KING SAUD UNIVERSITY

Patent Trials and Appeals Board

Mar 25, 2021

2020004374 (P.T.A.B. Mar. 25, 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.
16/120,120 08/31/2018 IBRAHIM S. ALNAJASHI 32903.77 4560
37833 7590 03/25/2021
Richard C. Litman
Nath, Goldberg & Meyer
112 S. West Street
Alexandria, VA 22314
EXAMINER
KISHORE, GOLLAMUDI S
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
03/25/2021 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):
litman@4patent.com
tharkins@nathlaw.com
uspto_nva@nathlaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte IBRAHIM S. ALNAJASHI and
GAMALELDIN I. HARISA
____________

Appeal 2020-004374
Application 16/120,120
Technology Center 1600
____________

Before DONALD E. ADAMS, RACHEL H. TOWNSEND, and
MICHAEL A. VALEK, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1, 3, and 6 (Final Act.2 1). 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 “KING
SAUD UNIVERSITY, RIYADH, SAUDI ARABIA” (Appellant’s
December 27, 2019, Appeal Brief (Br.) 3).
2 Examiner’s July 30, 2019, Final Office Action.
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Application 16/120,120

2
STATEMENT OF THE CASE
Appellant’s disclosure “relates to liposome, nanosome, and
nanoemulsion compositions including oleic acid and compositions including
oleic acid and linoleic acid” (Spec.3 ¶ 1). Appellant’s independent claim 1 is
reproduced below:
1. A pharmaceutical composition for upregulating defensin
expression, comprising oleic acid and linoleic acid, the
composition being in a form of a nanoliposome, wherein the
nanoliposome has an average particle size of 150 nm.
(Br. 11.)

Grounds of rejection before this Panel for review:
Claims 1, 3, and 6 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Hamada.4
Claims 1, 3, and 6 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Yoon5 and Hamada.

ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Hamada discloses “a method for producing a liposome encapsulating
a paclitaxel monoglycoside and/or a docetaxel monoglycoside” (Hamada
¶ 1).

3 Appellant’s August 31, 2018, Specification.
4 Hamada et al., US 2016/0256566 A2, published Sept. 8, 2016.
5 Yoon et al., US 2014/0037712 A1, published Feb. 6, 2014.
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Application 16/120,120

3
FF 2. Hamada discloses that “liposome constituent lipids include
phospholipids, cholesterols, fatty acids, etc.,” wherein “the fatty acids
include oleic acid, palmitoleic acid, linoleic acid, fatty acid mixtures
containing these unsaturated fatty acids” (Hamada ¶¶ 71–72).
FF 3. Hamada discloses that the liposome particle size “is generally about
50 to 300 nm to preferably use the liposome as a liposome formulation
encapsulating a paclitaxel monoglycoside and/or a docetaxel monoglycoside
having an anti-cancer effect,” wherein a “liposome with a particle size of 50
nm or more is preferable because substantial leakage to cells is not likely to
occur” and “a liposome with a particle size of 300 nm or less is preferable
because it is not likely to undergo phagocytosis by leucocytes
(macrophages) in blood after being administered to a living body” (Hamada
¶ 91).
FF 4. Hamada discloses that “the particle size of the liposome . . . can be
adjusted to a predetermined particle size . . . by changing various conditions
in the liposome formation treatment beforehand” or “by making the
liposome pass through a filter whose pore diameter is adjusted” (Hamada
¶ 92).
FF 5. Yoon discloses “methods for preventing or treating an eye disease
using adiponectin” (Yoon ¶ 3; see id. at Abstr. (Yoon discloses a
“composition for preventing or treating an eye disease includes adiponectin
as an active ingredient. Adiponectin as an active ingredient is eventually
revealed to show prevention or therapeutic efficacies for eye diseases such
as dry eye (syndrome), inflammatory eye disease and side effects due to the
use of contact lenses”)).
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FF 6. Yoon discloses that stability of the composition “may be improved
by encapsulating [it] into liposomes” (Yoon ¶ 62).
FF 7. Yoon discloses that liposomes “may be prepared by mixtures
including polyol, surfactants, phospholipids, fatty acids and water,” wherein
“the fatty acid used in preparation of the liposome as higher fatty acid may
include lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid and
linoleic acid as C12-22 alkyl chain saturated or unsaturated fatty acids, but
not limited thereto” (Yoon ¶¶ 63 and 67).
FF 8. Yoon discloses that liposome preparations “may be achieved through
various methods known in the art, for example, by applying the mixture
containing the above ingredients to high pressure homogenizer” (Yoon
¶ 67).
FF 9. Examiner finds that Yoon does not disclose the use of a mixture of
oleic acid and linoleic acid and relies on Hamada to make up for this
deficiency (Ans. 4).
ANALYSIS
The rejection over Hamada:
Based on Hamada, Examiner concludes that, at the time Appellant’s
invention was made, it would have been prima facie obvious to prepare a
nanoliposomes comprising oleic acid and linoleic acid having an average
particle size of 150 nm (see Ans. 3–4; see FF 1–4).6

6 Regarding the “for upregulating defensin expression” language in the claim
preamble, Examiner finds “it is a functional limitation without the
composition reciting any active agent. The intended use of the liposomes
has no significance in composition claims” (Ans. 4). Appellant does not
challenge this determination on appeal.
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Application 16/120,120

5
Hamada discloses liposomes having a particle size of about 50 to 300
nm, which is, by definition, a nonoliposome (see FF 3; see generally
Nomani7 1–10). Therefore, we are not persuaded by Appellant’s contention
that Hamada does not disclose a nanoliposome (Br. 8; see also id. at 6
(Appellant incorrectly contends that Hamada is limited to a liposome having
a diameter of 20-100 nm)).
Given Hamada’s disclosed liposomal particle size range of about 50 to
300 nm, disclosed significance of preparing liposomes within that particle
size range, and disclosed methodology for producing a liposome within that
particle size range, we find no error in Examiner’s prima facie case of
obviousness (see FF 1–4). “[W]here[, as 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.” In re Aller, 220
F.2d 454, 456 (CCPA 1955).

The rejection over Yoon and Hamada:
Based on the combination of Yoon and Hamada, Examiner concludes
that, at the time Appellant’s invention was made, it would have been prima
facie obvious to prepare a nanoliposomes comprising oleic acid and linoleic
acid having an average particle size of 150 nm (see Ans. 4–5; see FF 1–9).
For the reasons set forth above, having found that Hamada makes
obvious the subject matter of Appellant’s claim 1, we find no error in
Examiner’s prima facie case of obviousness. For the same reasons, we are
not persuaded by Appellant’s contention that “[a]bsent from the conclusion

7 Nomani et al., Nanoliposome: An alternative approach for drug delivery
system, 2016 Int. J. Adv. Pharmacy Med. Bioallied Sci. 1–10 (2016).
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of obviousness is the recitations of a ‘. . . composition being in a form of a
nanoliposome, wherein the nanoliposome has an average particle size of 150
nm” (Br. 9 (alteration original)).

CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable
over Hamada is affirmed. Claims 3 and 6 are not separately argued and fall
with claim 1.
The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Yoon and Hamada is affirmed. Claims 3 and 6 are
not separately argued and fall with claim 1.
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 6 103 Hamada 1, 3, 6
1, 3, 6 103 Yoon, Hamada 1, 3, 6
Overall
Outcome
1, 3, 6

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