Ex Parte Blau et alDownload PDFBoard of Patent Appeals and InterferencesMar 18, 201110508264 (B.P.A.I. Mar. 18, 2011) 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. 10/508,264 09/20/2004 Astrid Blau 13111-00016-US 5914 23416 7590 03/18/2011 CONNOLLY BOVE LODGE & HUTZ, LLP P O BOX 2207 WILMINGTON, DE 19899 EXAMINER WORLEY, CATHY KINGDON ART UNIT PAPER NUMBER 1638 MAIL DATE DELIVERY MODE 03/18/2011 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) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte ASTRID BLAU, MATHIEU KLEIN, and BIRGIT WENDEL __________ Appeal 2010-009081 Application 10/508,264 Technology Center 1600 __________ Before DEMETRA J. MILLS, MELANIE L. McCOLLUM, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL1 This is an appeal under 35 U.S.C. § 134(a) involving claims to a collection of transgenic plants comprising genes from a donor organism. The Patent Examiner rejected the claims on grounds of indefiniteness and 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2010-009081 Application 10/508,264 2 obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE Claims 1-4, 6, 12, 38 and 53-55 are on appeal. Claim 1 is representative and reads as follows: 1. A population of transgenic plants that comprises a plurality of transgenic plants of which each plant has integrated into its genome one or more than one copy of one codogenic gene segment of a cellular donor organism that encodes one protein of the cellular donor organism, but has integrated no other codogenic gene segment encoding another protein of the cellular donor organism, wherein the integrated codogenic gene segment comprises a start codon and a stop codon that define an open reading frame encoding the protein; [w]herein the integrated codogenic gene segment is operably linked to a regulatory sequence so that the open reading frame is transcribed and translated; wherein said plurality of transgenic plants as a whole comprises at least 50% of all codogenic gene segments that encode a protein of the cellular donor organism; and wherein the plurality of transgenic plants is obtained by a) providing a known codogenic gene segment that encodes one protein of a cellular donor organism and integrating one or more than one copy of the codogenic gene segment into the genome of a plant; b) providing another known codogenic gene segment that encodes another protein of the cellular donor organism and integrating one or more than one copy of the other codogenic gene segment into the genome of another plant; c) repeating step b) so that the resulting plurality of transgenic plants as a whole comprises at least 50% of all codogenic gene segments of the cellular donor organism. (App. Br. A-1.) The Examiner rejected the claims as follows: • claims 1-4, 6, 12, 38 and 53-55 under 35 U.S.C. § 112, second paragraph, as indefinite; Appeal 2010-009081 Application 10/508,264 3 • claims 1-4, 6, 12, 38, and 53-55 under 35 U.S.C. § 103(a) as unpatentable over Pineda2 and Lazo;3 and • claims 1-4, 6, 12, 38, and 53-55 under 35 U.S.C. § 103(a) as unpatentable over Reuber4 and Lazo. DEFINITENESS The Issue The rejection focuses on the meaning of “codogenic gene segment.” Claim 1 at part c) requires that the claimed plant population comprise “at least 50% of all codogenic gene segments of the cellular donor organism.” The Examiner’s position is that “it is unclear how one can define all of the codogenic gene segments in a donor organism given the definition and example in the specification.” (Ans. 5.) Appellants contend that “[t]he term ‘codogenic gene segment’ in claim 1 is recited as 1) encoding one protein of a cellular donor organism and 2) comprising a start codon and a stop codon that define an open reading frame encoding the protein.” (App. Br. 5.) That is, although the Specification lists alternative meanings, the “Examiner’s concern has focused on an embodiment which is not claimed.” (Id. at 6.) As Appellants read claim 1 part c), “the recitation of codogenic gene segment at line 19 2 Omaira Pineda et al., Environmental Stress Tolerance Genes, WO 01/36598 A1, published May 25, 2001. 3 Gerard R. Lazo et al., A DNA Transformation-Competent Arabidopsis Genomic Library in Agrobacterium, 9 BIO/TECHNOLOGY 963-967 (1991). 4 T. Lynne Reuber et al., Transcription Factors For Increasing Yield, US 2007/0022495 A1, published Jan. 25, 2007. Appeal 2010-009081 Application 10/508,264 4 also requires that the codogenic gene segment encode a protein.” (Reply Br. 5, referencing line numbers assigned at Reply Br. 3.) The issue is whether claim 1, part c) requires that the codogenic gene segment encode a protein. Findings of Fact 1. The Specification states: The term “codogenic gene segment” refers to a nucleic acid. Nucleic acids . . . include DNA and RNA sequences which can be single- or double-stranded . . . . In particular, the term “codogenic gene segment” refers to the coding sequence, i.e. the part of a gene which encodes a protein, polypeptide or part thereof. (Spec. 2, ll. 10-17.) Principles of Law During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow. When the applicant states the meaning that the claim terms are intended to have, the claims are examined with that meaning . . . . The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed. In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989) (citations omitted). Analysis Part c of claim 1 reads: (c) repeating step b) so that the resulting plurality of transgenic plants as a whole comprises at least 50% of all codogenic gene segments of the cellular donor organism. (Claim 1, emphasis added.) Appeal 2010-009081 Application 10/508,264 5 We agree with the Examiner that “codogenic gene segment” in line 195 of claim 1 includes the full scope of the Specification’s definition of the term. The Specification states that the term “refers to a nucleic acid.” (FF1.) Giving weight to “codogenic,” the definition includes gene segments coding for tRNAs, which are not proteins, as the Examiner found. We also agree with the Examiner that the Specification’s phrasing “[i]n particular, the term . . . refers to” is reasonably understood as particularly referring not only to a protein, but also to a polypeptide, and to parts thereof. (Ans. 5.) On its face, line 19 does not explicitly or impliedly limit “codogenic gene segment” to a segment that encodes a protein. Reading line 19 in light of the Specification’s guidance does not alter that conclusion. We agree with Appellants that the first nine occurrences of “codogenic gene segment” in claim 1 are further defined and explicitly limited by additional words or phrases: “. . . that encodes one protein” (lines 3 and 12); or “encoding another protein” (lines 4-5 and 15); or “comprises a start codon and a stop codon that define an open reading frame” (line 6); or “is operably linked to a regulatory sequence so that the open reading frame is transcribed and translated” (lines 7-8); or “that encode a protein” (lines 9- 10); or “the” referencing a defined antecedent (line 13); or “the other” referencing a defined antecedent (line 16). We do not agree with the Examiner that those usages or occurrences are unclear. (Ans. 6, discussing claim lines 5 and 6 and claim part b.) However, the tenth occurrence of 5 We reference the line numbers assigned in Appellants’ Reply Brief at 3. Although the numbers 5 and 10 are assigned to duplicate lines (in the format shown the line labeled 19 should be labeled 21), it is simpler to use the numbers Appellants assigned. Appeal 2010-009081 Application 10/508,264 6 “codogenic gene segments” in line 19 is unencumbered by explicit, implicit, or referential limiting words. (Ans. 5.) We cannot agree with Appellants that the segments recited in line 19 are necessarily limited by process limitations. Although step c) recites “repeating step b) so that the resulting plurality of transgenic plants as a whole comprises at least 50% of all codogenic gene segments,” the population may still include an unknown number of segments coding for tRNAs, or parts of proteins, which are balanced out by adding some number of protein encoding segments to make up 50% of the donor’s coding segments. Thus, we do not agree that reading the claim as a whole requires reading Appellants’ preferred limited embodiment into line 19. While the claim includes Appellants’ preferred embodiment, the claim is not properly interpreted as limited to that embodiment. The differences between the Examiner’s Specification-based interpretation and Appellants’ implied-process interpretation confirm there is an ambiguity in what claim part c) defines. The problem is in knowing what should be counted. (Ans. 5-6.) The Examiner wrote “the Examiner does not know how that can be quantitated,” but we are affirming on the ground that the person of ordinary skill in the art would find the claim ambiguous as to what should be counted, not because the person of ordinary skill would have difficulty counting if they knew what to count. We agree with the Examiner that the ambiguity about which segments to count should be removed. See Zletz, 893 F.2d at 322 (“[a]n essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process”). Even if we accept Appellants’ implied- Appeal 2010-009081 Application 10/508,264 7 process limitation of line 19 as another plausible construction, we still affirm. See Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (“if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite”). Claims 4-6, 12, 38, and 53-55 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). OBVIOUSNESS The Issues According to Appellants, the Reuber reference is a continuation-in- part application of the US counterpart of the Pineda PCT Application. We will consider the issues together, referring to Pineda and Lazo. The Examiner’s position is that Pineda described a population of transgenic plants in which each plant had integrated into its genome a gene encoding one transcription factor from the donor organism Arabidopsis. (Ans. 8.) The transcription factor genes that Pineda integrated into plants did not total more than 50% of all codogenic gene segments from Arabidopsis, and thus Pineda’s plant population as whole did not comprise at least 50% of all codogenic gene segments from the donor organism, Arabidopsis. (Id. at 9.) According to the Examiner, Lazo described a genomic library comprising more than 50% of the codogenic gene segments from Arabidopsis. (Id.) The Examiner concluded: “it would have been obvious and within the scope of one of ordinary skill in the art to extend the population taught by Pineda et al to cover at least 50% of the genome of the Appeal 2010-009081 Application 10/508,264 8 donor organism.” (Id.) The Examiner reasoned that (1) the necessary DNA was publically available in Lazo’s library, (2) Pineda had taught that one could make cDNA libraries from different tissues, and (3) “it would have been obvious . . . to extend the teachings of Pineda et al to go beyond a set of transcription factors to cover more of the available coding sequences from Arabidopsis.” (Id.) The Answer refers to Kumagai,6 Tomes,7 and Reuber for further evidence of the state of the art, each of which is said to teach “populations of plants expressing multiple nucleic acids, often referred to as a ‘library.’” (Id. at 10.) According to the rejection, the additional references disclosed “variations on the theme that it would have been useful to express nucleic acids in plants to determine the function or effect of the protein encoded by the nucleic acid.” (Id. at 11.) Appellants first contend that (1) the references do not provide any suggestion to modify Pineda’s population or teach the desirability of modification (App. Br. 10-13), (2) Pineda and Lazo are incompatible rather than combinable, and direct one in a different direction than the population claimed with its particular features (id. at 14-16), and (3) Pineda and Lazo do not teach or suggest all the claim limitations (id. at 16-18). Appellants contend that Tomes described delivering a plurality of vectors en bloc into plant cells, but that because Tomes used the donor’s transcriptome, it would have had an incomplete donor genome sample that could not be scaled up beyond 100 sequences. (Reply Br. 6-7.) Appellants contend that Kumagai did not provide a library covering 50% or more of any organism’s genome, 6 Monto H. Kumagai et al., WO 01/07600 A1, published Feb. 1, 2001. 7 Dwight T. Tomes et al., US 2003/0221212 A1, published Nov. 27, 2003. Appeal 2010-009081 Application 10/508,264 9 and that because Kumagai taught transient expression, it led away from creating transgenic organisms. (Id. at 8.) Finally, Appellants contend that even if the references had a common goal (to determine function or effect of the protein encoded by a nucleic acid), knowledge of the goal does not render its achievement obvious. (Id.) According to Appellants, the references achieved their goals in completely different ways, resulting in populations of plants different from the population claimed, which “has practical advantages over the products of the references.” (Id. at 9.) The issues are: whether Pineda and Lazo, in view of the state of the art, provided a reason to use the steps recited in the claims to obtain a population of plants having the properties defined in the claims; and whether Reuber and Lazo, in view of the state of the art, provided a reason to use the steps recited in the claims to obtain a population of plants having the properties defined in the claims. Findings of Fact 1. We adopt the Examiner’s specific findings of fact concerning the Pineda and Lazo disclosures. Principles of Law When determining whether a claim is obvious, an Examiner must make “a searching comparison of the claimed invention – including all its limitations – with the teachings of the prior art.” In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995). An invention composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art….[I]t can be important to identify a reason that would Appeal 2010-009081 Application 10/508,264 10 have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Thus, “[r]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Analysis Although the Examiner concluded the claims are indefinite, the Examiner nevertheless examined the claims by comparing the invention to combinations of references that teach transformation of one clone at a time into one individual plant at a time, “in order to expedite prosecution.” (Ans. 7-8.) We conclude that the embodiment examined would not have been obvious on this record. We agree with the Examiner that those of ordinary skill in the art were motivated to use transgenic plant populations to learn the functions and effects of proteins encoded by various genes. However, we also agree with Appellants that knowing the goal does not necessarily render particular solutions to the problem obvious. In this case, Appellants have pointed to particular differences between the claimed plants and those known in the art, and they argue that the rejection did not explain how each of those different features would have been obvious. (See App. Br. 16-18; Reply Br. 9-17.) The evidence shows that the plant population defined in the claims has features distinct from the plants described in Pineda, Reuber, Lazo, Tomes, or Kumagai. We are persuaded by Appellants’ arguments that the rejection did not explain why those distinctive features would have been obvious. Appeal 2010-009081 Application 10/508,264 11 SUMMARY We affirm the rejection of claims 1-4, 6, 12, 38 and 53-55 under 35 U.S.C. § 112, second paragraph, as indefinite. We reverse the rejection of claims 1-4, 6, 12, 38, and 53-55 under 35 U.S.C. § 103(a) as unpatentable over Pineda and Lazo. We reverse the rejection of claims 1-4, 6, 12, 38, and 53-55 under 35 U.S.C. § 103(a) as unpatentable over Reuber and Lazo. 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 lp CONNOLLY BOVE LODGE & HUTZ, LLP P O BOX 2207 WILMINGTON DE 19899 Copy with citationCopy as parenthetical citation