Hovid Berhad

Patent Trials and Appeals Board

May 5, 2021

2020005622 (P.T.A.B. May. 5, 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.
14/742,864 06/18/2015 Bee Hong Ng 274751.110_CON 2174
42161 7590 05/05/2021
MEYER UNKOVIC & SCOTT LLP
535 Smithfield Street
Suite 1300
Pittsburgh, PA 15222-2315
EXAMINER
MCMILLIAN, KARA RENITA
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
05/05/2021 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte BEE HONG NG, WAI PENG CHOY, JIA WOEI WONG,
JUNE LAY CHOO KHOO, DAVID SUE SAN HO, and KAH HAY YUEN
__________

Appeal 2020-005622
Application 14/742,864
Technology Center 1600
__________

Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
TAWEN CHANG, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1,2 under 35 U.S.C. § 134 involving claims to a
pharmaceutical composition. The Examiner rejected the claims as obvious.
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 Hovid BHD
(see Appeal Br. 3).
2 We have considered the Specification of June 18, 2015 (“Spec.” with the
unnumbered pages numbered sequentially from the first page); Final Office
Action of May 15, 2019 (“Final Act.”); Appeal Brief of Feb. 18, 2020
(“Appeal Br.”); Examiner’s Answer of May 26, 2020 (“Ans.”); and Reply
Brief of July 27, 2020 (“Reply Br.”).
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Statement of the Case
Background
“Emulsions have been known to improve absorption of oil-soluble
drugs” (Spec. 1). “[S]elf-emulsifying drug delivery systems (SEDDSs) have
gained increasing interests in recent years due to many advantages they have
over conventional emulsions” (id.). “[L]ike most SEDDS, the . . .
pharmaceutical carrier was found to be effective- only if the surfactant
concentration utilized was more than 50% by weight, with the preferred ratio
of oleic acid to non-ionic surfactant ranging from 1:l to 1:4 w/w” (id. at 4).
“The present invention led to . . . a pharmaceutical carrier comprising . . . a
combination of edible or pharmaceutically acceptable fatty acids and . . . a
combination of non-ionic surfactants to deliver a wide range of drugs” (id.).
The Claims
Claims 1, 4–8, 10, 11, and 13 are on appeal.3 Claim 1 is
representative and reads as follows:
1. A pharmaceutical composition comprising:
a solvent comprising an edible and pharmaceutically
acceptable fatty acid;
a drug; and
a non-ionic surfactant,
wherein the pharmaceutical composition is a self-
emulsifying drug delivery system,
wherein the drug is dissolved in the solvent,
wherein the fatty acid and non-ionic surfactant are
mixed in a ratio ranging from 9.5:0.5 w/w to 2:1 w/w.

3 We limit our consideration of the merits of the appealed rejection to the
elected species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987).
Thus, we read the claims as limited to the oleic acid as the fatty acid,
ibuprofen as the drug and Cremophor EL as the surfactant (see Final Act. 2).
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The Rejection
The Examiner rejected claims 1, 4–8, 10, 11, and 13 under 35 U.S.C.
§ 103(a) as obvious over Patel4 (Final Act. 3–6).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s conclusion that Patel renders
the claims obvious?
Findings of Fact
1. Patel teaches “pharmaceutical compositions for the improved
delivery of hydrophobic compounds” (Patel 1:9–10).
2. Patel teaches “the present invention provides a clear aqueous
dispersion containing a hydrophilic surfactant, a hydrophobic surfactant and
a hydrophobic therapeutic agent” (Patel 4:9–12).
3. Patel teaches “a combination of a hydrophilic surfactant and a
hydrophobic surfactant can solubilize therapeutically effective amounts of
hydrophobic therapeutic agents without recourse to the use of triglycerides”
(Patel 4:55–58). Patel explains that “[o]ne skilled in the art will appreciate
that a hydrophobic therapeutic agent may have a greater solubility in the pre-
concentrate carrier than in the aqueous dispersion” (Patel 27:43–45).
4. Patel teaches “[s]pecific non-limiting examples of hydrophobic
therapeutic agents that can be used in the pharmaceutical compositions of
the present invention include . . . ibuprofen” (Patel 22:1–10).
5. Patel teaches “preferred hydrophilic surfactants are PEG-35
castor oil” and Table 5 teaches that PEG-35 castor oil is Cremophor EL (see
Patel 8:66–9:1 and Table 5).

4 Patel et al., US 6,294,192 B1, issued Sept. 25, 2001.
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6. Patel teaches that “the hydrophobic surfactant can be any
hydrophobic surfactant suitable for use in pharmaceutical compositions”
including oleic acid esters (see Patel 5:63–65; 6:23–25). Patel also
specifically claims “wherein the hydrophobic surfactant is selected from the
group consisting of . . . oleic acid” (Patel 51:36–38, claim 29).
7. Patel teaches that “[f]or some particular surfactant
combinations, cloudy solutions result when the amount of hydrophobic
surfactant is greater than about 60% by weight, based on the amount of
hydrophilic surfactant. A preferred range for these surfactants is about 1%
to about 60%” (Patel 21:27–31). Patel teaches “[a]ddition of optional
excipients as described below can further increase the maximum relative
amount of hydrophobic surfactant that can be used” (Patel 21:33–35).
8. Patel teaches, however, that “any aqueous dispersion having the
properties described above is within the scope of the present invention
regardless of the specific relative amounts of hydrophobic and hydrophilic
surfactants” (Patel 21:14–17).
9. Patel teaches “it is expected that the amount of hydrophobic
surfactant will generally be less than about 200% by weight, based on the
amount of hydrophilic surfactant, and more specifically, in the range of
about 1 % to 200%” (Patel 21:16–21).
10. Patel teaches “the particular combination of surfactants used
can be optimized for a specific hydrophobic therapeutic agent to more
closely match the polarity distribution of the therapeutic agent, resulting in
still further enhanced solubilization” (Patel 30:63–67).
11. Patel teaches “the pharmaceutical compositions of the present
invention can optionally include additional compounds to enhance the
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solubility of the hydrophobic therapeutic agent in the carrier system” (Patel
25:15–17).
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 adopt the Examiner’s findings of fact and conclusion of law (see
Final Act. 3–6; FF 1–11) and agree that Patel renders claim 1 obvious. We
address Appellant’s arguments below.
Appellant contends “Patel teaches that the drug is solubilized by
micelles, which is a structure formed by a combination of two separate
surfactants. In contrast, Claim 1 specifies that the drug is dissolved by any
single component (i.e. a fatty acid)” (Appeal Br. 6).
We find this argument unpersuasive because Patel teaches that “a
combination of a hydrophilic surfactant and a hydrophobic surfactant can
solubilize therapeutically effective amounts of hydrophobic therapeutic
agents” (FF 3). Patel teaches the hydrophobic therapeutic agent may be
more soluble in this pre-concentrate carrier composed of a fatty acid, a drug,
and a non-ionic surfactant in a ratio of 2:1 w/w (FF 3–6, 9).
We agree with the Examiner that because Patel suggests “the same
solvent as claimed which is oleic acid, in combination with the same
hydrophobic drug as claimed which is ibuprofen, said solvent (oleic acid)
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will necessarily dissolve the ibuprofen as claimed,” resulting in a
composition that is structurally identical to the composition recited in claim
1 (Ans. 8–9; citing In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990)
(“Products of identical chemical composition can not have mutually
exclusive properties.”)). Appellant provides no evidence demonstrating a
structural difference between the claimed composition and that rendered
obvious by Patel. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977)
(“Where, as here, the claimed and prior art products are identical or
substantially identical, . . . the PTO can require an applicant to prove that the
prior art products do not necessarily or inherently possess the characteristics
of his claimed product.”).
Appellant contends
the Patel reference fails to teach oleic acid as a component of
the pharmaceutical composition. Rather, Patel teaches ester
derivatives of fatty acids for use as a surfactant. A person
having skill in the art would recognize that fatty acid
derivatives, particularly the fatty acid esters, have markedly
different properties than fatty acids
(Appeal Br. 7). Appellant acknowledges that claims 29 and 30 of Patel
expressly list oleic acid but contends that, because “claims 29-30 are
presented as Markush groups” and “[b]ase fatty acids would not have similar
properties and it would be improper to group them with the other
compounds identified in claims 29-30,” they must be in derivative form
because otherwise the claims would comprise improper Markush groups (see
Appeal Br. 8).
We find this argument unpersuasive because claim 29 of Patel
expressly teaches the use of oleic acid as a hydrophobic surfactant (FF 6).
The evidence does not support Appellant’s position that the recitation of
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oleic acid is an improper Markush group because MPEP § 706.03 notes that
a proper Markush group includes situations where there is a common
function and Patel teaches that oleic acid shares the common function of
serving as a hydrophobic surfactant (FF 6) with other hydrophobic
surfactants. To the extent that Appellant is arguing that the only disclosure
of oleic acid is in a claim of Patel, we note that a claim is “itself adequate
‘written description’ of the claimed invention. It was equally a ‘written
description’ whether located among the original claims or in the descriptive
part of the specification.” In re Gardner, 480 F.2d 879, 879–80 (CCPA
1973).5
Appellant contends “Patel is not enabling for teaching fatty acids used
in a pharmaceutical composition. As noted above, the specification of Patel
fails to teach oleic acid as a component of the pharmaceutical composition”
(Appeal Br. 8).
We are not persuaded. A “prior art printed publication cited by an
examiner is presumptively enabling barring any showing to the contrary by a
patent applicant.” In re Morsa, 713 F.3d 104, 109 (Fed. Cir. 2013). The
prior art is enabling if “a person of ordinary skill in the art could make or use
the claimed invention without undue experimentation based on the
disclosure of that particular document.” Id. at 110.
Here, Appellant provides no specific evidence or persuasive reasoning
as to why undue experimentation would have been required for an ordinary
artisan to follow the disclosure of Patel and prepare a composition of

5 We note, but need not rely upon, the recitation in Patel’s original filed
claim 31 of oleic acid as in the group of hydrophobic surfactants (see US
application 09/258,654, now US 6,294,192, filed Feb. 26, 1999).
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ibuprofen, Cremophor EL, and oleic acid. Simply stating that Patel’s
specification does not exemplify this embodiment is not sufficient because
working “examples are not required to satisfy section 112, first paragraph.”
In re Strahilevitz, 668 F.2d 1229, 1232 (CCPA 1982). And Patel provides a
number of working examples using forms of Cremophor and oils (see Patel
Tables 19–26). All Appellant presents is attorney argument, but “attorney
argument [is] not the kind of factual evidence that is required to rebut a
prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed.
Cir. 1997).
Appellant contends “Patel sets the limit for non-cloudy compositions
at .6:1 w/w, well below the range recited in Claim 1 of the present invention.
Patel teaches against cloudy formulations because ‘such a system would
suffer from many of the same disadvantages as conventional prior art
formulations, as described above’” (Appeal Br. 9; citing Patel 20:3–5).
Based on this, Appellant contends “Patel teaches away from a composition
having a ratio of fatty acid to non-ionic surfactant of 9.5:0.5 w/w to 2:1 w/w
(i.e. 95% to 66% fatty acid, total weight). Patel teaches that the ratio of
hydrophobic surfactant to hydrophilic surfactant is less than 2:1 w/w” (id.).
We find this teaching away argument unpersuasive. While Patel
teaches that some combinations result in cloudy solutions (FF 7), Appellant
identifies no evidence in Patel suggesting that a 2:1 w/w ratio of ibuprofen,
Cremophor EL, and oleic acid would result in a cloudy solution. Thus, Patel
does not teach away because Patel does not criticize, discourage, or
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otherwise discredit this particular obvious composition. See In re Fulton,
391 F.3d 1195, 1201 (Fed. Cir. 2004).
In addition, Patel specifically teaches a range for the two components
of 2:1 w/w (i.e. 200% by weight of hydrophobic surfactant based on the
amount of hydrophilic surfactant) (FF 9) and explains that if a higher
amount of hydrophobic surfactant is desired, the “[a]ddition of optional
excipients as described below can further increase the maximum relative
amount of hydrophobic surfactant that can be used” (FF 7). As claim 1 uses
the open transitional phrase “comprising,” claim 1 encompasses
compositions with the 2:1 w/w ratio that include optional excipients in the
composition that allow it to remain clear.
We note that a “given course of action often has simultaneous
advantages and disadvantages, and this does not necessarily obviate
motivation to combine.” Medichem, S.A. v. Rolabo S.L., 437 F.3d 1157,
1165 (Fed. Cir. 2006). In this case, the advantage identified by Patel
includes improved delivery of the hydrophobic drug such as ibuprofen (FF
1). Appellant asserts the disadvantage that the combination might, at a 2:1
w/w ratio, result in a cloudy solution, but provides no evidence that such a
cloudy solution would have been expected to occur. We agree with the
Examiner (see Final Act. 11–12) that Patel recognizes the need for
optimization because it teaches that “the particular combination of
surfactants used can be optimized for a specific hydrophobic therapeutic
agent to more closely match the polarity distribution of the therapeutic
agent, resulting in still further enhanced solubilization” (FF 10). Appellant
provides no evidence of secondary considerations, such as unexpected
results, to demonstrate that their selection of the particular species from the
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genera of fatty acids, surfactants, and active pharmaceuticals in the
Specification is anything other than routine (see Spec. 7–8). In re Boesch,
617 F.2d 272, 276 (CCPA 1980).
Conclusion of Law
A preponderance of the evidence of record supports the Examiner’s
conclusion that Patel renders the claims obvious.
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 4–8, 10, 11,
13
103(a) Patel 1, 4–8, 10,
11, 13

No time period for taking any subsequent action in connection with this appeal
may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED