there being no indication in the art that such a
procedure can and should occur, the Examiner reasons that it is prima facie
obvious to combine two compositions each of which is taught by the prior
art to be useful for the same purpose. Ans. 6. This is a combination of
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known elements with predictable results. See KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 416 (2007) (“The combination of familiar elements according
to known methods is likely to be obvious when it does no more than yield
predictable results.”).
Appellant argues that Ebel teaches that its composition, as a whole,
may enhance immune function in a respiratory condition, but there is no
evidence that shiitake mushroom extract, by itself, has the same effect.
Appeal Br. 12. This is not persuasive, however, because Ebel specifically
states that “the compositions of [its] invention can also comprise fungal-
derived components that are known to have beneficial effects with respect to
enhancing immune response to respiratory conditions. . . . Non-limiting
examples of such fungal-derived components include: Maitake and Shiitake
mushrooms.” Ebel ¶ 131 (emphasis added). Thus, Ebel teaches that
Maitake and Shiitake mushrooms are known to have beneficial effects with
respect to enhancing immune response.
Appellant argues that the Examiner’s position that the term
“comprising” in claim 1 allows unrecited components to be included is not
relevant because the Examiner has argued for the addition of shiitake or
maitake mushrooms only. Appeal Br. 13. Appellant asserts that if one
incorporated the entire composition taught by Ebel, there is no way to
reconcile the differences in amounts because Caenazzo teaches dramatically
lower amounts and Ebel teaches significantly higher amounts. Appeal Br.
13. This is not persuasive, because Ebel provides motivation to add only its
mushroom extract to the composition of Caenazzo in order to enhance
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immune response. Appellant’s argument with regard to the amounts taught
or suggested by the prior art have been addressed above.
We find that the Examiner has set forth a valid prima facie case of
obviousness and the Appellant has not provided evidence of secondary
considerations; therefore, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103 based on Caenazzo and Ebel. Claims 3, 5, 6, and 8 fall with claim 1.
37 C.F.R. § 41.37(c)(1)(iv).
Claim 7
Claim 7 stands rejected as being obvious in view of Caenazzo, Ebel,
and Bisen. Appellant relies on the same arguments as presented for claim 1.
Appeal Br. 10. Therefore, we affirm the rejection of claim 7 for the reasons
set forth above for claims 1, 3, 5, 6, and 8.
35 U.S.C. § 103 – Wahli, Deans, Xu, and Barre
Claims 1, 3, 5, 6, and 8 stand rejected as obvious in view of Wahli,
Deans, Xu, and Barre. The Examiner finds that Wahli teaches a
nutraceutical and/or food composition for regulating, among other things,
lipid metabolism in humans; the composition can comprise, per 100 g/100
mL, the combination of:
7 µg to 700 µg of at least two plant oils selected from rapeseed
oil, olive oil, grape seed oil, and evening primrose oil;
10 µg to 1000 µg of positively charged minerals chosen among
sodium, magnesium, and calcium;
10 µg to 1000 µg of metals chosen between zinc and iron;
7 µg to 700 µg of yeast or yeast extracts enriched with
selenium;
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7 µg to 700 µg of mushrooms or Shiitake mushroom extracts
(mycelium);
6 µg to 600 µg of at least two plant extracts from plants chosen
among samphire, garlic, and grapevine;
8 µg to 800 µg of at least one vitamin chosen among vitamins
A, B1, B9, C, E, F, and PP;
7 µg to 700 µg of animal oil and Copra oil (Cocos nucifera);
6 µg to 600 µg of at least one alga chosen among Palmaria
palmate (Dulse), Chondrus crispus (Carrageen), and Fucus
vesiculosus (Bladder wrack);
in combination with one or more phytosterols, stanols, or
mixtures thereof;
as well as a pharmaceutical acceptable excipient.
Ans. 8–9.
The Examiner finds that the only components required by instant
claim 1 that are not present in Wahli’s composition are blackcurrant seed oil
or palm oil and at least two plant extracts selected from thyme, chickpea,
and lentil extracts. Id. at 9. The Examiner finds that these missing
components are taught in the prior art:
• Deans teaches that thyme oil, an extract from Thymus vulgaris,
contains compounds with strong antioxidant activity, and thyme oil
confers higher levels of polyunsaturated fatty acids (PUFAs) and
elevated levels of glutathione peroxidase (a key enzyme in lipid
metabolism) when administered to mice. Id.

• Xu teaches extracts from various legumes, including lentils, and
shows that lentils conferred longer low-density lipoprotein (LDL)
oxidation lag times, and had powerful antioxidant activities against
LDL oxidation and free radicals. Xu also teaches that lentils seem to
be the best among all tested food legumes for a dietary supplement to
promote heart health and prevent cancers. Id.

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• Barre discusses the effects of black currant and evening primrose oil
on human health. Black currant oil (BCO) lowered plasma
triglyceride levels in hemodialysis patients, and also showed a
significant drop in total cholesterol in patients with hyperlipidemia.

Ans. 9–10.
The Examiner concludes that it would have been obvious to add thyme
and lentil extracts, and black currant seed oil, to Wahli’s composition,
reasoning that it is prima facie combine two compositions, each of which is
taught by the prior art to be useful for the same purpose (improving lipid
metabolism), in order to arrive at a third composition to be used for the same
purpose. Id. at 10 (citing In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980)).
We agree with the Examiner that the composition of claim 1 would
have been obvious to a person of ordinary skill in the art based on the cited
references. Wahli discloses a composition for regulation of lipid metabolism
that can include the magnesium, zinc or iron, Shiitake mushroom, vitamins,
and alga ingredients, in the same amounts as recited in claim 1. Wahli
¶¶ 64–74.
While Wahli does not teach that its composition includes black
currant seed oil or palm oil, Barre teaches that black currant oil (BCO),
“derived from the seed of Ribes nigrum” (Barre 48, left col.), has been found
to “result[] in lower plasma triglyceride levels in hemodialysis patients” (id.
at 51, right col.), as well as “a significant drop in total cholesterol” in
patients with hyperlipidemia (id. at 52, left col.).
Wahli also does not teach that its composition includes at least two
plant extracts selected from thyme, chickpea, and lentil extract. However,
Deans teaches that “volatile oil of thyme obtained by steam distillation”
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(Deans 178) was fed to mice (id. at 179). Deans reports that “[a]nimals fed
the diet supplemented with thyme oil showed significantly higher levels of
PUFAs [polyunsaturated fatty acids].” Id. at 177, abstract. Deans also
reports that “levels of the enzyme glutathione peroxidase, a key enzyme in
lipid metabolism, were elevated in animals fed thyme oil.” Id.
In addition, Xu teaches that “the consumption of dietary antioxidant
was associated with the prevention of atherosclerosis”; that lentil extract
resulted in a significantly “longer LDL oxidation lag time[]” than the
control; and that lentils “exhibited higher antioxidant capacities” than
several other legumes. Xu S522, abstract. Xu concludes that “[w]ith
powerful antioxidant activities against LDL oxidation and free radicals,
lentils seem to be the best among all tested food legumes for the
development of a dietary supplement for promoting heart health.” Id. at
S526, right col.
We agree that it would have been obvious to a person of ordinary skill
in the art to incorporate the black currant seed oil, thyme oil (extracted by
steam distillation), and lentil extract disclosed by Barre, Deans, and Xu into
Wahli’s composition. Wahli provides a reason to include the additional
ingredients, because it states that its composition can be used for “the
treatment and/or prevention of . . . cardiovascular diseases, dyslipidemia, . . .
[and] progression of atherosclerosis.” Wahli ¶ 40. Thus a skilled artisan
would have expected the ingredients disclosed by Barre, Deans, and Xu to
be useful in Wahli’s composition.
Appellant argues that Wahli reports their composition possesses
synergistic effects and unexpected benefits, and therefore one cannot
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reasonably conclude that adding ingredients to its composition would have
been obvious, because the effect of modifying the ingredients would have
been unpredictable. Appeal Br. 14.
First, we note that the Examiner’s rejection is based on adding the
ingredients disclosed by Barre, Deans, and Xu to Wahli’s composition,11 so
all of Wahli’s ingredients would still be present in the resulting composition.
In addition, the Examiner points to the beneficial effects on lipid profiles and
lipid metabolism of thyme and lentil extracts taught by Deans and Xu. Ans.
23. We find this is sufficient rationale for combining with a reasonable
expectation, albeit not a guarantee, of a beneficial effect on lipid profile and
metabolism from the combination. See In re O’Farrell, 853 F.2d 894, 903–
904 (Fed. Cir. 1988) ( “Obviousness does not require absolute predictability
of success. . . . For obviousness under § 103, all that is required is a
reasonable expectation of success.”).
Appellant argues that “none of the parameters measured in Wahli are
encompassed by the experiments in any of Barre, Xu, or Deans,” and without
knowing the mechanism of how the lipid metabolism is affected it would not
have been obvious to combine components because it would have been
unknown if such components would complement or if they would work in a
contradictory manner. Appeal Br. 14–15. Appellant also argues that there is
no indication that the prior art would lead the ordinary artisan to a
composition that retains the unexpected properties of Wahli. Id. at 15.

11 “It would have been obvious . . . to incorporate plant extracts such as
those from thyme, and lentils and black currant oil into the composition of
Wahli.” Ans. 10 (emphasis added).
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Appellant argues that the Examiner’s position that there is no evidence that
the desired outcomes of the applied prior art are not complementary to one
another is an improper shifting of the burden and that the Examiner must
show that the cited art can be combined in the manner suggested.12 Reply Br.
4.
These arguments are not persuasive because the prior art need not
provide a guarantee of success to support a prima facie case of obviousness;
rather, it is only required to provide a reasonable expectation of success.
Here, the prior art references are all directed to improving lipid profiles and
metabolism, in different ways, by administering their respective
components: Barre teaches that black currant seed oil lowers plasma
triglyceride and cholesterol levels; Deans teaches that thyme volatile oil
increases levels of polyunsaturated fatty acids and glutathione peroxidase;
and Xu teaches that lentil extract has high antioxidant activity, which is
associated with preventing atherosclerosis. In view of these different
effects, one of ordinary skill would have expected these components to
improve Wahli’s composition when included together, rather than interfering
with one another.
Appellant argues that, “to the extent that Deans, Xu, and Barre report
amounts of a given component, such amounts are different from those
recited in Claim 1.” Appeal Br. 15.

12 “As a practical matter, the Patent Office is not equipped to manufacture
products by the myriad of processes put before it and then obtain prior art
products and make physical comparisons therewith.” In re Brown, 459 F.2d
531, 535 (CCPA 1972).
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The Examiner acknowledges that Deans teaches 720 µg of thyme oil,
which is higher than the 6–600 µg recited in claim 1; however, the Examiner
points out that the claimed ranges are concentrations in µg per 100 g or 100
mL. Ans. 24. Deans teaches only that 720 µg of thyme oil was orally
administered every second day (Deans 177, abstract), and therefore, does not
disclose the concentration of thyme oil.
The Examiner argues that the amounts of each ingredient would be
optimized and can be altered by the presence or absence of additional
ingredients. Ans. 24. Xu supports this by teaching that legume extracts
(including lentil extract) were diluted 1:5, 1:10, and 1:50 as test samples (Xu
S524, right col.). With regard to optimization, we agree with the Examiner
that it would have been obvious to use “the disclosures of the amounts in the
prior art . . . as guidance for the optimization process.” Ans. 24.
Specifically, Wahli discloses that its composition contains 7–700 μg of
certain plant oils, and 6–600 μg of certain plant extracts, each per 100 g or
100 ml. Wahli ¶¶ 66, 71. Thus, these concentrations would have been
obvious guidelines for the skilled artisan when adding the components
suggested by Barre, Deans, and Xu.
The Examiner’s rejection is supported by a preponderance of the
evidence of record. We affirm the rejection of claim 1 under 35 U.S.C.
§ 103 based on Wahli, Barre, Deans, and Xu. Claims 3, 5, 6, and 8 fall with
claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
Claim 7
Claims 7 stands rejected as being obvious in view of Wahli, Deans,
Xu, Barre, and Bisen. Appellant relies on the same arguments as presented
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for claim 1. Appeal Br. 13. Therefore, we affirm the rejection of claim 7 for
the reasons set forth above for claims 1, 3, 5, 6, and 8.

Non-Statutory Double Patenting
Claims 1, 3, 5, 6, and 8 stand rejected for obviousness-type double
patenting based on claims 1–16 of U.S. Patent No. 8,361,517 in view of
Deans, Xu, and Barre (Ans. 12); and claims 1, 3, and 5–8 stand rejected on
the same basis, further in view of Bisen (Ans. 14).
Claims 1, 3, 5, 6, and 8 also stand rejected for obviousness-type
double patenting based on claims 1–13 of U.S. Patent No. 8,518,459 in view
of Deans, Xu, and Barre (Ans. 14); and in view of the same references,
further in view of Bisen (Ans. 16).
Appellant argues that all of these rejections are similar in nature to the
obviousness rejection over Wahli in view of Deans, Xu, Barre, and Bisen;
and argues that “[b]oth patents lack the plant oils or at least two plant
extracts as required in pending [c]laim 1,” and, therefore, have the same
deficiencies and short-comings as the obviousness rejection. Appeal Br. 16;
Reply Br. 4. For the reasons set forth in the decision for the obviousness
rejections over Wahli, Deans, Xu, and Barre, or Wahli, Deans, Xu, Barre,
and Bisen, the double patenting rejections are also affirmed.
CONCLUSION
The Examiner’s rejections based on 35 U.S.C. § 103 and non-
statutory double patenting are affirmed, and the Examiner’s rejection under
35 U.S.C. § 101 is reversed.
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DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 5–8 101 Eligibility 1, 3, 5–8
1, 3, 5, 6, 8 103 Caenazzo, Ebel 1, 3, 5, 6, 8
7 103 Caenazzo, Ebel,
Bisen
7
1, 3, 5, 6, 8 103 Wahli, Deans, Xu,
Barre
1, 3, 5, 6, 8
7 103 Wahli, Deans, Xu,
Barre, Bisen
7
1, 3, 5, 6, 8 Nonstatutory
Double Patenting
8,361,517, Deans,
Xu, Barre
1, 3, 5, 6, 8
1, 3, 5–8 Nonstatutory
Double Patenting
8,361,517, Deans,
Xu, Barre, Bisen
1, 3, 5–8
1, 3, 5, 6, 8 Nonstatutory
Double Patenting
8,518,459, Deans,
Xu, Barre
1, 3, 5, 6, 8
1, 3, 5, 6, 8 Nonstatutory
Double Patenting
8,518,459, Deans,
Xu, Barre, Bisen
1, 3, 5, 6, 8
Overall
Outcome
1, 3, 5–8
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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
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AFFIRMED