Ex Parte Esau et alDownload PDFPatent Trial and Appeal BoardJan 24, 201814596822 (P.T.A.B. Jan. 24, 2018) Copy Citation 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. 14/596,822 01/14/2015 Christine Esau 01138-0002-01US 3565 131817 7590 01/26/2018 Regulus Therapeutics / McNeill Baur 500 W. Silver Spring Drive, Suite K-200 Glendale, WI 53217 EXAMINER SHIN, DANA H ART UNIT PAPER NUMBER 1674 NOTIFICATION DATE DELIVERY MODE 01/26/2018 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): rebecca. scarr @ mcneillbaur. com eofficeaction @ appcoll.com docketing @ mcneillbaur. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CHRISTINE ESAU and SANJAY BHANOT1 Appeal 2017-004305 Application 14/596,822 Technology Center 1600 Before JEFFREY N. FREDMAN, TAWEN CHANG, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to methods for treating non-alcoholic fatty liver disease which have been rejected for non-statutory obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. STATEMENT OF THE CASE MicroRNAs (miRNAs) are noncoding RNA molecules which are believed to regulate the expression of genes by binding to the 3’-unsaturated 1 Appellants identify the Real Party in Interest as REGULUS THERAPEUTICS INC. Appeal Br. 3. Appeal 2017-004305 Application 14/596,822 regions of specific mRNAs. Spec. 1. MiR-122a is a miRNA expressed in the liver and is thought to be important in regulating the function of the liver. Spec. 2. The Specification describes a method for lowering serum cholesterol and triglyceride levels by administering an effective amount of as antisense compound complementary to miR-122a. Id. Claims 14, 15, 17, and 35—51 are on appeal. Claim 14 is illustrative and reads as follows: 14. A method of treating non-alcoholic fatty liver disease in a human comprising administering to a human with non-alcoholic fatty liver disease a therapeutically effective amount of an anti- sense compound having at least 90% nucleobase sequence complementarity to miR-122a (SEQ ID NO: 3). The claims stand rejected as follows: Claims 14, 15, 17, 35—45, 48, and 51 have been rejected for non- statutory double patenting over claims 1—37 of Esau I.2 Claims 14, 15, 35—45, 47, and 49—50 have been rejected for non- statutory double patenting over claim 1 of Bhat.3 Claims 49 and 50 have been rejected for non-statutory double patenting over claims of Esau I combined with Esau II.4 ESAU I Issue The issue with respect to this rejection is whether claims 14, 15, 35— 45, 48, and 51 are patentably distinct from claims 1—37 of Esau I. 2 Esau et al., US 8,969,314 B2, issued Mar. 3, 2015 (“Esau I”). 3 Bhat et al., US 9,309,513 B2, issued Apr. 12, 2016 (“Bhat”). 4 Esau et al., US 2005/0261218 Al, published Nov. 24, 2005 (“Esau II”). 2 Appeal 2017-004305 Application 14/596,822 Nonstatutory double patenting (also known as “obviousness-type double patenting”) prevents “issuance of a patent on claims that are nearly identical to claims in an earlier patent. This doctrine prevents an applicant from extending patent protection for an invention beyond the statutory term by claiming a slight variant.” Geneva Pharm., Inc. v. Glaxosmithkline, PLC, 349 F.3d 1373, 1377-78 (Fed. Cir. 2003). Obviousness-type double patenting entails a two-step analysis. First, the allegedly conflicting claims are construed and, second, the difference(s) between the claims are considered to determine whether the claims are patentably distinct. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968, 58 USPQ2d 1869, 1878 (Fed. Cir. 2001). “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.” Id. The Examiner finds that while the claims are not identical, the instant claims are not patentably distinct from the claims in Esau I in that the instant claims “are anticipated and encompassed by the ’314 patent claims drawn to a method of treating ‘nonalcoholic fatty liver disease’ or ‘non- alcoholic steatohepatitis’ comprising identical method steps as claimed in the instant case.” Non-Final Act.5 6 Appellants contends that Esau I is directed to an entirely different purpose than the instant claims and that the Examiner improperly ignore the preamble of claim 1 of Esau I. Appeal Br. 7—10. Appellants contend that the present claims are directed to a method for treating non-alcoholic fatty 5 Official Action mailed Aug. 24, 2015. 3 Appeal 2017-004305 Application 14/596,822 liver disease whereas the claims of Esau I are directed to a method for lowering serum cholesterol. Appeal Br. 7. Appellants contend that the Examiner has improperly read limitations into the claims of Esau I in that the Examiner reads the term therapeutically effective amount to include treating all of the disorders recited in the claims of Esau I. Appeal Br. 9. In response the Examiner contends the preambles of the claims were considered. Ans. 2. The Examiner contends that the claims of the instant application are patentably indistinguishable from the claims of Esau I in that they address the same patient population using the same amount of the same antisense compound. Ans. 3. The Examiner has the better argument. As the Examiner has shown, the patient population treated by the method of Esau I is indistinguishable from that treated by the claimed method. Ans. 3. While the method claimed in Esau I is directed to reducing serum cholesterol levels, claim 15 makes it clear that the patient population to be treated includes any animal which has “a disease or disorder selected from . . . nonalcoholic fatty liver disease.” Esau I claim 15. This is the same population treated by the instant claims which are directed to a method for treating nonalcoholic fatty liver disease in humans. Appeal Br. 14 (Claims App’x). The antisense compound and the amount administered are the same for both the method of Esau I and the method of the instant claims. Compare Esau I claim 1 with claim 14 above. Appellants contend the examiner has improperly interpreted claim 15 of Esau I in that the claim is not directed to treating nonalcoholic fatty liver disease but is directed to reducing serum cholesterol levels. Appeal Br. 10. 4 Appeal 2017-004305 Application 14/596,822 We are unpersuaded. As the Examiner points out, given that the same antisense compound is being administered in the same amount, the claimed method necessarily results in lowering serum cholesterol. Ans. 7. Thus the claimed method is not patentably distinct from the method of Esau I. Appellants also contend that the Examiner improperly used the disclosure of Esau I and mischaracterized the term “therapeutically effective amount.” Appeal Br. 8. Appellants argue that the Examiner has improperly read additional subject matter into the claims of Esau I. Again, we are unpersuaded. As the Examiner points out, the present application is a continuation of Esau I and thus shares a common disclosure. Ans. 5. The definition of the term “therapeutically effective amount” is identical in both disclosures. Id. As the Specification makes clear, a therapeutically effective amount is one which results in a clinically desirable outcome such as lowered serum cholesterol and lowered serum LDL-cholesterol. Spec. 8. We agree with the Examiner that one skilled in the art would understand that the instant claims necessarily and inherently result in lowered serum cholesterol levels in the treated human subject with non alcoholic fatty liver disease thus the person of ordinary skill in the art would reasonably conclude that the instant claims and the '314 patent claims are not patentably distinct from each other. Ans. 6. We conclude that claims 14, 15, 17, 35—46, 48, and 51 are not patentably distinct from claims 1—37 of Esau I. 5 Appeal 2017-004305 Application 14/596,822 ESAU I COMBINED WITH ESAU II Appellants’ argument with respect to this rejection is that Esau II does not remedy the deficiencies of Esau I. AppealBr.il. As discussed above, we do not find Esau I deficient. We therefore affirm this rejection. BHAT The issue with respect to this rejection is whether claims 14, 15, 17, 35—45, and 48—50 are patentably distinct from claim 1 of Bhat. The Examiner finds that the present claims are not patentably distinct from claim 1 of Bhat in that they are encompassed by claim 1 of Bhat. Non- Final Act. 7. The Examiner finds that claim 1 of Bhat is drawn to a method of treating a subject infected with HCV by administering an anti-miR-122 antisense compound conjugated to a carbohydrate. Id. The Examiner finds that the claimed method is identical to the method recited in claim 1 of Bhat. Id. Appellants contend that the Examiner has again improperly used the specification as prior art in that the Examiner relies on the present specification to find that the method recited in claim 1 of Bhat treats the same disorders as the claimed method. Appeal Br. 11—12. Appellants argue that the method of Bhat is directed to treating an HCV infection and that nothing in Bhat would lead one skilled in the art to use similar compounds to treat nonalcoholic fatty liver disease. Appeal Br. 11, Reply Br. 11—12. Appellants have the better position. We agree with Appellants that the Examiner has improperly used the teachings of the instant specification to support the conclusion that the instant claims are not patentably distinct from claim 1 of Bhat. Unlike the rejection based on Esau I above, the 6 Appeal 2017-004305 Application 14/596,822 Examiner has not pointed to anything in claims 1—15 of Bhat which would teach or suggest using the antisense compounds to treat fatty liver disease. Because double patenting is measured by the disclosure of the claims, not the Specification, the Examiner has not established a prima facie case. The Examiner contends that the Examiner has only used the specification to properly define that scope of the claim and that the term fatty liver disease encompasses disorders which may result from HCV infection. Ans. 9. The Examiner contends that the patient population for both methods overlaps. Ans. 10. We are unpersuaded. As mentioned above, the Examiner points to nothing in the claims of Bhat which suggests that the patient populations are related. Unlike Esau I, there is nothing in the definition of therapeutically effective amount as used in Bhat which links the treatment populations. Only by looking to the instant specification does the Examiner establish a connection between the two. See Ans. 10. We find that claims 14, 15, 17, 35—45, and 48—50 are patentably distinct from claim 1 of Bhat. SUMMARY We affirm the rejection of claims 14, 15, 17, 35—45, 48, and 51 for non-statutory double patenting over claims 1—37 of Esau I. We affirm the rejection of claims 49 and 50 for non-statutory double patenting over claims of Esau I combined with Esau II We reverse the rejection of claims 14, 15, 35—45, and 48—50 for non- statutory double patenting over claim 1 of Bhat. TIME PERIOD FOR RESPONSE 7 Appeal 2017-004305 Application 14/596,822 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 8 Copy with citationCopy as parenthetical citation