Ex Parte ReichDownload PDFPatent Trial and Appeal BoardFeb 24, 201611761940 (P.T.A.B. Feb. 24, 2016) Copy Citation 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"). 2 Appeal2013-004531 Application 11/761,940 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 3 Appeal2013-004531 Application 11/761,940 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.) 4 Appeal2013-004531 Application 11/761,940 (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 5 Appeal2013-004531 Application 11/761,940 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.) 6 Appeal2013-004531 Application 11/761,940 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- 7 Appeal2013-004531 Application 11/761,940 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. 8 Appeal2013-004531 Application 11/761,940 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 9 Appeal2013-004531 Application 11/761,940 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 10 Appeal2013-004531 Application 11/761,940 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. 11 Appeal2013-004531 Application 11/761,940 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 12 Copy with citationCopy as parenthetical citation