Ex Parte Reich

Patent Trial and Appeal Board

Feb 24, 2016

11761940 (P.T.A.B. Feb. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111761,940 06/12/2007 Samuel Jotham Reich
21269 7590 02/25/2016
PEPPER HAMIL TON LLP
500 GRANT STREET
SUITE 5000
PITTSBURGH, PA 15219-2507
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.
140613.01301 1867
EXAMINER
MCGARRY, SEAN
ART UNIT PAPER NUMBER
1674
MAILDATE DELIVERY MODE
02/25/2016 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 SAMUEL JOTHAM REICH 1
Appeal2013-004531
Application 11/761,940
Technology Center 1600
Before JEFFREYN. FREDMAN, ULRIKE W. JENKS, and
RICHARD J. SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of decreasing foveal thickness. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellant, the real party in interest is OPKO
PHARMACEUTICALS, LLC. (Appeal Br. 2.)
Appeal2013-004531
Application 11/761,940
STATEMENT OF THE CASE
Claims on Appeal
Claims 37--46 and 84 are on appeal. (Appeal Br. 18-19.) Claims 37
and 84 are illustrative and read as follows (emphasis added):
37. A method of decreasing foveal thickness in a subject in need thereof
comprising administering to the subject an effective amount of an siRNA
comprising a sense RNA strand of SEQ ID NO: 77 and an antisense RNA
strand of SEQ ID NO: 78.
84. The method of claim 37, wherein the siRNA consists of a sense RNA
strand of SEQ ID NO: 77 and an antisense RNA strand of SEQ ID NO: 78.
Examiner's Rejections
1. Claims 37--46 and 84 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1-25, 29, 32, 34, 35, 38, and
40-67 of U.S. Patent No. 7,345,027.2 (Ans. 5.)
2. Claims 37--46 and 84 stand rejected under 35 U.S.C. § 103(a) as
obvious over Vargeese3 in viev,r of Rosenfeld. 4 (ii .. ns. 6.)
As to the double patenting rejection, Appellant presented arguments
for the patentability of claims 37--46 and 84 as a group. (Appeal Br. 5-10.)
Therefore, we limit our discussion to claim 37 as representative of those
claims.
2 Tolentino et al., US Patent No. 7,345,027 B2, issued Mar. 18, 2008
("Tolentino").
3 Vargeese et al., US 2006/0217332 Al, published Sept. 28, 2006
("Vargeese").
4 Rosenfeld et al., Maximum Tolerated Dose of a Humanized Anti-Vascular
Endothelial Growth Factor Antibody Fragment for Treating Neovascular
Age-Related Macular Degeneration, 112 OPTHAMOLOGY 6, 1048-1053
(2005) ("Rosenfeld").
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As to the obviousness rejection, Appellant presented arguments for
the patentability of claims 37--46 as a group, and we limit our discussion to
claim 37 as representative of those claims. Appellant argues claim 84
separately.
FINDINGS OF FACT
We adopt the Examiner's findings and analysis as our own. The
following findings are included for emphasis and reference convenience.
FF 1. Claim 29 of Tolentino reads as follows (emphasis added):
29. A method of treating an angiogenic disease in a subject
comprising: administering to a subject an effective amount of a
short interfering ribonucleic acid (siRNA) comprising a sense
RNA strand and an antisense RNA strand, wherein the sense
and the antisense RNA strands form an RNA duplex, and
wherein the sense RNA strand comprises a nucleotide sequence
identical to a target sequence of about 19 to about 25
contiguous nucleotides in human vascular endothelial growth
factor (VEGF) mRNA, and wherein the sense RNA strand
comprises SEQ ID NO: 77 and the antisense strand comprises
SEQ ID NO: 78, such that angiogenesis associated with the
angiogenic disease is inhibited.
(Tolentino, col. 56, 11. 40-53.)
FF 2. Claim 32 of Tolentino recites "[t]he method of claim 29, wherein the
angiogenic disease is selected from the group consisting of diabetic
retinopathy, age-related macular degeneration, and inflammatory diseases."
(Tolentino, col. 56, 11. 64---67 .) (emphasis added).
FF 3. The Specification teaches that
Diabetic macular edema (DME), also called diabetic
retinopathy, is a complication of the chronically high blood
sugar afflicting diabetics. It is caused by leakiness of retinal
blood vessels and the growth of new blood vessels on the
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retina, optic nerve and the iris. The leaky blood vessels result
in swelling of the retina and visual loss. The new blood
vessels that grow on the optic nerve and retina can also bleed,
resulting in severe visual loss. In addition, new blood vessels
in the iris clog the drain of the eye and can result in
extremely high pressure in the eye with accompanying intense
pain and the potential loss of the eye.
(Spec. ii 35.)
FF 4. The Specification teaches that "[i]n another embodiment of the
invention, the foveal thickness of a subject diagnosed with diabetic
macular edema is decreased by administering to the subject an siRNA
targeting VEGF."5 (Spec. ii 83.)
FF 5. The Examiner finds that foveal thickening is a characteristic of
DME/diabetic retinopathy. (Ans. 7, 16.)
FF 6. Vargeese teaches nucleic acid molecules (sequences) for use in
inhibiting vascular endothelial growth factor (VEGF) and/or vascular
endothelial growth factor receptor (VEGFR). (Vargeese, Tables II and III.)
FF 7. Vargeese teaches methods of treating ocular disease, such as diabetic
retinopathy/DME, and angiogenesis disease or conditions, by administration
of a molecule taught by Vargeese. (Vargeese, i-fi-1215, 219, 227, and 862.)
FF 8. The Examiner finds that Vargeese teaches that, in any of its methods,
the molecule can be administered alone or in combination with additional
therapies. (Ans. 7, 18; Vargeese, ii 234.)
FF 9. The Examiner finds that one of the molecules taught by Vargeese is
SEQ ID NO: 3867, which is the same sequence as claimed SEQ ID NO: 77.
5 VEGF stands for vascular endothelial growth factor. (Spec. i-f 31.)
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(Ans. 7; Vargeese Table Ill; Spec. if 61, Table 1- VEGF Target Sequences.)
FF 10. Vargeese teaches that one of the nucleic acid sequences (Sima-027)
has been shown to decrease foveal thickness in patients treated with Sima-
027. (Vargeese, iii! 422, 772.)
FF 11. Rosenfeld discloses the use of ranibizumab for treating neovascular
age-related macular degeneration. (Rosenfeld, 1048.)
ISSUES
Whether a preponderance of evidence of record supports the
Examiner's conclusion of (1) obviousness-type double patenting, and (2)
obviousness under 35 U.S.C. § 103(a).
DISCUSSION
Obviousness-Type Double Patenting
Principles of Law
Obviousness-type double patenting prohibits the issuance of claims in
a second patent that are "not patentably distinct from the claims of the first
patent." In re Langi, 759 F.2d 887, 892 (Fed.Cir. 1985) (citations omitted).
"A later patent claim is not patentably distinct from an earlier patent claim if
the later claim is obvious over, or anticipated by, the earlier claim." Eli Lilly
& Co. v. Barr Labs., Inc., 251F.3d955, 968 (Fed.Cir. 2001) (citations
omitted).
Analysis
The Examiner found that claim 37 is not patentably distinct from the
cited Tolentino claims because they are both drawn to the use of the same
siRNA compound in treating angiogenic disease. (Ans. 5; FF 1.) The
Examiner points to claim 32 of Tolentino which identifies the angiogenic
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disease as including diabetic retinopathy and age-related macular
degeneration. (Id.; FF 2.) The Examiner also points to paragraphs 35 and
83 of the Specification to show that DME and diabetic retinopathy are the
same (FF 3), and that the Tolentino claims and the present claims are drawn
to the administration of the same siRNA to patients with DME/diabetic
retinopathy (FF 2, 4). (Ans. 13.) Based on the foregoing, we find that the
Examiner has established a prima facie case of obviousness-type double
patenting and, as discussed below, Appellant's arguments do not overcome
that prima facie case.
Appellant argues that the double patenting rejection must be
withdrawn "because the Office has failed to do the proper analysis."
(Appeal Br. 5, 9.) According to Appellant, the Examiner was required to
follow the analysis set forth in Graham v. John Deere Co., 383 U.S. 1
(1966). (Id. at 5-7.) We are not persuaded. An obviousness-type double
patenting rejection is "similar to, but not necessarily the same as, that
undertaken under 35 U.S.C. § 103." In re Basel! Poliolefine Italia SP.A.,
547 F.3d 1371, 1379 (Fed. Cir. 2008) (quoting In re Braat, 937 F.2d 589,
592-93 (Fed. Cir. 1991). The court in Bassel! thus rejected the notion that
the Office is required to conduct a full Graham analysis in connection with a
double patenting rejection. Id. ("we find no basis for reversing the Board's
decision merely because the Board failed to expressly set forth each of the
Graham factors in its analysis.") Here, the Examiner clearly articulated the
reasons why claim 37 is not patentably distinct from the cited Tolentino
claims consistent with a proper double-patenting rejection. (Ans. 5---6; 12-
15.)
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Appellant also takes issue with the statement in the Examiner's
Answer that "the treatment of one having diabetic retinopathy via the step of
administering an siRNA would anticipate a method of inhibiting foveal
thickening in a subject in need thereof via the administration of the same
siRNA." (Reply Br. 2, citing Ans. 13.) Appellant interpreted this statement
as meaning that the claims were anticipated, and replied by arguing that the
phrase "in need thereof' was limiting and thereby avoided anticipation.
(Reply Br. 2-5.)
We are not persuaded by Appellant's arguments. As an initial matter,
this is an obviousness-type double patenting rejection and the Examiner's
statement did not introduce an anticipation rejection under 35 U.S.C. § 102.
Furthermore, as the Examiner explains in the sentence following the one
quoted by Appellant, "[fJor example the same siRNA is utilized, both
methods include one step, which is administering the siRNA, and a subject
with diabetic retinopathy/DME is clearly one in need [of decreasing foveal
thickness]." (Ans. 13-14.) Thus, while "Appellants [sic] do not agree that
foveal thickening is a characteristic of every subject with DME" (Reply Br.
5.), Appellant acknowledges the correlation or linkage between treating a
subject with DME and reducing foveal thickness. (FF 4.) Accordingly, a
claim to a method of decreasing foveal thickening is not patentably distinct
from a claim to the same method used to treat DME, where at least some of
the DME subjects are in need of decreasing foveal thickness. See, e.g.,
Abbvie Inc. v. Mathilda and Terence Kennedy Institute of Rheumatology
Trust, 764 F.3d 1366, 1378 (Fed. Cir. 2014) (claims to treatment of a subset
of patients with more severe rheumatoid arthritis invalid for obviousness-
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type double patenting over claims to treatment of rheumatoid arthritis
patients generally).
Conclusion of Law
A preponderance of evidence of record supports the Examiner's
conclusion that claim 37 is unpatentable on the ground of nonstatutory
obviousness-type double patenting over claims 1-25, 29, 32, 34, 35, 38, and
40-67 of Tolentino. Claims 38--46 and 84 were not argued separately and
fall with claim 3 7.
Obviousness Under 35U.S.C.§103(a)
Principles of Law
The Examiner bears the initial burden of establishing a prima facie
case of obviousness. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Analysis
The Examiner concluded that claim 37 would have been obvious
based on the teachings of Vargeese of using siRNA compounds, including
the same siRNA as claimed, to target VEGF and to treat diabetic
retinopathy/DME. (Ans. 7.) The Examiner found that foveal thickening is a
characteristic of diabetic retinopathy/DME (FF 5). (Id.) The Examiner
concluded that claim 84 would also have been obvious because Vargeese
teaches that the compounds of the invention can be administered alone as a
monotherapy or in combination with additional therapies (FF 8). 6 (Id. at 18.)
6 The Examiner also cites to Rosenfeld for its teachings of ranibizumab (e.g.,
FF 11 ), and applies its teachings in combination with Vargeese with respect
to certain dependent claims (other than claim 84 ). (Ans. 11.) However,
because our discussion is limited to claims 3 7 and 84, Rosenfeld will not be
addressed further.
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We find that the Examiner has satisfied the burden of showing "some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007). Moreover, the Examiner has established a prima facie case of
obviousness and, as discussed below, Appellant has not overcome that prima
facie case.
Claim 37
Appellant argues that Vargeese discloses over four thousand siRNA
target sequences and that an siRNA that would correlate to the claimed SEQ
ID NO: 77 or 78 is just one of those thousands of sequences. (Appeal Br.
12.) Appellant also argues that the only sequence that Vargeese identifies as
reducing foveal thickness is Sima-027, and that "Sima-027 (SEQ ID NO:
3216) is not the same as SEQ ID NO: 77 or 78." (Appeal Br. 11-12.) It is
thus Appellant's position that the Examiner has not shown that one skilled in
the art would have selected an siRNA with the claimed sequence to decrease
foveal thickness in a subject in need thereof, or have had a reasonable
expectation of success in doing so. (Appeal Br. 12-15.) For the reasons
discussed below, we are not persuaded by Appellant's arguments.
Vargeese teaches a number of siRNA sequences that may be used to
treat diabetic retinopathy/DME, including a sequence that is the same as
claimed by Appellant. (FF 6, 7, 9.) Vargeese provides an example of one of
those sequences reducing foveal thickening. (FF 10.) Appellant's
Specification acknowledges the linkage or correlation between DME and
foveal thickening; namely, the decrease in foveal thickness resulting from
the treatment of a subject diagnosed with DME. (FF 4.) Thus, the fact that
Vargeese discloses a number of siRNA sequences does not overcome a
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conclusion of obviousness, particularly because the claimed sequence is
disclosed in Vargeese. See Merck & Co., Inc. v. Biocraft Labs., Inc., 874
F.2d 804, 807 (Fed. Cir. 1989) ("That the [prior art] patent discloses a
multitude of effective combinations does not render any particular
formulation less obvious").
Appellant's argument regarding a reasonable expectation of success
is equally unpersuasive. Based on the teachings of Vargeese, one of skill in
the art would have had a reasonable expectation that the use of molecules
disclosed in Vargeese other than Sima-027 would have reduced foveal
thickness. (FF 6, 7, 9, 10.) Indeed, to hold otherwise would mean that the
use of any of the molecules disclosed by Vargeese would be separately
patentable simply because their respective properties must be verified
through testing. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed.
Cir. 2007).
Appellant states in the Reply Brief that "the issue is whether the
specific outcome of practicing the presently claimed method with a specific
intent, i.e., intending to decrease foveal thickness, would have been
obvious." (Reply Br. 8.) We understand Appellant's corresponding
argument to be that the preamble phrase "decreasing foveal thickness in a
subject in need thereof" is limiting in that one practicing the method would
know that the subject had foveal thickness and had the specific intention of
decreasing the foveal thickness. However, even if claim 37 were so limited,
it would not overcome the conclusion of obviousness. Foveal thickening is a
known symptom or condition associated with DME (FF 4, 5), and treating a
subject for DME with the claimed siRNA would inevitably decrease foveal
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thickness in those subjects for which such result is desired or intended.7 See
In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012) ("there is no
question here that treating stroke-prone patients with ramipril does in fact
inevitably treat or prevent stroke"). Moreover, this is an obviousness
rejection and Vargeese teaches and suggests the use of an siRNA with the
intention of reducing foveal thickness. (FF 6-10.)
Claim 84
Claim 84 uses the "consists of' transitional phrase to preclude the
presence of another siRNA molecule, such as Sima-027. (Appeal Br. 15-
16.); see Vehicular Tech Corp. v. Titan Wheel Int'!, Inc., 212 F.3d 1377,
1383 (Fed. Cir. 2000) ("In simple terms, a drafter uses the phrase 'consisting
of' to mean 'I claim what follows and nothing else."'). According to
Appellant, "the Office must explain why one of skill in the art would only
administer an siRNA molecule that consists of SEQ ID NO.: 77 and 78 in
the absence of Sima-027." (Id. at 16.) That explanation is straightforward-
Vargeese teaches that its molecules can be administered alone or in
combination with additional therapies. (FF 8.) Thus, for the reasons set
forth above in connection with claim 3 7, and this additional reason, we
affirm the rejection of claim 84.
7 Again, we recognize that Appellant does not agree that foveal thickening is
a characteristic of every subject with DME. (Reply Br. 5.) However, an
intent to treat a subject with DME, known or believed to have the associated
condition of foveal thickness, is an intent to decrease foveal thickness in a
subject in need thereof.
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Conclusion ofLaw
A preponderance of evidence of record supports the Examiner's
conclusion that claims 37 and 84 are obvious under 35 U.S.C. § 103(a).
Claims 38--46 were not argued separately and fall with claim 37.
SUMMARY
We affirm all rejections 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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