14844007 (P.T.A.B. Sep. 14, 2018)

Ex Parte Levine et al

Patent Trial and Appeal BoardSep 14, 2018

14844007 (P.T.A.B. Sep. 14, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/844,007 09/03/2015 Beth C. Levine 23379 7590 09/18/2018 RICHARD ARON OSMAN 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. UTSD:2655-2US 9225 EXAMINER 530 Lawrence Expy # 332 HA, TIJLIE Sunnyvale, CA 94085 ART UNIT PAPER NUMBER 1675 NOTIFICATION DATE DELIVERY MODE 09/18/2018 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): richard@sci-tech.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Exparte BETH C. LEVINE, SANAE SHOJI-KAWATA, NICK V. GRISHIN, LISA N. KINCH, OLIVIER LICHTARGE, and ANGELAD. WILKINS 1 Appeal2017-009548 Application 14/844,007 Technology Center 1600 Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and DAVID COTTA, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134(a) involving claims to a peptide, which have been rejected as being directed to patent-ineligible subject matter. We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Board of Regents, The University of Texas System. Appeal Br. 1. Appeal 2017-009548 Application 14/844,007 STATEMENT OF THE CASE "Beclin 1 encodes a 450 amino acid protein .... Overexpression of Beclin 1 is sufficient to induce autophagy." Spec. ,r 3. The Specification discloses "compositions for inducing autophagy, including compounds comprising no more than a 9, 10 or 11-mer Beclin 1 peptide." Id. ,r 5. "Applications broadly encompass persons in need of enhanced autophagy, and include diseases and pathologies where the upregulation of autophagy is therapeutically beneficial, including infection with intracellular pathogens, neurodegenerative diseases, cancers, cardiomyopathy, and aging." Id. ,r 47. Claims 16 and 34 are on appeal. 2 Claim 16 is illustrative and reads as follows: 16. An autophagy-inducing compound comprising an autophagy-inducing 9, 10 or 11-mer peptide ofBeclin 1, and no more ofBeclin 1 than the 9, 10 or 11-mer peptide, the peptide comprising Beclin 1 residue 269 or 270 to Beclin 1 residue 278 or 279, wherein Beclin 1 residues 269-279 is VFNATFHIWHS (SEQ ID N0:01), or the D-retro-inverso sequence thereof, wherein up to six of said residues may be substituted, and F270 and F27 4 are optionally substituted and optionally linked. DISCUSSION The Examiner has rejected claims 16 and 34 under 35 U.S.C. Â§ 101 as being directed to patent-ineligible subject matter. Ans. 2. The Examiner finds that claim 16 is directed to "a natural-based product," specifically "a fragment of naturally occurring protein isolated from Homo sapiens." Id. at 2-3. 2 Claims 17, 18, 20, 26, 27, and 29-32 are also pending but are not rejected. Office Action mailed Jan. 19, 2017, page 7. 2 Appeal 2017-009548 Application 14/844,007 We agree with the Examiner that the claimed compound is not patent- eligible subject matter. Claim 16 is directed to fragments of the naturally occurring Beclin 1 protein. Thus, Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013), is controlling. In Myriad, the Court considered claims directed to isolated DNA encoding the BRCAl polypeptide and fragments of at least 15 nucleotides of that DNA. Id. at 2113. The Court held that "Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention." Id. at 211 7. "Myriad found the location of the BRCAl and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes 'new ... composition[ s] of matter,' Â§ 101, that are patent eligible." Id. "Nor are Myriad's claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule." Id. at 2118. The same analysis applies here. Claim 16 is directed to fragments of a naturally occurring protein, separated from the rest of the protein. Appellants have identified certain peptides, with naturally occurring amino acid sequences, that have the property of inducing autophagy, but this property does not render the peptides new compositions of matter that are patent-eligible. Rather, claim 16 is directed to products of nature. Appellants argue that [t]he recited product does not exist in nature -- in any way, shape or form. It never had existed on earth before it was made by these applicants. A novel peptide is not a natural product 3 Appeal 2017-009548 Application 14/844,007 just because its amino acid sequence overlaps an internal sequence of a distinct natural protein. Appeal Br. 2. Appellants argue that a "novel peptide is not a natural product just because its amino acid sequence overlaps an internal sequence of a distinct natural protein. The novel peptide has sequence overlap with an internal sequence of Beclin 1, but the common sequence is present in different polypeptides." Id. at 3. This argument is not persuasive because the Myriad Court expressly held that the isolated BRCA genes were not patent-eligible even though isolating the DNA required severing chemical bonds. Myriad, 133 S.Ct. at 2118. The same conclusion applies to a peptide that is isolated from a naturally occurring protein. See also In re BRCAJ- and BRCA2-based Hereditary Cancer Test Patent Litigation, 774 F.3d 755, 760 (Fed. Cir. 2014) ("The Supreme Court held ineligible claims directed to segments as short as 15 nucleotides, the same length as the primer claims at issue here, suggesting that even short strands identical to those found in nature are not patent eligible."). The logic of the Myriad Court also applies when the claimed product is a fragment of a naturally occurring protein rather than a gene. Appellants also argue that the Examiner misequates proteins/peptides with DNA, which derives its function from its linear code of sequence information .... However, one cannot rationally presume that every, or even any given function a protein will be recreated by any small peptide, even if it has sequence overlap with a portion of the protein. Reply Br. 3. 4 Appeal 2017-009548 Application 14/844,007 Appellants' Specification itself, however, states that "[ o ]verexpression of Beclin 1 is sufficient to induce autophagy." Spec. ,r 3. Thus, the property of inducing autophagy does not make the claimed peptides markedly different from the full-length Beclin 1 protein. Claim 34 was not argued separately and therefore falls with claim 16. 37 C.F.R. Â§ 4I.37(c)(l)(iv). SUMMARY We affirm the rejection of claims 16 and 34 under 35 U.S.C. Â§ 101. 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. Â§ 1.136(a). AFFIRMED 5