Ex Parte Kreutzer et al

Patent Trial and Appeal Board

Nov 29, 2016

13753438 (P.T.A.B. Nov. 29, 2016)

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
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/753,438 01/29/2013 Roland Kreutzer 26421-22560 US 1062
77328 7590 12/01/2016
ALNYL AM/FENWICK
SILICON VALLEY CENTER
801 CALIFORNIA STREET
MOUNTAIN VIEW, CA 94041
EXAMINER
VIVLEMORE, TRACY ANN
ART UNIT PAPER NUMBER
1674
NOTIFICATION DATE DELIVERY MODE
12/01/2016 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROLAND KREUTZER and STEFAN LIMMER1
Appeal 2014-005642
Application 13/753,438
Technology Center 1600
Before FRANCISCO C. PRATS, RICHARD J. SMITH, and TAWEN
CHANG, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to an
oligoribonucleotide of double-stranded structure (dsRNA). We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real party in interest is Alnylam
Pharmaceuticals, Inc. (Appeal Br. 2.)
Appeal 2014-005642
Application 13/753,438
STATEMENT OF THE CASE
Claims on Appeal
Claims 1—15 are on appeal.2 (Claims Appendix, Appeal Br. 14—15.)
Claim 1 (emphasis added) and claim 9 are illustrative and read as follows:
1. An oligoribonucleotide of double-stranded structure (dsRNA) for
introduction into a mammalian cell and for inhibiting the expression of a
given target gene in a mammalian cell, wherein an amount of the dsRNA
introduced into the mammalian cell is less than an amount of RNA transcript
of the target gene in the mammalian cell, the dsRNA having 15 to 49 base
pairs and having a complementary region I that is incorporated in the
dsRNA, and wherein the complementary region I has not more than 49
nucleotide pairs.
9. The dsRNA of claim 1, wherein the dsRNA is capable of inhibiting
expression at a concentration of the dsRNA that is lower by one order of
magnitude than a concentration required for a corresponding single-stranded
oligoribonucleotide to inhibit expression.
Examiner’s Rejections
1. Claims 1—9, 12, and 13 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1 and 2 of U.S. Patent No.
7,198,8143 in view of Crooke4 and Wengel.5 6(Ans. 2.)
2. Claims 1, 7, and 9-11 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 11 and 26 of U.S. Patent No.
7,745,418.6 {Id. at 3.)
2 Claims 16—18 are withdrawn from consideration as being directed to a non-
elected invention. (Final Act. dated Sept. 13, 2013, at 2.)
3 Endo et al., US 7,198,814 B2, issued Apr. 3, 2007.
4 Crooke, US 6,107,094, issued Aug. 22, 2000 (“Crooke”).
5 Wengel, US 2003/0134808 Al, published July 17, 2003 (“Wengel”).
6 John et al., US 7,745,418 B2, issued June 29, 2010.
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3. Claims 1, 7—9, 12, and 13 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1 and 3 of U.S. Patent No.
7,829,693.7 (Id.)
4. Claims 1 and 7—12 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1, 5—8, 13, 17—19, 22, 23, 29,
and 30 of U.S. Patent No. 7,994,309.8 (Id.)
5. Claims 1—9, 12, and 13 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1—24 of U.S. Patent No.
8.101.742.9 (Id. at 3^1.)
6. Claims 1—13 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1—22 of U.S. Patent No.
8.114.981.10 (Id. at 4.)
7. Claims 1—9, 12, and 13 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1—6 and 9-16 of U.S. Patent
No. 8,183,362.* 11 (Id. at^U5.)
8. Claims 1, 7—9, 12, and 13 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1—17 of U.S. Patent No.
8,202,980.12 (Id. at 5.)
7 Kreutzer et al., US 7,829,693 B2, issued Nov. 9, 2010.
8 Kreutzer et al., US 7,994,309 B2, issued Aug. 9, 2011.
9 Kreutzer et al., US 8,101,742 B2, issued Jan. 24, 2012.
10 Kreutzer et al., US 8,114,981 B2, issued Feb. 14, 2012.
11 Kreutzer et al., US 8,183,362 B2, issued May 22, 2012.
12 Kreutzer et al., US 8,202,980 B2, issued June 19, 2012.
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9. Claims 1 and 7—12 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1, 5—8, 14, 18—20, 30, and 31
of U.S. Patent No. 8,273,870.13 (Id. at 5-6.)
10. Claims 1, 7, and 9-11 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 9 and 22 of U.S. Patent No.
8,273,868.14 (Id. at 6.)
11. Claim 14 stands rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112
(pre-AIA), second paragraph, as indefinite. (Id.)
12. Claims 1—5, 7—9, 12, 13, and 15 stand rejected under 35 U.S.C.
§ 102(e) as anticipated by Crooke. (Id. at 6—8.)
13. Claims 1—13 and 15 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Crooke, Sridhar,15 and Wengel. (Id. at 8—9.)
FINDINGS OF FACT
We adopt as our own the Examiner’s findings and analysis concerning
the scope and content of the prior art. The following findings are included
for emphasis and reference convenience.
FF 1. The Examiner finds that Crooke teaches “oligomeric
compounds that bind to a target RNA strand and are substrates for dsRNase
enzymes,” and that the “oligomeric compounds include oligoribonucleotides
and other oligomeric compounds having a linear sequence of linked
ribonucleoside subunits incorporated therein.” (Ans. 6, citing Crooke col.
12.)
13 Kreutzer et al., US 8,273,870 B2, issued Sept. 25, 2012.
14 John et al., US 8,273,868 B2, issued Sept. 25, 2012.
15 Sridhar et al., US 5,739,271, issued Apr. 14, 1998 (“Sridhar”).
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FF 2. Crooke teaches that the compounds of the invention are “useful
for therapeutics, diagnostics and as research reagents.” (Crooke col. 1,11.
24—27.)
FF 3. Crooke teaches that “[i]t is more preferred that the
oligoribonucleotides and oligoribonucleosides of the present invention
comprise from about 15 to about 25 nucleoside subunits.” (Crooke col. 14,
11. 13-16.)
FF 4. The Examiner finds that
While Crooke does not explicitly disclose use of his compounds
to inhibit gene expression or that these compounds are capable
of inhibiting expression at a concentration one order of
magnitude lower than a single stranded compound, because
Crooke discloses compounds satisfying the structural limitations
of the claims, these characteristics are assumed in the absence of
factual evidence to the contrary to be inherent to the structure.
(Ans. 7—8.)
FF 5. The Examiner finds that “use of liposomes as a vehicle for
delivering nucleic acids to cells was well known at the time the invention
was made” and that “liposomes are useful for intracellular delivery of
oligonucleotides for diagnostic purposes.” (Ans. 9, citing Sridhar Abstract;
col. 1,1. 53-col. 2,1. 13.)
DISCUSSION
We adopt and agree with the Examiner’s findings, analysis, and
conclusions set forth in the Final Action (Final Act. 3—13) and Examiner’s
Answer (Ans. 2—14). The rejections are affirmed, and Appellants’
arguments are addressed below.
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Rejection Nos. 1—11
Appellants do not contest the rejections for obviousness-type double
patenting (Nos. 1—10) or the rejection for indefiniteness (No. 11).
Accordingly, those rejections are affirmed. See 37 C.F.R. § 41.37(c)(l)(iv);
Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008).
Rejection No. 12—Anticipation
Issue
Whether a preponderance of evidence of record supports the
Examiner’s finding of anticipation under 35 U.S.C. § 102(e).
Principles of Law
A claim is anticipated if a prior art reference discloses every limitation
of the claimed invention, either explicitly or inherently. In re Schreiber, 128
F.3d 1473, 1477 (Fed. Cir. 1997). In considering the disclosure of a
reference for anticipation, “it is proper to take into account not only specific
teachings of the reference but also the inferences which one skilled in the art
would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d
825, 826 (CCPA 1968). “Under the principles of inherency, if the prior art
necessarily functions in accordance with, or includes, the claimed
limitations, it anticipates.” MEHL/Biophile Int’l Corp. v. Milgraum, 192
F.3d 1362, 1365 (Fed. Cir. 1999).
Analysis
Appellants argue that neither claim 1 nor claim 9 are anticipated by
Crooke. (Appeal Br. 3—6; Reply Br. 2—5.)
Claim 1
Appellants argue that Crooke does not teach each and every limitation
of the claimed invention because “Crooke does not disclose a dsRNA for
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introduction into a mammalian cell and for inhibiting the expression of a
given target gene in the cell, wherein the amount of dsRNA is less than an
amount of RNA transcript of the target gene in the cell. ” (Appeal Br. 4.)
Appellants argue further that “an amount of Crooke’s RNA duplex substrate
is not disclosed in Crooke at all.” (Id.)
Appellants also challenge the finding that the italicized wherein clause
in claim 1 relates to an intended use of the claimed compound, arguing that
“the amount of dsRNA is not an intended use of the dsRNA . . . but refers to
an amount or a physical limitation associated with the claimed dsRNA.” (Id.
at 5.) Appellants argue further that, while claim 1 “recites ‘introduced into’
language that sounds like a use,” the “claim language merely specifies the
conditions by which the amount (physical aspect) is measured.” (Id.)
We are not persuaded. “[T]he patentability of apparatus or
composition claims depends on the claimed structure, not on the use or
purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com,
Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Appellants’ claim 1 is to a
composition of matter, i.e., an oligoribonucleotide of double-stranded
structure (dsRNA). (Appeal Br. 14.) Moreover, the claim language
“wherein an amount of the dsRNA introduced into the mammalian cell is
less than an amount of RNA transcript of the target gene in the mammalian
cell ” refers to the intended use of the dsRNA; namely, “for introduction into
a mammalian cell and for inhibiting the expression of a given target gene in
a mammalian cell.” (Id.) That the italicized phrase fails to recite a structural
limitation is further evidenced by the fact that the recited “amount” of
dsRNA depends on the amount of RNA transcript, i.e., depending on the use
of the claimed dsRNA. (Id.)
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We acknowledge, but are unpersuaded by, Appellants’ analogies to
the size of a widget or amount of a liquid (Appeal Br. 5), and Appellants’
arguments based on In re Lemin, 326 F.2d 437 (CCPA 1964) and In re
Wiggins, 397 F.2d 356 (CCPA 1968) (Reply Br. 2—5). The “amount of the
dsRNA” recited in claim 1 relates to an intended use and does not become a
structural limitation simply because of the word “amount.”16
We agree with the Examiner’s finding that Crooke discloses each and
every limitation of claim 1. Moreover, the argument that Crooke does not
disclose a dsRNA for introduction into a mammalian cell or an amount of its
RNA duplex structure (i.e., use of dsRNA for the same use as recited in
claim 1) does not overcome the anticipation finding. See Schreiber, 128
F.3d at 1475—77 (claim to a dispensing top for popcorn anticipated by patent
disclosing a spout useful for dispensing oil from an oil can).
Claim 9
Appellants argue that Crooke does not anticipate dependent claim 9
because “Crooke does not satisfy the structural limitations of the claims”
and, therefore, “a dsRNA capable of inhibiting expression at a particular
concentration is not inherent in Crooke.” (Appeal Br. 6.) We are not
persuaded. The contention that the claimed dsRNA is “capable” of
inhibiting expression does not impart patentable weight since the structure is
already known. See Schreiber, 128 F.3d at 1477. And because Crooke
discloses the claimed structure, Crooke’s dsRNA will necessarily have the
16 We do not agree with Appellants’ contention, based on Lemin and
Wiggins, that an amount recited in a composition claim is necessarily a
“physical limitation.” (Reply Br. 2—5.) See, e.g., Syntex (U.S.A.) LLC v.
Apotex, Inc., 407 F.3d 1371, 1378 (Fed. Cir. 2005) (construing the term “in a
stabilizing amount” in a drug formulation claim as not a limitation).
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same inherent property as recited in claim 9. (FF 4.) See MEHL/Biophile,
192 F.3d at 1365; In re Pearson, 494 F.2d 1399, 1403 (Fed. Cir. 1974)
(“These terms merely set forth the intended use for, or a property inherent in,
an otherwise old composition.”).
Conclusion
A preponderance of evidence of record supports the Examiner’s
finding that claims 1 and 9 are anticipated under 35 U.S.C. § 102(e). Claims
2—5, 7, 8, 12, 13, and 15 were not argued separately and fall with claim 1.
Rejection No. 13—Obviousness
Issue
Whether a preponderance of evidence of record supports the
Examiner’s conclusion of obviousness under 35 U.S.C. § 103(a).
Analysis
Appellants contest the obviousness rejection with respect to claims 1,
10, 11, and 15. (Appeal Br. 6—12; Reply Br. 5—7.) However, “anticipation
is the epitome of obviousness.” In re McDaniel, 293 F.3d 1379, 1385 (Fed.
Cir. 2002) (citations omitted). Accordingly, as to claims 1 and 15 that are
anticipated by Crooke, we affirm their rejection for obviousness as well.
Claims argued by Appellants that were not subject to the anticipation
rejection include claim 10 (dependent on claim 1) that recites “wherein the
dsRNA is enclosed by a micellar structure,” and claim 11 (dependent on
claim 10) that recites “wherein the micellar structure comprises a liposome.”
(Appeal Br. 15.) The Examiner cites Sridhar for teaching liposomes as a
vehicle for delivering nucleic acids to cells (FF 5), and concludes that
“[bjecause those of ordinary skill in the art were aware that liposomes are a
convenient delivery vehicle for nucleic acids, it would have been obvious to
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incorporate artificial nuclease substrates into liposomes in order to obtain the
advantages of liposome encapsulation.” (Ans. 9.)
Claim 10
Appellants argue that “Crooke did not present or express a desire to
present RNA duplexes into a cellular system” and, thus, “[o]ne skilled in the
art would not put the RNA duplexes of Crooke into liposomes, since there is
no reason or motivation to deliver Crooke’s RNA duplexes into cells.”
(Appeal Br. 9; see also Reply Br. 5—7.) Appellants also argue that “Crooke
only produced RNA duplexes to test whether the duplexes would be cleaved
in the presence of rat liver extracts” (Appeal Br. 9), and that “the skilled
artisan would have understood that it was necessary to introduce only a
single-stranded structure into the cell to cause degradation of the target
mRNA” (Id. at 10).
We are not persuaded. A prior art reference may be read for all that it
teaches, including uses beyond its primary purpose. In re Mouttet, 686 F.3d
1322, 1331 (Fed. Cir. 2012). Moreover, “[i]n determining whether the
subject matter of a patent claim is obvious, neither the particular motivation
nor the avowed purpose of the patentee controls,” KSR Int 7 Co. v. Teleflex
Inc., 550 U.S. 398, 419 (2007), and “[o]ne of ordinary skill in the art need
not see the identical problem addressed in a prior art reference to be
motivated to apply its teachings” Cross Med. Prods., Inc. v. Medtronic
Sofamor Danek, Inc. 424 F.3d 1293, 1323 (Fed. Cir. 2005). Furthermore,
evaluating suggestion or motivation in an obviousness analysis “not only
permits, but requires, consideration of common knowledge.” DyStar
Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d
1356, 1367 (Fed. Cir. 2006).
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Accordingly, we do not find that Crooke’s teachings are so limited as
argued by Appellants.17 Here, Crooke teaches that its compounds “are
useful for therapeutics, diagnostics and as research reagents” (FF 2) and
Appellants concede that “Crooke is not limited only to extracellular uses”
(Appeal Br. 9).
Given that Crooke’s compounds are useful for diagnostics (FF 2), and
Sridhar’s teaching that liposomes “can effectively be used for the
intracellular delivery of biomolecules for . . . diagnostic purposes” (Sridhar
Abstract), which was common knowledge in the art (FF 5), we find the
claimed invention to be the “predictable use of prior art elements according
to their established functions.” KSR, 550 U.S. at 417. Moreover, a person of
ordinary skill in the art would have been motivated to combine the dsRNA
of Crooke with the liposomes (micellar structures) of Sridhar “in order to
obtain the advantages of liposome encapsulation.” (Ans. 9.)
Claim 11
Appellants repeat the arguments advanced in connection with claim
10, and they are unpersuasive as to claim 11 for the reasons set forth above.
Conclusion of Law
A preponderance of evidence of record supports the Examiner’s
conclusion that claims 1, 10, 11, and 15 are obvious under 35 U.S.C.
§ 103(a). Claims 2—9, 12, and 13 were not argued separately and fall with
claim 1.
17 We also acknowledge, but are unpersuaded by, Appellants’ argument that
Crooke “teaches away.” (Appeal Br. 8.) Crooke does not teach away
because it does not criticize, discredit, or otherwise discourage the claimed
invention. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
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SUMMARY
We affirm the rejections of all claims on appeal.
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).
AFFIRMED
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