CRODA INTERNATIONAL PLC

Patent Trials and Appeals Board

Sep 22, 2020

2020001092 (P.T.A.B. Sep. 22, 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.
14/401,668 11/17/2014 Stephen Farrall Mellor CDA-127US 4575
23122 7590 09/22/2020
RATNERPRESTIA
2200 Renaissance Blvd
Suite 350
King of Prussia, PA 19406
EXAMINER
BERRIOS, JENNIFER A
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
09/22/2020 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):
PCorrespondence@ratnerprestia.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte STEPHEN FARRALL MELLOR, GREGORY CHARLES
WEATHERHEAD, and JAMES RICHARD HUMPHREY
__________

Appeal 2020-001092
Application1 14/401,668
Technology Center 1600
__________

Before ULRIKE W. JENKS, AMEE A. SHAH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

TOWNSEND, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
emulsion comprising polyunsaturated fatty acids, which have been rejected
as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Appellant’s Specification states: “long chain polyunsaturated fatty
acids, including omega-3, omega-6 and omega-9 fatty acids, are vital to
everyday life and function.” (Spec. 1.) “Since omega-3 fatty acids are not

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 Croda
International PLC. (Appeal Br. 1.)
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synthesised by the human body, they must be obtained through food or
dietary supplement.” (Id.) “Many polyunsaturated fatty acids are sensitive
to oxidation, can have an unpleasant taste and be difficult to formulate in a
stable form.” (Id.) Appellant’s invention is directed at an oil-in-water
emulsion comprising polyunsaturated fatty acids. (Id. at 2; see also claim 1.)
Claims 1–6, 9, 10, 12, and 14–23 are on appeal.2 Claim 1 is
representative and reads as follows:
1. An emulsion comprising:
(i) 65 to 74 by weight of an aqueous phase;
(ii) 26 to 35% by weight of an oil phase comprising
(a) 65 to 75% by weight of a capric/caprylic triglyceride, and
(b) 18 to 22% by weight of at least one polyunsaturated fatty
acid and/or derivative thereof, expressed as free fatty acid
concentration;
(iii) an emulsifier selected from the group consisting of
acacia gum and alkoxylated sorbitan esters, wherein the
emulsifier is present in an amount less than 4% by weight; and
(iv) one or both of a flavouring agent and a sweetening
agent that is selected from the group consisting of sucrose,
fructose, maltose, lactose, xylitol, and artificial sweeteners,
provided that the emulsion comprises a gum component,
wherein the gum component comprises guar gum and
xanthan gum at a weight ratio in the range from 0.1 to 10:1.
(Appeal Br. 7.)

The prior art relied upon by the Examiner is:

2 Claim 13 remains pending but has been withdrawn from consideration.
(Final Action 2.)
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Name Reference Date
Morgan US 4,875,929 Oct. 24, 1989
Chen US 6,720,001 B2 Apr. 13, 2004
Ferruzzi US 2004/0096547 A1 May 20, 2004
Srivastava US 2005/0196503 A1 Sept. 8, 2005
Newman US 2006/0134300 A1 June 22, 2006
Harel US 2008/0044481 A1 Feb. 21, 2008
Nuralam US 2008/0124439 A1 May 29, 2008
Mehansho US 2010/0104730 A1 Apr. 29, 2010
Driscoll WO 2010/104575 A2 Sept. 16, 2010
Puder US 2010/0256235 A1 Oct. 7, 2010
JA Casas, Viscosity of guar gum and xanthan/guar gum mixture solutions,
80 J. Sci Food Agric., 1722–27 (2000)

The following grounds of rejection by the Examiner are before us on
review:
Claims 1–6, 9, 10, 12, 14, 15, and 20 under 35 U.S.C. § 103(a) as
unpatentable over Driscoll, Harel, Mehansho, Puder, Morgan, and Casas.
Claim 16 under 35 U.S.C. § 103(a) as unpatentable over Driscoll,
Harel, Mehansho, Puder, Morgan, Casas, and Chen.
Claims 17 and 19 under 35 U.S.C. § 103(a) as unpatentable over
Driscoll, Harel, Mehansho, Puder, Morgan, Casas, and Ferruzzi.
Claim 18 under 35 U.S.C. § 103(a) as unpatentable over Driscoll,
Harel, Mehansho, Puder, Morgan, Casas, Ferruzzi, Srivastava, and Newman.
Claims 21–23 under 35 U.S.C. § 103(a) as unpatentable over Driscoll,
Harel, Mehansho, Puder, Morgan, Casas, and Nuralam.
DISCUSSION

We address the Examiner’s rejection as it relates to claim 1 below
because Appellant argues all of the rejections together and focuses only on
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claim 1. All other pending claims fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(iv).
The Examiner finds, and Appellant does not dispute, that Driscoll
teaches an oil-in-water emulsion that includes (a) an emulsifier such as a
phospholipid, (b) fish oil triglycerides, including the polyunsaturated fats
(PUFAs) EPA and DHA, and (c) at least one medium chain triglyceride,
such as a mixture of caprylic and capric acid, and that these elements are
within the ranges set forth in claim 1. (Final Action 4; see Appeal Brief 3–5
(arguing only that Driscoll is concerned with parenteral emulsions and “one
of ordinary skill in the art would not have a reason to apply the teachings
Mehansho, Morgan and Casas to the teachings of Driscoll” where those
references are concerned with including stabilizers to increase the viscosity
of an emulsion).) The Examiner finds that “the claims of Driscoll are
directed generically to emulsions” of PUFAs and thus, while Driscoll states
that the “‘emulsion can be used, for example, in parenteral administration’
(pg. 1),” such parenteral administration “is simply one embodiment of
administration” and Driscoll “does not teach away from other modes of
administration.” (Ans. 13.)
The Examiner recognizes that Driscoll does not teach including
flavoring agents or the claimed emulsifier or including xanthan gum and
guar gum, although it does teach that other pharmaceutical adjuvants, such
as stabilizers, can be added. (Final Action 6 (“Driscoll does not teach the
emulsifier to be an alkoxylated sorbitan ester.”), 7 (“Driscoll teaches that
additional ingredients can be added to stabilize the emulsions (Pg. 14)”), 8
(flavoring agent not taught).)
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The Examiner relies on Puder for teaching that it was known to
provide dietary formulas for nutrition in the form of an oil emulsion both
enterally and parenterally, and that for enteral bound formulations,
flavorings can be added to make the formulation more palatable. (Final
Action 8.) The Examiner concludes that inclusion of such an ingredient
would have been obvious in an enteral formulation of Driscoll to make such
a formulation more palatable. (Id.at 9.)
As to the claimed emulsifier, the Examiner finds, and Appellant does
not dispute, that Harel teaches the functional equivalence of the emulsifiers
taught in Driscoll and polysorbates, i.e., the claimed “alkoxylated sorbitan
esters” and concludes that substitution of a polysorbate for use in the
composition of Driscoll would have been obvious with a reasonable
expectation of success. (Final Action at 6.)
As to inclusion of xanthan gum and guar gum, the Examiner
concludes that these gums would have been obvious to add to the
formulation of Driscoll in light of the teachings of Mehansho, Morgan, and
Casas. (Id. at 7, 9.) The Examiner finds that Mehansho teaches stable
aqueous PUFA formulations that include emulsifiers of the type disclosed in
Driscoll in combination with stabilizers, such as whey protein, xanthan gum,
and guar gum, among others, which stabilizers may assist in “preventing
coalescence, flocculation, or creaming of the dispersed phase” and which
may be used in combination. (Id. at 7, 8 (“Mehans[h]o teaches that xanthan
gum/and or guar gum can be used”).) The Examiner relies on Morgan and
Casas for concluding that the use of guar gum in combination with xanthan
gum within the claimed ratio to have a stable and viscous emulsion over a
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variety of conditions would have been obvious with a reasonable expectation
of success, absent evidence to the contrary. (Id. at 9.)
Appellant does not dispute the Examiner’s findings regarding the
teachings of Mehansho, Morgan, and Casas, just the Examiner’s conclusion
that one of ordinary skill in the art would have combined viscosity
enhancing agents in the emulsion formulations of Driscoll destined for
parenteral use. (Appeal Br. 5–6; Reply Br. 2.) Appellant explains that
increasing the viscosity of Driscoll’s formulation to that suggested by
Morgan “would render the parenteral emulsion unsuitable for its intended
purpose.” (Appeal Br. 6.)
We do not find Appellant’s argument persuasive of Examiner error.
“The test for obviousness is not whether the features of a secondary
reference may be bodily incorporated into the structure of the primary
reference. . . . Rather, the test is what the combined teachings of those
references would have suggested to those of ordinary skill in the art.” In re
Keller, 642 F.2d 413, 425 (CCPA 1981)(citations omitted).
Driscoll teaches a PUFA emulsion. (Driscoll abs.) It is true that
Driscoll teaches the PUFA emulsion can be used for nutritional purposes in
those having a dysfunctional gastrointestinal tract or in critically ill patients
parenterally. (Driscoll 14–15.) However, Driscoll does not criticize or
discredit using PUFA formulations as nutritional supplements generally. As
the Examiner points out, Puder teaches dietary formulations in the form of
an oil emulsion that includes PUFA’s as in Driscoll, noting that such
formulations can be provided enterally or parenterally for nutrition. (Puder
¶¶ 9, 14, 23, 29.) In light of the foregoing, we conclude that one of ordinary
skill in the art would have considered that the Driscoll formulation could be
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used enterally, and as such could include stabilizers that increase the
viscosity of the oil-in-water emulsion. (See, e.g., Puder ¶ 84 (“The dietary
formulation or supplement of the invention may also contain a stabilizer
such as λ-carrageenan. λ-carrageenan increases the viscosity of the formula
without forming a gel structure,. . . Xanthan gum or other standard
stabilizers may also be used as a stabilizer in the same fashion as λ-
carrageenan.”).)
Moreover, the reason one would want to include such stabilizers is
provided by the teachings of Mehansho, another reference describing the
formulation of an emulsion of PUFA’s for enteral use, as the Examiner
points out, i.e., to assist in stabilizing the emulsion by preventing
coalescence, flocculation, or creaming of the dispersed phase. (Mehansho
¶¶ 38, 40.)
Thus, for the foregoing reasons, we affirm the Examiner’s rejection of
claim 1 as being obvious over Driscoll, Harel, Mehansho, Puder, Morgan,
and Casas. And because Appellant does not argue the claims or rejections
separately, we also affirm the Examiner’s rejection of the remaining claims
as being obvious over the cited references.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–6, 9, 10,
12, 14, 15,
20
103(a) Driscoll, Harel,
Mehansho, Puder,
Morgan, Casas
1–6, 9, 10,
12, 14, 15,
20

16 103(a) Driscoll, Harel,
Mehansho, Puder,
Morgan, Casas,
Chen
16
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17, 19 103(a) Driscoll, Harel,
Mehansho, Puder,
Morgan, Casas,
Ferruzzi
17, 19
18 103(a) Driscoll, Harel,
Mehansho, Puder,
Morgan, Casas,
Ferruzzi,
Srivastava,
Newman
18
21–23 103(a) Driscoll, Harel,
Mehansho, Puder,
Morgan, Casas,
Nuralam
21–23
Overall
Outcome
1–6, 9, 10,
12, 14–23

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).

AFFIRMED