APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 11/830,625 07/30/2007 Thomas Scholl D 3136

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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.

1 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 11/830,625 07/30/2007 Thomas Scholl D /29/2011 MYRIAD GENETICS INC. INTELLECTUAL PROPERTY DEPARTMENT 320 WAKARA WAY SALT LAKE CITY, UT ART UNIT 1642 EXAMINER AEDER, SEAN E PAPER NUMBER MAIL DATE DELIVERY MODE 03/29/2011 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)

11/830,625 07/30/2007 Thomas Scholl 3002-01-12D 3136 26698 7590 03/29/2011 MYRIAD GENETICS INC.

2 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES Ex parte THOMAS SCHOLL, BRANT C. HENDRICKSON, BENJAMIN WARD, and DMITRY PRUSS Appeal Technology Center 1600 Before DONALD E. ADAMS, FRANCISCO C. PRATS, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. ADAMS, Administrative Patent Judge, concurring. DECISION ON APPEAL This is an appeal under 35 U.S.C. 134(a) involving claims to a method for detecting a mutation in a BRCA1 allele. The Patent Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. 6(b). We reverse. STATEMENT OF THE CASE

PRATS, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. ADAMS, Administrative Patent Judge, concurring.

3 follows: Claims are on appeal. Claim 51 is representative and reads as 51. A method for detecting a mutation in a BRCA1 allele comprising: analyzing a nucleic acid from a sample obtained from a human subject; and detecting a mutation in a BRCA1 allele wherein said mutation results in a BRCA1 mrna encoding a polypeptide comprising SEQ ID No. 92. The Examiner rejected claims under 35 U.S.C. 103(a) as unpatentable over Rohlfs. 1 OBVIOUSNESS The Issues The Examiner acknowledged that SEQ ID NO:92 is a polypeptide encoded by a BRCA1 allele in which exons 14 through 20 have been deleted. (Ans. 4.) The Examiner s position is that Rohlfs taught methods comprising analyzing nucleic acid from a human subject and detecting a mutation in a BRCA1 allele. (Ans. 4.) The Examiner found that Rohlfs taught that the nucleotide sequence of the 24-exon BRCA1 is well known. (Id.) The Examiner also found that Rohlfs taught that the carboxy-terminal amino acids of BRCA1 (encoded by exons 15-24) are important in growth suppression and resistance to radiation. (Id. at 4-5.) Additionally, the Examiner found that Rohlfs did not expressly teach detecting a mutation that results in a BRCA1 mrna encoding a polypeptide comprising SEQ ID 1 Elizabeth M. Rohlfs et al., In-frame deletions of BRCA1 may define critical functional domains, 107 HUM GENET (2000). 2

results in a BRCA1 mrna encoding a polypeptide comprising SEQ ID No. 92. The Examiner rejected claims 51-64 under 35 U.S.C. 103(a) as unpatentable over Rohlfs.

4 NO:92. (Id. at 5.) However, the Examiner found that Rohlfs would have rendered this deficiency obvious. (Id.) According to the Examiner, a skilled artisan at the time of the invention would have been motivated, with a reasonable expectation of success, to assess resistance to radiation and growth suppression in a subject by analyzing nucleic acid from the subject and detecting a mutation in a BRCA1 allele, wherein the mutation results in a BRCA1 mrna encoding a polypeptide with deleted C-terminal regions, including nucleic acids encoding polypeptides comprising SEQ ID NO:92. (Id.) The Examiner explained that the artisan would have been motivated to do so because Rohlfs: (a) taught that the carboxy-terminal amino acids of BRCA1 (e.g., exons 16 and 17) are important in growth suppression and resistance, and (b) disclosed methods of detecting deletions in BRCA1. (Id.) Appellants contend 2 that the Examiner s obviousness analysis overlooks the fact that there are an almost infinite amount of possible genetic mutations, and the skilled artisan, at the time of filing would have no expectation of success analyzing or detecting the specific nucleic acids recited in Claim 51. (App. Br. 9) According to Appellants, searching a genus with innumerable species (i.e., BRCA1 nucleic acids that result in a polypeptide with deleted C-terminal regions) is not a problem with a finite number of identified, predictable solutions. (Id.) 2 Appellants also challenge the Examiner s refusal to enter amendments submitted by Appellants on March 11, 2010, seeking to correct claim dependencies. (App. Br. 3, 5-6.) However, we do not take up this issue because an examiner s refusal to enter an amendment is a petitionable matter not decided by the Board. See MPEP (c); 37 C.F.R ,

) According to the Examiner, a skilled artisan at the time of the invention would have been motivated, with a reasonable expectation of success, to assess resistance to radiation and growth

5 Further, Appellants assert rebuttal evidence allegedly demonstrating unexpected properties of the claimed invention. (Id.) According to Appellants, the declarations of Dmitry Pruss and Thaddeus Judkins show that the claimed invention, namely the detection of the recited BRCA1 mutation, is indicative of an increased predisposition to cancer and is prevalent in a certain ethnic patient population. (Id. at 11.) The issues with respect to this rejection are: (a) whether the record supports the Examiner s conclusion that Rohlfs would have made the claimed method of detecting a mutation in a BRCA1 allele wherein said mutation results in a BRCA1 mrna encoding a polypeptide comprising SEQ ID No. 92 prima facie obvious, and if so, (b) whether Appellants have provided evidence of unexpected results such that the totality of evidence weighs in favor of nonobviousness. Findings of Fact 1. We agree with the Examiner s specific findings regarding the scope and content of Rohlfs. (See Ans. 4-6.) Principles of Law A conclusion that the claimed subject matter is prima facie obvious must be supported by evidence, as shown by some objective teaching in the prior art or by knowledge generally available to one of ordinary skill in the art that would have led that individual to arrive at the claimed invention. See In re Fine, 837 F.2d 1071, 1074 (Fed. Cir. 1988). 4

predisposition to cancer and is prevalent in a certain ethnic patient population. (Id. at 11.

6 Analysis We are not persuaded by the Examiner s position. The evidence on this record suggests that the carboxy-terminal amino acids of BRCA1 are important in growth suppression and resistance to radiation. What is missing is evidence suggesting that a person of ordinary skill in this art would have reasonably expected to identify the specific mutation recited in instant claim 51. In other words, we agree with Appellants that the Examiner s obviousness analysis overlook[ed] the fact that there are an almost infinite amount of possible genetic mutations, and the skilled artisan, at the time of filing would have no expectation of success analyzing or detecting the specific nucleic acids recited in Claim 51. (App. Br. 9.) In rejecting the claims, the Examiner has not articulated sound reasoning supported by the evidence as to why a skilled artisan who analyzed a nucleic acid sample from a human subject for a mutation in the carboxy-terminal amino acids of BRCA1 would have been motivated, with a reasonable expectation of success, to specifically detect such a mutation resulting in a BRCA1 mrna encoding a polypeptide comprising SEQ ID No. 92, as required by the claimed invention. Without this showing, the Examiner has not established a prima facie case of obviousness. See Fine, 837 F.2d at CONCLUSIONS OF LAW The record does not support the Examiner s reasoning that Rohlfs would have made the claimed method of detecting a mutation in a BRCA1 allele wherein said mutation results in a BRCA1 mrna encoding a polypeptide comprising SEQ ID No. 92 prima facie obvious. 5

What is missing is evidence suggesting that a person of ordinary skill in this art would have reasonably expected to identify the specific mutation recited in instant claim 51.

7 SUMMARY We reverse the rejection of claims under 35 U.S.C. 103(a) as unpatentable over Rohlfs. REVERSED 6

8 ADAMS, Administrative Patent Judge, concurring I concur with the majority s decision to reverse the rejection of record. In addition, I direct attention to Ex parte Scholl, et al., (BPAI 2011) (non-precedential) in copending and commonly assigned Application 11/830,604. dm MYRIAD GENETICS INC. INTELLECTUAL PROPERTY DEPARTMENT 320 WAKARA WAY SALT LAKE CITY UT

system=bpai&flnm=fd2011000691-03-23-2011-1 (BPAI 2011) (non-precedential) in copending and commonly assigned

APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 10/958,191 10/04/2004 Ruth E. Bauhahn 151P11719USU1 1458

APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 10/958,191 10/04/2004 Ruth E. Bauhahn 151P11719USU1 1458 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