Ex parte Pike

• Decision Date: 22 March 2021
• Docket Number: Application 15/577,Appeal 2020-002657,522
• Parties: Ex parte IAN HUGO PIKE, MALCOLM ANDREW WARD, CLAIRE LOUISE RUSSELL, and VIKRAM MITRA Technology Center 1600
• Court: Patent Trial and Appeal Board

Ex parte IAN HUGO PIKE, MALCOLM ANDREW WARD, CLAIRE LOUISE RUSSELL, and VIKRAM MITRA Technology Center 1600

Appeal 2020-002657

Application 15/577, 522

United States Patent and Trademark Office, Patent Trial and Appeal Board

March 22, 2021

FILING DATE: 11/28/2017

Before ERIC B. GRIMES, FRANCISCO C. PRATS, and DEBRA L. DENNETT, Administrative Patent Judges.

DECISION ON APPEAL

PRATS, ADMINISTRATIVE PATENT JUDGE

STATEMENT OF THE CASE

Pursuant to 35 U.S.C. § 134(a), Appellant^[1] appeals from the Examiner's decision to reject claims 55-74. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.

CLAIMED SUBJECT MATTER

Appellant's Specification discloses that it is widely accepted that a specific protein, known as "tau," is involved in the pathology of neurodegenerative diseases like Alzheimer's Disease ("AD"), and that tau "actively participates in the formation of neurofibrillary tangles." Spec. 17.

The inventors of the present application "have surprisingly found that multiple cellular processes, the associated proteins and/or their levels are modified in a tau dose-dependent manner and that these affected pathways are correlated with several hallmarks of AD." Spec. 17-18.

Based on this discovery, Appellant's Specification identifies a panel of peptide biomarkers which are not only expressed in the brain, but "are surprisingly also identifiable in the cerebrospinal fluid (CSF) and most importantly their abundance in CSF is regulated between non-AD and AD patients with substantive memory effects." Spec. 18.

The Specification explains that the AD biomarkers identified by the inventors may be quantified in patient samples by a technique termed "selected reaction monitoring" ("SRM"), which is a specific type of mass spectrometry assay that involves fragmentation of a target parent ion and counting of daughter ions of a predefined mass-to-charge ratio. Spec. 14.

SRM assays involve the use of a reference peptide as an internal standard for quantifying the target peptide of interest. See Spec. 14 ("Typically, an equivalent precursor ion bearing a predefined number of stable isotope substitutions but otherwise chemically identical to the target ion is included in the method to act as a quantitative internal standard.").

The claims on appeal are directed to kits that contain sets of reference peptides. See Appeal Br. 7 (claim 55). The kits are useful in assays for measuring specific tau protein variants or peptide fragments, as well as other proteins. See id. at 7-8.

Claims 55 and 61 illustrate the appealed subject matter and read as follows:

55. A kit for assaying and/or measuring one or more biomarkers of a panel in a sample, comprising

a set of reference peptides in an assay-compatible format wherein each reference peptide is uniquely representative of a single biomarker in the panel

wherein the panel comprises a tau protein or a fragment thereof, wherein the tau protein

i) comprises the amino acid sequence of SEQ ID NO:29, and

ii) comprises one or more phosphorylated amino acids selected from T39, S46, T50, T52, T56, S61, T63, S64, S68, T69, SI 13, T181, S184, S185, S191, S195, S198, S199, S202, S205, S208, S210, T212, S214, T217, T231, S235, S237, S238, S258, S262, S285, S289, S356, Y394, S396, S400, T403, S404, S409, S412, S413, T414/S416 or S422 of SEQ ID NO:29;

wherein when the phosphorylated amino acid is T181, the panel further comprises a tau protein or a fragment thereof having at least one more phosphorylated amino acid.

61. The kit of claim 55, wherein the panel further comprises one or more biomarkers selected from: Actin alpha cardiac muscle 1 (SEQ ID NO: 11), Antithrombin-III (SEQ ID NO: 12), BH3-interacting domain death agonist (SEQ ID NO:3), cAMP-dependent protein kinase type I-beta regulatory subunit (SEQ ID NO:24), Catenin delta-1 (SEQ ID NO:4), Centrosomal protein of 170 kDa (SEQ ID NO:23), Clathrin light chain B (SEQ ID NO:5), Egl nine homolog 1 (SEQ ID NO: 13), Fibrinogen gamma chain (SEQ ID NO: 14), GMP reductase 1 (SEQ ID NO:27), Guanine nucleotide-binding protein G(q) subunit alpha (SEQ ID NO:6), Insulin-like growth factor-binding protein 6 (SEQ ID NO: 15), KxDL motif-containing protein 1 (SEQ ID NO:28), Lambda-crystallin homolog (SEQ ID NO: 18), Myelin-associated oligodendrocyte basic protein (SEQ ID NO:20), Neutral alpha-glucosidase AB (SEQ ID NO:7), Nuclear pore complex protein Nupl55 (SEQ ID NO: 19), OCIA domain-containing protein 1 (SEQ ID NO: 16), Protein KIAA1045 (SEQ ID NO:25), Secernin-2 (SEQ ID NO:8), Serum albumin (SEQ ID NO: 17), Short-chain specific acyl-CoA dehydrogenase (SEQ ID NO:9), Synaptoporin (SEQ ID NO:22), Syntaphilin (SEQ ID NO: 10), Transmembrane protein 119 (SEQ ID NO: 21) and/or Tubulin alpha chain-like 3 (SEQIDNO:26).

Appeal Br. 7-8.

REJECTIONS

The following rejections are before us for review:^[2]

(1) Claims 55-74, under 35 U.S.C. 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to...