Ex Parte McDonnell et alDownload PDFBoard of Patent Appeals and InterferencesJul 29, 200409266465 (B.P.A.I. Jul. 29, 2004) Copy Citation The opinion in support of the decision being entered today was not written for publication and is not binding precedent of the Board. Paper No. 33 UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte TIMOTHY J. McDONNELL, STEPHEN G. SWISHER, BINGLIANG FANG, ELIZABETH M. BRUCKHEIMER, MONA G. SARKISS, LIN JI, and JACK A. ROTH __________ Appeal No. 2003-2091 Application No. 09/266,465 __________ ON BRIEF __________ Before WILLIAM F. SMITH, SCHEINER, and GRIMES, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134 from the examiner’s final rejection of claims 1-3, 6, 7, 9-13, 17-21, 23, 29-32, 34, 36, 108, 109, and 115.1 Claims 1-3 and 9 are representative and read as follows: 1. An adenoviral expression construct comprising a first nucleic acid encoding a proapoptotic member of the Bcl-2 gene family and a non- adenoviral first promoter inducible by a non-adenoviral inducer 1 Claims 1-115 are pending. Claims 62-67 have been allowed, and the examiner has indicated that claims 4, 5, 8, 14, 16, 22, 24-27, 33, 35, 37, 38, 110, and 114 would be allowable if re-written to eliminate their dependence on rejected claims. See Paper No. 21, mailed June 21, 2002, and the Examiner’s Answer, page 4. Claims 15, 28, 39-61, 68-107, and 111-113 have been withdrawn from consideration. See Paper No. 21. Appeal No. 2003-2091 Page 2 Application No. 09/266,465 polypeptide wherein said first nucleic acid is under transcriptional control of said first promoter. 2. The expression construct of claim 1, wherein said proapoptotic Bcl-2 gene is a Bax, Bak, Bim, Bik, Bid, or Bad gene. 3. The expression construct of claim 1, further comprising a second nucleic acid encoding a second transgene. 9. The expression construct of claim 3, wherein said second gene encodes a protein selected from the group consisting of a tumor suppressor, a cytokine, a receptor, inducer of apoptosis, and differentiating agents. The examiner relies on the following references: June et al. (June) 6,143,291 Nov. 7, 2000 Zhang et al. (Zhang) 6,194,191 Feb. 27, 2001 Lillie et al. (Lillie), “Transcription activation by the adenovirus E1a protein,” Nature, Vol. 338, pp. 39-44 (1989) Kaufman, “Vectors used for expression in mammalian cells,” Methods in Enzymology, Vol. 185, pp. 487-511 (1990) Oligino et al. (Oligino), “In vivo transgene activation from an HSV-based gene therapy vector by GAL4:VP16,” Gene Therapy, Vol. 3, pp. 892-899 (1996) Wang et al. (Wang), “Positive and negative regulation of gene expression in eukaryotic cells with an inducible transcriptional regulator,” Gene Therapy, Vol. 4, pp. 432-441 (1997) Claims 1-3, 6, 17-21, 23, 29-32, 34, and 36 stand rejected under 35 U.S.C. § 102(e) as anticipated by Zhang. Claims 7, 108, 109, and 115 stand rejected under 35 U.S.C. § 103 as obvious: • claim 7 in view of Zhang and June; • claims 108 and 109 in view of Zhang, combined with any one of Oligino, Wang, or Lillie, and Kaufman; and • claim 115 in view of Zhang and Oligino. Appeal No. 2003-2091 Page 3 Application No. 09/266,465 Claims 9-13 stand rejected under 35 U.S.C. § 112, second paragraph, as indefinite. We affirm the indefiniteness rejection but reverse all of the rejections over the prior art. Background “Adenoviral vectors have become one of the leading vectors for gene transfer, especially in gene therapy contexts.” Specification, page 1. “Several studies have demonstrated the ability of adenovirus-mediated wild-type p53 [tumor suppressor] replacement gene therapy to induce . . . apoptosis in malignant cells carrying p53 gene mutations.” Id. “Apoptosis, or programmed cell death, is an essential occurring process for normal embryonic development . . . and suppressing carcinogenesis.” Id., page 2. “[L]ittle is known of the mechanisms by which wild-type p53 induces apoptosis. It appears that p53 induces apoptosis, at least in part, by up-regulating proapoptotic members of the Bcl-2 family of proteins.” Id., page 1. “Bcl-2 acts to suppress cell death triggered by a variety of stimuli. . . . [T]here is a family of Bcl-2 cell death regulatory proteins which share in common structural and sequence homologies. These different family members have been shown to either possess similar functions to Bcl-2 or counteract Bcl-2 function and promote cell death.” Id., page 2. “One such family member having Bcl-2 counteracting function is Bax.” Id. Other proapoptotic members of the Bcl-2 family include Bak, Bad, Bid, Bik, and Harikiri. Specification, pages 21-22. Appeal No. 2003-2091 Page 4 Application No. 09/266,465 Discussion Claim 1, the broadest claim on appeal, is directed to an adenoviral vector comprising a nucleic acid encoding one of the proapoptotic members of the Bcl-2 gene family, under the control of a non-adenoviral inducible promoter. The examiner rejected most of the claims as either anticipated by Zhang or obvious in view of Zhang and other prior art. The examiner rejected claims 9-13 as indefinite. 1. Definiteness The examiner rejected claim 9 (and claims 10-13 because of their dependence on claim 9) as indefinite. Claim 9 depends on claim 3 which, in turn, depends on claim 1 and adds the limitation that the vector “compris[es] a second nucleic acid encoding a second transgene.” Claim 9 adds to claim 3 the limitation that “said second gene encodes a protein selected from the group consisting of a tumor suppressor,” etc. The examiner concluded that claim 9 is indefinite because “there is no antecedent basis for the term ‘said second gene.’” Paper No. 21, mailed June 21, 2002, page 10. In response, Appellants have authorized the examiner to enter an examiner’s amendment that would change claim 9 to recite “said second transgene”, thereby overcoming the rejection. Appeal Brief, page 14. The examiner has indicated, as we understand it, that he would enter such an examiner’s amendment, which would overcome the rejection. Examiner’s Answer, page 9. Thus, the examiner and Appellants apparently agree that claims 9-13 are indefinite as they currently stand, but that the indefiniteness can be cured via the Appeal No. 2003-2091 Page 5 Application No. 09/266,465 agreed-upon examiner’s amendment. We therefore affirm the rejection of claims 9-13, in their current form, under 35 U.S.C. § 112, second paragraph. 2. Anticipation The examiner rejected claims 1-3, 6, 17-21, 23, 29-32, 34, and 36 as anticipated by Zhang, reasoning that Zhang “recite[s] an adenoviral expression construct . . . comprising a nucleic acid (which can be a cDNA or genomic DNA) encoding a Bax gene product which can be under the control of a CMV IE promoter and polyA signal. . . . Zhang et al. therefore teaches the claimed invention.” Paper No. 16, mailed October 10, 2001. The examiner specifically cited the disclosure in Zhang’s columns 2, 25, 27- 30, and 38-39. Appellants argue that Zhang does not describe an adenoviral expression vector as defined by instant claim 1; i.e., one having a proapoptotic, Bcl-2-family gene under the control of a non-adenoviral promoter. Rather, they argue, Zhang describes a method for the production and purification of adenoviral vectors generally. In describing such vectors, the Zhang patent lists a great number of potential components that might be included in adenoviral vectors amenable to the methods claimed by Zhang. There is a large number of possible therapeutic genes listed, including p53, kinases, CDK- inhibitors, cell adhesion molecules, numerous enzymes, over a dozen interleukins, three dozen hormones, tumor suppressor genes, and inducers of apoptosis – a total of nearly 100 possible genes. Within this laundry list is found a listing of some Bcl-2 gene family members. The [Zhang] patent also lists promoters of various sorts, including at least 17 inducible promoters and their inducing compounds. . . . Although the [Zhang] patent does describe substitution of genes and promoters, it does not illustrate the particular combination presently claimed. Appeal Brief, page 7. Thus, Appellants argue, in order to derive the claimed product from Zhang’s disclosure, Appeal No. 2003-2091 Page 6 Application No. 09/266,465 one must select particular species of gene from a very large genus, and then select a particular species of promoter form a similarly large genus of possible promoters. And even then, the claimed invention is still not taught, as these particular elements must be combined. Forcing the skilled artisan to make each of these selection[s] is akin to asking . . . that person to modify the prior art. That is not anticipation. Id., page 9. We agree with Appellants that Zhang does not anticipate the instant claims. “Under 35 U.S.C. § 102, every limitation of a claim must identically appear in a single prior art reference for it to anticipate the claim.” Gechter v. Davidson, 116 F.3d 1454, 1457, 43 USPQ2d 1030, 1032 (Fed. Cir. 1997). “Every element of the claimed invention must be literally present, arranged as in the claim.” Richardson v. Suzuki Motor Co., Ltd., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The examiner has not pointed to a single, specific construct disclosed by Zhang that includes all of the limitations of the instant claims. Rather, the examiner has pointed to the disclosure in Zhang’s columns 2, 25, 27-30, and 38-39. Those columns describe particular promoters that can be used in adenoviral vectors (column 2, lines 34-38, and columns 27-30), specific therapeutic genes that can be included in adenoviral vectors as cancer treatment agents (column 2, lines 46-57, and columns 23- 26), and pharmaceutical compositions (columns 38-39). Thus, as Appellants point out, deriving the claimed adenoviral constructs from Zhang’s disclosure requires picking a promoter from among the many promoters disclosed by Zhang, some of which are not inducible and some of which are not non-adenoviral promoters, then picking a therapeutic gene from among the many possible genes disclosed by Zhang, only a few of which are proapoptotic members of the Bcl-2 gene family. Appeal No. 2003-2091 Page 7 Application No. 09/266,465 It is true that all of the elements of the claimed product are encompassed by the genera described in Zhang. However, when a claimed product is not specifically described in a reference, but must be derived by choosing and combining different elements that are separately disclosed, the proper basis for rejection (if any) is 35 U.S.C. § 103. In response to Appellants’ argument on this point, the examiner cited guidance from the MPEP to the effect that a claimed product can be anticipated by a prior art reference, even if it is necessary to select portions of the reference and combine them, so long as the classes from which the selections are made are “sufficiently limited or well delineated.” Examiner’s Answer, page 6 (citing MPEP § 2131.02). The examiner also relied on the MPEP for the following proposition: If one of ordinary skill in the art is able to “at once envisage” the specific [claimed] compound within the generic [known] chemical formula, the compound is anticipated. One of ordinary skill in the art must be able to draw the structural formula or write the name of each of the compounds included in the generic formula before any of the compounds can be “at once envisaged.” Id. (citing In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962)). The examiner argues that this passage from the MPEP supports the rejection because “one of ordinary skill could write out the combinations of promoters and genes; indeed, many different combinations of the promoters and Bcl-2 transgenes disclosed in the ‘191 patent would anticipate the claimed invention. For example, in claims reciting any [non-adenoviral] inducible promoter . . . many of the 17 inducible promoters listed in Table 3 . . . and several of the promoters listed in Table 2 . . . combined with any of the Appeal No. 2003-2091 Page 8 Application No. 09/266,465 Bcl-2 family member genes . . . would anticipate claims reciting these limitations.” Id., pages 6-7. The facts of this case are not analogous to those of Petering. At issue in Petering was a claimed chemical compound that had been rejected over a prior art patent (Karrer). See id. at 995-96, 133 USPQ at 276-77. Karrer disclosed a similar compound having substituents at various positions that could be, but were not necessarily, the same as those in the claimed compound. The court concluded that the generic disclosure did not anticipate Petering’s claims: “Even though appellants’ claimed compounds are encompassed by [Karrer’s] broad generic disclosure, we do not think this disclosure by itself describes appellants’ invention, as defined by them in any of the appealed claims, within the meaning of 35 U.S.C. 102(b).” Id. at 1000, 133 USPQ at 279 (emphasis in original). The court noted, however, that Karrer also described preferred substituents for each of the variable positions. When the disclosed preferences were taken into account, the court found that only 20 compounds were within the preferred subgenus taught by Karrer. See id. at 1000, 133 USPQ at 279-80. The court concluded that “one skilled in this art would, on reading the Karrer patent, at once envisage each member of this limited class.” Id. at 1001, 133 USPQ at 280 (emphasis in original). In the present case, by contrast, Zhang lists at least 57 promoters that could be used in the disclosed adenoviral vectors. See Tables 2 and 3 in columns 29-30. In addition, Appellants have asserted (and the examiner has not disputed) that Zhang discloses nearly 100 different therapeutic agents that could be used. Thus, it would appear that Zhang discloses a genus of adenoviral vectors comprising nearly 5700 Appeal No. 2003-2091 Page 9 Application No. 09/266,465 different members. The examiner has pointed to nothing in Zhang indicating a preference for inducible promoters over other types of promoters, or indicating a preference for proapoptotic members of the Bcl-2 gene family over other cancer therapeutic genes. Thus, the record does not indicate that one skilled in the art, on reading the Zhang patent, would have at once envisaged each member of a limited class, as in Petering. Zhang does not describe with specificity any product within the scope of claim 1. The rejection for anticipation is therefore reversed. 3. Obviousness The examiner rejected claims 7, 108, 109, and 115 as obvious in view of Zhang combined with other prior art references. Each of these rejections, however, cited Zhang as disclosing the basic adenoviral construct defined in claim 1, and relied on the other references to meet limitations of the dependent claims. The examiner did not cite any evidence or provide any reasoning to show that those skilled in the art would have found it obvious to combine a specific promoter (or class of promoters) with a proapoptotic member of the Bcl-2 gene family. Since we have already concluded that Zhang does not describe an adenoviral construct within the scope of claim 1, and the examiner has not shown that Zhang would have made such a construct obvious, our reversal of the § 102 rejection mandates reversal of the § 103 rejections as well. Appeal No. 2003-2091 Page 10 Application No. 09/266,465 Summary We reverse the rejections based on the prior art because the examiner has not shown that the claimed adenoviral construct was described or would have been obvious based on Zhang. We affirm the rejection for indefiniteness, with the understanding that Appellants and the examiner have agreed on acceptable alternative language. No time period for taking any subsequent action in connection with this appeal may be extended under 37 CFR § 1.136(a). AFFIRMED IN PART WILLIAM F. SMITH ) Administrative Patent Judge ) ) ) ) BOARD OF PATENT TONI R. SCHEINER ) Administrative Patent Judge ) APPEALS AND ) ) INTERFERENCES ) ERIC GRIMES ) Administrative Patent Judge ) EG/jlb Appeal No. 2003-2091 Page 11 Application No. 09/266,465 STEVEN L. HIGHLANDER FULBRIGHT & JAWORSKI L.L.P. 600 CONGRESS AVENUE SUITE 2400 AUSTIN, TX 78701 Copy with citationCopy as parenthetical citation