Ex Parte 7232656 et alDownload PDFPatent Trial and Appeal BoardSep 18, 201495000528 (P.T.A.B. Sep. 18, 2014) 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. 95/000,528 03/05/2010 7232656 048522-0002 8947 26853 7590 09/19/2014 COVINGTON & BURLING, LLP ATTN: PATENT DOCKETING 1201 PENNSYLVANIA AVENUE, N.W. WASHINGTON, DC 20004-2401 EXAMINER PONNALURI, PADMASHRI ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 09/19/2014 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 ____________ LIFE TECHNOLOGIES CORPORATION Requester Cross-Appellant and Respondent v. ILLUMINA, INC. Patent Owner, Appellant and Respondent ____________ Appeal 2014-000794 Reexamination Control 95/000,528 Patent 7,232,656 B2 Technology Center 3900 ____________ Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, 1 JEFFREY B. ROBERTSON, and, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. 1 Administrative Patent Judge Rae Lynn P. Guest was on the original panel which decided this case, but is unavailable at this time. Judge Fredman has been added to the merits panel. In re Bose Corp., 772 F.2d 866, 869 (Fed. Cir. 1985). Appeal 2014-000794 Reexamination Control 95/000,528 Patent 7,232,656 B2 2 DECISION ON REHEARING This is a Request for Rehearing under 37 C.F.R. § 41.79(a)(4) of the February 3, 2014 Decision under 37 C.F.R. § 41.77(f) (“41.77 Dec.”) in which the Board affirmed the anticipation and obviousness rejections of claim 9 of US 7,232,656 (“the ’656 patent”), but reversed the written description rejection of the claim. 41.77 Dec. 12. The full text of claim 9, and claim 8, from which it depends, is reproduced in the 41.77 Decision. Claim 9 recites “a polynucleotide duplex forming a hairpin loop structure.” The hairpin has a target polynucleotide at one end and a primer at the other end. Requester contends that claim 9 is broader than the supporting disclosure in the '656 patent because the disputed language covers a hairpin structure in which the primer for the template strand is not covalently linked to primer. Requester Comments 10-11, dated May 20, 2013. The Examiner agreed with Requester and rejected claim 9 as lacking a written description as required by 35 U.S.C. § 112, first paragraph. Examiner's Determination 4, dated March 19, 2013. In the Decision, the hairpin structure was interpreted to cover only those structures in which the primer and template are covalently linked. Requester contends that this interpretation was an error and requests rehearing under 37 C.F.R. § 41.79(a)(4). Request for Rehearing (“Req. Reh’g”), dated March 3, 2014. Patent Owner has filed on comments on the Request for Rehearing. Patent Owner Comments, April 2, 2014. The Decision arrived at the clam interpretation by examining the plain language of the claim. As indicated in claim 8, upon which claim 9 depends, the target polynucleotide is sequenced. The target polynucleotide is Appeal 2014-000794 Reexamination Control 95/000,528 Patent 7,232,656 B2 3 recited in step ii) of claim 8 to be contacted with a nucleotide primer used for DNA sequencing. The primer is therefore used to sequence the polynucleotide in the array. Claim 9 refers to the same polynucleotide ("target polynucleotide molecule") and expressly requires a) the target polynucleotide which is sequenced, and b) the primer for sequencing the target polynucleotide, to be on the same "polynucleotide duplex forming a hairpin loop structure" because the claim states a) and b) are on either end of the molecule. 41.77 Dec. 12. Requester contends that we erred because there is no requirement that the polynucleotide be a single polynucleotide. Requester’s argument, which is unbuttressed by objective evidence, is that “a ‘molecule’ can be made of other smaller molecules that are associated together only by non-covalent interactions such as hydrogen bonding.” Req. Reh’g 3. As an example, Requester states that DNA is referred to as a single molecule although it contains “two different DNA strands held together only by hydrogen bonding - the two.” Id. The Requester points to the definition of “hairpin loop structure” in the specification which defines the term “as a structure in which the hairpin and the target sequence are on the same single strand.” Id. at 5. However, Requester contends that claim 9 is broader and that the polynucleotide molecule in claim 9 can comprise two separate molecules with the target polynucleotide at one end (first molecule) and the unlinked primer at the other end (second molecule), just as a DNA molecule is comprised of two separate single-stranded molecules hybridized together. Id. We agree with Requester that our analysis was flawed, but not for the reasons given by Requester. Specifically, we did not reference the Appeal 2014-000794 Reexamination Control 95/000,528 Patent 7,232,656 B2 4 specification of the ‘656 patent in construing claim 9. However, as explained below, this defect does not change the interpretation of the claim as set forth in the § 41.77(f) Decision. During reexamination of an unexpired patent, claims are given their broadest reasonable interpretation consistent with the patent specification. In re Suitco Surface, Inc., 603 F.3d 1255, 1259 (Fed. Cir. 2010); In re Abbott Diabetes Care Inc., 696 F.3d 1142 (Fed. Cir. 2012). The “PTO applies to verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). “Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.” Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). We shall first turn to the patent specification to determine the usage of the phrase “hairpin loop structure.” The patent describes the embodiment of claim 9 as follows. Underlining has been added to indicate where the verbiage of the specification and the claim are the same; brackets have been added to show where the claim language diverges from the specification: In one aspect of the present invention, the devices comprise arrayed polynucleotides, each polynucleotide [of the array] Appeal 2014-000794 Reexamination Control 95/000,528 Patent 7,232,656 B2 5 comprising [comprises a polynucleotide duplex forming] a hairpin loop structure, one end of which comprises a [the] target polynucleotide, the other end comprising a relatively short polynucleotide capable of acting as a primer in the polymerase reaction. Col. 7, ll. 1-6. As indicated by both Requester and Patent Owner, the ’656 expressly describes what is meant by “hairpin loop structure.” Following the paragraph reproduced above, the following passage appears: The term “hairpin loop structure” refers to a molecular stem and loop structure formed from the hybridisation of complementary polynucleotides that are covalently linked. The stem comprises the hybridised polynucleotides and the loop is the region that covalently links the two complementary polynucleotides. Anything from a 10 to 20 (or more) base pair double-stranded (duplex) region may be used to form the stem. In one embodiment, the structure may be formed from a single- stranded polynucleotide having complementary regions. The loop in this embodiment may be anything from 2 or more non- hybridised nucleotides. In a second embodiment, the structure is formed from two separate polynucleotides with complementary regions, the two polynucleotides being linked (and the loop being at least partially formed) by a linker moiety. The linker moiety forms a covalent attachment between the ends of the two polynucleotides. Linker moieties suitable for use in this embodiment will be apparent to the skilled person. For example, the linker moiety may be polyethylene glycol (PEG). Col. 7, ll. 11-30. The ‘656 Patent refers to the hairpin loop structures as “a molecular stem and loop structure formed from the hybridisation of complementary polynucleotides that are covalently linked,” indicating that the latter phrase is a denotation for a hairpin loop structure. Col. 7, ll. 11-13. Each of the Appeal 2014-000794 Reexamination Control 95/000,528 Patent 7,232,656 B2 6 two examples that follow is of hybridized complementary polynucleotides covalently linked on a single molecule. In the first example, the two complementary polynucleotides are the same single-strand. Col. 7, ll. 18-20 (“the structure may be formed from a single-stranded polynucleotide having complementary regions”). The second embodiment is of the two polynucleotides covalently attached by a linker. Col. 7, ll. 21-25. From these disclosures in the ’656 Patent, which use substantially the same language that appears in claim 9 (col. 7, ll. 1-6), it is apparent that “hairpin loop structure,” as recited in the claim, is defined to mean a structure formed by two hybridized polynucleotides which are covalently linked (col. 7, ll. 11-13). Requester specifically acknowledged this definition. Req. Reh’g 5. Despite this express definition, Requester takes a broader view that a hairpin loop structure also encompasses a primer which is not covalently linked to the template to which it is hybridized. Requester’s interpretation is inconsistent with the definition of a hairpin loop as formed by “hybridisation of complementary polynucleotides that are covalently linked,” where the template and primer constitute the hybridized complementary polynucleotides. Under Requester’s interpretation, the primer is not necessarily covalently joined to the target because “molecule” can mean two separate single-stranded molecules together. While this is a possible interpretation left open in the Decision by our sole reliance on the claim language, when the written description of the ’656 patent is consulted, the definition of “hairpin loop structure” which appears in the patent excludes Requester’s interpretation. This is not a case of importing a limitation from the Appeal 2014-000794 Reexamination Control 95/000,528 Patent 7,232,656 B2 7 specification into the claims, because there is an express description of what is meant by “hairpin loop structure.” Superguide, 358 F.3d at 875. REHEARING DENIED CC Patent Owner: COVINGTON & BURLING, LLP ATTN: PATENT DOCKETING 1201 PENNSYLVANIA AVENUE, N.W. WASHINGTON, DC 20004-2401 Third Party Requester: LIFE TECHNOLOGIES CORPORATION ATTN: IP DEPARTMENT 5791 VAN ALLEN WAY CARLSBAD, CA 92008 Copy with citationCopy as parenthetical citation