Ex Parte Low et al

Patent Trials and Appeals Board

May 7, 2019

13700358 - (D) (P.T.A.B. May. 7, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/700,358 11/27/2012 Philip Stewart Low
105335 7590 05/09/2019
Barnes & Thornburg LLP (PRF)
11 S. Meridian Street
Indianapolis, IN 46204
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
3220-223498 5069
EXAMINER
CABRAL, ROBERTS
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
05/09/2019 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):
indocket@btlaw.com
otcpatent@prf.org
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PHILIP STEWART LOW and SCOTT POH
Appeal 2018-0063 80
Application 13/700,358 1
Technology Center 1600
Before DEMETRA J. MILLS, ROBERT A. POLLOCK, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
LA VIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants seek review of the
Examiner's rejections of claims 44-62.2 We have jurisdiction under 35
U.S.C. § 6(b).
For the reasons set forth below, we AFFIRM.
1 Appellants identify the real party in interest as Purdue Research
Foundation. Appeal Br. 2.
2 Claim 12 is listed among the rejected claims in the Answer (see Ans. 2),
but claim 12 is withdrawn (see Appeal Br. 2).
Appeal 2018-0063 80
Application 13/700,358
BACKGROUND
The Specification describes using folate-receptor targeted agents in
the treatment of inflammatory disease, including folate-targeted liposomes.
See Spec. 1 :7-14. Claim 61 is illustrative:
61. A liposomal composition comprising
(i) an anti-inflammatory agent and
(ii) a lipid bilayer comprising a folate-targeting conjugate
compnsmg
(a) a lipid having a polar head group and a hydrophobic
tail,
(b) a hydrophilic polymer having a first end and a second
end, said polymer attached at its first end to the head
group of the lipid, and
( c) a folate ligand attached to the second end of the
polymer, wherein the folate ligand is a folic acid residue
or an analog or derivative thereof, and
wherein the liposomal composition is electrically neutral or
negatively charged.
Appeal Br. 25 (Claims Appendix) (some formatting added).
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Application 13/700,358
REJECTIONS MAINTAINED ON APPEAL
1. Claims 44-46, 48-56, 61, and 62 stand rejected under 35
U.S.C. § 103(a) as unpatentable over Lee3 and Lakkaraju.4 Final
Action 2; Ans. 2.
2. Claims 47 and 57-60 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Lee, Lakkaraju, and Ng. 5 Final Action 6-7; Ans.
2.
DISCUSSION
A. Rejection 1
Appellants argue the claims subject to Rejection 1 as a group, except
that they present additional arguments with respect to claim 48. See Appeal
Br. 5. Accordingly, we treat claim 61 as representative as to the general
arguments, and address the additional arguments regarding claim 48
separately. See 37 C.F.R. § 41.37(c)(l)(iv).
1. Claim 61
The Examiner finds that Lee teaches folate-PEG-liposomes. See Final
Action 3 (citing Lee 136). The Examiner also finds:
Although Lee et al. does not expressly illustrate the orientation
of the folate-PEG-liposomes (a) and (b) as recited in claim
6l(ii)(a)-( c ), such orientations would be understood by an
3 Robert J. Lee & Philip S. Low, Folate-Mediated Tumor Cell Targeting of
Liposome-Entrapped Doxorubicin In Vitro, 1233 BIOCHIMICA ET
BIOPHYSICAACTA 133-144 (1995).
4 Lakkaraju et al., US 2003/0026831 Al, published Feb. 6, 2003.
5 Ng et al., US 2011/0237686 Al, published Sept. 29, 2011.
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Application 13/700,358
ordinarily skilled artisan based on the nature of the amphiphilic,
and noncationic or cationic nature of the recited materials
and/or nomenclature.
Insofar as Lee et al. is silent with respect to "wherein the
liposomal composition is electrically neutral or negatively
charged," Lee et al. 's folate-PEG-liposomes would be expected
to be electrically neutral or negatively charged because they
comprises the same materials and combination as recited by the
instant claims. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d
1655, 1658 (Fed. Cir. 1990) ("Products of identical chemical
composition cannot have mutually exclusive properties.") [.]
Final Action 3 (footnote omitted).
As Lee does not teach an anti-inflammatory (see id.), the Examiner
turns to Lakkaraju. See id. at 3-4. The Examiner finds that Lakkaraju is
directed generally to "anionic liposomes for delivery of bioactive agents"
(id. at 3 ( quoting Lakkaraju Title)), including "an anti-inflammatory agent"
(id. (quoting Lakkaraju ,i 56)). The Examiner further notes that Lakkaraju
teaches that its compositions can be targeted to any site in animal tissue,
including tumors or growths. Id. at 4 ( citing Lakkaraju ,i 127).
The Examiner finds it would have been obvious to modify the
liposomes of Lee by adding an anti-inflammatory agent as taught by
Lakkaraju, "to incorporate an anti-inflammatory therapeutic feature." Id. at
4; see also Ans. 4. The Examiner also finds that the motivation to combine,
and reasonable expectation of success, comes from Lakkaraju expressly,
specifically the "teaching and recognition of anionic liposomes that have
been used for targeting delivery of therapeutic agents that may includ[ e]
anti-inflammatory agents in combination with other agents and for targeting
to tumors and growths." Id.
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Application 13/700,358
Having considered Appellants' arguments (see generally Appeal Br.
5-18), we are not persuaded of any reversible error by the Examiner in
rejecting claim 61 over Lee and Lakkaraju. Appellants' assertion that the
liposomal composition of Lee and the anti-inflammatory agent of Lakkaraju
do not have the same function, and as such there is no valid basis articulated
by the Examiner for the combination of the cited references. See id. 9-10.
This is not persuasive, as the record includes a finding by the Examiner to
support the combination: that the ordinarily skilled artisan would have been
motivated by a desire to "incorporate an anti-inflammatory therapeutic
feature" in Lee's liposome. Final Action 4; see also Ans. 4.
Appellants attempt to undermine the Examiner's reliance on
Lakkaraju, noting that it "does not teach the type of selective targeting
described by Lee." Appeal Br. 10; see also Reply Br. 4-5. This is not
persuasive because the Examiner relies on the targeting mechanism of Lee
(i.e., folate), not Lakkaraju. See Final Action 3. To be sure, the Examiner
mentions Lakkaraju's general teaching of targeting its compositions to
tumors (see id. at 3-4 (citing Lakkaraju ,i 127)), but this goes to the rationale
for combining the references (see id. at 4), and does not imply that the
rejection relies on Lakkaraju for the manner in which the combined
references would accomplish the claimed targeting. 6,7 See In re Keller, 642
6 Nor would it have made sense for the Examiner to have done so. Claim 61
recites a "folate-targeting conjugate," and only Lee, not Lakkaraju, teaches
targeting using folate.
7 Appellants also focus on the delivery mechanism of Lakkaraju and the
anionic nature of Lakkaraju's liposomes to argue against a reasonable
expectation of success in combining the references. See Appeal Br. 12-15.
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F.2d 413,426 (CCPA 1981) (citation omitted) ("But one cannot show non-
obviousness by attacking references individually where, as here, the
rejections are based on combinations of references."). Appellants' criticism
of Lee as providing "no working example with a tumor or an anti-
inflammatory agent" (Appeal Br. 12) likewise fails to persuade as it argues
Lee in isolation from the combination with Lakkaraju. Furthermore, the
teachings of a reference are not limited to working examples; rather, a
reference is prior art for all that it teaches or suggests. See In re Mills, 470
F .2d 649, 651 ( CCP A 1972) ( citations omitted) ("All the disclosures in a
reference must be evaluated, including nonpreferred embodiments."); In re
Lemelson, 397 F.2d 1006, 1009 (CCPA 1968) ("The use of patents as
references is not limited to what the patentees describe as their own
inventions or to the problems with which they are concerned. They are part
of the literature of the art, relevant for all they contain.").
Also, we cannot agree with Appellants (see Appeal Br. 12) that the
different targeting mechanisms of Lakkaraju and Lee amount to a teaching
away from combining the references, or suggest impermissible hindsight.
Appellants point to an embodiment of Lakkaraju in which the bioactive
agent is an oligonucleotide that targets a specific mRNA, and argue that "if a
bioactive agent having binding affinity to some protein or receptor is
incorporated into the liposome taught by Lakkaraju, then it would be argued
by Lakkaraju that the liposome will move to that 'target."' Appeal Br. 11
( discussing Lakkaraju ,i 251 ). But it does not follow from this one example
As the Examiner relies on Lee, not Lakkaraju, for these features, these
arguments are equally unpersuasive.
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that the many bioactives contemplated in Lakkaraju ( especially non-
oligonucleotides) also have targeting properties. Without further evidence,
Appellants' inference amounts to inadequately supported attorney argument.
Accordingly, Appellants have not shown persuasively that combining an
anti-inflammatory of Lakkaraju with Lee's liposome would interfere with
the folate-targeting capabilities described in Lee.
Appellants' assertions of unexpected results (see Appeal Br. 15-18)
likewise do not persuade us of any reversible error by the Examiner. The
characterization of these results as "unexpected" (Appeal Br. 15) appears to
be unsupported attorney argument: Appellants offer no citations to the
Specification or other evidence indicating that the results were considered
unpredictable or surprising, and we discern none. See In re Pearson, 494
F.2d 1399, 1405 (CCPA 1974) ("Attorney's argument in a brief cannot take
the place of evidence."). Indeed, Appellants' unexpected results argument
seems to tum on the Examiner's alleged failure to establish a prima facie
case, rather than some independent showing:
As discussed above, the references cited by the Examiner
do not teach or suggest treating inflammation with an
electrically neutral or negatively charged folate-targeting
liposomal composition. As such, the therapeutic activity
exhibit by the claimed liposomal compositions, as evidenced by
the instant specification, is unexpected.
Appeal Br. 18. This is also not persuasive. As explained above, Appellants
have not persuaded us of any reversible error in the Examiner's prima facie
case of obviousness of claim 61. Accordingly, the burden shifts to
Appellants to present persuasive evidence of secondary considerations ( such
as unexpected results) to rebut the prima facie case. See In re Oetiker, 977
F.2d 1443, 1445 (Fed. Cir. 1992). Appellants have not satisfied this burden.
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Accordingly, we affirm the Examiner's rejection of claim 61. Claims
44-46, 49-56, and 62 are not separately argued, and fall with claim 61. See
37 C.F.R. § 41.37(c)(l)(iv).
2. Claim 48
Claim 48, which depends from claim 61, recites:
48. The liposomal composition of claim 61 wherein the anti-
inflammatory agent is a drug useful in the treatment of
rheumatoid arthritis or another autoimmune disease including
an antiproliferative, immunomodulator or immunosuppressant
agent.
Appeal Br. 23 (Claims Appendix). The Examiner finds that the additional
limitation of claim 48 is an intended use, and not a structural limitation of
the claim. Final Action 6. Appellants argue claim 48 further limits the
structure of claim 61 "because not all anti-inflammatory agents are useful in
the treatment of rheumatoid arthritis or another autoimmune disease .... "
Appeal Br. 19.
"A mere statement of a new use for an otherwise old or obvious
composition cannot render a claim to the composition patentable." In re
Zierden, 411 F.2d 1325, 1328 (CCPA 1969). In describing the "anti-
inflammatory agent" as "a drug useful in the treatment of rheumatoid
arthritis or another autoimmune disease," Appellants have recited what the
anti-inflammatory agent is intended to do (i.e., what it is "useful" for), not
what it is. This is true notwithstanding the open-ended examples of
particular functional mechanisms ("antiproliferative, immunomodulatory or
immunosuppressant agent[ s ]") at the conclusion of claim 48.
Independently, the Examiner also finds that it would have been
obvious for the ordinarily skilled artisan to have contemplated the anti-
inflammatories of Lakkaraju to be useful in the treatment of rheumatoid
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arthritis or other autoimmune diseases. Final Action 6. Appellants
characterize this finding as a "conclusory allegation." Appeal Br. 19. We
are not persuaded, as this argument presumes that the ordinarily skilled
artisan would not have understood rheumatoid arthritis or other autoimmune
diseases to be related to inflammation. As the Examiner points out:
one of ordinary skill in the art would have known that
"[i]nflammation is closely linked to cancer, and many anti-
cancer agents are also used to treat inflammatory diseases, such
as rheumatoid arthritis. Moreover, chronic inflammation
increases the risk for various cancers, indicating that
eliminating inflammation may represent a valid strategy for
cancer prevention and therapy."
Ans. 4 ( quoting Rayburn8 Abstract). Indeed, this passage of Rayburn not
only categorizes rheumatoid arthritis as an inflammatory disease, but further
teaches the "close[] link[]" between inflammation and cancer, and suggests
an approach to treating or preventing cancer by eliminating inflammation.
Accordingly, Appellants' additional arguments regarding claim 48
have not persuaded us of any reversible error by the Examiner in rejecting
claim 48. We affirm the rejection of claim 48.
B. Rejection 2
For Rejection 2, Appellants argue only that the additional reference
relied on by the Examiner for Rejection 2, Ng, fails to cure the alleged
deficiencies of Lee and Lakkaraju. See Appeal Br. 20. For the reasons
discussed above with respect to Rejection 1, we are not persuaded of any
8 Rayburn et al., Anti-Inflammatory Agents for Cancer Therapy, I MOL.
CELL PHARMACOL. 29-43 (2009).
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reversible errors in the Examiner's reliance on Lee and Lakkaraju.
Accordingly, we affirm the rejection of claims 47 and 57-60.
CONCLUSION
We affirm Rejections 1 and 2. No time period for taking any
subsequent action in connection with this appeal may be extended under 37
C.F.R. § l.136(a)(l )(iv).
AFFIRMED
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