BASF AS

Patent Trials and Appeals Board

Oct 18, 2021

2021002915 (P.T.A.B. Oct. 18, 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.
14/770,862 08/27/2015 Svein Olaf HUSTVEDT 14622.0084-00000 1321
22852 7590 10/18/2021
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
LLP
901 NEW YORK AVENUE, NW
WASHINGTON, DC 20001-4413
EXAMINER
QAZI, SABIHA NAIM
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
10/18/2021 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):
regional-desk@finnegan.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte SVEIN OLAF HUSTVEDT,
PREBEN HOULBERG OLESEN, and ANNETTE MÜLLERTZ
__________

Appeal 2021-002915
Application 14/770,862
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and
DAVID COTTA, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a
medical composition. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We reverse.

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 NorthSea
Therapeutics, B.V. (see Appeal Br. 3). An oral hearing was held on Oct. 7,
2021.
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Application 14/770,862

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Statement of the Case
Background
Hovland2 discloses “discloses that 2-((5Z,8Z,11Z,14Z,17Z)-icosa-5,8,
11, 14, 17-pentaenyloxy)butanoic acid favorably influences lipid profiles
and inhibits the development of atherosclerosis” (Spec. ¶ 4). “To be
effective in such prevention or treatment regimes, the active ingredient . . .
must reach its biological target. Evidence suggests, however, that such
targeting is complicated by enzymes that interconvert long chain fatty acids
and alcohols in vivo” (id. ¶ 5).
The Specification teaches “a need for compositions comprising 2-
((5Z,8Z,11Z, 14Z,17Z) -icosa-5,8,11,14,17-pentaenyloxy)butanoic acid . . .
that improve or enhance solubilization, digestion, bioavailability, and/or
absorption in vivo, while maintaining the ability . . . to cross cell membranes
and reach its biological targets” (Spec. ¶ 8).
The Claims
Claims 139–160 are on appeal. Claim 139 is an independent claim, is
representative and reads as follows:
139. A composition comprising
from 5% to 60% by weight of the total composition of 2-
((5Z,8Z, 11Z, 14Z, 17Z)icosa-5,8,11,14,17-pentaenyloxy)butanoic
acid, an ester derivative, or a pharmaceutically acceptable salt thereof;
from 15% to 60% by weight of the total composition of a
medium-chain triglyceride (MCT) oil; and
from 10% to 60% by weight of the total composition of a
nonionic surfactant.

2 Hovland et al., WO 2010/128401 A1, published Nov. 11, 2010.
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The Rejection
The Examiner rejected claims 139–160 under 35 U.S.C. § 103(a) as
obvious over Hovland, Kuhrts,3 and Dudley4 (Final Act. 10–15).
The Examiner finds Hovland
teaches 2-((5Z, 8Z, 11 Z, 14Z, 17Z)-icosa-5, 8, 11, 14, 17-
pentaen-1-yloxy)butanoic acid (example 2), and its isomers for
lowering total cholesterol, increased HDL cholesterol and
inhibits development of atherosclerosis. It teaches that these
compounds may be useful for treatment of various conditions
such as inflammation, hyperlipidemia and diabetic conditions.
(Final Act. 10). The Examiner finds “[o]ne skilled in the art would expect
stereoisomers containing the same properties as the parent compound” (id. at
11). The Examiner finds Kuhrts teaches “water-soluble dietary fatty acid
formulations, solutions, and methods for increasing the water solubility
and/or bioavailability of dietary fatty acids” (id.). The Examiner finds
Kuhrts teaches a “method for enhancing the bioavailability by using
surfactant and triglycerides” including “medium-chain triglycerides” (id.).
The Examiner finds it obvious “to add triglycerides, non-ionic
surfactants, EPA and DHA as taught by Kuhrts because it also teaches
increase in bioavailability by using surfactants and triglycerides” (Final Act.
12). The Examiner finds Dudley “show[s] that medium chain triglyceride,
non-ionic surfactants and various oils, and other ingredients are commonly
used in a drug composition to enhance the bioavailability, solubility,

3 Kuhrts, E., US 2011/0054029 A1, published Mar. 3, 2011.
4 Dudley et al., US 2008/0317844 A1, published Dec. 25, 2008.
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stability, emulsification, and self-emulsification compositions are obvious
for a person skilled in the art” (id. at 14).
Appellant contends
that the Office failed to establish a prima facie case of
obviousness at least because:
1) the Office fails to establish the requisite motivation of
a person of ordinary skill in the art to combine Hovland with
Kuhrts or Dudley; and
2) the Office errored in attempting to establish how the
cited art meets the claimed requirement to formulate the recited
compounds with a nonionic surfactant and a medium chain
triglyceride.
(Appeal Br. 5).
The issue with respect to this rejection is: Does a preponderance of the
evidence of record support the Examiner’s conclusion that the combination
of Hovland, Kuhrts, and Dudley render claim 1 obvious?
Findings of Fact
1. Hovland teaches “pharmaceutical compositions and lipid
compositions comprising at least one compound of formula (I). In addition,
the present disclosure includes compounds of formula (I) for use as
medicaments or for use in therapy such as for the treatment of diseases
related to the cardiovascular, metabolic, and inflammatory disease”
(Hovland ¶ 4).
2. Hovland teaches particular compounds of formula (I) including
“2-((5Z, 8Z, 11Z, 14Z, 17Z)icosa-5,8,11,14,17-pentaenyloxy)butanoic acid”
(Hovland ¶ 70, Example 2). This compound was tested as compound A in
Example 18 (Hovland ¶ 89).
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3. Hovland teaches these compounds “are capable of existing in
stereoisomeric forms, i.e.[,] all optical isomers of the compounds and
mixtures thereof are encompassed. Hence, the said compounds may be
present as diastereomers, racemates, and enantiomers” (Hovland ¶ 47).
4. Table 1 of Hovland is reproduced below:

“Table 1: PPAR activation in vitro” (Hovland ¶ 90).
5. Hovland teaches:
This animal model has proven to be representative of the
human situation with respect to plasma lipoprotein levels and
its responsiveness to hypolipidemic drugs, such as statins and
fibrates, and nutritional intervention. In addition, depending on
the level of plasma cholesterol, APOE*3Leiden mice develop
atherosclerotic lesions in the aorta resembling those found in
humans with respect to cellular composition and morphological
and immunohistochemical characteristics.
(Hovland ¶ 91).
6. Kuhrts teaches “a method of delivering a dietary fatty acid to a
subject can comprise administering the water-soluble dietary fatty acid gel
formulation to a subject such that the dietary fatty acid is more bioavailable
then when the same amount of dietary fatty acid is delivered alone” (Kuhrts
¶ 5).
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7. Kuhrts teaches “that non-ionic surfactants can be used to
increase the solubility and/or bioavailability of dietary fatty acids when
combined appropriately” (Kuhrts ¶ 19).
8. Kuhrts teaches “1 wt% to 75 wt% of dietary fatty acid; and
from 25 wt % to 99 wt% of non-ionic surfactant” (Kuhrts ¶ 21).
9. Kuhrts teaches “[u]seful non-ionic surfactants that can be used
include, for example, non-ionic water-soluble mono-, di-, and tri-glycerides”
that include “medium-chain triglycerides (e.g.[,] caprylic and capric
triglycerides such as LAVRAFAC, MIGLYOL 810 or 812, CRODAMOL
GTCCPN, and SOFTISON 378)” (Kuhrts ¶¶ 24–25).
Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
We find the Appellant has the better position. While Kuhrts provides
persuasive reasons to combine a butanoic acid compound of Hovland with a
non-ionic surfactant for bioavailability (FF 6–7), the Examiner provides no
persuasive reason based in the prior art to then further add an additional
medium chain triglyceride to the composition. The Examiner finds:
It would have been obvious to one skilled in the art at the time
the invention was filed to add median chain glyceride and a
non-ionic surfactant in a composition of compound with
reasonable expectation of success because due to the many
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desirable properties of nutritional or dietary fatty acids, it would
be advantageous to provide a more water-soluble formulation
and/or enhanced bioavailability formulation of these fatty acids
for in vivo use. (Kuhrts. [0004]).
(Ans. 13). However, paragraph 4 of Kuhrts does not suggest combining
both a medium chain triglyceride and a non-ionic surfactant together for
bioavailability. In its entirety, paragraph 4 of Kuhrts states “[d]ue to the
many desirable properties of nutritional or dietary fatty acids, it would be
advantageous to provide a more water-soluble formulation and/or enhanced
bioavailability formulation of these fatty acids for in vivo use” (Kuhrts ¶ 4).
And the Examiner does not point to any other teaching in Kuhrts,
Hovland or Dudley that suggests or provides a reason for the use of both a
medium chain triglyceride and a non-ionic surfactant together. There is no
cited prior art evidence on the current record that adding both components to
Hovland’s compound would further improve bioavailability, water solubility
or provide any other advantage or reason for the resulting composition. The
Examiner has not shown “there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue.” KSR, 550
U.S. at 418. Nor has there been a showing that “there is a design need or
market pressure to solve a problem and there are a finite number of
identified, predictable solutions” with one such solution being the
combination of medium chain triglycerides and non-ionic surfactant with
Hovland’s compounds. Id. at 421.
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner’s conclusion that the combination of Hovland, Kuhrts, and Dudley
render claim 1 obvious.
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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
139–160 103 Hovland, Kuhrts,
Dudley
139–160

REVERSED