Ex Parte Jensen et al

Board of Patent Appeals and Interferences

Aug 28, 2012

10723423 (B.P.A.I. Aug. 28, 2012)

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.
10/723,423 11/26/2003 Gerard M. Jensen 01992.005US1 6232
53137 7590 08/28/2012
VIKSNINS HARRIS & PADYS PLLP
7900 International Drive
Suite 670
Bloomington, MN 55425
EXAMINER
KISHORE, GOLLAMUDI S
ART UNIT PAPER NUMBER
1612
MAIL DATE DELIVERY MODE
08/28/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte GERARD M. JENSEN, NING HU, SU-MING CHIANG,
CRAIG SKENES, and RICHARD FAHRNER
__________

Appeal 2011-004529
Application 10/723,423
Technology Center 1600
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
LORA M. GREEN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
Appellants request reconsideration (rehearing) of the Board's decision
entered June 11, 2012 (Decision) affirming the rejection of claims 54 and 58
under 35 U.S.C. § 103 over the combination of Hersch,
1
Allen,
2
Fujii,
3
and
O’Rear;
4
and the rejection of claims 54-57 over the combination of Hersch,

1
Hersch et al., US 5,759,571, issued Jun. 2, 1998.
2
T.M. Allen and L.G. Cleland, Serum-Induced Leakage of Liposome
Contents, 597 BIOCHIMICA ET BIOPHYSICA ACTA 418-426 (1980).
3
Fujii et al., US 5,328,678, issued Jul. 12, 1994.
4
O’Rear III et al., US 5,503,850, issued Apr. 2, 1996.
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Allen, Fujii, O’Rear, and Lopez-Berestein.
5
The Board designated its
affirmance as a new ground of rejection (Decision 9-10 and 13-14).
We have jurisdiction under 35 U.S.C. § 6(b).
Appellants present the following issues for our review on rehearing:
Issue 1: Whether a preponderance of the evidence supports a
conclusion that the liposomal formulation of claim 54 with the
claimed ration of components is obvious over the evidence of record;
Issue 2: Whether a preponderance of the evidence supports a
conclusion that the liposomes of claims 55 and 56 with DEPC as the
phosphatidylcholine are obvious over the evidence of record; and
Issue 3: Whether a preponderance of the evidence supports a
conclusion that the liposomes of claim 57 with DOPC as the
phosphatidylcholine are obvious over the evidence of record.
We take each in turn.

ISSUE 1:
Appellants appear to recognize that Hersch suggests a of
HSPC:cholesterol:DSPG ratio range that encompasses the range set forth in
claim 54, but nonetheless contend that (1) Hersch’s “range is too great to
disclose the specific range set forth in the present claims”; (2) no reason was
provided to use a ratio of ingredients other than what Hersch “specifically
recited” and “exemplified”; and (3) “[i]f one were to adopt the . . . [Board’s
reasoning] and decrease the amount of DSPG in the liposomes of Hersch,

5
Lopez-Berestein et al., US 5,032,404, issued Jul. 16, 1991.
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one would arrive at liposomes having a composition of 4:2:01, not the
claimed ratio of 4:1:0.1” (Req. Reh’g 8-9). We are not persuaded.
Appellants fail to identify an evidentiary basis on this record to
support a conclusion that Hersch’s suggested ratio ranges are “too great to
disclose the specific range set forth in the present claims” (Req. Reh’g 8).
“[W]here there is a range disclosed in the prior art, and the claimed
invention falls within that range, there is a presumption of obviousness.”
Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir.
2004). Further, given Hersch’s disclosure, the determination of workable or
optimum ratios would have been within the level of the ordinary skill. In re
Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)(“The normal desire of
scientists or artisans to improve upon what is already generally known
provides the motivation to determine where in a disclosed set of percentage
ranges is the optimum combination of percentages.”); In re Aller, 220 F.2d
454, 456 (CCPA 1955)(“[W]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.”).
“[A] reference must be considered not only for what it expressly
teaches, but also for what it fairly suggests.” In re Burckel, 592 F.2d 1175,
1179 (CCPA 1979), quoted with approval in In re Baird, 16 F.3d 380, 383
(Fed. Cir. 1994). Therefore we are not persuaded by Appellants’ intimation
that Hersch is limited to its exemplified or specifically recited ratios of
HSPC:cholesterol:DSPG (Req. Reh’g 8).
Appellants fail to identify an evidentiary basis on this record to
support a conclusion that the amount of cholesterol must be modified if the
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amount of DSPG in Hersch’s liposome is decreased (Cf. Req. Reh’g 9). As
Appellants recognize “varying the amount of DSPG to HSPC . . . does not
automatically vary the amount of cholesterol present” in Hersch’s
formulation (id.).

ISSUES 2 and 3:
Appellants consolidated issues 2 and 3, therefore we address these
issues together (see Req. Reh’g 9).
Appellants contend that Lopez-Berestein suggests the entrapment of
antibiotics having both hydrophilic and hydrophobic properties and “that the
properties of lipids used in encapsulation of the hydrophobic agents of
Lopez-Berestein would not automatically apply to the properties of lipids
used in encapsulation of the hydrophilic agents of Hersch” (Req. Reh’g 10).
We are not persuaded.
Hersch suggests that “phosphatidylcholines include, among others,
hydrogenated egg phosphatidylcholine (HEPC), hydrogenated soybean
phosphatidylcholine (HSPC), and distearoyl phosphatidylcholine (DSPC)
(FF 4)” and “that other suitable phosphatidylcholines may be used (FF 6)”
(Decision 12: 3-7 (emphasis added)). Lopez-Berestein suggests liposomes
comprising “egg PC, DSPC, DEPC, and DOPC (FF 26, 27)” (id. at ll. 13-14
(emphasis added)). Therefore,
Since Hersch expressly discloses the phosphatidylcholines
HSPC, egg PC and DSPC and discloses that other
phosphatidylcholines may be used, and Lopez-Berestein
discloses that DEPC and DOPC may be used in a similar way
as egg PC and DSPC, it would have been obvious for one of
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5
skill in the art to use the DEPC and DOPC of Lopez-Berestein
in the Hersch formulations as an alternative.

(Id. at ll. 17-22 (emphasis added).) Stated differently, Hersch and Lopez-
Berestein both suggest the use of egg PC and DSPC as liposome
components , as well as other components useful in prepareing liposomes
(e.g., HSPC, DEPC, and DOPC); therefore, a person of ordinary skill in this
art at the time of Appellants’ claimed invention would have reasonably
considered HSPC, DEPC, and DOPC as alternative ingredients for the
formulation of the liposome suggested by the combination of references
relied upon by Examiner and would have reasonably expected these
ingredients to yield predictable results (see id.). “The combination of
familiar elements according to known methods is likely to be obvious when
it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 416 (2007). In this situation, since the references suggest
their use, “a person of ordinary skill has good reason to pursue the known
options within his or her technical grasp”. Id. at 421. “If this leads to the
anticipated success, it is likely the product not of innovation but of ordinary
skill and common sense. In that instance the fact that a combination was
obvious to try might show that is was obvious under § 103.” Id.
Accordingly, we are not persuaded by Appellants’ contention to the
contrary.
Because the references relied upon by Examiner are not limited to
their preferred embodiments we are not persuaded by Appellants’
contentions regarding Lopez-Berestein’s suggestion “that DMPG is the
preferred phosphatidylglycerol” and Hersch’s suggestion that “[o]ther
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phosphatidylglycerols that may be used are . . . (DMPG)” (Req. Reh’g 10-
11; Hersch, col. 5, l. 66 - col. 6, l. 2). Baird, 16 F.3d at 383.

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

REHEARING DENIED

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