Mohamed Nabil. Bosco et al.

Patent Trials and Appeals Board

Aug 18, 2020

14127606 - (D) (P.T.A.B. Aug. 18, 2020)

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.
14/127,606 12/19/2013 Mohamed Nabil Bosco 3712036-02063 1907
29157 7590 08/18/2020
K&L Gates LLP-Nestec S.A.
P.O. Box 1135
Chicago, IL 60690
EXAMINER
MELLER, MICHAEL V
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
08/18/2020 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):
USpatentmail@klgates.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
_________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_________________

Ex parte MOHAMED NABIL BOSCO, MANUEL OLIVEIRA,
FREDERIC DESTAILLATS, VIRAL BRAHMBHATT,
and JALIL BENYACOUB

_________________

Appeal 2019-000716
Application 14/127,606
Technology Center 1600
_________________

Before RAE LYNN P. GUEST, DEBORAH KATZ, and TAWEN CHANG,
Administrative Patent Judges.

KATZ, Administrative Patent Judge.

DECISION ON APPEAL

Appellant1 seeks our review2, under 35 U.S.C. § 134(a), of the
Examiner’s decision to reject claims 1, 4–6, 8, 9, 12, and 14–20. We have
jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Nestec S.A. (Appeal
Br. 2.)
2 We consider the Final Office Action issued March 26, 2018 (“Final Act.”),
the Appeal Brief filed July 5, 2018 (“Appeal Br.”), the Examiner’s Answer
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The Examiner rejects claims 1, 4–6, 8, 9, 12, and 14–20 under 35
U.S.C. § 103(a) as being unpatentable over Berge,3 Chen,4 Web MD,5
Grootjans.6 (Final Act. 4–9.)
Appellant’s claim 1 recites:
A method for the treatment of intestinal damages
following ischemia-reperfusion in a splanchnic area of a human
patient, the method comprising:
administering a composition comprising DHA and EPA
as active ingredients to a human patient needing treatment of
intestinal damages following ischemia-reperfusion in a
splanchnic area of the human patient, the EPA and DHA
provided from a lipid source consisting essentially of marine
oils and optionally one or more additional lipid sources selected
from the group consisting of soybean oil, sunflower oil, and
cocoa butter, in a combined daily dose of at least 400 mg and in
a weight ratio of 2:1 to 1:1.
(Appeal Br. 15.) Appellant’s claim 5 is also independent, reciting a
composition with EPA and DHA provided from a lipid source consisting
essentially of 15–25 weight-% fish oil, and optional lipid sources of about 5–

issued on October 5, 2018 (“Ans.”), the Reply Brief filed October 25, 2018
(“Reply Br.”).
3 Berge, International Patent Application Publication WO 2006/009464 A2,
published January 26, 2006.
4 Chen et al., “Oxidative Stress in Ischemic Brain Damage: Mechanisms of
Cell Death and Potential Molecular Targets for Neuroprotection,”
Antioxidants & Redox Signaling, 14:1505–17 (2011).
5 WebMD: Inflammatory Bowel Disease available at
https://www.webmd.com/ibd-crohns-disease/inflammatory-bowel-
syndrome.
6 Grootjans, et al., “Human Intestinal Ischemia-Reperfusion-Induced
Inflammation Characterized,” The American Journal of Pathology,
176:2283–91 (2010).
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10 weight-% cocoa butter, about 45–55 weight-% soybean oil, and about
20–25 weight-% sunflower oil. (See id. at 15.)
Berge teaches using combinations of β-oxidizable fatty acids and
plant or fish oils to treat a number of ailments, including myocardial
infarction, stroke (oxidative stress induced by ischemia reperfusion), and
inflammatory disorders, including inflammatory bowel disease (“IBD”).
(See Berge 1, 39 (claim 3); see Final Act. 5.) Table 2 of Berge teaches
including EPA (called “20:5 n-3”) at 5.9, 5.9, and 5.8 % of the total fatty
acids and DHA (called “22:6 n-3”) at 6.4, 6.2, and 6.2 % of the total fatty
acids in a composition. (See Berge Tables 2 and 7, p. 22; see Final Act. 5.)
The Examiner finds that it is inherent to the method of Berge that
intestinal damage following ischemia reperfusion would be limited by the
composition taught because Berge teaches treating stroke and IBD with the
composition. (See Final Act. 5, citing Berge claim 5.) The Examiner
supports this finding by citing WebMD, which teaches that IBD involves
inflammation of the intestine, and by citing Chen, which teaches that
ischemia/reperfusion after stroke causes oxidative stress. (See Final Act. 6;
see Chen Abstract.) The Examiner also cites Grootjans for its teaching that
human intestinal, i.e. splanchnic or abdominal, ischemia reperfusion is
known to cause inflammation. (See Final Act. 6.) According to the
Examiner, because Berge teaches that fish oils are known to be used to treat
stroke, myocardial infarctions, and IBD and because IBD is known to cause
inflammation in the intestines, it would have been obvious that the fish oil
could be used to treat intestinal damages following ischemia-reperfusion in a
splanchnic area. (See id. at 6–7.)
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Appellant argues that Berge teaches away from the claimed method
because it teaches that non β-oxidizable fatty acid analogues such as the 3-
thia fatty acid tetradecylthioacetic acid (“TTA”) can lead to increased
hepatic and muscle mitochondrial and peroxisomal fatty acid oxidation in
mammals. (See Appeal Br. 7, citing Berge ¶¶ 1, 5; see also Reply Br. 2–3.)
According to Appellant, this “oxidation is precisely the opposite of what is
needed for the treatment of intestinal damages following ischemia-
reperfusion in a splanchnic area of a human patient, as recited in present
Claim 1, as ischemia reperfusion is a disorder related to oxidative stress.”
(Appeal Br. 7, citing Spec. 2:8–11.)
Although we agree that Berge teaches β-oxidation can lead to
increased hepatic and muscle mitochondrial and peroxisomal fatty acid
oxidation in farm animals when used “for muscle growth,” we disagree that
this teaches away from Appellant’s claimed method, which recites
“intestinal damages.” First, Appellant’s argument that the increase in
oxidation caused by β-oxidizable fatty acid analogues is the opposite of the
method of claim 1 is not supported by evidence. The portions of the
Specification, page 2, lines 8–11, cited by Appellant states that “there is a
need in the art for alternative compositions that – when administered – allow
to treat, prevent or alleviate disorders related to oxidative stress, in particular
following ischemia reperfusion (IR).” This statement does not indicate that
the oxidation discussed in Berge would interfere or prevent treating
“intestinal damages” resulting from ischemia reperfusion. Appellant’s
assertion that the oxidation from feeding animals as discussed in Berge and
intestinal damage resulting from ischemia reperfusion are the same is
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unsupported. “Attorney’s argument in a brief cannot take the place of
evidence.” In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974).
In addition, Appellant does not dispute the Examiner’s finding that
Berge’s teachings of treating stroke, myocardial infarction, and IBD
inherently teaches treating intestinal damages following ischemia
reperfusion in a splanchnic area of a human patient. Thus, because Berge
teaches treating these conditions with EPA and DHA, we are not persuaded
that Berge would have discouraged one of ordinary skill from administering
a composition comprising DHA and EPA for intestinal damages following
ischemia-reperfusion as claimed. See In re Gurley, 27 F.3d 551, 553 (Fed.
Cir. 1994) (“A reference may be said to teach away when a person of
ordinary skill, upon reading the reference, would be discouraged from
following the path set out in the reference, or would be led in a direction
divergent from the path that was taken by the applicant.).
Appellant also argues that the lipid source of claim 1 excludes non β-
oxidizable fatty acid analogues such as the 3-thia fatty acid
tetradecylthioacetic acid taught in Berge because it recites “the EPA and
DHA provided from a lipid source consisting essentially of marine oils.”
(See Appeal Br. 8; see Reply Br. 3–4.) Similarly, Appellant argues that
claim 5 excludes non-β-oxidizable fatty acid analogues taught in Berge
because it recites “the EPA and DHA provided from a lipid source
consisting essentially of 15-25 weight-% fish oil.” (See Reply Br. 3–4.)
According to Appellant, because Berge includes plant oil in the
pharmaceutical or nutritional composition for synergistic beneficial
biological effects, its teachings are excluded by the transitional phrase
“consisting essentially of.” (See Appeal Br. 8.)
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We are not persuaded by this argument because the methods of claim
1 and claim 5 recite a “method comprising: administering a composition
comprising DHA and EPA as active ingredients to a human patient . . .”
(See Appeal Br. 15 (emphasis added).) Thus, although the source of the
DHA and EPA consists essentially of marine oil (claim 1) or a lipid source
of 15–25% weight fish oil (claim 5), the overall composition administered in
Appellant’s claims may include other ingredients. Appellant argues that the
Specification discloses DHA and EPA as the only active ingredients
provided from marine oils to treat oxidative stress, but we review the scope
of what Appellant claims, not discloses, in our analysis of obviousness.
Appellant’s claims requires EPA and DHA be provided from a lipid source
“consisting essentially” of marine or fish oils but does not limit the overall
composition administered to the patient. (See Ans. 5–6.) Appellant does not
dispute that Berge teaches a composition comprising DHA and EPA sourced
from fish (marine) oil. (See Appeal Br. 8.)
Appellant argues further that Berge does not teach an EPA to DHA
weight ratio of 2:1 to 1:1, as required in claim 1. (See Appeal Br. 9.)
Appellant argues that neither Tables 2 or 7–9 teaches a weight ratio within
the claimed range, and instead, Table 2 provides weight ratios of EPA to
DHA of 5.9/6.4, 5.9/6.2, and 5.8/6.2, which are less than 1:1 and that none
of the other examples provide weight ratios within range. (See Appeal Br.
9.)
We are not persuaded by Appellant’s argument because we agree with
the Examiner that the weight ratio provided in claim 1 does not indicate the
order of components present “in a weight ratio of 2:1 to 1:1.” (See Ans. 8–
9.) Instead, claim 1 recites both “DHA and EPA” and to “EPA and DHA” at
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different parts of the claim. Thus, the broadest reasonable interpretation of
claim 1 encompasses a ratio of DHA to EPA of 2:1 to 1:1, as well as a ratio
of EPA to DHA of 2:1 to 1:1. Accordingly, the ratios taught in Table 2 of
Berge fall within the scope of Appellant’s claims. Furthermore, we agree
with the Examiner that even if claim 1 is limited to a weight ratio of DHA to
EPA of 2:1 to 1:1, the ratios taught in Berge would be rounded to 1:1 if
expressed in single digits. (See Ans. 9.) Accordingly, we are not persuaded
that Appellant’s claimed method is non-obvious because of the recited ratio.
Appellant argues that the Specification demonstrates unexpected
results that render the claimed method non-obvious. (See Appeal Br. 9–12.)
Appellant points to the examples in the Specification, wherein rats
underwent either an I/R procedure of ischemia and reperfusion, or a sham
procedure, followed by either a control diet or a diet supplemented with a
lipid blend that included cocoa butter, soybean oil, fish oil, and sunflower
oil. (See Appeal Br. 10; see Spec. 10–15.) Appellant reports that the
specific EPA and DHA provided from a lipid source comprising marine oils,
in a combined daily dose of at least 400 mg and in a weight ratio of 2:1 to
1:1, resulted in a statistically significant increase of CAT, SOD, 17, 18-EEP,
and TXB3 expression. (See Appeal Br. 10–11; see Reply Br. 4–7.)
We are not persuaded by Appellant’s argument for several reasons.
First, Appellant does not point to evidence that these results would have
been unexpected by those of ordinary skill in the art over the teachings of
the prior art. For example, Appellant does not direct us to evidence of a
comparison between the effects of the composition recited in claims 1 or 5
and the composition taught in Berge on the treatment of intestinal damage
following ischemia-reperfusion. See In re Baxter Travenol Labs., 952 F.2d
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388, 392 (Fed. Cir. 1991) (“when unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.”). The Specification states only that “[i]nterestingly,
NRC lipid blend fed animals display a higher expression of enzymes of the
oxidative stress machinery and lipidomic analyses of intestinal tissue clearly
show global increase of antiinflammatory lipid metabolites” and that the
results were shown for the first time (Spec. 15), but fails to state or show that
these results were unexpected over the prior art.
We are also not persuaded by Appellant’s argument of unexpected
results because the results presented are not commensurate with the scope of
the claims. The lipid blend used in the examples includes cocoa butter,
soybean oil, and sunflower oil, as well as fish oil. (See Spec. 13, Table 1a.)
Because these other oils are only optional in Appellant’s claimed method, a
persuasive showing of unexpected results would also include results without
plant-based oils because they are not necessary to the invention. “It is well
settled ‘that objective evidence o[f] non-obviousness must be commensurate
in scope with the claims which the evidence is offered to support.’” In re
Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983) (quoting In re Tiffin, 448 F.2d
791 (CCPA 1971)).
Appellant’s argument that the oils other than fish oil are simply a
mixture to provide EPA and DHA in the context of a food matrix that
corresponds to a normal diet does not persuade us otherwise. (See Reply Br.
6–7.) Claims 1 and 5 encompass administering compositions without these
other oils. Therefore Appellant’s burden is to show that compositions
without these oils also produce the results asserted to be unexpected. We
note further that the control composition in the examples of Appellant’s
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Specification has a different amount of corn oil, cocoa butter, and sunflower
oil than the “NRC blend” experimental composition.7 (See Spec. 13, Table
1a.) Thus, the example does not necessarily show the effects of only EPA
and DHA administration following ischemia-reperfusion, as Appellant
argues, because the effects could be due to the different plant-based oils
components of the comparative compositions. (See Reply Br. 7.)
Appellant relies on the same arguments in regard to the rejection of
independent claim 5. (See Appeal Br. 12–13.) For the reasons provided
above, we do not find these arguments to be persuasive and are not
persuaded that the Examiner erred in rejecting claim 1 or claim 5.
Appellant does not provide separate arguments for the rejection of the
claims that depend on claim 1 or claim 5. Accordingly, we are not
persuaded that the Examiner erred in rejecting them either.
Conclusion
Upon consideration of the record and for the reasons given, we affirm
the Examiner’s rejection.
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 4–6, 8, 9,
12, 14–20
103(a) Berge, Chen, Web
MD, Grootjans
1, 4–6, 8, 9,
12, 14–20

7 The control composition is reported to have 35% corn oil, 15% cocoa
butter, and 50% soybean oil, whereas the “NRC blend” has 7% cocoa
butter, 50% soybean oil, 20% fish oil, and 23% sunflower oil. (See Spec.
13, Table 1a.)
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.

AFFIRMED